Joining device with positioning system

Abstract

An implantable prosthesis and delivery system for treating tricuspid regurgitation (TVR). The system is configured for preloading into a transdermal delivery system. The system includes a self-expanding anchor bracket having an attached and positionable engagement member. The stent is implanted in the inferior vena cava adjacent the right atrium and is connected to the engagement member with a steering tube and multi-directional coupler and gimbal assembly. The engagement member is fabricated from a porous or semi-porous material formed on a wire frame and is configured to possibly have a leaflet matching curvature prior to implantation. When deployed, the engagement member is self-aligned, self-swelled, and shaped over several cardiac cycles to conform to a patient's TV defect and provide an engagement surface for the native valve leaflet to mitigate TVR.

Description

Background Art Technical Field

[0001] The present invention most generally relates to medical procedures and devices for repairing damaged or diseased valves, and more specifically, to a tricuspid valve prosthesis having a delivery system that enables precise positioning and placement during implantation and deployment to effectively provide an efficient engagement surface when treating tricuspid regurgitation (TR) in a variety of patient anatomies.

[0002] Background Discussion

[0003] The tricuspid valve (TV) comprises a variety of native tissue leaflet arrangements and corresponding circumferential tissue rings (annuli) within the right heart structure. The inferior vena cava (IVC) returns deoxygenated blood to the right atrium (RA) for subsequent reoxygenation through the TV into the right ventricle (RV) and ultimately into the lungs. In TVR, the tricuspid valve between the right atrium and the right ventricle fails to close properly after blood is pumped from the right atrium into the right ventricle. Improper coaptation between the native leaflets (anterior, posterior, and septal) can be caused by several reasons including enlargement of the TV annulus, damage to the chordae tendineae, and damage to the papillary muscles. Due to improper coaptation, blood flows back from the right ventricle into the right atrium at high ventricular systolic pressures during ventricular contraction.

[0004] Designing a medical device that effectively reduces TR in patients is a challenging problem. When pharmacological interventions such as diuretics or vasodilators are ineffective, there are currently two main solutions: (1) mechanical solutions to reshape and size the TV annulus to force the leaflets closer together for coaptation, which increases the risk of fragile tissue; (2) insertion of a "gap-closing" device to prevent or reduce TR in the TV by coapting with the native leaflets.

[0005] The design proposed in this application is directed to the latter type of solution, wherein a new and improved prosthesis (i.e., the coaptation device) is securely anchored in the 1VC and easily positioned within the TV leaflets using a novel delivery system that enables multi-directional positioning and placement of the coaptation device in an optimal position within the TV. The delivery system of the present invention and the coaptation prosthesis it delivers are unique in their freedom to move in multiple axes to allow unimpeded contact with the native leaflets and thereby avoid the creation of a new TR. Summary of the invention

[0006] In its most basic aspects, the present invention is an implantable prosthesis and delivery system for treating TVR. A prosthesis configured for preloading into a percutaneous, coaxial, trans-wire delivery system. It includes a self-expanding anchoring stent having an attached and positionable engagement member, referred to herein as a coaptationsail.

[0007] The stent is implanted in the inferior vena cava at a position adjacent to the right atrium and connected to the coaptation sail with a steering tube. The coaptation sail is made of porous or semi-porous materials and is constructed to closely match the patient's anatomical structure and the morphological type of TVR to be treated (e.g., leaflet damage, annular dilatation or right heart remodeling pattern) before implantation and deployment. When deployed, the coaptation sail conforms to the patient's valve defect in the following ways within several cardiac cycles: self-alignment in the TV, absorption of blood, isolation of the absorbed blood from turbulent blood flow, allowing a certain volume of such absorbed blood to coagulate and mechanically deform when in contact with the leaflets, thereby ultimately presenting a size and shape that fills the treated coaptation gap and provides a coaptation surface for the native TV leaflets.

[0008] The main component of the prosthetic system is the engagement sail. In an embodiment, it can be made of medical grade surgical fabric sutured on a wire frame that is permanently attached to the steering tube. The fabric-covered sail frame extends into the tricuspid valve (TV) to provide an engagement structure for the native TV leaflets. Materials other than surgical fabrics can also be used, including several porous, semi-porous and even non-porous materials, such as woven fabrics or polymer barriers. Several types of open-cell medical grade foams can also be used, including polyurethane foam (PU), reticulated polyurethane, polytetrafluoroethylene (PTFE), etc.

[0009] In an embodiment, a coupler permanently connects the engagement member (engagement sail) to the steering tube and allows the sail to perform multi-axial rotational movement to achieve self-alignment with the native leaflet coaptation line and commissure. The steering tube itself is an adjustable member that responds to tensioning input (i.e., tightening of the internal structure) that rotates the engagement sail toward the TV to help position the engagement sail within the native TV valve annulus. The steering tube is connected to the delivery system handle to achieve engagement sail positioning.

[0010] The anchor securely locks the adjusted steering tube position during the implantation procedure; and it can also be disconnected to enable delivery system removal. The stent is positioned in the IVC near the junction of the right atrium (RA) and IVC and provides an anchor for the coaptation prosthesis.

[0011] Deliberate control input during the implantation procedure is performed through the delivery system handle, which provides multiple functions during the preparation and implantation of the prosthesis of the present invention. If necessary, the control system handle can achieve finely controlled implantation and complete retrieval of the prosthesis.

[0012] A flush port on the handle allows for easy flushing of the system with heparinized saline to remove any air from the inner catheter and prosthesis.

[0013] The sheath dial on the control handle is rotated to retract the outer sheath and slowly expose the prosthesis and stent.

[0014] A heparinized saline drip line through the control system handle promotes non-coagulation of the adjustment mechanism during prosthesis delivery, and a stent release button prevents accidental release of the prosthesis by preventing full retraction of the outer sheath until the button is pushed.

[0015] A tension knob at the proximal end of the handle adjusts the amount of tension applied to the prosthesis when rotated, and a release button disconnects the delivery system from the prosthesis. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 is a perspective view of a tricuspid valve prosthesis and steering system subassembly of the present invention;

[0017] Figure 2 is a front view of an elevation of a control handle of a prosthesis delivery system;

[0018] Figures 3A-3C is a perspective view of the distal end of the steering tube, gimbal, and coupler assembly including the nitinol wire engaging the sail, wherein Figure 3A is the upper front view, Figure 3B is its exploded view, and Figure 3C is a side view showing the components assembled and operatively connected;

[0019] Figures 4A-4C is a perspective view showing several orientations of a steering system at various amounts of bend and rotation, thereby highlighting the degrees of freedom and range of motion of the steering system for positioning and placing an engagement sail in a TV;

[0020] Figure 5 is a detailed view of a stent and steering system subassembly of a delivery system and an engaged prosthetic device of the present invention, featuring here the connection between the stent and steering tube subassembly;

[0021] Figure 6 is an upper perspective view showing a tension rod subassembly coupled to a steering system subassembly;

[0022] Figures 7A-7C yes Figure 6 A perspective view of a tension rod assembly shown in ; Fig. 7A is the assembly view, Figure 7B is an exploded view, and Figure 7C is a cross-sectional view of the tension rod assembly;

[0023] Figure 8 yes Figures 7A-7C Detailed exploded view of selected components of the tension rod subassembly shown in .

[0024] Fig. 9 is along Figure 5 A detailed cross-sectional view of the steering system and tension rod subassembly taken along section line 9-9;

[0025] Fig.10 is a detailed view of the attachment structure used to connect the steering tube to the bracket;

[0026] Fig.11 yes Fig. 9 A more detailed view of the steering tube and tensioner rod subassembly shown in;

[0027] Figures 12A-12C is a perspective view showing details of an alternative tension member locking mechanism, wherein Fig. 12A is an exploded view, Fig. 12B It is shown Fig. 12A A detailed view of the details of window 12B, and Fig. 12C Details are shown in which a detailed view is incorporated showing an alternative tension member locking mechanism

[0028] Figures 13A-13C is a perspective view of the distal end of the delivery system control handle, Fig.13A is the assembly view, Fig. 13B is a cross-sectional view, and Fig. 13C is an assembled view showing the tension knob extended; and

[0029] Fig.14 is a highly schematic cross-sectional view of an aligned engagement sail in the TV and an anchor bracket in the IVC (the two components being connected by a steering tube), all in accordance with an embodiment of the present invention.

[0030] Best Mode for Carrying Out the Invention

[0031] First reference Figure 1 The inventive anastomosis device delivery system 10 of the present invention as described herein is best understood in conjunction with the prosthesis it is configured to deliver. Therefore, the description herein first includes a description of the TV prosthesis 100 (referred to herein as an anastomosis sail) positioned and placed by the delivery system. Figure 1 Shown, in an embodiment, the coaptation sail 100 comprises an inner 3D-shaped nitinol wire 102, which is at least partially enclosed and covered in various porous and non-porous materials 104. It includes a proximal medial section 106 between the nitinol wires. The coaptation sail 100 extends slightly centrally into the TV to provide a coaptation surface for the native TV leaflets.

[0032] At the proximal medial section of the engagement sail, the 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 relative to the coupler 204 within the TV annulus. The coupler 204 includes a proximal portion 204a and a distal portion 204b that capture the gimbal in a manner such that the gimbal includes degrees of freedom via rotational and swivel motion relative to the coupler. The coupler is connected to the distal end 300a of the steering tube by a pin 300b. And the nitinol wire frame 102 of the engagement sail 100 is connected to the distal end of the gimbal to the gimbal shaft 202a by a coupling clamp 202b.

[0033] The steering tube 300 and associated tensioner rod subassembly 500 are attached to the stent 400 and the delivery system handle to provide multi-axially adjustable positioning of the engagement sail 100. After tensioning and / or rotation of the steering tube subassembly within the stent 400, the engagement sail is positioned and aligned with the TV annulus, thereby engaging the native TV leaflets to treat a wide variety of anatomies. The IVC stent 400 is constructed of Nitinol and is positioned in the IVC near the junction of the right atrium (RA) and the IVC, and it provides anchoring of the tricuspid valve prosthesis in the IVC. Note that the anti-thrombotic covering on the steering tube 300 is not shown.

[0034] Figure 2 The main components of the delivery system are illustrated in Figures 4-13. In view of the further disclosure (see below and Figures 13A-13C Related description), and now refer to Figure 2 and Figures 13A-13C , the system includes a prosthesis delivery system handle 600 at its proximal end, which provides multiple functions during the preparation and implantation of the tricuspid valve prosthesis and provides a controlled implantation that allows retrieval (if necessary). The control handle includes a tension knob 602, a release knob 604, and a guide wire lumen and a Luer lock 606. A flush port 608 allows the system to be flushed with heparinized saline to remove all air in the inner catheter and the prosthesis. A sheath dial 610 is operatively connected to the delivery sheath and retracts the outer sheath after rotation to slowly expose the joint prosthesis. A heparinized saline drip line 612 promotes non-coagulation of the adjustment mechanism during prosthesis delivery. A stent release button 614 prevents accidental release of the prosthesis by preventing the outer sheath from fully retracting until it is pushed. The tension dial knob 602 adjusts the amount of tension applied to the prosthesis after rotation, and the release knob button 604 disconnects the delivery system from the prosthesis.

[0035] The TR patient population includes many anatomical variations beyond the basic dimensions (such as IVC diameter and TV annulus size). The orientation of the IVC ostium (IVC ostium plane) and the distance to the TV annulus, as well as the orientation of the TV annulus (TV annulus plane), present additional challenges to positioning the coaptation velum. However, the orientation and position of the coaptation velum in the 3D volume of the RA and TV annuli are critical to successfully mitigating TR. Therefore, additional prosthesis and delivery system capabilities are needed to ensure that the coaptation prosthesis and delivery system of the present invention can treat a wide variety of TR patient population anatomies.

[0036] The following novel systems provide desired capabilities, having features and functions that enable the present coaptation prosthesis and delivery system to treat a wider variety of TR patient anatomies. Each of these capabilities provides advantages individually or in combination. It is noteworthy that several novel aspects of the coaptation sail 100 and gimbal 202 and coupler 204 have been disclosed in a co-pending international patent application, which is filed concurrently with the present invention by the same inventor as the present invention, and is entitled "Coaptation Device", the entire contents of which are incorporated herein by reference.

[0037] The prosthesis and delivery system elements included in the present disclosure include the following as major components: (1) a novel gimbal design made of medically suitable materials such as polyetheretherketone (PEEK), stainless steel, titanium, etc.; (2) a steering tube (having multi-axis adjustability and made of materials such as nitinol, PEEK, etc.); (3) a bracket design for steering tube attachment, also made of the same materials; and (4) a tension rod assembly made of PEEK, stainless steel, titanium, polyimide, etc.

[0038] Gimbal 202 connects coupler 204 to coaptation sail 100 and enables multi-axial movement of the coaptation sail relative to the coupler. The ability of the coaptation sail to self-orient within the TV annulus ensures that it does not impinge upon the native leaflets, thereby causing more TR, but rather self-aligns with the coaptation commissures to increase coaptation of the native leaflets. Figures 3A-3C Several views of the gimbal and coupler assembly are shown to illustrate the design elements. The porous and non-porous covering materials including the intermediate sections between the Nitinol wires or the porous and non-porous covering between the outer layer and the Nitinol wires are not shown.

[0039] Figures 3A-3C is a perspective view showing steering tube 300 attached to gimbal 202 and coupler 204 (including nitinol wire 102). Figure 3BThe exploded view of illustrates the different components of the assembly, including the gimbal 202 and the coupler 204. Note the angular protrusion 301 on the distal end 301b of the nitinol steering tube 300. During sheathing of the prosthesis (engagement sail), the protrusion 301 is generally aligned with the axis of the steering tube; and after sheathing, the protrusion bends inward to the position shown. This is due to the elastic properties of the protrusion material.

[0040] Figure 3C The cross-sectional view of illustrates the coupler 204 attached to the steering tube 300 via the pin 300a. Note that the gimbal is contained within, captured by, and extends through the proximal and distal portions 204a, 204b of the coupler, respectively.

[0041] The purpose of the steering tube 300 is to position the coaptation sail 100 relative to the TV annulus. The multi-axis adjustability of this design, bending in several planes, and rotation relative to the support, together allow the position of the coaptation sail to be finely tuned to the patient's anatomy.

[0042] Figures 4A-4C The schematic in depicts several orientations of a steering system at various amounts of flex and rotation. Note that the steering tube flexes due to rotating the threaded insert (which interacts with the tension rod subassembly) to increase the tension in the tensioning member, effectively shortening either side of the steering tube (where material is removed) to create the flex. The steering tube material is typically Nitinol, but other materials (PEEK, stainless steel, etc.) are also suitable.

[0043] A configuration of a steering system subassembly in assembled form Figure 5 Shown in. Fig. 9 and Fig.11 The diagram in Figure 5 A cross-sectional view of a steering configuration and further includes details of a tensioning rod subassembly coupled to the steering rod subassembly.

[0044] Figure 6 is an upper perspective view showing the components including the steering system and tension rod subassembly, and also illustrating here how the tensioning member 501 (i.e., suture) is wrapped around the suture pin 502 (i.e., anchor pin). Note that as the threaded member 504 rotates to generate tension, it applies almost no torque to the tensioning member 501, and the axial load on the threaded member effectively locks it in place because there is no counter torque to unthread.

[0045] Figure 5 to Figure 12 and their respective functions is the steering tube 300, as described above. It will be appreciated that, depending on the original cut pattern (and the additional cross-through pins), bending can occur in several different directions. The serrated collar 302 is attached to the steering tube 300 using a cross-through pin 303 which provides serrations at the inboard / proximal end and thereby locks the steering tube rotation angle to a serrated bracket collar 304 which has serrations that intersect and mate with the serrations of the serrated collar. This provides bending direction via the routing of the tension members below the cross-through pins (see in particular FIG. 2 ). Fig. 9 ). The serrated bracket collar 304 attaches the steering tube 300 to the bracket 400 while allowing the steering tube to rotate relative to the bracket.

[0046] The compression spring 306 provides a spring force to engage the serrations of the serrated collar 302 with the serrated distal (first) bracket collar 304 while allowing manual rotation of the steering tube relative to the bracket. In an embodiment, the compression spring 306 may be located inside the steering tube (not shown) to provide a locking spring force.

[0047] Although the use of a serrated collar is shown, alternative embodiments include a tapered collet (which provides greater angular rotation resolution), or a cross pin and grooved collar configuration, etc. Alternative embodiments (also not shown here) may enable compression of the spring, rotation of the steering tube, and locking of the rotation angle via delivery system handle control.

[0048] An annular collar 308 is also attached to the steering tube using a cross pin 305 and counteracts the spring force of the compression spring 306. A proximal (second) stent collar 310 is attached to the steering tube and allows rotation and translation of the steering tube relative to the stent.

[0049] The tensioner rod subassembly 500 provides a secure connection between the prosthesis and the delivery system handle to deliver rotational (torque) forces to the steering tube through the tension rod and thereby adjust tension for steering tube flexion.

[0050] Figures 7A-7C The tension rod subassembly illustrated in FIG. 1 is shown in three views: an isometric assembly view, an exploded perspective view, and a cross-sectional perspective view. The various components and corresponding functions shown include a suture pin 502 ( 502 ) attached to a threaded tensioner 504 and connected to a tensioning member 501. Figure 7B). The threaded tensioner 504 component adjusts the tension in the tensioning member when it is threaded into or out of the threaded insert 312 to provide a bend to the steering tube 300. The balled wire 506 is combined with the threaded tensioner 504 using a balled expansion portion 506a located at the distal end of the balled wire, which is captured in and between the formed recesses 504a and 510a of the proximal end of the threaded tensioner and the distal end 510a of the tension interlock device 510 surrounded by the tension collar 508 to provide a lock in place to provide a twistable assembly while allowing an interface for disconnection when the tension interlock device 510 is translated away from the threaded tensioner 504. The balled wire is connected at its proximal end to a release button 604 in the delivery system (see Figure 2 and 13A -13C). A tensioner collar 508 is attached 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 attached to the tension tube 514 and the torsion tube 514.

[0051] A radiopaque strip 512 is attached over the tension tube 514 and provides a fluoroscopic imaging aid in evaluating the relative position of the threaded tensioner 504 within the threaded insert 312. The tension tube 514 is attached to the tension interlock 510 and connected to the tension knob 602 in the delivery system.

[0052] Fig.10 504. The various components of the interlock assembly are shown side by side in FIG. Although the illustration shows the components arranged separately, the final assembly is essentially coaxial. Here, the tension interlock 510 has also been rotated 180 degrees to illustrate the end features that capture the balled end 506a of the balled wire 506. As noted, the expanded spherical end of the balled wire 506 fits into the pocket at the end of the threaded tensioner 504, and the balled wire is completely captured when the tension interlock 510 is positioned over the rounded end and the tensioner collar 508 is positioned over all components at the interface. The threaded tensioner 504 and the tension interlock 510 both have "D" shaped ends that are contained within the tensioner collar 508 when together. This interlock assembly provides a locked in place assembly to provide a torqueable assembly while allowing the interface to be disconnected when the tension interlock 510 is translated away from the threaded tensioner 504.

[0053] Although this configuration describes a "ballooned wire captured in a pocket," this is not limiting: alternatives include L-shaped wire ends that fit into L-shaped pockets on either side of the D-shaped end or slots in the end with holes for the L-shaped wire ends. Each alternative requires a tensioner collar to constrain the joint until disconnection is desired.

[0054] Cross-sectional view of the steering system and tension rod assembly in Fig. 9 and Fig.11 516 . Note that in this configuration, the tensioning member (i.e., sutures, etc.) is routed from the distal end 516, under the medial point 518, to the proximal return 520, and back to 516 along the same route. Typical assembly methods require routing the tensioning member within a protective lubricating tube (i.e., FEP, PTFE, etc.) that is wrapped around the pin 520 and tied at 516 while passing under the cross pin 518. The protective lubricating 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 setting. Additional cross pins can be distributed throughout the length of the steering tube to create additional pivot points that provide multi-directional steering tube bending when combined with various laser cutting patterns.

[0055] The path of the tensioning members over / under or from side to side of each cross pin can be varied depending on the desired bend. Additional guides can be placed on the cross pins that control the path of the tensioning members. Additional tensioning members can be connected to these cross pins to apply various amounts of force to different sections of the steering tube by using coaxial or non-coaxial threaded inserts and tensioning rod configurations (not shown).

[0056] The attachment of the threaded insert to the steerer tube provides a fastening without snap fits or adhesives, wherein the steerer tube has a "T" shaped feature that interlocks with the threaded insert.

[0057] As in Figure 9-10 As can be seen in FIG. 4 , the bracket 400 is configured for attachment to a steering tube. The serrated bracket collar 304 and the bracket collar 310 each include two alignment holes 402, 404 that pass through the collar into the bracket (see FIG. 4 ). Fig.10 ) to attach the steerer tube to the bracket. The bracket post gap between the holes enables the integrated bracket collar to be securely captured on the bracket post.

[0058] Fig.11 A single coaxial tension rod subassembly is shown. It can be assumed so far that the purpose of the tension rod subassembly is to adjust the bend of the steering tube and, once positioned, to fix the amount of tension and then be disconnected from the prosthesis after the implantation procedure is completed. Figure 7A-9, 11-12 each of the tension rod subassembly is shown in detail. The connection between the steering system subassembly and the tension rod subassembly is achieved by a threaded insert 312 that is attached to the steering tube and is threaded to threadably connect with the threaded tensioner 504.

[0059] Figures 13A-13C The proximal end of the delivery system as it relates to the tension rod subassembly is shown. Note the delivery system handle 600, tension knob 602, release knob 604, and guide wire lumen and Luer lock 606. Cross-sectional view ( Fig. 13B ) illustrates how each component is structurally and operationally related, and how the compression spring within the tension knob 602 applies a spring force to keep the interlock assembly connected. For safety, a side set screw 605 is also included to ensure that the two components remain connected. When ready to disconnect, the side set screw is loosened, allowing the tension knob 602 to retract and disconnect from the prosthesis.

[0060] Expanded View( Fig. 13C ) illustrates a white ring visual indicator 607 that provides a reference point for applied tension. Additional delivery system handle configurations (not shown) include multiple dials for rotating and / or bending the steering tube, levers for locking or unlocking the engagement device position, and other control and actuation mechanisms for multi-directional movement of the engagement device to ensure very precise positioning and placement in the TV. The implantation procedure using the engagement device and its delivery system is similar to other transcatheter procedures using fluoroscopic and echographic visualization, and includes the following steps:

[0061] First, enter the femoral vein and perform dissection and TVR assessment. Next, prepare to engage the prosthesis and sheath it, and verify system readiness. Insert the cardiac guide wire through the distal tip (i.e., nose cone) of the control handle and pass it to the outlet at the proximal Luer lock near the release knob. Afterwards, the heparinized saline pressure bag is connected to the side stopcock of the delivery system handle, and the bag pressure is set accordingly to ensure that there is a slight flow through the sheath tip. The prosthesis is loaded in a percutaneous delivery system (a 0.035 inch 0.89 mm nitrex / nitinol / stainless steel guide wire compatible system in the embodiment).

[0062] The physician / operator will next use image guidance to advance the engagement prosthesis and its control mechanism over the guide wire through the access site into the right atrium. The physician / operator will then use fluoroscopy to visualize the radiopaque nose cone and outer sheath tip markers.

[0063] To deploy the coaptation prosthesis, the delivery handle is pinned to the surface and the sheath dial is rotated (CW) so that the tip of the outer sheath is retracted and the sail is gradually exposed into the right atrium, during which the outer sheath slides through the introducer sheath. When the coaptation sail and steering tube are completely unsheathed, the sheath dial rotation is stopped. At this point, the position of the coaptation sail relative to the TV annulus and its interaction with the native leaflets are assessed.

[0064] For optimal results, the sail can be repositioned as needed by: (1) advancing, retracting, or rotating the entire prosthesis system; (2) further rotating the sheath dial (CW) to expose more of the prosthesis; or (3) rotating the tension knob (CCW) to flex the distal portion of the stent, taking care to ensure that this action is performed only when the stent is exposed.

[0065] Ultrasound imaging (ICE, TTE) can then be used to assess regurgitation and changes in valvular function.

[0066] Prosthesis Deployment: To deploy the prosthesis, the physician / operator needs to carefully rotate the sheath dial 610 (CW) until it stops to expose the stent while maintaining the position of the stent distal edge in the IVC. Note that the stent remains constrained within the sheath at its proximal end and that the stent is apposed in the IVC during expansion.

[0067] The operator uses the hex wrench provided in the sterile preparation materials to carefully loosen the set screw 605 connecting the tension knob 602 to the release button 604. To disconnect the delivery system from the stent, the operator provides a slight push / pull motion with the tension knob and release button - the tension knob provides the pulling force and the release button provides the pushing force. Carefully observe the results and verify disconnection by carefully pulling the tension knob with the release button away from the handle 600.

[0068] To fully release the stent in the IVC, push and hold the release button on the delivery system handle, then rotate the sheath dial (CW) until the stent is fully expanded in the IVC.

[0069] Note that in this case the order of some steps may be reversed if appropriate.

[0070] Next, the operator must verify that the delivery system is completely detached from the prosthesis by gently advancing / retracting the delivery system.

[0071] Then rotate (CCW) the guard dial to advance the guard into the nose cone.

[0072] Finally, the guide wire is removed prior to stent deployment and is removed from the now implanted and positioned prosthetic system.

[0073] Fig.14 is a highly schematic cross-sectional view of an engagement sail 108 aligned and deployed in the TV and an anchor bracket 400 in the IVC (the two components being connected by a steering tube 300), all in accordance with an embodiment of the present invention.

[0074] The foregoing description is directed to the preferred embodiments of the present invention, including the best mode of implementing the present invention currently envisioned by the inventor. However, these do not exhaust or even begin to exhaust possible alternative embodiments, whether these embodiments are found in substantially equivalent alternative structures or substantially equivalent alternative operations, or both. On the contrary, these embodiments are described and presented for illustrative purposes, but it should be understood by those skilled in the art that this is not intended to limit the present invention to the precise architecture (construction), dimensional relationships and operations shown and described. Those skilled in the art will easily think of various modifications, alternative architectures, changes and equivalents, and can be appropriately adopted without departing from the true spirit and scope of the present invention. Such changes may involve alternative materials, parts, structural arrangements, sizes, shapes, forms, functions, operating characteristics, alternative sequences of method steps, etc. Therefore, the above description and explanation should not be interpreted as limiting the scope of the present invention, and the scope of the present invention is limited by the appended claims.

Claims

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

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

3. The system of claim 2, wherein the coupler / gimbal assembly includes a coupler having a proximal portion pivotally connected to the distal end of the steering tube, a distal portion pivotally connected to the proximal portion, the distal portion having a cylindrical through-channel; a gimbal having a head captured between the proximal and distal portions of the coupler and a cylindrical shaft inserted through the through-channel, the gimbal shaft having a distal end constructed to be attached to the engaging 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.

5. A system as described in claim 4, wherein the coupler / gimbal assembly is constructed to provide multi-axial rotation of the engagement member relative to the coupler within the TV annulus.

6. The system of claim 1, wherein the steering tube remains in place after the engagement member is deployed, thereby connecting the bracket and the swivel device.

7. The system of claim 6, wherein the stent is connected to the steering tube with at least two stent collars, the stent collars locking the steering tube in rotation but selectively allowing the operator to manually rotate the steering tube during an implantation procedure.

8. The system of claim 1, wherein the steering tube is operatively connected to the control handle.

9. The system of claim 8, wherein the steering tube and the control handle are cooperatively configured such that control inputs by the operator through the control handle can bend and rotate the steering tube after the stent is anchored in the IVC.

10. The system of claim 9, wherein the bend in the steering tube is controlled by an original cut pattern during manufacture and one or more cross pins placed in the steering tube.

11. The system of claim 10, wherein the steering tube includes a plurality of transverse pins around which tensioning members are routed and operatively connected to the control handle, whereby input to the tensioning members by the control handle induces bending of the steering tube.

12. The system of claim 11, comprising: a first traversing pin located in a proximal portion of the steering tube; a second traversing pin located distally relative to the first traversing pin; and an eyelet in the distal end of the steering tube, wherein the tensioning member is connected internally at the eyelet, and wherein an input pulling the tensioning member causes the steering tube to bend.

13. The system of claim 12, further comprising: a steering subassembly slidably disposed in the proximal end of the steering tube and threadably connected to a tension rod subassembly sandwiched between the steering tube and the control handle, the tension rod subassembly including a tension tube connected to the control handle; The first cross pin is disposed within the steering tube subassembly, whereby an operator's input of pulling the tension tube transmits a pulling force to the steering tube subassembly and thereby causes the steering tube to bend.

14. The system of claim 1, further comprising an angular protrusion made of a shape memory alloy and disposed on the distal end of the steering tube, wherein During sheathing of the engagement member and the coupler / gimbal assembly, the angular projections are generally aligned with the axis of the steering tube and, therefore, unsheathing the coupler / gimbal assembly allows the angular projections to flex inwardly due to the elastic properties of the angular projection material.

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