Bonding device

Abstract

An implantable prosthesis and delivery system for treating tricuspid regurgitation. The system is configured for preloading into a percutaneous delivery system and includes a self-expanding anchoring stent having an attached and positionable engagement member. The stent is implanted in the inferior vena cava adjacent the right atrium and connected to the engagement member via a 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 tricuspid valve defect of a patient and provide an engagement surface for the native valve leaflet to mitigate TVR.

Description

Background Art Technical Field

[0001] The present invention relates most generally to medical devices and, more particularly, to a tricuspid valve prosthesis providing an efficient articulation surface for treating tricuspid regurgitation (TR) in a variety of patient anatomies.

[0002] Background Discussion

[0003] This description and accompanying figures describe a novel tricuspid valve prosthesis that emphasizes novel features related to its ability to provide an efficient articulating surface in treating tricuspid regurgitation (TR) in a variety of patient anatomies.

[0004] 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.

[0005] 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.

[0006] The design proposed in this application is directed to the latter type of solution, wherein a new and improved coaptation device is securely anchored in the IVC and easily positioned within the TV leaflets. The coaptation device of the present invention is unique in its freedom to move in multiple axes to allow unhindered contact with the native leaflets and thereby avoid creating new TRs. The novel 3D shape of the coaptation member precisely meets the "need" to mitigate TRs. Summary of the invention

[0007] The tricuspid valve prosthesis of the present invention, in its most essential aspects, comprises an IVC stent made of nickel titanium (Nitinol) and constructed for positioning in the IVC at a location near the junction of the right atrium (RA) and the IVC. The stent thereby provides anchoring for the tricuspid valve prosthesis within the IVC itself. A coupler connects the IVC stent to a gimbal, which in turn connects the coupler to an engagement member (hereinafter referred to as the "engagement sail") and provides multi-axial rotation of the engagement sail relative to the coupler within the TV annulus. The engagement sail comprises a 3D-shaped Nitinol wire frame that is covered or enclosed by, or covered or enclosed in, various porous and non-porous fabric materials. Sutures attach the engagement sail to the gimbal, and in an embodiment, the Nitinol wire frame is also captured within the gimbal structure. When deployed, the fabric-covered engagement sail portion extends centrally into the TV to provide an engagement surface for the native TV leaflet.

[0008] Delivery, implantation, and deployment of the fascia are accomplished using the delivery system described in co-pending international patent application serial number PCT / US23 / 69296 (filing date June 28, 2023), which is incorporated herein by reference in its entirety.

[0009] The TR patient population includes many anatomical variations that deviate from 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 and the orientation of the TV annulus (TV annulus plane) present additional challenges for 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, several prosthetic capabilities are needed and provided to enable the coaptation system of the present invention to treat a wide variety of TR patient population anatomies. Therefore, variations may be included in the embodiments of the present invention without departing from the spirit and scope of the inventive concept. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] When considering the following detailed description of the invention, the present invention will be better understood and various objects and advantages of the present invention in addition to those set forth above will become apparent. This description refers to the accompanying drawings, in which:

[0011] Figure 1 is an isometric side view of a tricuspid valve prosthesis without showing the tensioner and anchoring components;

[0012] Figure 2A is a perspective view showing a gimbal and coupler assembly used in the present invention;

[0013] Figure 2B is a top view of the gimbal and coupler assembly;

[0014] Figure 2C is the vertical surface of the gimbal and coupler assembly Figure 2A-2B A cross-sectional side view taken along section line 2C-2C;

[0015] Figure 2D is a highly schematic view of a gimbal configuration featuring a degree of rotation, pivoting and swivel relative to the coupler;

[0016] Figures 3A-3D is a highly schematic illustration of a method for enabling an engagement sail to be sheathed in a delivery system sheath while being able to self-orient into position after removal of the sheath, wherein Figure 3A The engagement device assembly is shown ready for sheathing in a delivery sheath; Figure 3B showing the angular configuration of the distal portion of the coupler and the gimbal relative to the proximal portion of the coupler after the sheath is removed; Figure 3C (a) again schematically shows the alignment with the sheath; and Figure 3C (b) shows the angular alignment after the sheath is removed;

[0017] Figure 4A is a cross-sectional side view showing an elevation of the gimbal and coupler assembly housed in a delivery system sheath;

[0018] Figure 4B is an isometric view of the gimbal and coupler assembly with the jacket removed prior to pivoting the gimbal relative to the coupler;

[0019] Figure 4C is a cross-sectional side view showing the gimbal and coupler unjacketed and in an angular configuration;

[0020] Figures 5A-5C is a schematic cross-sectional side view of a TV leaflet illustrating possible coaptation configurations or scenarios, wherein Figure 5A The valve leaflets are fully coapted with no coaptation gap. Figure 5B Shows the width of the coaptation gap in the TV leaflets, Figure 5C Shows narrow joint space;

[0021] Figures 6A-6C is a schematic side view in elevation illustrating how the coaptation velum changes shape over several cardiac cycles to produce a coaptation surface that abuts against the native leaflet during the cardiac cycle, wherein Fig. 6A The shape of the engaged sail when first deployed is shown, Figure 6B shows the shape of blood during its filling and early stages of coagulation, and Figure 6C The shape of the final sail of the joint is shown when it is configured in vivo to effectively fill the joint gap and prevent TR;

[0022] Figures 7A-7Fis a highly schematic view illustrating various engagement sail configurations that enable the sail to be sheathed in a delivery system sheath, but to self-orient and self-align into position after removal of the sheath, wherein Fig. 7A and 7B are front and end views showing the wedge-engaged sail; Figure 7C is a top view showing a pre-bent configuration; Fig.7D is a top view showing a lanceolate shape; Fig. 7E 7F is a front view showing a heart shape with a lower fork; and 7F is a front view of a heart-shaped engaged sail;

[0023] Figures 8A-8C [Previous 6B] is a highly schematic view showing a further commissure configuration suitable for use with a curved commissure, wherein Fig. 8A is an end view showing a curved joint sail configured for use with a curved joint commissure; Figure 8B is a front view showing a bifurcated or pleated engagement sail, which is also suitable for improving engagement around bends, and Figure 8C is a top view of the jointed sail;

[0024] Fig. 9 1 is a schematic diagram showing the degrees of freedom and axes along which the coaptation sail is translated and rotated respectively so that the operator (doctor) can perform precise positioning of the coaptation sail within the TV valve annulus;

[0025] Fig.10 is a perspective view of an alternative embodiment of a tricuspid valve prosthesis, where it can be seen that the steering rod and tension rod subassemblies are connected for precisely controlling the placement, positioning, implantation and deployment of the engagement device of the present invention;

[0026] Figures 11A-11C is a perspective view of selected components of the steering subassembly shown with an engagement device, showing the distal end of the steering tube, gimbal, and coupler assembly (including the nitinol wire engaging the sail), wherein Fig.11A is the upper front view, Fig. 11B is its exploded view, and Fig. 11C is a side view showing the components assembled and operatively connected;

[0027] Figures 12A-12C is a perspective view showing several orientations of a steering system at various amounts of bending and rotation, thereby highlighting the degrees of freedom and range of motion of the steering system for positioning and placing the engagement sail in the TV, wherein Fig. 12A Showing the steerer tube bending away from the side of the IVC bracket it is attached to, Fig. 12B shows that it is bent towards the attachment side, and Fig. 12C shows the steering tube flexing more dramatically under operator control;

[0028] Fig.13 is a detailed view of the proximal portion of the stent and steering system subassembly and engagement sail of the delivery system of the present invention, featuring the connection between the stent and steering tube subassembly and the coupling of the distal end of the steering tube to the coupler / gimbal assembly and ultimately to the engagement sail;

[0029] Fig.14 is an upper perspective view showing components comprising a steering system and a tension rod subassembly;

[0030] Figures 15A-15C yes Fig.14 , Figure 15 and Fig.17 A perspective view of the tension rod assembly shown in FIG. Fig.18 a is the assembly view, Fig.18 B is an exploded view, and Fig.18 C is a cross-sectional view of the tension rod assembly;

[0031] Fig.16 yes Figures 15A-15C Detailed exploded view of selected components of the tension rod subassembly shown in;

[0032] FIG15 is an upper perspective view showing the tension rod subassembly coupled to the steering system subassembly, which in turn is connected to the bracket;

[0033] Fig.16 is a detailed view of the attachment structure used to connect the steering tube to the bracket;

[0034] Fig.17 is along Fig.13 A detailed cross-sectional view of the steering system and tension rod subassembly taken along section line 17-17;

[0035] Fig.18 is a detailed perspective view of the attachment structure for connecting the steering tube to the bracket;

[0036] Fig.19 yes Fig.17 A more detailed view of the steering tube and tensioner rod subassembly shown in;

[0037] Figure 20A-20 C is a perspective view showing details of an alternative tension member locking mechanism, wherein Fig. 20A is an exploded view, Fig. 20B It is shown Fig. 20A A detailed view of the details of window 20B, and Fig. 20 C shows a detail incorporating a detailed view showing an alternative tension member locking mechanism;

[0038] Fig.21is a front view in elevation of a control handle of a prosthesis delivery system; and

[0039] Figures 22A-22C is a perspective view of the proximal end of the delivery system control handle, Fig.22A is the assembly view, Fig. 22B is a cross-sectional view, and Fig. 22C is an assembled view showing the tension knob extended.

[0040] Best Mode for Carrying Out the Invention

[0041] The following structures, features and functions enable the tricuspid valve prosthesis of the present invention and its delivery system to treat a larger and diverse TR patient anatomical structure. Each provides advantages alone or in combination. The new prosthetic elements include a self-aligning gimbal, a self-filling 3D engagement sail, a coupler, a pre-bent prosthetic configuration (which does not use a tensioning system) and an automatic rotation mechanism for the engagement sail.

[0042] First reference Figure 1 , a perspective view of the tricuspid valve prosthesis 100 of the present invention is shown. This view does not feature the assumed tensioner or anchoring components. A Nitinol IVC stent 102 is positioned in the IVC near the junction of the right atrium (RA) and the IVC. The stent provides anchoring for the tricuspid valve prosthesis when deployed and is implemented in the IVC itself. A coupler 104 includes a proximal portion 104a tethered to the IVC stent 102 via a Nitinol or other medical grade wire 103, a distal portion 104b connected to a gimbal 106. The gimbal is then connected to an engagement sail 108.

[0043] The coupler / gimbal assembly provides multi-axial rotation of the coaptation sail relative to the coupler within the TV valve annulus. The coaptation sail itself includes an internal 3D-shaped nitinol wire frame 110a, 110b covered with a porous or semi-porous material (such as a braid 112). The material can be selected from any of a number of porous, semi-porous and even non-porous materials, such as woven fabrics, polymer barriers, polyurethane foam (PU), reticulated polyurethane, polytetrafluoroethylene (PTFE), etc. Polyester sutures are used to attach the coaptation sail to the gimbal. Once deployed, the coaptation sail will extend at least partially and approximately centrally into the TV. This provides a coaptation surface for the native TV leaflets sufficient to resolve the valve coaptation gap.

[0044] 2 shows that the distal portion 104b of the coupler 104 includes a base 114 and an integral yoke 116 having axially aligned through holes 118 through the arms 120a, 120b for passing an axle or pin (see Figures 5A-5C) to connect the distal portion 104b of the coupler 104 to the proximal portion 104a. The coupler base 114 includes a cylindrical frustum passage 122 that is centrally and longitudinally disposed between the arms 120a, 120b. A platform 124 between the bases of the arms includes a first elliptical hole or recess 126 having sidewalls 128 and having a center 130 that is over-aligned with the central axis of the cylindrical frustum passage. A deeper second elliptical recess 132 also has a center located above the central axis 123 of the cylindrical frustum passage and includes a major axis 134 located between its vertices, which is perpendicular to the major axis 136 of the first elliptical recess.

[0045] The gimbal 106 includes a cylindrical shaft 140 having a central axis 141 which coincides with a central axis 123 of the cylindrical frustum passage 122 when the shaft is inserted through the cylindrical frustum passage 122 in the coupler distal portion base 114, wherein the clearance between the shaft and the cylindrical frustum passage allows the shaft to pivot through an arc of approximately 20 to 50 degrees about the entire cylindrical frustum passage axis (see FIG. Figure 2C ). In embodiments, the pivoting may be a substantially symmetrical swing, but need not be so, and in some embodiments, the swing may be customized to a particular patient and may be made to have an asymmetrical range of motion. Gimbal axis motion to support the self-alignment function of the engagement sail is further achieved by a gimbal head 142, which is located in the first elliptical recess 126 and has a generally planar oval top 144, and in embodiments, may include a hemispherical ball 146 disposed between the shaft 140 and the top 144. The apex of the oval head has clearance with the sidewalls of the first oval recess so that the head can also rotate within the cylindrical frustum channel by approximately 10 to 40 degrees. In summary, it will be appreciated that the gimbal can both pivot and rotate relative to the coupler.

[0046] The distal end 148 of the gimbal shaft 140 includes a male thread 150 to which a gimbal wing nut 152 can be threadably attached to secure the end of the nitinol wire within the gimbal. More specifically, in an embodiment, the wires of the nitinol frame pass through slots or holes 140a in the gimbal shaft and are wrapped around a circumferential channel where the wires are captured by the gimbal nut when threadably mounted on the gimbal shaft. In an embodiment, sutures can be used to secure the material covering, embedding or enclosing the nitinol wire frame. The wings 154 of the gimbal wing nut include holes 156 to further facilitate attachment (via sutures) of the engagement sail fabric to the gimbal assembly.

[0047] So constructed and as in Figure 2B and Figure 2CAs can be seen in the figure, the gimbal shaft rotates within the cylindrical frustum channel of the coupler, and the head rotates within the groove in the coupler platform.

[0048] The coaptation devices of the present invention (and more specifically, the configuration and components of the coaptation velum itself) provide a three-dimensional surface for the native leaflets to contact (coapt) so that blood does not flow into the RA during RV systole. Previous devices with generally planar configurations and coaptation surfaces may have been effective in extending the native leaflets, but in many cases these devices were insufficient to address the coaptation gap and therefore insufficient to mitigate TR.

[0049] Figure 3A -3E is a highly schematic view showing the contact area of ​​the coupler 104 and gimbal 106 after the system is retracted into the delivery sheath 101. Because the coupler distal portion 104b rotates about an axle or pin 119 disposed through a hole 118 in the yoke 116 connecting the coupler distal portion with the coupler proximal portion 104a, the gimbal shaft is pulled into the delivery sheath 101 for delivery so that the components are axially aligned with the axis of the sheath ( Figure 3A , 3C (a) and 3D (a)). When the sheath is removed during delivery, the distal portion 104b of the coupler is rotated into an angular configuration, which may be assisted by a push rod operated by the physician ( Figure 3B , 3C (b) and 3D(b)).

[0050] This operation is further illustrated in Figures 4A-4C , where it can be seen that when pushed into the delivery sheath ( Figure 4A ), in an embodiment, the nitinol wire torsion spring 125 is captured within the cylindrical sheath wall and moved into a curved configuration so as to be in a state of tension. When the sheath is removed, the spring 125 straightens and applies an angular force to the distal portion 104b to cause it to rotate about the axle 119 and rotate into an angular relationship with the proximal portion 104a so that when delivered, the axis 141 of the gimbal is tilted laterally downward to be approximately coaxial with the junction of the septal leaflet, posterior leaflet, and anterior leaflet coaptation lines. This automatic rotation mechanism of the coupler / gimbal / sail assembly helps to achieve the optimal orientation of the coaptation sail, wherein the top of the coaptation sail is preferably parallel to the TV valve annulus. This will help to ensure that the coaptation sail is maximally engaged with the native leaflet.

[0051] Next watch Figures 5A-5C , several schematic diagrams show the TV leaflets ( Figure 5A 501) and the joint gap (wide 502 and narrow 503), the latter in Figure 5B , 5C Shown in.

[0052] In an embodiment, the nitinol wire that joins the sail can be pre-bent to better match the target TV. The stent can also be constructed with a pre-bent section, but without the tensioner and anchoring system. This alternative construction may be desired to reduce the complexity of the procedure. It will be appreciated that there are multiple pre-bend variations available to the physician to address the anatomical issues of a particular patient.

[0053] Figures 6A-6C The diagram shows a method for accommodating several joining scenarios 510, 511, 512 and Figure 5B-5C Performance of a coaptation velum of the type shown in the gap after deployment. For simplicity, the corresponding chordae tendineae and papillary muscles are not shown. Also, for purposes of this disclosure, it is not necessary to characterize the coaptation void, as it will be appreciated that the void may extend completely or only partially through the anterior-septal, anterior-posterior, or septal-posterior coaptation line. Both narrow and wide coaptation voids, whether extending partially or completely through the coaptation line, will induce TR. Importantly, these views also illustrate the changing configuration of the coaptation velum over several cardiac cycles to adapt and conform to the coaptation void and thereby produce a coaptation surface that fits against the native leaflet during the cardiac cycle. Fig. 6A The shape of the engaged sail when first deployed is shown, Figure 6B shows the shape of blood during its filling and early stages of coagulation, and Figure 6C The shape of the final sail of the coaptation is shown, which is configured to effectively fill the coaptation gap and prevent TR after several cardiac cycles.

[0054] In an embodiment, the coaptation device includes the following features: When deployed, the coaptation sail can be shaped in three dimensions by using a semi-porous or porous material such as, for example, a fabric, a woven fabric, a polymer barrier, polyurethane foam (PU), a reticulated polyurethane, polytetrafluoroethylene (PTFE), etc. The coaptation sail material allows blood to fill the interior of the 3D coaptation sail while taking on the shape of the native leaflets and any interspaces between the leaflets without the use of a balloon. This also provides an internal expansion structure that the physician can load into the delivery system sheath.

[0055] Figures 6A-6C The view in illustrates how the coaptation velum changes shape over time to create a coaptation surface that fits the native leaflet. The blood-filling feature of the 3D coaptation velum occurs naturally during the cardiac cycle due to pressure differences in the RA and RV. Initially, the pressure within the coaptation velum (Sp) is equal to the right atrial pressure (RAp) as it expands within the right atrium (RA).

[0056] At t=0,510, as the velum passes through the TV annulus and is positioned between the native leaflets, it experiences a pressure differential because during systole, RVp>RAp. During diastole, this pressure is more uniform and has minimal effect on the velum pressure. Note that during the cardiac cycle, pressure differences permeate the velum structure.

[0057] At t = 1,511, the porous anastomosis sail material allows uncoagulated blood and other blood components to enter the interior of the anastomosis sail as blood flows from high pressure to low pressure and slowly fills the interior. Note that as the anastomosis sail fills, it also increasingly closes the anastomosis gap, which in turn increases the pressure differential, thereby more fully filling the anastomosis sail.

[0058] In embodiments, variable porosity constructs can be used to adjust air pressure variations and resulting blood volume, as well as coaptation sail shape. There are a number of ways to control the final coaptation sail shape and prevent it from becoming a ball floating uselessly on top of the leaflet, such as varying the porosity relative to insertion depth.

[0059] At t = 2,512, the interior of the velum is filled with blood, and the blood coagulates inside the velum due to being out of turbulent blood flow. As the blood coagulates, even if the pressure difference still exists, the coagulated blood cannot pass back through the porous material of the velum, effectively creating a 3D velum shape that matches the shape of the native leaflet.

[0060] Ultimately, endothelialization of the velum surface seals clotted blood within the velum, although the velum may change shape over time in response to the changing annulus.

[0061] Note that the extent of coaptation of the coaptation sail is determined by the extent of TR present and the coaptation void size. Because the cross-section of the coaptation sail is roughly linear at the base and slowly transitions to a 3D ovoid at the top, the amount of trans-annular insertion provides the ability to treat a wide range of anatomically different TR types. Thus, the bottom planar portion of the coaptation sail effectively provides native leaflet extension, while the upper portion provides TR void filling. Therefore, depending on the patient's anatomy and insertion depth, the long axis of the coaptation sail may be at various angles (not necessarily perpendicular) to the plane of the TV annulus, yet still achieve TR mitigation. Figures 7A-7F Various configurations of joined sails 701 - 705 are shown.

[0062] refer to Figures 8A-8C, the engagement sail 801 may include a lower planar section 802 which may include one or more folds or forks 803 to create discrete leaf portions 801a, 801b to facilitate bending of the engagement sail around a curved engagement commissure, thereby enabling the engagement sail to provide improved engagement around a curve. Figures 8A-8C Shown in.

[0063] Fig. 9 is a schematic diagram showing the degrees of freedom that indicate the physician's ability to control the positioning of the coaptation sail within the TV annulus via delivery system handle movements, and showing the relative movement of the gimbal to facilitate improved coaptation.

[0064] Next reference Fig.10 In an alternative embodiment of the engagement device 200 of the present invention, the device includes and is structurally and operatively connected to a delivery system that facilitates precise positioning and placement of the engagement device during installation and deployment. The following narrative includes a description of the TV prosthesis itself, which again includes the engagement sail 108, which is positioned and placed by a dedicated engagement device delivery system. The engagement sail 108, its porous / semi-porous material covering 112 and its nitinol frame 110a, 110b remain substantially identical to the previously described embodiments and therefore maintain the same reference numbers. Other elements (such as couplers and gimbals) are substantially identical but have been modified for use with the new delivery and placement system and therefore carry new numbers along with the newly described elements and features.

[0065] Next, refer to Fig.10 As will be seen in the alternative embodiment 200, the coaptation sail 108 includes inner 3D shaped nitinol wires 110a, 110b that are at least partially enclosed and covered in various porous and non-porous materials 112. The coaptation sail includes a proximal medial section 106 between the nitinol wires. The coaptation sail 100 extends slightly medially into the TV to provide a coaptation surface for the native TV leaflets.

[0066] At the proximal medial section of the engagement sail, an alternative embodiment of the gimbal / coupler subassembly 220 connects the engagement sail 108 to the nitinol steering tube subassembly 300. The gimbal 222 connects the coupler 224 to the engagement sail 108 and provides multi-axial rotation of the engagement sail within the TV annulus relative to the coupler 224. The coupler 224 includes a proximal portion 224a and a distal portion 224b 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 224 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 108 is connected to the distal end of the gimbal by a coupling clamp 222b to the gimbal shaft 222a.

[0067] 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 108. 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.

[0068] 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 successful reduction of 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.

[0069] 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 the gimbal 222 and coupler 224 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.

[0070] 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.

[0071] The gimbal 222 connects the coupler 224 to the coaptation sail 108 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 impact the native leaflets, thereby causing more TR, but rather self-aligns with the coaptation commissures to increase coaptation of the native leaflets. Figures 11A-11C 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.

[0072] Figures 11A-11C is a perspective view showing the steering tube 300 attached to the gimbal 222 and the coupler 224 (including the nitinol wires 110a, 110b). Fig. 11B The exploded view of illustrates the different components of the assembly, including the gimbal 222 and the coupler 224. Note the angled 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.

[0073] Fig. 11C The cross-sectional view of illustrates the attachment of the coupler 224 to the steering tube 300 via the pin 300a. Note that the gimbals are contained within, captured by, and extend through the proximal and distal portions 224a, 224b of the coupler, respectively.

[0074] The purpose of the steering tube 300 is to position the coaptation sail 108 relative to the TV annulus. The multi-axis adjustability of this design, bending in several planes, and rotation relative to the stent, together allow the position of the coaptation sail to be finely tuned to the patient's anatomy.

[0075] Figures 12A-12CThe 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.

[0076] A configuration of a steering system subassembly in assembled form Fig.13 Figure 15 and Fig.17 The icon in Fig.13 A cross-sectional view of a steering configuration and further includes details of a tensioning rod subassembly coupled to the steering rod subassembly.

[0077] Fig.14 is an upper perspective view showing the components including the steering system and tension rod subassembly, and also illustrating how the tensioning member 501 (e.g., suture, thin cable or chain, medical wire, etc.) 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.

[0078] The various components and corresponding functions of the multi-directional positioning and placement system notably include the novel steering tube 300 as described above. It should be understood that depending on the original cutting pattern (and the additional cross-through pins), bending may occur in several different directions. This can be determined based on the patient's anatomy and the control system requirements of the specific procedure. The serrated collar 302 is attached to the steering tube 300 using a cross-through pin 303, which provides serrations on the inboard / proximal end and thereby locks the steering tube rotation angle to the serrated support collar 304, which has serrations that intersect and cooperate with the serrations of the serrated collar. This provides bending direction via tensioning member routing below the cross-through pin (see, in particular, Figures 15 and Fig.17 ). 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.

[0079] 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.

[0080] 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 arrangement, 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.

[0081] 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.

[0082] 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.

[0083] Figures 15A-15C 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. Fig. 15B ). The threaded tensioner 504 component adjusts the tension in the tensioning member when 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 506a at the distal end of the balled wire that is captured in and 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 a tension collar 508 to provide a lock in place to provide a twistable assembly while allowing an interface for disconnection when the tension interlock 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. The 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.

[0084] A radiopaque strap 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 is connected to an operator control knob in the delivery system (not shown in these views).

[0085] Fig.16504. 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 device 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 device 510 is positioned above the rounded end and the tensioner collar 508 is positioned above all components at the interface. The threaded tensioner 504 and the tension interlock device 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 device 510 is translated away from the threaded tensioner 504.

[0086] 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.

[0087] Cross-sectional view of the steering system and tension rod assembly in Fig.17 and Fig.19 516 . Note that in this configuration, the tensioning member (i.e., suture, wire, cable, chain, etc.) is routed from distal end 516, under medial point 518, to 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 pin 520 and tied at 516 while passing under 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 bending 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.

[0088] 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 enable various amounts of force to be applied to different sections of the steering tube by using coaxial or non-coaxial threaded insert and tensioning rod configurations (not shown).

[0089] 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.

[0090] As in Figure 17-18 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 (see FIG. 4 ) that pass through the collar into the bracket. Fig.18 ) 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.

[0091] Fig.19 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 15A to Figure 17 and Figure 19-20 The tension rod subassembly is shown in detail in each of the figures in FIG. 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 .

[0092] The proximal end of the delivery system (when it is associated with the tensioning rod assembly) is operatively coupled to a conventional endoscope control handle having a tensioning knob, a release knob, a guide wire lumen and Luer lock, multiple dials for rotating and / or bending the steering tube, a lever for locking or unlocking the engagement device position, and other actuation mechanisms for controlling multi-directional positioning and placement of the engagement device.

[0093] Figure 21-22CThe main components of the control handle for the delivery system are illustrated. With reference to each and all of these views, 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 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 cylindrical channel 620 in the control handle routes the tension tube 514 to an operative connection with the tension dial knob 602, which adjusts the amount of tension applied to the prosthesis when rotated, while the release knob button 604 disconnects the delivery system from the prosthesis. The cylindrical channel 622 receives the cardiac guide wire, which passes through the handle and out of the Luer lock 606 located at the proximal end of the handle.

[0094] exist Figures 22A-22C , note the delivery system handle 600, tension knob 602, release knob 604, and guide wire lumen and Luer lock 606. Cross-sectional view ( Fig. 22B ) 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.

[0095] Expanded View( Fig. 22C ) 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.

[0096] The implantation procedure using the engagement device and its delivery system is similar to other transcatheter procedures using fluoroscopy and echographic visualization and includes the following steps:

[0097] First, the femoral vein is accessed and the anatomy and TVR are assessed. Next, the joint prosthesis is prepared and sheathed, and the system readiness is verified. After that, a heparinized saline pressure bag is connected to the side stopcock of the delivery system handle, and the bag pressure is set accordingly to ensure a slight flow through the sheath tip. The prosthesis is loaded into the delivery system. The physician / operator then uses image guidance to advance the joint prosthesis and its control mechanism through the guide wire through the entry site into the right atrium. The physician / operator will then use fluoroscopy to observe the radiopaque nose cone and outer sheath tip markings.

[0098] 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.

[0099] 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 maneuver is performed only when the stent is exposed.

[0100] Ultrasound imaging (ICE, TTE) can then be used to assess regurgitation and changes in valvular function.

[0101] 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.

[0102] 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.

[0103] 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. (Note that in this case, the order of some steps can be reversed if appropriate). The operator must then verify that the delivery system is fully disengaged from the prosthesis by gently advancing / retracting the delivery system.

[0104] Then rotate (CCW) the guard dial to advance the guard into the nose cone.

[0105] Finally, the guide wire is removed prior to stent deployment and is removed from the now implanted and positioned prosthetic system.

[0106] 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 tricuspid valve prosthesis for treating tricuspid valve regurgitation (TVR), the tricuspid valve prosthesis comprising: a stent configured for implantation in the inferior vena cava (IVC) adjacent to a junction with the right atrium (RA); a coupler and gimbal assembly tethered to the bracket; and an engagement sail having a wire frame connected to the coupler and gimbal assembly and enclosed within a material covering, the engagement sail being configured for percutaneous delivery to the RA for deployment within a tricuspid valve (TV) annulus; Wherein, when the stent is implanted in the IVC and the tethered coaptation sail is deployed within the TV annulus, the coaptation sail material absorbs and retains blood, causing the blood to coagulate within the coaptation sail, and over multiple cardiac cycles, the pressure differential between the RA and the right ventricle, blood flow, and physical engagement with the native leaflets of the TV shape the coaptation sail, thereby forming a coaptation surface for the native leaflets and reducing the size of the coaptation gap, thereby reducing the three-dimensional shape of the TVR.

2. The tricuspid valve prosthesis of claim 1, wherein the tether is a wire.

3. The tricuspid valve prosthesis of claim 1, wherein the stent is made of nitinol.

4. The tricuspid valve prosthesis of claim 1, wherein the wire frame is made of nitinol wire.

5. The tricuspid valve prosthesis of claim 4, wherein the wire frame is constructed to have a curvature for matching the native valve leaflets prior to implantation.

6. The tricuspid valve prosthesis of claim 1 wherein the material covering is porous.

7. The tricuspid valve prosthesis of claim 1, wherein the material covering is non-porous.

8. A tricuspid valve prosthesis as described in claim 1, wherein the coupler and gimbal assembly includes a coupler having a proximal portion tethered to the support, a distal portion pivotally connected to the proximal portion, the distal portion having a cylindrical straight-through channel; a gimbal having a head captured between the proximal and distal portions of the coupler and a cylindrical shaft inserted through the straight-through channel, the shaft having a distal end constructed to be attached to the wire frame of the engagement sail.

9. The tricuspid valve prosthesis of claim 8, wherein the head of the gimbal and the distal portion of the coupler are configured such that the gimbal can rotate about its longitudinal axis and can pivot relative to the coupler.

10. The tricuspid valve prosthesis of claim 9, wherein the coupler and gimbal assembly are configured to provide multi-axial rotation of the engagement sail relative to the coupler within the TV annulus.

11. A tricuspid valve prosthesis as described in claim 10, wherein the engagement sail has substantially flat sides, top sides and bottom edges, and is constructed to automatically rotate relative to the coupler when deployed so that the top is parallel to the TV valve annulus to maximize engagement with the native leaflet.

12. The tricuspid valve prosthesis of claim 10, wherein the cylindrical shaft of the gimbal has an attachment structure at a distal end for connecting to the wire frame.

13. A tricuspid valve prosthesis as described in claim 12, wherein the attachment structure includes a male threaded portion located on the distal end of the cylindrical shaft and a wing nut threadably attached to the male threaded portion, wherein the wires of the wire frame are captured by the wing nut and fastened to the cylindrical shaft by the wing nut.

14. The tricuspid valve prosthesis of claim 9, wherein the gimbal includes a hemispherical ball positioned beneath the head, the hemispherical ball engaging a surface on the distal portion of the coupler and thereby facilitating rotational movement relative to the distal portion of the coupler.

15. The tricuspid valve prosthesis of claim 1 further comprising a torsion spring disposed between the proximal and distal portions of the coupler to urge the proximal and distal portions toward an angular orientation relative to each other when deployed from a delivery sheath.

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