Transcatheter self-expanding tricuspid valve replacement system

Abstract

The present application provides a tricuspid valve device, which may include a frame and an associated new prosthetic valve. The frame serves as a stabilizing structure, with its head extending into the morphological or functional right atrium (upstream) and its tail extending into the morphological or functional right ventricle (downstream). The frame includes an atrial dome with struts that conform to the atrium without blocking blood flow from the incoming great veins (i.e., the superior vena cava and the inferior vena cava) or other abnormal veins and / or tributaries. The frame also includes ventricular struts placed in the right ventricle to secure the new prosthetic valve in a desired position. The assembly of the frame and valve is retractable so that the assembly can be placed in a vascular catheter prior to deployment and then self-expanded when released in the heart (heart chamber).

Description

Technical Field

[0001] The present application relates to the treatment of heart valve regurgitation. Background Art

[0002] Heart valve regurgitation can cause acute and chronic symptoms (e.g., shortness of breath, poor endurance, leg swelling, abdominal discomfort, malnutrition) and lead to considerable morbidity (e.g., acute pulmonary edema, heart failure, pulmonary hypertension, organ dysfunction, cachexia, anorexia) and mortality. Open heart valve surgery has proven to be effective but carries problems associated with perioperative mortality and postoperative complications. This invasive surgery requires a long (months) recovery time after open heart surgery, and many patients may not be suitable. Therefore, a less invasive method for treating the tricuspid valve between the right atrium and the right ventricle is needed.

[0003] Currently, treatment for tricuspid regurgitation includes the use of a valve repair system called TriAlign developed by MitrAlign Systems, which uses intravascular transcatheter placement of sutures and swabs to reshape (valvuloplasty) the morphology of the target valve, reducing the annulus, valve orifice area, and valve area. However, the TriAlign System is a repair system rather than a replacement system.

[0004] Additionally, current treatments for tricuspid regurgitation may include the use of mitral valve repair systems, such as MitraClip, which have been used for tricuspid valve repair, which is not an approved use. Mitral valve repair systems are not intended or designed for use with the tricuspid valve, and the FDA has not approved this indication. Furthermore, use of such mitral valve repair systems requires deployment of one or more devices due to the tricuspid anatomy of the tricuspid valve, as compared to the bicuspid nature of the mitral valve, for which the MitraClip system is intended. Thus, the use of mitral valve repair systems to treat tricuspid regurgitation is limited to a limited patient population with eligible valves and cardiac anatomy, and may also have issues with safety and effectiveness.

[0005] Therefore, there is a need for dedicated tricuspid valve replacement devices and related methods for patients who are unable to undergo or are not suitable for open heart surgery. Summary of the invention

[0006] The present application provides a tricuspid valve device having a frame and an associated new prosthetic valve. The frame serves as a stabilizing structure, with its head extending into the morphological or functional right atrium (upstream) and its tail extending into the morphological or functional right ventricle (downstream). The frame includes a strutted atrial dome that conforms to the atrium without blocking blood flow from the incoming great veins (i.e., the superior vena cava and the inferior vena cava) or other abnormal veins and / or tributaries. The frame also includes a ventricular strut placed in the right ventricle to secure the new prosthetic valve in a desired position. The assembly of the frame and valve is retractable so that the assembly can be placed in a vascular catheter prior to deployment and then self-expanded when released in the heart (heart chamber).

[0007] In a first aspect, the present application provides a tricuspid valve replacement system for a patient's heart, comprising:

[0008] Framework; and

[0009] The flap is connected to the frame,

[0010] wherein the frame includes a central ring, a plurality of atrial struts extending from a first side of the central ring and defining an atrial dome, and a plurality of ventricular struts extending from a second side of the central ring opposite the first side;

[0011] wherein the valve is connected to the central ring and the plurality of atrial struts, and

[0012] The tricuspid valve replacement system is configured to be placed in the patient's heart, wherein the atrial dome is located in the right atrium of the heart, the central ring and the valve are located in the ring of the natural tricuspid valve of the heart, and the multiple ventricular struts are located in the right ventricle of the heart, so that the atrial dome and the multiple ventricular struts stabilize the tricuspid valve replacement system in the heart so that the function of the natural tricuspid valve is replaced by the valve.

[0013] In some embodiments, the plurality of atrial struts includes three atrial struts.

[0014] In some embodiments, the three atrial struts are bent away from the central axis of the frame such that the maximum diameter of the atrial dome is greater than the maximum diameter of the central ring.

[0015] In some embodiments, the frame further comprises end rings, and wherein the three atrial struts are connected to and extend between the central ring and the end rings.

[0016] In some embodiments, the plurality of ventricular struts includes two ventricular struts.

[0017] In some embodiments, the ventricular struts and the atrial struts are radially spaced apart in a non-overlapping manner around the central ring.

[0018] In some embodiments, the tricuspid valve replacement system is configured to be placed in a collapsed state within a catheter for delivery into the heart.

[0019] In some embodiments, the frame is formed of a shape memory alloy and is configured to self-expand, such that the tricuspid valve replacement system self-expands from a contracted state to a deployed state within the heart.

[0020] In some embodiments, the inner diameter of the catheter is less than 7 mm in diameter.

[0021] In some embodiments, the flap is sutured to the frame.

[0022] In a second aspect, the present application provides a tricuspid valve replacement method, comprising:

[0023] A catheter containing a tricuspid valve replacement device in a contracted state is placed into the patient's heart, wherein the tricuspid valve replacement device comprises:

[0024] Framework; and

[0025] The flap is connected to the frame,

[0026] wherein the frame comprises a central ring, a plurality of atrial struts extending from a first side of the central ring and defining an atrial dome, and a plurality of ventricular struts extending from a second side of the central ring opposite the first side; and

[0027] The tricuspid valve replacement device is removed from the catheter so that the tricuspid valve replacement device changes from a contracted state to an expanded state, wherein the atrial dome is located in the right atrium of the heart, the central ring and the valve are located in the ring of the natural tricuspid valve of the heart, and the ventricular strut is located in the right ventricle of the heart, so that the atrial dome and the ventricular strut stabilize the tricuspid valve replacement system in the heart so that the function of the natural tricuspid valve is replaced by the valve.

[0028] In some embodiments, the plurality of atrial struts includes three atrial struts.

[0029] In some embodiments, the three atrial struts are bent away from the central axis of the frame such that the maximum diameter of the atrial dome is greater than the maximum diameter of the central ring.

[0030] In some embodiments, the frame further comprises end rings, and wherein the three atrial struts are connected to and extend between the central ring and the end rings.

[0031] In some embodiments, the plurality of ventricular struts includes two ventricular struts.

[0032] In some embodiments, the ventricular struts and the atrial struts are radially spaced apart in a non-overlapping manner around the central ring.

[0033] In some embodiments, the catheter has a gauge of 7 mm or less.

[0034] In some embodiments, the frame is formed of a shape memory alloy and is capable of self-expanding from a contracted state to an expanded state within the heart.

[0035] In some embodiments, the method further comprises suturing the flap to the frame.

[0036] In a third aspect, the present application provides a method for manufacturing the tricuspid valve replacement system according to the first aspect, comprising:

[0037] Provide a framework;

[0038] suturing the valve to the atrial dome of the frame; and

[0039] The flap is sutured to the central ring of the frame. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] A person skilled in the art can easily understand the contents of the present application through the following detailed description in conjunction with the accompanying drawings, wherein like reference numerals represent like structural elements, wherein:

[0041] Figure 1 An annotated diagram of the anatomy of the heart is shown.

[0042] Figure 2A A perspective view of a tricuspid valve replacement system according to some embodiments of the present application is shown.

[0043] Figure 2B Shows Figure 2A Front view of the tricuspid valve replacement system.

[0044] Figures 3A-3C A perspective view of a frame of a tricuspid valve replacement system according to the present application is shown.

[0045] Figure 3D and 3E A front view of a frame of a tricuspid valve replacement system according to some embodiments of the present application is shown.

[0046] Figure 3F A side view of a frame of a tricuspid valve replacement system according to some embodiments of the present application is shown.

[0047] Figure 3G A top view of a frame of a tricuspid valve replacement system according to some embodiments of the present application is shown.

[0048] Figure 3H A bottom view of a frame of a tricuspid valve replacement system according to some embodiments of the present application is shown.

[0049] Figure 4A and 4B A valve of a frame of a tricuspid valve replacement system according to some embodiments of the present application is shown.

[0050] Figure 5A -E shows the steps of a manufacturing process of a tricuspid valve replacement system according to some embodiments of the present application.

[0051] Fig. 6A -F shows a tricuspid valve replacement system in a collapsed state within a catheter according to some embodiments of the present application.

[0052] Figures 7A-7D A placement procedure of a tricuspid valve replacement system according to some embodiments of the present application is shown. DETAILED DESCRIPTION

[0053] Throughout the specification, for the purpose of explanation, many specific details are set forth to provide a thorough understanding of the various aspects and embodiments disclosed herein. However, it will be apparent to those skilled in the art that the various aspects and embodiments of the present application may be implemented without some of the specific details. In other examples, known structures and devices are shown in diagrammatic or schematic form to avoid ambiguity in the underlying principles of the described aspects and embodiments.

[0054] The present application relates to the field of tricuspid regurgitation technology. Specifically, the present application relates to the field of transcatheter placement of self-expanding devices for tricuspid valve structure and / or function replacement. According to some embodiments of the present application, the device disclosed herein is placed to replace the function of the native tricuspid valve and / or the structure adjacent to the tricuspid valve, and allows restoration of right-sided heart function and / or reversal of pathophysiology associated with severe tricuspid regurgitation. The device can be deployed, for example, under a fluoroscope (e.g., X-ray) or under other energy sources (e.g., ultrasound), for guidance that can image the position and function of the device, and / or deployed using a surgical navigation system.

[0055] According to some embodiments of the application, the device can be deployed by a vascular catheter (transcatheter method), or other methods that a surgical intervention expert or surgeon considers to be clinically and technically feasible can be deployed and placed. According to some embodiments of the application, the device may be applicable to a clinical environment where open heart surgery or cardiothoracic surgery is contraindicated at least in the initial stage. For example, the device may be applicable to conservative indications, such as right heart disease, right heart failure, portal hypertension secondary to cirrhosis of the liver and / or systemic organ or multi-organ dysfunction and failure (such as enteropathy, severe ascites, lymphedema) in advanced patients (including terminal stage). This conservative therapy can improve patient symptoms (primary purpose) and potentially extend life expectancy (possible collateral benefits). The placement or implantation of these devices is not limited to adult patient populations, and can be used in pediatric populations.

[0056] Figure 2A and Figure 2B A perspective view and a front view are shown, respectively, of a tricuspid valve replacement system 100 (also referred to as device 100 ) according to some embodiments of the present application. As shown, the system 100 includes a frame 102 and a valve 104 connected to the frame 102 .

[0057] Figures 3A-3C 1 shows a perspective view of a frame 102 of a tricuspid valve replacement system 100 according to some embodiments of the present application. Figure 3D As shown, the frame 102 includes a central ring 202 , an atrial end 204 extending from the superior / atrial side of the central ring 202 , and a ventricular end 206 extending from the inferior / ventricular side (opposite the superior side) of the central ring 202 .

[0058] exist Figures 3A-3H 1 shows the frame 102 in an expanded state, where the expanded state is the form that the frame 102 exhibits when no external forces are applied. When deformed, the frame 102 is designed to self-expand toward the expanded state when the external forces are reduced or eliminated (e.g., when the restraining mechanism is released). As will be discussed in more detail below, the elements of the frame 102 are designed to be resilient and conform to various sizes of cavities in which the frame is placed during use, such as inside a catheter or inside various parts of the heart.

[0059] Center Ring

[0060] The center ring 202 is sized to be placed within or near the annulus of the tricuspid valve of a human patient. Figure 3G and 3HAs shown, the center ring 202 can be substantially circular in the expanded state. In some embodiments, the center ring 202 can be elliptical or other rounded. In some embodiments, in the expanded state, the center ring 202 can be planar, or can be non-planar, for example, the center ring can be defined on the surface of a hyperbolic parabola (i.e., a saddle). The center ring 202 and other portions of the frame 102 can be formed by wires, the specification / diameter of the wires being between 0.2 mm and 0.8 mm, preferably 0.5 mm. The rigidity of the center ring 202 or portions thereof can be selected so that in the placed state, when the frame 102 is placed in the heart and subjected to normal forces from the walls of the heart, the shape of the center ring 202 corresponds to the shape and size of the ring of the tricuspid valve.

[0061] In some embodiments, the frame 102 can have center rings 202 of different sizes / diameters for tricuspid anns of different sizes. In normal individuals, the circumference of the tricuspid annulus is, for example, approximately 120 mm, and in individuals with tricuspid regurgitation (i.e., a diseased state), the circumference can be 140 mm-150 mm or greater. In severe tricuspid regurgitation, the average diameter of the tricuspid annulus can be >35 mm, while the average diameter in normal individuals can be 28±5 mm. In addition, in diseased individuals, the right heart can be very dilated or inflated. In some embodiments, the circumference of the center ring 202 can be 45 mm-120 mm, and the average diameter in the expanded state is 15 mm-40 mm.

[0062] Atrial Dome

[0063] The frame 102 also includes an atrial dome 208 extending from the atrial end 204 of the central ring 202. The atrial dome 208 includes a plurality of atrial struts 210 extending from the central ring 202 to the atrial end of the frame 102. Figure 3G As shown in the top view of FIG. 2 , in some embodiments, the atrial dome 208 can include three atrial struts 210. In some embodiments, the atrial dome 208 can include 2, 3, 4, or more atrial struts 210. More atrial struts 210 provide the advantage of a more stable device, however, more atrial struts 210 also increase the size of the catheter required to accommodate the device in the contracted delivery state and increase the risk of complications associated with a larger surface area of ​​foreign matter in the heart.

[0064] In some embodiments, the atrial struts 210 terminate at the atrial end in an end ring 212. As discussed below, the end ring 212 can receive a guide wire during placement of the frame 102. The end ring 212 can have an inner diameter of 5 mm to 10 mm.

[0065] In some embodiments, the atrial end may not include an end ring 212, and the atrial struts 210 may be connected together at the intersection. In some embodiments, using an even number of atrial struts 210, two opposing atrial struts 210 may be formed from the same wire, and the tops of the rings forming the paired atrial struts 210 overlap to define the atrial end.

[0066] The length of the atrial dome 208 from the central ring 202 to the atrial end corresponds to the length of the patient's right atrium. Patients with tricuspid regurgitation and other right-sided heart or cardiopulmonary diseases (including severe pulmonary hypertension) may have an enlarged right atrium. In order to select the appropriate size of the atrial dome 208 to correspond to the patient's enlarged atrium, the patient can be imaged pre-operatively (e.g., computed tomography, cardiac magnetic resonance, ultrasound) to determine the measured length and diameter of the enlarged atrium. Figures 3A-3H As shown, in some embodiments, the atrial struts 210 are bent outwardly so that the maximum diameter 214 (eg, Figure 3G 210 is larger than the diameter of the central ring 202. In some embodiments, each atrial strut 210 is bent in a plane parallel to the central axis 216 of the frame 102 and extending through the central axis 216 of the frame 102.

[0067] During use in the heart, the atrial dome 208 is placed in the right atrium and the central ring 202 is placed in the plane of the tricuspid valve annulus or directly above the plane of the tricuspid valve annulus. The purpose of the outer surface of the atrial struts 210 defining the atrial dome 208 is to contact the wall of the right atrium so as to maintain the position of the central ring 202 in a fixed position relative to the tricuspid valve annulus.

[0068] In the deployed state, the atrial struts 210 have an inherent level of stiffness (depending on the composition and forgeability of the metal or metal alloy) such that in the deployed state, the atrial struts 210 are able to continuously deform or conform to the dynamic shape of the anatomy of the right atrium and move with the heart during heart pumping. In some embodiments, each atrial strut 210 of the frame 102 has the same length. In some embodiments, the atrial struts 210 of the frame can have different lengths and / or stiffness levels to correspond to the asymmetric shape of the right atrium.

[0069] Ventricular struts

[0070] The frame 102 includes a plurality of ventricular struts 218 extending from the ventricular side of the central ring 202. Figures 3A-3H As shown, in some embodiments, the frame 102 includes two ventricular struts 218. In some embodiments, the frame can include three or more ventricular struts 218.

[0071] In some embodiments, the ventricular struts 218 terminate independently of each other at the ventricular end of the frame 102. During placement in the heart, the ventricular end is positioned in a subapical direction toward the right ventricle. The ventricular struts 218 are bent outwardly so that the maximum distance 220 between the ventricular struts 218 at the maximum bending point away from the central axis 216 of the frame 102 is greater than the diameter of the center ring 202. When the right ventricle is larger than the right atrium, the maximum distance of the ventricular struts 218 can be wider than the maximum diameter of the atrial dome 208 so as to be located in the right ventricle. In addition, in patients with right atrial dilatation, the right atrium can be larger than the right ventricle, and the maximum diameter of the atrial dome 208 can be greater than the maximum distance of the ventricular struts 218. During use, the ventricular struts 218 are placed in the right ventricle while the center ring 202 is placed in the tricuspid annulus. The outer surface of the ventricular struts 218 contacts the wall of the right ventricle so as to maintain the position of the center ring 202 in the tricuspid annulus. Both the atrial dome 208 and the ventricular struts 218 maintain the position and orientation of the frame 102 within the heart.

[0072] The ventricular strut 218 terminates in an atraumatic end 222, which may be a pigtail-like geometry, such as Figure 3D and 3F As shown. The atraumatic end 222 is configured not to damage / puncture the ventricular wall. In some embodiments, the atraumatic end 222 is formed by curling the end of the wire forming the ventricular strut 218 so that the other parts of the ventricular strut cover the tip of the wire so that the sharp tip is not exposed and therefore does not contact the ventricular wall surface.

[0073] The distance that each ventricular strut 218 extends from the central ring 202 can correspond to the length of the right ventricle of a human patient, by having a similar length or a shorter length. In some embodiments, the distance is 50 mm-60 mm. The size of the gap 224 between the atraumatic ends 222 is designed to avoid contact and entanglement with the chordae tendineae of the right ventricle, such as Figure 1 Annotated diagram of the center of the heart is shown.

[0074] Figure 3D 1 shows the expanded state of the frame 102. The rigidity of the ventricular struts 218 is selected so that the ventricular struts 218 can conform to the dynamic shape of the anatomical structure of the right ventricle in the deployed state. In some embodiments, each ventricular strut 218 has the same length. In some embodiments, the ventricular struts 218 of the frame 102 can have different lengths and / or stiffness levels to correspond to the asymmetric shape of the right ventricle.

[0075] like Figure 3HAs shown, the ventricular struts 218 can be bent in the same plane as one another and define a ventricular strut plane 226. In some embodiments, the ventricular struts 218 can be bent in a non-planar manner, ie, have a shape that does not lie in a single plane.

[0076] Support rod setting

[0077] Figure 3G and 3H The top and bottom aspects of the frame 102 and the orientation of the atrial struts 210 and ventricular struts 218 relative to the central ring 202 are shown.

[0078] In some embodiments, the atrial struts 210 are evenly spaced around the perimeter of the atrial side of the center ring 202. For example, in some embodiments having a circular center ring 202 and three atrial struts 210, such as Figure 3G As shown, the atrial struts 210 are spaced 120 degrees apart between adjacent atrial struts 210. Figure 3H As shown, in some embodiments, the ventricular struts 218 can be located on the opposite side of the center ring 202, i.e., 180 degrees. In addition, the ventricular struts 218 can be spaced apart from the atrial struts 210 so that the atrial struts 210 are not directly opposite the ventricular struts 218 on the center ring 202. For example, Figure 3G and 3H As shown, each ventricular strut 218 is spaced 30, 90, and 150 degrees apart from the three atrial struts 210, respectively.

[0079] valve

[0080] Figure 4A and 4B The lateral and bottom underside of the valve 104 are shown respectively. The valve 104 can include a bovine pericardial support and buttress 401, and a tissue pericardial valve with three new valve leaflets 402. As shown, the pericardial support and buttress 401 can be cone-shaped and can form a support layer to direct flow above the plane of the new valve leaflets 402. The pericardial support and buttress 401 can help maintain the structure and rigidity of the new valve leaflets 402. The base size of the valve 104 is selected to correspond to the size of the central ring 202 of the frame 102, so that the valve 104 is located within the central ring 202.

[0081] preparation

[0082] In some embodiments, the frame 102 is self-expanding and can be made of a shape memory alloy. For example, the frame 102 can be made of a nickel-titanium (Nitinol) alloy. The frame 102 can have a wire gauge of 0.5 mm. The components and components of the frame 102 can have different sizes, thicknesses (wire gauges), and / or materials.

[0083] The components of the frame 102 (including struts and rings) can be individually preformed into the desired shape in the expanded state (shape memory effect) and then connected together to form the overall structure. The components of the frame 102 can be connected together, for example, by adhesives and / or welding.

[0084] In some embodiments, the lower periphery of the valve 104 is sewn to the central ring 202 and portions of the side walls of the valve 104 are sewn to the atrial struts 210 . Figures 5A-5E The steps of assembling the tricuspid valve replacement system 100 are shown. Figure 5A As shown, the valve 104 can be placed in the atrial dome 208 of the frame 102, and the plane of the leaflets of the valve 104 is substantially consistent with the plane of the central ring 202. Figure 5B and 5D As shown, the valve 104 can be initially connected to the frame 102 by suturing 502 the side walls of the valve 104 to each atrial strut 210. Next, as shown in FIG. Figure 5C and 5E As shown, the lower perimeter of the flap 104 may be sewn 504 to the center ring 202. In some embodiments, the flap 104 may be connected to the frame 102 in other ways, such as with an adhesive.

[0085] In some embodiments, the frame 102 can have a coating to alter the biological response to foreign matter. For example, the coating can include an anti-thrombotic agent (eg, heparin).

[0086] catheter

[0087] Fig. 6A The tricuspid valve replacement system 100 is shown in a collapsed state within a catheter 600. Figure 6B-6F Cross-sections of different portions of the tricuspid valve replacement system 100 are shown within a catheter.

[0088] like Fig. 6AAs shown, the frame 102 is oriented to be consistent with the longitudinal axis of the catheter 600, the collapsed atrial dome 208 is away from the distal opening of the catheter 600, and the collapsed ventricular struts 218 are close to the distal opening of the catheter 600. The catheter can be 6mm to 7mm in size, 18Fr to 21Fr. In the collapsed state, the center ring 202 can be folded and / or spirally twisted, and the prosthetic new valve can be gathered and / or folded to enable the device to be stored in the catheter. In the collapsed state, the atrial struts 210 are straightened so that the elongated collapsed atrial dome 208 is located in the catheter 600. In some embodiments, the diameter of the catheter 600 and the end ring 212 is selected so that the end ring 212 does not deform in the collapsed state, so that the guide wire (to be discussed below) can pass through the end ring 212. In the collapsed state, the ventricular struts 218 are straightened so that the atraumatic ends 222 are close to, in contact with, or overlap each other in the catheter 600. In the contracted state, the valve 104 folds or rolls up within the contracted atrial dome 208 .

[0089] method

[0090] Figures 7A-7D Method steps for placing a tricuspid valve replacement system 100 within a heart 700 are shown. In some embodiments, the system can be placed via intravascular transcatheter deployment. However, placement of the device is not limited to transcatheter deployment. For example, the device can be placed via open heart surgery.

[0091] Before placing the device 100, cardiovascular imaging (e.g., computed tomography (CT), cardiac magnetic resonance imaging (MRI), and ultrasound) can be performed to determine the suitability of the patient's cardiac anatomy and to understand the size and shape of the tricuspid annulus, right atrium, and right ventricle. For example, during Heart Team planning, the use of preoperative CT and / or cardiac MRI may potentially improve postoperative outcomes and success. In addition, preoperatively, three-dimensional (3D) imaging and / or 3D printing guidance can be used to plan the orientation of the physical device within the 3D model. These preoperative steps can be used to maximize the success rate of the operation and reduce postoperative complications, including paravalvular leakage or device peripheral flow leakage, device displacement, and / or non-optimal placement. Intraoperatively, ultrasound guidance on a fluoroscope (e.g., transesophageal echocardiography (TEE), intracardiac echocardiography (ICE)) can also be used to enhance the positioning and placement of the device. Based on the available data from imaging, the best matching frame 102 and valve 104 of appropriate shape and size can be selected.

[0092] With proper preoperative planning, the correctly sized device 100 is placed in a collapsed state and positioned within the end of the catheter 702 .

[0093] A catheter 702 loaded with the device 100 is passed into the superior vena cava (if entering via a transjugular approach) or the inferior vena cava (if entering via a transfemoral approach) and into the right atrium. In some embodiments, prior to inserting the catheter 702, a guide wire 704 is first inserted through the superior vena cava or the inferior vena cava, through the right atrium, through the tricuspid annulus and into the right ventricle, such as Fig. 7A Then, as Figure 7B As shown, a guidewire 704 can be used to introduce a delivery catheter 702 of the device 100, which is maintained in a contracted state, into the heart. The delivery catheter 702 and the device 100 can be extended over the guidewire 704 so that the guidewire extends through the central ring 202 and opens in the valve between the new valve leaflet 402 and the end ring 212.

[0094] Using cardiac imaging, the distal end of the catheter 702 loaded with the device 100 is positioned to a deployment position such that the collapsed central ring 202 is within or slightly above the tricuspid annulus, the collapsed ventricular struts 218 are within the right ventricle, and the collapsed atrial dome 208 is within the right atrium. The distal end of the catheter 702 with the collapsed device 100 can be rotated so that when deployed, the ventricular strut plane 226 and the frame 102 are in a desired rotational position about the axis of the device 100. In some embodiments, after the frame 102 is deployed and self-deployed, the frame 102 can be oriented in the desired rotational position within the heart 700.

[0095] After the catheter 702 is deployed at the placement location, the catheter 702 is withdrawn by pulling the catheter 702 back while the device 100 remains stationary. As the catheter 702 is withdrawn over the frame 102, the frame 102 will release and self-expand from the collapsed state to the expanded state. Figure 7C and 7D As shown, when the catheter 702 is withdrawn over the constriction device 100 by pulling back, the ventricular struts 218 expand and contact the wall of the right ventricle. As the catheter 702 is further withdrawn, the center ring 202 expands with the annulus of the native tricuspid valve, thereby holding or wedging the flap of the native heart valve into an open position. As the catheter 702 is further withdrawn, the atrial dome 208 expands and contacts the wall of the right atrium, as shown. Fig.7D In some embodiments, a guide wire may not be used in the method of placing the device.

[0096] exist Fig.7D In the delivery state shown, the atrial end of the device 100 is located at the junction of the superior vena cava and the inferior vena cava. In the delivery state, the central ring 202 can reside on or adjacent to the native tricuspid valve annulus, and the native tricuspid valve becomes operatively open (or wedged open) and is functionally replaced by the new prosthetic tricuspid valve 104.

[0097] After placement, the atrial struts 210 will be isolated over time through endothelialization and / or coverage by fibroblasts and fibrocytes, and the device will be further anchored in place. The ventricular struts 218 continue to stabilize the device 100. When the heart contracts with the device in this position, the atraumatic (pigtail) ends of the ventricular struts 218 cushion the impact on the ventricular wall.

[0098] The method can be used to replace diseased native tricuspid valves of the heart, including tricuspid regurgitation, mixed tricuspid regurgitation and stenosis, and congenital tricuspid valve anomalies.

[0099] The method of using the device to deploy improves the physiology and abnormal hemodynamics associated with a diseased tricuspid valve. In addition, the deployed device 100 restores the pressure gradient in the right heart and lungs and peripheral venous circulation, and improves or reverses the abnormal circulatory physiology in the venous system that causes intestinal edema, ascites, congestive liver disease, transvaginal inflammation, peripheral edema, and other pathologies caused by venous congestion caused by an abnormal tricuspid valve.

[0100] The various aspects, embodiments, implementations or features of the described embodiments of the present application may be used alone or in any combination. In particular, it should be understood that the various aspects, embodiments, implementations or features of the described embodiments may be combined without departing from the spirit or scope of the present application. Figure 2A-7D Various elements of the concept.

[0101] The terms "one" and "said" and similar references used in the context of describing the application (especially in the context of the claims) should be interpreted as including singular and plural, unless otherwise specified herein or clearly contradictory to the context. Unless otherwise specified, the terms "comprising", "having", "including" and "containing" should be interpreted as open terms (that is, meaning "including but not limited to"). The term "connection" should be interpreted as being partially or entirely contained therein, attached to or connected together, even if there are some intermediates. Unless otherwise specified herein, the numerical range herein is only intended to be a shorthand way of describing each individual value or its gradient falling within the range individually, and each individual value is incorporated into this specification, which is equivalent to being described individually herein. All methods described herein can be carried out in any suitable order, unless otherwise specified herein or clearly contradictory to the context. The use of any and all examples or exemplary languages ​​(e.g., "such as") provided herein is only intended to better illustrate the embodiments of the application, and unless otherwise stated, the scope of the application is not limited. The language in this specification should not be interpreted as indicating that any unspecified element is necessary for the practice of the application.

[0102] As used herein, the term "substantially" refers to a degree or level of complete or nearly completeness of an action, characteristic, property, state, structure, item, or result. For example, a "substantially" enclosed object means that the object is completely or nearly completely enclosed. The exact degree of deviation allowed from absolute completeness may in some cases depend on the particular circumstances. However, in general, the degree of approach to completeness will have the same overall result as obtaining absolute completeness and total completeness.

[0103] Preferred embodiments of the present application are described herein, including the best mode of implementing the various inventions of the present application known to the inventor. The present application may be subject to various modifications and other structures, and certain exemplary embodiments of the present application are shown in the drawings and have been described in detail above. Within the essence of the present application, variations of those preferred embodiments may be easily thought of by those of ordinary skill in the art after reading the above description. The inventors of the present application expect that such variations will be appropriately adopted by those skilled in the art, and the inventors of the present application intend to practice the present application in a manner different from that specifically described herein. Therefore, it should be understood that it is not intended to limit the present application to one or more specific forms disclosed; on the contrary, the present application includes all modifications and equivalents of the subject matter described in the claims as permitted by applicable law. In addition, the present application includes any combination of the above elements in all possible variations thereof, unless otherwise specified herein or clearly contradictory to the context. For the purpose of explanation, the above description uses specific nomenclature to provide a thorough understanding of the described embodiments. However, it is obvious to those skilled in the art that all specific details are not required in order to practice the described embodiments. Therefore, for the purpose of illustration and description, the above description of specific embodiments is given. They are not intended to be exhaustive or limit the embodiments to the precise form disclosed. It will be apparent to those skilled in the art that many modifications and variations are possible in light of the above teachings.

Claims

1. A tricuspid valve replacement system for a patient's heart, comprising: frame; and The flap is connected to the frame, The framework includes a central ring defined by the line unfolding in a circle; a plurality of atrial struts extending from a first side of the central ring and terminating at an atrial end of the frame, the plurality of atrial struts defining an atrial dome; as well as a plurality of ventricular struts extending from a second side of the central ring opposite the first side to a ventricular end of the frame; wherein the valve is connected to the central ring and the plurality of atrial struts, wherein the plurality of ventricular struts terminate independently of one another at the ventricular end of the frame and are each bent away from the central axis such that a maximum distance between the ventricular struts at a point of maximum bending away from the central axis is greater than a diameter of the central ring, The tricuspid valve replacement system is configured to be placed in the patient's heart, wherein the atrial dome is located in the right atrium of the heart, the central ring and the valve are located in the ring of the natural tricuspid valve of the heart, and the multiple ventricular struts are located in the right ventricle of the heart, so that the atrial dome and the multiple ventricular struts stabilize the tricuspid valve replacement system in the heart so that the function of the natural tricuspid valve is replaced by the valve.

2. The system of claim 1, wherein the plurality of atrial struts comprises two to four atrial struts.

3. The system of claim 2, wherein the plurality of atrial struts are bent away from the central axis of the frame such that a maximum diameter of the atrial dome is greater than a maximum diameter of the central ring.

4. The system of claim 3, wherein the frame further comprises end rings, and wherein the three atrial struts are connected to and extend between the central ring and the end rings.

5. The system of claim 2, wherein the plurality of ventricular struts comprises two ventricular struts.

6. The system of claim 5, wherein the ventricular struts and the atrial struts are radially spaced apart in a non-overlapping manner around the central ring.

7. The system of claim 1, wherein the tricuspid valve replacement system is configured to be placed in a collapsed state within a catheter for delivery into the heart.

8. The system of claim 7, wherein the frame is formed of a shape memory alloy and is configured to self-expand so that the tricuspid valve replacement system self-expands from a contracted state to a deployed state within the heart.

9. The system of claim 7, wherein the catheter inner diameter is less than 7 mm in diameter.

10. The system of claim 1, wherein the flap is sutured to the frame.

11. The system of claim 1 , wherein the center ring has a set, fixed diameter when deployed, the diameter being selected based on a particular size of the patient's tricuspid valve.

12. The system of claim 11, wherein the set diameter is any single diameter in the range of 15 mm to 40 mm.

13. The system of claim 1, wherein the length of each of the ventricular struts corresponds to the length of a ventricle, and the length of the atrial dome corresponds to the length of an atrium in a human heart.

14. The system of claim 1, wherein the system is configured and dimensioned such that the atrial dome and the ventricular struts stabilize the tricuspid valve replacement system within the heart so that the valve replaces the function of the native tricuspid valve without reliance on anchoring stents or hooks.

15. A method of manufacturing the tricuspid valve replacement system according to claim 1, comprising: Provide a framework; suturing the valve to the atrial dome of the frame; and The flap is sutured to the central ring of the frame.

Images