Transcatheter valve leads and valve elements

Abstract

The cardiac valve delivery system includes a lead (200) configured to be inserted into the heart through the venous system and having a distal end (202) with myocardial attachment devices (204, 206), and a transcatheter prosthetic element (600) configured to be delivered along the lead (200). The transcatheter prosthetic element (600) is configured with anchor elements (604, 606) located on the outer edge of the prosthetic element and configured to secure the transcatheter prosthetic element (600) in place along the lead (200). The prosthetic element (600) is also movable along the lead (200) and maneuverable to achieve proper angulation with the lead.

Description

[Technical field]

[0001] The present disclosure relates to atrioventricular transcatheter valve replacement, and more particularly to transcatheter tricuspid valve replacement for tricuspid regurgitation (regurgitation). [Background technology]

[0002] When a valve in the human heart becomes damaged or diseased, or when the heart itself becomes damaged or diseased, backflow through a one-way valve can occur. This is known as valvular regurgitation. If the backflow continues, it can further weaken the valve and make it more difficult for the heart muscle to move, which can lead to heart failure, cardiac complications, and ultimately death. For damaged valves, such as the aortic valve, transcatheter procedures are used to insert and deploy a replacement valve into the calcified area of ​​the damaged valve and secure the prosthesis while opening the damaged valve. However, there are few or no calcified or solidly secured areas in the vicinity of the atrioventricular valves, especially the tricuspid valve. Percutaneous repair of damaged valves using sutures or other adhesive devices is particularly difficult due to the weakness of the valve tissue or heart muscle in the atrioventricular area, especially the tricuspid valve area. Thus, replacement or repair valves do not have a suitable backing to which they can be attached or secured.

[0003] Thus, repair and replacement of the atrioventricular valves, particularly the tricuspid valve, is more difficult and less effective than repair and / or replacement of other valves, and is more prone to significant residual regurgitation and insufficiency. Furthermore, the atrioventricular valve apparatus, particularly the tricuspid valve, has thin tissue, and the valve and surrounding annular and myocardial tissue are weak and prone to tearing. Furthermore, the myocardium of the ventricles and atria is thinner on the right side of the heart than on the left side, making repair and / or replacement of the tricuspid valve even more difficult, resulting in devices that are more prone to tearing the myocardium, causing rupture and death.

[0004] It is estimated that over 3.5 million patients in the United States are affected by mitral regurgitation and 1.6 million patients are affected by tricuspid regurgitation, with over 80% of patients not being treated during their lifetime. This results in an estimated 350,000-400,000 new cases of mitral regurgitation and 160,000-240,000 new cases of tricuspid regurgitation each year. One reason for the inability to treat patients with mitral and tricuspid valve disease is the high risk of surgical intervention, including poor tolerance to cardiopulmonary bypass and high failure of surgical treatment. Thus, recent data show that patients affected by mitral and tricuspid regurgitation experience a significant excess mortality following the diagnosis of this disease.

[0005] The most common cause of tricuspid regurgitation is functional (with structurally normal leaflets) with enlargement of the tricuspid annulus or right ventricle, often due to other cardiac or pulmonary disorders such as mitral valve disease, heart failure, or pulmonary hypertension. These disorders induce excessive tenting of the heart valve leaflets and / or annular hypertrophy, causing the tricuspid valve to separate and fail to close completely.

[0006] Tricuspid regurgitation may also be caused by organic valve disease (structurally abnormal valve leaflets) such as congenital heart disease (including Ebstein's anomaly), trauma, infection of the heart valve related to illicit drug use (infective endocarditis), chemical toxicity (carcinoid, ergot), post-inflammatory conditions (rheumatic fever) or iatrogenic conditions (pacemakers, biopsy).

[0007] The accepted treatment for tricuspid regurgitation is surgical valve repair or replacement, but this approach is hampered by high operative mortality and frequent recurrence of regurgitation and is rarely used. Regarding transcatheter techniques for the treatment of tricuspid regurgitation, the tricuspid valve has a complex anatomical structure that is difficult to repair and does not provide a reasonable anchor location to hold an implanted prosthetic valve due to the lack of calcium accumulation. Furthermore, the fragile nature of the tricuspid valve leaflets and annulus, as well as the right ventricular myocardium, makes safe implantation and fixation of such treatments as tricuspid valve replacement or repair very challenging. Summary of the Invention [Problem to be solved by the invention]

[0008] This Summary and Abstract herein are provided to present in a simplified form a selection of concepts that are further described below in the Detailed Description. This Summary and Abstract are not intended to identify key features or essential features of the claimed subject matter, nor are they intended to be used as an aid in determining the scope of the claimed subject matter. The claimed subject matter is not limited to implementations that solve any or all of the shortcomings noted in the Background. [Means for solving the problem]

[0009] In one embodiment, the cardiac valve delivery system includes a lead configured to be inserted into the heart through the venous system and having a distal end with a myocardial attachment device, and a transcatheter prosthetic element configured to be delivered along the lead, the transcatheter prosthetic being configured with an anchor element located at an outer edge of the prosthesis and configured to secure the transcatheter prosthesis in place along the lead, and the prosthesis being movable along the lead and maneuverable to achieve proper angulation with the lead.

[0010] In various additional features of this embodiment, the myocardial attachment device includes a screw positionable at an angle of approximately 90 degrees from the longitudinal axis of the distal end. In one embodiment, the myocardial attachment system further includes a mesh deliverable from the distal end, the mesh configured to be secured through the cardiac tissue. The attachment of the lead to the myocardium can be made by hooks or struts deployable through the interventricular septum and / or right ventricular myocardium. The transcatheter prosthesis includes a prosthetic mesh compressible to include a valve element in a compressed state deliverable along the lead.

[0011] In one embodiment, the anchor element includes a central stationary element attached to the prosthetic mesh and a pair of articulating semi-cylindrical wings movably coupled to the central stationary element. The pair of wings are movable between a delivery position in which the wings do not engage the lead and an anchor position in which the wings close around the lead to secure the transcatheter prosthesis to the lead. The anchor element is attached to the prosthetic mesh and can include a loop attached around the lead.

[0012] In another aspect, the prosthetic mesh is conical when uncompressed, has a first opening at the ventricular opening and a second opening larger than the first opening, and is configured to be deployed within the atrium when anchored.

[0013] In another aspect, the transcatheter prosthesis is configured to allow existing valve tissue in the heart to take up residence over the outside of the prosthetic mesh.

[0014] The different features can be combined with each other in different combinations.

[0015] In another embodiment, a transcatheter prosthesis includes a prosthetic mesh compressible to include a valve element in a compressed state deliverable along a lead, and an anchor element configured to secure the transcatheter prosthesis in place along the lead, The transcatheter prosthesis is configurable for delivery along the lead through a vein to the heart by the anchor element.

[0016] In another feature, the anchor element further includes a central immobile element attached to the prosthetic mesh and a pair of articulating semi-cylindrical wings movably coupled to the central immobile element, the pair of wings being movable between a delivery position in which the wings do not engage the lead and an anchor position in which the wings close around the lead to secure the transcatheter prosthesis to the lead.

[0017] The various features can be combined with each other in various combinations.

[0018] This summary is not intended to describe each disclosed embodiment or every implementation of the transcatheter valve leads and valve elements as described herein. Many other novel advantages, features and relationships will become apparent as the specification proceeds. The figures and description that follow more particularly exemplify exemplary embodiments. [Brief description of the drawings]

[0019] [Figure 1A] FIG. 1 is a partial front cutaway view of the human heart. [Figure 1B] FIG. 1 is a partial rear cutaway view of a portion of the human heart. [Diagram 2] FIG. 1 is a partial cutaway view of a human heart illustrating an embodiment of the present disclosure. [Diagram 3] FIG. 2 is a partial cutaway view of a human heart illustrating another embodiment of the present disclosure. [Figure 4] FIG. 4 is an enlarged view of a portion of the heart illustrating the embodiment of FIG. 3. [Diagram 5] 1 is a diagram of a portion of a lead according to an embodiment of the present disclosure. [Figure 6A] FIG. 1 is a perspective view of an expanded valve element according to an embodiment of the present disclosure. [Figure 6B] FIG. 2 is a side view of a crimped valve element according to an embodiment of the present disclosure. [Figure 6C] FIG. 6C is a cross-sectional view of the compressed valve element of FIG. 6B taken along line 6C-6C. [Figure 6D] FIG. 13 is a plan view of an open valve element according to another embodiment of the present disclosure. [Figure 6E] 6D is an illustration of another clamping process of the valve element of FIG. 6C. [Figure 7] 1 is a partial cutaway view of a heart showing one embodiment of a compressed valve element being introduced along a lead according to an embodiment of the present disclosure. [Figure 8] FIG. 8 is a post-expansion view of the prosthetic valve of FIG. 7 in a properly deployed position. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] The present disclosure generally relates to a system for transcatheter treatment of tricuspid regurgitation. The system includes implantation of a support and guiding lead attached to the right side of the heart, in one embodiment at the apex or mid-ventricular septum, although various other locations of interest can be used to complement this implantation site. The lead is inserted in one embodiment through the left or right subclavian vein and superior vena cava via the systemic venous system. In other embodiments, an alternative approach using an initial inferior vena cava approach with lasso capture from the superior vena cava can be considered. Attachment of the lead to the ventricular septal myocardium is in one embodiment fixed using a screw or multiple screws implanted into the ventricular myocardium, preferentially the ventricular septum, and in some embodiments includes placement of a support mesh (or in other embodiments a hook, metal rod or scalloped (wave) device) on the left side of the ventricular septum. In one embodiment, a screw is carried at the end of the lead, and after implantation, the lead is rotated to keep it perpendicular to the implanted screw.

[0021] The lead may in some embodiments be formed from a wider section at the tricuspid annulus or leaflet level that includes an elastic hysteresis system that elastically supports the position of the prosthesis. After implantation and secure attachment of the lead to the ventricular myocardium, the lead serves as a guide for sliding the compressed prosthesis introduced via the same venous approach.

[0022] In one embodiment, the guide system is formed by anchors attached to the outer wall of the compressed prosthesis and carrying approximations of rings, loops or wings that allow the prosthesis to slide over the lead in the compressed state, outside the body of the prosthesis. The compressed prosthesis is thus guided through the superior vena cava and the right atrium to the tricuspid valve. The prosthesis is then moved to a suitable position between the leaflets of the tricuspid valve. Once this position is deemed suitable, the prosthesis is fixed on the lead by tightening a winged system (or a looped or annular guide system) attached to the outer anchors of the compressed prosthesis over the implanted lead. The compressed prosthesis is then deployed, its sides covered by the remnants of the existing tricuspid valve tissue.

[0023] In some embodiments, the prosthesis can be steered using a rotating anchor system, which allows the practitioner to orient the prosthesis to the septal or inferior wall of the ventricle. The implanted prosthesis is made of a nitinol mesh in one embodiment, which is covered by a skirt in some embodiments, and in some embodiments, is frustoconical in shape. The leaflets of the implanted replacement prosthesis in the form of nitinol can be made of human, equine, porcine or bovine tissue or synthetic fabric. The external location of the anchor system ensures interference-free coaptation of the lead through the prosthesis.

[0024] 1A and 1B show a front (FIG. 1A) and rear (FIG. 1B) cross-sectional view of a heart 100. FIGS. 1A and 1B show partial details of the atrioventricular valves (including the mitral valve 102, tricuspid valve 104, pulmonary valve 106, and aortic valve 108) and their operation. The atrioventricular valves of the heart operate to control the flow of blood into and out of the atria (right atrium 110 and left atrium 112) and ventricles (right ventricle 114 and left ventricle 116). The bicuspid (or mitral) valve 102 regulates blood flow from the left atrium 112 to the left ventricle 116 and, in normal operation, prevents blood flow from the left ventricle 116 back into the left atrium 112. The tricuspid valve 104 regulates blood flow from the right atrium 110 to the right ventricle 114 and, under normal operation, prevents blood flow from the right ventricle 114 back into the right atrium 110. When the valves 102, 104 are healthy and working properly, they act as one-way valves. A vein 120 in the body supplies deoxygenated blood to the right atrium 110 of the heart, and a vein 122 supplies oxygenated blood from the lungs. Arteries provide a pathway from the heart to the body, with the pulmonary artery 124 providing a pathway from the right ventricle 114 to the lungs and the aorta 126 providing a pathway from the left ventricle 114 to the rest of the body.

[0025] 1A, the tricuspid valve 104 separates the right atrium 110 from the right ventricle 114. In particular, venous access through the superior vena cava 120 provides a direct path to the right atrium, right ventricle, and tricuspid valve. Note that the wall of the right ventricle 114 is much thinner than that of the left ventricle 116.

[0026] 1B, a normal tricuspid valve is best seen on the right with its three leaflets. In the case of tricuspid regurgitation, the leaflets exhibit incomplete coaptation during systole, resulting in regurgitation.

[0027] As the heart 100 beats, blood is pumped into the atria (right 110 and left 114) of the heart 100, exits the ventricles (via the pulmonary valve 106 and aortic valve 108), and exits the right ventricle 114 and left ventricle 116. When the right atrium 110 contracts, blood collected in the right atrium 110 is forced through the tricuspid valve 104 into the right ventricle 114. At the same time, the left atrium 112 contracts, forcing blood collected in the left atrium 112 through the mitral valve 102 into the left ventricle 116. The right ventricle 114 and left ventricle 116 then contract, forcing blood in the right ventricle 114 and left ventricle 116 through the pulmonary valve 106 and aortic valve 108, respectively, into the pulmonary artery 124 and aorta 126. The pericardium, or heart wall 128, is the outer sheath (covering) of the heart. The interventricular septum 130 separates the right ventricle 114 and the left ventricle 116. A normally functioning valve allows one-way blood flow.

[0028] 2 illustrates the insertion of a lead 200 via the superior vena cava 120 into the right atrium 110 and through the tricuspid valve 104 into the right ventricle 114. Such introduction and positioning of the lead 200 allows for subsequent replacement and / or repair of the tricuspid valve 104. This transcatheter insertion of the lead 200, in one embodiment, positions the lead 200 having an end 202 in contact with the interventricular septum 130 and into the right ventricle 114. In one embodiment, the lead 200 guides and supports a transcatheter prosthesis.

[0029] The catheter lead 200 is introduced through the superior vena cava 120 and advanced through the right atrium 110 and right ventricle 114 into intimate contact with the interventricular septum 130. In other embodiments, the lead 200 can be introduced through the inferior vena cava and captured by a lasso introduced through the superior vena cava 120.

[0030] Figure 3 shows the view of Figure 2 with a screw 204 placed on the end 202 of the lead 200. The screw 204 is threaded into and attached to the apex of the ventricular septum 130. In one embodiment, the end 206 of the screw 204 that extends into the apex of the ventricular septum 130 carries a mesh 208 that is positioned from the screw 204 to provide a backing on the right ventricle 116 side of the ventricular septal apex.

[0031] The head 202 of the catheter is apposed against the ventricular septum 30. This positioning allows a screw 204 attached to the head of the catheter / lead to be introduced into the ventricular septum 130 to securely attach the lead 200 to the ventricular septum 130. In other embodiments, other methods of attaching the lead to the ventricular septum 130 can be used, such as hooks, metal rods, or scalloped devices used to secure the attachment of the lead 200 to the ventricular septum 130. The attachment can be further secured by placing a mesh 208 from the tip 206 of the screw 204 to the left ventricular side of the septum. In other embodiments, the mesh 208 can be replaced with any type of restraining device that holds the left side of the ventricular septum 130 to prevent slippage of the septal attachment device or tearing of the myocardium.

[0032] Figure 4 is an enlarged view of a portion of the heart 100 of Figure 3 showing the lead 200, end 202, screw 204 with end 206, and mesh 208. It can be seen that the end 202 of the lead is in close apposition to the right side of the interventricular septum 130, delivering an attachment device (screw shown at 204 or any other embodiment) with material (mesh shown at 208, or other embodiment of a septal contention device) that may be for contention of the left side of the septum.

[0033] 5 illustrates one embodiment of a lead 200. A proximal portion 502 of the lead has a first diameter 503, which in one embodiment is approximately the diameter of the body of the lead 200, near the end 202 of the lead 200 where the screw 504 is located, and a middle portion 504 of the lead 200 has a diameter that changes from diameter 505A to diameter 505B between the proximal portion 502 and the distal portion 506. This middle portion 504 allows for hysteretic elongation of the elastic system. The distal portion 506 of the lead 200 has a diameter 507 smaller than the first diameter 503 to accommodate the screw 204 for myocardial implantation, such as in the ventricular septum 130, as described elsewhere herein.

[0034] In one embodiment, the screw 204 is used for implantation, for example, into the cusp of the ventricular septum 130 to secure a lead for placement of a replacement tricuspid valve. Although a diameter of the lead 200 is described as being tubular, it should be understood that the lead 200 may have different cross-sectional shapes, such as generally tubular, elliptical, etc. One skilled in the art will recognize that any cardiac catheter through which a lead can be inserted is suitable for use with the embodiments of the present disclosure.

[0035] The intracardiac portion of the lead 200 is shown diagrammatically in three parts, the distal part 202 (tip 507) of the lead carries a myocardial attachment device (screw 204 or other embodiment). In other embodiments of this part of the lead, the myocardial attachment device (screw or other) is placed at the tip of the lead in the myocardial insertion direction and rotated at an angle (closest to 90°) to ensure a traction force perpendicular to the myocardial insertion. The tip 206 of the screw 204, or in other embodiments, other types of myocardial insertion, can place the myocardial competitor on the left side of the ventricular septum. The intermediate / middle part of the lead 505A-B continues to the distal part of the lead and includes a hysteresis mechanism for damping the traction exerted by the prosthetic valve during systole. The hysteresis mechanism can be formed by a spring, a hydraulic system, a solenoid or other electrical system, or any other embodiment that dampens the traction force. The proximal part of the lead 503 is intended for fixation of a transcatheter prosthesis and is enlarged to provide a more secure grip on the fixation of the prosthesis.

[0036] In one embodiment, a portion of the lead 200 includes a damping element configured to dampen forces pushing the prosthesis backwards during systole of the heart. Such a damping element can be, by way of example and not limitation, one of a spring, a fluid, a semi-solid buffer, or an elastic element formed by a loop of the lead.

[0037] FIG. 6A is a diagram of an expanded valve element 600 that can be delivered via a transcatheter approach on the lead 200 shown above. The valve element 600 includes a frame 602 with anchors 604 attached. The anchors 604 have wings 606 on both sides of the frame. In one embodiment, the frame 602 includes a cone-shaped frame constructed of nickel titanium (e.g., Nitinol) and a prosthetic valve, such as a tissue valve of equine, ovine, bovine, porcine or human tissue, or a tissue valve of artificial material. The properties of Nitinol are well known, as are their uses in repairing and / or implanting valves. Attached to an outer portion of the Nitinol frame 602 are anchors 604. The anchors 604 are used to support the Nitinol frame 602 and tissue or other prosthetic valve as a frame that comprises and / or includes the prosthetic valve, and are introduced through the lead 200. In one embodiment, a pair of wings 606 are attached laterally to the anchor 604, one wing 606 attached to each side of the anchor 604. The valve element 600 is expanded when the frame 602 is introduced into the heart along with the lead 200 in a compressed form and properly aligned with the area where the valve is to be implanted / repaired. The nitinol frame 602 is expanded once properly positioned within the heart, as shown below. The valve element 600 is shown in FIG. 6A for a tricuspid valve repair / implantation between the right atrium 110 and the right ventricle 114. Blood flow from the atrium 110 to the ventricle 114 is shown moving in the direction of the arrow 620. The expanded nitinol frame 602 is cone-shaped in one embodiment, with a larger cross-sectional area 608 at the valve and tapering toward the right ventricle 114.

[0038] The transcatheter prosthesis 600 is shown in FIG. 6A in a perspective view showing the right ventricular opening at the top. It is formed by a mesh of metal (Nitinol or other metal) that results in a cone shape 602 when deployed. The ventricular opening is the smallest opening of the cone 610, and the base of the cone 608 is deployed to be in the atrium when anchored. The leaflets of the implanted / repaired valve are located inside the metal mesh, which in various embodiments can be formed by equine, bovine or porcine tissue, or synthetic textiles. Various embodiments include the presence of a skirt that covers the outer surface of the metal mesh that supports the leaflets. The anchoring mechanism 604 is located on and attached to the outer surface of the metal mesh. The anchoring mechanism 604 as shown includes a central immobile element attached to the metal mesh, to which are attached two articulated semi-cylindrical wings 606 that close around the lead 200 when implanted to anchor the prosthesis to the lead 200. These wings 606 are in a semi-closed state on the lead 200 to guide the prosthesis over the lead 200 to the tricuspid valve opening during venous insertion of the compressed prosthesis in a venous guide needle. In another embodiment, the anchoring mechanism is formed by a loop attached to the prosthetic anchor. The loop is placed around the lead and introduced with the prosthesis to allow guidance to the appropriate position and fixation by tightening the loop on the lead. The shape of the prosthesis is intended to allow the existing valve tissue to take a position on the outside of the prosthesis cone and prevent backflow around the prosthesis. This anchoring process therefore allows the leaflets to avoid interference in the prosthesis and allows the positioning of the prosthesis to be adjusted to avoid excessive intraventricular protrusion.

[0039] FIG. 6B is a side view of the valve element 600 of FIG. 6A , showing an unexpanded Nitinol frame 602 containing a prosthetic valve, an anchor 604 to which the frame 602 is attached or otherwise attached, and curved wings 606 that can be wrapped around the lead 200 to introduce the valve element 600 into the body along the lead.

[0040] The view in Fig. 6B is from a lateral position to the anchor mechanism, showing the interaction of the lead 200 with the anchor mechanism. The lead is oriented horizontally with the right ventricle 114 to the right and the right atrium 110 to the left. At the bottom, the mesh of the prosthesis 610 is shown with a central anchor 604 attached to it. One semi-cylindrical wing 606 can be seen wrapping around and securing the lead 200. In other embodiments, the anchor 604 is attached to a loop that encircles the lead, allowing the prosthesis to slide along the lead and that can be tightened around the lead to ensure full fixation of the anchor.

[0041] Figure 6C is a view of the valve element 600 and lead 200 of Figure 6B along line 6C-6C. Figure 6C shows wings 606 that wrap around and clamp the lead 200 when the valve element 600 is in place in the heart. In this view, the prosthesis in a compressed state is seen on top of an anchor 604, which has two semi-cylindrical wings 606 attached to it that surround the lead 200.

[0042] 6D is a diagram of another embodiment of a valve element 650. In the valve element 650, the included nitinol frame 602 and prosthetic valve are the same as the valve element 600. The wings 606 of the valve element 650 are the same as the wings 606 of the valve element 600. However, the anchors 604 are replaced with anchors 654 that allow for manipulation or rotation of the valve element 650 to improve the ability of the valve element 654 to be properly positioned in its position within the heart. In particular, the anchors 654 are maneuverable using a rotation system to orient the valve element frame 602 toward the septal or inferior wall of the ventricle. The anchors 654 include two anchor components, an upper anchor 656 and a lower anchor 658. To allow for maneuverability and proper positioning of the valve element 650 within the heart, the upper anchor 656 and the lower anchor 658 are movable relative to one another.

[0043] The cross section shows the anchor with two articulating portions, an upper portion 656 attached to the prosthetic mesh and a lower portion 658 attached to the semi-cylindrical wings 606 that orient and secure the prosthesis to the lead 200. This embodiment allows the deployed prosthesis to be properly septally oriented by rotation, minimizing ventricular and proper valvular interaction of the prosthesis and minimizing regurgitation around the prosthesis. Two semi-cylindrical wings 606 are shown surrounding the lead 200.

[0044] Although curved wings 606 are shown, it should be understood that different structures for guiding the valve element 600 into the area of ​​the tricuspid valve 104 (or other valve) can be used without departing from the scope of the present disclosure. By way of example and not limitation, the valve element 670 shown in FIG. 6E includes a ring 672 instead of the wings 606. Similar to the wings 606, the ring 672 can be tightened to fix its position along the lead 200.

[0045] In this cross-sectional view, FIG. 6E shows an anchoring mechanism that includes a loop, and once the valve is in place (guided by the loop around the lead), the loop tightens around the lead to ensure proper fixation.

[0046] 7 is a cutaway view of the heart 100 with the lead 200 secured within the ventricular septum 130 by the screw 204. In operation, the lead 200 is implanted as previously described, in one embodiment through the superior vena cava into the right atrium 110, through the tricuspid valve 104 into the right ventricle 114, and attached to the ventricular septum 130 by the screw 204 in an orientation approximately perpendicular to the orientation of the lead 200 insertion. Thus, any pulling or tension along the longitudinal axis of the lead 200, which is the most likely pulling or tension direction, is approximately perpendicular to the anchor and is less likely to pull out, move, or become dislodged than a parallel anchor. As shown, the valve elements 600, 650, 670 are introduced along the lead 200 toward the tricuspid valve region. The valve elements 600, 650, 670 are shown in a compressed configuration to facilitate introduction through a vein, such as the superior vena cava 120.

[0047] In operation, the lead 200 is implanted as previously described and, in one embodiment, passes through the superior vena cava into the right atrium 110, through the tricuspid valve 104 into the right ventricle 114, and is attached to the ventricular septum 130 by the screw 204 in an orientation approximately perpendicular to the orientation of insertion of the lead 200. Thus, any pulling or tension along the longitudinal axis of the lead 200, which is the most likely direction of pulling or tension, will be approximately perpendicular to the anchor and less likely to pull out, migrate, or become dislodged than a parallel anchor.

[0048] The compressed prosthesis 600, 650, 670 is attached to a previously inserted lead 200, which was secured by a screw 204 in the ventricular septum 130 during initial insertion. This attachment allows it to slide over the lead 200, which is ensured by an anchor (loop or semi-cylindrical wing) that is partially closed around the lead 200. The lead 200 guides the compressed prosthesis through the superior vena cava 120, where the prosthesis is seen after it has advanced into the right atrium 110.

[0049] 8 is a cutaway view of the heart 100 with the lead 200 secured within the ventricular septum 130 by the screws 204. Once the valve elements 600, 650, 670 are in the proper position relative to the tricuspid valve 104, the nitinol frame 602 of the valve elements is expanded and any adjustments that need to be made for proper placement of the prosthetic valve are made. Once this is done, the wings 606 or ring 674 are tightened against the lead 200, fixing the position of the valve elements 600, 650, 670 along the lead 200.

[0050] The transcatheter tricuspid valve prosthesis 602 is shown occupying the tricuspid valve orifice 104 after being fully expanded. Its frustoconical shape allows the atrial orifice 608 to be larger than the ventricular orifice 610, reducing impingement into the right ventricle 114 while supporting the tricuspid valve and avoiding regurgitation around the prosthesis. This shape also accelerates blood flow and prevents the formation of blood clots. The prosthesis anchors are tightened on the lead 200 after proper placement and can be manipulated as previously described to change the angulation of the prosthesis relative to the ventricular septum.

[0051] As previously described, the valve elements 600, 650, 670 are introduced along the lead, with the valve elements 600, 650, 670 laterally offset from the lead so that they are adjacent to the lead 200. In contrast, valve elements introduced centrally around the lead, i.e., surrounding the lead, must deal with repeated impacts of the valve elements on the lead itself. Such centrally located leads that run through the center of the prosthetic valve suspend the valve from the lead. Thus, tissue elements of the prosthetic valve may impact the rigid structure of the lead, damaging the prosthetic valve leaflets and ultimately causing failure or damage. In contrast, the valve elements of the present disclosure do not impact the lead during actuation, and are therefore much less susceptible to damage and eventual failure due to impacts on hard materials.

[0052] Thus, an embodiment of the present disclosure provides a heart valve delivery system, comprising a myocardial attachment system that is introduced via a vein to the right ventricle of the heart and implanted through the septal myocardium from the right side of the interventricular septum and can have a secondary attachment point on the adjacent myocardium of the interventricular septum or on the right ventricle, a lead configured to be inserted via the venous system leading to the heart and having a distal (or near-distal) end at the myocardial attachment system and capable of being oriented perpendicular (or near 90 degrees) to the myocardial attachment system, and a transcatheter prosthetic element configured to be delivered in a compressed state using a guide along the lead by a guide system arranged at the outer edge of the transcatheter prosthesis. The placement of the prosthesis in the tricuspid valve is ensured by an anchor element configured to fix the transcatheter prosthesis in place along the lead.

[0053] In other embodiments, the myocardial attachment device includes a screw positionable at an angle of approximately 90 degrees from the longitudinal axis of the distal end. Alternatively, the myocardial attachment system may be comprised of hooks, rods or struts that are placed into the septal myocardium and / or adjacent right ventricular myocardium.

[0054] In other aspects, the myocardial attachment system further comprises a mesh deliverable from the distal end (or a hook, rod or any other additional anchor system positionable to the left of the ventricular septum), the mesh configured to be secured via or by pressure to the cardiac tissue.

[0055] In other embodiments, the transcatheter prosthesis includes a prosthetic mesh that is compressible to include a valve element in a compressed state that is deliverable along a lead by a guide system disposed on the periphery of the prosthesis.

[0056] In another aspect, the guide and anchor element of the prosthesis includes a central immobile element attached to the prosthetic mesh and a pair of articulating semi-cylindrical wings movably coupled to the central immobile element, the pair of wings being movable between a delivery position in which the wings do not engage the lead and an anchor position in which the wings close around the lead to secure the transcatheter prosthesis to the lead. Alternatively, the guide and anchor element includes a central immobile element attached to the prosthetic mesh and a loop attached to the prosthetic mesh and attached around the lead.

[0057] In other embodiments, the prosthetic mesh is conical when uncompressed, has a first opening at the ventricular opening and a second opening larger than the first opening, and is deployed within the atrium when anchored.

[0058] The transcatheter prosthesis may be configured to allow existing valve tissue in the heart to take up residence over the outside of the prosthetic mesh.

[0059] In other aspects, the lead for guiding and supporting the transcatheter prosthesis includes a spring, a fluid, a semi-solid buffer, or an elastic element formed by a loop of the lead, so as to be able to attenuate the force pushing the prosthesis backward during systole, or the lead for guiding and supporting the transcatheter prosthesis is wider in any part of its body, so as to improve fixation of the prosthesis to the lead.

[0060] In another embodiment, a transcatheter prosthesis includes a prosthetic mesh compressible to include a compressed valve element deliverable along a lead and an anchor element configured to secure the transcatheter prosthesis in place along the lead, the transcatheter prosthesis being configurable to be delivered intravenously along the lead to the heart by the guide and anchor element.

[0061] In another aspect, the anchor element further comprises a central immobile element attached to the prosthetic mesh, a movable steerable secondary element, and a pair of articulating semi-cylindrical wings movably coupled to the central immobile element, the pair of wings being movable between a delivery position in which the wings do not engage the lead and an anchor position in which the wings close around the lead to secure the transcatheter prosthesis to the lead. This steerable guide and anchor system allows the prosthesis to be oriented against the myocardial wall and allows flow direction to be optimized.

[0062] Having an anchor in the heart is important for other devices that can be used for devices related to repair, i.e. leads are used to support devices that pull on the annulus or replace the valve, or devices that are spacers in the center of the valve where leakage may occur. The force applied to the spacer in the center of the valve is very large and is repeated with each beat of the heart. The ability to place a properly anchored device using embodiments of the present disclosure is another advantage of the present disclosure.

[0063] While the disclosure has been primarily discussed herein with respect to the repair and / or replacement of tricuspid valves, it should be understood that embodiments of the disclosure may be used to repair or replace additional valves, with minor modifications that would be apparent to one of ordinary skill in the art, and without departing from the scope of the disclosure. For example, embodiments of the heart valve delivery system and transcatheter prosthesis may be used to repair and / or replace the mitral valve of the heart. In mitral valve embodiments, the implantation route may be different.

[0064] In one embodiment, the mitral valve repair / replacement is transseptal; that is, implantation of a valve attached to the ventricular septum into the mitral valve is suitable for implementation according to embodiments of the present disclosure. However, in such a procedure, the lead cannot be manipulated from the superior vena cava to the transseptal puncture. Therefore, a needle is introduced via the inferior vena cava. The lead 200 is captured with the needle used for the transseptal puncture and attached to the septum from the left atrium. The structure and operation of the transcatheter prostheses and leads are suitable for such use without departing from the scope of the present disclosure.

[0065] Additionally, implantation of such anchors on the left or right side of the heart for mitral and / or tricuspid valve repair or treatment is also suitable for use with embodiments of the present disclosure.

[0066] Also, the embodiments of the present disclosure can be implemented in various variations of the examples shown herein and the aspects of the present disclosure highlighted above.

Claims

1. A transcatheter delivery system comprising: a support and guiding lead configured to be inserted through a venous system leading to a heart and attached to the heart, the support and guiding lead having a distal end; a myocardial attachment system attached to a distal end of the supporting and guiding lead, the myocardial attachment system being configured to be introduced via a vein together with the supporting and guiding lead to a right ventricle of the heart and implanted into the ventricular septum from the right side of the heart using an anchor; a transcatheter prosthetic element configured to be delivered in a compressed state using a guide along the supporting and guiding lead, the transcatheter prosthetic element having a guide system arranged on an outer edge of the transcatheter prosthetic element and configured to be capable of manipulating the transcatheter prosthetic element; Including, the myocardial attachment system includes a screw positionable at a 90 degree angle from a longitudinal axis of the distal end; the myocardial attachment system further comprising a mesh deliverable from a distal end thereof, the mesh configured to be secured by pressure through or to cardiac tissue; the transcatheter prosthetic element comprises a prosthetic mesh compressible to include a valve element in a compressed state deliverable along the support and guiding lead by the guide system disposed on the outer edge of the transcatheter prosthetic element; the prosthetic mesh is conical when uncompressed, has a first opening at the ventricular opening and a second opening larger than the first opening, and is deployed within the atrium when anchored; Transcatheter delivery system.

2. The transcatheter delivery system of claim 1, wherein positioning of the transcatheter prosthetic element is ensured by an anchor element configured to secure the transcatheter prosthetic element in place along the supporting and guiding lead.

3. 10. The transcatheter delivery system of claim 1, wherein the myocardial attachment system further comprises hooks, rods, scallops and struts positionable to the left of the ventricular septum.

4. The transcatheter delivery system of claim 1, wherein the supporting and guiding lead is wider along its body to improve fixation of the transcatheter prosthetic element to the supporting and guiding lead.

5. The anchor element is a central immobile element attached to the prosthetic mesh; a movable and operable secondary element; The transcatheter delivery system of claim 2 , further comprising:

6. A transcatheter delivery system comprising: a support and guiding lead configured to be inserted through a venous system leading to a heart and attached to the heart, the support and guiding lead having a distal end; a myocardial attachment system attached to a distal end of the supporting and guiding lead, the myocardial attachment system being configured to be introduced via a vein together with the supporting and guiding lead to a right ventricle of the heart and implanted into the ventricular septum from the right side of the heart using an anchor; a transcatheter prosthetic element configured to be delivered in a compressed state using a guide along the supporting and guiding lead, the transcatheter prosthetic element having a guide system arranged on an outer edge of the transcatheter prosthetic element and configured to be capable of manipulating the transcatheter prosthetic element; Including, The guide system of the transcatheter prosthetic element comprises: a central immobile element attached to the prosthetic mesh; a pair of articulated semi-cylindrical wings movably coupled to the central stationary element, the pair of wings being movable between a delivery position in which the wings do not engage the supporting and guiding leads and an anchor position in which the wings close around the supporting and guiding leads to secure the transcatheter prosthetic element to the supporting and guiding leads; 13. A transcatheter delivery system comprising:

7. The transcatheter delivery system of claim 6 , wherein the supporting and guiding lead is positionable perpendicular to the myocardial attachment system.

8. The transcatheter delivery system of claim 6 , wherein the myocardial attachment system includes a screw positionable at a 90 degree angle from a longitudinal axis of the distal end.

9. 10. The transcatheter delivery system of claim 8, wherein the myocardial attachment system further comprises a mesh deliverable from a distal end, the mesh configured to be secured by pressure through or to cardiac tissue.

10. 10. The transcatheter prosthetic delivery system of claim 9, wherein the transcatheter prosthetic element is configured to allow existing valve tissue in the heart to occupy an exterior of the prosthetic mesh.

11. A transcatheter delivery system comprising: a support and guiding lead configured to be inserted through a venous system leading to a heart and attached to the heart, the support and guiding lead having a distal end; a myocardial attachment system attached to a distal end of the supporting and guiding lead, the myocardial attachment system being configured to be introduced via a vein together with the supporting and guiding lead to a right ventricle of the heart and implanted into the ventricular septum from the right side of the heart using an anchor; a transcatheter prosthetic element configured to be delivered in a compressed state using a guide along the supporting and guiding lead, the transcatheter prosthetic element having a guide system arranged on an outer edge of the transcatheter prosthetic element and configured to be maneuverable relative to the supporting and guiding lead; Including, the myocardial attachment system includes a screw positionable at a 90 degree angle from a longitudinal axis of the distal end; the myocardial attachment system further comprising a mesh deliverable from a distal end thereof, the mesh configured to be secured by pressure through or to cardiac tissue; the transcatheter prosthetic element comprises a prosthetic mesh compressible to include a valve element in a compressed state deliverable along the support and guiding lead by the guide system disposed on the outer edge of the transcatheter prosthetic element; The guide system comprises: a central immobile element attached to the prosthetic mesh; a ring attached to the prosthetic mesh and attached around the support and guiding lead; 13. A transcatheter delivery system comprising:

12. 12. The transcatheter delivery system of claim 11, wherein the myocardial attachment system includes a secondary attachment point on an adjacent myocardium of the interventricular septum.

13. The transcatheter delivery system of claim 11 , wherein the myocardial attachment system includes a secondary attachment point on the left ventricle.

14. 12. The transcatheter delivery system of claim 11, wherein the myocardial attachment system includes at least one of a hook, a rod, or a post positioned in the septal myocardium and / or adjacent left ventricular myocardium.

15. 1. A transcatheter prosthesis comprising: a prosthetic mesh compressible to include a valve element in a compressed state deliverable along a supporting and guiding lead; an anchor element configured to fix the transcatheter prosthesis in place on the support and guiding lead and to be able to manipulate the transcatheter prosthesis, the anchor element having a rotating anchor system configured to be able to manipulate the valve element relative to the support and guiding lead; Including, the anchor element is configurable for delivery along the support and guiding lead through a vein to a heart; The anchor element further comprises: a central immobile element attached to the prosthetic mesh; a movable and operable secondary element; a pair of articulated semi-cylindrical wings movably coupled to the central stationary element, the pair of wings being movable between a delivery position in which the wings do not engage the supporting and guiding leads and an anchor position in which the wings close around the supporting and guiding leads to secure the transcatheter prosthesis to the supporting and guiding leads.

16. The transcatheter prosthesis of claim 15, wherein the anchor element enables the transcatheter prosthesis to be oriented to the myocardial wall by the maneuverable guide and anchor system, thereby improving flow direction.

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