Double heart valve anchoring

Abstract

To provide a heart valve device comprising a tricuspid valve device and a mitral valve device, which is advantageous for patients suffering from dysfunction in the tricuspid valve and the mitral valve.SOLUTION: A double heart valve anchoring system includes: a first anchor having at least a portion configured to be secured into a first trans-septal opening in an interventricular septum; a tricuspid valve device coupled to the first anchor; and a mitral valve device coupled to the first anchor.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] Any and all applications for which a foreign or domestic priority claim is identified in an Application Data Sheet filed with this application are hereby incorporated by reference under 37 CFR 1.57. This application claims priority to U.S. Provisional Patent Application No. 62 / 811,453, entitled DOUBLE HEART VALVE ANCHORING, filed February 27, 2019, the disclosure of which is incorporated by reference herein in its entirety.

[0002] The present disclosure relates generally to the field of medical implant devices. [Background technology]

[0003] Implantation of heart valve devices may be performed to address a variety of heart valve abnormalities. Implantation of both the tricuspid and mitral valve devices may be beneficial for patients suffering from dysfunction in both valves. Summary of the Invention [Means for solving the problem]

[0004] Described herein are one or more methods and / or devices for anchoring both a tricuspid valve device and a mitral valve device to the septum. In some implementations, the present disclosure relates to a dual heart valve anchoring system comprising a first anchoring portion having at least a portion configured to be secured within a first transseptal opening in the interventricular septum, a tricuspid valve device coupled to the first anchoring portion, and a mitral valve device coupled to the first anchoring portion.

[0005] In some embodiments, the tricuspid valve apparatus comprises a tricuspid valve replacement and the mitral valve apparatus comprises a mitral valve replacement. The first coupler can extend between the tricuspid valve replacement and the mitral valve replacement and is configured to couple the tricuspid valve replacement and the mitral valve replacement to the first anchor and to extend through the first transseptal opening.

[0006] In some embodiments, the dual heart valve anchoring system may include a second connector extending between and coupling the tricuspid and mitral valve replacements. Both the first connector and the second connector may couple the tricuspid and mitral valve replacements to the first anchoring portion, and both the first connector and the second connector may be configured to extend through the first transseptal opening.

[0007] In some embodiments, the dual heart valve anchoring system can include a second anchoring portion having at least a portion configured to be secured within a second transseptal opening in the ventricular septum, and a second connector couples the tricuspid valve replacement portion and the mitral valve replacement portion to the second anchoring portion, the second connector configured to extend through the second transseptal opening.

[0008] A respective end of at least one of the first and second couplers may be coupled to a portion of the tricuspid valve replacement configured to be positioned in the right ventricle and a portion of the mitral valve replacement configured to be positioned in the left ventricle. In some embodiments, a respective end of at least one of the first and second couplers is coupled to a distal end of the tricuspid valve replacement configured to be positioned in the right ventricle and a distal end of the mitral valve replacement configured to be positioned in the left ventricle.

[0009] In some embodiments, the length of at least one of the first coupler and the second coupler is adjustable. The dual heart valve anchoring system may further comprise at least one locking mechanism for locking at least one of the first coupler and the second coupler at a respective selected length.

[0010] In some embodiments, the length of at least one of the first coupler and the second coupler is selected prior to implantation.

[0011] In some embodiments, at least one of the first coupler and the second coupler comprises a Nitinol wire.In some embodiments, at least one of the first coupler and the second coupler is a flexible cord.

[0012] In some embodiments, at least one of the first coupler and the second coupler comprises a rigid coupler portion configured to extend through the septum into at least one of the right and left ventricles to provide a predetermined angle of septal anchoring for the tricuspid and mitral valve replacements.

[0013] In some embodiments, at least one of the first anchor portion and the second anchor portion comprises a rigid anchor portion configured to extend into at least one of the right and left ventricles to provide a predetermined angle of septal anchoring for the tricuspid and mitral valve replacements.

[0014] In some embodiments, the tricuspid valve apparatus comprises a tricuspid valve replacement and the mitral valve apparatus comprises a mitral valve repair.

[0015] In some embodiments, the tricuspid valve apparatus comprises a tricuspid valve repair and the mitral valve apparatus comprises a mitral valve replacement.

[0016] In some embodiments, the tricuspid valve device comprises a tricuspid valve repair and the mitral valve device comprises a mitral valve repair. The tricuspid valve repair can comprise a first connector configured to couple the tricuspid valve leaflet to the first anchor, and the mitral valve repair can comprise a second connector to couple the mitral valve leaflet to the first anchor. In some embodiments, the dual heart valve anchoring system comprises a connector to couple the tricuspid valve repair to the mitral valve repair, the connector configured to couple to the first anchor and extend through the first transseptal opening. In some embodiments, the tricuspid valve repair and the mitral valve repair comprise connectors, the connector configured to couple the tricuspid valve leaflet and the mitral valve leaflet to the first anchor and extend through the first transseptal opening.

[0017] In some implementations, the present disclosure relates to a dual heart valve anchoring system comprising a tricuspid valve replacement, a mitral valve replacement, and a first connector connecting the tricuspid valve replacement and the mitral valve replacement and configured to extend through a first transseptal opening in the ventricular septum.

[0018] In some embodiments, the dual heart valve anchoring system may include a second connector coupling the tricuspid valve replacement and the mitral valve replacement. In some embodiments, both the first connector and the second connector are configured to extend through the first transseptal opening. In some embodiments, the second connector is configured to extend through the second transseptal opening.

[0019] A respective end of at least one of the first and second couplers may be coupled to a portion of the tricuspid valve replacement configured to be positioned in the right ventricle and a portion of the mitral valve replacement configured to be positioned in the left ventricle. A respective end of at least one of the first and second couplers may be coupled to a distal end of the tricuspid valve replacement configured to be positioned in the right ventricle and a distal end of the mitral valve replacement configured to be positioned in the left ventricle.

[0020] In some embodiments, the length of at least one of the first coupler and the second coupler is adjustable. The dual heart valve anchoring system may further comprise at least one locking mechanism for locking at least one of the first coupler and the second coupler at a respective selected length.

[0021] In some embodiments, the length of at least one of the first coupler and the second coupler is selected prior to implantation.

[0022] In some embodiments, at least one of the first coupler and the second coupler comprises a Nitinol wire.In some embodiments, at least one of the first coupler and the second coupler is a flexible cord.

[0023] In some embodiments, at least one of the first coupler and the second coupler comprises a rigid coupler portion configured to extend through the interventricular septum into at least one of the right and left ventricles to provide a predetermined angle of septal anchoring for the tricuspid and mitral valve replacements.

[0024] In some implementations, the present disclosure relates to a method of replacing tricuspid and mitral valves. The method may include introducing a delivery catheter carrying a dual heart valve anchoring system into the right atrium through the inferior or superior vena cava. The dual heart valve anchoring system may include a tricuspid valve replacement, a mitral valve replacement, and a first connector that couples the tricuspid valve replacement and the mitral valve replacement. The delivery catheter may be advanced from the right atrium through an opening formed by the native tricuspid valve into the right ventricle. The delivery catheter may then be threaded through a transseptal opening in the ventricular septum to insert the delivery catheter from the right ventricle into the left ventricle. The distal end of the delivery catheter may be positioned at a target site for the mitral valve replacement, and the mitral valve replacement may be released at the target site for the mitral valve replacement. The delivery catheter may be retracted through the left ventricle, the transseptal opening into the right ventricle. A portion of each of the first couplers can be released in the left ventricle, the transseptal opening, and the right ventricle while retracting the delivery catheter through the left ventricle, the transseptal opening, and into the right ventricle After retracting the delivery catheter into the right ventricle, the distal end of the delivery catheter can be positioned at a target site for the tricuspid valve replacement, and the tricuspid valve replacement can be released at the target site for the tricuspid valve replacement.

[0025] In some embodiments, introducing the delivery catheter includes introducing the delivery catheter through the inferior vena cava.

[0026] In some embodiments, introducing the delivery catheter includes introducing a dual heart valve anchoring system including an anchor portion, the anchor portion being between the tricuspid valve replacement portion and the mitral valve replacement portion and coupled to the first connector. Retracting the delivery catheter may include releasing at least a portion of the anchor portion at the transseptal opening. Releasing at least a portion of the anchor portion at the transseptal opening may include sealing the transseptal opening.

[0027] In some embodiments, introducing the delivery catheter includes introducing a delivery catheter carrying a dual heart valve anchoring system with a second connector coupling the tricuspid valve replacement and the mitral valve replacement. The method may include releasing a portion of each of the second connectors in the left ventricle, the transseptal opening, and the right ventricle while retracting the delivery catheter through the left ventricle, the transseptal opening, and into the right ventricle.

[0028] In some embodiments, the method may include adjusting a length of at least one of the first coupler and the second coupler after the step of introducing the delivery catheter, and the locking mechanism may be actuated to secure at least one of the first coupler and the second coupler at a respective selected length after adjusting the length.

[0029] For the purpose of summarizing this disclosure, certain aspects, advantages, and novel features are described herein. It is understood that not all such advantages may be achieved by any particular embodiment. Thus, the disclosed embodiments may be implemented in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

[0030] Various embodiments are depicted in the accompanying drawings for illustrative purposes, but should not be construed as limiting the scope of the present invention. Alternatively, various features of different disclosed embodiments can be combined to form additional embodiments that are part of this disclosure. Reference numerals may be reused throughout the drawings to indicate correspondence between reference elements. However, it should be understood that the use of the same reference numeral in association with multiple drawings does not necessarily include similarities between the respective embodiments associated therewith. Furthermore, it should be understood that the features of each drawing are not necessarily to scale, and that their depicted dimensions are presented for purposes of illustrating aspects of the invention. In general, some of the depicted features may be relatively smaller than depicted in some embodiments or configurations. [Brief description of the drawings]

[0031] [Figure 1] 1 is a cross-sectional view of the human heart. [Diagram 2] FIG. 1 is a schematic diagram of an example of a dual heart valve anchoring system comprising two heart valve replacements. [Diagram 3] FIG. 3 is a schematic diagram showing the dual heart valve anchoring system of FIG. 2 positioned at a target site in the heart. [Figure 4] FIG. 13 is a schematic diagram of an example of a dual heart valve anchoring system positioned at a target site and without an anchor. [Figure 5A] FIG. 1 is a schematic diagram of an example of a dual heart valve anchoring system with an adjustable coupler positioned at a target site. [Figure 5B] 13A-13C are schematic diagrams of example locking mechanisms for fixing the adjustable coupler at a selected length. [Figure 6] FIG. 1 is a schematic diagram of a dual heart valve anchoring system positioned at a target site and including a coupler that includes a rigid or semi-rigid portion. [Figure 7A]FIG. 1 is a schematic diagram of a dual heart valve anchoring system positioned at a target site and comprising anchoring portions each comprising a rigid or semi-rigid portion configured to extend into the left and right ventricles. [Figure 7B] FIG. 7B is a schematic diagram of the anchoring portion described with reference to FIG. 7A. [Figure 8] FIG. 1 is a schematic diagram of a dual heart valve anchoring system with three connectors positioned at a target site. [Figure 9] FIG. 1 is a schematic diagram of a dual heart valve anchoring system with three couplers and three anchors positioned at a target site. [Figure 10] FIG. 1 is a schematic diagram of an example of a dual heart valve anchoring system including a tricuspid valve repair and a mitral valve repair positioned at a target site. [Figure 11] FIG. 1 is a schematic diagram of an example of a dual heart valve anchoring system including a tricuspid valve replacement portion and a mitral valve repair portion positioned at a target site. [Figure 12] FIG. 1 is a schematic diagram of a dual heart valve anchoring system positioned at a target site and including an example tricuspid valve replacement and an example mitral valve replacement. [Figure 13A] 1A-1C are schematic diagrams showing examples of paths along which a delivery catheter carrying a dual heart valve anchoring system may be advanced and retracted. [Figure 13B] 1A-1C are schematic diagrams showing examples of paths along which a delivery catheter carrying a dual heart valve anchoring system may be advanced and retracted. [Figure 14A] 13A-13C are schematic diagrams illustrating other examples of paths along which a delivery catheter carrying a dual heart valve anchoring system may be advanced and retracted. [Figure 14B] 13A-13C are schematic diagrams illustrating other examples of paths along which a delivery catheter carrying a dual heart valve anchoring system may be advanced and retracted. [Figure 15] 1 is a flow diagram of an example implantation procedure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0032] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0033] The present disclosure relates to systems, devices, and methods for anchoring both the tricuspid and mitral valve apparatus to the septum.

[0034] Although certain preferred embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as to modifications and equivalents thereof. Thus, the scope of claims that may arise from this specification is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process can be performed in any suitable order and are not necessarily limited to any specific order disclosed. Although various operations may be described one after the other as multiple separate operations in a manner that may aid in understanding a particular embodiment, the order of description should not be construed to imply that these operations are order-dependent. Also, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any specific embodiment. Thus, for example, various embodiments may be practiced in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages that may also be taught or suggested herein.

[0035] Certain standard anatomical terms of location are used herein with reference to animal anatomy, and thus human anatomy, in the context of preferred embodiments. Certain spatially relative terms, such as "outer," "inner," "superior," "lower," "below," "above," "vertical," "horizontal," "above," "below," and similar terms, are used herein to describe the spatial relationship of one device / element or anatomical structure to another device / element or anatomical structure, but these terms are used herein for ease of description to describe the positional relationships between the elements / structures as shown in the drawings. It should be understood that the spatially relative terms are intended to cover different orientations of the elements / structures in use or operation in addition to the orientation depicted in the drawings. For example, an element / structure described as "above" another element / structure can represent a position below or beside such other element / structure with respect to the subject or alternative orientation of the element / structure, and vice versa.

[0036] Various features of the heart 1 are described with reference to FIG. 1 to aid in understanding the present disclosure. The heart 1 comprises four chambers: the left atrium 2, the left ventricle 3, the right ventricle 4, and the right atrium 5. A muscular wall, called the septum 10, separates the left atrium 2 from the right atrium 5, and the left ventricle 3 from the right ventricle 4. Blood flow through the heart 1 is controlled, at least in part, by four valves: the mitral valve 6, the aortic valve 7, the tricuspid valve 8, and the pulmonary valve 9. The mitral valve 6 separates the left atrium 2 from the left ventricle 3 and controls blood flow therebetween. The aortic valve 7 separates the left ventricle 3 from the aorta 12 and controls blood flow therebetween. The tricuspid valve 8 separates the right atrium 5 from the right ventricle 4 and controls blood flow therebetween. The pulmonary valve 9 separates the right ventricle 4 from the pulmonary artery 11 and controls blood flow therebetween.

[0037] Heart valves may generally comprise a relatively dense fibrous ring, referred to herein as the annulus, and multiple cusps or leaflets attached to the annulus. For example, the tricuspid valve 8, the aortic valve 7, and the pulmonary valve 9 generally have three cusps or leaflets. The mitral valve 6 generally has two cusps or leaflets. The size of the cusps or leaflets may be such that they coapt to close the valve and move apart to open the valve. The atrioventricular heart valves (i.e., the mitral and tricuspid valves) may further comprise a collection of chordae tendineae and papillary muscles (not shown) to anchor the leaflets of the respective valves to promote and / or facilitate proper coaptation of the leaflets and prevent leaflet prolapse. The papillary muscles may generally comprise, for example, finger-like projections from the ventricular wall. The leaflets are connected to the papillary muscles by the chordae tendineae.

[0038] In a healthy heart, the heart valves can open and close appropriately in response to pressure gradients that exist during the various phases of the cardiac cycle (e.g., relaxation and contraction) to control, at least to some extent, the flow of blood to respective regions and / or vessels of the heart. Deoxygenated blood coming from other parts of the body generally flows to the right side of the heart for transport to the lungs, and oxygenated blood from the lungs generally flows to the left side of the heart for transport to other parts of the body.

[0039] During ventricular diastole (i.e., when the ventricular myocardium is relaxed), a negative pressure difference between the right ventricle 4 and the right atrium 5 can push the leaflets of the tricuspid valve 8 apart to open the tricuspid valve 8 and allow deoxygenated blood in the right atrium 5 coming from the inferior vena cava 15 and superior vena cava 16 to flow into the right ventricle 4. The leaflets of the pulmonary valve 9 are coapted during ventricular diastole and remain apposed to one another to keep the pulmonary valve 9 closed. A negative pressure difference between the left ventricle 3 and the left atrium 2 can push the leaflets of the mitral valve 6 apart during ventricular diastole to open the mitral valve 6 and allow oxygenated blood in the left atrium 2 coming from the pulmonary veins to flow into the left ventricle 3. The leaflets of the aortic valve 7 can remain coapted during ventricular diastole to keep the aortic valve 7 closed.

[0040] During ventricular contraction (e.g., when the ventricular myocardium contracts), a positive pressure difference between the right ventricle 4 and the right atrium 5 can keep the leaflets of the tricuspid valve 8 coapted or apposed to one another to close the tricuspid valve 8. Properly coapted leaflets can prevent leakage of blood from the right ventricle 4 to the right atrium 5. Meanwhile, the leaflets of the pulmonary valve 9 can be pushed apart during ventricular contraction to send deoxygenated blood from the right ventricle 4 to the pulmonary artery 11 for transport to the lungs. The pulmonary artery 11 can carry deoxygenated blood from the right side of the heart to the lungs. The pulmonary artery 11 can comprise a pulmonary trunk and a left pulmonary artery 14 and a right pulmonary artery 13 that branch off from the pulmonary trunk. A positive pressure difference between the left ventricle 3 and the left atrium 2 during ventricular contraction can keep the leaflets of the mitral valve 6 coapted or apposed to one another to close the mitral valve 6. Properly coapted leaflets can prevent leakage of blood from the left ventricle 3 into the left atrium 2. The leaflets of the aortic valve 7 can be pushed apart during ventricular contraction to permit the flow of oxygenated blood from the left ventricle 3 into the aorta 12 for transport to the rest of the body.

[0041] Diseased heart valves and / or associated leaflets (e.g., tricuspid and / or mitral valve dysfunction) can lead to valve leakage and / or other health complications. Valve stenosis can cause the valve to narrow or become clogged. Tricuspid and mitral stenosis can restrict blood flow from the right atrium to the right ventricle and from the left atrium to the left ventricle, respectively. Valve regurgitation occurs when a valve does not close properly. For example, regurgitation can occur due to improper coaptation of the valve leaflets. Tricuspid regurgitation can result in leakage of blood flow back from the right ventricle to the right atrium when the right ventricle contracts. Leaking of blood back to the right atrium can result in inefficient pumping of deoxygenated blood to the lungs. Mitral regurgitation can result in leakage of blood flow back from the left ventricle to the left atrium when the left ventricle contracts. If regurgitation is severe, the heart enlarges to keep the blood flowing forward and can lead to heart failure, such as when the heart cannot pump enough blood to the body. This can create symptoms ranging from shortness of breath during exertion, to coughing, blood congestion around the heart and lungs, and swelling in the legs and feet. Valve repairs can be performed to address various valve diseases. In more severe cases, valve replacements can be performed.

[0042] The present disclosure relates to devices, systems, and / or methods for anchoring both a tricuspid valve device and a mitral valve device to each other at the ventricular septum. The tricuspid valve device may include a tricuspid valve replacement or tricuspid valve repair. The mitral valve device may include a mitral valve replacement or mitral valve repair. In a deployed state, the dual heart valve anchoring system described herein may include a mitral valve repair or replacement and a tricuspid valve repair or replacement that are connected to each other through the septum. In some embodiments, the dual heart valve anchoring system may include a connector configured to extend through a transseptal opening, connecting the tricuspid valve replacement and the mitral valve replacement to each other and coupling the tricuspid valve replacement and the mitral valve replacement to the septum. The dual heart valve anchoring system may include an anchoring portion with at least a portion configured to be positioned in the transseptal opening. The connector may be coupled to the anchoring portion with a portion that extends through an opening in the anchoring portion, for example.

[0043] In some embodiments, the mitral valve repair and the tricuspid valve repair may be coupled to one another via a transseptal opening that anchors the mitral valve repair and the tricuspid valve repair to the septum and to one another. In some embodiments, the mitral valve repair and the tricuspid valve replacement may be coupled to one another via a transseptal opening. In some embodiments, the mitral valve replacement and the tricuspid valve repair may be coupled to one another via a transseptal opening.

[0044] During ventricular contraction, the contraction of the ventricles pushes the tricuspid and mitral valve apparatus toward the right and left atria, respectively, potentially displacing the apparatus undesirably. Anchoring the tricuspid and mitral valve apparatus to the septal wall can facilitate secure positioning of each of the apparatus at their respective target sites. Tethering the mitral and tricuspid valve apparatus to each other can advantageously balance the forces exerted on the apparatus by contraction of the heart. For example, the forces exerted on the tricuspid valve apparatus can be balanced against the forces exerted on the mitral valve apparatus, thereby reducing or eliminating the imbalance of forces exerted on the septal wall. Reducing or eliminating the imbalance of forces exerted on the septal wall can reduce or prevent damage to the septal wall due to tethering the tricuspid and mitral valve apparatus.

[0045] Anchoring the tricuspid and mitral valve devices to the septal wall can allow for the use of valve devices with reduced anchoring features in the device itself to achieve firm positioning of the devices in their respective target locations. The valve devices can have reduced anchoring features for coupling to the native valve to achieve the desired anchoring, allowing for the use of valve devices with reduced size and / or reduced complexity. For example, a dual heart valve anchoring system as described herein can include a tricuspid and / or mitral valve replacement that can have a shorter profile and / or a thinner diameter. The tricuspid and / or mitral valve replacement can be easier to compress for implantation and / or easier to fabricate.

[0046] In some embodiments, one or more systems described herein may be advantageously delivered using a minimally invasive transcatheter approach. Both the replacement tricuspid valve and the replacement mitral valve may be delivered using a minimally invasive transcatheter approach, including positioning the devices at their respective target sites using a single surgical procedure. For example, a delivery catheter carrying both the tricuspid valve replacement and the mitral valve replacement may be inserted through the inferior vena cava (IVC) or superior vena cava (SVC) into the right atrium (RA), from the RA into the right ventricle (RV), and then through the septal wall into the left ventricle (LV). After reaching the target site of the mitral valve replacement, the mitral valve replacement may be released from the delivery catheter. The delivery catheter may then be retracted along or substantially along the same path that it was inserted. After the delivery catheter is retracted to the target site for the tricuspid valve replacement, the tricuspid valve replacement may be deployed. Such a procedure may provide a less invasive percutaneous delivery method, reducing trauma to the patient during the surgical procedure and facilitating recovery.

[0047] 2 is a schematic diagram of an example of a dual heart valve anchoring system 100 comprising two heart valve replacements. In some embodiments, the dual heart valve anchoring system 100 may be delivered to a target site using a minimally invasive transcatheter approach. The dual heart valve anchoring system 100 may comprise a tricuspid valve replacement 200, a mitral valve replacement 300, and a coupler 400 coupling the tricuspid valve replacement 200 and the mitral valve replacement 300 to each other. The coupler 400 may be configured to extend through a transseptal opening formed in the interventricular septum. As described in further detail herein, the coupler 400 may be configured to anchor the tricuspid valve replacement 200 and the mitral valve replacement 300 to the septum while balancing the forces exerted by the contractions of the heart on the tricuspid valve replacement 200 against the forces exerted by the contractions of the heart on the mitral valve replacement 300.

[0048] 2, the tricuspid valve replacement 200 may include a tricuspid valve body portion 206 having a first distal end 202 and a second distal end 204. The mitral valve replacement 300 may include a mitral valve body portion 306 having a first distal end 302 and a second distal end 304. A coupler 400 may be coupled to the second ends 204 and 304 of the tricuspid valve replacement 200 and the mitral valve replacement 300, respectively. As described in further detail herein, the coupler 400 may be coupled to opposing ventricular ends of the tricuspid valve replacement 200 and the mitral valve replacement 300. For example, the coupler 400 may have a first portion 402 coupled to the second distal end 204 of the tricuspid valve replacement 200 and a second portion 404 coupled to the second distal end 304 of the mitral valve replacement 300. Although FIG. 2 illustrates that the coupler 400 may be coupled to the distal ends of each of the tricuspid valve replacement portion 200 and the mitral valve replacement portion 300, it will be understood that the coupler 400 may be coupled to one or more other portions of the tricuspid valve replacement portion 200 and / or the mitral valve replacement portion 300.

[0049] In some embodiments, the coupler may be coupled to a distal portion of the heart valve replacement, such as a distal portion proximate the distal end of the body portion of the heart valve replacement, rather than at the distal end of the body portion of the heart valve replacement. In some embodiments, the coupler may be coupled to a central portion of the body portion of the heart valve replacement. In some embodiments, the coupler may be coupled to the heart valve replacement in multiple locations, including one or more portions of the heart valve replacement as described herein. The location at which the coupler couples to the heart valve replacement may be selected to provide a desired angle of anchoring to the septum and / or coupling to other heart valve replacements.

[0050] As described in further detail herein, in some embodiments, the length of the coupler may be predetermined. For example, the length may be selected prior to insertion of a delivery catheter carrying the dual heart valve anchoring system into a patient. In some embodiments, the length may be adjustable during the implantation procedure. For example, the length may be adjusted during the implantation procedure depending on the individual's anatomy.

[0051] In some embodiments, the dual heart valve anchoring system 100 may comprise an anchor 500 comprising at least a portion configured to be secured within a transseptal opening. The anchor 500 may comprise an anchor body 506 and a first septal contacting portion 502 and a second septal contacting portion 504 coupled to opposed distal ends 516, 518 of the anchor body 506. The anchor may comprise an internal lumen 520 extending along the entire longitudinal length of the anchor body 506.

[0052] While the tether 500 is positioned at its target site, a first distal end 516 of the tether body 506 can be positioned adjacent or proximal to the right ventricular surface of the septum, and a second distal end 518 of the tether body 506 can be positioned adjacent or proximal to the left ventricular surface of the septum. In some embodiments, the longitudinal length of the tether body 506 can be the same or substantially the same as the thickness of the septum at its target site. The tether 500 can be positioned at the transseptal opening such that the lumen 520 extends across the entire thickness of the septum at the opening. The coupler 400 can extend through the lumen 520 to couple the tricuspid valve replacement 200 and the mitral valve replacement 300 to one another.

[0053] The first septal contact portion 502 may be configured to be positioned in contact with or adjacent to a right ventricular surface of the septum, and the second septal contact portion 504 may be configured to be positioned in contact with or adjacent to a left ventricular surface of the septum. As shown in FIG. 2, the first septal contact portion 502 and the second septal contact portion 504, which are coupled to distal ends 516, 518, respectively, of the anchor body 506, may have openings corresponding to the lumen 520 such that the coupler 400 may extend through the lumen 520. Extending the coupler 400 through the anchor portion 500 may facilitate stable anchoring of the tricuspid valve replacement 200 and the mitral valve replacement 300 to the septum while reducing or preventing damage to the septum from the anchoring.

[0054] The first septal contact portion 502 and the second septal contact portion 504 can be configured to engage the septum to facilitate stable positioning of the anchor portion 500 at the transseptal opening. A portion of the septum can be between the first septal contact portion 502 and the second septal contact portion 504, e.g., sandwiched between the first septal contact portion 502 and the second septal contact portion 504. The first septal contact portion 502 can have a first surface 508 configured to face the right ventricle and a second surface 510 configured to face the right ventricular surface of the septum. In some embodiments, the second surface 510 can be configured to be positioned adjacent to and in contact with the right ventricular surface. In some embodiments, the second surface 510 can be adjacent to but not in contact with the right ventricular surface. The second septal contact portion 504 can have a first surface 512 configured to face the left ventricle and a second surface 514 configured to face the left ventricular side surface of the septum. In some embodiments, the second surface 514 can be configured to be positioned adjacent to and in contact with the left ventricular side surface. In some embodiments, the second surface 514 can be adjacent to but not in contact with the left ventricular side surface.

[0055] 2 may comprise a circular or substantially circular shape extending around the entire circumference of the lumen 520, it is understood that the septal contacts may extend only partially around the circumference of the lumen 520. In some embodiments, the septal contacts may comprise one or more features on a septum-facing surface to facilitate secure positioning of the anchoring portion 500, such as one or more protrusions and / or indentations.

[0056] The lumen 520 can have any number of cross-sectional shapes. In some embodiments, the cross-sectional shape of the lumen 520 includes an arcuate shape, including a circular or elliptical shape. In some embodiments, the cross-sectional shape of the lumen 520 includes straight edges, such as a rectangular or triangular shape. The cross-sectional shape of the lumen 520 can be selected based on the cross-sectional shape of the coupler 400, for example, to receive the coupler 400. The cross-sectional dimensions of the lumen 520, such as diameter, can be selected to receive the coupler 400. As described in more detail herein, the dual heart valve anchoring system may include multiple couplers. The cross-sectional shape and / or dimensions of the lumen 520 can be configured to receive multiple couplers.

[0057] In some embodiments, the tether 500 can facilitate occlusion of a transseptal opening to prevent or reduce blood flow between the left and right ventricles. For example, the lumen 520 can have a size and cross-sectional shape to accommodate the coupler 400 without allowing or substantially allowing blood flow past the tether 500 while the tether 500 is deployed at its target site. In some embodiments, the cross-sectional diameter of the lumen 520 is the same or similar to the cross-sectional diameter of the coupler 400. In some embodiments, the lumen 520 can have the same or similar cross-sectional shape as the coupler 400.

[0058] In some embodiments, the tether 500 and / or the coupler 400 may comprise a flexible, deformable, and / or elastic biocompatible material configured to facilitate transcatheter delivery to the respective target site. Materials with shape memory may be used. The tether 500 and / or the coupler 400 may comprise one or more of a flexible, deformable, and / or elastic biocompatible polymer and / or metal alloy. In some embodiments, the tether 500 and / or the coupler 400 may comprise one or more of a polypropylene (PP), polyethylene (PE), polymethyl methacrylate (PMMA), polystyrene (PS), polyvinyl chloride (PVC), polytetrafluoroethylene (PTFE), polyurethane (PU), polyamide (nylon), polyethylene terephthalate (PET), polyethersulfone (PES), polyetherimide (PEI), polyetheretherketone (PEEK), polyvinyl chloride (PVC), and poly(lactic-co-glycolic) acid (PLGA). In some embodiments, the tether 500 and / or the coupler 400 may comprise stainless steel and / or nickel titanium. In some embodiments, the coupler 400 may comprise a flexible cord. The coupler 400 may be a flexible cord. In some embodiments, the coupler 400 may comprise a Nitinol wire. For example, the coupler 400 may be a Nitinol wire. In some embodiments, the coupler 400 may be a polymer wire. In some embodiments, the tether 500 may comprise a shape memory material such that it may be advanced through a delivery catheter in a reduced profile configuration. After delivery to the target site, the tether 500 may be released from the delivery catheter and may assume an expanded profile configuration.

[0059] In some embodiments, the dual heart valve anchoring system may not include an anchor, for example, the dual heart valve anchoring system may have a coupler extending through a transseptal opening without being coupled to an anchor positioned at and / or through the septum.

[0060] 3 is a schematic diagram showing a dual heart valve anchoring system 100 positioned at a target site in the heart. The dual heart valve anchoring system 100 may have a tricuspid valve replacement part 200 with at least a portion positioned in the native tricuspid valve and a mitral valve replacement part 300 with at least a portion positioned in the native mitral valve. A connector 400 may connect the tricuspid valve replacement part 200 and the mitral valve replacement part 300 to each other. An anchor part 500 may be positioned in the interventricular septum at a transseptal opening. The connector 400 may extend through the anchor part 500 to connect the tricuspid valve replacement part 200 and the mitral valve replacement part 300.

[0061] A portion of the tricuspid valve body portion 206 can be in close proximity and / or direct contact with one or more components of the native tricuspid valve. The first distal end 202 of the tricuspid valve replacement 200 can be oriented toward the right atrium and the second distal end 204 can be oriented toward the right ventricle. In some embodiments, the second distal end 204 can be positioned in the right ventricle. In some embodiments, the first distal end 202 can be positioned in the right atrium. A portion of the mitral valve body portion 306 can be in close proximity and / or direct contact with one or more components of the native mitral valve. The first distal end 302 can be oriented toward the left atrium and the second distal end 304 can be oriented toward the left ventricle. In some embodiments, the second distal end 304 can be positioned in the left ventricle. In some embodiments, the first distal end 302 can be positioned in the left atrium. The first portion 402 of the connector 400 can be coupled to a distal portion of the tricuspid valve replacement 200, such as the second distal end 204 oriented toward the right ventricle, and the second portion 404 of the connector 400 can be coupled to a distal portion of the mitral valve replacement 300, such as the second distal end 304 oriented toward the left ventricle.

[0062] During ventricular contraction, forces exerted on the tricuspid and mitral valve replacements 200 and 300 by the contraction of the ventricles can push the tricuspid and mitral valve replacements 200 and 300 toward the right and left atria, respectively. The forces exerted on the tricuspid and mitral valve replacements 200 and 300 can tend to displace the tricuspid and mitral valve replacements 200 and 300 from their corresponding desired positions in the heart. The coupler 400, which is coupled to the anchor 500 at the septum, can provide a force to counter the forces exerted on the tricuspid and mitral valve replacements 200 and 300 by the heart to facilitate retaining the tricuspid and mitral valve replacements 200 and 300 in their respective target positions. The length of the coupler 400 can be selected such that the coupler 400 is pulled tight while the tricuspid and mitral valve replacements 200 and 300 are pushed toward the right and left atria during systole, holding the tricuspid and mitral valve replacements 200 and 300 in place. The length of the coupler 400 can be selected such that it is taut when the heart is in a systole period. In some embodiments, the length of the coupler 400 between the tricuspid and mitral valves can be predetermined. For example, the length of the coupler 400 can be selected prior to insertion into a delivery catheter. As described in more detail herein, in some embodiments, the length can be adjustable, for example, determined during the implantation procedure.

[0063] The anchoring portion 500 may be positioned at a location along the septum to provide a desired anchoring of the dual heart valve anchoring system 100 to the septum. For example, a trans-septal opening may be formed at a location along the septum to reduce or avoid interference with the chordae by the anchoring portion 500 and / or the coupler 400 while selecting an area of ​​the septum that can provide a desired angle of anchoring and / or provide a desired strength. In some embodiments, the trans-septal opening may be formed at or near the midpoint along the septal wall. In some embodiments, the trans-septal opening may be formed above the midpoint along the septal wall.

[0064] As described herein, during a period of systole, the native tricuspid and mitral valves can exert forces on the tricuspid and mitral valve replacements 200 and 300, respectively, to push the replacement tricuspid and mitral valve replacements 200 and 300 toward the right and left atria. The transseptal opening can be located at or proximate to an area in the septum where the force vectors of the forces intersect to provide the tricuspid and mitral valve replacements 200 and 300 with the desired angle of anchoring to the septum. In some embodiments, the transseptal opening can be formed above the intersection location.

[0065] In some embodiments, the dual heart valve anchoring system does not include an anchoring portion. Figure 4 is a schematic diagram showing an example of a dual heart valve anchoring system 110 positioned at its target site in the heart, where the dual heart valve anchoring system 110 does not include an anchoring portion. The dual heart valve anchoring system 110 may have a coupler 410 that couples the tricuspid valve replacement portion 200 and the mitral valve replacement portion 300 to each other. The tricuspid valve replacement portion 200 may have at least a portion that is positioned in the native tricuspid valve, and the mitral valve replacement portion 300 may have at least a portion that is positioned in the native mitral valve. The dual heart valve anchoring system 110 does not include an anchoring portion 500. As shown in Figure 4, the coupler 410 can extend through the transseptal opening without being coupled to an anchoring portion.

[0066] A first portion 412 of the coupler 410 can be coupled to the tricuspid valve replacement 200, such as at the second distal end 204. A second portion 414 of the coupler 410 can be coupled to the mitral valve replacement 300, such as at the second distal end 304. The coupler 410 can include a transseptal portion 416 configured to extend through a transseptal opening. For example, the transseptal portion 416 can be in direct contact with the septum.

[0067] In some embodiments, the septal crossing portion 416 of the coupler 410 may include one or more features for engaging the septum, protecting the septum, and / or blocking the transseptal opening. The septal crossing portion 416 may engage the septum and / or have a septal protection feature to facilitate insertion of the coupler 410 through the transseptal opening. Blockage of the transseptal opening may reduce or eliminate blood flow between the left and right ventricles. The dual heart valve anchoring system 110 may be more compact and / or have a reduced profile, as compared to dual heart valve anchoring systems with anchors, etc. The compact size and / or reduced profile may provide ease of delivery and / or implantation at a target site.

[0068] Fig. 5A is a schematic diagram of a dual heart valve anchoring system 120 with an adjustable coupler 420. The length of the coupler 420 can be adjusted during the implantation procedure. The dual heart valve anchoring system 120 is shown in Fig. 5A as positioned at a target location in the heart. The dual heart valve anchoring system 120 can include a tricuspid valve replacement 200 and a mitral valve replacement 300. The coupler 420 can have a first portion 422 coupled to the tricuspid valve replacement 200 and a second portion 424 coupled to the mitral valve replacement 300. The coupler 420 can extend through an anchoring portion 500 positioned at the transseptal opening. The tricuspid valve replacement 200, the mitral valve replacement 300, and the anchoring portion 500 can be positioned in the heart as described herein, such as with reference to Fig. 3.

[0069] In some embodiments, the length of the coupler 420 may be adjusted to accommodate the patient's anatomy. For example, the length of the coupler 420 may be adjusted after the dual heart valve anchoring system 120 has been inserted into the patient. As described in further detail herein, the length of the coupler 420 may be adjusted one or more times during the implantation procedure, including after the dual heart valve anchoring system 120 has been positioned at its target site.

[0070] In some embodiments, the dual heart valve anchoring system 120 may include a locking mechanism 600 configured to fix the length of the coupler 420 at a selected length after adjustments are made based on the individual's specific anatomy. The locking mechanism 600 may be deployed, actuated, and / or activated after the appropriate length is selected to lock the length of the coupler 420 at the determined length. In some embodiments, the locking mechanism 600 may be coupled to or integrated as part of the tricuspid valve replacement 300.

[0071] 5A shows that the dual heart valve anchoring system 120 may include one locking mechanism 600, it is understood that two or more locking mechanisms 600 may be included. In some embodiments, one or more of the tricuspid valve replacement portion 200, the mitral valve replacement portion 300, and the anchoring portion 500 may include a locking mechanism 600 coupled thereto or integral therewith.

[0072] 5B shows a top-down plan view of an example locking mechanism 600. The locking mechanism 600 can be in an open state and a closed state. In the open state, the locking mechanism 600 allows the coupler 420 to move freely therethrough. In the closed state, the locking mechanism 600 can reduce or prevent movement of the coupler 420 such that the coupler 420 is locked at a selected length. FIG. 5B shows the locking mechanism 600 in the closed state.

[0073] The locking mechanism 600 may include a first moveable flap 602, a second moveable flap 604, and a third moveable flap 606 coupled to one another at respective first distal portions 602a, 604a, 606a. The second distal portions 602b, 604b, 606b of the first moveable flap 602, the second moveable flap 604, and the third moveable flap 606 may define an opening 608. The coupler 420 may extend through the opening 608.

[0074] To achieve the open state, the movable flaps 602, 604, 606 can be moved in a first direction to push the second distal portions 602b, 604b, and 606b away from each other to enlarge the opening 608. The coupler 420 can be free to move through the opening 608 when the locking mechanism is in the open state, for example to allow adjustment of the length of the coupler 420 during the implantation procedure. The movable flaps 602, 604, 606 can be configured to be moved in a second direction, opposite the first direction, to move the second distal portions 602b, 604b, and 606b closer together to achieve the closed state and reduce the size of the opening 608. One or more edges of the second distal portions 602b, 604b, and 606b that define the opening 608 can be configured to contact the coupler 420 sufficiently while in the closed state to reduce or prevent movement of the coupler 420 through the opening 608, thereby facilitating locking or substantially locking the coupler 420 at a tailored length. For example, the opening 608 can be sized the same as or smaller than the cross-sectional area of ​​the coupler 420 in the closed state such that one or more edges of the second distal portions 602b, 604b, and 606b can contact the coupler 420 sufficiently to reduce or prevent movement of the coupler 420 through the opening 608.

[0075] In some embodiments, the locking mechanism 600 can have a non-planar configuration. For example, the movable flaps 602, 604, 606 can be oriented at an angle to one another and extend in a direction into the page of FIG. 5B such that movement of the flaps 602, 604, 606 in a first direction (e.g., into the page) pushes the second distal portions 602b, 604b, 606b further apart to achieve an open state. Movement of the flaps 602, 604, 606 in a second direction (e.g., out of the page) can bring the second distal portions 602b, 604b, 606b closer together to achieve a closed state.

[0076] Opening and closing of the locking mechanism 600 can be controlled using various techniques. In some embodiments, opening and closing of the locking mechanism 600 can be actuated by pressure. For example, application of pressure can be used to move the movable flaps 602, 604, and 606 to open and / or close the locking mechanism. In some embodiments, contacting the coupler 420 with the movable flaps 602, 604, and 606 can cause the locking mechanism 600 to open and / or close. For example, contacting the coupler 420 with the movable flaps 602, 604, and 606 and moving the coupler 420 relative to the movable flaps 602, 604, and 606 can move the movable flaps 602, 604, and 606 in a desired direction. Moving the coupler 420 in a first direction while in contact with the moveable flaps 602, 604, and 606 can open the locking mechanism 600, and moving the coupler 420 in a second direction while in contact with the moveable flaps 602, 604, and 606 can close the locking mechanism 600. In some embodiments, the coupler 420 can include one or more features, such as protrusions and / or notches, to facilitate engagement with the moveable flaps 602, 604, and 606.

[0077] 6 is a schematic diagram of a dual heart valve anchoring system 130 comprising a coupler 430 comprising a rigid or semi-rigid portion 436. The dual heart valve anchoring system 130 is shown positioned at a target site in the heart. The tricuspid valve replacement 200, the mitral valve replacement 300, and the anchoring portion 500 may be positioned at their respective target locations, such as those described with reference to FIG. 3. The coupler 430 may extend through the anchoring portion 500, which is configured to be positioned at the transseptal opening, and may couple the tricuspid valve replacement 200 and the mitral valve replacement 300 to each other. The coupler 430 may have a first portion 432 coupled to the tricuspid valve replacement 200 and a second portion 434 coupled to the mitral valve replacement 300.

[0078] The rigid or semi-rigid portion 436 of the coupler 430 may be configured to extend through a transseptal opening, for example, through an anchor 500 configured to be positioned at the transseptal opening. The rigid or semi-rigid portion 436 may extend into one or both of the right and left ventricles. For example, the rigid or semi-rigid portion 436 may include a first segment 436a configured to extend into the right ventricle and a second segment 436b configured to extend into the left ventricle. The longitudinal length of the first segment 436a and / or the second segment 436b may be selected to provide a desired anchoring of the tricuspid valve replacement 200 and the mitral valve replacement 300 to the septum. In some embodiments, the length of the first segment 436a and / or the second segment 436b may be selected to provide a predetermined angle of anchoring of the tricuspid valve replacement 200 and the mitral valve replacement 300 to the septum. The length of the first segment 436a and / or second segment 436b can be selected to provide the desired anchoring of the tricuspid valve replacement 200 and mitral valve replacement 300 to the septum while allowing the transseptal opening to be positioned at a location in the septum to reduce or avoid interference with the chordae tendineae.

[0079] In some embodiments, the longitudinal length of the first segment 436a may be the same or similar to the longitudinal length of the second segment 436b. In some embodiments, the longitudinal length of the first segment 436a is different from the length of the second segment 436b. The longitudinal length of the first segment 436a and / or the second segment 436b may be predetermined or adjustable. For example, the longitudinal length of the first segment 436a and / or the second segment 436b may be selected prior to inserting the dual heart valve anchoring system 130 into the patient. In some embodiments, the length of the first segment 436a and / or the second segment 436b may be adjusted during the implantation procedure based on the individual's anatomy to provide the desired anchoring. In some embodiments, the length of the first segment 436a and / or the second segment 436b may be adjusted after insertion of the dual heart valve anchoring system 130 into the patient. For example, the length of the first segment 436a and the length of the second segment 436b can be adjusted by moving the rigid or semi-rigid portion 436 back and forth within the lumen 520 of the anchor 500. In some embodiments, the rigid or semi-rigid portion 436 can be translated distally to decrease the length of the first segment 436a while increasing the length of the second segment 436b. In some embodiments, the rigid or semi-rigid portion 436 can be translated proximally to decrease the length of the second segment 436b while increasing the length of the first segment 436a.

[0080] The coupler 430 may comprise one or more biocompatible materials described herein, including polymeric and / or metallic materials. In some embodiments, the rigid or semi-rigid portion 436 of the coupler 430 may comprise a different material than the remainder of the coupler 430. In some embodiments, the rigid or semi-rigid portion 436 of the coupler 430 may comprise the same material as the remainder of the coupler 430.

[0081] 7A is a schematic diagram of an example of a dual heart valve anchoring system 140 comprising anchoring portions 550 each comprising a rigid or semi-rigid portion configured to extend into the right and left ventricles. The dual heart valve anchoring system 140 may comprise a tricuspid valve replacement portion 200, a mitral valve replacement portion 300, and a connector 400 connecting the tricuspid valve replacement portion 200 and the mitral valve replacement portion 300 to each other. The connector 400 may extend through the anchoring portion 550 positioned in the transseptal opening. The tricuspid valve replacement portion 200 and the mitral valve replacement portion 300 may be positioned in the heart, such as described with reference to FIG. 3.

[0082] 7B is a schematic diagram of an anchoring portion 550. The anchoring portion 550 may comprise an anchoring body portion 556 comprising a first rigid or semi-rigid portion 556a configured to extend into the right ventricle and a second rigid or semi-rigid portion 556b configured to extend into the left ventricle. For example, the anchoring body portion 556 may comprise a first distal end 552 that extends into the right ventricle and a second distal end 554 that extends into the left ventricle. The first rigid or semi-rigid portion 556a may extend into the right ventricle such that the first distal end 552 is positioned in the right ventricle, and the second rigid or semi-rigid portion 556b may extend into the left ventricle such that the second distal end 554 is positioned in the left ventricle. The anchoring portion 550 may include an internal lumen 560 extending along the entire longitudinal length of the anchoring body portion 556 so that the connector 400 may be inserted to couple the tricuspid valve replacement portion 200 and the mitral valve replacement portion 300 to one another, while the anchoring portion 550 is positioned in the transseptal opening.

[0083] The anchoring portion may include first and second septal contacting portions 562, 564 extending from anchoring body portion 556 and spaced apart to engage the septum. In some embodiments, first and second septal contacting portions 562, 564 may include one or more features of first and second septal contacting portions 502, 504 described with reference to FIG.

[0084] Rigid or semi-rigid portions 556a, 556b of anchoring portion 500 may be configured to extend into the right and left ventricles, respectively, to facilitate the desired anchoring of tricuspid and mitral valve replacements 200, 300 to the septum. In some embodiments, the longitudinal dimension of the first rigid or semi-rigid portion 556a and / or the longitudinal dimension of the second rigid or semi-rigid portion 556b may be selected such that tricuspid and mitral valve replacements 200, 300 may be adequately anchored to the septum without interfering or substantially interfering with the chordae tendineae.

[0085] In some embodiments, the longitudinal length of the first rigid or semi-rigid portion 556a and the longitudinal length of the second rigid or semi-rigid portion 556b may be the same or similar. In some embodiments, the longitudinal length of the first rigid or semi-rigid portion 556a and the longitudinal length of the second rigid or semi-rigid portion 556b may differ. In some embodiments, the tether 500 may comprise either the first rigid or semi-rigid portion 556a or the second rigid or semi-rigid portion 556b, but not both.

[0086] The tether 550 may comprise one or more biocompatible materials described herein, including polymeric and / or metallic materials. In some embodiments, the rigid or semi-rigid portions 556a, 556b of the tether 550 may comprise a different material than the remainder of the tether 550. In some embodiments, the rigid or semi-rigid portions 556a, 556b of the tether 550 may comprise the same material as the remainder of the tether 550.

[0087] In some embodiments, the dual heart valve anchoring system 140 may include one or more other features as described herein. In some embodiments, the dual heart valve anchoring system 140 may include multiple couplers 400. In some embodiments, the dual heart valve anchoring system 140 may include one or more adjustable couplers 420. In some embodiments, the dual heart valve anchoring system 140 may include one or more of the couplers 430 that include a rigid or semi-rigid portion 436. For example, the multiple couplers may extend through the anchoring portion 550. The distal end of each of the multiple couplers may be coupled to a corresponding location at the distal end of each of the tricuspid valve replacement portion 200 and the mitral valve replacement portion 300.

[0088] In some embodiments, the dual heart valve anchoring system can include multiple connectors, where the multiple connectors extend through the same anchoring portion. Figure 8 is a schematic diagram of an example of a dual heart valve anchoring system 150 including three connectors 400. The dual heart valve anchoring system 150 is shown positioned at a target site. The dual heart valve anchoring system 150 can include a tricuspid valve replacement portion 200, a mitral valve replacement portion 300, and an anchoring portion 500 positioned at respective target sites, such as those described with reference to Figure 3. The three connectors 400 can couple the tricuspid valve replacement portion 200 and the mitral valve replacement portion 300 to each other.

[0089] In some embodiments, corresponding ends of the three couplers 400 may be coupled to respective distal ends of the tricuspid valve replacement 200 and the mitral valve replacement 300. For example, a first portion 402 at an end of each of the three couplers 400 may be coupled to a second distal end 204 of the tricuspid valve replacement 200 oriented toward the right ventricle. A second portion 404 at an end of each of the three couplers 400 may be coupled to a second distal end 304 of the mitral valve replacement 300 oriented toward the left ventricle. The locations at the second distal end 204 of the tricuspid valve replacement 200 and the second distal end 304 of the mitral valve replacement 300 to which the couplers 400 are coupled may be selected to provide a desired anchoring to the septum. In some embodiments, the locations at which the couplers 400 are coupled to the tricuspid valve replacement 200 and / or the mitral valve replacement 300 may be evenly distributed across the corresponding second distal ends 204, 304. For example, the locations where the couplers 400 are coupled to the second distal ends 204,304 may be evenly distributed around the circumference of the second distal ends 204,304.

[0090] The three couplers 400 can extend through the same transseptal opening. For example, the three couplers 400 can each include a corresponding portion that extends through an anchor 500 positioned in the transseptal opening. In some embodiments, the length for one or more of the three couplers 400 can be predetermined, such as selected, prior to insertion into the patient.

[0091] In some embodiments, the dual heart valve anchoring system 150 may include one or more other features as described herein. In some embodiments, the dual heart valve anchoring system 150 may include an anchoring portion 550 rather than an anchoring portion 500. In some embodiments, the dual heart valve anchoring system 150 may include one or more of the couplers 430 that include a rigid or semi-rigid portion 436. In some embodiments, the dual heart valve anchoring system 150 may include one or more adjustable couplers 420. In some embodiments, the length for one or more of the three couplers may be adjusted during the implantation procedure independent of the other couplers. For example, the three couplers may not be coupled to each other in the anchoring portion such that each coupler can move relative to the other couplers within the lumen of the anchoring portion. In some embodiments, corresponding portions of the three couplers that extend through the anchoring portion are coupled to each other. In some embodiments, the dual heart valve anchoring system 150 may include one or more locking mechanisms 600 as described herein to fix the length of the coupler after the desired length has been selected.

[0092] In some embodiments, the dual heart valve anchoring system can include multiple connectors, each extending through a corresponding anchoring portion. FIG. 9 is a schematic diagram of an example of a dual heart valve anchoring system 160 including three connectors 400 and three anchoring portions 500. The dual heart valve anchoring system 160 is shown positioned at a target site. The dual heart valve anchoring system 160 can include a tricuspid valve replacement portion 200 and a mitral valve replacement portion 300. The tricuspid valve replacement portion 200 and the mitral valve replacement portion 300 can be positioned at respective target sites, such as those described with reference to FIG. 3. The three connectors 400 can couple the tricuspid valve replacement portion 200 and the mitral valve replacement portion 300 to each other. Each of the three connectors 400 can extend through a corresponding anchoring portion 500 positioned at the septum.

[0093] A corresponding end of each of the three couplers 400 may be coupled to a respective distal end of the tricuspid valve replacement 200 and the mitral valve replacement 300. For example, a first portion 402 of each of the three couplers 400 may be coupled to the second distal end 204 of the tricuspid valve replacement 200, and a second portion 404 of each of the three couplers 400 may be coupled to the second distal end 304 of the mitral valve replacement 300. In some embodiments, the locations at which the couplers 400 are coupled to the tricuspid valve replacement 200 and / or the mitral valve replacement 300 may be evenly distributed across the corresponding second distal ends 204, 304. For example, the locations at which the couplers 400 are coupled to the second distal ends 204, 304 may be evenly distributed around the circumference of the second distal ends 204, 304. The location at the second distal end 204 of the tricuspid valve replacement portion 200 and the location at the second distal end 304 of the mitral valve replacement portion 300 to which the coupler 400 is coupled can be selected to provide a desired anchoring to the septum.

[0094] The location of the transseptal opening for positioning the three anchoring portions 500 may be selected to provide the desired anchoring. FIG. 9 illustrates the three anchoring portions 500 as being located at three different locations along the vertical dimension of the septum. In some embodiments, at least some of the three anchoring portions 500 may be positioned along the same vertical location on the septum. In some embodiments, at least some of the three anchoring portions 500 may be positioned along the same lateral location on the septum. In some embodiments, each of the three anchoring portions 500 may be positioned at different lateral and vertical locations on the septum.

[0095] In some embodiments, the dual heart valve anchoring system 160 may comprise one or more of the other features as described herein. In some embodiments, the dual heart valve anchoring system 160 may comprise one or more of the anchoring portions 550. In some embodiments, the dual heart valve anchoring system 150 may comprise one or more of the couplers 430 comprising a rigid or semi-rigid portion 436. In some embodiments, the dual heart valve anchoring system 150 may comprise one or more adjustable couplers 420. For example, the dual heart valve anchoring system 160 may comprise one or more locking mechanisms as described herein to fix the length of the coupler after a desired length is selected.

[0096] In some embodiments, two couplers may extend through the same anchor. Although the dual heart valve anchoring system 150 described with reference to Figure 8 comprises three couplers and the dual heart valve anchoring system 160 described with reference to Figure 9 comprises three couplers, it is understood that the dual heart valve anchoring systems may comprise more or fewer couplers.

[0097] In some embodiments, the dual heart valve anchoring system may include a tricuspid valve repair and a mitral valve repair anchored to the septum. FIG. 10 is a schematic diagram of an example of a dual heart valve anchoring system 170 including a tricuspid valve repair 700 and a mitral valve repair 800. The tricuspid valve repair 700 and the mitral valve repair 800 may be coupled to each other and configured to be anchored to the septum. For example, the tricuspid valve repair 700 and the mitral valve repair 800 may be coupled to an anchoring portion 500 configured to be positioned at a transseptal opening. The tricuspid valve repair 700 may include a plurality of connectors 710 configured to couple leaflets of the native tricuspid valve to the anchoring portion 500 positioned at the transseptal opening. A first distal portion 712 of each connector 710 may be coupled to a leaflet of the native tricuspid valve, and a second distal portion 714 may be coupled to the anchoring portion 500. The mitral valve repair 800 may include multiple couplers 810 configured to couple leaflets of the native mitral valve to the anchoring portion 500 positioned in the transseptal opening. For example, a first distal portion 814 of each coupler 810 can be coupled to a leaflet of the native mitral valve and a second distal portion 812 can be coupled to the anchoring portion 500. Although FIG. 10 illustrates that the tricuspid valve repair 700 can include two couplers 710 and the mitral valve repair 800 can include two couplers 810, it should be understood that more couplers 710, 810 or fewer couplers 710, 810 can be used.

[0098] In some embodiments, coupler 710 and coupler 810 can be a single coupler, whereby a single coupler extends through anchoring portion 500 and is configured to couple the native tricuspid valve leaflets and the native mitral valve leaflets to one another. For example, each of the multiple couplers 710 and a corresponding one of the multiple couplers 810 can be the same coupler. In some embodiments, none of the multiple couplers 710 and the multiple couplers 810 are the same coupler.

[0099] In some embodiments, the dual heart valve anchoring system may comprise a heart valve replacement portion and a heart valve repair portion. For example, the dual heart valve anchoring system may comprise a tricuspid valve replacement portion and a mitral valve repair portion. Alternatively, the dual heart valve anchoring system may comprise a tricuspid valve repair portion and a mitral valve replacement portion.

[0100] 11 is a schematic diagram of an example of a dual heart valve anchoring system 180 comprising a tricuspid valve replacement portion 200 and a mitral valve repair portion 800 coupled to each other via a septum. The tricuspid valve replacement portion 200 and the mitral valve repair portion 800 may be coupled to an anchoring portion 500 configured to be positioned at a transseptal opening. The mitral valve repair portion 800 may comprise a coupler 810 configured to couple the leaflets of the native mitral valve to the anchoring portion 500. A coupler 900 may couple the tricuspid valve replacement portion 200 to the anchoring portion 500. For example, a first end 902 of the coupler 900 may be coupled to the tricuspid valve replacement portion 200, such as the second distal end 204 of the tricuspid valve replacement portion 200. A second end 904 of the coupler 900 may be coupled to the anchoring portion 500.

[0101] 12, a schematic diagram of a dual heart valve anchoring system 190 is shown, comprising an example tricuspid valve replacement portion 1000 and an example mitral valve replacement portion 1100. A coupler 400 can couple the tricuspid valve replacement portion 1000 and the mitral valve replacement portion 1100 to each other. A corresponding portion of the coupler 400 can extend through an anchor portion 500 that is positioned in the transseptal opening.

[0102] The tricuspid valve replacement 1000 may include a tricuspid valve body portion 1006 with a first distal end 1002 and a second distal end 1004. The mitral valve replacement 1100 may include a mitral valve body portion 1106 with a first distal end 1102 and a second distal end 1104. As shown in FIG. 12, the first distal end 1002 of the tricuspid valve replacement 1000 and the first distal end 1102 of the mitral valve replacement 1100 may be oriented toward the right atrium and the left atrium, respectively. The second distal ends 1004, 1104 may be oriented toward the right ventricle and the left ventricle, respectively. The tricuspid valve replacement 1000 may include a frame 1008 and valve tissue 1010. The mitral valve replacement 1100 may include a frame 1108 and valve tissue 1110. In some embodiments, the first portion 402 of the coupler 400 may be coupled to the second distal end 1004 of the tricuspid valve replacement 1000 and the second portion 404 of the coupler 400 may be coupled to the second distal end 1104 of the mitral valve replacement 1100. In some embodiments, the coupler 400 may be coupled to frames 1008, 1108 of the tricuspid valve replacement 1000 and the mitral valve replacement 1100 at their respective second distal ends 1004, 1104. For example, the frames 1008, 1108 may include one or more features to facilitate attachment of the coupler 400 thereto.

[0103] In some embodiments, the dual heart valve anchoring system 190 may comprise one or more other features as described herein. In some embodiments, the dual heart valve anchoring system 190 may comprise multiple couplers 400. In some embodiments, the dual heart valve anchoring system 190 may comprise one or more adjustable couplers 420. In some embodiments, the dual heart valve anchoring system 190 may comprise one or more of the couplers 430 comprising a rigid or semi-rigid portion 436. In some embodiments, the dual heart valve anchoring system 190 may comprise an anchoring portion 550 rather than an anchoring portion 500.

[0104] In some embodiments, one or more of the heart valve replacements described herein may be one or more commercially available heart valve replacements (e.g., Sapien 3™, CardiAQ™, and Centera™, available from Edwards Lifesciences LLC, Irvine, CA). In some embodiments, one or more of the dual heart valve anchoring systems described herein may not include an anchoring portion. For example, the couplers described with reference to Figures 5A, 6, 7A, 8, 9, 10, 11, and 12 may extend through the transseptal opening without extending through an anchoring portion.

[0105] A procedure for positioning the dual heart valve anchoring system at its target site may include inserting and retracting the dual heart valve anchoring system delivery catheter along the same or similar pathways. Using one pathway for both inserting and retracting the delivery catheters to deploy both the septally anchored tricuspid and mitral valve replacements may, for example, enable a simpler, less invasive transcatheter approach, reduce trauma to the patient, and / or facilitate an improved patient recovery process.

[0106] 13A and 13B are schematic diagrams showing examples of paths along which a delivery catheter carrying a dual heart valve anchoring system may be advanced and retracted to position the dual heart valve anchoring system at its target site. The dual heart valve anchoring system may have one or more features described herein (e.g., dual heart valve anchoring systems 100, 110, 120, 130, 140, 150, 190). For example, the dual heart valve anchoring system may include a tricuspid valve replacement section, a mitral valve replacement section, and a coupler that couples the tricuspid valve replacement section and the mitral valve replacement section to each other. The coupler may extend through an anchoring section that is positioned at a transseptal opening. FIG. 13A shows the path along which the delivery catheter is inserted, and FIG. 13B shows the path along which the delivery catheter is retracted.

[0107] Referring to FIG. 13A, a delivery catheter carrying the dual heart valve anchoring system can be advanced through the inferior vena cava (IVC). For example, a transfemoral approach can be used, inserting the delivery catheter into the inferior vena cava through the femoral vein. The distal end of the delivery catheter can be extended from the inferior vena cava into the right atrium (RA). The distal end of the delivery catheter can then be inserted through an opening formed by the native tricuspid valve and advanced from the right atrium into the right ventricle (RV). The delivery catheter can then be extended from the right ventricle through a transseptal opening formed in the septum into the left ventricle (LV). After the delivery catheter is inserted into the left ventricle, the distal end of the delivery catheter can be positioned at a target site for a mitral valve replacement, and the mitral valve replacement can be deployed at the target location.

[0108] With reference to FIG. 13B, after the mitral valve replacement is positioned at its target site, the delivery catheter can be retracted toward the right ventricle. The delivery catheter can be retracted along the same or substantially the same path along which the delivery catheter was advanced. As the delivery catheter is retracted through the left ventricle toward the right ventricle, a corresponding portion of the coupler can be released from the distal end of the delivery catheter in the left ventricle. The distal end of the delivery catheter can then be retracted back from the left ventricle through the transseptal opening into the right ventricle (RV), leaving the tether at its target site. At least a portion of the tether and a corresponding portion of the coupler can be positioned at the transseptal opening as the delivery catheter is moved back through the transseptal opening. The corresponding portion of the coupler can then be released in the right ventricle as the distal end of the delivery catheter is retracted through the right ventricle toward the right atrium. The distal end of the delivery catheter can then be positioned at the desired location for the tricuspid valve replacement. After positioning the distal end of the delivery catheter at the desired location for the tricuspid valve replacement, the tricuspid valve replacement may be deployed at its target site. The delivery catheter may then be retracted into the right atrium and removed through the inferior vena cava.

[0109] 14A and 14B are schematic diagrams showing other examples of paths along which a delivery catheter carrying a dual heart valve anchoring system may be advanced and retracted to position the dual heart valve anchoring system at its target site. The dual heart valve anchoring system may have one or more features described herein, such as a coupler connecting the tricuspid and mitral valve replacements and a coupler extending through the anchoring portions (e.g., dual heart valve anchoring systems 100, 110, 120, 130, 140, 150, 190). FIG. 14A shows a path along which a delivery catheter may be inserted, and FIG. 14B shows a path along which a delivery catheter may be retracted.

[0110] Referring to FIG. 14A, a delivery catheter carrying a dual heart valve anchoring system can be advanced through the superior vena cava (SVC). For example, a transclavian or transcervical approach can be used, inserting the delivery catheter into the superior vena cava through the subclavian or jugular vein. The distal end of the delivery catheter can be extended from the superior vena cava into the right atrium (RA), and then from the right atrium into the right ventricle (RV) through an opening formed by the native tricuspid valve. The delivery catheter can then be extended from the right ventricle into the left ventricle (LV) through a transseptal opening formed in the septum. After the delivery catheter is inserted into the left ventricle, the distal end of the delivery catheter can be positioned at a target site for the mitral valve replacement. The mitral valve replacement can then be deployed at its target location.

[0111] Referring to FIG. 14B, after deployment of the mitral valve replacement, the delivery catheter can be retracted toward the right ventricle. The delivery catheter can be retracted along the same or substantially the same path along which the delivery catheter was advanced. When the delivery catheter is retracted through the left ventricle toward the right ventricle, the corresponding portion of the coupler can be released from the distal end of the delivery catheter in the left ventricle. The distal end of the delivery catheter can then be retracted back into the right ventricle (RV) through the transseptal opening. The tether can be released at the target site in the transseptal opening along with the corresponding portion of the coupler. The corresponding portion of the coupler can then be released in the right ventricle when the distal end of the delivery catheter is retracted through the right ventricle toward the right atrium. The distal end of the delivery catheter can then be positioned at the desired location for the tricuspid valve replacement, and the tricuspid valve replacement can be deployed. The delivery catheter can then be retracted into the right atrium and removed through the superior vena cava.

[0112] 15 is a flow diagram showing an example of an implantation procedure 1500 for positioning a dual heart valve anchoring system at its target site. The dual heart valve anchoring system can be carried by a delivery catheter. The dual heart valve anchoring system can have one or more features described herein, including, for example, a coupler that couples a tricuspid valve replacement and a mitral valve replacement (e.g., dual heart valve anchoring systems 100, 110, 120, 130, 140, 150, 190). In some embodiments, the dual heart valve anchoring system includes an anchoring portion such that the coupler extends through the anchoring portion. In some embodiments, the dual heart valve anchoring system does not include an anchoring portion.

[0113] 15, in block 1502, a delivery catheter may be introduced into the right atrium through the inferior or superior vena cava. In block 1504, the delivery catheter may be advanced from the right atrium through an opening formed by the native tricuspid valve into the right ventricle. The delivery catheter may be advanced through the right ventricle toward the left ventricle. In block 1506, the delivery catheter may be threaded through a trans-septal opening in the ventricular septum to insert the delivery catheter from the right ventricle into the left ventricle. In some embodiments, the trans-septal opening may be pre-formed, e.g., formed prior to insertion of the delivery catheter into the superior or inferior vena cava. In some embodiments, the trans-septal opening may be formed by one or more instruments also carried by the delivery catheter. For example, the trans-septal opening may be formed during advancement of the delivery catheter into the septum.

[0114] After moving through the transseptal opening, the delivery catheter may be advanced through the left ventricle toward the native mitral valve. At block 1508, the distal end of the delivery catheter may be positioned at a target site for the mitral valve replacement. At block 1510, the mitral valve replacement may be released at the target site. The mitral valve replacement may be deployed from the distal end of the delivery catheter and positioned at a desired location on the native mitral valve.

[0115] After release of the mitral valve replacement, the delivery catheter may be retracted along the same or substantially the same path along which it was advanced. In block 1512, the delivery catheter may be retracted through the left ventricle, the transseptal opening, and into the right ventricle. In block 1514, respective portions of the couplers may be released in the left ventricle, the transseptal opening, and the right ventricle while retracting the delivery catheter through the left ventricle, the transseptal opening, and into the right ventricle.

[0116] As described herein, in some embodiments, the dual heart valve anchoring system may include an anchor portion. The anchor portion may be between the tricuspid valve replacement portion and the mitral valve replacement portion and may be coupled to a coupler. In some embodiments, the coupler may extend through an opening in the anchor portion. At least a portion of the anchor portion and a corresponding portion of the coupler may be deployed at the transseptal opening during retraction of the delivery catheter through the transseptal opening. The anchor portion may include an occluder configured to facilitate sealing of the transseptal opening. For example, releasing at least a portion of the anchor portion and a corresponding portion of the coupler at the transseptal opening may include sealing the transseptal opening. In some embodiments, the transseptal opening may be sealed when the anchor portion is positioned at its target site with a corresponding portion of the coupler threaded therethrough.

[0117] The delivery catheter may be retracted back through the right ventricle toward the right atrium. In block 1516, the distal end of the delivery catheter may be positioned at the target site for the tricuspid valve replacement after retracting the delivery catheter into the right ventricle. In block 1518, the tricuspid valve replacement may be released at the target site. The delivery catheter is retracted through the right atrium and subsequently removed from the heart along the same path used to advance the delivery catheter, such as via the superior or inferior vena cava.

[0118] As described herein, in some embodiments, the dual heart valve anchoring system may include multiple connectors. For example, the dual heart valve anchoring system may include one or more additional connectors, such as a second connector, that connect the tricuspid valve replacement and the mitral valve replacement to each other. Retracting the delivery catheter through the left ventricle, the transseptal opening, and the right ventricle may include releasing a portion of each of both connectors in the left ventricle, the transseptal opening, and the right ventricle. In some embodiments, the dual heart valve anchoring system may include an anchoring portion that includes at least a portion configured to be positioned in the transseptal opening. In some embodiments, both connectors may extend through the anchoring portion. Retracting the delivery catheter through the left ventricle, the transseptal opening, and the right ventricle may include releasing a portion of each of both connectors in the left ventricle, the transseptal opening, and the right ventricle, and placing the anchoring portion at a target position in the transseptal opening.

[0119] In some embodiments, the coupler may comprise an adjustable length. The length of the coupler may be adjusted during the implantation procedure, such as depending on the individual's anatomy. In some embodiments, one or more imaging techniques may be used during the procedure when determining the appropriate length of the coupler. In some embodiments, the implantation procedure may be performed under the guidance of one or more of transesophageal (TEE), echocardiography, transthoracic echocardiography (TTE), and intracardiac echocardiography (ICE). Other known visualization techniques may additionally or alternatively be used.

[0120] The length of one or more couplers of the dual heart valve anchoring system may be adjusted with the aid of one or more imaging techniques after insertion of the one or more couplers into the patient. The length of the one or more couplers may be selected based on the individual's anatomy to provide the desired anchoring to the septum. In some embodiments, the length of the coupler may be adjusted such that the coupler is taut during ventricular contraction.

[0121] In some embodiments, the length of one or more connectors can be adjusted after the delivery catheter is introduced into the superior or inferior vena cava. In some embodiments, the length of one or more connectors can be adjusted after all replacement valves are positioned at their respective target sites. For example, the length of one or more connectors can be adjusted after the tricuspid valve replacement is placed at its desired location. In some embodiments, the length of one or more connectors can be adjusted multiple times. For example, the length of the connector can be adjusted after the mitral valve replacement, the anchoring portion, and the tricuspid valve replacement are positioned at their respective target locations one or more times. In some embodiments, the length of the connector can be adjusted after one or more of its corresponding portions are released from the delivery catheter. For example, the length of the coupler may be adjusted after deployment of the mitral valve replacement and before deployment of the tether (e.g., after the corresponding portion of the coupler is released in the left ventricle), after deployment of the tether and before further retraction of the delivery catheter, after deployment of the tether and before deployment of the tricuspid valve replacement (e.g., after the corresponding portion of the coupler is released in the right ventricle), after deployment of the tricuspid valve replacement, In some embodiments, the length of the coupler may be adjusted after each of its corresponding portions is released from the delivery catheter.

[0122] The locking mechanism may be deployed, actuated, and / or activated to secure the coupler at the selected length after the appropriate length is determined during the implantation procedure. In some embodiments, the locking mechanism may be deployed, actuated, and / or activated after each adjustment. As described herein, in some embodiments, the dual heart valve anchoring system may include multiple locking mechanisms. In some embodiments, the locking mechanism may be deployed, actuated, and / or activated after one or more portions of the coupler are released and adjusted, including after each portion is released and adjusted.

[0123] Additional Embodiments Depending on the embodiment, certain acts, results, or functions of any of the processes or algorithms described herein may be performed in a different order, added, combined, or removed, and thus, in a particular embodiment, not all described acts and events are required to implement a process.

[0124] In particular, conditional words used herein such as "can," "may," "could," "may," "for example," and the like, unless expressly stated otherwise or understood otherwise within the context as used, are intended in their original sense and are generally intended to convey that a particular embodiment includes certain features, elements, and / or steps while other embodiments do not. Thus, such conditional words are generally not intended to imply that features, elements, and / or steps are in any way required for one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without author input or motivation, whether those features, elements, and / or steps are included in or performed in any particular embodiment. Terms such as "comprises," "includes," "having," and the like, are synonymous and are used in their ordinary sense and are used in an inclusive, open-ended manner and do not exclude additional elements, features, acts, operations, and the like. Also, the term "or," when used, for example, to join a list of elements, is used in its inclusive sense (and not its exclusive sense) to mean one, some, or all of the elements in the list. Conjunctions such as the phrase "at least one of X, Y, and Z" are to be understood in the context as they are generally used to convey that an item, term, element, etc., can be either X, Y, or Z, unless expressly stated otherwise. Thus, such conjunctive terms are generally not intended to imply that a particular embodiment requires at least one of X, at least one of Y, and at least one of Z to each be present.

[0125] In the preceding description of the embodiments, it should be understood that various features may have been combined together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than are expressly set forth in that claim. Furthermore, any component, feature, or step illustrated and / or described in a specific embodiment herein may be applied to or used with any other embodiment. Furthermore, any group of components, features, or steps among the components, features, or steps is not necessary or essential for each embodiment. Thus, it is intended that the scope of the invention disclosed herein and later claimed should not be limited by the specific embodiments described above, but should be determined solely by a fair reading of the claims that follow.

[0126] It should be understood that certain ordinal terms (e.g., "first" or "second") may be provided for ease of reference, but do not necessarily imply physical characteristics or ranking. Thus, as used herein, ordinal terms (e.g., "first," "second," "third," etc.) used to modify elements, such as structures, components, operations, etc., do not necessarily indicate a priority or order of the element relative to any other elements, but rather may generally distinguish the element (because of the use of ordinal terms) from other elements having similar or identical names. Also, as used herein, the indefinite article ("a, an") may indicate "one or more" rather than "one." Furthermore, an action performed "based on" a condition or event may be performed based on one or more other conditions or events not expressly proposed.

[0127] Unless otherwise specified, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by those skilled in the art to which the exemplary embodiments belong. It is further understood that terms such as those defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and should not be interpreted in an idealized or overly formal sense unless expressly defined herein.

[0128] Spatially relative terms such as "outside," "inside," "up," "down," "down of," "above," "vertical," "horizontal," and similar terms may be used herein for ease of description to describe the relationship between one element or component and another element or component as shown in the drawings. It should be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the drawings. For example, if the device shown in the drawings is turned upside down, a device positioned "down" or "below" another device may be disposed "above" the other device. Thus, the illustrated term "down" can include both a below position and an above position. Devices may be oriented in other directions, and thus the spatially relative terms may be interpreted differently depending on the orientation.

[0129] Unless expressly stated otherwise, comparison and / or quantity terms such as "less," "more," "greater," etc. are intended to cover equivalence concepts. For example, "less" can mean not only "less" in the strict mechanical sense, but also "less than or equal to." [Explanation of symbols]

[0130] 1. Heart 2 left atrium 3 left ventricle 4 Right ventricle 5 Right atrium 6. Mitral Valve 7. Aortic Valve 8 Tricuspid Valve 9 Pulmonary valve 10 septum 11 Pulmonary artery 12 Aorta 13 Right pulmonary artery 14 Left pulmonary artery 100, 110, 120, 130, 140, 150, 160, 170, 180, 190 Dual Heart Valve Tethering System 200 Tricuspid valve replacement 202 first distal end 204 second distal end 206 Tricuspid valve body part 300 Mitral valve replacement 302 first distal end 304 Second Distal End 400, 410, 420, 430 coupler 402, 412, 422, 432 First part 404, 414, 424, 434 Second part 416 Transseptal section 420 Adjustable Coupler 436 Part of a rigid or semi-rigid body 436a First division 436b Second division 500, 550 Moorings 502 First septal contact 504 Second septal contact 506 Mooring body 508 First surface of first septum contact portion 502 510 Second surface of first septum contact portion 502 512 a first surface of the second septum contact portion 504 514 Second surface of second septum contact portion 504 516 First Distal End 518 Second Distal End 520 Lumen 552 first distal end 554 Second Distal End 556 Mooring body part 556a A portion of a first rigid or semi-rigid body 556b Part of a second rigid or semi-rigid body 560 Lumen 562 First septal contact 564 Second septal contact 600 Locking mechanism 602 First Movable Flap 604 Second movable flap 606 Third Movable Flap 602a, 604a, 606a First distal portion 608 Aperture 700 Tricuspid valve repair section 710 Coupler 712 First Distal Portion 714 Second Distal Part 800 Mitral Valve Repair Department 810 Coupler 812 second distal portion 814 First Distal Part 900 coupler 902 First Edge 904 Second End 1000 Tricuspid valve replacement 1002 first distal end 1004 second distal end 1006 Tricuspid valve body part 1008 Frame 1010 Valve tissue 1100 Mitral valve replacement 1102 first distal end 1104 second distal end 1106 Mitral valve body 1008 Frame 1110 Valve tissue

Claims

1. a first anchoring portion having at least a portion configured to be secured within a first transseptal opening in the interventricular septum; a tricuspid valve device coupled to the first anchor; a mitral valve apparatus coupled to the first anchor; 1. A dual heart valve anchoring system comprising:

2. 10. The system of claim 1, wherein the tricuspid valve apparatus comprises a tricuspid valve replacement and the mitral valve apparatus comprises a mitral valve replacement.

3. 3. The system of claim 2, further comprising a first connector extending between the tricuspid valve replacement and the mitral valve replacement, the first connector coupling the tricuspid valve replacement and the mitral valve replacement to the first anchor and configured to extend through the first transseptal opening.

4. 4. The system of claim 3, further comprising a second connector extending between the tricuspid valve replacement portion and the mitral valve replacement portion, the second connector coupling the tricuspid valve replacement portion and the mitral valve replacement portion.

5. 5. The system of claim 4, wherein both the first connector and the second connector couple the tricuspid valve replacement portion and the mitral valve replacement portion to the first anchor portion and are both configured to extend through the first transseptal opening.

6. 5. The system of claim 4, further comprising a second anchor portion having at least a portion configured to be secured within a second transseptal opening in the ventricular septum, the second connector coupling the tricuspid valve replacement portion and the mitral valve replacement portion to the second anchor portion, the second connector configured to extend through the second transseptal opening.

7. 7. The system of claim 4, wherein a respective end of at least one of the first connector and the second connector is coupled to a portion of the tricuspid valve replacement configured to be positioned in a right ventricle and a portion of the mitral valve replacement configured to be positioned in a left ventricle.

8. 8. The system of claim 7, wherein a respective end of at least one of the first connector and the second connector is coupled to a distal end of the tricuspid valve replacement configured to be positioned in the right ventricle and a distal end of the mitral valve replacement configured to be positioned in the left ventricle.

9. 9. The system of claim 4, wherein at least one of the first coupler and the second coupler is adjustable in length.

10. 10. The system of claim 9, further comprising at least one locking mechanism for locking at least one of the first coupler and the second coupler at a respective selected length.

11. 11. The system of claim 4, wherein a length of at least one of the first coupler and the second coupler is selected prior to implantation.

12. 12. The system of claim 4, wherein at least one of the first coupler and the second coupler comprises a Nitinol wire.

13. 13. The system of any one of claims 4 to 12, wherein at least one of the first coupler and the second coupler comprises a rigid coupler portion configured to extend through the septum into at least one of a right ventricle and a left ventricle to provide a predetermined angle of septal anchoring for the tricuspid valve replacement and the mitral valve replacement.

14. 13. The system of claim 4, wherein at least one of the first coupler and the second coupler is a flexible cord.

15. 15. The system of any one of claims 6-14, wherein at least one of the first tether portion and the second tether portion comprises a rigid tether portion configured to extend into at least one of a right ventricle and a left ventricle to provide a predetermined angle of septal anchoring for the tricuspid valve replacement portion and the mitral valve replacement portion.

16. 10. The system of claim 1, wherein the tricuspid valve apparatus comprises a tricuspid valve replacement portion and the mitral valve apparatus comprises a mitral valve repair portion.

17. 10. The system of claim 1, wherein the tricuspid valve apparatus comprises a tricuspid valve repair portion and the mitral valve apparatus comprises a mitral valve replacement portion.

18. 10. The system of claim 1, wherein the tricuspid valve apparatus comprises a tricuspid valve repair and the mitral valve apparatus comprises a mitral valve repair.

19. 20. The system of claim 18, wherein the tricuspid valve repair portion comprises a first connector configured to couple a tricuspid valve leaflet to the first anchor portion, and the mitral valve repair portion comprises a second connector that couples a mitral valve leaflet to the first anchor portion.

20. 20. The system of claim 18, further comprising a coupler coupling the tricuspid valve repair portion to the mitral valve repair portion, the coupler being configured to couple to the first anchor portion and extend through the first transseptal opening.

21. 21. The system of claim 20, wherein the tricuspid valve repair portion and the mitral valve repair portion comprise the couplers, the couplers being configured to couple the tricuspid valve leaflets and the mitral valve leaflets to the first anchor portion and to extend through the first transseptal opening.

22. A tricuspid valve replacement portion; A mitral valve replacement portion; a first connector connecting the tricuspid valve replacement and the mitral valve replacement, the first connector being configured to extend through a first transseptal opening in the ventricular septum; 1. A dual heart valve anchoring system comprising:

23. 23. The system of claim 22, further comprising a second connector connecting the tricuspid valve replacement and the mitral valve replacement.

24. 24. The system of claim 23, wherein both the first coupler and the second coupler are configured to extend through the first transseptal opening.

25. 24. The system of claim 23, wherein the second coupler is configured to extend through a second transseptal opening.

26. 26. The system of any one of claims 23 to 25, wherein a respective end of at least one of the first connector and the second connector is coupled to a portion of the tricuspid valve replacement configured to be positioned in a right ventricle and a portion of the mitral valve replacement configured to be positioned in a left ventricle.

27. 27. The system of claim 26, wherein a respective end of at least one of the first connector and the second connector is coupled to a distal end of the tricuspid valve replacement configured to be positioned in the right ventricle and a distal end of the mitral valve replacement configured to be positioned in the left ventricle.

28. 28. The system of any one of claims 23 to 27, wherein the length of at least one of the first coupler and the second coupler is adjustable.

29. 30. The system of claim 28, further comprising at least one locking mechanism for locking at least one of the first coupler and the second coupler at a respective selected length.

30. 30. The system of any one of claims 23 to 29, wherein a length of at least one of the first coupler and the second coupler is selected prior to implantation.

31. 31. The system of any one of claims 23 to 30, wherein at least one of the first coupler and the second coupler comprises a Nitinol wire.

32. 32. The system of any one of claims 23 to 31, wherein at least one of the first coupler and the second coupler comprises a rigid coupler portion configured to extend through the ventricular septum into at least one of a right ventricle and a left ventricle to provide a predetermined angle of septal anchoring for the tricuspid valve replacement and the mitral valve replacement.

33. 33. The system of any one of claims 23 to 32, wherein at least one of the first coupler and the second coupler is a flexible cord.

34. 1. A method for replacing tricuspid and mitral valves, comprising: Introducing a delivery catheter carrying a dual heart valve anchoring system into the right atrium through the inferior or superior vena cava, the dual heart valve anchoring system comprising a tricuspid valve replacement portion, a mitral valve replacement portion, and a first connector connecting the tricuspid valve replacement portion and the mitral valve replacement portion; advancing the delivery catheter from the right atrium through an opening formed by the native tricuspid valve into the right ventricle; passing the delivery catheter through a transseptal opening in the interventricular septum to insert the delivery catheter from the right ventricle into the left ventricle; positioning a distal end of the delivery catheter at a target site for the mitral valve replacement; releasing the mitral valve replacement at the target site for the mitral valve replacement; retracting the delivery catheter through the left ventricle, the trans-septal opening, and into the right ventricle, and releasing a portion of each of the first coupler in the left ventricle, the trans-septal opening, and the right ventricle while retracting the delivery catheter through the left ventricle, the trans-septal opening, and into the right ventricle; retracting the delivery catheter into the right ventricle, then positioning a distal end of the delivery catheter at a target site for the tricuspid valve replacement and releasing the tricuspid valve replacement at the target site for the tricuspid valve replacement; The method includes:

35. 35. The method of claim 34, wherein introducing the delivery catheter comprises introducing the delivery catheter through the inferior vena cava.

36. 36. The method of claim 34 or 35, wherein the step of introducing the delivery catheter comprises introducing a dual heart valve anchoring system comprising an anchor portion, the anchor portion being between the tricuspid valve replacement portion and the mitral valve replacement portion and coupled to the first connector, and the step of retracting the delivery catheter comprises releasing at least a portion of the anchor portion at the transseptal opening.

37. 37. The method of claim 36, wherein the step of releasing at least a portion of the tether at the transseptal opening comprises sealing the transseptal opening.

38. 38. The method of any one of claims 34 to 37, wherein the step of introducing the delivery catheter comprises the steps of: introducing a delivery catheter carrying a dual heart valve anchoring system including a second connector connecting the tricuspid valve replacement and the mitral valve replacement; and releasing a portion of the second connector in the left ventricle, the transseptal opening, and the right ventricle while retracting the delivery catheter through the left ventricle, the transseptal opening, and into the right ventricle.

39. 40. The method of claim 38, further comprising the step of adjusting a length of at least one of the first coupler and the second coupler after the step of introducing the delivery catheter.

40. 40. The method of claim 39, further comprising the step of activating a locking mechanism after adjusting the length to secure at least one of the first coupler and the second coupler at their respective selected lengths.

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