Dual heart valve anchoring

Abstract

The invention relates to dual heart valve anchoring. In some embodiments, a dual heart valve anchoring system may include a first anchor having at least a portion configured to be secured within a first transseptal opening in a ventricular septum; a tricuspid valve device, the tricuspid valve device being coupled to the first anchor; and a mitral valve device, the mitral valve device being coupled to the first anchor.

Description

[0001] This application is a divisional application. The application date of the original application is February 6, 2020, the application number is 202080027534.7, and the name of the invention is "Dual Heart Valve Anchoring", which is incorporated herein by reference in its entirety.

[0002] Related Applications

[0003] Any and all applications claiming foreign or domestic priority identified in the Application Data Sheet filed with this application are hereby incorporated by reference pursuant to CFR 1.57. This application claims priority to U.S. Provisional Application No. 62 / 811,453, filed on February 27, 2019, entitled DOUBLEHEART VALVE ANCHORING, the disclosure of which is hereby expressly incorporated herein by reference in its entirety. Technical Field

[0004] The present disclosure relates generally to the field of medical implant devices. Background Art

[0005] Implantation of a heart valve device can be performed to address a variety of heart valve abnormalities. Implantation of a tricuspid valve device and a mitral valve device can be beneficial for patients who have dysfunction in both valves. Summary of the invention

[0006] One or more methods and / or devices for anchoring both a tricuspid valve device and a mitral valve device to the septum are described herein. In some embodiments, the present disclosure relates to a dual heart valve anchoring system comprising: a first anchor including at least a portion configured to be fixed within a first transseptal opening in the interventricular septum; a tricuspid valve device coupled to the first anchor; and a mitral valve device coupled to the first anchor.

[0007] In some embodiments, the tricuspid valve device includes a tricuspid valve replacement and the mitral valve device includes a mitral valve replacement. A first connector can extend between the tricuspid valve replacement and the mitral valve replacement, couple the tricuspid valve replacement and the mitral valve replacement to the first anchor, and be configured to extend through the first transseptal opening.

[0008] In some embodiments, the dual heart valve anchoring system may include a second connector extending between the tricuspid valve replacement and the mitral valve replacement, coupling the tricuspid valve replacement and the mitral valve replacement. The first connector and the second connector can both couple the tricuspid valve replacement and the mitral valve replacement to the first anchor, and the first connector and the second connector can both be configured to extend through the first transseptal opening.

[0009] In some embodiments, a dual heart valve anchoring system can include a second anchor comprising at least a portion configured to be secured within a second transseptal opening in the interventricular septum, and wherein a second connector couples the tricuspid valve replacement and the mitral valve replacement to the second anchor, and wherein the second connector is configured to extend through the second transseptal opening.

[0010] The ends of at least one of the first connector and the second connector can be respectively connected to a portion of the tricuspid valve replacement configured to be positioned within the right ventricle and a portion of the mitral valve replacement configured to be positioned within the left ventricle. In some embodiments, the ends of at least one of the first connector and the second connector are respectively connected to a distal end of the tricuspid valve replacement configured to be positioned within the right ventricle and a distal end of the mitral valve replacement configured to be positioned within the left ventricle.

[0011] In some embodiments, the length of at least one of the first connector and the second connector is adjustable.The dual heart valve anchoring system can include at least one locking mechanism to lock at least one of the first connector and the second connector at a corresponding selected length.

[0012] In some embodiments, the length of at least one of the first connector and the second connector is selected prior to implantation.

[0013] In some embodiments, at least one of the first connector and the second connector comprises a nitinol wire. In some embodiments, at least one of the first connector and the second connector is a flexible cord.

[0014] In some embodiments, at least one of the first connector and the second connector includes a rigid connector portion configured to extend through the septum and into at least one of the right ventricle and the left ventricle to provide a predetermined septal anchoring angle for the tricuspid valve replacement and the mitral valve replacement.

[0015] In some embodiments, at least one of the first anchor and the second anchor includes a rigid anchor portion configured to extend into at least one of the right ventricle and the left ventricle to provide a predetermined septal anchoring angle for the tricuspid valve replacement and the mitral valve replacement.

[0016] In some embodiments, the tricuspid valve device comprises a tricuspid valve replacement and the mitral valve device comprises a mitral valve repair device.

[0017] In some embodiments, the tricuspid valve device comprises a tricuspid valve repair device and the mitral valve device comprises a mitral valve replacement.

[0018] In some embodiments, the tricuspid valve device includes a tricuspid valve repair device, and the mitral valve device includes a mitral valve repair device. The tricuspid valve repair device may include a first connector configured to connect the tricuspid valve leaflet to the first anchor, and the mitral valve repair device may include a second connector connecting the mitral valve leaflet to the first anchor. In some embodiments, the dual heart valve anchoring system includes a connector connecting the tricuspid valve repair device to the mitral valve repair device, the connector being configured to connect to the first anchor and extending through the first transseptal opening. In some embodiments, the tricuspid valve repair device and the mitral valve repair device include a connector configured to connect the tricuspid valve leaflet and the mitral valve leaflet to the first anchor and extending through the first transseptal opening.

[0019] In some embodiments, the present disclosure is directed to a dual heart valve anchoring system comprising: a tricuspid valve replacement, a mitral valve replacement, and a first connector coupling the tricuspid valve replacement and the mitral valve replacement and configured to extend through a first transseptal opening in the interventricular septum.

[0020] In some embodiments, the dual heart valve anchoring system can include a second connector that couples 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.

[0021] The ends of at least one of the first connector and the second connector can be respectively connected to a portion of the tricuspid valve replacement configured to be positioned within the right ventricle and a portion of the mitral valve replacement configured to be positioned within the left ventricle. The ends of at least one of the first connector and the second connector can be respectively connected to a distal end of the tricuspid valve replacement configured to be positioned within the right ventricle and a distal end of the mitral valve replacement configured to be positioned within the left ventricle.

[0022] In some embodiments, the length of at least one of the first connector and the second connector is adjustable.The dual heart valve anchoring system can include at least one locking mechanism to lock at least one of the first connector and the second connector at a corresponding selected length.

[0023] In some embodiments, the length of at least one of the first connector and the second connector is selected prior to implantation.

[0024] In some embodiments, at least one of the first connector and the second connector comprises a nitinol wire. In some embodiments, at least one of the first connector and the second connector is a flexible cord.

[0025] In some embodiments, at least one of the first connector and the second connector includes a rigid connector portion configured to extend through the interventricular septum and into at least one of the right ventricle and the left ventricle to provide a predetermined septal anchoring angle for the tricuspid valve replacement and the mitral valve replacement.

[0026] In some embodiments, the present disclosure relates to a method for replacing a tricuspid valve and a mitral valve. The method may include introducing a delivery catheter carrying a dual heart valve anchoring system through the inferior vena cava or the superior vena cava and into the right atrium. The dual heart valve anchoring system may include a tricuspid valve replacement, a mitral valve replacement, and a first connector connecting the tricuspid valve replacement and the mitral valve replacement. The delivery catheter may be advanced from the right atrium into the right ventricle through an opening formed by a natural tricuspid valve. The delivery catheter may then be passed through a transseptal opening in the interventricular 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 of the mitral valve replacement, and the mitral valve replacement may be released at the target site of the mitral valve replacement. The delivery catheter may be retracted through the left ventricle, through the septal opening, and into the right ventricle. When the delivery catheter is retracted through the left ventricle, through the septal opening, and into the right ventricle, the corresponding portion of the first connector may be released in the left ventricle, through the septal opening, and in 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.

[0027] In some embodiments, introducing the delivery catheter comprises introducing the delivery catheter through the inferior vena cava.

[0028] In some embodiments, introducing the delivery catheter includes introducing a dual heart valve anchoring system including an anchor between a tricuspid valve replacement and a mitral valve replacement and coupled to a first connector. Retracting the delivery catheter may include releasing at least a portion of the anchor in the transseptal opening. Releasing at least a portion of the anchor in the transseptal opening may include sealing the transseptal opening.

[0029] In some embodiments, introducing the delivery catheter includes introducing a delivery catheter carrying a dual heart valve anchoring system including a second connector coupling a tricuspid valve replacement and a mitral valve replacement. The method may include releasing corresponding portions of the second connector in the left ventricle, through the septal opening, and into the right ventricle while retracting the delivery catheter through the left ventricle, through the septal opening, and into the right ventricle.

[0030] In some embodiments, the method may include adjusting the length of at least one of the first connector and the second connector after introducing the delivery catheter.After adjusting the length, a locking mechanism may be activated to fix at least one of the first connector and the second connector at a corresponding selected length.

[0031] For the purpose of summarizing the disclosure, certain aspects, advantages and novel features have been described herein. It should be understood that such advantages may not all be realized according to any specific embodiment. Thus, the disclosed embodiments may be performed in a manner that realizes or optimizes one advantage or a group of advantages taught herein without necessarily realizing other advantages taught or proposed herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] For illustrative purposes, various embodiments are depicted in the accompanying drawings, and they are not to be construed in any way as limiting the scope of the present invention. In addition, various features of different disclosed embodiments may be combined to form additional embodiments, which are part of the present disclosure. Throughout the accompanying drawings, reference numbers may be reused to indicate the corresponding relationship between reference elements. However, it should be understood that the use of similar reference numbers in conjunction with multiple drawings does not necessarily imply similarities between corresponding embodiments associated therewith. In addition, it should be understood that the features of the corresponding drawings are not necessarily drawn to scale, and their example sizes are presented to illustrate their inventive aspects. In general, some example features may be relatively smaller than the examples in some embodiments or configurations.

[0033] Figure 1 A cross-section of a human heart.

[0034] Figure 2 is a schematic diagram of an example of a dual heart valve anchoring system including two heart valve replacements.

[0035] Figure 3 Yes Display Figure 2 Schematic diagram of a dual heart valve anchoring system positioned at its target site in the heart.

[0036] Figure 4 is a schematic diagram of an example of a dual heart valve anchoring system that does not include an anchor and is positioned at its target site.

[0037] Figure 5A is a schematic diagram showing an example of a dual heart valve anchoring system including an adjustable connector positioned at its target site.

[0038] Figure 5B is a schematic diagram of an example of a locking mechanism for securing an adjustable connector at a selected length.

[0039] Figure 6 is a schematic diagram of a dual heart valve anchoring system including a connector including a rigid or semi-rigid portion positioned at its target site.

[0040] Fig. 7A is a schematic diagram of a dual heart valve anchoring system including anchors including respective rigid or semi-rigid portions configured to extend into the left and right ventricles, the dual heart valve anchoring system being positioned at its target site.

[0041] Figure 7B It is a reference Fig. 7A Schematic diagram of the described anchor.

[0042] Figure 8 is a schematic diagram of a dual heart valve anchoring system including three connectors positioned at its target site.

[0043] Fig. 9 is a schematic diagram of a dual heart valve anchoring system including three connectors and three anchors positioned at its target site.

[0044] Fig.10 is a schematic diagram of an example of a dual heart valve anchoring system including a tricuspid valve prosthesis and a mitral valve prosthesis positioned at their target sites.

[0045] Fig.11 is a schematic diagram of an example of a dual heart valve anchoring system including a tricuspid valve replacement and a mitral valve repair device positioned at their target sites.

[0046] Fig.12 is a schematic diagram of a dual heart valve anchoring system including an example tricuspid valve replacement and an example mitral valve replacement positioned at their target sites.

[0047] Fig.13A and 13B is a schematic diagram showing an example of a path by which a delivery catheter carrying a dual heart valve anchoring system may be advanced and retracted.

[0048] Fig.14A and 14B is a schematic diagram showing another example of a path by which a delivery catheter carrying a dual heart valve anchoring system may be advanced and retracted.

[0049] Fig.15 is a flow chart of an example of an implantation procedure. DETAILED DESCRIPTION

[0050] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention.

[0051] The present disclosure relates to systems, devices, and methods for anchoring tricuspid and mitral valve devices to the septum.

[0052] Although certain preferred embodiments and examples are disclosed below, the subject matter of the present invention extends beyond the specifically disclosed embodiments to other optional embodiments and / or uses and variations and equivalents thereof. Therefore, the scope of the claims that may arise therefrom is not limited by any specific embodiment described below. For example, in any method or process disclosed herein, the actions or operations of the method or process may be performed in any suitable order, without necessarily being limited to any specific disclosed order. Various operations may further be described as multiple discrete operations in a manner that helps to understand certain embodiments; however, the order of description should not be interpreted as implying that these operations are sequence-dependent. In addition, the structures, systems and / or devices described herein may be implemented as integrated components or separate components. For the purpose of comparing various embodiments, certain aspects and advantages of these embodiments are described. Such aspects or advantages may not all be realized by any specific embodiment. Therefore, for example, various embodiments may be carried out in a manner that realizes or optimizes an advantage or a group of advantages as taught herein, without necessarily realizing other aspects or advantages that may also be taught or proposed herein.

[0053] With regard to preferred embodiments, certain standard anatomical position terms are used herein to refer to the anatomical structures of animals (and, i.e., humans). Although certain spatially relative terms, such as "outside", "inside", "up", "down", "below", "above", "vertical", "horizontal", "top", "bottom" and similar terms, are used herein to describe the spatial relationship between a device / element or anatomical structure and another device / element or anatomical structure, it should be understood that these terms are used herein for the convenience of description to describe the positional relationship between the element (one or more) / structure (one or more) illustrated in the accompanying drawings. It should be understood that, in addition to the orientations depicted in the accompanying drawings, spatially relative terms are intended to also cover different orientations of element (one or more) / structure (one or more) in use or operation. For example, an element / structure being described as being "above" another element / structure can represent, with respect to the optional orientation of the subject patient or element / structure, a position below or beside this other element / structure, and vice versa.

[0054] refer to Figure 1Various features of the heart 1 are described to aid in understanding the present disclosure. The heart 1 includes four chambers, namely 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.

[0055] Heart valves can generally include a relatively dense fibrous ring (referred to herein as an annulus) and a plurality of 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 leaflets or cusps. The size of the leaflets or cusps can allow the leaflets or cusps to mate to close the valve and move apart to open the valve. The atrioventricular (i.e., mitral and tricuspid) heart valves can further include a collection of chordae tendineae and papillary muscles (not shown) for fixing the leaflets of the corresponding valves to promote and / or facilitate the correct mate of the valve leaflets and prevent their prolapse. For example, the papillary muscles can generally include finger-like projections from the ventricular wall. The valve leaflets are connected to the papillary muscles by chordae tendineae.

[0056] In a healthy heart, the heart valves can open and close appropriately in response to pressure gradients present during different phases of the cardiac cycle (e.g., diastole and systole) to at least partially control blood flow to corresponding regions and / or vessels of the heart. Deoxygenated blood from the rest of the body generally flows into the right side of the heart for delivery to the lungs, and oxygenated blood from the lungs generally flows into the left side of the heart for delivery to the rest of the body.

[0057] During ventricular diastole (e.g., when the ventricular myocardium relaxes), the negative pressure differential 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, allowing deoxygenated blood from the inferior vena cava 15 and the superior vena cava 16 in the right atrium 5 to flow into the right ventricle 4. The leaflets of the pulmonary valve 9 coapt during ventricular diastole, maintaining apposition to each other, to keep the pulmonary valve 9 closed. The negative pressure differential between the left ventricle 3 and the left atrium 2 can push the leaflets of the mitral valve 6 apart to open the mitral valve 6 during ventricular diastole, allowing oxygenated blood from the pulmonary veins in the left atrium 2 to flow into the left ventricle 3. The leaflets of the aortic valve 7 can remain coapted during ventricular diastole, keeping the aortic valve 7 closed.

[0058] During ventricular systole (e.g., when the ventricular myocardium contracts), the positive pressure differential between the right ventricle 4 and the right atrium 5 can keep the leaflets of the tricuspid valve 8 in coaptation or in apposition with each other to close the tricuspid valve 8. Properly coapted leaflets can prevent blood from leaking from the right ventricle 4 into the right atrium 5. At the same time, the leaflets of the pulmonary valve 9 can be pushed apart during ventricular systole to send deoxygenated blood from the right ventricle 4 to the pulmonary artery 11 for delivery to the lungs. The pulmonary artery 11 can carry deoxygenated blood from the right side of the heart to the lungs. As shown, the pulmonary artery 11 can include a pulmonary trunk and a left pulmonary artery 14 and a right pulmonary artery 13 that branch from the pulmonary trunk. The positive pressure differential between the left ventricle 3 and the left atrium 2 during ventricular systole can keep the leaflets of the mitral valve 6 in coaptation or in apposition with each other to close the mitral valve 6. Properly coapted mitral valve leaflets can prevent blood from leaking from the left ventricle 3 into the left atrium 2. The leaflets of the aortic valve 7 can be pushed apart during ventricular systole to allow oxygenated blood to flow from the left ventricle 3 to the aorta 12 for delivery to the rest of the body.

[0059] 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. Valvular stenosis can lead to narrowing or obstruction of the valve. Tricuspid stenosis and mitral stenosis can limit blood flow from the right atrium to the right ventricle and from the left atrium to the left ventricle, respectively. Valvular regurgitation occurs when the valve is not properly closed. For example, regurgitation can occur due to improper coaptation of the valve leaflets. Tricuspid regurgitation can cause blood flow to leak back into the right atrium from the right ventricle when the right ventricle contracts. Blood leaking back into the right atrium can cause ineffective pumping of deoxygenated blood to the lungs. Mitral regurgitation can cause blood flow to leak back into the left atrium from the left ventricle when the left ventricle contracts. If the regurgitation is severe enough, the heart may enlarge to keep the blood flowing forward, leading to heart failure, such as when the heart does not pump enough blood to the body. This can produce symptoms including shortness of breath, coughing, congestion in the heart and lungs, and swelling of the legs and feet when exerting effort. Valve repair can be done to address various valve diseases. In more severe cases, valve replacement can be done.

[0060] The present disclosure relates to devices, systems and / or methods for anchoring a tricuspid valve device and a mitral valve device to each other on the interventricular septum. The tricuspid valve device may include a tricuspid valve replacement or a tricuspid valve repair device. The mitral valve device may include a mitral valve replacement or a mitral valve repair device. 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 tethered 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, tether the tricuspid valve replacement and the mitral valve replacement to each other and connect the tricuspid valve replacement and the mitral valve replacement to the septum. The dual heart valve anchoring system may include an anchor, which includes at least a portion configured to be positioned within the transseptal opening. The connector may be connected to the anchor, for example, including a portion extending through an opening in the anchor.

[0061] In some embodiments, the mitral valve repair device and the tricuspid valve repair device can be coupled to each other via a trans-septal opening, anchoring the mitral valve repair device and the tricuspid valve repair device to the septum and to each other. In some embodiments, the mitral valve repair device and the tricuspid valve replacement device can be coupled to each other via a trans-septal opening. In some embodiments, the mitral valve replacement device and the tricuspid valve repair device can be coupled to each other via a trans-septal opening.

[0062] During ventricular contraction, ventricular contraction can push the tricuspid valve device and the mitral valve device toward the right atrium and the left atrium, respectively, possibly undesirably dislodging the devices. Anchoring the tricuspid valve device and the mitral valve device to the septal wall can facilitate secure positioning of each device at its corresponding target site. Tethering the mitral valve device and the tricuspid valve device to each other can advantageously balance the forces applied thereto due to cardiac contraction. For example, the forces applied to the tricuspid valve device can counterbalance the forces applied to the mitral valve device, thereby reducing or eliminating an imbalance in the forces applied to the septal wall. Reducing or eliminating an imbalance in the forces applied to the septal wall can reduce or prevent damage to the septal wall caused by anchoring the tricuspid valve device and the mitral valve device to the septal wall.

[0063] Anchoring the tricuspid valve device and the mitral valve device to the septal wall can allow the use of valve devices that include reduced anchoring features on the device itself to achieve secure positioning within its corresponding target location. The valve device can have reduced anchoring features for connecting to the native valve to achieve the desired anchoring, enabling the use of valve devices with reduced size and / or complexity. For example, the dual heart valve anchoring system described herein can include a tricuspid valve replacement and / or a mitral valve replacement that can have a shorter profile and / or a narrower diameter. The tricuspid valve replacement and / or mitral valve replacement can be more easily compressed for implantation and / or simpler to manufacture.

[0064] In some embodiments, one or more systems described herein can be advantageously delivered using a minimally invasive transcatheter approach. Both the replacement tricuspid valve and the replacement mitral valve can be delivered using a minimally invasive transcatheter approach, including being positioned at the corresponding target site using a single surgical procedure. For example, a delivery catheter carrying a tricuspid valve replacement and a mitral valve replacement can be inserted into the right atrium (RA) through the inferior vena cava (IVC) or the superior vena cava (SVC), and enter the right ventricle (RV) from the RA, and then enter the left ventricle (LV) via the septal wall. After reaching the target site of the mitral valve replacement, the mitral valve replacement can be released from the delivery catheter. Subsequently, the delivery catheter can be retracted along or substantially along the same path in which it was inserted. After the delivery catheter is retracted to the target site of the tricuspid valve replacement, the tricuspid valve replacement can be deployed. This procedure can provide a less invasive percutaneous delivery method, reduce the trauma caused to the patient during the surgical procedure, and is easy to recover.

[0065] Figure 2 is a schematic diagram of an example of a dual heart valve anchoring system 100 including two heart valve replacements. In some embodiments, the dual heart valve anchoring system 100 can be delivered to its target site using a minimally invasive transcatheter method. The dual heart valve anchoring system 100 can include a tricuspid valve replacement 200, a mitral valve replacement 300, and a connector 400 that connects the tricuspid valve replacement 200 and the mitral valve replacement 300 to each other. The connector 400 can be configured to extend through a transseptal opening formed in the interventricular septum. As further described in detail herein, the connector 400 can be configured to anchor the tricuspid valve replacement 200 and the mitral valve replacement 300 to the septum while balancing the forces exerted on the tricuspid valve replacement 200 due to heart contraction with the forces exerted on the mitral valve replacement 300 due to heart contraction.

[0066] Reference again Figure 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 have a mitral valve body portion 306 including a first distal end 204 and a second distal end 304. The connector 400 may be coupled to the corresponding second distal ends 204 and 304 of the tricuspid valve replacement 200 and the mitral valve replacement 300. As described in further detail herein, the connector 400 may be coupled to the pro-ventricular ends of the tricuspid valve replacement 200 and the mitral valve replacement 300. For example, the connector 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 Figure 2The connector 400 is shown as being coupled to respective distal ends of the tricuspid valve replacement 200 and the mitral valve replacement 300 , but it will be understood that the connector 400 may be coupled to one or more other portions of the tricuspid valve replacement 200 and / or the mitral valve replacement 300 .

[0067] In some embodiments, the connector can be coupled to a distal portion of a heart valve replacement other than at the distal end of the main portion of the heart valve replacement, such as at a distal portion proximal to the distal end of the main portion of the heart valve replacement. In some embodiments, the connector can be coupled to a central portion of the main portion of the heart valve replacement. In some embodiments, the connector can be coupled to more than one location of a heart valve replacement, including one or more portions of the heart valve replacements described herein. The location at which the connector is coupled to the heart valve replacement can be selected to provide a desired angle for anchoring to the septum and / or coupling to another heart valve replacement.

[0068] As described in further detail herein, in some embodiments, the length of the connector can be predetermined. For example, the length can be selected prior to inserting a delivery catheter carrying a dual heart valve anchoring system into a patient. In some embodiments, the length is adjustable during an implantation procedure. For example, the length can be adjusted during an implantation procedure in response to an individual's anatomy.

[0069] In some embodiments, the dual heart valve anchoring system 100 may include an anchor 500 including at least a portion configured to be fixed within a transseptal opening. The anchor 500 may include an anchor body 506, and a first septum contact 502 and a second septum contact 504 coupled to opposite distal ends 516, 518 of the anchor body 506. The anchor may include an inner cavity 520 extending along the entire longitudinal length of the anchor body 506.

[0070] When anchor 500 is positioned at its target site, the first distal end 516 of anchor body 506 can be positioned adjacent to or near the right ventricular surface of the septum, and the second distal end 518 of anchor body 506 can be positioned adjacent to or near the left ventricular surface of the septum. In some embodiments, the longitudinal length of anchor body 506 can be the same or substantially the same as the thickness of the septum at its target site. Anchor 500 can be positioned at the septal opening so that lumen 520 extends across the entire thickness of the septum at the opening. Connector 400 can extend through lumen 520 to connect tricuspid valve replacement 200 and mitral valve replacement 300 to each other.

[0071] The first septal contact 502 can be configured to be positioned against or proximate to the right ventricular surface of the septum, and the second septal contact 504 can be configured to be positioned against or proximate to the left ventricular surface of the septum. Figure 2 As shown, the first septum contact 502 and the second septum contact 504 coupled to the corresponding distal ends 516, 518 of the anchor body 506 can have an opening corresponding to the inner cavity 520 so that the connector 400 can extend therethrough. Extending the connector 400 through the anchor 500 can 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 by the anchoring.

[0072] The first septum contact 502 and the second septum contact 504 can be configured to engage the septum to facilitate stable positioning of the anchor 500 in the transseptal opening. A portion of the septum can be between the first septum contact 502 and the second septum contact 504, for example, sandwiched by the first septum contact 502 and the second septum contact 504. The first septum contact 502 can have a first surface 508 configured to face the right ventricle and a second surface 510 configured to face the right ventricle surface of the septum. In some embodiments, the second surface 510 can be configured to be positioned adjacent to and contact the right ventricle surface. In some embodiments, the second surface 510 can be close to but not in contact with the right ventricle surface. The second septum contact 504 can have a first surface 512 configured to face the left ventricle and a second surface 514 configured to face the left ventricle surface of the septum. In some embodiments, the second surface 514 can be configured to be positioned adjacent to and contact the left ventricle surface. In some embodiments, the second surface 514 can be proximal to but not in contact with the left ventricle surface.

[0073] Although reference Figure 2 The depicted first and second septum contacts 504, 506 may include a circular or substantially circular shape and extend around the entire circumference of the lumen 520, but it will be appreciated that the septum contacts may extend only partially around the circumference of the lumen 520. In some embodiments, the septum contacts may include one or more features on the septum-facing surface that facilitate secure positioning of the anchor 500, such as one or more protrusions and / or recesses.

[0074] The inner cavity 520 can have any of a variety of cross-sectional shapes. In some embodiments, the cross-sectional shape of the inner cavity 520 includes an arcuate shape, including a circular or elliptical shape. In some embodiments, the cross-sectional shape of the inner cavity 520 includes straight edges, such as a rectangle or a triangle. The cross-sectional shape of the inner cavity 520 can be selected based on the cross-sectional shape of the connector 400, for example to accommodate the connector 400. The cross-sectional size of the inner cavity 520, such as the diameter, can be selected to accommodate the connector 400. As described in further detail herein, the dual heart valve anchoring system can include multiple connectors. The cross-sectional shape and / or size of the inner cavity 520 can be configured to accommodate multiple connectors.

[0075] In some embodiments, anchor 500 can promote occlusion of the septal opening to prevent or reduce blood flow between the left ventricle and the right ventricle. For example, lumen 520 can have a size and cross-sectional shape that adapts to connector 400, not allowing or substantially not allowing blood to flow through anchor 500 when anchor 500 is deployed at its target site. In some embodiments, the cross-sectional diameter of lumen 520 is the same or similar to the cross-sectional diameter of connector 400. In some embodiments, lumen 520 can have a cross-sectional shape that is the same or similar to connector 400.

[0076] In some embodiments, anchor 500 and / or connector 400 may include flexible, deformable and / or elastic biocompatible materials, which are configured to facilitate transcatheter delivery to its corresponding target site. Materials with shape memory can be used. Anchor 500 and / or connector 400 may include one or more of flexible, deformable and / or elastic biocompatible polymers and / or metal alloys. In some embodiments, anchor 500 and / or connector 400 may include 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 acid-co-glycolic acid) (PLGA). In some embodiments, anchor 500 and / or connector 400 may include stainless steel and / or nickel-titanium. In some embodiments, the connector 400 may include a flexible cord. The connector 400 may be a flexible cord. In some embodiments, the connector 400 may include a nitinol wire. For example, the connector 400 may be a nitinol wire. In some embodiments, the connector 400 may be a polymer wire. In some embodiments, the anchor 500 may include a shape memory material so that the anchor 500 may be advanced through the delivery catheter in a reduced profile configuration. After delivery to the target site, the anchor 500 may be released from the delivery catheter and assume an expanded profile configuration.

[0077] 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 connector that extends through the transseptal opening without coupling with any anchor positioned in and / or through the septum.

[0078] Figure 3 is a schematic diagram showing a dual heart valve anchoring system 100 positioned at its target site in the heart. The dual heart valve anchoring system 100 can have a tricuspid valve replacement 200 and a mitral valve replacement 300, the tricuspid valve replacement 200 including at least a portion positioned within the native tricuspid valve, and the mitral valve replacement 300 including at least a portion positioned within the native mitral valve. A connector 400 can connect the tricuspid valve replacement 200 and the mitral valve replacement 300 to each other. Anchor 500 can be positioned at a transseptal opening in the interventricular septum. Connector 400 can extend through anchor 500 to connect the tricuspid valve replacement 200 and the mitral valve replacement 300.

[0079] A portion of the tricuspid body portion 206 can be close to and / or directly contact one or more portions of the natural 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 within the right ventricle. In some embodiments, the first distal end 202 can be positioned within the right atrium. A portion of the mitral body portion 306 can be close to and / or directly contact one or more portions of the natural 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 within the left ventricle. In some embodiments, the first distal end 302 can be positioned within the left atrium. A first portion 402 of connector 400 may be coupled to a distal portion of tricuspid valve replacement 200, such as second distal end 202 oriented toward the right ventricle, and a second portion 404 of connector 400 may be coupled to a distal portion of mitral valve replacement 300, such as second distal end 302 oriented toward the left ventricle.

[0080] During ventricular contraction, the forces exerted on the tricuspid valve replacement 200 and the mitral valve replacement 300 due to ventricular contraction can push the tricuspid valve replacement 200 and the mitral valve replacement 300 toward the right atrium and the left atrium, respectively. The forces exerted on the tricuspid valve replacement 200 and the mitral valve replacement 300 can tend to move the tricuspid valve replacement 200 and the mitral valve replacement 300 away from their respective desired positions in the heart. The connector 400 connected to the anchor 500 in the septum can provide a force to resist those forces exerted by the heart, thereby facilitating the maintenance of the tricuspid valve replacement 200 and the mitral valve replacement 300 in their respective target positions. The length of the connector 400 can be selected so that the connector 400 is tightened when the tricuspid valve replacement 200 and the mitral valve replacement 300 are pushed toward the right atrium and the left atrium during contraction, keeping the tricuspid valve replacement 200 and the mitral valve replacement 300 in place. The length of the connector 400 can be selected so that the connector 400 is tightened when the heart is in systole. In some embodiments, the length of the connector 400 between the tricuspid valve and the mitral valve can be predetermined. For example, the length of the connector 400 can be selected before it is inserted into the delivery catheter. As further described herein, in some embodiments, the length can be adjustable, for example, determined during the implantation procedure.

[0081] The anchor 500 can be positioned at a location along the septum to provide the desired anchoring of the dual heart valve anchoring system 100 to the septum. For example, a transseptal opening can be formed at a location along the septum to reduce or avoid interference of the anchor 500 and / or connector 400 with the chordae tendineae while providing the desired anchoring angle, and / or selecting a septal region that can provide the desired strength. In some embodiments, a transseptal opening can be formed at or near the midpoint along the septal wall. In some embodiments, a transseptal opening can be formed at the midpoint along the septal wall.

[0082] As described herein, when the heart is in systole, the native tricuspid valve and the native mitral valve can exert forces on the tricuspid valve replacement 200 and the mitral valve replacement 300, respectively, to push the replacement tricuspid valve 200 and the replacement mitral valve 300 toward the right atrium and the left atrium. The transseptal opening can be located at or near the area where the force vectors of multiple forces on the septum intersect, thereby providing a desired angle for anchoring the tricuspid valve replacement 200 and the mitral valve replacement 300 to the septum. In some embodiments, the transseptal opening can be formed at the intersection point.

[0083] In some embodiments, the dual heart valve anchoring system does not include an anchor. 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, wherein the dual heart valve anchoring system 110 does not include an anchor. The dual heart valve anchoring system 110 can have a connector 410 that connects the tricuspid valve replacement 200 and the mitral valve replacement 300 to each other. The tricuspid valve replacement 200 can include at least a portion positioned within the native tricuspid valve, and the mitral valve replacement 300 can include at least a portion positioned within the native mitral valve. The dual heart valve anchoring system 110 does not include the anchor 500. As shown in FIG. Figure 4 As shown, connector 410 can extend through the transseptal opening without being coupled to an anchor.

[0084] The first portion 412 of the connector 410 can be coupled to the tricuspid valve replacement 200, such as at the second distal end 204. The second portion 414 of the connector 410 can be coupled to the mitral valve replacement 300, such as at the second distal end 304. The connector 410 can include a transseptal portion 416 configured to extend through the transseptal opening. For example, the transseptal portion 416 can be in direct contact with the septum.

[0085] In some embodiments, the transseptal portion 416 of the connector 410 can include one or more components for engaging the septum, protecting the septum, and / or blocking the transseptal opening. The transseptal portion 416 can engage the septum and / or have a septal protection component to facilitate insertion of the connector 410 through the transseptal opening. Blockage of the transseptal opening can reduce or eliminate blood flow between the left ventricle and the right ventricle. The dual heart valve anchoring system 110 can be more compact and / or have a reduced profile, such as compared to a dual heart valve anchoring system including an anchor. The compact size and / or reduced profile can provide convenience for delivery and / or implantation at a target site.

[0086] Figure 5A is a schematic diagram of a dual heart valve anchoring system 120 including an adjustable connector 420. The length of the connector 420 can be adjusted during the implantation procedure. Figure 5A 4 and 5. The dual heart valve anchoring system 120 can include a tricuspid valve replacement 200 and a mitral valve replacement 300. The connector 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 connector 420 can extend through an anchor 500 positioned in a transseptal opening. The tricuspid valve replacement 200, the mitral valve replacement 300, and the anchor 500 can be positioned in the heart as described herein, as shown in reference Figure 3 .

[0087] In some embodiments, the length of the connector 420 can be adjusted to accommodate the patient's anatomy. For example, the length of the connector 420 can 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 connector 420 can 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.

[0088] In some embodiments, the dual heart valve anchoring system 120 can include a locking mechanism 600 configured to fix the length of the connector 420 at a selected length after it has been adjusted based on the individual's specific anatomy. The locking mechanism 600 can be deployed, activated, and / or triggered after the appropriate length has been selected, thereby locking the length of the connector 420 at the determined length. In some embodiments, the locking mechanism 600 can be coupled to or integrated as part of the tricuspid valve replacement 300.

[0089] although Figure 5AThe dual heart valve anchoring system 120 is shown to include one locking mechanism 600, but it is understood that more than one locking mechanism 600 may be included. In some embodiments, one or more of the tricuspid valve replacement 200, mitral valve replacement 300, and anchor 500 may include a locking mechanism 600 coupled or integrated therewith.

[0090] Figure 5B A top plan view of an example of a locking mechanism 600 is shown. The locking mechanism 600 can be in an open state and a closed state. In the open state, the locking mechanism 600 can enable the connector 420 to move freely therethrough. In the closed state, the locking mechanism 600 can reduce or prevent movement of the connector 420, thereby locking the connector 420 at a selected length. Figure 5B The locking mechanism 600 is shown in a closed position.

[0091] The locking mechanism 600 may include a first movable flap 602, a second movable flap 604, and a third movable flap 606 coupled to each other at corresponding first distal portions 602a, 604a, 606a. Second distal portions 602b, 604b, 606b of the first movable flap 602, the second movable flap 604, and the third movable flap 606 may define an opening 608. The connector 420 may extend through the opening 608.

[0092] 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 expand the opening 608. When the locking mechanism is in the open state, the connector 420 can move freely through the opening 608, for example, so that the length of the connector 420 can be adjusted during the implantation procedure. The movable flaps 602, 604, 606 can be configured to be moved in a second direction opposite to the first direction to move the second distal portions 602b, 604b, and 606b more 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 substantially contact the connector 420 when the locking mechanism 600 is in the closed state, thereby reducing or preventing the movement of the connector 420 through the opening 608, thereby facilitating locking or substantially locking the connector 420 at the adjusted length. For example, in the closed state, the size of the opening 608 can be equal to or less than the cross-sectional area of ​​the connector 420 so that one or more edges of the second distal portions 602b, 604b and 606b can sufficiently contact the connector 420 to reduce or prevent movement of the connector 420 therethrough.

[0093] 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 relative to each other, extending into the Figure 5B The flaps 602, 604, 606 are moved in a first direction (e.g., into the page) to push the second distal portions 602b, 604b, 606b further apart to achieve the open state. The flaps 602, 604, 606 are moved in a second direction (e.g., out of the page) to bring the second distal portions 602b, 604b, 606b closer together to achieve the closed state.

[0094] The opening and closing locking mechanism 600 can be controlled using various techniques. In some embodiments, the opening and closing locking mechanism 600 can be triggered by pressure. For example, the 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 connector 420 with the movable flaps 602, 604, and 606 can trigger the opening and / or closing of the locking mechanism 600. For example, contacting the connector 420 with the movable flaps 602, 604, and 606 and moving the connector 420 relative to the movable flaps 602, 604, and 606 can cause the movable flaps 602, 604, and 606 to move in the desired direction. Moving the connector 420 in a first direction while contacting the connector 420 and the movable flaps 602, 604, and 606 can open the locking mechanism 600, and moving the connector 420 in a second direction while contacting the connector 420 and the movable flaps 602, 604, and 606 can close the locking mechanism 600. In some embodiments, the connector 420 can include one or more features, such as protrusions and / or recesses, to facilitate engagement with the movable flaps 602, 604, and 606.

[0095] Figure 6 is a schematic diagram of a dual heart valve anchoring system 130, which includes a connector 430, which includes a rigid or semi-rigid portion 436. The dual heart valve anchoring system 130 is shown positioned at its target site in the heart. The tricuspid valve replacement 200, the mitral valve replacement 300, and the anchor 500 can be positioned at their respective target locations, as shown in reference Figure 3 The connector 430 may extend through the anchor 500 configured to be positioned in the transseptal opening and couple the tricuspid valve replacement 200 and the mitral valve replacement 300 to each other. The connector 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.

[0096] The rigid or semi-rigid portion 436 of the connector 430 can be configured to extend through the transseptal opening, for example, extending through an anchor 500 configured to be positioned in the transseptal opening. The rigid or semi-rigid portion 436 can extend into one or both of the right ventricle and the left ventricle. For example, the rigid or semi-rigid portion 436 can 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 can be selected to provide the 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 can be selected to provide a predetermined angle at which the tricuspid valve replacement 200 and the mitral valve replacement 300 are tethered to the septum. The length of the first segment 436a and / or the second segment 436b can be selected so as to position the transseptal opening at a location on the septum to reduce or avoid interference with the chordae tendineae while providing desired anchoring of the tricuspid valve replacement 200 and the mitral valve replacement 300 to the septum.

[0097] In some embodiments, the longitudinal length of the first segment 436a can 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 longitudinal length of the second segment 436b. The longitudinal length of the first segment 436a and / or the second segment 436b can be predetermined or adjustable. For example, the longitudinal length of the first segment 436a and / or the second segment 436b can be selected before the dual heart valve anchoring system 130 is inserted into the patient's body. In some embodiments, the length of the first segment 436a and / or the second segment 436b can be adjusted based on the individual anatomical structure during the implantation procedure to provide the desired anchoring. In some embodiments, the length of the first segment 436a and / or the second segment 436b can be adjusted after the dual heart valve anchoring system 130 is inserted into the patient's body. For example, the length of the first section 436a and the length of the second section 436b can be adjusted by moving the rigid or semi-rigid portion 436 forward or backward within the lumen 520 of the anchor 500. In some embodiments, the rigid or semi-rigid portion 436 can be translated distally to increase the length of the second section 436b while reducing the length of the first section 436a. In some embodiments, the rigid or semi-rigid portion 436 can be translated proximally to increase the length of the first section 436a while reducing the length of the second section 436b.

[0098] The connector 430 can include one or more biocompatible materials described herein, including polymers and / or metallic materials. In some embodiments, the rigid or semi-rigid portion 436 of the connector 430 can include a different material than the rest of the connector 430. In some embodiments, the rigid or semi-rigid portion 436 of the connector 430 can include the same material as the rest of the connector 430.

[0099] Fig. 7A is a schematic diagram of an example of a dual heart valve anchoring system 140, which includes an anchor 550 that includes corresponding rigid or semi-rigid portions configured to extend into the right ventricle and the left ventricle. The dual heart valve anchoring system 140 may include a tricuspid valve replacement 200 and a mitral valve replacement 300 and a connector 400 that couples the tricuspid valve replacement 200 and the mitral valve replacement 300 to each other. The connector 400 may extend through the anchor 550, which is configured to be positioned in a transseptal opening. The tricuspid valve replacement 200 and the mitral valve replacement 300 may be positioned in the heart, as shown in reference Figure 3 described.

[0100] Figure 7B 5 is a schematic diagram of an anchor 550. Anchor 550 may include an anchor body portion 556, which includes 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 anchor body portion 556 may include a first distal end 552 extending into the right ventricle and a second distal end 554 extending into the left ventricle. The first rigid or semi-rigid portion 556a may extend into the right ventricle so 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 so that the second distal end 554 is positioned in the left ventricle. The anchor 550 can include an inner cavity 560 extending along the entire longitudinal length of the anchor body portion 556 so that the connector 400 can be inserted therethrough to connect the tricuspid valve replacement 200 and the mitral valve replacement 300 to each other while positioning the anchor 550 in the transseptal opening.

[0101] The anchor may include a first septum contact 562 and a second septum contact 564 extending from the anchor body portion 556 and spaced apart to engage the septum. In some embodiments, the first septum contact 562 and the second septum contact 564 may include a reference Figure 2 One or more components of the first septum contact 502 and the second septum contact 504 are described.

[0102] The rigid or semi-rigid portions 556a, 556b of the anchor 500 can be configured to extend into the right ventricle and the left ventricle, respectively, to facilitate desired anchoring of the tricuspid valve replacement 200 and the mitral valve replacement 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 can be selected so that the tricuspid valve replacement 200 and the mitral valve replacement 300 can be properly anchored to the septum without interfering or substantially interfering with the chordae tendineae.

[0103] 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 can 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 can be different. In some embodiments, the anchor 500 can include the first rigid or semi-rigid portion 556a or the second rigid or semi-rigid portion 556b, but not both.

[0104] The anchor 550 can include one or more biocompatible materials described herein, including polymers and / or metallic materials. In some embodiments, the rigid or semi-rigid portions 556a, 556b of the anchor 550 can include a different material than the rest of the anchor 550. In some embodiments, the rigid or semi-rigid portions 556a, 556b of the anchor 550 can include the same material as the rest of the anchor 550.

[0105] In some embodiments, the dual heart valve anchoring system 140 can include one or more other components described herein. In some embodiments, the dual heart valve anchoring system 140 can include a plurality of connectors 400. In some embodiments, the dual heart valve anchoring system 140 can include one or more adjustable connectors 420. In some embodiments, the dual heart valve anchoring system 140 can include one or more connectors 430 comprising a rigid or semi-rigid portion 436. For example, a plurality of connectors can extend through the anchor 550. The corresponding distal ends of the plurality of connectors can be coupled to corresponding locations on the corresponding distal ends of the tricuspid valve replacement 200 and the mitral valve replacement 300.

[0106] In some embodiments, a dual heart valve anchoring system can include multiple connectors, wherein the multiple connectors extend through the same anchor. Figure 8is a schematic diagram of an example of a dual heart valve anchoring system 150, which includes three connectors 400. The dual heart valve anchoring system 150 is shown positioned at its target site. The dual heart valve anchoring system 150 may include a tricuspid valve replacement 200, a mitral valve replacement 300, and an anchor 500 positioned at their respective target sites, as shown in reference Figure 3 The three connectors 400 may connect the tricuspid valve replacement 200 and the mitral valve replacement 300 to each other.

[0107] In some embodiments, the respective ends of each of the three connectors 400 can be coupled to the corresponding distal ends of the tricuspid valve replacement 200 and the mitral valve replacement 300. For example, the first portion 402 of each of the three connectors 400 can be coupled to the second distal end 204 of the tricuspid valve replacement 200 oriented toward the right ventricle. The second portion 404 of each of the three connectors 400 can be coupled to the second distal end 304 of the mitral valve replacement 300 oriented toward the left ventricle. The locations at which the connectors 400 are coupled on the second distal end 204 of the tricuspid valve replacement 200 and the second distal end 304 of the mitral valve replacement 300 can be selected to provide the desired anchoring to the septum. In some embodiments, the locations at which the connectors 400 are coupled to the tricuspid valve replacement 200 and / or the mitral valve replacement 300 can be evenly distributed across the respective second distal ends 204, 304. For example, the locations where the connector 400 is coupled to the second distal end 204 , 304 may be evenly distributed around the perimeter of the second distal end 204 , 304 .

[0108] The three connectors 400 can extend through the same transseptal opening. For example, the three connectors 400 can each include a corresponding portion of the anchor 500 extending through the transseptal opening. In some embodiments, the length of one or more of the three connectors 400 can be predetermined, such as selected before it is inserted into the patient.

[0109] In some embodiments, the dual heart valve anchoring system 150 may include one or more other components described herein. In some embodiments, the dual heart valve anchoring system 150 may include an anchor 550 instead of an anchor 500. In some embodiments, the dual heart valve anchoring system 150 may include one or more connectors 430 including a rigid or semi-rigid portion 436. In some embodiments, the dual heart valve anchoring system 150 may include one or more adjustable connectors 420. In some embodiments, the length of one or more of the three connectors may be adjusted independently of other connectors during the implantation procedure. For example, the three connectors may not be coupled to each other within the anchor so that each connector may move within the lumen of the anchor relative to other connectors. In some embodiments, the corresponding portions of the three connectors extending through the anchor are coupled to each other. In some embodiments, the dual heart valve anchoring system 150 may include one or more locking mechanisms 600 described herein to fix the length of the connector after selecting the desired length.

[0110] In some embodiments, a dual heart valve anchoring system can include a plurality of connectors, wherein each of the plurality of connectors extends through a respective anchor. Fig. 9 is a schematic diagram of an example of a dual heart valve anchoring system 160, which includes three connectors 400 and three anchors 500. The dual heart valve anchoring system 160 is shown positioned at its target site. The dual heart valve anchoring system 160 may include a tricuspid valve replacement 200 and a mitral valve replacement 300. The tricuspid valve replacement 200 and the mitral valve replacement 300 may be positioned at their respective target sites, as shown in FIG. Figure 3 The three connectors 400 may couple the tricuspid valve replacement 200 and the mitral valve replacement 300 to each other. Each of the three connectors 400 may extend through a corresponding anchor 500 positioned in the septum.

[0111] A corresponding portion of each of the three connectors 400 can be coupled to the corresponding distal ends of the tricuspid valve replacement 200 and the mitral valve replacement 300. For example, the first portion 402 of each of the three connectors 400 can be coupled to the second distal end 204 of the tricuspid valve replacement 200, and the second portion 404 of each of the three connectors 400 can be coupled to the second distal end 304 of the mitral valve replacement 300. In some embodiments, the locations where the connectors 400 are coupled to the tricuspid valve replacement 200 and / or the mitral valve replacement 300 can be evenly distributed across the respective second distal ends 204, 304. For example, the locations where the connectors 400 are coupled to the second distal ends 204, 304 can be evenly distributed around the periphery of the second distal ends 204, 304. The locations where the connectors 400 are coupled on the second distal ends 204 of the tricuspid valve replacement 200 and the second distal ends 304 of the mitral valve replacement 300 can be selected to provide a desired anchoring to the septum.

[0112] The location of the transseptal opening used to position the three anchors 500 can be selected to provide the desired anchoring. Fig. 9 Shown are three anchors 500 arranged at three different positions along the vertical dimension of the septum. In some embodiments, at least some of the three anchors 500 can be positioned along the same vertical position on the septum. In some embodiments, at least some of the three anchors 500 can be positioned along the same lateral position on the septum. In some embodiments, each of the three anchors 500 can be positioned at different lateral and vertical positions on the septum.

[0113] In some embodiments, the dual heart valve anchoring system 160 can include one or more other components described herein. In some embodiments, the dual heart valve anchoring system 160 can include one or more anchors 550. In some embodiments, the dual heart valve anchoring system 150 can include one or more connectors 430 comprising a rigid or semi-rigid portion 436. In some embodiments, the dual heart valve anchoring system 150 can include one or more adjustable connectors 420. For example, the dual heart valve anchoring system 160 can include one or more locking mechanisms described herein to secure the length of the connector after the desired length is selected.

[0114] In some embodiments, both connectors may extend through the same anchor. Figure 8 The dual heart valve anchoring system 150 described includes three connectors and refers to Fig. 9 The depicted dual heart valve anchoring system 160 includes three connectors, but it will be appreciated that the dual heart valve anchoring system may include more or fewer connectors.

[0115] In some embodiments, a dual heart valve anchoring system can include a tricuspid valve prosthesis and a mitral valve prosthesis anchored to the septum. Fig.10 is a schematic diagram of an example of a dual heart valve anchoring system 170, which includes a tricuspid valve repair device 700 and a mitral valve repair device 800. The tricuspid valve repair device 700 and the mitral valve repair device 800 can be connected to each other and configured to anchor to the septum. For example, the tricuspid valve repair device 700 and the mitral valve repair device 800 can be connected to an anchor 500, which is configured to be positioned in a transseptal opening. The tricuspid valve repair device 700 may include a plurality of connectors 710, which are configured to connect a natural tricuspid valve leaflet to an anchor 500 positioned in a transseptal opening. A first distal portion 712 of each connector 710 can be connected to the natural tricuspid valve leaflet, and a second distal portion 714 can be connected to the anchor 500. The mitral valve repair device 800 may include a plurality of connectors 810 configured to couple the native mitral valve leaflets to the anchor 500 positioned in the transseptal opening. For example, a first distal portion 814 of each connector 810 may be coupled to the native mitral valve leaflets, and a second distal portion 812 may be coupled to the anchor 500. Fig.10 The tricuspid valve repair device 700 is shown to include two connectors 710, and the mitral valve repair device 800 can include two connectors 810, although it should be understood that more or fewer connectors 710, 810 can be used.

[0116] In some embodiments, connector 710 and connector 810 can be one connector, such that the one connector is configured to extend through anchor 500 and couple the native tricuspid valve leaflet and the native mitral valve leaflet to each other. For example, each of the plurality of connectors 710 and a corresponding one of the plurality of connectors 810 can be the same connector. In some embodiments, none of the plurality of connectors 710 and the plurality of connectors 810 are the same connector.

[0117] In some embodiments, the dual heart valve anchoring system can include a heart valve replacement and a heart valve repair device. For example, the dual heart valve anchoring system can include a tricuspid valve replacement and a mitral valve repair device. Optionally, the dual heart valve anchoring system can include a tricuspid valve repair device and a mitral valve replacement.

[0118] Fig.11is a schematic diagram of an example of a dual heart valve anchoring system 180, which includes a tricuspid valve replacement 200 and a mitral valve repair device 800 connected to each other via a septum. The tricuspid valve replacement 200 and the mitral valve repair device 800 can be connected to an anchor 500, which is configured to be positioned in a transseptal opening. The mitral valve repair device 800 may include a connector 810, which is configured to connect a natural mitral valve leaflet to the anchor 500. The connector 900 can connect the tricuspid valve replacement 200 to the anchor 500. For example, the first end 902 of the connector 900 can be connected to the tricuspid valve replacement 200, such as the second distal end 204 of the tricuspid valve replacement 200. The second end 904 of the connector 900 can be connected to the anchor 500.

[0119] refer to Fig.12 , shows a schematic diagram of a dual heart valve anchoring system 190, which includes an example of a tricuspid valve replacement 1000 and an example of a mitral valve replacement 1100. A connector 400 can couple the tricuspid valve replacement 1000 and the mitral valve replacement 1100 to each other. A corresponding portion of the connector 400 can extend through an anchor 500, which is configured to be positioned in a transseptal opening.

[0120] The tricuspid valve replacement 1000 may include a tricuspid valve body portion 1006 including a first distal end 1002 and a second distal end 1004. The mitral valve replacement 1100 may include a mitral valve body portion 1106 including a first distal end 1102 and a second distal end 1104. Fig.12 As shown, the first distal end 1002 of the tricuspid valve replacement 1000 and the first distal end 1102 of the mitral valve replacement 1100 can be oriented toward the right atrium and the left atrium, respectively. The second distal ends 1004, 1104 can be oriented toward the right ventricle and the left ventricle, respectively. The tricuspid valve replacement 1000 can include a frame 1008 and valve tissue 1010. The mitral valve replacement 1100 can include a frame 1108 and valve tissue 1110. In some embodiments, the first portion 402 of the connector 400 can be coupled to the second distal end 1004 of the tricuspid valve replacement 1000, and the second portion 404 of the connector 400 can be coupled to the second distal end 1104 of the mitral valve replacement 1100. In some embodiments, the connector 400 can be coupled to the 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 components to facilitate attachment of the connector 400 thereto.

[0121] In some embodiments, the dual heart valve anchoring system 190 can include one or more of the other components described herein. In some embodiments, the dual heart valve anchoring system 190 can include a plurality of connectors 400. In some embodiments, the dual heart valve anchoring system 190 can include one or more adjustable connectors 420. In some embodiments, the dual heart valve anchoring system 190 can include one or more connectors 430 comprising a rigid or semi-rigid portion 436. In some embodiments, the dual heart valve anchoring system 190 can include an anchor 550 instead of the anchor 500.

[0122] In some embodiments, one or more of the heart valve replacements described herein can be one or more commercially available heart valve replacements (e.g., Sapien 3 TM 、CardiAQ TM and Centera TM , commercially 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 anchor. For example, referring to Figure 5A , 6 , 7A, 8, 9, 10, 11 and 12 describe a connector(s) that may extend through a transseptal opening without extending through any anchor.

[0123] The procedure for positioning the bivalve anchoring system at its target site may include inserting or retracting the bivalve anchoring system delivery catheter along the same or similar path. One path for inserting and retracting the delivery catheter to deploy both a tricuspid valve replacement and a mitral valve replacement anchored to the septum may, for example, enable a simpler minimally invasive transcatheter approach, reduce trauma to the patient, and / or promote an improved patient recovery process.

[0124] Fig.13A and 13B is a schematic diagram showing an example of a path along which a delivery catheter carrying a dual heart valve anchoring system can be advanced and retracted to position the dual heart valve anchoring system at its target site. The dual heart valve anchoring system can have one or more components described herein (e.g., dual heart valve anchoring systems 100, 110, 120, 130, 140, 150, 190). For example, the dual heart valve anchoring system can include a tricuspid valve replacement and a mitral valve replacement and a connector that couples the tricuspid valve replacement and the mitral valve replacement to each other. The connector can extend through an anchor configured to be positioned in a transseptal opening. Fig.13A The insertion path of the delivery catheter is shown. Fig. 13B The retraction path of the delivery catheter is shown.

[0125] refer to Fig.13A , a delivery catheter carrying a dual heart valve anchoring system can be advanced through the inferior vena cava (IVC). For example, a transfemoral approach can be used to insert a 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 the opening formed by the natural tricuspid valve and advanced from the right atrium into the right ventricle (RV). Subsequently, the delivery catheter can be extended from the right ventricle via the 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 the target site of the mitral valve replacement, and the mitral valve replacement can be deployed at its target location.

[0126] refer 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 a path that is the same or substantially the same as the advancement path of the delivery catheter. When the delivery catheter is retracted toward the right ventricle through the left ventricle, the corresponding portion of the connector can be released in the left ventricle from the distal end of the delivery catheter. The distal end of the delivery catheter can then be withdrawn from the left ventricle to the right ventricle (RV) through the septal opening, leaving the anchor at its target site. When the delivery catheter is moved back through the septal opening, at least a portion of the anchor and the corresponding portion of the connector can be positioned in the septal opening. Subsequently, when the distal end of the delivery catheter is retracted toward the right atrium through the right ventricle, the corresponding portion of the connector can be released in the right ventricle. The distal end of the delivery catheter can then be positioned at the desired position of the tricuspid valve replacement. After the distal end of the delivery catheter is positioned at the desired position of the tricuspid valve replacement, the tricuspid valve replacement can be deployed at its target site. The delivery catheter can then be withdrawn into the right atrium and removed through the inferior vena cava.

[0127] Fig.14A and 14B is a schematic diagram showing another example of a path along which a delivery catheter carrying a dual heart valve anchoring system can be advanced and retracted to position the dual heart valve anchoring system at its target site. The dual heart valve anchoring system can have one or more components described herein (e.g., dual heart valve anchoring systems 100, 110, 120, 130, 140, 150, 190), such as a connector that couples a tricuspid valve replacement and a mitral valve replacement, and the connector extends through the anchor. Fig.14A shows the path through which the delivery catheter can be inserted, Fig. 14B The path by which the delivery catheter can be retracted is shown.

[0128] refer 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 delivery catheter can be inserted into the superior vena cava through the subclavian vein or jugular vein using a subclavian or transcervical approach. 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 natural tricuspid valve. Subsequently, the delivery catheter can be extended from the right ventricle via 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 the target site of the mitral valve replacement. The mitral valve replacement can then be deployed at its target location.

[0129] refer to Fig. 14B , after the mitral valve replacement is deployed, the delivery catheter can be retracted toward the right ventricle. The delivery catheter can be retracted along a path that is the same or substantially the same as the advancement path of the delivery catheter. When the delivery catheter is retracted toward the right ventricle through the left ventricle, the corresponding portion of the connector can be released in the left ventricle from the distal end of the delivery catheter. The distal end of the delivery catheter can then be withdrawn into the right ventricle (RV) through the septal opening. The anchor can be released together with the corresponding portion of the connector at its target site in the septal opening. Subsequently, when the distal end of the delivery catheter is retracted toward the right atrium through the right ventricle, the corresponding portion of the connector can be released in the right ventricle. The distal end of the delivery catheter can then be positioned at the desired position of the tricuspid valve replacement, and the tricuspid valve replacement can be deployed. The delivery catheter can then be withdrawn into the right atrium and removed through the superior vena cava.

[0130] Fig.15 1 is a flow chart 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 include one or more components described herein (e.g., dual heart valve anchoring systems 100, 110, 120, 130, 140, 150, 190), such as including a connector that connects a tricuspid valve replacement and a mitral valve replacement. In some embodiments, the dual heart valve anchoring system includes an anchor such that the connector extends through the anchor. In some embodiments, the dual heart valve anchoring system does not include an anchor.

[0131] refer to Fig.15, in box 1502, a delivery catheter can be introduced through the inferior vena cava or the superior vena cava and into the right atrium. In box 1504, the delivery catheter can be advanced from the right atrium into the right ventricle through the opening formed by the natural tricuspid valve. The delivery catheter can be advanced through the right ventricle toward the left ventricle. In box 1506, the delivery catheter can be passed through the transseptal opening in the interventricular septum to insert the delivery catheter from the right ventricle into the left ventricle. In some embodiments, the transseptal opening can be pre-formed, such as formed before the delivery catheter is inserted into the superior vena cava or the inferior vena cava. In some embodiments, the transseptal opening can be formed by one or more instruments, which are also carried by the delivery catheter. For example, a transseptal opening can be formed in the process of advancing the delivery catheter through the septum.

[0132] After moving through the transseptal opening, the delivery catheter can be advanced through the left ventricle toward the native mitral valve. In box 1508, the distal end of the delivery catheter can be positioned at the target site of the mitral valve replacement. In box 1510, the mitral valve replacement can be released at its target site. The mitral valve replacement can be deployed from the distal end of the delivery catheter and positioned at its desired location in the native mitral valve.

[0133] After the mitral valve replacement is released, the delivery catheter may be retracted along the same or substantially the same path as it was advanced. In block 1512, the delivery catheter may be retracted through the left ventricle, through the septal opening, and into the right ventricle. In block 1514, upon retracting the delivery catheter through the left ventricle, through the septal opening, and into the right ventricle, corresponding portions of the connector may be released in the left ventricle, through the septal opening, and into the right ventricle.

[0134] As described herein, in some embodiments, a dual heart valve anchoring system may include an anchor. The anchor may be between a tricuspid valve replacement and a mitral valve replacement and connected to a connector. In some embodiments, the connector may extend through an opening of the anchor. During the process of retracting the delivery catheter through the transseptal opening, at least a portion of the anchor and a corresponding portion of the connector may be deployed in the transseptal opening. The anchor may include an occluder configured to facilitate sealing of the transseptal opening. For example, releasing at least a portion of the anchor and a corresponding portion of the connector in the transseptal opening may include sealing the transseptal opening. In some embodiments, the transseptal opening may be sealed after the anchor (including the corresponding portion of the connector passing therethrough) is positioned at its target site.

[0135] The delivery catheter may be withdrawn through the right ventricle toward the right atrium. In block 1516, after the delivery catheter is retracted into the right ventricle, the distal end of the delivery catheter may be positioned at the target site of the tricuspid valve replacement. In block 1518, the tricuspid valve replacement may be released at its target site. The delivery catheter may be withdrawn 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 vena cava or the inferior vena cava.

[0136] 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, through the septal opening, and into the right ventricle may include releasing the corresponding parts of the two connectors in the left ventricle, through the septal opening, and in the right ventricle. In some embodiments, the dual heart valve anchoring system may include an anchor that includes at least a portion configured to be positioned in the septal opening. In some embodiments, both connectors may extend through the anchor. Retracting the delivery catheter through the left ventricle, through the septal opening, and into the right ventricle may include releasing the corresponding parts of the two connectors in the left ventricle, through the septal opening, and in the right ventricle, and arranging the anchor at its target position in the septal opening.

[0137] In some embodiments, the connector can include an adjustable length. The length of the connector can be adjusted during the implantation procedure, such as in response to individual anatomical structures. In some embodiments, one or more imaging techniques can be used in the procedure to determine the appropriate length of the connector. In some embodiments, the implantation procedure can be performed under the guidance of one or more of a transesophageal (TEE) echocardiogram, a transthoracic echocardiogram (TTE), and an intracardiac echocardiogram (ICE). Other known visualization techniques may be used additionally or alternatively.

[0138] The length of one or more connectors of the dual heart valve anchoring system can be adjusted after the one or more connectors are inserted into the patient, with the aid of one or more imaging techniques. The length of the one or more connectors can be selected based on the individual anatomy to improve the desired anchoring to the septum. In some embodiments, the length of the connector can be adjusted so that the connector is tightened during ventricular systole.

[0139] In some embodiments, the length of the one or more connectors can be adjusted after the delivery catheter is introduced into the superior vena cava or the inferior vena cava. In some embodiments, the length of the one or more connectors can be adjusted after all replacement valves are positioned at their corresponding target sites. For example, the length of the one or more connectors can be adjusted after the tricuspid valve replacement is arranged in its desired position. In some embodiments, the length of the 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 anchor and the tricuspid valve replacement are positioned in one or more of their corresponding target positions. In some embodiments, the length of the connector can be adjusted after one or more of its corresponding parts are released from the delivery catheter. For example, the length of the connector can be adjusted at one or more times in the following: after the mitral valve replacement is deployed and before the anchor is deployed (for example, after the corresponding part of the connector has been released in the left ventricle), after the anchor is deployed and before the delivery catheter is further retracted, after the anchor is deployed and before the tricuspid valve replacement is deployed (for example, after the corresponding part of the connector has been released in the right ventricle), after the tricuspid valve replacement is deployed. In some embodiments, the length of the connector can be adjusted after each of its respective portions are released from the delivery catheter.

[0140] After the appropriate length has been determined during the implantation procedure, the locking mechanism can be deployed, activated and / or triggered to secure the connector at the selected length. In some embodiments, the locking mechanism can be deployed, activated and / or triggered after each adjustment. As described herein, in some embodiments, the dual heart valve anchoring system can include multiple locking mechanisms. In some embodiments, the locking mechanism can be deployed, activated and / or triggered after releasing and adjusting one or more portions of the connector, including after releasing and adjusting each portion.

[0141] Other Implementations

[0142] According to the embodiment, some actions, events or functions in any method or algorithm described herein may be performed in different orders, may be added, merged or omitted entirely. Therefore, in some embodiments, not all actions or events are necessary for the practice of the method.

[0143] Conditional language used herein, such as "can," "could," "might," "may," "for example," and the like, unless specifically stated otherwise or otherwise understood in the context in which it is used, is intended to be in its ordinary sense and is generally intended to convey that certain embodiments include and other embodiments do not include certain features, elements, and / or steps. Thus, such conditional language is not generally intended to imply that one or more embodiments require features, elements, and / or steps in any way or that one or more embodiments necessarily include (with or without author input or revelation) logic that determines whether such features, elements, and / or steps are included or performed in any specific embodiment. The terms "comprising," "including," "having," and the like are synonymous, are used in their ordinary sense, and are used in an open, inclusive manner and do not exclude additional elements, features, actions, operations, and the like. Similarly, the term "or" is used in its inclusive sense (rather than an exclusive sense) such that when used, for example, to connect listed elements, the term "or" means one, some, or all of the listed elements. Unless specifically stated otherwise, conjunctions such as the phrase "at least one of X, Y, and Z" are understood in conjunction with the context in which they are used to generally convey that an item, term, element, etc. can be X, Y, or Z. Thus, such conjunctions are not generally intended to imply that certain embodiments require that at least one of X, at least one of Y, and at least one of Z are all present.

[0144] It should be understood that in the above description of the embodiments, various features are sometimes grouped together in a single embodiment, figure or description thereof for the purpose of simplifying the disclosure and helping to understand one or more of the various inventive aspects. However, this disclosure method should not be interpreted as reflecting the intention of any claim to have more features than the features clearly stated in the claims. In addition, any component, feature or step illustrated and / or described in the specific embodiments herein can be applied to any other embodiment (one or more) or used in conjunction with it. Further, no component, feature, step, or group of components, features or steps is necessary or indispensable for each embodiment. Therefore, it is intended that the scope of the present invention disclosed and claimed herein should not be limited by the above-mentioned specific embodiments, but should only be determined by a reasonable reading of the attached claims.

[0145] It should be understood that certain ordinal terms (e.g., "first" or "second") may be provided for ease of reference without necessarily implying physical properties or ordering. Therefore, 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 the priority or order of the element relative to any other element, but can generally distinguish the element from another element with a similar or identical name (except for the use of ordinal terms). In addition, as used herein, indefinite articles ("a" and "a kind") can mean "one / kind or more / kinds", rather than "one / kind". Further, an operation performed "based on" a condition or event can also be performed based on one or more other conditions or events that are not explicitly described.

[0146] Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the example 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 context in the relevant technical field and should not be interpreted in an idealized or overly formal sense unless so explicitly defined herein.

[0147] Spatially relative terms "external", "internal", "upper", "lower", "below", "above", "vertical", "horizontal" and similar terms may be used herein for convenience of description to describe the relationship between one element or member and another element or member illustrated in the drawings. It should be understood that the spatially relative terms are intended to cover different orientations of the device in use or operation in addition to the orientation depicted in the drawings. For example, in the case where the device shown in the drawings is turned over, a device located "below" or "below" another device can be placed "above" the other device. Therefore, the exemplary term "below" can include both lower and upper positions. The device can also be oriented in other directions, and therefore, the spatially relative terms can be interpreted differently depending on the orientation.

[0148] Unless expressly stated otherwise, comparative and / or quantitative terms such as "less", "more", "greater", etc. are intended to encompass equivalent concepts. For example, "less" may not only mean "less" in the strictest mathematical sense, but may also mean "less or equal".

Claims

1. Double heart valve anchoring system, including: a first anchor including 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; and A mitral valve device is coupled to the first anchor.

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

3. The system according to claim 2 further includes a first connector, which extends between the tricuspid valve replacement and the mitral valve replacement, connects the tricuspid valve replacement and the mitral valve replacement to the first anchor, and is configured to extend through the first transseptal opening.

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

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

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

7. A system according to any one of claims 4-6, wherein ends of at least one of the first connector and the second connector are respectively connected to a portion of the tricuspid valve replacement configured to be positioned within the right ventricle and a portion of the mitral valve replacement configured to be positioned within the left ventricle.

8. A system according to claim 7, wherein the ends of at least one of the first connector and the second connector are respectively connected to a distal end of the tricuspid valve replacement configured to be positioned within the right ventricle and a distal end of the mitral valve replacement configured to be positioned within the left ventricle.

9. The system of any one of claims 4-8, wherein a length of at least one of the first connector and the second connector is adjustable.

10. The system of claim 9, further comprising at least one locking mechanism to lock at least one of the first connector and the second connector at a corresponding selected length.

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