EP4017421A1

EP4017421A1 - Heart valve leaflet tethering

Info

Publication number: EP4017421A1
Application number: EP20764188.7A
Authority: EP
Inventors: Sakyasingh TRIPATHY; Hengchu Cao; Douglas Thomas DOMINICK; Nima V. NIA; Bingquan Su
Original assignee: Edwards Lifesciences Corp
Current assignee: Edwards Lifesciences Corp
Priority date: 2019-08-22
Filing date: 2020-08-11
Publication date: 2022-06-29
Also published as: WO2021034538A1; CN114269293A

Abstract

A method of tethering a heart valve leaflet can comprise anchoring a second anchor portion to a ventricular septum, deploying a first tether portion, and anchoring a first anchor portion to a posterior leaflet of a tricuspid valve. The method can comprise anchoring a fourth anchor portion to a right ventricular free wall, deploying a second tether portion, and anchoring a third anchor portion to an anterior leaflet of the tricuspid valve. The method can comprise anchoring a sixth anchor portion to another portion of the right ventricular free wall, deploying a third tether portion, and anchoring a fifth anchor portion to a septal leaflet of the tricuspid valve. A method of tethering a heart valve leaflet can comprise anchoring a first anchor portion to an anterior leaflet of a mitral valve, deploying a first tether portion, and anchoring a second anchor portion to a left ventricular free wall to couple the anterior leaflet to the left ventricular free wall; and anchoring a third anchor portion to a posterior leaflet of the mitral valve, deploying a second tether portion, and anchoring a fourth anchor portion to a left ventricular free wall to couple the posterior leaflet to the left ventricular free wall.

Description

HEART VALVE LEAFLET TETHERING

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Patent Application No. 62/890,530, filed August 22, 2019, entitled “HEART VALVE LEAFLET TETHERING”, the disclosure of which is hereby expressly incorporated by reference herein in its entirety for all purposes.

BACKGROUND

Field

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

Description of Related Art

[0003] Implantation of heart valve devices can be performed to address various heart valve abnormalities. Implantation of a tricuspid valve device and/or a mitral valve device can be advantageous for patients suffering from dysfunction in one or both valves.

SUMMARY

[0004] Described herein are one or more methods, devices and systems to provide tethering for one or more leaflets of a tricuspid valve and/or a mitral valve. In some implementations, the present disclosure relates to one or more of tethering a posterior leaflet of a tricuspid valve to a ventricular septum, tethering an anterior leaflet of the tricuspid valve to a posteromedial portion of a right ventricular free wall or a posterior portion of the right ventricular free wall, tethering a septal leaflet of the tricuspid valve to a posterolateral portion of the right ventricular free wall, tethering a posterior leaflet of a mitral valve to the ventricular septum, and tethering an anterior leaflet of the mitral valve to a posterolateral portion of the left ventricular free wall.

[0005] In some implementations, a method of tethering a heart valve leaflet can comprise introducing a heart valve leaflet tethering system into a right atrium, the heart valve leaflet tethering system comprising a first anchor portion, a second anchor portion, and a first tether portion coupling the first anchor portion and the second anchor portion. The method can comprise advancing the heart valve leaflet tethering system from the right atrium into the right ventricle via a gap between leaflets of a tricuspid valve, and anchoring the second anchor portion to a ventricular septum, The method can comprise deploying the first tether portion, wherein deploying the first tether portion comprises moving the first anchor portion toward a posterior leaflet of the tricuspid valve while the second anchor portion is anchored to the ventricular septum; and anchoring the first anchor portion to the posterior leaflet of the tricuspid valve to couple the posterior leaflet of the tricuspid valve to the ventricular septum.

[0006] In some embodiments, anchoring the second anchor portion comprises anchoring the second anchor portion to a portion of the ventricular septum below the right ventricular outflow tract. In some embodiments, anchoring the second anchor portion comprises anchoring the second anchor to a portion of the ventricular septum below the leaflets of the tricuspid valve when the leaflets are in an open position. In some embodiments, anchoring the second anchor portion comprises positioning at least a portion of the second anchor portion in contact with a left ventricle facing portion of the ventricular septum. In some embodiments, wherein anchoring the second anchor portion comprises positioning at least a portion of the second anchor portion in contact with a right ventricle facing portion of the ventricular septum. In some embodiments, anchoring the second anchor portion comprises positioning at least a portion of the second anchor portion within the ventricular septum.

[0007] In some embodiments, introducing the heart valve leaflet tethering system comprises introducing a third anchor portion, a fourth anchor portion, and a second tether portion coupling the third anchor portion and the fourth anchor portion, and wherein advancing the heart valve leaflet tethering system from the right atrium into the right ventricle comprises advancing the third anchor portion, the fourth anchor portion, and the second tether portion from the right atrium into the right ventricle via the gap between the leaflets of the tricuspid valve.

[0008] In some embodiments, the method can comprise anchoring the fourth anchor portion to a right ventricular free wall. The method can comprise deploying the second tether portion, wherein deploying the second tether portion comprises moving the third anchor portion toward an anterior leaflet of the tricuspid valve while the fourth anchor portion is anchored to the right ventricular free wall. The method can further comprise anchoring the third anchor portion to the anterior leaflet of the tricuspid valve to couple the anterior leaflet of the tricuspid valve to the right ventricular free wall.

[0009] In some embodiments, anchoring the fourth anchor portion comprises anchoring the fourth anchor portion to a posterior portion of the right ventricular free wall. In some embodiments, anchoring the fourth anchor portion comprises anchoring the fourth anchor portion on a posteromedial portion of the right ventricular free wall. In some embodiments, anchoring the fourth anchor portion comprises anchoring the fourth anchor portion to a portion of the ventricular septum below leaflets of the tricuspid valve when the leaflets are in an open position.

[0010] In some embodiments, introducing the heart valve leaflet tethering system comprises introducing a fifth anchor portion, a sixth anchor portion, and a third tether portion coupling the fifth anchor portion and the sixth anchor portion, and wherein advancing the heart valve leaflet tethering system from the right atrium into the right ventricle comprises advancing the fifth anchor portion, the sixth anchor portion, and the third tether portion from the right atrium into the right ventricle via the gap between the leaflets of the tricuspid valve.

[0011] In some embodiments, the method can comprise anchoring the sixth anchor portion to a right ventricular free wall. The method can comprise deploying the third tether portion, wherein deploying the third tether portion comprises moving the fifth anchor portion toward a septal leaflet of the tricuspid valve while the sixth anchor portion is anchored to the right ventricular free wall. The method can further comprise anchoring the fifth anchor portion to the septal leaflet of the tricuspid valve to couple the septal leaflet of the tricuspid valve to the right ventricular free wall.

[0012] In some embodiments, anchoring the sixth anchor portion comprises anchoring the sixth anchor portion on a posterolateral portion of the right ventricular free wall. In some embodiments, anchoring the sixth anchor portion comprises anchoring the sixth anchor portion to the right ventricular free wall below leaflets of the tricuspid valve when the leaflets are in an open position.

[0013] In some embodiments, the method is minimally invasive.

[0014] In some implementations, a heart valve leaflet tethering system can comprise a first anchor portion configured to be secured to a posterior leaflet of a tricuspid valve, a second anchor portion configured to be secured to a ventricular septum, and a first tether portion coupling the first anchor portion and the second anchor portion.

[0015] In some embodiments, the second anchor portion is configured to be secured to a portion of the ventricular septum below the right ventricular outflow tract. In some embodiments, the second anchor portion is configured to be secured to a portion of the ventricular septum below leaflets of the tricuspid valve in an open position.

[0016] In some embodiments, the system can comprise a third anchor portion configured to be secured to an anterior leaflet of the tricuspid valve, a fourth anchor portion configured to be secured to a right ventricular free wall, and a second tether portion coupling the third anchor portion and the fourth anchor portion.

[0017] In some embodiments, the fourth anchor portion is configured to be secured to the right ventricular free wall below leaflets of the tricuspid valve when the leaflets are in an open position. In some embodiments, the fourth anchor portion is configured to be secured to a posterior portion of the right ventricular free wall. In some embodiments, the fourth anchor portion is configured to be secured to a posteromedial portion of the right ventricular free wall.

[0018] In some embodiments, the system can comprise a fifth anchor portion configured to be secured to a septal leaflet of the tricuspid valve, a sixth anchor portion configured to be secured to a right ventricular free wall, and a third tether portion coupling the fifth anchor portion and the sixth anchor portion.

[0019] In some embodiments, the sixth anchor portion is configured to be secured to a posterolateral portion of the right ventricular free wall. In some embodiments, the sixth anchor portion is configured to be secured to the right ventricular free wall below leaflets of the tricuspid valve when the leaflets are in an open position.

[0020] In some implementations, a method of tethering a heart valve leaflet can comprise introducing a heart valve leaflet tethering system into a right atrium. The heart valve leaflet tethering system can comprise a first anchor portion, a second anchor portion, and a first tether portion coupling the first anchor portion and the second anchor portion; and a third anchor portion, a fourth anchor portion, and a second tether portion coupling the third anchor portion and the fourth anchor portion. The method can comprise advancing the heart valve leaflet tethering system from the right atrium into the right ventricle via a gap between leaflets of a tricuspid valve, inserting the heart system through a ventricular septum from the right ventricle into the left ventricle. The method can comprise anchoring the first anchor portion to an anterior leaflet of a mitral valve, and deploying the first tether portion, wherein deploying the first tether portion comprises moving the second anchor portion toward a left ventricular free wall while the first anchor portion is anchored to the anterior leaflet, and anchoring the second anchor portion to the left ventricular free wall to couple the anterior leaflet of the mitral valve to the left ventricular free wall. The method can comprise anchoring the third anchor portion on to a posterior leaflet of the mitral valve, deploying the second tether portion, wherein deploying the second tether portion comprises moving the fourth anchor portion toward the ventricular septum while the third anchor portion is anchored to the posterior leaflet, and anchoring the fourth anchor portion to the ventricular septum to couple the posterior leaflet of the mitral valve to the ventricular septum.

[0021] In some embodiments, anchoring the second anchor portion comprises anchoring the second anchor portion to a posterolateral portion of the left ventricular free wall. In some embodiments, anchoring the second anchor portion comprises anchoring the second anchor portion to a portion of the left ventricular free wall below leaflets of the mitral valve when the leaflets are in an opening position.

[0022] In some embodiments, anchoring the fourth anchor portion comprises anchoring the fourth anchor portion to a portion of the ventricular septum below leaflets of the mitral valve when the leaflets are in an opening position. In some embodiments, anchoring the fourth anchor comprises anchoring the fourth anchor portion to a portion of the ventricular septum below a left ventricular outflow tract. In some embodiments, anchoring the fourth anchor portion comprises positioning at least a portion of the fourth anchor portion in contact with a left ventricle facing portion of the ventricular septum. In some embodiments, anchoring the fourth anchor portion comprises positioning at least a portion of the fourth anchor portion in contact with a right ventricle facing portion of the ventricular septum. In some embodiments, anchoring the fourth anchor portion comprises positioning at least a portion of the fourth anchor portion within the ventricular septum.

[0023] In some embodiments, the method is minimally invasive.

[0024] In some implementations, a heart valve leaflet tethering system can comprise a first anchor portion configured to be secured to an anterior leaflet of a mitral valve, a second anchor portion configured to be secured to a left ventricular free wall, a first tether portion coupling the first anchor portion and the second anchor portion, a third anchor portion configured to be secured to a posterior leaflet of the mitral valve, a fourth anchor portion configured to be secured to a ventricular septum, and a second tether portion coupling the third anchor portion and the fourth anchor portion.

[0025] In some embodiments, the second anchor portion is configured to be secured to a posterolateral portion of the left ventricular free wall. In some embodiments, the second anchor portion is configured to be secured to a portion of the left ventricular free wall below leaflets of the mitral valve in an open position.

[0026] In some embodiments, the fourth anchor portion is configured to be secured to a portion of the ventricular septum below the left ventricular outflow tract. In some embodiments, the fourth anchor portion is configured to be secured to a portion of the ventricular septum below leaflets of the mitral valve in an open position. [0027] For purposes of summarizing the disclosure, certain aspects, advantages and novel features have been described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, the disclosed embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Various embodiments are depicted in the accompanying drawings for illustrative purposes and should in no way be interpreted as limiting the scope of the inventions. In addition, various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between reference elements. However, it should be understood that the use of similar reference numbers in connection with multiple drawings does not necessarily imply similarity between respective embodiments associated therewith. Furthermore, it should be understood that the features of the respective drawings are not necessarily drawn to scale, and the illustrated sizes thereof are presented for the purpose of illustration of inventive aspects thereof. Generally, certain of the illustrated features may be relatively smaller than as illustrated in some embodiments or configurations.

[0029] Figure 1 is a cross-sectional view of a human heart.

[0030] Figure 2 is a schematic diagram of an example of a heart valve leaflet tethering system positioned at a target site within the heart, where the system is configured to couple a posterior tricuspid valve leaflet to a ventricular septum.

[0031] Figure 3 is a schematic diagram of an example of a heart valve leaflet tethering system positioned at a target site within the heart, where the system is configured to couple an anterior tricuspid valve leaflet to a right ventricular free wall.

[0032] Figure 4 is a schematic diagram of an example of a heart valve leaflet tethering system positioned at a target site within the heart, where the system is configured to couple a septal tricuspid valve leaflet to a right ventricular free wall.

[0033] Figure 5 is a flow diagram of an example of an implantation procedure for deploying a heart valve leaflet tethering system to couple a posterior tricuspid valve leaflet to a ventricular septum. [0034] Figure 6 is a flow diagram of an example of an implantation procedure for deploying a heart valve leaflet tethering system to couple an anterior leaflet or a septal leaflet of a tricuspid valve leaflet to a right ventricular free wall.

[0035] Figure 7 is a schematic diagram of an example of a heart valve leaflet tethering system positioned at a target site within the heart, where the system is configured to couple a posterior mitral valve leaflet to a ventricular septum.

[0036] Figure 8 is a schematic diagram of an example of a heart valve leaflet tethering system positioned at a target site within the heart, where the system is configured to couple an anterior mitral valve leaflet to a left ventricular free wall.

[0037] Figure 9 is a flow diagram of an example of an implantation procedure for deploying a heart valve leaflet tethering system to couple a posterior mitral valve leaflet to a ventricular septum.

[0038] Figure 10 is a flow diagram of an example of an implantation procedure for deploying a heart valve leaflet tethering system to couple an anterior mitral valve leaflet to a left ventricular free wall.

DETAILED DESCRIPTION

[0039] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed invention. The present disclosure relates to methods, devices and systems for tethering one or more leaflets of a tricuspid valve to a respective location on a ventricular septum or right ventricular free wall, and/or tethering one or both leaflets of a mitral valve to a respective location on the ventricular septum or a left ventricular free wall.

[0040] Although certain preferred embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and to modifications and equivalents thereof. Thus, the scope of the claims that may arise herefrom is not limited by any of the particular embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain embodiments; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components. For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

[0041] Certain standard anatomical terms of location are used herein to refer to the anatomy of animals, and namely humans, with respect to the preferred embodiments. Although certain spatially relative terms, such as “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms, are used herein to describe a spatial relationship of one device/element or anatomical structure to another device/element or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationship between element(s)/structures(s), as illustrated in the drawings. It should be understood that spatially relative terms are intended to encompass different orientations of the element(s)/structures(s), in use or operation, in addition to the orientations depicted in the drawings. For example, an element/structure described as “above” another element/structure may represent a position that is below or beside such other element/structure with respect to alternate orientations of the subject patient or element/structure, and vice-versa.

[0042] Various features of a heart 1 are described with reference to Figure 1 to assist 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 wall of muscle, referred to as the septum 10, separates the left atrium 2 and right atrium 5, and the left ventricle 3 and right ventricle 4. Blood flow through the heart 1 is at least partially controlled by four valves, the mitral valve 6, aortic valve 7, tricuspid valve 8, and pulmonary valve 9. The mitral valve 6 separates the left atrium 2 and the left ventricle 3 and controls blood flow therebetween. The aortic valve 7 separates and controls blood flow between the left ventricle 3 and the aorta 12. The tricuspid valve 8 separates the right atrium 5 and the right ventricle 4 and controls blood flow therebetween. The pulmonary valve 9 separates the right ventricle 4 and the pulmonary artery 11, controlling blood flow therebetween.

[0043] The heart valves may generally comprise a relatively dense fibrous ring, referred to herein as the annulus, as well as a plurality of cusps or leaflets attached to the annulus. For example, the tricuspid valve 8, aortic valve 7 and 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 may be such that the leaflets or cusps coapt to close the valves, and move apart to open the valves. The atrioventricular (i.e., mitral and tricuspid) heart valves may further comprise a collection of chordae tendineae and papillary muscles (not shown) for securing the leaflets of the respective valves to promote and/or facilitate proper coaptation of the valve leaflets and prevent prolapse thereof. The papillary muscles, for example, may generally comprise finger-like projections from the ventricle wall. The valve leaflets are connected to the papillary muscles by the chordae tendineae.

[0044] In a healthy heart, the heart valves can properly open and close in response to a pressure gradient present during various stages of the cardiac cycle (e.g., relaxation and contraction) to at least partially control the flow of blood to a respective region of the heart and/or to blood vessels. Deoxygenated blood arriving from the rest of the body generally flows into the right side of the heart for transport to the lungs, and oxygenated blood from the lungs generally flows into the left side of the heart for transport to the rest of the body.

[0045] During ventricular diastole (e.g., when the ventricular heart muscles are relaxed), a negative pressure differential between the right ventricle 4 and the right atrium 5 can push leaflets of the tricuspid valve 8 apart to open the tricuspid valve 8, allowing deoxygenated blood in the right atrium 5 arriving from the inferior vena cava 15 and superior vena cava 16 to flow into the right ventricle 4. Leaflets of the pulmonary valve 9 are coapted during ventricular diastole, remaining in apposition to each other to keep the pulmonary valve 9 closed. A negative pressure differential between the left ventricle 3 and the left atrium 2 can push leaflets of the mitral valve 6 apart during ventricular diastole to open the mitral valve 6, allowing oxygenated blood in the left atrium 2 arriving from the pulmonary veins to flow into the left ventricle 3. Leaflets of the aortic valve 7 can remain coapted during ventricular diastole, keeping the aortic valve 7 closed.

[0046] During ventricular systole (e.g., when the ventricular heart muscles contract), a positive pressure differential between the right ventricle 4 and the right atrium 5 can keep leaflets of the tricuspid valve 8 coapted, or in apposition with one another, to close the tricuspid valve 8. Properly coapted leaflets can prevent leakage of blood from the right ventricle 4 into the right atrium 5. Meanwhile, leaflets of the pulmonary valve 9 can be pushed apart during ventricular systole, sending deoxygenated blood from the right ventricle 4 into the pulmonary artery 11 for transport to the lungs. The pulmonary artery 11 can carry deoxygenated blood from the right side of the heart to the lungs. The pulmonary artery 11 can include a pulmonary trunk and left 14 and right 13 pulmonary arteries that branch off of the pulmonary trunk, as shown. A positive pressure differential between the left ventricle 3 and the left atrium 2 during ventricular systole can keep leaflets of the mitral valve 6 coapted, or in apposition with one another, to close the mitral valve 6. Properly coapted mitral valve leaflets can prevent leakage of blood from the left ventricle 3 into the left atrium 2. Leaflets of the aortic valve 7 can be pushed apart during ventricular systole to allow flow of oxygenated blood from the left ventricle 3 to the aorta 12 for transport to the rest of the body.

[0047] Diseased heart valve and/or associated leaflets (e.g., tricuspid valve and/or mitral valve dysfunction) can result in valve leakage and/or other health complications. Valve stenosis can cause a valve to become narrowed or obstructed. Tricuspid valve stenosis and mitral valve stenosis can restrict blood flow from the right atrium to the right ventricle, and from the left atrium to the left ventricle, respectively. Valve regurgitation occurs when a valve does not close properly. For example, regurgitation can occur due to improper coaptation of the valve leaflets. Tricuspid valve regurgitation can result in blood flow leakage back into the right atrium from the right ventricle when the right ventricle contracts. Leakage of blood back into the right atrium can result in ineffective pumping of deoxygenated blood into the lungs. Mitral valve regurgitation can result in blood flow leakage back into the left atrium from the left ventricle when the left ventricle contracts. If regurgitation is severe enough, the heart may enlarge to maintain forward flow of blood, causing heart failure, such as when the heart does not pump enough blood to the body. This may produce symptoms ranging from shortness of breath during exertion, coughing, congestion around the heart and lungs, swelling of the legs and feet. Valve repair can be performed to address various valve diseases. In more severe cases, valve replacement can be performed.

[0048] The present disclosure relates to methods, devices, and systems for tethering one or more leaflets of a tricuspid valve to a respective location on a ventricular septum or right ventricular free wall, and/or tethering one or both leaflets of a mitral valve to a respective location on the ventricular septum or a left ventricular free wall. For example, a posterior leaflet of a tricuspid valve can be tethered to the ventricular septum. An anterior leaflet of the tricuspid valve can be tethered to a posteromedial portion of the right ventricular free wall. Alternatively, the anterior leaflet can be tethered to a posterior portion of the right ventricular free wall. A septal leaflet of the tricuspid valve can be tethered to a posterolateral portion of the right ventricular free wall. A posterior leaflet of a mitral valve can be tethered to the ventricular septum. An anterior leaflet of the mitral valve can be tethered to a posterolateral portion of the left ventricular free wall. In some embodiments, more than one leaflet of the tricuspid valve can be tethered. In some embodiments, all three leaflets of the tricuspid valve can be tethered. In some embodiments, both leaflets of the mitral valve can be tethered. An anchor portion can be anchored to a leaflet and another anchor portion can be anchored to the ventricular septum or ventricular free wall, and a tether portion can couple the two anchor portions to one another such that the leaflet can be tethered to the ventricular septum or the ventricular free wall. In some embodiments, more than one anchor portion can be anchored to any one leaflet. In some embodiments, the plurality of anchor portions on any one leaflet can be coupled to one anchor portion or to more than one anchor portion secured to the ventricular free wall or the ventricular septum. In some embodiments, tethering of the one or more leaflets of the tricuspid valve and/or the one or more leaflets of the mitral valve can be performed using a minimally invasive procedure. In some embodiments, as described herein, a system for tethering the one or more leaflets of the tricuspid valve and/or the one or more leaflets of the mitral valve can be deployed using a transcatheter approach.

[0049] Coupling one or more leaflets of a tricuspid valve and/or one or more leaflets of a mitral valve to a ventricular septum or ventricular free wall as described herein can provide a desired annuloplasty effect so as to facilitate improved leaflet coaptation. In some embodiments, tethering one or more leaflets to corresponding locations on the ventricular septum and ventricular free wall can provide desired distance between leaflets to enable proper coaptation. In some embodiments, the tethering can replace functionality of any degenerated chordae tendineae. One or more tether portions as described herein can be tensioned and/or a length of the one or more tether portions can be adjusted to provide the desired leaflet coaptation. Sufficient coaptation of the leaflets can reduce or eliminate blood leakage across the heart valves, improving or restoring heart function.

[0050] One or more of the tether portions as described herein can have any number of configurations to couple, such as at opposing distal portions, including at opposing distal ends, anchor portions implanted in different locations in the heart. A tether portion can be flexible, deformable, stretchable, and/or have shape memory. In some embodiments, a length of the tether portion can be adjustable, for example to provide desired tension in the tethering of a leaflet to the ventricular septum or the ventricular free wall. In some embodiments, a tether can comprise a cord, a suture and/or a coil. An anchor portion as described herein can have a number of different configurations for stably positioning at a target location when coupled to another anchor portion positioned at a different target location. An anchor portion can be configured to be positioned at a target location on a tricuspid valve leaflet, a mitral valve leaflet, a ventricular septum or a ventricular free wall. An anchor portion can be configured to securely engage with the leaflet, the ventricular septum or the ventricular free wall. In some embodiments, an anchor portion can have a configuration to engage with a surface of the leaflet, a surface of the ventricular septum, be positioned within the ventricular septum, and/or engage with a surface of a layer of the ventricular free wall. Although the anchor portions are described herein as being a pledget, it will be understood that one or more of the anchor portions can have one or more other configurations. In some embodiments, an anchor portion can comprise a screw, a pin, a disc, and/or a suture knot.

[0051] The term “associated with” is used herein according to its broad and ordinary meaning. For example, where a first feature, element, component, device, or member is described as being “associated with” a second feature, element, component, device, or member, such description should be understood as indicating that the first feature, element, component, device, or member is physically coupled, attached, or connected to, integrated with, embedded at least partially within, or otherwise physically related to the second feature, element, component, device, or member, whether directly or indirectly.

[0052] Reference herein to “catheters” and/or “delivery catheters” can refer or apply generally to any type of elongate tubular delivery device comprising an inner lumen configured to slidably receive instrumentation, such as for positioning within an atrium or coronary sinus, including for example delivery sheaths and/or cannulas.

[0053] Figure 2 is a schematic diagram of an example of a heart valve leaflet tethering system 100 positioned at a target site within the heart. The heart valve leaflet tethering system 100 can comprise a first anchor portion 102, a second anchor portion 104, and a tether portion 106 coupling the first anchor portion 102 and the second anchor portion 104. The first anchor portion 102 can be configured to be secured to a posterior leaflet of a tricuspid valve. The second anchor portion 104 can be configured to be secured to a ventricular septum. The tether portion 106 can extend between the first anchor portion 102 and the second anchor portion 104 to couple the posterior leaflet of the tricuspid valve to the ventricular septum. Corresponding distal portions of the tether portion 106 can be coupled to each of the anchor portions. For example, a first end 108 of the tether portion 106 can be coupled to the first anchor portion 102 and the second end 110 of the tether portion 106 can be coupled to the second anchor portion 104.

[0054] In Figure 2, the first anchor portion 102 is shown as being secured to the posterior leaflet. For example, the first anchor portion 102 can be positioned over an upper surface of the posterior leaflet, such as an atrial facing surface of the posterior leaflet. The first anchor portion 102 can be positioned adjacent to and in contact with the upper surface of the posterior leaflet. [0055] In some embodiments, a first anchor portion can comprise a portion over the upper surface of, such as adjacent to and in contact with the upper surface, and a portion within the posterior leaflet. In some embodiments, the first anchor portion can be within the posterior leaflet. In some embodiments, the first anchor portion can comprise a portion over the upper surface of, a portion over a lower surface of, such as a ventricle facing surface, and a portion within the posterior leaflet. For example, the first anchor portion can sandwich the posterior leaflet, comprising a portion adjacent to and in contact with the upper surface and a portion adjacent to and in contact with the lower surface of the posterior leaflet, and a portion within the leaflet extending between the portions adjacent to and in contact with the upper and lower surfaces.

[0056] Referring again to Figure 2, the second anchor portion 104 is shown as being secured to the ventricular septum. In some embodiments, the second anchor portion 104 can be anchored to a portion of the ventricular septum below the right ventricular outflow tract. In some embodiments, the second anchor portion 104 can be anchored to a portion of the ventricular septum below the leaflets of the tricuspid valve when the leaflets are in an open position. The location on the ventricular septum to which the second anchor portion 104 is secured can be selected such that tethering of the posterior leaflet can provide a desired annuloplasty effect to enable sufficient coaptation of the tricuspid leaflets. The tethering can provide desired tensioning force upon the posterior leaflet such that the posterior leaflet is within a desired distance of the anterior and/or septal leaflets to allow proper coaptation.

[0057] Figure 2 shows the second anchor portion 104 as being positioned in the left ventricle. For example, the second anchor portion 104 can be positioned over a portion of the ventricular septum facing the left ventricle. In some embodiments, the second anchor portion 104 can be positioned adjacent to and in contact with the portion of the ventricular septum facing the left ventricle. The tether portion 106 can extend through the ventricular septum to couple the first anchor portion 102 to the second anchor portion 104 such that the posterior leaflet is coupled to the ventricular septum.

[0058] In some embodiments, a second anchor portion can comprise at least a portion over, such as adjacent to and in contact with, a surface of the ventricular septum facing the right ventricle and a portion within the ventricular septum. In some embodiments, the second anchor portion can be within the ventricular septum. In some embodiments, the second anchor portion can comprise a portion within the ventricular septum and a portion over, such as adjacent to and in contact with, a surface of the ventricular septum facing the left ventricle. In some embodiments, the second anchor portion can comprise a portion over, such as adjacent to and in contact with, a right ventricle facing surface of the ventricular septum, a portion within the ventricular septum, and a portion over, such as adjacent to and in contact with, a surface of the ventricular septum facing the left ventricle.

[0059] In some embodiments, the first anchor portion 102 can comprise a first pledget and the second anchor portion 104 can comprise a second pledget. The first pledget can be positioned adjacent to and in contact with an atrial facing surface of the posterior mitral valve leaflet. The second pledget can be positioned adjacent to and in contact with a left ventricle facing surface of the ventricular septum. The tether portion 106 can comprise a flexible and/or stretchable cord having opposing ends 108, 110 coupled to the first pledget and the second pledget, tethering the posterior leaflet to the ventricular septum.

[0060] Figure 3 is a schematic diagram of an example of a heart valve leaflet tethering system 200 positioned at a target site within the heart. A first anchor portion 202 of the heart valve leaflet tethering system 200 can be configured to be secured to an anterior leaflet of a tricuspid valve. A second anchor portion 204 (not shown) can be configured to be secured to a right ventricular free wall. A tether portion 206 can couple the first anchor portion 202 and the second anchor portion 204. Corresponding distal portions of the tether portion 206 can be coupled to each of the anchor portions. For example, a first end 208 of the tether portion 206 can be coupled to the first anchor portion 202 and the second end 210 of the tether portion 106 can be coupled to the second anchor portion 204. The heart valve leaflet tethering system 200 can be configured to couple the anterior leaflet to the right ventricular free wall.

[0061] The first anchor portion 202 can be configured to be positioned over an upper surface of the anterior leaflet, such as an atrial facing surface of the anterior leaflet. The first anchor portion 202 can be positioned adjacent to and in contact with the upper surface of the anterior leaflet. In some embodiments, a first anchor portion can comprise a portion adjacent to and in contact with an atrial facing surface of the anterior leaflet and a portion within the anterior leaflet. In some embodiments, a first anchor portion can be within the anterior leaflet. In some embodiments, a first anchor portion can comprise a portion adjacent to and in contact with a lower surface, such as a ventricle facing surface, of the anterior leaflet and a portion within the anterior leaflet. In some embodiments, a first anchor portion can comprise a portion over the upper surface of, a portion over the lower surface of, and a portion within the anterior leaflet. For example, the first anchor portion can sandwich the anterior leaflet, comprising a portion adjacent to and in contact with the upper surface and a portion adjacent to and in contact with the lower surface of the anterior leaflet, and a portion within the leaflet extending between the portions adjacent to and in contact with the upper and lower surfaces.

[0062] The second anchor portion 204 can be secured to the right ventricular free wall. In some embodiments, the second anchor portion 204 can be anchored to a portion of the right ventricular free wall below the leaflets of the tricuspid valve when the leaflets are in an open position. In some embodiments, the second anchor portion 204 can be secured to a posteromedial portion of the right ventricular free wall. Alternatively, in some embodiments, the second anchor portion 204 can be secured to a posterior portion of the right ventricular free wall. Coupling the anterior leaflet as described herein can provide a desired distance between the anterior and the posterior and/or septal leaflets to allow sufficient coaptation. A location on the right ventricular free wall to which the second anchor portion 204 is secured can be selected to provide an annuloplasty effect such that the tricuspid valve leaflets can demonstrate proper coaptation. In some embodiments, the location on the right ventricular free wall can be selected to reduce or avoid interference with coronary arteries and/or coronary veins. The tether portion 206 can couple the anterior leaflet to a posteromedial portion or a posterior portion of the right ventricular free wall such that an annuloplasty effect can be achieved to allow desired coaptation of the leaflets.

[0063] Figure 4 is a schematic diagram of an example of a heart valve leaflet tethering system 300 positioned at a target site within the heart. The heart valve leaflet tethering system 300 can couple a septal leaflet of a tricuspid valve to the right ventricular free wall. The heart valve leaflet tethering system 300 can comprise a first anchor portion 302 configured to be secured to a septal leaflet of the tricuspid valve, a second anchor portion 304 (not shown) configured to be secured to the right ventricular free wall, and a tether portion 306 coupling the first anchor portion 302 and the second anchor portion 304. Corresponding distal portions of the tether portion 306 can be coupled to each of the anchor portions. A first end 308 of the tether portion 306 can be coupled to the first anchor portion 302 and the second end 310 of the tether portion 306 can be coupled to the second anchor portion 304.

[0064] Figure 4 shows the first anchor portion 302 as being positioned over an upper surface of the septal leaflet, such as over an atrial facing surface of the septal leaflet.

For example, the first anchor portion 302 can be positioned adjacent to and in contact with the upper surface of the septal leaflet. The second anchor portion 304 is shown as being secured to the right ventricular free wall. The location on the right ventricular free wall to which the second anchor portion 304 is anchored can be selected to facilitate desired coaptation of the tricuspid leaflets. The location can be selected such that the tethering portion 306 can provide a tensioning force upon the septal leaflet to bring the septal leaflet closer to the anterior and/or posterior leaflets to thereby achieve an annuloplasty effect. In some embodiments, the second anchor portion 304 can be anchored to a posterolateral portion of the right ventricular free wall. In some embodiments, the second anchor portion 304 can be anchored to a portion of the right ventricular free wall below the leaflets of the tricuspid valve when the leaflets are in an open position. For example, the location can be on a posterolateral portion of the right ventricular free wall below the leaflets of the tricuspid valve when the leaflets are in an open position. The location on the right ventricular free wall for securing the second anchor portion 304 can be selected to avoid or reduce interference with the coronary arteries and/or coronary veins.

[0065] In some embodiments, a first anchor portion can comprise at least a portion over a lower surface of the septal leaflet and/or a portion within the septal leaflet. For example, the first anchor portion can comprise a portion adjacent to and in contact with a ventricle facing surface of the septal leaflet. In some embodiments, a first anchor portion can be within the septal leaflet. In some embodiments, a first anchor portion can comprise a portion over the upper surface, a portion over the lower surface, and a portion within the septal leaflet. For example, the first anchor portion can comprise a portion adjacent to and in contact with an atrial facing surface and a portion adjacent to and in contact with a ventricle facing surface of the septal leaflet to sandwich the leaflet, and a portion within the leaflet extending between the portions adjacent to and in contact with the atrial facing surface and ventricle facing surface.

[0066] A second anchor portion, such as the second anchor portion 204 described with reference to Figure 3 and the second anchor portion 304 described with reference to Figure 4, can be secured to the right ventricular free wall in various manners. In some embodiments, the second anchor portion can be positioned within the right ventricular free wall. For example, the second anchor portion can be positioned between two layers of the heart wall. As is known in the art, the heart wall can include an endocardium, an inner most layer of the heart. A myocardium can be outside of the endocardium, and an epicardium can be outside of the myocardium. The epicardium can be contained within a pericardium. The heart call can include a space, referred to as the pericardial cavity, between the epicardium and the pericardium. In some embodiments, the second anchor portion can be positioned within the pericardial cavity. In some embodiments, the second anchor portion can be positioned in the pericardial cavity over the epicardium, such as adjacent to and in contact with a pericardial cavity facing surface of the epicardium. For example, the tether portion, such as the tether portion 206 described with reference to Figure 3 and/or the tether portion 306 described with reference to Figure 4, can extend through the endocardium, myocardium and epicardium to couple to the second anchor portion positioned within the pericardial cavity. In some embodiments, the second anchor portion can be positioned external of the pericardium. For example, the second anchor portion can be positioned on an exterior surface of the pericardium. The corresponding tether portion can extend through the endocardium, myocardium, epicardium, pericardial cavity and pericardium to couple to the second anchor portion.

[0067] In some embodiments, a first anchor portion, such as the first anchor portion 202 described with reference to Figure 3 and/or the first anchor portion 302 described with reference to Figure 4, can each comprise a respective first pledget. In some embodiments, a second anchor portion, such as the second anchor portion 204 described with reference to Figure 3 and/or the second anchor portion 304 described with reference to Figure 4, can each comprise a respective second pledget. In some embodiments, the tether portion can comprise a flexible and/or stretchable cord. Each of the first pledget can be positioned adjacent to and in contact with an atrial facing surface of an anterior leaflet or a septal leaflet of the tricuspid valve. Each of the second pledget can be positioned within the pericardial cavity, or alternatively, on an external surface of the pericardium of a right ventricular free wall. A corresponding tether portion can be coupled to a respective first pledget and a respective second pledget, such that the anterior leaflet or septal leaflet is tethered to the right ventricular free wall.

[0068] In some embodiments, a heart valve leaflet tethering system can comprise tethering for more than one tricuspid leaflet. For example, the heart valve leaflet tethering system can comprise tethering for two or more of the posterior leaflet, anterior leaflet and septal leaflet of the tricuspid valve. In some embodiments, the heart valve leaflet tethering system can comprise tethering for both the posterior leaflet and the anterior leaflet. In some embodiments, the heart valve leaflet tethering system can comprise tethering for all three leaflets of the tricuspid valve. In some embodiments, tethering for more than one leaflet can facilitate desired reduction in distance between the leaflets, thereby improving an annuloplasty effect provided by the tethering of the leaflets such that the leaflets can achieve sufficient coaptation. For example, the heart valve leaflet tethering system can comprise tether portions coupling more than one leaflet to respective locations on the ventricular septum and/or ventricular free wall, where the respective locations are selected to provide a desired annuloplasty effect.

[0069] In some embodiments, a heart valve leaflet tethering system can comprise a first anchor portion configured to be secured to a posterior leaflet of a tricuspid valve, a second anchor portion configured to be secured to a ventricular septum, and a first tether portion coupling the first anchor portion and the second anchor portion. In some embodiments, the heart valve leaflet tethering system can comprise a third anchor portion configured to be secured to an anterior leaflet of the tricuspid valve, a fourth anchor portion configured to be secured to a right ventricular free wall, and a second tether portion coupling the third anchor portion and the fourth anchor portion. For example, the fourth anchor portion can be secured to a posterior portion or posteromedial portion of the right ventricular free wall. In some embodiments, the heart valve leaflet tethering system can comprise a fifth anchor portion configured to be secured to a septal leaflet of the tricuspid valve, a sixth anchor portion configured to be secured to a right ventricular free wall, and a third tether portion coupling the fifth anchor portion and the sixth anchor portion. For example, the sixth anchor portion can be secured to a posterolateral portion of the right ventricular free wall.

The location on the ventricular septum and right ventricular free wall can be selected to provide a desired annuloplasty effect such that the tethered leaflets can achieve desired coaptation.

[0070] In some embodiments, more than one anchor portion can be secured to any one of the leaflets of the tricuspid valve. For example, a plurality of anchor portions can be anchored to the posterior leaflet, anterior leaflet and/or septal leaflet. In some embodiments, the plurality of anchor portions anchored to a leaflet can be tethered to a ventricular septum or ventricular free wall using one tether portion or a plurality of tether portions. For example, an anchor portion can be coupled to a corresponding tether portion. In some embodiments, more than one anchor portion can be anchored to the ventricular septum or ventricular free wall. For example, more than one anchor portion can be anchored to respective target locations on the ventricular septum or ventricular free wall. The plurality of anchor portions can be secured to locations proximate or adjacent to one another on the ventricular septum or ventricular free wall.

[0071] Figure 5 is a process flow diagram of an example of an implantation procedure 500 for deploying a heart valve leaflet tethering system for tethering a posterior leaflet of the tricuspid valve to a ventricular septum. In some embodiments, the procedure/process 500 can be minimally invasive. In some embodiments, the procedure/process 500 can comprise a transcatheter approach. At block 502, the procedure/process 500 involves introducing the heart valve leaflet tethering system into the right atrium. The heart valve leaflet tether system can comprise a first anchor portion, a second anchor portion and a tether portion coupling the first anchor portion and the second anchor portion. The heart valve leaflet tethering system can be introduced into the right atrium through the superior vena cava or the inferior vena cava. For example, a transjugular or trans-subclavian approach can be used to access the superior vena cava. Alternatively, a transfemoral approach can be used to access the inferior vena cava. The heart valve leaflet tethering system can be advanced to the heart using a delivery catheter. For example, the heart valve leaflet tethering system can be positioned within a lumen of the delivery catheter and deployed as described herein.

[0072] At block 504, the procedure/process 500 involves advancing the heart valve leaflet tethering system from the right atrium into the right ventricle via a gap between leaflets of the tricuspid valve. For example, the delivery catheter carrying the heart valve leaflet tethering system can be advanced through the gap between the leaflets of the tricuspid valve.

[0073] At block 506, the procedure/process 500 involves anchoring the second anchor portion to the ventricular septum. A distal portion, including a distal end, of the delivery catheter can be used to contact the ventricular septum such that the second anchor portion can be deployed onto the ventricular septum. The delivery catheter can be used to contact a portion of the ventricular septum below the right ventricular outflow tract. The portion of the ventricular septum can be below the leaflets of the tricuspid valve when the leaflets are in an open position. As described herein, in some embodiments, the second anchor portion can be positioned over a left ventricle facing surface of the ventricular septum. The delivery catheter can be inserted through the ventricular septum and into the left ventricle. The delivery catheter can then be withdrawn, leaving the second anchor portion over the left ventricle facing surface of the septum.

[0074] In some embodiments, the second anchor portion can comprise a portion within the ventricular septum. For example, the delivery catheter can be inserted into the ventricular septum to deploy the second anchor portion into the ventricular septum. The delivery catheter can be inserted into the ventricular septum. The delivery catheter can then be withdrawn, leaving the second anchor portion within the septum. In some embodiments, the second anchor portion can comprise a portion within the ventricular septum and a portion over the right ventricle facing surface of the ventricular septum. In some embodiments, the second anchor portion can be deployed into the ventricular septum and onto a right ventricle facing surface of the ventricular septum, as the delivery catheter is withdrawn from the ventricular septum toward the tricuspid valve.

[0075] At block 508, the procedure/process 500 involves deploying the tether portion. Deploying the tether portion can comprise moving the first anchor portion toward the posterior leaflet while the second anchor portion is anchored to the ventricular septum. In some embodiments, deploying the tether portion can comprise releasing the tether portion, such as from the delivery catheter. For example, the delivery catheter can be withdrawn from ventricular septum toward the tricuspid valve and the tether portion can be released from the distal portion, including from the distal end, of the delivery catheter. The tether portion can be coupled to the second anchor portion anchored to the ventricular septum such that moving the delivery catheter away from the ventricular septum can pull the tether portion from the delivery catheter.

[0076] At block 510, the procedure/process 500 involves anchoring the first anchor portion to the posterior leaflet of the tricuspid valve to couple the posterior leaflet to the ventricular septum. In some embodiments, the posterior leaflet can be captured using a leaflet capture component associated with a distal portion, including the distal end, of the delivery catheter. For example, the delivery catheter can be used to contact the posterior leaflet such that the first anchor portion can be deployed to anchor to the leaflet. The first anchor portion can be deployed to be positioned over, under and/or within the posterior leaflet. In some embodiments, deploying the first anchor portion can comprise positioning the first anchor portion on an upper surface of the leaflet, such as adjacent to and in contact with an atrial facing surface of the leaflet. In some embodiments, deploying the first anchor portion can comprise positioning the first anchor portion over an upper surface of, over a lower surface of, and within the leaflet. For example, deploying the first anchor portion can comprise positioning the first anchor portion adjacent to and in contact with an atrial facing surface, within the leaflet, and adjacent to and in contact with a ventricle facing surface of the leaflet. The second anchor portion can be coupled to the tether portion and the tether portion can be coupled to the first anchor portion such that anchoring the first anchor portion to the posterior leaflet can thereby couple the posterior leaflet to the ventricular septum.

[0077] Figure 6 is a process flow diagram of an example of an implantation procedure 600 for deploying a heart valve leaflet tethering system for tethering an anterior leaflet or a septal leaflet of the tricuspid valve to a right ventricular free wall. In some embodiments, the procedure/process 600 can be minimally invasive. In some embodiments, the procedure/process 600 can comprise a transcatheter approach. At block 602, the procedure/process 600 involves introducing the heart valve leaflet tethering system into the right atrium. The heart valve leaflet tether system can comprise a first anchor portion, a second anchor portion and a tether portion coupling the first anchor portion and the second anchor portion. The heart valve leaflet tethering system can be introduced into the right atrium through the superior vena cava or the inferior vena cava. For example, a transjugular or trans-subclavian approach can be used to access the superior vena cava. Alternatively, a transfemoral approach can be used to access the inferior vena cava. The heart valve leaflet tethering system can be advanced to the heart using a delivery catheter. For example, the heart valve leaflet tethering system can be positioned within a lumen of the delivery catheter and deployed as described herein.

[0078] At block 604, the procedure/process 600 involves advancing the heart valve leaflet tethering system from the right atrium into the right ventricle via a gap between leaflets of the tricuspid valve. For example, the delivery catheter carrying the heart valve leaflet tethering system can be advanced through the gap.

[0079] At block 606, the procedure/process 600 involves anchoring the second anchor portion to the right ventricular free wall. A distal portion, including a distal end, of the delivery catheter can be used to contact the right ventricular free wall such that the second anchor portion can be secured to the right ventricular free wall. The second anchor portion can be secured to a posterior portion of the right ventricular free wall or a posterolateral portion of the right ventricular free wall. Alternatively, the second anchor portion can be secured to a posteromedial portion of the right ventricular free wall. In some embodiments, the second anchor portion can be deployed into a pericardial cavity in the right ventricular free wall or over, including onto and in contact with, an exterior surface of the pericardium.

In some embodiments, a tissue puncturing component associated with the delivery catheter can be used to pierce layers of the heart wall such that the delivery catheter can be used to deliver the second anchor portion into the pericardial cavity or over the exterior surface of the pericardium.

[0080] At block 608, the procedure/process 600 involves deploying the tether portion. The tether portion can extend through layers of the heart wall to couple the second anchor portion to the first anchor portion. Deploying the tether portion can comprise moving the first anchor portion toward the anterior leaflet or the septal leaflet while the second anchor portion is anchored to the right ventricular free wall. In some embodiments, deploying the tether portion can comprise releasing the tether portion, such as from the delivery catheter. For example, the delivery catheter can be withdrawn from the right ventricular free wall toward the tricuspid valve and the tether portion can be released from the distal portion, including from the distal end, of the delivery catheter as the delivery catheter is moved away from the right ventricular free wall.

[0081] At block 610, the procedure/process 600 involves anchoring the first anchor portion to one of an anterior leaflet or septal leaflet of the tricuspid valve to couple the anterior leaflet or the septal leaflet to the right ventricular free wall. For example, a first anchor portion configured to be anchored to the anterior leaflet can be coupled to a second anchor portion anchored to a posterior portion of the right ventricular free wall. Alternatively, the second anchor portion coupled to the first anchor portion secured to the anterior leaflet can be anchored to a posteromedial portion of the right ventricular free wall. A first anchor portion configured to be anchored to the septal leaflet can be coupled to a second anchor portion anchored to a posterolateral portion of the right ventricular free wall.

[0082] In some embodiments, the anterior leaflet or the septal leaflet can be captured using a leaflet capture component associated with a distal portion, including the distal end, of the delivery catheter. For example, the delivery catheter can be used to contact the leaflet such that the first anchor portion can be deployed to anchor to the leaflet. The first anchor portion can be deployed to be positioned over, under and/or within the leaflet. As described herein, the first anchor portion can comprise a portion for positioning over an upper surface of, over a lower surface of, and/or within the leaflet. The second anchor portion can be coupled to the tether portion and the tether portion can be coupled to the first anchor portion such that anchoring the first anchor portion to the anterior leaflet or septal leaflet can thereby couple the anterior leaflet or septal leaflet to the right ventricular free wall.

[0083] As described herein, in some embodiments, a heart valve leaflet tethering system can comprise tethering for more than one tricuspid valve leaflet. In some embodiments, a process for deploying the heart valve leaflet tethering system can comprise deploying tethering for two of a posterior leaflet, an anterior leaflet, and a septal leaflet. In some embodiments, a process for deploying the heart valve leaflet tethering system can comprise deploying tethering for all three of the posterior leaflet, anterior leaflet and septal leaflet. Each of the posterior leaflet, anterior leaflet, and septal leaflet can be coupled to respective locations on the ventricular septum or right ventricular free wall. For example, the heart valve leaflet tethering system can be introduced into a right atrium. The heart valve leaflet tethering system can be advanced from the right atrium into the right ventricle via a gap between leaflets of a tricuspid valve. In some embodiments, the heart valve leaflet tethering system can comprise a first anchor portion configured to be anchored to the posterior leaflet, a second anchor portion configured to be anchored to the ventricular septum, and a first tether portion extending therebetween. The second anchor portion can be anchored to the ventricular septum. The second anchor portion can be deployed to be positioned over a left ventricle facing surface of the septum, within the septum and/or over a right ventricle facing surface of the septum. The first tether portion can be deployed. For example, after the second anchor portion has been secured to the ventricular septum, the first tether portion can be released from the delivery catheter, such as from a distal portion, including a distal end of the delivery catheter. The first anchor portion can be subsequently anchored to the posterior leaflet. Methods for anchoring the first anchor portion to the posterior leaflet, deploying the first tether portion and/or anchoring the second anchor portion to the ventricular septum can comprise methods described herein, such as described with reference to Figure 5.

[0084] In some embodiments, after the posterior leaflet of the tricuspid valve is tethered to the ventricular septum, the anterior leaflet of the tricuspid valve can be tethered to the right ventricular free wall. In some embodiments, the heart valve leaflet tethering system can further comprise a third anchor portion configured to be anchored to the anterior leaflet of the tricuspid valve, a fourth anchor portion configured to be anchored to the right ventricular free wall, and a second tether portion coupling the third anchor portion and the fourth anchor portion. The fourth anchor portion can be anchored to the right ventricular free wall. For example, the fourth anchor can be anchored to a posteromedial portion of the right ventricular free wall or a posterior portion of the right ventricular free wall. The second tether portion can then be deployed. The third anchor portion can subsequently be anchored to the anterior leaflet. Methods for anchoring the third anchor portion to the anterior leaflet, deploying the second tether portion, and/or anchoring the fourth anchor portion to the right ventricular free wall, can comprise methods as described with reference to Figure 6.

[0085] In some embodiments, after the posterior leaflet of the tricuspid valve is tethered to the ventricular septum and the anterior leaflet of the tricuspid valve is tethered to the right ventricular free wall, the septal leaflet of the tricuspid valve is tethered to the right ventricular free wall. In some embodiments, the heart valve leaflet tethering system can further comprise a fifth anchor portion configured to be anchored to the septal leaflet of the tricuspid valve, a sixth anchor portion configured to be anchored to the right ventricular free wall, and a third tether portion coupling the fifth anchor portion and the sixth anchor portion. The sixth anchor portion can be anchored to the right ventricular free wall. For example, the sixth anchor portion can be anchored to a posterolateral portion of the right ventricular free wall. The third tether portion can then be deployed. The fifth anchor portion can subsequently be anchored to the septal leaflet. Methods for anchoring the fifth anchor portion to the septal leaflet, deploying the third tether portion, and/or anchoring the sixth anchor portion to the right ventricular free wall, can comprise methods as described with reference to Figure 6.

[0086] In some embodiments, one or more portions of a process as described herein can be repeated to deploy one or more additional anchor portions and/or tether portions. In some embodiments, a process for tethering one or more leaflets of the tricuspid valve can include a different sequence. In some embodiments, an anchor can be anchored to the leaflet prior to anchoring an anchor to the left ventricular free wall or the ventricular septum. In some embodiments, tethering of the anterior leaflet and/or septal leaflet can be performed prior to tethering of the posterior leaflet. In some embodiments, tethering of the septal leaflet can be performed prior to tethering of the anterior leaflet.

[0087] Figure 7 is a schematic diagram of an example of a heart valve leaflet tethering system 700 positioned at a target site within the heart. The heart valve leaflet tethering system 700 can comprise a first anchor portion 702 (not shown) configured to be secured to a posterior leaflet of a mitral valve, a second anchor portion 704 (not shown) configured to be secured to a ventricular septum, and a tether portion 706 coupling the first anchor portion 702 and the second anchor portion 704. Corresponding distal portions of the tether portion 706 can be coupled to each of the anchor portions. A first end 708 of the tether portion 706 can be coupled to the first anchor portion 702 and the second end 710 of the tether portion 706 can be coupled to the second anchor portion 704.

[0088] In some embodiments, the first anchor portion 702 can be positioned over an upper surface of, over a lower surface of, and/or within the posterior leaflet. For example, the first anchor portion 702 can be positioned adjacent to and in contact with an atrial facing surface of the posterior leaflet.

[0089] In some embodiments, a first anchor portion can comprise a portion over the upper surface, a portion over the lower surface, and a portion within the posterior leaflet. For example, the first anchor portion can comprise a portion adjacent to and in contact with an atrial facing surface, adjacent to and in contact with a ventricle facing surface of the posterior leaflet, and within the posterior leaflet. In some embodiments, the first anchor portion can comprise a portion over the upper surface and a portion over the lower surface of the posterior leaflet to sandwich the leaflet, and a portion within the leaflet extending between the portions over the upper surface and lower surface. [0090] The second anchor portion 704 is shown as being secured to the ventricular septum. In some embodiments, the second anchor portion 704 can be anchored to a portion of the ventricular septum below the left ventricular outflow tract. In some embodiments, the second anchor portion 704 can be anchored to a portion of the ventricular septum below the leaflets of the mitral valve when the leaflets are in an open position. The location on the ventricular septum to which the second anchor portion 704 is secured can be selected to provide a desired annuloplasty effect so as to facilitate sufficient coaptation of the leaflets. The tethering can provide a desired tension upon the posterior leaflet such that a desired distance between the posterior leaflet and the anterior leaflet of the mitral valve can be maintained to facilitate proper coaptation. In some embodiments, the second anchor portion 704 can be positioned in the right ventricle. For example, the second anchor portion 704 can be positioned over a portion of the ventricular septum facing the right ventricle. The tether portion 706 can extend through the ventricular septum to couple the first anchor portion 702 to the second anchor portion 704. In some embodiments, the second anchor portion 704 can be positioned adjacent to and in contact with the portion of the ventricular septum facing the right ventricle.

[0091] In some embodiments, the first anchor portion 702 can comprise a first pledget and the second anchor portion 704 can comprise a second pledget. The first pledget can be positioned adjacent to and in contact with an atrial facing surface of the posterior mitral valve leaflet. The second pledget can be positioned adjacent to and in contact with a right ventricle facing surface of the ventricular septum. The tether portion 706 can comprise a flexible and/or stretchable cord having opposing ends 708, 710 coupled to the first pledget and the second pledget, tethering the posterior mitral valve leaflet to the ventricular septum.

[0092] In some embodiments, a second anchor portion can be within the ventricular septum. In some embodiments, a second anchor portion can comprise a portion positioned over a surface of the ventricular septum facing the right ventricle, such as adjacent to and in contact with the surface, and a portion within the ventricular septum. In some embodiments, a second anchor portion can comprise a portion positioned over, such as adjacent to and in contact with, a surface of the ventricular septum facing the left ventricle, and a portion within the ventricular septum. In some embodiments, a second anchor portion can comprise a portion positioned over a portion of the ventricular septum facing the left ventricle, a portion positioned over a portion of the ventricular septum facing the right ventricle, and a portion within the ventricular septum, such that the second anchor portion sandwiches the ventricular septum. [0093] Figure 8 is a schematic diagram of an example of a heart valve leaflet tethering system 800 positioned at a target site within the heart. The heart valve leaflet tethering system 800 can comprise a first anchor portion 802 (not shown) configured to be secured to an anterior leaflet of a mitral valve, a second anchor portion 804 (not shown) configured to be secured to a left ventricular free wall, and a tether portion 806 coupling the first anchor portion 802 and the second anchor portion 804. Corresponding distal portions of the tether portion 806 can be coupled to each of the anchor portions. The tether portion 806 can comprise a first end 808 coupled to the first anchor portion 802 and a second end 810 coupled to the second anchor portion 804. In some embodiments, the first anchor portion 802 can be positioned over an upper surface of, over a lower surface of, and/or within the anterior leaflet. For example, the first anchor portion 802 can be positioned adjacent to and in contact with an atrial facing surface of the anterior leaflet.

[0094] In some embodiments, a first anchor portion can comprise a portion over the upper surface, a portion over the lower surface, and a portion within the anterior leaflet. For example, the first anchor portion can comprise a portion adjacent to and in contact with an atrial facing surface, adjacent to and in contact with a ventricle facing surface of the posterior leaflet, and within the anterior leaflet. In some embodiments, the first anchor portion can comprise a portion over the upper surface and a portion over the lower surface of the posterior leaflet to sandwich the leaflet, and a portion within the leaflet extending between the portions over the upper surface and lower surface.

[0095] The second anchor portion 804 can be secured to the left ventricular free wall. In some embodiments, the second anchor portion 804 can be secured to a posterolateral portion of the left ventricular free wall. In some embodiments, the second anchor portion 804 can be anchored to a portion of the left ventricular free wall below the leaflets of the mitral valve when the leaflets are in an open position. The location can be selected such that the tethering portion 806 can provide a tensioning force upon the anterior leaflet to bring the anterior leaflet closer to the posterior leaflet of mitral valve to thereby achieve a desired annuloplasty effect such that the leaflets can properly coapt. The location on the left ventricular free wall for securing the second anchor portion 804 can be selected to avoid or reduce interference with the coronary arteries and/or coronary veins.

[0096] In some embodiments, the second anchor portion 804 can be positioned within the left ventricular free wall. For example, the second anchor portion can be positioned between two layers of the heart wall, such as between the epicardium and the pericardium. The second anchor portion 804 can be positioned within the pericardial cavity. In some embodiments, the second anchor portion 804 can be positioned in the pericardial cavity over the epicardium, such as adjacent to and in contact with a pericardial cavity facing surface of the epicardium. The tether portion 806 can extend through inner layers of the heart wall, such as the endocardium, myocardium and epicardium, to couple to the second anchor portion 804 positioned within the pericardial cavity. In some embodiments, the second anchor portion 804 can be positioned external of the pericardium, including over, such as on and in contact with, an exterior surface of the pericardium. The tether portion 806 can extend through the endocardium, myocardium, epicardium, pericardial cavity and pericardium to couple to the second anchor portion 804 on the exterior surface of the pericardium.

[0097] In some embodiments, the first anchor portion 802 can comprise a first pledget and the second anchor portion 804 can comprise a second pledget. The first pledget can be positioned adjacent to and in contact with an atrial facing surface of an anterior leaflet of the mitral valve. The second pledget can be positioned within the pericardial cavity, or alternatively, over an external surface of the pericardium. The tether portion 806 can comprise a flexible and/or stretchable cord coupled to the first pledget and the second pledget, such that the anterior leaflet is tethered to the left ventricular free wall.

[0098] In some embodiments, a heart valve leaflet tethering system can comprise tethering for more than one mitral valve leaflet. For example, the heart valve leaflet tethering system can comprise tethering for both the posterior leaflet and anterior leaflet of the mitral valve. In some embodiments, tethering for more than one mitral valve leaflet to respective locations on the ventricular septum and ventricular free wall can provide an improved annuloplasty effect, facilitating sufficient coaptation by the leaflets. In some embodiments, a heart valve leaflet tethering system can comprise a first anchor portion configured to be secured to a posterior leaflet of a mitral valve, a second anchor portion configured to be secured to a ventricular septum, and a first tether portion coupling the first anchor portion and the second anchor portion so as to couple the posterior leaflet to the ventricular septum. In some embodiments, the heart valve leaflet tethering system can comprise a third anchor portion configured to be secured to an anterior leaflet of the mitral valve, a fourth anchor portion configured to be secured to a left ventricular free wall, and a second tether portion coupling the third anchor portion and the fourth anchor portion. In some embodiments, the fourth anchor portion can be secured to a posterolateral portion of the right ventricular free wall. The locations on the ventricular septum and right ventricular free wall can be selected to provide a desired annuloplasty effect such that the tethered leaflets can achieve desired coaptation. [0099] In some embodiments, more than one anchor portion can be secured to any one of the leaflets of the mitral valve. For example, a plurality of anchor portions can be anchored to the posterior leaflet, and/or anterior leaflet. In some embodiments, the plurality of anchor portions anchored to a leaflet can be tethered to a ventricular septum or ventricular free wall using one tether portion or a plurality tether portions. An anchor portion can be coupled to a corresponding tether portion. In some embodiments, more than one anchor portion can be anchored to respective target locations on the ventricular septum or ventricular free wall. For example, the plurality of anchor portions can be secured to locations proximate or adjacent to one another on the ventricular septum or ventricular free wall.

[0100] Figure 9 is a process flow diagram of an example of an implantation procedure 900 for deploying a heart valve leaflet tethering system. The heart valve leaflet tethering system can be deployed to tether a posterior leaflet of a mitral valve to a ventricular septum. For example, the heart valve leaflet tether system can comprise a first anchor portion, a second anchor portion and a tether portion coupling the first anchor portion and the second anchor portion. In some embodiments, the procedure/process 900 can be minimally invasive. In some embodiments, the procedure/process 900 can comprise a transcatheter approach. At block 902, the procedure/process 900 involves introducing the heart valve leaflet tethering system into the right atrium. The heart valve leaflet tethering system can be introduced into the right atrium through the superior vena cava (e.g., using a transjugular or trans- subclavian approach) or the inferior vena cava (e.g., using a transfemoral approach). The heart valve leaflet tethering system can be advanced to the heart using a delivery catheter, such as being advanced to the heart while positioned within a lumen of the delivery catheter.

[0101] At block 904, the procedure/process 900 involves advancing the heart valve leaflet tethering system from the right atrium into the right ventricle via a gap between leaflets of the tricuspid valve. The delivery catheter carrying the heart valve leaflet tethering system can be advanced through the gap. At block 906, the procedure/process 900 involves inserting the heart valve leaflet tethering system through the ventricular septum from the right ventricle into a left ventricle.

[0102] At block 908, the procedure/process 900 involves anchoring the first anchor portion to the posterior leaflet of the mitral valve. In some embodiments, the posterior leaflet can be captured using a leaflet capture component associated with a distal portion, including a distal end, of the delivery catheter. For example, the delivery catheter can be used to contact the posterior leaflet such that the first anchor portion can be deployed to anchor to the leaflet. The first anchor portion can be deployed to be positioned over, under and/or within the posterior leaflet. In some embodiments, deploying the first anchor portion can comprise positioning the first anchor portion on an upper surface of the posterior leaflet, such as adjacent to and in contact with an atrial facing surface of the leaflet. For example, the delivery catheter can be positioned beneath the posterior leaflet. A leaflet puncturing component associated with the delivery catheter can be used to puncture the leaflet such that the leaflet puncturing component can be extended through the leaflet from the lower surface through the upper surface of the leaflet. The first anchor portion can then be positioned over the upper surface. In some embodiments, deploying the first anchor portion can comprise positioning the first anchor portion over an upper surface of, over a lower surface of, and within the leaflet. For example, deploying the first anchor portion can comprise positioning the first anchor portion adjacent to and in contact with an atrial facing surface, within the leaflet, and adjacent to and in contact with a ventricle facing surface of the leaflet.

[0103] At block 910, the procedure/process 900 involves deploying the tether portion. Deploying the tether portion can comprise moving the second anchor portion toward the ventricular septum while the first anchor portion is anchored to the posterior leaflet. In some embodiments, the tether portion can be released from the delivery catheter, including from a distal portion, such as a distal end, of the delivery catheter. In some embodiments, after the first anchor portion has been secured to the posterior leaflet, the delivery catheter can be withdrawn from the mitral valve toward the ventricular septum. The tether portion can be released from the delivery catheter as the delivery catheter is withdrawn. The tether portion can be coupled to the first anchor portion secured to the posterior leaflet of the mitral valve such that moving the delivery catheter away from the mitral valve can release the tether portion from the delivery catheter.

[0104] At block 912, the procedure/process 900 involves anchoring the second anchor portion to the ventricular septum to couple the posterior leaflet of the mitral valve to the ventricular septum. The second anchor portion can be coupled to the tether portion and the tether portion can be coupled to the first anchor portion such that anchoring the second anchor portion to the ventricular septum can thereby couple the posterior leaflet to the ventricular septum.

[0105] In some embodiments, the second anchor portion can be positioned over a right ventricle facing portion of the ventricular septum. In some embodiments, the delivery catheter can be withdrawn through the ventricular septum after the first anchor portion is secured to the posterior leaflet. For example, the delivery catheter can be withdrawn through the same opening in the ventricular septum used to advance the delivery catheter from the right ventricle into the left ventricle. A corresponding portion of the tether portion can be released as the delivery catheter is withdrawn through the ventricular septum such that the tether portion can extend through the ventricular septum. The first anchor portion can be released from the delivery catheter and positioned over the right ventricle facing portion of the ventricular septum after the delivery catheter is withdrawn into the right ventricle.

[0106] In some embodiments, the second anchor portion can be within the ventricular septum. For example, the second anchor can be released into the ventricular septum as the delivery catheter is withdrawn through the ventricular septum. In some embodiments, the second anchor portion can comprise a portion over a left ventricle facing surface of the ventricular septum, and a portion within the ventricular septum. The second anchor can be released to be positioned over the left ventricle facing surface, into the ventricular septum, and/or over the right ventricle facing surface as the delivery catheter is withdrawn through the ventricular septum from the left ventricle into the right ventricle.

[0107] In some embodiments, the location on the ventricular septum for securing the second anchor portion can be selected to provide a desired annuloplasty effect. For example, the location can be selected such that when the posterior leaflet is coupled to the ventricular septum, the tethering can provide a desired annuloplasty effect to facilitate sufficient coaptation of the mitral valve leaflets.

[0108] Figure 10 is a process flow diagram of an example of an implantation procedure 1000 for deploying a heart valve leaflet tethering system to tether an anterior leaflet of a mitral valve to a left ventricular free wall. In some embodiments, the procedure/process 1000 can be minimally invasive. In some embodiments, the procedure/process 1000 can comprise a transcatheter approach. At block 1002, the procedure/process 1000 involves introducing the heart valve leaflet tethering system into the right atrium. The heart valve leaflet tethering system can be introduced into the right atrium through the superior vena cava, such as using a transjugular or trans-subclavian approach. Alternatively, the heart valve leaflet tethering can be introduced through the inferior vena cava, such as using a transfemoral approach. The heart valve leaflet tethering system can be advanced to the heart carried by a delivery catheter.

[0109] At block 1004, the procedure/process 1000 involves advancing the heart valve leaflet tethering system from the right atrium into the right ventricle via a gap between leaflets of the tricuspid valve. The delivery catheter carrying the heart valve leaflet tethering system can be advanced through the gap. At block 1006, the procedure/process 1000 involves inserting the heart valve leaflet tethering system through the ventricular septum from the right ventricle into a left ventricle.

[0110] At block 1008, the procedure/process 1000 involves anchoring the first anchor portion to the anterior leaflet of the mitral valve. The anterior leaflet can be captured using a leaflet capture component associated with a distal portion, including a distal end, of the delivery catheter. The delivery catheter can be used to contact the anterior leaflet such that the first anchor portion can be deployed to anchor to the leaflet. The first anchor portion can be deployed to be positioned over, under and/or within the anterior leaflet.

[0111] In some embodiments, deploying the first anchor portion can comprise positioning the first anchor portion on an upper surface of the anterior leaflet, such as adjacent to and in contact with an atrial facing surface of the leaflet. The delivery catheter can be positioned beneath the anterior leaflet. A leaflet puncturing component associated with the delivery catheter can be used to puncture the leaflet such that the leaflet puncturing component can be extended through the leaflet from the lower surface through the upper surface of the leaflet. The first anchor portion can then be positioned over the upper surface.

[0112] In some embodiments, deploying the first anchor portion can comprise positioning the first anchor portion over an upper surface of, over a lower surface of, and within the leaflet. For example, deploying the first anchor portion can comprise positioning the first anchor portion adjacent to and in contact with an atrial facing surface, within the leaflet, and adjacent to and in contact with a ventricle facing surface of the leaflet.

[0113] At block 1010, the procedure/process 1000 involves deploying the tether portion. In some embodiments, deploying the tether portion can comprise moving the second anchor portion toward the left ventricular free wall while the first anchor portion is anchored to the anterior leaflet. For example, the tether portion can be released from the delivery catheter, including from a distal portion, such as a distal end, of the delivery catheter. In some embodiments, after the first anchor portion has been secured to the anterior leaflet, the delivery catheter can be withdrawn from the mitral valve toward a location for securing the second anchor portion, such as toward the left ventricular free wall. The tether portion can be released from the delivery catheter as the delivery catheter is withdrawn. The tether portion can be coupled to the first anchor portion secured to the anterior leaflet of the mitral valve such that moving the delivery catheter away from the mitral valve can release the tether portion from the delivery catheter.

[0114] At block 1012, the procedure/process 1000 involves anchoring the second anchor portion to the left ventricular free wall to couple the anterior leaflet of the mitral valve to the left ventricular free wall. The second anchor portion can be coupled to the tether portion and the tether portion can be coupled to the first anchor portion such that anchoring the second anchor portion to the left ventricular free wall can thereby couple the anterior leaflet to the left ventricular free wall. A distal portion, including a distal end, of the delivery catheter can be used to contact the left ventricular free wall such that the second anchor portion can be secured to the left ventricular free wall. The second anchor portion can be secured to a posterolateral portion of the left ventricular free wall. In some embodiments, the second anchor portion can be deployed into a pericardial cavity in the left ventricular free wall or on an exterior surface of the pericardium. In some embodiments, a tissue puncturing component associated with the delivery catheter can be used to pierce layers of the heart wall such that the delivery catheter can be used to deliver the second anchor portion into the pericardial cavity or onto the exterior surface of the pericardium.

[0115] In some embodiments, a process for deploying a heart valve leaflet tethering system can comprise tethering both a posterior leaflet and an anterior leaflet of the mitral valve to a location on a ventricular septum and a left ventricular free wall, respectively. In some embodiments, a process for deploying the heart valve leaflet tethering system can comprise deploying tethering for both the posterior leaflet and the anterior leaflet. For example, the heart valve leaflet tethering system can be introduced into a right atrium. The heart valve leaflet tethering system can be advanced from the right atrium into the right ventricle via a gap between leaflets of a tricuspid valve. In some embodiments, the heart valve leaflet tethering system can comprise a first anchor portion configured to be anchored to the anterior leaflet of the mitral valve, a second anchor portion configured to be anchored to the left ventricular free wall, and a first tether portion coupling the first anchor portion and the second anchor portion. In some embodiments, the heart valve leaflet tethering system can further comprise a third anchor portion configured to be anchored to the posterior leaflet, a fourth anchor portion configured to be anchored to the ventricular septum, and a second tether portion extending therebetween.

[0116] The heart valve leaflet tethering system can be inserted through the ventricular septum. The first anchor portion can be anchored to the anterior leaflet. The first tether portion can then be deployed. For example, deploying the first tether portion can comprise moving the second anchor portion toward the left ventricular free wall while the first anchor portion is secured to the anterior leaflet. The second anchor portion can subsequently be anchored to the left ventricular free wall. Methods for anchoring the first anchor portion to the anterior leaflet, deploying the first tether portion, and/or anchoring the second anchor portion to the left ventricular free wall, can comprise methods as described with reference to Figure 10.

[0117] In some embodiments, after the anterior leaflet of the mitral valve is tethered to the left ventricular free wall, the posterior leaflet of the mitral valve can be tethered to the ventricular septum. For example, the posterior leaflet can be tethered without having to reintroduce a second delivery system. The third anchor portion can be anchored to the posterior leaflet. The second tether portion can then be deployed. For example, deploying the second tether portion can be comprise moving the fourth anchor portion toward the ventricular septum while the third anchor portion is secured to the posterior leaflet. The fourth anchor portion can subsequently be anchored to the ventricular septum. Methods for anchoring the third anchor portion to the posterior leaflet, deploying the second tether portion, and anchoring the fourth anchor portion to the ventricular septum, can comprise methods as described with reference to Figure 9.

[0118] In some embodiments, one or more portions of a process as described herein can be repeated to deploy one or more additional anchor portions and/or tether portions. In some embodiments, a process for tethering one or more leaflets of the mitral valve can include a different sequence. In some embodiments, an anchor can be anchored to the left ventricular free wall or the ventricular septum prior to anchoring an anchor to a mitral valve leaflet. In some embodiments, tethering of the posterior leaflet can be performed prior to tethering of the anterior leaflet.

[0119] Any of the anchor portions and the tether portions described herein can comprise a number of different configurations (e.g., as described with reference to Figures 2- 4 and 7-8). The anchor portions and the tether portions as described herein can comprise any number of different materials, including any number of biocompatible materials. In some embodiments, the anchor portions can comprise polytetrafluoroethylene (PTFE). For example, a first anchor portion and/or a second anchor portion can each comprise a PTFE pledget. In some embodiments, a tether portion can comprise a PTFE tether portion, including a PTFE cord.

Additional Embodiments

[0120] Depending on the embodiment, certain acts, events, or functions of any of the processes or algorithms described herein can be performed in a different sequence, may be added, merged, or left out altogether. Thus, in certain embodiments, not all described acts or events are necessary for the practice of the processes. [0121] Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is intended in its ordinary sense and is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular embodiment. The terms “comprising,” “including,” “having,” and the like are synonymous, are used in their ordinary sense, and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y and Z,” unless specifically stated otherwise, is understood with the context as used in general to convey that an item, term, element, etc. may be either X, Y or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y and at least one of Z to each be present.

[0122] It should be appreciated that in the above description of embodiments, various features are sometimes grouped together in a single embodiment, Figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than are expressly recited in that claim. Moreover, any components, features, or steps illustrated and/or described in a particular embodiment herein can be applied to or used with any other embodiment(s). Further, no component, feature, step, or group of components, features, or steps are necessary or indispensable for each embodiment. Thus, it is intended that the scope of the inventions herein disclosed and claimed below should not be limited by the particular embodiments described above, but should be determined only by a fair reading of the claims that follow.

[0123] It should be understood that certain ordinal terms (e.g., “first” or “second”) may be provided for ease of reference and do not necessarily imply physical characteristics or ordering. Therefore, as used herein, an ordinal term (e.g., “first,” “second,” “third,” etc.) used to modify an element, such as a structure, a component, an operation, etc., does not necessarily indicate priority or order of the element with respect to any other element, but rather may generally distinguish the element from another element having a similar or identical name (but for use of the ordinal term). In addition, as used herein, indefinite articles (“a” and “an”) may indicate “one or more” rather than “one.” Further, an operation performed “based on” a condition or event may also be performed based on one or more other conditions or events not explicitly recited.

[0124] 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 example embodiments belong. It be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

[0125] The spatially relative terms “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” and similar terms, may be used herein for ease of description to describe the relations between one element or component and another element or component as illustrated in the drawings. It be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation, in addition to the orientation depicted in the drawings. For example, in the case where a device shown in the drawing is turned over, the device positioned “below” or “beneath” another device may be placed “above” another device. Accordingly, the illustrative term “below” may include both the lower and upper positions. The device may also be oriented in the other direction, and thus the spatially relative terms may be interpreted differently depending on the orientations.

[0126] Unless otherwise expressly stated, comparative and/or quantitative terms, such as “less,” “more,” “greater,” and the like, are intended to encompass the concepts of equality. For example, “less” can mean not only “less” in the strictest mathematical sense, but also, “less than or equal to.”

Claims

WHAT IS CLAIMED IS:

1. A method of tethering a heart valve leaflet, the method comprising: introducing a heart valve leaflet tethering system into a right atrium, the heart valve leaflet tethering system comprising a first anchor portion, a second anchor portion, and a first tether portion coupling the first anchor portion and the second anchor portion; advancing the heart valve leaflet tethering system from the right atrium into the right ventricle via a gap between leaflets of a tricuspid valve; anchoring the second anchor portion to a ventricular septum; deploying the first tether portion, wherein deploying the first tether portion comprises moving the first anchor portion toward a posterior leaflet of the tricuspid valve while the second anchor portion is anchored to the ventricular septum; and anchoring the first anchor portion to the posterior leaflet of the tricuspid valve to couple the posterior leaflet of the tricuspid valve to the ventricular septum.

2. The method of claim 1, wherein anchoring the second anchor portion comprises anchoring the second anchor portion to a portion of the ventricular septum below the right ventricular outflow tract.

3. The method of claim 1 or 2, wherein anchoring the second anchor portion comprises anchoring the second anchor to a portion of the ventricular septum below the leaflets of the tricuspid valve when the leaflets are in an open position.

4. The method of any of claims 1 to 3, wherein anchoring the second anchor portion comprises positioning at least a portion of the second anchor portion in contact with a left ventricle facing portion of the ventricular septum.

5. The method of any of claims 1 to 4, wherein anchoring the second anchor portion comprises positioning at least a portion of the second anchor portion in contact with a right ventricle facing portion of the ventricular septum.

6. The method of any of claims 1 to 5, wherein anchoring the second anchor portion comprises positioning at least a portion of the second anchor portion within the ventricular septum.

7. The method of any of claims 1 to 6, wherein introducing the heart valve leaflet tethering system comprises introducing a third anchor portion, a fourth anchor portion, and a second tether portion coupling the third anchor portion and the fourth anchor portion, and wherein advancing the heart valve leaflet tethering system from the right atrium into the right ventricle comprises advancing the third anchor portion, the fourth anchor portion, and the second tether portion from the right atrium into the right ventricle via the gap between the leaflets of the tricuspid valve.

8. The method of any of claim 7, further comprising: anchoring the fourth anchor portion to a right ventricular free wall; deploying the second tether portion, wherein deploying the second tether portion comprises moving the third anchor portion toward an anterior leaflet of the tricuspid valve while the fourth anchor portion is anchored to the right ventricular free wall; and anchoring the third anchor portion to the anterior leaflet of the tricuspid valve to couple the anterior leaflet of the tricuspid valve to the right ventricular free wall.

9. The method of claim 8, wherein anchoring the fourth anchor portion comprises anchoring the fourth anchor portion to a posterior portion of the right ventricular free wall.

10. The method of claim 8, wherein anchoring the fourth anchor portion comprises anchoring the fourth anchor portion on a posteromedial portion of the right ventricular free wall.

11. The method of any of claims 8 to 10, wherein anchoring the fourth anchor portion comprises anchoring the fourth anchor portion to a portion of the ventricular septum below leaflets of the tricuspid valve when the leaflets are in an open position.

12. The method of any of claims 1 to 11, wherein introducing the heart valve leaflet tethering system comprises introducing a fifth anchor portion, a sixth anchor portion, and a third tether portion coupling the fifth anchor portion and the sixth anchor portion, and wherein advancing the heart valve leaflet tethering system from the right atrium into the right ventricle comprises advancing the fifth anchor portion, the sixth anchor portion, and the third tether portion from the right atrium into the right ventricle via the gap between the leaflets of the tricuspid valve.

13. The method of claim 12, further comprising: anchoring the sixth anchor portion to a right ventricular free wall; deploying the third tether portion, wherein deploying the third tether portion comprises moving the fifth anchor portion toward a septal leaflet of the tricuspid valve while the sixth anchor portion is anchored to the right ventricular free wall; and anchoring the fifth anchor portion to the septal leaflet of the tricuspid valve to couple the septal leaflet of the tricuspid valve to the right ventricular free wall.

14. The method of claim 13, wherein anchoring the sixth anchor portion comprises anchoring the sixth anchor portion on a posterolateral portion of the right ventricular free wall.

15. The method of claim 13 or 14, wherein anchoring the sixth anchor portion comprises anchoring the sixth anchor portion to the right ventricular free wall below leaflets of the tricuspid valve when the leaflets are in an open position.

16. The method of any of claims 1 to 15, wherein the method is minimally invasive.

17. A heart valve leaflet tethering system comprising: a first anchor portion configured to be secured to a posterior leaflet of a tricuspid valve; a second anchor portion configured to be secured to a ventricular septum; and a first tether portion coupling the first anchor portion and the second anchor portion.

18. The system of claim 17, wherein the second anchor portion is configured to be secured to a portion of the ventricular septum below the right ventricular outflow tract.

19. The system of claim 17 or 18, wherein the second anchor portion is configured to be secured to a portion of the ventricular septum below leaflets of the tricuspid valve in an open position.

20. The system of any of claims 17 to 19, further comprising: a third anchor portion configured to be secured to an anterior leaflet of the tricuspid valve; a fourth anchor portion configured to be secured to a right ventricular free wall; and a second tether portion coupling the third anchor portion and the fourth anchor portion.

21. The system of claim 20, wherein the fourth anchor portion is configured to be secured to the right ventricular free wall below leaflets of the tricuspid valve when the leaflets are in an open position.

22. The system of claim 20 or 21, wherein the fourth anchor portion is configured to be secured to a posterior portion of the right ventricular free wall.

23. The system of claim 20 or 21, wherein the fourth anchor portion is configured to be secured to a posteromedial portion of the right ventricular free wall.

24. The system of any of claims 17 to 23, further comprising: a fifth anchor portion configured to be secured to a septal leaflet of the tricuspid valve; a sixth anchor portion configured to be secured to a right ventricular free wall; and a third tether portion coupling the fifth anchor portion and the sixth anchor portion.

25. The system of claim 24, wherein the sixth anchor portion is configured to be secured to a posterolateral portion of the right ventricular free wall.

26. The system of claim 24 or 25, wherein the sixth anchor portion is configured to be secured to the right ventricular free wall below leaflets of the tricuspid valve when the leaflets are in an open position.

27. A method of tethering a heart valve leaflet, the method comprising: introducing a heart valve leaflet tethering system into a right atrium, the heart valve leaflet tethering system comprising: a first anchor portion, a second anchor portion, and a first tether portion coupling the first anchor portion and the second anchor portion, and a third anchor portion, a fourth anchor portion, and a second tether portion coupling the third anchor portion and the fourth anchor portion; advancing the heart valve leaflet tethering system from the right atrium into the right ventricle via a gap between leaflets of a tricuspid valve; inserting the heart system through a ventricular septum from the right ventricle into the left ventricle; anchoring the first anchor portion to an anterior leaflet of a mitral valve; deploying the first tether portion, wherein deploying the first tether portion comprises moving the second anchor portion toward a left ventricular free wall while the first anchor portion is anchored to the anterior leaflet; anchoring the second anchor portion to the left ventricular free wall to couple the anterior leaflet of the mitral valve to the left ventricular free wall; anchoring the third anchor portion on to a posterior leaflet of the mitral valve; deploying the second tether portion, wherein deploying the second tether portion comprises moving the fourth anchor portion toward the ventricular septum while the third anchor portion is anchored to the posterior leaflet; and anchoring the fourth anchor portion to the ventricular septum to couple the posterior leaflet of the mitral valve to the ventricular septum.

28. The method of claim 27, wherein anchoring the second anchor portion comprises anchoring the second anchor portion to a posterolateral portion of the left ventricular free wall.

29. The method of claim 27 or 28, wherein anchoring the second anchor portion comprises anchoring the second anchor portion to a portion of the left ventricular free wall below leaflets of the mitral valve when the leaflets are in an opening position.

30. The method of any of claims 27 to 29, wherein anchoring the fourth anchor portion comprises anchoring the fourth anchor portion to a portion of the ventricular septum below leaflets of the mitral valve when the leaflets are in an opening position.

31. The method of any of claims 27 to 30, wherein anchoring the fourth anchor comprises anchoring the fourth anchor portion to a portion of the ventricular septum below a left ventricular outflow tract.

32. The method of any of claims 27 to 31, wherein anchoring the fourth anchor portion comprises positioning at least a portion of the fourth anchor portion in contact with a left ventricle facing portion of the ventricular septum.

33. The method of any of claims 27 to 32, wherein anchoring the fourth anchor portion comprises positioning at least a portion of the fourth anchor portion in contact with a right ventricle facing portion of the ventricular septum.

34. The method of any of claims 27 to 33, wherein anchoring the fourth anchor portion comprises positioning at least a portion of the fourth anchor portion within the ventricular septum.

35. The method of any of claims 27 to 34, wherein the method is minimally invasive.

36. A heart valve leaflet tethering system comprising: a first anchor portion configured to be secured to an anterior leaflet of a mitral valve; a second anchor portion configured to be secured to a left ventricular free wall; a first tether portion coupling the first anchor portion and the second anchor portion; a third anchor portion configured to be secured to a posterior leaflet of the mitral valve; a fourth anchor portion configured to be secured to a ventricular septum; and a second tether portion coupling the third anchor portion and the fourth anchor portion.

37. The system of claim 36, wherein the second anchor portion is configured to be secured to a posterolateral portion of the left ventricular free wall.

38. The system of claim 36 or 37, wherein the second anchor portion is configured to be secured to a portion of the left ventricular free wall below leaflets of the mitral valve in an open position.

39. The system of any of claims 36 to 38, wherein the fourth anchor portion is configured to be secured to a portion of the ventricular septum below the left ventricular outflow tract.

40. The system of any of claims 36 to 39, wherein the fourth anchor portion is configured to be secured to a portion of the ventricular septum below leaflets of the mitral valve in an open position.