Improving coaptation of the mitral valve using a tether that runs between a non-elongated support member positioned within the right atrium and a plate positioned against an outer wall of the left ventricle

Abstract

Mitral valve regurgitation can be ameliorated by creating one passageway between the right atrium and the left ventricle at a portion of the tricuspid annulus that is directly above the interventricular septum and creating another passageway through an outer wall of the left ventricle near at least one of the left-ventricular papillary muscles. A non-elongated support member is positioned within the right atrium in contact with a septal portion of the tricuspid annulus, and a support plate is positioned against the outer wall of the left ventricle adjacent to the second passageway. The support plate is pulled towards the non-elongated support member using a tether under tension that runs between the first support plate and the non-elongated support member and passes through both passageways. And the tension in the tether moves the roots of the chordae closer to the mitral valve, which ameliorates the mitral valve regurgitation.

Description

Atty. Docket No. 1463-0015W001IMPROVING COAPTATION OF THE MITRAL VALVE USING A TETHER THAT RUNS BETWEEN A NON-ELONGATED SUPPORT MEMBER POSITIONED WITHIN THE RIGHT ATRIUM AND A PLATE POSITIONED AGAINST AN OUTER WALL OF THE LEFT VENTRICLECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This Application claims the benefit of US Provisional Application 63 / 728,971, filed December 6, 2024, which is incorporated herein by reference in its entirety.FIELD OF THE INVENTION

[0002] The present invention relates to medical devices, in particular devices for repairing insufficiency (leaking) of the Mitral valve.BACKGROUND

[0003] FIG. 1 is an anterior cutaway view of a healthy person’s heart in which the left ventricle LV, the right ventricle RV, the left atrium LA, the right atrium RA, the mitral valve MV, the aortic valve AO, and the tricuspid valve TV are visible. Two chordae tendinea (CT) are attached to the posterior wall of the left ventricle via the papillary muscles (PM). And in the healthy subject depicted in FIG. 1, the chordae do not prevent the leaflets of the mitral valve from closing.

[0004] Ischemic mitral regurgitation (IMR) is mitral regurgitation (MR) caused by chronic changes of left ventricle (LV) structure and function due to ischemic heart disease. FIG. 2 is a cross section of a subject who suffers from IMR, along the same cutaway view depicted in FIG. 1. In this subject, the posterior wall of the left ventricle is dilated, causing the papillary muscles to be shifted more posteriorly with respect to the posterior wall in the healthy heart depicted in FIG. 1. This shift increases the distance between the papillary muscles and the mitral valve leaflets. And because the leaflets of the mitral valve are tethered to the papillary muscles via the chordae, the chordae in this FIG. 2 subject will prevent the leaflets of the mitral valve from fully closing, which results in a gap G. The restricted motion of the valve leaflets can often eliminate coaptation altogether, resulting in severe leaking of the valve.SUMMARY OF THE INVENTION

[0005] One aspect of the invention is directed to a first method of ameliorating mitral regurgitation in a heart within a subject’s body. The heart has a right atrium, a right ventricle,a left ventricle, two left-ventricular papillary muscles, an interventricular septum, a tricuspid valve, and a tricuspid annulus. The first method comprises creating a first passageway between the right atrium and the left ventricle at a septal portion of the tricuspid annulus that is directly above the interventricular septum; creating a second passageway through an outer wall of the left ventricle near at least one of the left-ventricular papillary muscles; positioning a non-elongated support member within the right atrium in contact with a septal portion of the tricuspid annulus; positioning a first support plate against the outer wall of the left ventricle adjacent to the second passageway; and pulling the first support plate towards the non-elongated support member using a first tether under tension. The first tether runs between the first support plate and the non-elongated support member and passes through both the first passageway and the second passageway, and a first end of the first tether is secured to the first support plate.

[0006] In some instances of the first method, the second passageway is located between the two left-ventricular papillary muscles. In some instances of the first method, a second end of the first tether is secured to the non-elongated support member.

[0007] In some instances of the first method, the first support plate has an area of 3- 13 cm2, the non-elongated support member has a length of 3-8 mm, and the first tether has a length of 60-85 mm. In some instances of the first method, the first support plate has an area of 4-16 cm2, the non-elongated support member has a length of 7-12 mm, and the first tether has a length of 65-90 mm. In some instances of the first method, the first support plate has an area of 7-20 cm2, the non-elongated support member has a length of 11-16 mm, and the first tether has a length of 70-95 mm.

[0008] In some instances of the first method, the positioning of the first support plate against the outer wall of the left ventricle comprises positioning a polymer bag outside the outer wall of the left ventricle adjacent to the second passageway; injecting a liquid material into the polymer bag; and allowing the liquid material to solidify. The solidification of the liquid material forms the first support plate.

[0009] Some instances of the first method further comprise creating a third passageway through an outer wall of the right ventricle near at least one right-ventricular papillary muscle; positioning a second support plate against an outer wall of the right ventricle adjacent to the third passageway; and pulling the second support plate towards the non-elongated support member using a second tether under tension. The second tether runsbetween the second support plate and the non-elongated support member, and a first end of the second tether is secured to the second support plate.

[0010] Some instances of the first method further comprise positioning a second support member against an outer wall of the heart at a second location adjacent to an anterior leaflet of the tricuspid valve; and pulling the second support member towards the nonelongated support member using a second tether under tension. The second tether runs between the second support member and the non-elongated support member, and a first end of the second tether is secured to the second support member.

[0011] Some instances of the first method further comprise positioning a second support member against an outer wall of the heart at a second location adjacent to a posterior leaflet of a mitral valve; and pulling the second support member towards the non-elongated support member using a second tether under tension. The second tether runs between the second support member and the non-elongated support member, and a first end of the second tether is secured to the second support member.

[0012] Another aspect of the invention is directed to a second method of ameliorating mitral regurgitation in a heart within a subject’s body. The heart has a right atrium, a left atrium, a right ventricle, a left ventricle, two left-ventricular papillary muscles, an interventricular septum, a tricuspid valve, a mitral valve, and a cardiac skeleton. The second method comprises (a) introducing a first needle into the right atrium, with a first advancing tether affixed to the first needle; (b) creating a first passageway between the right atrium and the left ventricle through the cardiac skeleton at a location that is directly above the interventricular septum and pushing the first needle through the first passageway into the left ventricle; (c) creating a second passageway through an outer wall of the left ventricle at a location between the left-ventricular papillary muscles and pushing the first needle through the second passageway; (d) advancing the first needle in a distal direction until a distal portion of the first advancing tether exits the heart; (e) advancing the first advancing tether in a distal direction until a portion of the first advancing tether exits the subject’s body; (f) securing a first support plate to a first retracting tether that is threaded through both the first passageway and the second passageway; and (g) retracting the first retracting tether and moving the first support plate in a proximal direction between the subject’s ribs until the first support plate reaches an outer surface of the outer wall of the left ventricle adjacent to the second passageway. The second method also comprises positioning a non-elongated support member within the right atrium adjacent to the first passageway. And the second method alsocomprises, after steps (a) through (g), pulling the first retracting tether in a proximal direction while the non-elongated support member is positioned adjacent to the first passageway, and subsequently securing the first retracting tether to the non-elongated support member under tension.

[0013] In some instances of the second method, a single tether serves as both the first advancing tether and the first retracting tether. In some instances of the second method, the first advancing tether and the first retracting tether are distinct from each other, and the first advancing tether is used to thread the first retracting tether through both the first passageway and the second passageway.

[0014] Some instances of the second method further comprise introducing a second needle into the right ventricle, with a second tether affixed to the second needle; creating a third passageway through an outer wall of the right ventricle at a location between the subject’s right-ventricular papillary muscles and pushing the second needle through the third passageway; advancing the second needle in a distal direction until a distal portion of the second tether exits the heart; advancing the second tether in a distal direction until a portion of the second tether exits the subject’s body; advancing a second support plate over the second tether in a proximal direction until the second support plate reaches an outer surface of the outer wall of the right ventricle adjacent to the third passageway; pushing the second support plate against the outer wall of the right ventricle; and securing one portion of the second tether to the second support plate and securing another portion of the second tether to the non-elongated support member so that the second tether is under tension.

[0015] Some instances of the second method further comprise introducing a second needle into the right ventricle, with a second advancing tether affixed to the second needle; creating a third passageway through an outer wall of the right ventricle at a location between the subject’s right-ventricular papillary muscles and pushing the second needle through the third passageway; advancing the second needle in a distal direction until a distal portion of the second advancing tether exits the heart; advancing the second advancing tether in a distal direction until a portion of the second advancing tether exits the subject’s body; securing a second support plate to a second retracting tether that is threaded through the third passageway; retracting the second retracting tether and moving the second support plate in a proximal direction between the subject’s ribs until the second support plate reaches an outer surface of the outer wall of the right ventricle adjacent to the third passageway; and pullingthe second retracting tether in a proximal direction, and subsequently securing the second retracting tether to the non-elongated support member under tension.

[0016] Some instances of the second method further comprise introducing a second needle into the right atrium, with a second tether affixed to the second needle; creating a third passageway through an anterior outer wall of the right atrium at a location above the tricuspid valve and pushing the second needle through the third passageway; advancing the second needle in a distal direction until a distal portion of the second tether exits the heart; advancing the second tether in a distal direction until a portion of the second tether exits the subject’s body; advancing a curved support member over the second tether in a proximal direction until the curved support member reaches an outer surface of the outer wall of the right atrium adjacent to the third passageway, wherein the curved support member has a curvature that fits the outer wall of the right atrium; pushing the curved support member against the outer wall of the right atrium; and securing one portion of the second tether to the curved support member and securing another portion of the second tether to the non-elongated support member so that the second tether is under tension.

[0017] Some instances of the second method further comprise introducing a second needle into the right atrium, with a second advancing tether affixed to the second needle; creating a third passageway through an anterior outer wall of the right atrium at a location above the tricuspid valve and pushing the second needle through the third passageway; advancing the second needle in a distal direction until a distal portion of the second advancing tether exits the heart; advancing the second advancing tether in a distal direction until a portion of the second advancing tether exits the subject’s body; securing a curved support member to a second retracting tether that is threaded through the third passageway, wherein the curved support member has a curvature that fits the outer wall of the right atrium; retracting the second retracting tether and moving the curved support member in a proximal direction between the subject’s ribs until the curved support member reaches an outer surface of the outer wall of the right atrium adjacent to the third passageway; and pulling the second retracting tether in a proximal direction, and subsequently securing the second tether to the non-elongated support member under tension.

[0018] Some instances of the second method further comprise introducing a second needle into the right atrium, with a second tether affixed to the second needle; advancing the second needle through the heart until the second needle enters the left atrium; creating a third passageway through a posterior outer wall of the left atrium at a location above the mitralvalve and pushing the second needle through the third passageway; advancing the second needle in a distal direction until a distal portion of the second tether exits the heart; advancing the second tether in a distal direction until a portion of the second tether exits the subject’s body; advancing a curved support member over the second tether in a proximal direction until the curved support member reaches an outer surface of the outer wall of the left atrium adjacent to the third passageway, wherein the curved support member has a curvature that fits the outer wall of the left atrium; pushing the curved support member against the outer wall of the left atrium; and securing one portion of the second tether to the curved support member and securing another portion of the second tether to the non-elongated support member so that the second tether is under tension.

[0019] Some instances of the second method further comprise introducing a second needle into the right atrium, with a second advancing tether affixed to the second needle; advancing the second needle through the heart until the second needle enters the left atrium; creating a third passageway through a posterior outer wall of the left atrium at a location above the mitral valve and pushing the second needle through the third passageway; advancing the second needle in a distal direction until a distal portion of the second advancing tether exits the heart; advancing the second advancing tether in a distal direction until a portion of the second advancing tether exits the subject’s body; securing a curved support member to a second retracting tether that is threaded through the third passageway, wherein the curved support member has a curvature that fits the outer wall of the left atrium; retracting the second retracting tether and moving the curved support member in a proximal direction between the subject’s ribs until the curved support member reaches an outer surface of the outer wall of the left atrium adjacent to the third passageway; and pulling the second retracting tether in a proximal direction, and subsequently securing the second tether to the non-elongated support member under tension.

[0020] Another aspect of the invention is directed to a first apparatus for ameliorating mitral regurgitation in a heart within a subject’s body. The first apparatus comprises a nonelongated support member, a first support plate, and a first tether. The non-elongated support member is positioned within the subject’s right atrium, adjacent to a first passageway that runs between the subject’s right atrium and the subject’s left ventricle. The first passageway is located directly above the subject’s interventricular septum. The first support plate is positioned against an outer surface of a subject’s left ventricle, adjacent to a second passageway that runs through an outer wall of a subject’s left ventricle. The secondpassageway is located between the subject’s left-ventricular papillary muscles. The first tether runs between the non-elongated support member and the first support plate and passes through both the first passageway and the second passageway. A first portion of the first tether is secured to the non-elongated support member and a second portion of the first tether is secured to the first support plate. And the first tether is under tension so that the first support plate is pulled towards the non-elongated support member.

[0021] In some embodiments of the first apparatus, the first support plate has an area of 3-13 cm2, the non-elongated support member has a length of 3-8 mm, and the first tether has a length of 60-85 mm. In some embodiments of the first apparatus, the first support plate has an area of 4-16 cm2, the non-elongated support member has a length of 7-12 mm, and the first tether has a length of 65-90 mm. In some embodiments of the first apparatus, the first support plate has an area of 7-20 cm2, the non-elongated support member has a length of 11- 16 mm, and the first tether has a length of 70-95 mm.

[0022] Some embodiments of the first apparatus further comprise a second support plate and a second tether. The second support plate is positioned against an outer surface of an outer wall of the subject’s right ventricle, adjacent to a third passageway that runs through the outer wall of the subject’s right ventricle. The second passageway is located between the subject’s right-ventricular papillary muscles. The second tether runs between the nonelongated support member and the second support plate and passes through the third passageway. A first portion of the second tether is secured to the non-elongated support member and a second portion of the second tether is secured to the second support plate. And the second tether is under tension so that the second support plate is pulled towards the nonelongated support member.

[0023] Some embodiments of the first apparatus further comprise a curved support member and a second tether. The curved support member is positioned against an outer surface of an outer wall of the subject’s right atrium, adjacent to a third passageway that runs through the outer wall of the subject’s right atrium. The third passageway is located above the subject’s tricuspid valve. The second tether runs between the non-elongated support member and the curved support member and passes through the third passageway. A first portion of the second tether is secured to the non-elongated support member and a second portion of the second tether is secured to the curved support member. And the second tether is under tension so that the curved support member is pulled towards the non-elongated support member.

[0024] Some embodiments of the first apparatus further comprise a curved support member and a second tether. The curved support member is positioned against an outer surface of an outer wall of the subject’s left atrium, adjacent to a third passageway that runs through the outer wall of the subject’s left atrium. The third passageway is located above the subject’s mitral valve. The second tether runs between the non-elongated support member and the curved support member and passes through the third passageway. A first portion of the second tether is secured to the non-elongated support member and a second portion of the second tether is secured to the curved support member. And the second tether is under tension so that the curved support member is pulled towards the non-elongated support member.

[0025] Another aspect of the invention is directed to a second apparatus for ameliorating mitral regurgitation in a heart within a subject’s body. The heart has two left- ventricular papillary muscles, each of which has a respective center. The second apparatus comprises a support plate, a non-elongated support member, and a tether. The support plate is configured for being positioned against an outer surface of a posterior wall of the heart, at a location that is within 3 cm of a midpoint between the centers of the two left-ventricular papillary muscles. The non-elongated support member is configured for being positioned within the heart’s right atrium, against a surface of the heart’s tricuspid annulus that is adjacent to a posterior wall of the right atrium. And the tether runs between the support plate and the non-elongated support member. The tether is under tension so that the support plate is pulled towards the non-elongated support member.

[0026] In some embodiments of the second apparatus, the support plate is positioned against the outer surface of the posterior wall of the heart, at a location that is within 2 cm of the midpoint between the centers of the two left-ventricular papillary muscles.

[0027] In some embodiments of the second apparatus, the support plate is formed by injecting a first liquid material into a first polymer bag, and allowing the first liquid material to solidify. Optionally, in these embodiments, the non-elongated support member is formed by injecting a second liquid material into a second polymer bag, and allowing the second liquid material to solidify.

[0028] In some embodiments of the second apparatus, the non-elongated support member is configured to be positioned adjacent to a first passageway that runs between the subject’s right atrium and the subject’s left ventricle, the support plate is configured to be positioned adjacent to a second passageway that runs through an outer wall of a subject’s leftventricle, the tether is configured to pass through both the first passageway and the second passageway, and a first portion of the tether is secured to the non-elongated support member and a second portion of the tether is secured to the support plate.

[0029] In some embodiments of the second apparatus, the support plate has an area of 3-13 cm2, the first support member has a length of 3-8 mm, and the tether has a length of 60- 85 mm. In some embodiments of the second apparatus, the support plate has an area of 4-16 cm, the first support member has a length of 7-12 mm, and the tether has a length of 65-90 mm. In some embodiments of the second apparatus, the support plate has an area of 7-20 cm2, the first support member has a length of 11-16 mm, and the tether has a length of 70-95 mm.BRIEF DESCRIPTION OF THE DRAWINGS

[0030] FIG. 1 depicts the heart of a healthy subject.

[0031] FIG. 2 depicts the heart of a subject who suffers from IMR.

[0032] FIG. 3 depicts an example in which a support plate is pulled inward towards a support bar by a tether under tension in order to ameliorate a subject’s IMR.

[0033] FIG. 4 depicts the support bar of the FIG. 3 example, as viewed on the valves plane.

[0034] FIG. 5 depicts how the support bar in the FIG. 3 example can shift to a problematic position in which the support bar interferes with the normal operation of the tricuspid valve.

[0035] FIG. 6 depicts the support bar of the FIG. 5 example, as viewed on the valves plane.

[0036] FIG. 7 depicts the puncturing area on the tricuspid annulus, in the proximity of the mitral annulus, as viewed on the valves plain.

[0037] FIG. 8 depicts a catheter advanced through the vascular system into the RA, and a needle creating a diagonal direct puncture from the RA into the LV.

[0038] FIG. 9 depicts the catheter advanced into the LV and a needle creating a puncture through the ventricle wall between the papillary muscles.

[0039] FIG. 10 depicts a tether that has been pulled out of the patient’s body between the ribs and attached to a first support plate.

[0040] FIG. 11 depicts the tether being pulled back, and the first support plate being inserted into the patient’s body between the ribs and approximated to the outer wall of the LV.

[0041] FIG. 12 depicts a non-elongated support member after it has been advanced over the tether through the vascular system, into the RA adjacent to the puncture that was created between the RA and the LV.

[0042] FIG. 13 depicts the non-elongated support member location after it has been placed in position, as viewed on the valves plane.

[0043] FIG. 14 depicts the first support plate being pulled inward by the tether in direction D towards the non-elongated support member and secured to it under tension, to improve coaptation of the mitral valve.

[0044] FIG. 15 depicts the interconnection between a doubled tether and a support plate in an alternative embodiment.

[0045] FIG. 16 depicts the interconnection between the doubled tether and a nonelongated support member in the FIG. 15 embodiment.

[0046] FIG. 17 depicts the FIG. 15 embodiment when the support plate and the nonelongated support member are interconnected by the doubled tether.

[0047] FIG. 18 depicts adding another support plate to the FIG. 14 embodiment to support the RV wall under tension, to relieve the tethering forces of the tricuspid valve chordae tendinea.

[0048] FIG. 19 depicts the FIG. 18 embodiment as viewed on the valves plane.

[0049] FIG. 20 depicts adding a curved support member to the FIG. 14 embodiment to compress the tricuspid annulus under tension, to reduce or prevent dilatation of that annulus.

[0050] FIG. 21 depicts the FIG. 20 embodiment as viewed on the valves plane.

[0051] FIG. 22 depicts adding a curved support member to the FIG. 14 embodiment to compress the mitral annulus under tension, to reduce or prevent dilatation of the mitral annulus.

[0052] FIG. 23 depicts the FIG. 22 embodiment as viewed on the valves plane.

[0053] FIG. 24 depicts the components of the FIG. 14 embodiment, with labels for indicating corresponding dimensions.

[0054] FIG. 25 depicts the components of the FIG. 18 embodiment, with labels for indicating corresponding dimensions.

[0055] FIG. 26 depicts the components of the FIG. 20 embodiment, with labels for indicating corresponding dimensions.

[0056] FIG. 27 depicts an alternative embodiment in which the support plate is formed by solidifying a liquid precursor into a solid pad, at a stage before the support plate has been connected to the non-elongated support member using a tether.

[0057] Various embodiments are described in detail below with reference to the accompanying drawings, wherein like reference numerals represent like elements.DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0058] FIGS. 3 and 4 depict one of the inventor’s previous attempts to restore the proper coaptation of the mitral valve leaflets in patients suffering from IMR, as described in WO 2024 / 166001. That application describes positioning a support plate against an outer surface of a subject’s heart near the left-ventricular papillary muscles; positioning a support bar against a surface of the tricuspid annulus within the right atrium, directly above the interventricular septum; and using a tether under tension to pull the support plate towards the support bar. The tether pulls the papillary muscles (to which the chordae are attached) toward the right atrium, which reduces the pulling force that the chordae exert on the leaflets of the mitral valve.

[0059] In animal studies, the approach described in WO 2024 / 166001 worked successfully in a number of pigs. But in one pig, the inventor recognized that the support bar had rotated from the position depicted in FIGS. 3-4 to the position depicted in FIGS. 5-6.And the inventor further recognized that the rotated support bar was interfering with the normal operation of the tricuspid valve.

[0060] This application discloses a number of alternative approaches for moving the posterior wall of the left ventricle so that it more closely resembles the healthy person’s heart depicted in FIG. 1. These approaches rely on positioning a support plate against an outer wall of the left ventricle, and using a tether that runs through the left ventricle to pull that support plate diagonally towards the right atrium. But unlike the approach described above in connection with FIGS. 3-6, the embodiments and approaches described below use a nonelongated support member within the right atrium (as opposed to a support bar). And due to the non-elongated nature of the support member in the embodiments and approaches described below, the support member will not interfere with the normal operation of the tricuspid valve if it rotates away from its original orientation.

[0061] FIGS. 7-14 depict a first example of such an approach. It is envisioned (although not required) that the procedures described herein will be implemented by two practitioners. The first practitioner could be, for example an interventional cardiologist who is experienced in accessing a subject’s heart via a catheter that has been introduced through the subject’s vasculature. And notably, the terminologies “distal” and “proximal” used herein are with respect to the frame of reference of the first practitioner (i.e., the interventional cardiologist). The second practitioner could be, for example, a thoracic surgeon who knows how to access a subject’s heart from outside of the heart using surgical techniques, including minimally invasive surgical techniques.

[0062] The first practitioner inserts a catheter 21 through the vascular system into the right atrium (with access obtained, e.g., via the jugular vein or another approach). The catheter 21 is manipulated (e.g., using echo and / or fluoro imaging) to the vicinity of the puncturing area depicted in FIG. 7, and a first needle 22 (e.g., made of metal) is advanced to protrude from the catheter 21. The first needle 22 is manipulated and advanced to create a direct diagonal puncture from the right atrium into the left ventricle as shown in FIG. 8. The puncture is performed at a portion of the tricuspid annulus that is directly above the interventricular septum, between the mitral and the tricuspid annulus as shown in FIG. 7. And this puncture serves as a first passageway between the right atrium and the left ventricle.

[0063] The catheter 21 is then further advanced through the first passageway into the left ventricle, and the first needle 22 is advanced through the catheter 21 to a location in the outer wall of the LV that is near at least one of the left-ventricular papillary muscles, and more preferably between the two left-ventricular papillary muscles. The first needle 22 is then pushed through the outer wall of the LV to puncture it and be exteriorized through that wall, as depicted in FIG. 9. The puncture in the outer wall of the LV serves as a second passageway.

[0064] Notably, because the first needle 22 is introduced from within the heart, it will be relatively easy to line the first needle up between the papillary muscles (e.g., using echo and / or fluoro imaging). This is important because moving the papillary muscles will move the “roots” of the chordae to be closer to the leaflets of the mitral valve, which means that the chordae will either no longer prevent those leaflets from fully coapting, or at the very least improve coaptation of the leaflets.

[0065] The first needle 22 is attached to a thin, strong polymeric tether 23, and because of the very low profile of the puncture hole in the LV wall (along with the fact that immediately after the puncture is made, the puncture is plugged with the tether), no bleeding out of the ventricle will occur in the second puncture site. The first needle 22 in FIGS. 7-9 could be, for example, short (e.g., 3-5 cm) and rigid, longer (e.g., 10-20 cm) and flexible, or another type of needle may be used. The attachment detail of the tether 23 to needle 22 may be implemented using any conventional approach.

[0066] An access is created between the patient's ribs into the mediastinum cavity using regular surgical techniques as often used in lung surgery procedures or using minimal invasive techniques as practiced in many thoracic lung surgeries. The second practitioner captures the first needle 22 (e.g., using forceps or a similar tool), e.g., as it emerges out of the ventricle wall. The first needle 22 and the tether 23 are then advanced (e.g., pulled out) in a distal direction (with respect to the first practitioner) until a first portion of the tether 23 exits the subject’s body e.g., through two adjacent ribs.

[0067] The second practitioner then secures a first support plate 24 to the tether 23 as depicted in FIG. 10 (e.g., using a knot or any other suitable approach).

[0068] The first practitioner then pulls the tether 23 through catheter 21 in the proximal direction to retract the tether 23. Meanwhile, the second practitioner guides the firstsupport plate 24 so that it passes smoothly into the subject’s body through the ribs (e.g., by rotating the first support plate 24 sideways so that it will fit between the ribs through a minimal invasive cut into the mediastinum cavity). This process continues until the first support plate 24 reaches the outer surface of the outer wall of the left ventricle adjacent to the second passageway (which is in the vicinity of the left-ventricular papillary muscles), as depicted in FIG. 11. The approximation of the first support plate 24 to the second passageway can be aided by the second practitioner’s manual manipulation.

[0069] In some embodiments, the surface of the first support plate 24 that faces the outer wall of the left ventricle is completely flat. But in alternative embodiments, that surface can be either convex or concave curved to some extent.

[0070] A non-elongated support member 25 is then advanced over the tether 23 via the vascular system until it contacts the tissue at the site of the puncture between the right atrium and the left ventricle (as depicted in FIG. 12 and FIG. 13). In the illustrated embodiments, the non-elongated support member 25 is round. But in alternative embodiments, the non-elongated support member 25 can have a different non-elongated shape (e.g., square, hexagonal, octagonal, etc.). The shape of the non-elongated support member 25 should be such that the non-elongated support member can be delivered via a catheter.

[0071] The first support plate 24 and the non-elongated support member 25 can be made from a suitable molded or machined biocompatible plastic (including but not limited to PEEK, PC, PSU, and / or ABS). And the tether 23 can be a suitable braided plastic with a high tensile strength (including but not limited to nylon and / or ultra-high-molecular-weight polyethylene).

[0072] The location of the non-elongated support member 45 just before it has reached this position is depicted in FIG. 12 (a cross section of the heart chambers' view). And the location of the non-elongated support member 45 after it has reached its final position is depicted in FIG. 13 (a cross section of the heart valves plane). More specifically, in its final position, the non-elongated support member 25 should be positioned within the right atrium in contact with a septal portion of the tricuspid annulus, and adjacent to the first passageway. In some embodiments, the surface of the non-elongated support member 25 that faces thetricuspid annulus is completely flat. But in alternative embodiments, that surface can be either convex or concave curved to some extent.

[0073] In some preferred embodiments, the non-elongated support member 25 has a through-hole 25T, and the tether 23 is threaded through this through hole 25T before the nonelongated support member 25 is delivered into the right atrium by advancing it over the tether 23. In the illustrated embodiment, the through hole 25T is in the center of the non-elongated support member 25. But in alternative embodiments, the through hole 25T could be offset from the center e.g., by up to 25% of the non-elongated support member’s length.

[0074] A pull force in the proximal direction is then applied on the tether 23 while maintaining the position of the non-elongated support member 25 in contact with the tissue. The pull force may be applied by pulling a portion of the tether 23 that remains outside of the subject’s body in a proximal direction. And the position of the non-elongated support member 25 may be maintained by using a catheter-based tool to push the non-elongated support member 25 against the tricuspid annulus. This creates tension in the tether 23, which acts to pull the first support plate 24 towards the non-elongated support member 25, as depicted by the arrow D in FIG. 14 (which depicts the non-elongated support member 25 in its final position, within the right atrium in contact with a septal portion of the tricuspid annulus, and adjacent to the first passageway).

[0075] The anatomical location at the contact area of the non-elongated support member 25 is a central part of the fibrotic skeleton of the heart, which is much more rigid relative to the heart muscle tissue at the anatomical location of the first support plate 24. Therefore, the tension on tether 23 acts to apply traction in direction D to the segment of the relatively soft ventricle wall which is the base of the papillary muscles as shown in FIG. 14. The directional traction of the papillary muscles acts to relieve tension from the mitral valve chordae tendinea and allow better coaptation of the leaflets and thereby improve the valve functioning.

[0076] When the desired improvement in the valve functioning has been achieved, tether 23 is secured to the non-elongated support member 25 e.g., using a knot or a clip (not shown) to maintain tension between the first support plate 24 and the non-elongated support member 25 and preserve the improved hemodynamics. In some embodiments, the procedure is nearly complete after the knot has been tied or the clip has been installed. In theseembodiments, the portion of the tether 23 that is proximal with respect to the knot or clip is cut off and discarded, at which point the procedure is complete. In other embodiments, additional components can be installed after the knot / clip has been tied / installed. Examples of these embodiments are described below in connection with FIGS. 18-23. In these embodiments, the portion of the tether 23 that is proximal with respect to the knot / clip is not cut off. Instead, that portion is used to connect to the additional components, as described below in connection with FIGS. 18-23.

[0077] The FIG. 14 embodiment can be particularly advantageous because the geometry is such that the “roots” of the chordae will be urged in a direction that can effectively ameliorate the tension that the chordae exert on the leaflets of the mitral valve.

[0078] The non-elongated support member 25 described above in connection with FIGS. 12-15 differs from the support bar described in WO 2024 / 166001 in two significant ways. First, because the non-elongated support member 25 is not elongated, it will not interfere with the operation of the tricuspid valve if the non-elongated support member 25 rotates after it is installed in the subject’s heart. This constitutes a significant improvement with respect to the approach described in WO 2024 / 166001 (in which the rotation of the support bar will interfere with the operation of the tricuspid valve, as described above in connection with FIGS. 5-6).

[0079] The second difference between the non-elongated support member 25 described above in connection with FIGS. 12-15 and the support bar described in WO 2024 / 166001 is that the latter has a larger surface area, and will therefore distribute its pressing force against a larger portion of the septal portion of the tricuspid annulus. In this respect, the support bar is superior to the non-elongated support member 25 (because the reduction in force per unit area associated with the support bar will expose the septal portion of the tricuspid annulus to less mechanical stress). But because the danger of interfering with the normal operation of the tricuspid valve exceeds the danger of applying additional mechanical stress on the tricuspid annulus, the inventor believes that the non-elongated support member 25 described above in connection with FIGS. 12-15 is superior to the support bar described in WO 2024 / 166001.

[0080] Note that the embodiments described above in connection with FIGS. 7-14 rely on a single tether 23 that is (a) initially advanced from the right atrium into the leftventricle, (b) subsequently advanced from the left ventricle until it exits the subject’s heart, (c) subsequently advanced until it exits the subject’s body, and (d) subsequently retracted until the first support plate reaches an outer surface of the outer wall of the left ventricle adjacent to the second passageway.

[0081] But in an alternative set of embodiments, distinct tethers can be used for the advancing function and the retracting function. These embodiments begin in the same manner described above in connection with FIGS. 7-10, up to and including the point where a first portion of the tether 23 exits the subject’s body e.g., through two adjacent ribs. But after this initial portion of the procedure, instead of securing the first support plate 24 to the original tether 23 as depicted in FIG. 10, a second doubled tether 43 is looped through and back two through-holes in a support plate 34, as depicted in FIG. 15.

[0082] The proximal end of the doubled tether 43 is affixed to the distal end of the original tether 23, and the original tether 23 is used to pull the proximal end of the doubled tether 43 in a proximal direction all the way out of the subject’s body via the original catheter 21 that was used to introduce the needle 22 (as described above in connection with FIG. 8). More specifically, the proximal end of the doubled tether will first be pulled in a proximal direction into the subject’s left ventricle (via the second passageway), subsequently be pulled in a proximal direction into the subject’s right atrium (via the first passageway), and subsequently be pulled in a proximal direction out of the subject’s body via the jugular access to the right atrium.

[0083] After the proximal end of the doubled tether 43 has exited the subject’s body, the first practitioner threads each of the two ends of the doubled tether 43 through a respective hole in a non-elongated support member 35, as depicted in FIG. 16. The first practitioner then advances the non-elongated support member 35 in a distal direction over the doubled tether 43 via the subject’s vasculature until the non-elongated support member 35 enters the right atrium and contacts the tissue at the site of the puncture between the right atrium and the left ventricle. Meanwhile, the distal end of the doubled tether 43 (which is looped through the two through-holes in the support plate 34) as well as the support plate 34 itself both remain outside the subject’s body.

[0084] In the illustrated embodiments, the non-elongated support member 35 is round. But in alternative embodiments, the non-elongated support member 35 can have adifferent shape (e.g., square, hexagonal, octagonal, etc.). The shape of the non-elongated support member 35 should be such that the non-elongated support member can be delivered via a catheter. The location of the non-elongated support member 35 after it has been placed in position is similar to the position of the non-elongated support member 25 described above in connection with FIGS. 12 and 13. More specifically, the non-elongated support member 35 is positioned within the right atrium in contact with a septal portion of the tricuspid annulus, and adjacent to the first passageway. In some embodiments, the surface of the non-elongated support member 35 that faces the tricuspid annulus is completely flat. But in alternative embodiments, that surface can be either convex or concave curved to some extent.

[0085] The first practitioner then pulls the doubled tether 43 through catheter 21 in the proximal direction to retract the doubled tether 43 and pull the support plate 34 in a proximal direction. Meanwhile, the second practitioner guides the support plate 34 so that it passes smoothly into the subject’s body through the ribs (e.g., by rotating the support plate 34 sideways so that it will fit between the ribs through a minimal invasive cut into the mediastinum cavity). This process continues until the support plate 34 reaches the outer surface of the outer wall of the left ventricle adjacent to the second passageway (which is in the vicinity of the left-ventricular papillary muscles), which is similar to the position of the support plate 24 depicted in FIG. 11. The approximation of the support plate 34 to the second passageway can be aided by the second practitioner’s manual manipulation.

[0086] In some embodiments, the surface of the support plate 34 that faces the outer wall of the left ventricle is completely flat. But in alternative embodiments, that surface can be either convex or concave curved to some extent.

[0087] A pull force in the proximal direction is then applied on the doubled tether 43 while maintaining the position of non-elongated support member 35 in contact with the tissue. The pull force may be applied by pulling a portion of the doubled tether 43 that remains outside of the subject’s body in a proximal direction. And the position of the nonelongated support member 35 may be maintained by using a catheter-based tool to push the non-elongated support member 35 against the tricuspid annulus. This creates tension in the doubled tether 43, which acts to pull the support plate 34 towards the non-elongated support member 35.

[0088] The anatomical location at the contact area of non-elongated support member 35 is (as described above for the non-elongated support member 25 in connection with FIGS. 12-14) much more rigid relative to the heart muscle tissue at the anatomical location of the support plate 34. Therefore, the tension on the doubled tether 43 acts to apply traction to the segment of the relatively soft ventricle wall which is the base of the papillary muscles (similar to the situation described above in connection with FIG. 14). The directional traction of the papillary muscles acts to relieve tension from the mitral valve chordae tendinea and allow better coaptation of the leaflets and thereby improve the valve functioning.

[0089] When the desired improvement in the valve functioning has been achieved, the doubled tether 43 is secured to the non-elongated support member 35 as depicted in FIG. 17 to maintain tension between the support plate 34 and the non-elongated support member 35 and preserve the improved hemodynamics. This can be accomplished e.g., using a knot or a clip (not shown). In some embodiments, the procedure is nearly complete after the knot has been tied or the clip has been installed. In these embodiments, the portion of the doubled tether 43 that is proximal with respect to the knot or clip is cut off and discarded, at which point the procedure is complete. In other embodiments, additional components can be installed after the knot / clip has been tied / installed. In these embodiments, the portion of the doubled tether 43 that is proximal with respect to the knot / clip is not cut off. Instead, that portion is used to connect to the additional components, in a manner that is analogous to the embodiments described below in connection with FIGS. 18-23.

[0090] Notably, in the embodiments described above in connection with FIGS. 15-17, the original tether 23 (which is used for advancing) and the doubled tether 43 (which is used for retracting) are distinct from each other, and the original tether 23 is used to thread the doubled tether 43 through both the first passageway and the second passageway.

[0091] FIGS. 18 and 19 depict two views of another embodiment in which the secured position of the non-elongated support member 25 described above serves as an Archimedean point to ameliorate functioning of the tricuspid valve by relieving tension forces on the chordae tendinea of that valve. This embodiment begins as described above in connection with FIGS. 7-14, but includes the additional steps described below.

[0092] After the position of the non-elongated support member 25 has been secured, a second needle is connected to a proximal extension of the tether 23 and advanced into theright ventricle, and a third puncture is created in the anterior wall of the right ventricle at a location between the subject’s right-ventricular papillary muscles. This can be done by pushing the second needle through an outer wall of the right ventricle at a location between the subject’s right-ventricular papillary muscles to create a third passageway (similar to how the second passageway was created, as described above). An extension of the tether 23 is exteriorized through the outer wall of the right ventricle, and a second support plate 26 is advanced over the tether in a proximal direction and though the ribs until the second support plate reaches an outer surface of the outer wall of the right ventricle adjacent to the third passageway. The second support plate is then pushed against the outer wall of the right ventricle, which will move the “roots” of the right-ventricular chordae to a position that will improve coaptation of the tricuspid valve leaflets. The tether is then fastened to the second support plate 26 e.g., using a suitable clip or knot while the tether is under tension. Note that in this example, a single tether 23 is depicted. The portion of this tether that runs between the non-elongated support member 25 and the first support plate 24 is referred to herein as the first tether, and the portion of the tether that runs between the non-elongated support member 25 and the second support plate 26 is referred to herein as the second tether. But in alternative embodiments, two separate tethers may be used instead of a single tether.

[0093] In a variation of the FIG. 18 / 19 embodiment, two separate tethers are used, with one tether running between the non-elongated support member 25 and the first support plate 24, and a separate second tether that runs between the non-elongated support member 25 and the second support plate 26. This variation begins as described above in connection with FIGS. 7-14, but includes the additional steps described below. A second needle is introduced into the right ventricle, with the second tether affixed to the second needle. The second needle is pushed through an anterior wall of the right ventricle at a location between the subject’s right-ventricular papillary muscles to create a third passageway (similar to how the second passageway was created, as described above. The second needle is advanced in a distal direction until a distal portion of the second tether exits the heart. The second tether is advanced in a distal direction until a portion of the second tether exits the subject’s body. The second support plate 26 is secured to the second tether e.g., in a manner similar to how the first support plate 24 was secured to the first tether 23. The second tether is then retracted and the second support plate 26 is moved in a proximal direction between the subject’s ribs until it reaches an outer surface of the outer wall of the right ventricle adjacent to the third passageway. (This is similar to the way the first support plate 24 was moved in a proximaldirection until it reached the outer wall of the left ventricle, as described above.) The second tether is then pulled in a proximal direction to create tension, and subsequently the second tether is secured to the non-elongated support member 25 under tension (e.g., using a knot or clip that is inserted via a suitable catheter).

[0094] Note that both of the variations of the FIG. 18 / 19 embodiment described above can be combined with the doubled tether embodiment described above in connection with FIGS. 15-17. When this combination is implemented, a doubled tether can be used to hold the second support plate against the outer surface of the outer wall of the right ventricle adjacent to the third passageway (instead of the single tether described in the two previous paragraphs). This can be accomplished e.g., using techniques similar to those described above in connection with FIGS. 15-17.

[0095] FIGS. 20 AND 21 depict two views of another embodiment in which the secured position of the non-elongated support member 25 described above serves as an Archimedean point to deform the tricuspid valve annulus to improve the coaptation of that valve. This embodiment begins as described above in connection with FIGS. 7-14, but includes the additional steps described below.

[0096] After the position of the non-elongated support member 25 has been secured, a second needle is connected to a proximal extension of the tether 23 and advanced into the right atrium, and a third puncture is created through an anterior outer wall of the right atrium at a location above the tricuspid valve to create a third passageway. An extension of the tether 23 is exteriorized through the outer wall of the right atrium, and a curved support member 27 is advanced over the tether in a proximal direction and though the ribs until the curved support member reaches an outer surface of the outer wall of the right atrium adjacent to the third passageway. The curved support member 27 has a curvature that fits the outer wall of the right atrium. The curved support member 27 is then pushed against the outer wall of the right atrium, which will deform the tricuspid valve annulus and improve coaptation of the tricuspid valve leaflets. The tether is then fastened to the curved support member 27 e.g., using a suitable clip or knot at a position where the tether is under tension. Note that in this example, a single tether 23 is depicted. The portion of this tether that runs between the nonelongated support member 25 and the first support plate 24 is referred to herein as the first tether, and the portion of the tether that runs between the non-elongated support member 25and the second curved support member 27 is referred to herein as the second tether. But in alternative embodiments, two separate tethers may be used instead of a single tether.

[0097] In a variation of the FIG. 20 / 21 embodiment, two separate tethers are used, with one tether running between the non-elongated support member 25 and the first support plate 24, and a separate second tether that runs between the non-elongated support member 25 and the curved support member 27. This variation begins as described above in connection with FIGS. 7-14, but includes the additional steps described below. A second needle is introduced into the right atrium, with a second tether affixed to the second needle. The second needle is pushed through an anterior outer wall of the right atrium at a location above the tricuspid valve to create a third passageway. The second needle is advanced in a distal direction until a distal portion of the second tether exits the heart. The second tether is then advanced in a distal direction until a portion of the second tether exits the subject’s body. The curved support member 27 is secured to the second tether. The curved support member 27 has a curvature that fits the outer wall of the right atrium. The second tether is then retracted and the curved support member 27 is moved in a proximal direction between the subject’s ribs until it reaches an outer surface of the outer wall of the right atrium adjacent to the third passageway. The second tether is then pulled in a proximal direction to create tension, and subsequently the second tether is secured to the non-elongated support member 25 under tension.

[0098] Note that both of the variations of the FIG. 20 / 21 embodiment described above can be combined with the doubled tether embodiment described above in connection with FIGS. 15-17. When this combination is implemented, a doubled tether can be used to hold the curved support member against the outer surface of the outer wall of the right atrium adjacent to the third passageway (instead of the single tether described in the two previous paragraphs). This can be accomplished e.g., using techniques similar to those described above in connection with FIGS. 15-17.

[0099] FIGS. 22 and 23 depict two views of another embodiment in which the secured position of the non-elongated support member 25 described above serves as an Archimedean point to deform the mitral valve annulus to improve the coaptation of that valve. This embodiment begins as described above in connection with FIGS. 7-14, but includes the additional steps described below.

[0100] After the position of the non-elongated support member 25 has been secured, a second needle is connected to a proximal extension of the tether 23 and introduced into the right atrium and advanced through the heart until it enters the left atrium. The second needle is then used to create a third puncture through a posterior outer wall of the left atrium at a location above the mitral valve to create a third passageway. An extension of the tether 23 is exteriorized through the outer wall of the left atrium, and a curved support member 28 is advanced over the tether in a proximal direction and though the ribs until the curved support member reaches an outer surface of the outer wall of the left atrium adjacent to the third passageway. The curved support member 28 has a curvature that fits the outer wall of the left atrium. The curved support member 28 is then pushed against the outer wall of the left atrium, which will deform the mitral valve annulus and improve coaptation of the mitral valve leaflets. The tether is then fastened to the curved support member 28 e.g., using a suitable clip or knot while the tether is under tension. Note that in this example, a single tether 23 is depicted. The portion of this tether that runs between the non-elongated support member 25 and the first support plate 24 is referred to herein as the first tether, and the portion of the tether that runs between the non-elongated support member 25 and the second curved support member 28 is referred to herein as the second tether. But in alternative embodiments, two separate tethers may be used instead of a single tether.

[0101] In a variation of the FIG. 22 / 23 embodiment, two separate tethers are used, with one tether running between the non-elongated support member 25 and the first support plate 24, and a separate second tether that runs between the non-elongated support member 25 and the curved support member 28. This variation begins as described above in connection with FIGS. 7-14, but includes the additional steps described below. A second needle is introduced into the right atrium, with a second tether affixed to the second needle. The second needle is advanced through the heart until it enters the left atrium and is then pushed through a posterior outer wall of the left atrium at a location above the mitral valve to create a third passageway. The second needle is advanced in a distal direction until a distal portion of the second tether exits the heart. The second tether is then advanced in a distal direction until a portion of the second tether exits the subject’s body. The curved support member 28 is secured to the second tether. The curved support member 28 has a curvature that fits the outer wall of the left atrium. The second tether is then retracted and the curved support member 28 is moved in a proximal direction between the subject’s ribs until it reaches an outer surface of the outer wall of the left atrium adjacent to the third passageway. The second tether is thenpulled in a proximal direction to create tension, and subsequently the second tether is secured to the non-elongated support member 25 under tension.

[0102] Note that both of the variations of the FIG. 22 / 23 embodiment described above can be combined with the doubled tether embodiment described above in connection with FIGS. 15-17. When this combination is implemented, a doubled tether can be used to hold the curved support member against the outer surface of the outer wall of the left atrium adjacent to the third passageway (instead of the single tether described in the two previous paragraphs). This can be accomplished e.g., using techniques similar to those described above in connection with FIGS. 15-17.

[0103] FIG. 24 depicts the components of the FIG. 14 embodiment, with labels for indicating corresponding dimensions. The values for the various dimensions that are suitable for small, medium, and large sized adults are provided below in table 1. All dimensions in table 1 are in millimeters.TABLE 1

[0104] FIG. 25 depicts the components of the FIG. 18 embodiment, with labels for indicating corresponding dimensions. The values for the various dimensions that are suitable for small, medium, and large sized adults are provided above in table 1.

[0105] FIG. 26 depicts the components of the FIG. 20 embodiment, with labels for indicating corresponding dimensions. The values for the various dimensions that are suitable for small, medium, and large sized adults are provided above in table 1.

[0106] FIG. 27 depicts an alternative embodiment for positioning a support plate against an outer surface of a posterior wall of the heart near the two left-ventricular papillarymuscles, and positioning a non-elongated support member within the heart’s right atrium, against a surface of the heart’s tricuspid annulus that is adjacent to a posterior wall of the right atrium, with a tether under tension connecting the support plate and the non-elongated support member.

[0107] This embodiment begins as described above in connection with FIGS. 7-9, up to the point where the catheter is advanced through the first passageway into the left ventricle. A needle (similar to the needle 22 described above in connection with FIGS. 7-9) is advanced through the catheter 51 to a location in the outer wall of the LV that is near at least one of the left-ventricular papillary muscles, and more preferably between the two left- ventricular papillary muscles. The needle is then pushed through the outer wall of the LV to puncture the outer wall of the LV (again similar to the needle 22 described above in connection with FIGS. 7-9). The puncture in the outer wall of the LV serves as a second passageway.

[0108] A second, smaller catheter 52 incorporating a thin wall bag at the distal end is tracked through catheter 51 and over the needle through the second passageway, and the needle is pulled back and removed from the patient’s body. The thin wall bag is then expanded and spread radially into a flat mushroom shape outside the ventricle wall as depicted in FIG. 27. The thin wall bag is then filled with solidifying polymer, which upon solidification will become a rigid structural plate 54 that is attached to a tether. Details on how to form a rigid structural plate at this location with an attached tether are described in US patent 10,299,928, which is incorporated herein by reference in its entirety.

[0109] After the rigid structural plate 54 has been formed and fully cured, a nonelongated support member is advanced over the tether that is attached to the rigid structural plate 54. The installation of this non-elongated support member (and the nature of the nonelongated support member itself) can be similar to the non-elongated support member 25 described above in connection with FIGS. 12-14.

[0110] Note that in the embodiments described above, the various passageways (e.g., the first passageway, the second passageway, etc.) are created using a conventional needle that is pushed through a respective portion of tissue in the subject’s body. As a result, the creation of the various passageways and the pushing of the needle through those passageways occur simultaneously. But in alternative embodiments, any of these passageways could becreated first (e.g., using an RF needle), and a needle could then be pushed through the passage.

[0111] Finally, it is important to note that the usage of the identifiers (a), (b), (c), (d), etc. in the claims below does not imply a particular sequence in time for the corresponding steps. For while it is certainly possible that step (a) will precede step (b) in time, different sequencings of those steps are also possible, except in cases where a particular sequencing is inconsistent with the internal language of the various steps or with other language in the claims. For example, a step labeled (b) could precede a step labeled (a) in time. It is also possible for two or more steps to occur simultaneously or to overlap to an extent, except in cases where simultaneity or overlapping would be inconsistent with the internal language of the various steps or with other language in the claims.

[0112] While the present invention has been disclosed with reference to certain embodiments, numerous modifications, alterations, and changes to the described embodiments are possible without departing from the sphere and scope of the present invention, as defined in the appended claims. Accordingly, it is intended that the present invention not be limited to the described embodiments, but that it has the full scope defined by the language of the following claims, and equivalents thereof.

Claims

WHAT IS CLAIMED IS:

1. A method of ameliorating mitral regurgitation in a heart within a subject’s body, the heart having a right atrium, a right ventricle, a left ventricle, two left-ventricular papillary muscles, an interventricular septum, a tricuspid valve, and a tricuspid annulus, the method comprising: creating a first passageway between the right atrium and the left ventricle at a septal portion of the tricuspid annulus that is directly above the interventricular septum; creating a second passageway through an outer wall of the left ventricle near at least one of the left-ventricular papillary muscles; positioning a non-elongated support member within the right atrium in contact with a septal portion of the tricuspid annulus; positioning a first support plate against the outer wall of the left ventricle adjacent to the second passageway; and pulling the first support plate towards the non-elongated support member using a first tether under tension, wherein the first tether runs between the first support plate and the nonelongated support member and passes through both the first passageway and the second passageway, and wherein a first end of the first tether is secured to the first support plate.

2. The method of claim 1, wherein the second passageway is located between the two left-ventricular papillary muscles.

3. The method of claim 1, wherein a second end of the first tether is secured to the nonelongated support member.

4. The method of claim 1, wherein the first support plate has an area of 3-13 cm2, wherein the non-elongated support member has a length of 3-8 mm, and wherein the first tether has a length of 60-85 mm.

5. The method of claim 1, wherein the first support plate has an area of 4-16 cm2, wherein the non-elongated support member has a length of 7-12 mm, and wherein the first tether has a length of 65-90 mm.

6. The method of claim 1, wherein the first support plate has an area of 7-20 cm2, wherein the non-elongated support member has a length of 11-16 mm, and wherein the first tether has a length of 70-95 mm.

7. The method of claim 1, wherein the positioning of the first support plate against the outer wall of the left ventricle comprises: positioning a polymer bag outside the outer wall of the left ventricle adjacent to the second passageway; injecting a liquid material into the polymer bag; and allowing the liquid material to solidify, wherein the solidification of the liquid material forms the first support plate.

8. The method of claim 1, further comprising: creating a third passageway through an outer wall of the right ventricle near at least one right- ventricular papillary muscle; positioning a second support plate against an outer wall of the right ventricle adjacent to the third passageway; and pulling the second support plate towards the non-elongated support member using a second tether under tension, wherein the second tether runs between the second support plate and the non-elongated support member, and wherein a first end of the second tether is secured to the second support plate.

9. The method of claim 1, further comprising: positioning a second support member against an outer wall of the heart at a second location adjacent to an anterior leaflet of the tricuspid valve; and pulling the second support member towards the non-elongated support member using a second tether under tension, wherein the second tether runs between the second support member and the non-elongated support member, and wherein a first end of the second tether is secured to the second support member.

10. The method of claim 1, further comprising: positioning a second support member against an outer wall of the heart at a second location adjacent to a posterior leaflet of a mitral valve; andpulling the second support member towards the non-elongated support member using a second tether under tension, wherein the second tether runs between the second support member and the non-elongated support member, and wherein a first end of the second tether is secured to the second support member.

11. A method of ameliorating mitral regurgitation in a heart within a subject’s body, the heart having a right atrium, a left atrium, a right ventricle, a left ventricle, two left- ventricular papillary muscles, an interventricular septum, a tricuspid valve, a mitral valve, and a cardiac skeleton, the method comprising:(a) introducing a first needle into the right atrium, with a first advancing tether affixed to the first needle;(b) creating a first passageway between the right atrium and the left ventricle through the cardiac skeleton at a location that is directly above the interventricular septum and pushing the first needle through the first passageway into the left ventricle;(c) creating a second passageway through an outer wall of the left ventricle at a location between the left-ventricular papillary muscles and pushing the first needle through the second passageway;(d) advancing the first needle in a distal direction until a distal portion of the first advancing tether exits the heart;(e) advancing the first advancing tether in a distal direction until a portion of the first advancing tether exits the subject’s body;(f) securing a first support plate to a first retracting tether that is threaded through both the first passageway and the second passageway;(g) retracting the first retracting tether and moving the first support plate in a proximal direction between the subject’s ribs until the first support plate reaches an outer surface of the outer wall of the left ventricle adjacent to the second passageway; positioning a non-elongated support member within the right atrium adjacent to the first passageway; and after steps (a) through (g), pulling the first retracting tether in a proximal direction while the non-elongated support member is positioned adjacent to the first passageway, and subsequently securing the first retracting tether to the non-elongated support member under tension.

12. The method of claim 11, wherein a single tether serves as both the first advancing tether and the first retracting tether.

13. The method of claim 11, wherein the first advancing tether and the first retracting tether are distinct from each other, and wherein the first advancing tether is used to thread the first retracting tether through both the first passageway and the second passageway.

14. The method of claim 11, further comprising: introducing a second needle into the right ventricle, with a second tether affixed to the second needle; creating a third passageway through an outer wall of the right ventricle at a location between the subject’s right-ventricular papillary muscles and pushing the second needle through the third passageway; advancing the second needle in a distal direction until a distal portion of the second tether exits the heart; advancing the second tether in a distal direction until a portion of the second tether exits the subject’s body; advancing a second support plate over the second tether in a proximal direction until the second support plate reaches an outer surface of the outer wall of the right ventricle adjacent to the third passageway; pushing the second support plate against the outer wall of the right ventricle; and securing one portion of the second tether to the second support plate and securing another portion of the second tether to the non-elongated support member so that the second tether is under tension.

15. The method of claim 11, further comprising: introducing a second needle into the right ventricle, with a second advancing tether affixed to the second needle; creating a third passageway through an outer wall of the right ventricle at a location between the subject’s right-ventricular papillary muscles and pushing the second needle through the third passageway; advancing the second needle in a distal direction until a distal portion of the second advancing tether exits the heart;advancing the second advancing tether in a distal direction until a portion of the second advancing tether exits the subject’s body; securing a second support plate to a second retracting tether that is threaded through the third passageway; retracting the second retracting tether and moving the second support plate in a proximal direction between the subject’s ribs until the second support plate reaches an outer surface of the outer wall of the right ventricle adjacent to the third passageway; and pulling the second retracting tether in a proximal direction, and subsequently securing the second retracting tether to the non-elongated support member under tension.

16. The method of claim 11, further comprising: introducing a second needle into the right atrium, with a second tether affixed to the second needle; creating a third passageway through an anterior outer wall of the right atrium at a location above the tricuspid valve and pushing the second needle through the third passageway; advancing the second needle in a distal direction until a distal portion of the second tether exits the heart; advancing the second tether in a distal direction until a portion of the second tether exits the subject’s body; advancing a curved support member over the second tether in a proximal direction until the curved support member reaches an outer surface of the outer wall of the right atrium adjacent to the third passageway, wherein the curved support member has a curvature that fits the outer wall of the right atrium; pushing the curved support member against the outer wall of the right atrium; and securing one portion of the second tether to the curved support member and securing another portion of the second tether to the non-elongated support member so that the second tether is under tension.

17. The method of claim 11, further comprising: introducing a second needle into the right atrium, with a second advancing tether affixed to the second needle;creating a third passageway through an anterior outer wall of the right atrium at a location above the tricuspid valve and pushing the second needle through the third passageway; advancing the second needle in a distal direction until a distal portion of the second advancing tether exits the heart; advancing the second advancing tether in a distal direction until a portion of the second advancing tether exits the subject’s body; securing a curved support member to a second retracting tether that is threaded through the third passageway, wherein the curved support member has a curvature that fits the outer wall of the right atrium; retracting the second retracting tether and moving the curved support member in a proximal direction between the subject’s ribs until the curved support member reaches an outer surface of the outer wall of the right atrium adjacent to the third passageway; and pulling the second retracting tether in a proximal direction, and subsequently securing the second tether to the non-elongated support member under tension.

18. The method of claim 11, further comprising: introducing a second needle into the right atrium, with a second tether affixed to the second needle; advancing the second needle through the heart until the second needle enters the left atrium; creating a third passageway through a posterior outer wall of the left atrium at a location above the mitral valve and pushing the second needle through the third passageway; advancing the second needle in a distal direction until a distal portion of the second tether exits the heart; advancing the second tether in a distal direction until a portion of the second tether exits the subject’s body; advancing a curved support member over the second tether in a proximal direction until the curved support member reaches an outer surface of the outer wall of the left atrium adjacent to the third passageway, wherein the curved support member has a curvature that fits the outer wall of the left atrium; pushing the curved support member against the outer wall of the left atrium; and securing one portion of the second tether to the curved support member and securing another portion of the second tether to the non-elongated support member so that the second tether is under tension.

19. The method of claim 11, further comprising: introducing a second needle into the right atrium, with a second advancing tether affixed to the second needle; advancing the second needle through the heart until the second needle enters the left atrium; creating a third passageway through a posterior outer wall of the left atrium at a location above the mitral valve and pushing the second needle through the third passageway; advancing the second needle in a distal direction until a distal portion of the second advancing tether exits the heart; advancing the second advancing tether in a distal direction until a portion of the second advancing tether exits the subject’s body; securing a curved support member to a second retracting tether that is threaded through the third passageway, wherein the curved support member has a curvature that fits the outer wall of the left atrium; retracting the second retracting tether and moving the curved support member in a proximal direction between the subject’s ribs until the curved support member reaches an outer surface of the outer wall of the left atrium adjacent to the third passageway; and pulling the second retracting tether in a proximal direction, and subsequently securing the second tether to the non-elongated support member under tension.

20. An apparatus for ameliorating mitral regurgitation in a heart within a subject’s body, the apparatus comprising: a non-elongated support member positioned within the subject’s right atrium, adjacent to a first passageway that runs between the subject’s right atrium and the subject’s left ventricle, wherein the first passageway is located directly above the subject’s interventricular septum; a first support plate positioned against an outer surface of a subject’s left ventricle, adjacent to a second passageway that runs through an outer wall of a subject’s left ventricle, wherein the second passageway is located between the subject’s left-ventricular papillary muscles; and a first tether that runs between the non-elongated support member and the first support plate and passes through both the first passageway and the second passageway, wherein a first portion of the first tether is secured to the non-elongated support member and a second portion of the first tether is secured to the first support plate, andwherein the first tether is under tension so that the first support plate is pulled towards the non-elongated support member.

21. The apparatus of claim 20, wherein the first support plate has an area of 3-13 cm2, wherein the non-elongated support member has a length of 3-8 mm, and wherein the first tether has a length of 60-85 mm.

22. The apparatus of claim 20, wherein the first support plate has an area of 4-16 cm2, wherein the non-elongated support member has a length of 7-12 mm, and wherein the first tether has a length of 65-90 mm.

23. The apparatus of claim 20, wherein the first support plate has an area of 7-20 cm2, wherein the non-elongated support member has a length of 11-16 mm, and wherein the first tether has a length of 70-95 mm.

24. The apparatus of claim 20, further comprising: a second support plate positioned against an outer surface of an outer wall of the subject’s right ventricle, adjacent to a third passageway that runs through the outer wall of the subject’s right ventricle, wherein the second passageway is located between the subject’s right-ventricular papillary muscles; and a second tether that runs between the non-elongated support member and the second support plate and passes through the third passageway, wherein a first portion of the second tether is secured to the non-elongated support member and a second portion of the second tether is secured to the second support plate, and wherein the second tether is under tension so that the second support plate is pulled towards the non-elongated support member.

25. The apparatus of claim 20, further comprising: a curved support member positioned against an outer surface of an outer wall of the subject’s right atrium, adjacent to a third passageway that runs through the outer wall of the subject’s right atrium, wherein the third passageway is located above the subject’s tricuspid valve; and a second tether that runs between the non-elongated support member and the curved support member and passes through the third passageway,wherein a first portion of the second tether is secured to the non-elongated support member and a second portion of the second tether is secured to the curved support member, and wherein the second tether is under tension so that the curved support member is pulled towards the non-elongated support member.

26. The apparatus of claim 20, further comprising: a curved support member positioned against an outer surface of an outer wall of the subject’s left atrium, adjacent to a third passageway that runs through the outer wall of the subject’s left atrium, wherein the third passageway is located above the subject’s mitral valve; and a second tether that runs between the non-elongated support member and the curved support member and passes through the third passageway, wherein a first portion of the second tether is secured to the non-elongated support member and a second portion of the second tether is secured to the curved support member , and wherein the second tether is under tension so that the curved support member is pulled towards the non-elongated support member.

27. An apparatus for ameliorating mitral regurgitation in a heart within a subject’s body, the heart having two left-ventricular papillary muscles, each of which has a respective center, the apparatus comprising: a support plate configured for being positioned against an outer surface of a posterior wall of the heart, at a location that is within 3 cm of a midpoint between the centers of the two left-ventricular papillary muscles, a non-elongated support member configured for being positioned within the heart’s right atrium, against a surface of the heart’s tricuspid annulus that is adjacent to a posterior wall of the right atrium; and a tether that runs between the support plate and the non-elongated support member, wherein the tether is under tension so that the support plate is pulled towards the nonelongated support member.

28. The apparatus of claim 27, wherein the support plate is positioned against the outer surface of the posterior wall of the heart, at a location that is within 2 cm of the midpoint between the centers of the two left-ventricular papillary muscles.

29. The apparatus of claim 27, wherein the support plate is formed by injecting a first liquid material into a first polymer bag, and allowing the first liquid material to solidify.

30. The apparatus of claim 29, wherein the non-elongated support member is formed by injecting a second liquid material into a second polymer bag, and allowing the second liquid material to solidify.

31. The apparatus of claim 27, wherein the non-elongated support member is configured to be positioned adjacent to a first passageway that runs between the subject’s right atrium and the subject’s left ventricle, wherein the support plate is configured to be positioned adjacent to a second passageway that runs through an outer wall of a subject’s left ventricle, wherein the tether is configured to pass through both the first passageway and the second passageway, and wherein a first portion of the tether is secured to the non-elongated support member and a second portion of the tether is secured to the support plate.

32. The apparatus of claim 27, wherein the support plate has an area of 3-13 cm2, wherein the first support member has a length of 3-8 mm, and wherein the tether has a length of 60-85 mm.

33. The apparatus of claim 27, wherein the support plate has an area of 4-16 cm, wherein the first support member has a length of 7-12 mm, and wherein the tether has a length of 65-90 mm.

34. The apparatus of claim 27, wherein the support plate has an area of 7-20 cm2, wherein the first support member has a length of 11-16 mm, and wherein the tether has a length of 70-95 mm.

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