Improving mitral valve coaptation using a tether extending from within the right atrium to the lateral wall of the left ventricle

Abstract

Mitral regurgitation can be reduced by creating one passageway between the right atrium and left ventricle in a portion of the tricuspid annulus just above the ventricular septum and another passageway through the outer wall of the left ventricle near at least one of the left ventricular papillary muscles. A support rod is positioned in the right atrium in contact with the septal portion of the tricuspid annulus, and a support plate is positioned adjacent to the second passageway and against the outer wall of the left ventricle. The support plate is pulled toward the support rod using a tether that extends between the first support plate and the support rod, passes through both passageways, and is under tension. The tension in the tether moves the root of the tendon closer to the mitral valve, which reduces mitral regurgitation.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 443,751 (filed February 7, 2023) and U.S. Provisional Patent Application No. 63 / 527,440 (filed July 18, 2023), each of which is incorporated by reference in its entirety.

[0002] This application relates to medical devices, and in particular to devices for repairing mitral valve insufficiency (leaking). [Background technology]

[0003] Ischemic mitral regurgitation (IMR) is mitral valve regurgitation (MR) caused by chronic changes in left ventricular (LV) structure and function due to ischemic heart disease. IMR represents a consequence of increased tethering forces exerted on the mitral valve by the chordae tendineae. These increased tethering forces compromise the sealing properties of the coaptation surfaces of the mitral valve leaflets. Restricted leaflet movement can often lead to complete loss of coaptation and severe valve leakage.

[0004] The coaptation device was a notable attempt to reduce IMR by reducing the tethering forces exerted by the tendons on the mitral valve leaflets. The coaptation device used two extracardiac pads that were surgically implanted and connected by flexible, transventricular subvalvular chordae. Shortening the chordae after the pads were in place drew the ventricular walls together, which reduced the pulling force exerted by the tendons on the leaflets. This in turn improved leaflet coaptation and reduced the severity of MR.

[0005] However, the grafted device had two significant drawbacks. First, placing the device required a highly invasive median sternotomy to gain complete access to the outside of the subject's heart. Second, a substantial puncture of the heart was required to place the device, which created an associated risk of bleeding. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent No. 10,299,928 Summary of the Invention [Means for solving the problem]

[0007] One aspect of the present invention is directed to a first method for improving mitral valve regurgitation in a heart within a subject's body. The first method includes positioning a first needle within the left ventricle of the heart with a first tether secured to the first needle and pushing the first needle through the posterior wall at a first location until a distal portion of the first tether passes through the posterior wall and exits the heart. The first method also includes advancing the first tether distally until the first portion of the first tether exits the subject's body and securing a first expandable support structure to the first portion of the first tether. The first method also includes retracting the first tether and moving the first expandable support structure proximally until the first expandable support structure reaches the outer surface of the posterior wall adjacent the first location, and expanding the first expandable support structure so that an area of ​​contact is formed between the first expandable support structure and the outer surface of the posterior wall. The first method also includes the step of securing the first tether to a portion of the subject's body positioned anteriorly relative to the left ventricle.

[0008] In some examples of the first method, the first location is between papillary muscles of the heart. In some examples of the first method, the first expandable support structure includes a first polymer bag, and expanding includes injecting a liquid material into the first polymer bag, the liquid material being configured to subsequently solidify. In some examples of the first method, the first expandable support structure includes a plurality of metal arms, and expanding includes moving the metal arms from an initial collapsed position to a final expanded position.

[0009] In some examples of the first method, the area of ​​contact between the first expandable support structure and the exterior surface of the posterior wall is at least 2 cm 2 In some examples of the first method, the area of ​​contact between the first expandable support structure and the exterior surface of the posterior wall is at least 5 cm 2 In some examples of the first method, the area of ​​contact between the first expandable support structure and the exterior surface of the posterior wall is 6 cm 2 From 15cm 2 It has an area between

[0010] In some examples of the first method, securing the first tether includes positioning the second needle in the left ventricle of the heart with the second tether secured to the second needle; pushing the second needle through the septum of the heart at a second location and through the outer wall of the right ventricle of the subject until a distal portion of the second tether passes through the outer wall of the right ventricle and exits the heart; advancing the second tether distally until a first portion of the second tether exits the body of the subject; and securing the second tether to form a linked tether. the first tether, moving the second expandable support structure proximally over the coupled tether until the second expandable support structure enters the right ventricle and reaches the septum adjacent the second location, expanding the second expandable support structure to form an area of ​​contact between the second expandable support structure and the septum, and attaching the second expandable support structure to the coupled tether in a manner that establishes tension in the first tether, the tension pulling the first expandable support structure toward the second expandable support structure.

[0011] Optionally, in the example described in the preceding paragraph, the area of ​​contact between the first expandable support structure and the exterior surface of the back wall is at least 5 cm 2 and the area of ​​contact between the second expandable support structure and the septum is at least 5 cm 2 It has an area of

[0012] In some examples of the first method, securing the first tether includes positioning a second needle in the left ventricle of the heart with a second tether secured to the second needle; pushing the second needle through the septum of the heart and through the outer wall of the right ventricle of the subject at a second location until a distal portion of the second tether passes through the outer wall of the right ventricle and exits the heart; advancing the second tether distally until a first portion of the second tether exits the subject's body; and securing the second tether to form a linked tether. The method includes attaching a tether to the first tether, moving the second expandable support structure proximally over the coupled tether until the second expandable support structure reaches an exterior surface of the right ventricle adjacent the second location, expanding the second expandable support structure to form an area of ​​contact between the second expandable support structure and the exterior surface of the right ventricle, and attaching the second expandable support structure to the coupled tether in a manner that establishes tension in the first tether, the tension pulling the first expandable support structure toward the second expandable support structure.

[0013] Optionally, in the example described in the preceding paragraph, the area of ​​contact between the first expandable support structure and the exterior surface of the back wall is at least 5 cm 2 and the area of ​​contact between the second expandable support structure and the exterior surface of the right ventricle is at least 5 cm 2 It has an area of

[0014] In some examples of the first method, securing the first tether includes positioning a second needle within the left ventricle of the heart with a second tether secured to the second needle, pushing the second needle through the septum of the heart and through the outer wall of the right ventricle of the subject until a distal portion of the second tether passes through the outer wall of the right ventricle and exits the heart, securing the second tether to a bone in the subject's body, and attaching the second tether to the first tether in a manner that establishes tension in the first tether, the tension pulling the first expandable support structure toward the bone.

[0015] In some examples of the first method, securing the first tether includes positioning the second needle within the left ventricle of the heart with the second tether secured to the second needle; pushing the second needle through the anterior wall of the subject's left ventricle at the second location until a distal portion of the second tether exits the heart; advancing the second tether distally until a first portion of the second tether exits the subject's body; attaching the second tether to the first tether to form a linked tether; moving the second expandable support structure proximally over the linked tether until it reaches an outer surface of the anterior wall adjacent the second location; expanding the second expandable support structure so that an area of ​​contact between the second expandable support structure and the outer surface of the anterior wall is formed; and attaching the second expandable support structure to the linked tether in a manner to establish tension in the first tether. The tension pulls the first expandable support structure towards the second expandable support structure.

[0016] In some examples of the first method, securing the first tether includes positioning a second needle within the left ventricle of the heart with a second tether secured to the second needle; pushing the second needle through the anterior wall of the left ventricle and through the posterior wall of the right atrium of the subject at a second location positioned directly above the tricuspid annulus of the subject; subsequently pushing the second needle through the outer wall of the right atrium until a distal portion of the second tether passes through the outer wall of the right atrium and exits the heart; advancing the second tether distally until a first portion of the second tether exits the subject's body; and securing the coupled tethers. the second expandable support structure is attached to the first tether in a manner that establishes tension in the first tether, the tension pulling the first expandable support structure toward the second expandable support structure, the second expandable support structure is moved proximally over the coupled tether until the second expandable support structure reaches the posterior wall of the right atrium adjacent the second location and directly above the tricuspid annulus of the subject, the second expandable support structure is expanded to form an area of ​​contact between the second expandable support structure and the surface of the tricuspid annulus, and the second expandable support structure is attached to the coupled tether in a manner that establishes tension in the first tether, the tension pulling the first expandable support structure toward the second expandable support structure.

[0017] Another aspect of the present invention is directed to a first device for improving mitral regurgitation in a heart within a subject's body. The first device includes a first pad, a second pad, and a tether. The first pad is positioned against the outer surface of the posterior wall of the heart, within 3 cm of the midpoint between the centers of two papillary muscles. The second pad is positioned in the right atrium of the heart against the surface of the tricuspid annulus of the heart adjacent to the posterior wall of the right atrium. The tether extends between the first and second pads and is under tension so as to pull the first pad toward the second pad.

[0018] In some embodiments of the first device, the first pad is positioned against the exterior surface of the posterior wall of the heart at a location within 2 cm of the midpoint between the centers of the two papillary muscles. In some embodiments of the first device, the first pad is formed by injecting a first liquid material into a first polymer bag and allowing the first liquid material to solidify, and the second pad is formed by injecting a second liquid material into a second polymer bag and allowing the second liquid material to solidify.

[0019] In some embodiments of the first method, the area of ​​contact between the first pad and the exterior surface of the posterior wall is at least 2 cm 2 In some embodiments of the first device, the area of ​​contact between the first pad and the exterior surface of the rear wall is at least 5 cm 2 In some embodiments of the first device, the area of ​​contact between the first pad and the outer surface of the rear wall is 6 cm 2 From 15cm 2 It has an area between

[0020] Another aspect of the present invention is directed to a second method for improving mitral regurgitation in a heart within a subject's body. The second method includes creating a first passageway between the right atrium and the left ventricle in a portion of the tricuspid annulus immediately above the interventricular septum, creating a second passageway through the outer wall of the left ventricle near at least one of the left ventricular papillary muscles, positioning a support bar in the right atrium in contact with the 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 toward the support bar using a first tether under tension. The first tether extends between the first support plate and the support bar and passes through both the first and second passageways, with a first end of the first tether secured to the first support plate.

[0021] In some examples of the second method, the second passage is positioned between two left ventricular papillary muscles. In some examples of the second method, the second end of the first tether is secured to the support bar.

[0022] In some examples of the second method, the first support plate is 3 to 13 cm 2 In some examples of the second method, the first support plate has an area of ​​4 to 16 cm, and the support rod has a length of 10 to 20 mm and a width of 3 to 8 mm. 2 In some examples of the second method, the first support plate has an area of ​​7 to 20 cm, and the support rod has a length of 15 to 25 mm and a width of 3 to 8 mm. 2 The support rod has a length of 20 to 30 mm and a width of 3 to 8 mm.

[0023] In some examples of the second method, positioning the first support plate against the exterior wall of the left ventricle includes positioning a polymer bag on the exterior of the exterior wall of the left ventricle adjacent the second passageway, injecting a liquid material into the polymer bag, and solidifying the liquid material, wherein the solidifying liquid material forms the first support plate.

[0024] Some examples of the second method further include creating a third passageway through the outer wall of the right ventricle near at least one right ventricular papillary muscle, positioning a second support plate against the outer wall of the right ventricle adjacent to the third passageway, and pulling the second support plate toward the support bar using a second tether under tension. In these examples, the second tether extends between the second support plate and the support bar, with a first end of the second tether anchored to the second support plate.

[0025] Some examples of the second method further include positioning a second support member against the outer wall of the heart at a second location adjacent the anterior leaflet of the tricuspid valve and pulling the second support member toward the support bar using a second tether under tension, wherein the second tether extends between the second support member and the support bar, and a first end of the second tether is secured to the second support member.

[0026] Some examples of the second method further include positioning a second support member against the outer wall of the heart at a second location adjacent the posterior leaflet of the mitral valve and pulling the second support member toward the support rod using a second tether under tension, in these examples, the second tether extends between the second support member and the support rod, and a first end of the second tether is anchored to the second support member.

[0027] Another aspect of the present invention is directed to a third method for improving mitral regurgitation in a heart within a subject's body, the third method including the steps of: (a) introducing a first needle into the right atrium with a first tether secured to the first needle; (b) pushing the first needle through the cardiac skeleton into the left ventricle at a location just above the interventricular septum to create a first passageway between the right atrium and the left ventricle; (c) pushing the first needle through the outer wall of the left ventricle at a location between the left ventricular papillary muscles to create a second passageway; and (d) fastening a distal portion of the first tether to the left ventricle. (e) advancing the first needle distally until a portion of the first tether exits the heart; (f) securing the first support plate to the first tether; and (g) retracting the first tether and moving the first support plate proximally between the subject's ribs until the first support plate reaches the outer surface of the outer wall of the left ventricle adjacent the second passageway. The third method also includes positioning a support rod in the right atrium adjacent to the first passageway. After steps (a)-(g), the third method also includes pulling the first tether proximally while the support rod is positioned adjacent to the first passageway, and subsequently securing the first tether to the support rod while under tension.

[0028] Some examples of the third method further include introducing a second needle with a second tether secured to the second needle into the right ventricle, pushing the second needle through the outer wall of the right ventricle at a location between the subject's right ventricular papillary muscles to create a third passageway, advancing the second needle distally until a distal portion of the second tether exits the heart, advancing the second tether distally until a portion of the second tether exits the subject's body, advancing a second support plate proximally over the second tether until the second support plate reaches an outer surface of the outer wall of the right ventricle adjacent the third passageway, pressing the second support plate against the outer wall of the right ventricle, and securing a portion of the second tether to the second support plate and another portion of the second tether to a support rod so that the second tether is under tension.

[0029] Some examples of the third method further include introducing a second needle with a second tether secured to the second needle into the right ventricle; pushing the second needle through the outer wall of the right ventricle at a location between the subject's right ventricular papillary muscles to create a third passageway; advancing the second needle distally until a distal portion of the second tether exits the heart; advancing the second tether distally until a portion of the second tether exits the subject's body; securing a second support plate to the second tether; retracting the second tether and moving the second support plate proximally between the subject's ribs until the second support plate reaches the outer surface of the outer wall of the right ventricle adjacent the third passageway; and pulling the second tether proximally and subsequently securing the second tether to the support bar while under tension.

[0030] Some examples of the third method further include introducing a second needle into the right atrium with a second tether secured to the second needle; pushing the second needle through the anterior lateral wall of the right atrium at a location above the tricuspid valve to create a third passageway; advancing the second needle distally until a distal portion of the second tether exits the heart; advancing the second tether distally until a portion of the second tether exits the subject's body; advancing a curved support member proximally over the second tether until the curved support member reaches an outer surface of the outer wall of the right atrium adjacent the third passageway, the curved support member having a curvature that conforms to the outer wall of the right atrium; pressing the curved support member against the outer wall of the right atrium; and securing a portion of the second tether to the curved support member and another portion of the second tether to a support rod so that the second tether is under tension.

[0031] Some examples of the third method further include introducing a second needle into the right atrium with a second tether secured to the second needle; pushing the second needle through the anterior lateral wall of the right atrium at a location above the tricuspid valve to create a third passageway; advancing the second needle distally until a distal portion of the second tether exits the heart; advancing the second tether distally until a portion of the second tether exits the subject's body; securing a curved support member to the second tether, the curved support member having a curvature that conforms to the lateral wall of the right atrium; retracting the second tether and moving the curved support member proximally between the subject's ribs until the curved support member reaches the outer surface of the lateral wall of the right atrium adjacent the third passageway; and pulling the second tether proximally and subsequently securing the second tether to a support rod while under tension.

[0032] Some examples of the third method include introducing a second needle into the right atrium with a second tether secured to the second needle; advancing the second needle through the heart until the second needle enters the left atrium; pushing the second needle through the posterior outer wall of the left atrium at a location above the mitral valve to create a third passageway; advancing the second needle distally until a distal portion of the second tether exits the heart; and advancing the second tether distally until a portion of the second tether exits the subject's body. the support rod; advancing the curved support member in a proximal direction over the second tether until the curved support member reaches an outer surface of the outer wall of the left atrium adjacent the third passage, the curved support member having a curvature that conforms to the outer wall of the left atrium; pressing the curved support member against the outer wall of the left atrium; and fixing a portion of the second tether to the curved support member and another portion of the second tether to the support rod so that the second tether is under tension.

[0033] Some examples of the third method include introducing a second needle into the right atrium with a second tether secured to the second needle; advancing the second needle through the heart until the second needle enters the left atrium; pushing the second needle through the posterior outer wall of the left atrium at a location above the mitral valve to create a third passageway; advancing the second needle distally until a distal portion of the second tether exits the heart; and advancing the second tether distally until a portion of the second tether exits the subject's body. the curved support member having a curvature that conforms to the outer wall of the left atrium; retracting the second tether and moving the curved support member proximally between the subject's ribs until the curved support member reaches the outer surface of the outer wall of the left atrium adjacent the third passage; and pulling the second tether proximally and subsequently securing the second tether to the support bar while under tension.

[0034] Another aspect of the present invention is directed to a second device for improving mitral valve regurgitation in a heart within a subject's body. The second device includes a support rod, a first support plate, and a first tether. The support rod is positioned within the subject's right atrium adjacent to a first passageway extending between the subject's right atrium and the subject's left ventricle. The first passageway is positioned immediately above the subject's interventricular septum. The first support plate is positioned against the outer surface of the subject's left ventricle adjacent to a second passageway extending through the outer wall of the subject's left ventricle. The second passageway is positioned between the subject's left ventricular papillary muscles. The first tether extends between the support rod 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 support rod, and a second portion of the first tether is secured to the first support plate. Additionally, the first tether is under tension such that the first support plate is pulled towards the support bar.

[0035] In some embodiments of the second device, the first support plate is 3 to 13 cm 2In some embodiments of the second device, the first support bar has an area of ​​10-20 mm, a length of 10-20 mm, a width of 3-8 mm, and the first tether has a length of 60-85 mm. 2 In some embodiments of the second device, the first support plate has an area of ​​7 to 20 cm, the support bar has a length of 15 to 25 mm and a width of 3 to 8 mm, and the first tether has a length of 65 to 90 mm. 2 The support rod has a length of 20 to 30 mm and a width of 3 to 8 mm, and the first tether has a length of 70 to 95 mm.

[0036] Some embodiments of the second device further include a second support plate and a second tether. The second support plate is positioned against the outer surface of the outer wall of the subject's right ventricle adjacent to a third passageway extending through the outer wall of the right ventricle, with the second passageway positioned between the subject's right ventricular papillary muscles. The second tether extends between the support rod and the second support plate and passes through the third passageway. A first portion of the second tether is fixed to the support rod, and a second portion of the second tether is fixed to the second support plate. The second tether is under tension such that the second support plate is pulled toward the support rod.

[0037] Some embodiments of the second device further include a curved support member and a second tether. The curved support member is positioned against the outer surface of the outer wall of the subject's right atrium adjacent to a third passageway extending through the outer wall of the right atrium, the third passageway being positioned above the subject's tricuspid valve. The second tether extends between the support bar and the curved support member and passes through the third passageway. A first portion of the second tether is secured to the support bar, and a second portion of the second tether is secured to the curved support member. The second tether is under tension such that the curved support member is pulled toward the support bar.

[0038] Some embodiments of the second device further include a curved support member and a second tether. The curved support member is positioned against the outer surface of the outer wall of the subject's left atrium adjacent to a third passageway extending through the outer wall of the subject's left atrium, the third passageway being positioned above the subject's mitral valve. The second tether extends between the support bar and the curved support member and passes through the third passageway. A first portion of the second tether is secured to the support bar, and a second portion of the second tether is secured to the curved support member. The second tether is under tension such that the curved support member is pulled toward the support bar.

[0039] Another aspect of the present invention is directed to a fourth method of improving 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 fourth method includes the steps of: (a) introducing a first needle into the right atrium with a first advancement tether secured to the first needle; (b) creating a first passageway between the right atrium and the left ventricle through the cardiac skeleton at a location just above the interventricular septum and pushing the first needle through the first passageway into the left ventricle; (c) creating a second passageway through the outer wall of the left ventricle at a location between the left ventricular papillary muscles and pushing the first needle through the second passageway; and (d) advancing the first needle so that a distal portion of the first advancement tether exits the heart. (e) advancing the first advancement tether distally until a portion of the first advancement tether exits the subject's body; (f) securing a first support plate to the first retraction tether threaded through both the first and second passages; and (g) retracting the first retraction tether until the first support plate reaches an outer surface of the outer wall of the left ventricle adjacent the second passage, and moving the first support plate proximally between the subject's ribs. The fourth method also includes positioning a support rod in the right atrium adjacent to the first passage. The fourth method also includes, after steps (a)-(g), pulling the first retraction tether proximally while the support rod is positioned adjacent to the first passage, and subsequently securing the first retraction tether to the support rod while under tension.

[0040] In some examples of the fourth method, a single tether serves as both the first forward tether and the first retraction tether. In some examples of the fourth method, the first forward tether and the first retraction tether are separate from one another, and the first forward tether is used to thread the first retraction tether through both the first passage and the second passage.

[0041] Some examples of the fourth method further include introducing a second needle into the right ventricle with a second tether secured to the second needle; creating a third passageway through the outer wall of the right ventricle of the subject at a location between the right ventricular papillary muscles and pushing the second needle through the third passageway; advancing the second needle distally until a distal portion of the second tether exits the heart; advancing the second tether distally until a portion of the second tether exits the subject's body; advancing a second support plate proximally over the second tether until the second support plate reaches an outer surface of the outer wall of the right ventricle adjacent the third passageway; pressing the second support plate against the outer wall of the right ventricle; and securing a portion of the second tether to the second support plate and another portion of the second tether to a support rod so that the second tether is under tension.

[0042] Some examples of the fourth method further include introducing a second needle into the right ventricle with a second advancement tether secured to the second needle; creating a third passageway through the 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 distally until a distal portion of the second advancement tether exits the heart; advancing the second advancement tether distally until a portion of the second advancement tether exits the subject's body; securing a second support plate to the second retraction tether threaded through the third passageway; retracting the second retraction tether until it reaches the outer surface of the outer wall of the right ventricle adjacent the third passageway and moving the second support plate proximally between the subject's ribs; and pulling the second retraction tether proximally and subsequently securing the second retraction tether to the support plate while under tension.

[0043] Some examples of the fourth method further include introducing a second needle into the right atrium with a second tether secured to the second needle; creating a third passageway through the anterior lateral 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 distally until a distal portion of the second tether exits the heart; advancing the second tether distally until a portion of the second tether exits the subject's body; advancing a curved support member proximally over the second tether until the curved support member reaches an outer surface of the outer wall of the right atrium adjacent the third passageway, the curved support member having a curvature that conforms to the outer wall of the right atrium; pressing the curved support member against the outer wall of the right atrium; and securing a portion of the second tether to the curved support member and another portion of the second tether to a support rod so that the second tether is under tension.

[0044] Some examples of the fourth method include introducing a second needle into the right atrium with a second advancement tether secured to the second needle; creating a third passageway through the anterior lateral 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 distally until a distal portion of the second advancement tether exits the heart; advancing the second advancement tether distally until a portion of the second advancement tether exits the subject's body; and the curved support member having a curvature that conforms to the outer wall of the right atrium adjacent the third passage; retracting the second retraction tether and moving the curved support member proximally between the subject's ribs until the curved support member reaches the outer surface of the outer wall of the right atrium adjacent the third passage; and pulling the second retraction tether proximally and subsequently securing the second tether to the support bar while under tension.

[0045] Some examples of the fourth method include introducing a second needle into the right atrium with a second tether secured to the second needle; advancing the second needle through the heart until the second needle enters the left atrium; creating a third passageway through the 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 distally until a distal portion of the second tether exits the heart; and advancing the second tether distally until a portion of the second tether exits the subject's body. the support rod; advancing the curved support member in a proximal direction over the second tether until the curved support member reaches an outer surface of the outer wall of the left atrium adjacent the third passage, the curved support member having a curvature that conforms to the outer wall of the left atrium; pressing the curved support member against the outer wall of the left atrium; and securing a portion of the second tether to the curved support member and another portion of the second tether to the support rod so that the second tether is under tension.

[0046] Some examples of the fourth method include introducing a second needle into the right atrium with a second advancement tether secured to the second needle; advancing the second needle through the heart until the second needle enters the left atrium; creating a third passageway through the 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 distally until a distal portion of the second advancement tether exits the heart; and advancing the second advancement tether distally until a portion of the second advancement tether exits the subject's body. the third passageway; securing the curved support member to a second retraction tether that is threaded through the third passageway, the curved support member having a curvature that conforms to the outer wall of the left atrium; retracting the second retraction tether and moving the curved support member proximally between the subject's ribs until the curved support member reaches the outer surface of the outer wall of the left atrium adjacent the third passageway; and pulling the second retraction tether proximally and subsequently securing the second tether to the support bar while under tension.

[0047] Another aspect of the present invention is directed to a third device for improving mitral valve regurgitation in a heart within a subject's body. The heart has two left ventricular papillary muscles, each having a respective center. The third device includes a support plate, a support rod, and a tether. The support plate is positioned against the outer surface of the posterior wall of the heart at a location within 3 cm of the midpoint between the centers of the two left ventricular papillary muscles. The support rod is positioned in the right atrium of the heart against the surface of the tricuspid annulus of the heart adjacent to the posterior wall of the right atrium. The tether extends between the support plate and the support rod. The tether is under tension such that the support plate is pulled toward the support rod.

[0048] In some embodiments of the third device, the support plate is positioned against the exterior surface of the posterior wall of the heart at a location within 2 cm of the midpoint between the centers of the two left ventricular papillary muscles.

[0049] In some embodiments of the third apparatus, the support plate is formed by injecting a first liquid material into a first polymer bag and solidifying the first liquid material. Optionally, in these embodiments, the support rods can be formed by injecting a second liquid material into a second polymer bag and solidifying the second liquid material.

[0050] In some embodiments of the third device, the area of ​​contact between the support plate and the outer surface of the rear wall is at least 2 cm 2 In some embodiments of the third device, the area of ​​contact between the support plate and the outer surface of the rear wall is at least 5 cm 2 In some embodiments of the third device, the area of ​​contact between the support plate and the outer surface of the rear wall is 6 cm 2 From 15cm 2 It has an area between [Brief explanation of the drawings]

[0051] [Figure 1A] FIG. 1 is a diagram of the heart of a healthy subject. [Figure 1B] FIG. 1 is a diagram of the heart of a subject with IMR. [Figure 2] 10A-10C are diagrams of steps in the procedure where the needle passes through the posterior wall of the left ventricle. [Figure 3] FIG. 10 is a diagram of subsequent steps after the needle has passed through the posterior wall of the left ventricle with the first tether attached. [Figure 4] FIG. 10 illustrates subsequent steps after the first tether has been exteriorized between the subject's ribs and the expandable support has been attached to the first tether. [Figure 5] FIG. 10 illustrates a subsequent step after the expandable support has been brought closer to the site of the puncture by retracting the first tether. [Figure 6] FIG. 10 is a detailed view of the first expandable support in a position against the outside of the posterior left ventricular wall after the first expandable support has been expanded. [Figure 7] FIG. 10 is a diagram of subsequent steps after the second needle and second tether have been advanced through the interventricular septum, then through the right ventricular wall, and then exteriorized between the subject's ribs. [Figure 8] FIG. 10 illustrates a subsequent step in which the introducer sheath is advanced over the second tether into the right ventricle. [Figure 9] FIG. 10 shows a subsequent step in which, after the tethers have been linked together, a second expandable support 10 is introduced into the right ventricle over the linked tethers. [Figure 10] FIG. 10 is a diagram of a subsequent step in which the second expandable support is expanded. [Figure 11] FIG. 10 illustrates a subsequent step in which the second expandable support is secured to the first expandable support via an associated tether. [Figure 12] FIG. 10 is a diagram of an alternative approach in which a second expandable support is positioned against the exterior surface of the right ventricle. [Figure 13] FIG. 10 is a diagram of an alternative approach in which forward tension is provided by anchoring the first tether to one of the subject's ribs. [Figure 14] FIG. 10 is a diagram of an alternative approach in which a second expandable support is positioned against the exterior surface of the anterior wall of the subject's left ventricle. [Figure 15] FIG. 10 is a diagram of yet another alternative approach in which a second expandable support is positioned in the right atrium in contact with the septal side of the tricuspid annulus above the interventricular septum. [Figure 16] FIG. 10 is a detailed view of the first expandable support in an expanded state. [Figure 17] FIG. 10 is a detailed view of the first expandable support in its initial folded state. [Figure 18] FIG. 1 is a diagram of the heart of a healthy subject. [Figure 19] FIG. 1 is a diagram of the heart of a subject with IMR. [Figure 20] FIG. 1 is a diagram of the puncture area in the tricuspid annulus, in proximity to the mitral annulus, as viewed in the valve plane. [Figure 21] FIG. 1 shows the catheter advanced through the vascular system to the RA, with the needle creating a direct oblique puncture from the RA to the LV. [Figure 22] FIG. 1 shows the catheter advanced into the LV and the needle creating a puncture through the ventricular wall between the papillary muscles. [Figure 23] FIG. 10 is a diagram of the tether pulled out of the patient's body between the ribs and attached to the first support plate. [Figure 24] The tether is pulled back and the first support plate is inserted into the patient's body between the ribs and brought close to the outer wall of the LV. [Figure 25] FIG. 10 is a view of the support rod after it has been advanced through the vascular system, over the tether, and into the RA, adjacent to the puncture created between the RA and the LV. [Figure 26] FIG. 10 is a diagram of the location of the support rods after they are in place, as viewed in the valve plane. [Figure 27] FIG. 10 shows a first support plate being pulled inward by a tether in direction D toward the support rod and secured to the tether under tension to improve mitral valve coaptation. [Figure 28] FIG. 10 is a diagram of an interconnection between a double tether and a support plate in an alternative embodiment. [Figure 29] FIG. 29 is a diagram of the interconnection between the double tether and the support bar in the embodiment of FIG. 28. [Figure 30] 29 is a view of the embodiment of FIG. 28 when the support plate and support bar are interconnected by a double tether. [Figure 31] FIG. 28 shows the addition of another support plate to the embodiment of FIG. 27 to support the RV wall under tension to relieve tethering forces on the tricuspid chordae. [Figure 32] FIG. 32 is a view of the embodiment of FIG. 31 as viewed in the valve plane. [Figure 33] FIG. 28 illustrates the addition of a curved support member to the embodiment of FIG. 27 to compress the tricuspid annulus under tension to reduce or prevent dilation of the annulus. [Figure 34] FIG. 34 is a view of the embodiment of FIG. 33 as viewed in the valve plane. [Figure 35] FIG. 28 illustrates the addition of a curved support member to the embodiment of FIG. 27 to compress the mitral annulus to reduce or prevent dilation of the mitral annulus under tension. [Figure 36] FIG. 36 is a view of the embodiment of FIG. 35 as viewed in the valve plane. [Figure 37] 28 is a diagram of components of the embodiment of FIG. 27, with reference numbers to indicate corresponding dimensions. [Figure 38] 32 is a diagram of components of the embodiment of FIG. 31 with reference numbers to indicate corresponding dimensions. [Figure 39] 34 is a diagram of components of the embodiment of FIG. 33 with reference numbers to indicate corresponding dimensions. [Figure 40] 28 is a view of an embodiment similar to the embodiment of FIG. 27 except that the straight support bars from the embodiment of FIG. 27 have been replaced with curved support bars. [Figure 41] FIG. 10 is a diagram of an alternative embodiment in which the support plate is formed by solidifying a liquid precursor into a solid pad before the support plate is connected to the support rods using tethers. DETAILED DESCRIPTION OF THE INVENTION

[0052] Various embodiments are described in detail below with reference to the accompanying drawings, in which like reference numerals represent like elements.

[0053] Section 1 The embodiments described in this section pull the papillary muscles (to which the tendons are attached) in an anterior direction, thereby reducing the pulling force the tendons exert on the valve leaflets. Also, notably, these embodiments use techniques that are much less invasive than those used to install prior art coaptation devices.

[0054] Figure 1A shows a longitudinal cross-section of a healthy human heart in a plane passing through the heart between the papillary muscles of the mitral valve. The left ventricle (LV), right ventricle (RV), left atrium (LA), right atrium (RA), mitral valve (MV), aortic valve (AO), and tricuspid valve (TV) are all shown. Notably, the chordae tendineae (CT) are attached to the posterior wall of the left ventricle via the papillary muscles (PM). Furthermore, in the healthy subject depicted in Figure 1A, the chordae tendineae do not interfere with mitral valve leaflet closure.

[0055] Figure 1B shows a cross-section of a subject with IMR caused by chronic changes in left ventricular structure along the same plane as depicted in Figure 1A. In this subject, the posterior wall of the left ventricle is positioned laterally relative to the posterior wall in the healthy heart depicted in Figure 1A. This misalignment increases the distance between the papillary muscles and the mitral valve. Furthermore, because the mitral valve leaflets are connected to the papillary muscles via tendons, the tendons in this subject in Figure 1B prevent the mitral valve leaflets from fully closing, resulting in a gap G.

[0056] This application discloses several techniques for displacing the posterior wall of the left ventricle anteriorly to more closely resemble the healthy human heart depicted in Figure 1 A. All of the techniques described in this section rely on positioning a support structure on the exterior surface of the posterior wall of the left ventricle and using a tether extending through the left ventricle to pull the support structure anteriorly.

[0057] Figures 2-11 depict a first example of such a technique. It is envisioned (but not required) that the procedures described in this section will be performed by two practitioners. The first practitioner may be, for example, an interventional cardiologist with experience in accessing a subject's heart via a catheter introduced through the subject's vasculature. Notably, the terminology "distal" and "proximal" used in this section is with respect to the frame of reference of the first practitioner (i.e., the interventional cardiologist). The second practitioner may be, for example, a thoracic surgeon who knows how to access a subject's heart from outside the heart using surgical techniques, including minimally invasive surgical techniques.

[0058] A first practitioner inserts catheter 1 through the aorta into the LV, as depicted in Figure 2, and catheter 1 is navigated (e.g., using echo and / or fluoroscopic imaging) to a specific first location 3 in the posterior wall of the LV between the papillary muscles, and a first needle 2 (e.g., made from metal) is pushed through the posterior wall of the LV to puncture the posterior wall and exit the body through the posterior wall at first location 3. The first needle 2 is advanced until a distal portion of a first tether 4 passes through the posterior wall of the LV and exits the heart.

[0059] Notably, because the first needle is introduced from inside the heart, it is relatively easy to align the first needle between the papillary muscles (e.g., using echo and / or fluoroscopic imaging). This is important because moving the papillary muscles moves the "root" of the tendon anteriorly, where it is closer to the leaflets of the mitral valve, meaning that the tendon either no longer prevents the leaflets from fully coapting or at least improves leaflet coaptation.

[0060] The first needle 2 is attached to a thin, strong polymer first tether 4, as depicted in FIG. 3, and due to the very small profile of the puncture hole (combined with the fact that the puncture is sealed with the tether immediately after it is created), bleeding from the ventricle does not occur at the first puncture site 3. The first needle 2 in FIG. 3 can be, for example, a short (e.g., 3-5 cm) rigid needle, a long (e.g., 100-200 cm) flexible needle, or other types of needles may be used. The details of attachment of the first tether 4 to the needle 2 can be performed using any conventional technique, such as, for example, a commonly used needle and thread as depicted in FIG. 3.

[0061] Using minimally invasive techniques such as those performed in many thoracic and pulmonary surgeries, the second practitioner captures (e.g., using forceps or a similar tool) the first needle 2 as it emerges outside the ventricular wall. The first needle 2 and first tether 4 are then advanced (e.g., pulled) distally (relative to the first practitioner) until a first portion of the first tether exits the subject's body, such as through two adjacent ribs as depicted in FIG. 4.

[0062] Next, the second practitioner secures (e.g., using a knot not shown or any other suitable technique) the first expandable support 5 to the first tether 4. At this stage, the first expandable support 5 is in its initial folded state.

[0063] Next, the first practitioner pulls the first tether 4 through the catheter 1 in the proximal direction depicted by the arrow in FIG. 5 to retract the first tether 4. Meanwhile, the second practitioner guides the first expandable support 5 so that it passes smoothly through the ribs (e.g., through a minimally invasive cut) and into the subject's body. This process continues until the first expandable support 5 reaches the outer surface of the posterior wall of the left ventricle adjacent to the first puncture location 3. The access of the first expandable support 5 to the first location 3 can be assisted by the second practitioner's manual navigation through the minimally invasive cut, as in other surgical procedures.

[0064] The first expandable support 5 can be made from a thin-walled plastic bag 11 that can be folded as shown in FIG. 17 and expanded as shown in FIG. 16. The plastic bag 11 can be filled with a liquid polymer through a tube 13, which is configured to solidify when desired through a controlled chemical reaction, such as a two-component thermoset polymer (i.e., epoxy or acrylic). Optionally, an expandable skeleton 12 (e.g., made from flexible metal arms) can be placed within the plastic bag 11 like the arms of an umbrella. In an initial, collapsed state, the plastic bag 11 can be constrained within a small-diameter tube (not shown) to facilitate insertion into the body, with the optional arms 12 also collapsing within the tube. When the first expandable support 5 reaches its destination, it exits the insertion tube, after which the arms 12 expand, causing the plastic bag 11 to unfold into a flat shape as depicted in FIG. 16. The skeleton of the arm 12 is attached (eg, using a knot, clip, clasp, etc.) to a first tether 4 .

[0065] The first expandable support 5 is filled with a medical-grade solidifying polymer through tubing 13 after the first expandable support 5 is expanded as depicted in FIG. 16, and once the polymer has solidified, tubing 13 can be removed. Because the liquid polymer is converted to a solid, there is no leakage of the liquid polymer from the plastic bag 11 when the filling tube is removed. At this point in the procedure, we have a single expandable support 5 in its expanded state positioned just outside the subject's heart, at a location within 3 cm (or more preferably within 2 cm) of the midpoint between the centers of the two papillary muscles, with an area of ​​contact between the first expandable support 5 and the exterior surface of the posterior wall of the LV, as seen in FIG. 6. In some embodiments, the area of ​​contact is within 2 cm. 2 In some embodiments, the area of ​​contact is 5 cm 2 In some embodiments, the area of ​​contact is between 6 and 15 cm 2 It has an area of

[0066] In the next step of the procedure, as depicted in FIG. 7 , a second needle (not shown) is introduced into the left ventricle (e.g., as previously described for first needle 2). The second needle is secured to second tether 6. The first practitioner pushes the second needle through the septum of the heart at second location 7, and subsequently through the outer wall of the subject's right ventricle at location 8, until a distal portion of second tether 6 passes through the outer wall of the right ventricle and exits the heart. Next, second tether 6 is advanced distally until a first portion of second tether 6 exits the subject's body (e.g., between two ribs). This step of the procedure on the anterior surface of the heart can be performed as previously described for the first tether on the posterior surface of the heart.

[0067] An introducer sheath 9 is then advanced through the puncture at location 8, between the subject's ribs, and over the second tether 6 into the RV, as depicted in Figure 8. In some embodiments, a second practitioner advances a second expandable support 10 over the second tether 6, through the introducer sheath 9, into the subject's body (i.e., proximally relative to the first practitioner), and into the right ventricle.

[0068] In some embodiments, after the second expandable support 10 enters the right ventricle and reaches the septum adjacent to the second location 7, the second tether 6 is coupled (e.g., using a knot, clip, etc.) to the first tether 4 at this point in the procedure, resulting in the coupled tether configuration depicted in FIG. 9. The second expandable support structure 10 is then expanded (e.g., as described above in connection with the first expandable support structure 5) such that an area of ​​contact between the second expandable support structure 10 and the septum is formed at location 7, as depicted in FIG. 10.

[0069] In these embodiments, the second tether 6 can pass freely through the second expandable support structure 10 at this stage in the procedure, allowing tension to be applied to the first expandable support 5 at the posterior aspect of the heart through the second tether 6 while the second expandable support structure is bottomed out with the introducer sheath 9. The tension applied to the linked tethers 6 and 4 acts to approximate the first expandable support 5 in the direction of the second expandable support 10 and to create a directional deformation vector D in the posterior wall of the LV. The second expandable support 10 is then secured to the second tether 6 (e.g., using a knot, fastener, clip, clasp, etc.), thereby securing the first tether 4, via an intervening component (i.e., the second tether 6), to a portion of the subject's body that is positioned anteriorly relative to the left ventricle, as depicted in FIG. 11 .

[0070] It should be noted that the first tether 4 can be secured either directly or indirectly (i.e., through one or more intervening components, including but not limited to the second tether 6) to a portion of the anteriorly positioned subject's body (e.g., the ventricular septum). For example, the second tether can be attached to the first tether in a manner that establishes tension in the first tether that pulls the first expandable support structure toward the second expandable support structure. Alternatively, if the connected tethers 6 and 4 are formed using a relatively long section of the first tether 4 and a relatively short section of the second tether 6, the entire second tether 6 can be pulled distally over the second expandable support 10, in which case the second expandable support 10 is directly secured to the first tether 4 (e.g., using a knot, fastener, clip, clasp, etc.), thereby directly securing the first tether 4 to a portion of the subject's body that is positioned anteriorly relative to the left ventricle.

[0071] The subsequent deformation of the LV wall creates a pulling deformation on the PM in the same direction, which opposes the tethering force in the tendon, loosening the tethering force and allowing the mitral valve leaflets to better coapt, repairing mitral valve dysfunction.

[0072] In alternative embodiments, the second expandable support 10 can be positioned in different anatomical locations, some examples of which are described below in connection with Figures 12-15.

[0073] 12 depicts one alternative location for the second expandable support 10 outside the RV on the anterior surface of the heart. The second expandable support 10 is placed using a procedure similar to that described above in connection with FIGS. 7-11, except that the second expandable support 10 is positioned on the outer surface of the right ventricle.

[0074] 13 depicts another option for anchoring the anterior hinge point by securing a second tether 6 to a rib or bone in the subject's chest. The tether can be secured to this location B by tying the tether around a rib, by attaching the tether to the bone with a screw, or by any other means. Notably, this embodiment does not presuppose a second expandable support.

[0075] 14 depicts another alternative location for the second expandable support 10 outside the LV (and RV) on the anterior surface of the heart. The second expandable support 10 is placed using a procedure similar to that described above in connection with FIGS. 7-11, except that the second expandable support 10 is positioned on the exterior surface of the anterior wall of the left ventricle.

[0076] Finally, Figure 15 depicts yet another alternative location for the second expandable support 10 inside the right atrium, in contact with the septal side of the tricuspid annulus above the interventricular septum. The second expandable support 10 is placed using a procedure similar to that previously described in connection with Figures 7-11, with the second expandable support 10 positioned within the right atrium in contact with the tricuspid annulus and the outer surface of the aortic arch at the location of the membranous septum and right fibrous trigone. This location may be particularly advantageous because the "roots" of the tendons are shaped to bias in a direction that can more effectively improve the tension the tendons exert on the mitral valve leaflets.

[0077] Placing the second expandable support 10 in this position can be performed by having the first practitioner push the second needle through the anterior wall of the LV so that it enters the RA just above the tricuspid annulus, and then pushing the needle through the outer wall of the subject's right atrium until a distal portion of the second tether passes through the outer wall of the right atrium and exits the heart. The second tether is then advanced distally until a first portion of the second tether exits the subject's body (e.g., between two ribs).

[0078] An introducer sheath is then advanced over the second tether into the RA, between the subject's ribs, through a puncture in the outer wall of the RA. In some embodiments, the second practitioner advances the second expandable support 10 over the second tether, through the introducer sheath, into the subject's body (i.e., proximally relative to the first practitioner), and into the right atrium. After the second expandable support 10 enters the right atrium and reaches the posterior wall of the RA directly above the tricuspid annulus, the second tether is coupled (e.g., using a knot, clip, etc.) to the first tether at this point in the procedure, resulting in a coupled tether configuration. The second expandable support structure 10 is then expanded (e.g., as described above in connection with the first expandable support structure 5) so that an area of ​​contact between the second expandable support structure 10 and the surface of the tricuspid annulus is formed adjacent the posterior wall of the RA. The remainder of the procedure is similar to that described above in connection with FIGS.

[0079] Section 2 The embodiments described in this section pull the papillary muscles (to which the tendons are attached) toward the right atrium, thereby reducing the pulling force the tendons exert on the valve leaflets. These embodiments also use techniques that are much less invasive than those used to install prior art coaptation devices.

[0080] Figure 18 shows a cross-sectional view of a healthy human heart from the anterior view, in which the left ventricle (LV), right ventricle (RV), left atrium (LA), right atrium (RA), mitral valve (MV), aortic valve (AO), and tricuspid valve (TV) are visible. Two chordae tendineae (CT) are attached to the posterior wall of the left ventricle via the papillary muscles (PM). Also, in the healthy subject depicted in Figure 18, the chordae tendineae do not prevent the mitral valve leaflets from closing.

[0081] FIG. 19 is a cross-section of a subject suffering from IMR caused by chronic changes in left ventricular structure, along the same cutaway view depicted in FIG. 18. In this subject, the posterior wall of the left ventricle is dilated, causing the papillary muscles to be displaced more posteriorly relative to the posterior wall in the healthy heart depicted in FIG. 18. This displacement increases the distance between the papillary muscles and the mitral valve leaflets. Also, because the mitral valve leaflets are tethered to the papillary muscles via tendons, the tendons in this subject in FIG. 19 prevent the mitral valve leaflets from fully closing, resulting in gap G.

[0082] This application discloses several techniques for moving the posterior wall of the left ventricle to more closely resemble the healthy human heart depicted in Figure 18. All of the techniques described in this section rely on positioning a support plate against the outer wall of the left ventricle and using a tether extending through the left ventricle to pull the support plate diagonally toward the right atrium.

[0083] 20-27 depict a first example of such a technique. It is envisioned (but not required) that the procedures described in this section will be performed by two practitioners. The first practitioner may be, for example, an interventional cardiologist with experience in accessing a subject's heart via a catheter introduced through the subject's vasculature. Notably, the terminology "distal" and "proximal" used in this section is with respect to the frame of reference of the first practitioner (i.e., the interventional cardiologist). The second practitioner may be, for example, a thoracic surgeon who knows how to access a subject's heart from outside the heart using surgical techniques, including minimally invasive surgical techniques.

[0084] A first practitioner inserts catheter 21 through the vascular system (e.g., by access gained through the jugular vein or other techniques) into the right atrium. Catheter 21 is navigated (e.g., using echo and / or fluoroscopic imaging) to the vicinity of the puncture area depicted in FIG. 20 and advanced so that a first needle 22 (e.g., made from metal) protrudes from catheter 21. First needle 22 is navigated and advanced to create a direct oblique puncture from the right atrium to the left ventricle, as shown in FIG. 21. The puncture is performed in a portion of the tricuspid annulus just above the interventricular septum, between the mitral and tricuspid annulus, as shown in FIG. 20. This puncture serves as a first passageway between the right atrium and the left ventricle.

[0085] Next, catheter 21 is further advanced into the left ventricle through the first passageway, and first needle 22 is advanced through catheter 21 to a location in the lateral wall of the LV near at least one of the left ventricular papillary muscles, more preferably between two left ventricular papillary muscles. First needle 22 is then pushed through the lateral wall of the LV to puncture it, as depicted in Figure 22, and exteriorized through the wall. The puncture in the lateral wall of the LV serves as a second passageway.

[0086] Notably, because first needle 22 is introduced from within the heart, it is relatively easy to align the first needle between the papillary muscles (e.g., using echo and / or fluoroscopic imaging). This is important because moving the papillary muscles moves the "roots" of the tendons closer to the mitral valve leaflets, meaning that the tendons either no longer prevent the leaflets from fully coapting or at least improve leaflet coaptation.

[0087] The first needle 22 is attached to a thin, strong polymer tether 23, and because of the very small profile of the puncture hole in the LV wall (combined with the fact that the puncture is sealed with the tether immediately after it is created), bleeding from the ventricle does not occur at the second puncture site. The first needle 22 in Figures 20-22 can be, for example, short (e.g., 3-5 cm) and rigid; longer (e.g., 10-20 cm) flexible needles, or other types of needles, may also be used. The details of attachment of the tether 23 to the needle 22 can be performed using any conventional technique.

[0088] Using common surgical techniques such as those often used in pulmonary surgical procedures, or using minimally invasive techniques such as those performed in many thoracic lung surgeries, a tether 23 is created between the patient's ribs and into the mediastinal cavity. A second practitioner, for example, captures first needle 22 (e.g., using forceps or a similar instrument) as it exits the ventricular wall. First needle 22 and tether 23 are then advanced (e.g., pulled) distally (relative to the first practitioner) until a first portion of first tether 23 exits the subject's body, such as through two adjacent ribs.

[0089] Next, the second practitioner secures the first support plate 24 to the tether 23 as depicted in FIG.

[0090] The first practitioner then pulls the tether 23 proximally through the catheter 21 to retract the tether 23. Meanwhile, the second practitioner guides the first support plate 24 (e.g., by rotating the first support plate 24 sideways so that the first support plate 24 fits into the mediastinal cavity through a minimally invasive incision between the ribs) so that the first support plate 24 passes smoothly through the ribs and into the subject's body. 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 (near the left ventricular papillary muscles), as depicted in FIG. 24 . The approach of the first support plate 24 to the second passageway can be assisted by manual manipulation by the second practitioner.

[0091] 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 may be curved to some degree, either convex or concave.

[0092] Next, the support rod 25 is advanced over the tether 23 through the vascular system until it contacts tissue between the right atrium and the left ventricle at the site of the puncture (as depicted in FIGS. 25 and 26 ). In some preferred embodiments, the support rod 25 is cylindrical. However, in alternative embodiments, the support rod 25 can have a different shape (e.g., semi-cylindrical, or a shape described below in connection with FIG. 40 ). The shape of the support rod 25 should allow it to be delivered via a catheter. The location of the support rod 25 after it is in place is depicted in FIG. 25 (cross-section of a view of the heart chamber) and FIG. 26 (cross-section of the heart valve plane). More specifically, the support rod 25 is positioned in the right atrium in contact with the septal portion of the tricuspid annulus and adjacent to the first passageway.

[0093] In some preferred embodiments, the support rod 25 has a through hole 25T through which the tether 23 is threaded, and the support rod 25 is then delivered to the right atrium by advancing the support rod 25 over the tether 23. In the illustrated embodiment, the through hole 25T is in the center of the support rod 25. However, in alternative embodiments, the through hole 25T may be offset from the center, for example, by up to 25% of the length of the support rod.

[0094] Next, a proximal pulling force is applied to tether 23 while maintaining the position of support bar 25 in contact with the tissue. The pulling force can be applied by pulling the portion of tether 23 that remains outside the subject's body in the proximal direction. The position of support bar 25 can be maintained by using a catheter-based tool to press support bar 25 against the tricuspid annulus. This creates tension in tether 23, which acts to pull first support plate 24 toward support bar 25, as depicted by arrow D in FIG. 27 .

[0095] The anatomical location of the contact area of ​​support bar 25 is in the center of the heart's fibrous skeleton, which is much more rigid than the cardiac muscle tissue at the anatomical location of first support plate 24. As such, tension in tether 23 acts to apply pull in direction D to the relatively soft sections of the ventricular wall that are the bases of the papillary muscles as shown in FIG. 27. The directional pull of the papillary muscles acts to relieve tension from the chordae tendineae of the mitral valve, allowing for better coaptation of the valve leaflets, thereby improving valve functionality.

[0096] When the desired improvement in valve functionality is achieved, the tether 23 is secured to the support rod 25, for example, using a knot or clip (not shown), to maintain tension between the first support plate 24 and the support rod 25 and to maintain improved hemodynamics. In some embodiments, the procedure is nearly complete after the knot is tied or the clip is deployed. In these embodiments, the portion of the tether 23 proximal to the knot or clip is cut and discarded, at which point the procedure is complete. In other embodiments, additional components may be deployed after the knot is tied / clip is deployed. Examples of these embodiments are described below in conjunction with FIGS. 31-36. In these embodiments, the portion of the tether 23 proximal to the knot / clip is not cut. Instead, that portion is used to connect to additional components, as described below in conjunction with FIGS. 31-36.

[0097] The embodiment of Figure 27 may be particularly advantageous because the "root" of the tendon is shaped such that it is biased in a direction that can effectively improve the tension that the tendon exerts on the leaflets of the mitral valve.

[0098] The embodiments described above in connection with Figures 20-27 assume a single tether 23 that is (a) initially advanced from the right atrium into the left ventricle, (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 the outer surface of the outer wall of the left ventricle adjacent the second passageway.

[0099] However, in an alternative set of embodiments, separate tethers may be used for the advancement and retraction functions. These embodiments begin in the same manner as described above in connection with Figures 20-23, including up to the point where a first portion of tether 23 exits the subject's body, for example, through two adjacent ribs. However, after this initial portion of the procedure, instead of securing first support plate 24 to the original tether 23 as depicted in Figure 23, a second, double tether 43 is looped back through two through-holes in support plate 34, as depicted in Figure 28.

[0100] The proximal end of double tether 43 is secured to the distal end of original tether 23, which is used to pull double tether 43 proximally all the way out of the subject's body through the original catheter 21 used to introduce needle 22 (as described above in connection with FIG. 21 ). More specifically, the proximal end of the double tether is first pulled proximally into the subject's left ventricle (via the second passageway), then pulled proximally into the subject's right atrium (via the first passageway), and then pulled proximally out of the subject's body via jugular venous access to the right atrium.

[0101] After the proximal end of double tether 43 exits the subject's body, the first practitioner threads each of the two ends of double tether 43 through a respective hole in support rod 35, as depicted in Figure 29. The first practitioner then advances support rod 35 distally over double tether 43 through the subject's vasculature until support rod 35 enters the right atrium and contacts tissue at the site of puncture between the right atrium and the left ventricle. Meanwhile, both the distal end of double tether 43 (looped through the two through-holes in support plate 34) as well as support plate 34 itself remain outside the subject's body.

[0102] In some preferred embodiments, the support rod 35 is cylindrical. In alternative embodiments, the support rod 35 can have a different shape (e.g., semi-cylindrical or a shape described below in connection with FIG. 40). The shape of the support rod 35 should allow it to be delivered via a catheter. The location of the support rod 35 after it is in place is similar to the location of the support rod 25 described above in connection with FIGS. 25 and 26. More specifically, the support rod 35 is positioned in the right atrium in contact with the septal portion of the tricuspid annulus and adjacent to the first passageway.

[0103] The first practitioner then retracts the double tether 43 and pulls the support plate 34 proximally through the catheter 21 to pull the support plate 34 proximally. Meanwhile, the second practitioner guides the support plate 34 (e.g., by rotating the support plate 34 sideways so that the support plate 34 fits into the mediastinal cavity through a minimally invasive incision between the ribs) so that the support plate 34 passes smoothly through the ribs and into the subject's body. 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 (near the left ventricular papillary muscles), similar to the position of the support plate 24 depicted in FIG. 24 . The approach of the support plate 34 to the second passageway can be assisted by manual manipulation by the second practitioner.

[0104] In some embodiments, the surface of the support plate 34 facing the outer wall of the left ventricle is completely flat, but in alternative embodiments, the surface may be curved to some degree, either convex or concave.

[0105] Next, a proximal pulling force is applied to the dual tether 43 while maintaining the position of the support bar 35 in contact with the tissue. The pulling force can be applied by pulling the portion of the dual tether 43 that remains outside the subject's body in the proximal direction. The position of the support bar 35 can be maintained by using a catheter-based tool to press the support bar 35 against the tricuspid annulus. This creates tension in the dual tether 43, which acts to pull the support plate 34 toward the support bar 35.

[0106] The anatomical location of the contact area of ​​support rod 35 is much more rigid relative to the cardiac muscle tissue at the anatomical location of support plate 34 (as previously described for support rod 25 in connection with FIGS. 25-27). Therefore, tension in dual tether 43 acts to apply pull to the relatively soft sections of the ventricular wall that are the base of the papillary muscles (similar to the situation previously described in connection with FIG. 27). The directional pull of the papillary muscles acts to relieve tension from the chordae tendineae of the mitral valve, allowing for better coaptation of the valve leaflets, thereby improving valve functionality.

[0107] When the desired improvement in valve functionality is achieved, the double tether 43 is secured to the support rod 35, as depicted in FIG. 30 , to maintain tension between the support plate 34 and the support rod 35 and to maintain improved hemodynamics. This can be accomplished using, for example, a knot or clip (not shown). In some embodiments, the procedure is nearly complete after the knot is tied or the clip is deployed. In these embodiments, the portion of the double tether 43 proximal to the knot or clip is cut and discarded, at which point the procedure is complete. In other embodiments, additional components can be deployed after the knot is tied / clip is deployed. In these embodiments, the portion of the double tether 43 proximal to the knot / clip is not cut. Instead, that portion is used to connect to additional components in a manner similar to the embodiment described below in connection with FIGS. 31-36.

[0108] Notably, in the embodiment previously described in connection with Figures 28-30, the original tether 23 (used for forward movement) and the double tether 43 (used for backward movement) are separate from each other, and the original tether 23 is used to thread the double tether 43 through both the first passage and the second passage.

[0109] Figures 31 and 32 depict two views of another embodiment in which the fixed location of the support rod 25 described above serves as an Archimedes' point for improving tricuspid valve functionality by relieving tension on the chordae tendineae of that valve. This embodiment begins as described above in connection with Figures 20-27, but includes the additional steps described below.

[0110] After the position of the support rod 25 is fixed, a second needle is connected to the proximal extension of the tether 23 and advanced into the right ventricle, creating a third puncture 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 the 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). The extension of the tether 23 is exteriorized through the outer wall of the right ventricle, and a second support plate 26 is advanced proximally over the tether through the ribs until it reaches the outer surface of the outer wall of the right ventricle adjacent to the third passageway. The second support plate is then pressed against the outer wall of the right ventricle, which moves the "root" of the right ventricular tendon into a position that improves coaptation of the tricuspid valve leaflets. The tether is then fastened to the second support plate 26 while under tension, for example, using a suitable clip or knot. It should be noted that in this example, a single tether 23 is depicted. The portion of this tether extending between support bar 25 and first support plate 24 is referred to in this section as the first tether, and the portion of the tether extending between support bar 25 and second support plate 26 is referred to in this section as the second tether. However, in alternative embodiments, two separate tethers may be used in place of a single tether.

[0111] In a variation of the embodiment of Figures 31 / 32, two separate tethers are used, one tether extending between the support rod 25 and the first support plate 24 and another second tether extending between the support rod 25 and the second support plate 26. This variation begins as previously described in connection with Figures 20-27, but includes the additional steps described below. A second needle is introduced into the right ventricle with the second tether secured to the second needle. The second needle is pushed through the anterior wall of the right ventricle at a location between the right ventricular papillary muscles of the subject to create a third passageway (similar to how the second passageway was created, as previously described). The second needle is advanced distally until a distal portion of the second tether exits the heart. The second tether is advanced distally until a portion of the second tether exits the subject's body. The second support plate 26 is secured to the second tether, for example, in a manner similar to the manner in which the first support plate 24 was secured to the first tether 23. The second tether is then retracted and moved proximally between the subject's ribs until the second support plate 26 reaches the outer surface of the outer wall of the right ventricle adjacent the third passageway. (This is similar to the manner in which the first support plate 24 was moved proximally until it reached the outer wall of the left ventricle, as described above.) The second tether is then pulled proximally to create tension, and the second tether is then secured to the support rod 25 while under tension (e.g., using a knot or clip inserted through an appropriate catheter).

[0112] Both of the previously described variations of the embodiment of Figures 31 / 32 can be combined with the dual tether embodiment previously described in connection with Figures 28-30. When this combination is implemented, a dual tether (instead of the single tether described in the two previous paragraphs) can be used to hold the second support plate against the exterior surface of the exterior wall of the right ventricle adjacent the third passageway. This can be accomplished, for example, using techniques similar to those previously described in connection with Figures 28-30.

[0113] Figures 33 and 34 depict two views of another embodiment in which the fixed location of the support rod 25 described above serves as an Archimedes' point for deforming the tricuspid valve annulus to improve valve coaptation. This embodiment begins as described above in connection with Figures 20-27, but includes the additional steps described below.

[0114] After the position of the support rod 25 is fixed, a second needle is connected to the proximal extension of the tether 23 and advanced into the right atrium, and a third puncture is made through the anterior lateral wall of the right atrium at a location above the tricuspid valve to create a third passageway. The extension of the tether 23 is exteriorized through the lateral wall of the right atrium, and the curved support member 27 is advanced proximally over the tether through the ribs until it reaches the lateral surface of the lateral wall of the right atrium adjacent the third passageway. The curved support member 27 has a curvature that conforms to the lateral wall of the right atrium. The curved support member 27 is then pressed against the lateral wall of the right atrium, which deforms the tricuspid valve annulus and improves coaptation of the tricuspid valve leaflets. The tether is then fastened to the curved support member 27 using, for example, an appropriate clip or knot in a tensioned position. Note that a single tether 23 is depicted in this example. The portion of this tether extending between support bar 25 and first support plate 24 is referred to in this section as the first tether, and the portion of the tether extending between support bar 25 and curved support member 27 is referred to in this section as the second tether. However, in alternative embodiments, two separate tethers may be used in place of a single tether.

[0115] In a variation of the embodiment of Figures 33 / 34, two separate tethers are used, one extending between the support bar 25 and the first support plate 24, and another extending between the support bar 25 and the curved support member 27. This variation begins as previously described in connection with Figures 20-27, but includes the additional steps described below. A second needle is introduced into the right atrium with the second tether secured to the second needle. The second needle is pushed through the anterior outer wall of the right atrium at a location above the tricuspid valve to create a third passageway. The second needle is advanced distally until a distal portion of the second tether exits the heart. The second tether is then advanced distally until a portion of the second tether exits the subject's body. A curved support member 27 is secured to the second tether. The curved support member 27 has a curvature that conforms to the outer wall of the right atrium. Next, the second tether is retracted and the curved support member 27 is moved proximally between the subject's ribs until the curved support member 27 reaches the outer surface of the outer wall of the right atrium adjacent the third passageway. The second tether is then pulled proximally to create tension, and the second tether is then secured to the support rod 25 while under tension.

[0116] Both of the previously described variations of the embodiment of Figures 33 / 34 can be combined with the dual tether embodiment previously described in connection with Figures 28-30. When this combination is implemented, dual tethers (instead of the single tether described in the two previous paragraphs) can be used to hold the curved support member against the outer surface of the outer wall of the right atrium adjacent the third passageway. This can be accomplished, for example, using techniques similar to those previously described in connection with Figures 28-30.

[0117] Figures 35 and 36 depict two views of another embodiment in which the fixed location of the support rod 25 described above serves as an Archimedes' point for deforming the mitral valve annulus to improve coaptation of the valve. This embodiment begins as described above in connection with Figures 20-27, but includes the additional steps described below.

[0118] After the position of the support rod 25 is fixed, a second needle is connected to the proximal extension of the tether 23 and introduced into the right atrium. The second needle is then advanced through the heart until it enters the left atrium. The second needle is then used to create a third puncture through the posterior lateral wall of the left atrium at a location above the mitral valve to create a third passageway. The extension of the tether 23 is exteriorized through the lateral wall of the left atrium, and the curved support member 28 is advanced proximally through the ribs over the tether until it reaches the lateral surface of the lateral wall of the left atrium adjacent the third passageway. The curved support member 28 has a curvature that conforms to the lateral wall of the left atrium. The curved support member 28 is then pressed against the lateral wall of the left atrium, which deforms the mitral valve annulus and improves coaptation of the mitral valve leaflets. The tether is then fastened to the curved support member 28 while under tension, for example, using an appropriate clip or knot. Note that a single tether 23 is depicted in this example. The portion of this tether extending between support bar 25 and first support plate 24 is referred to in this section as the first tether, and the portion of the tether extending between support bar 25 and curved support member 28 is referred to in this section as the second tether. However, in alternative embodiments, two separate tethers may be used in place of a single tether.

[0119] In a variation of the embodiment of Figures 35 / 36, two separate tethers are used, one extending between the support bar 25 and the first support plate 24, and another extending between the support bar 25 and the curved support member 28. This variation begins as previously described in connection with Figures 20-27, but includes the additional steps described below. A second needle is introduced into the right atrium with the second tether secured to the second needle. The second needle is advanced through the heart until it enters the left atrium and then pushed through the posterior outer wall of the left atrium at a location above the mitral valve to create a third passageway. The second needle is advanced distally until a distal portion of the second tether exits the heart. The second tether is then advanced distally 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 conforms to the outer wall of the left atrium. Next, the second tether is retracted and the curved support member 28 is moved proximally between the subject's ribs until the curved support member 28 reaches the outer surface of the outer wall of the left atrium adjacent the third passageway. The second tether is then pulled proximally to create tension, and the second tether is then secured to the support rod 25 while under tension.

[0120] Both of the previously described variations of the embodiment of Figures 35 / 36 can be combined with the dual tether embodiment previously described in connection with Figures 28-30. When this combination is implemented, a dual tether (instead of the single tether described in the two previous paragraphs) can be used to hold the curved support member against the outer surface of the outer wall of the left atrium adjacent the third passageway. This can be accomplished, for example, using techniques similar to those previously described in connection with Figures 28-30.

[0121] Figure 37 depicts the components of the embodiment of Figure 27 with symbols to indicate corresponding dimensions. Values ​​for various dimensions suitable for small, medium, and large adults are provided below in Table 1. All dimensions in Table 1 are in millimeters.

[0122] [Table 1]

[0123] Figure 38 depicts the components of the embodiment of Figure 31 with symbols to indicate corresponding dimensions. Values ​​for various dimensions suitable for small, medium, and large adults are provided above in Table 1.

[0124] Figure 39 depicts the components of the embodiment of Figure 33 with symbols to indicate corresponding dimensions. Values ​​for various dimensions suitable for small, medium, and large adults are provided above in Table 1.

[0125] In Figures 24-38, the support rod 25 is depicted as a straight cylinder. However, in alternative embodiments, the support rod need not be straight. Figure 40 depicts an embodiment that is similar to the embodiment of Figure 27, except that the straight support rod 25 from the embodiment of Figure 27 has been replaced with a curved support rod 29. The symbols in Figure 40 indicate corresponding dimensions, and values ​​for various dimensions suitable for small, medium, and large adults are provided above in Table 1.

[0126] FIG. 41 depicts an alternative embodiment for positioning a support plate against the exterior surface of the posterior wall of the heart near two left ventricular papillary muscles, and a second support rod in the right atrium of the heart against the surface of the tricuspid annulus of the heart adjacent the posterior wall of the right atrium with a tensioned tether connecting the support plate and the support rod.

[0127] This embodiment begins as previously described in connection with Figures 20-22, up to the point where a catheter is advanced into the left ventricle through a first passageway. A needle (similar to needle 22 previously described in connection with Figures 20-22) is advanced through catheter 51 to a location in the lateral wall of the LV near at least one of the left ventricular papillary muscles, and more preferably between two left ventricular papillary muscles. The needle is then pushed through the lateral wall of the LV (again, similar to needle 22 previously described in connection with Figures 20-22) to puncture the lateral wall of the LV. The puncture in the lateral wall of the LV serves as a second passageway.

[0128] A second, smaller catheter 52 incorporating a thin-walled bag at its distal end is threaded through catheter 51, through a second passageway, and over the needle, which is then pulled back and removed from the patient's body. The thin-walled bag is then expanded, spreading radially into a flat mushroom shape on the outside of the ventricular wall, as depicted in FIG. 41. The thin-walled bag is then filled with a hardening polymer that, upon solidification, becomes a rigid structural plate 54 attached to the tether. Details of how to form the rigid structural plate in this location, along with the attached tether, are described in U.S. Pat. No. 10,299,928, which is incorporated herein by reference in its entirety.

[0129] After the rigid structural plate 54 is formed and fully cured, a support rod is advanced over a tether attached to the rigid structural plate 54. The installation of this support rod (and the nature of the support rod itself) may be similar to the support rod 25 described above in connection with Figures 25-27.

[0130] In the previously described embodiments, the various passageways (e.g., first passageway, 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, creating the various passageways and pushing the needle through those passageways occurs simultaneously. However, in alternative embodiments, any of these passageways may be created first (e.g., using an RF needle), and then the needle may be pushed through the passageway.

[0131] Finally, it is important to note that the use of identifiers (a), (b), (c), (d), etc. in the following claims does not imply a specific temporal sequence of the corresponding steps. While step (a) can, of course, precede step (b) in time, different sequences of those steps are also possible, unless the specific sequence is inconsistent with the language in the various steps or other language in the claims. For example, a step labeled (b) may precede in time a step labeled (a). Two or more steps may occur simultaneously or overlap to some extent, unless the simultaneousness or overlap is inconsistent with the language in the various steps or other language in the claims.

[0132] While the present invention has been disclosed with reference to particular embodiments, numerous improvements, modifications, and variations to the described embodiments are possible without departing from the sphere and scope of the invention as defined in the appended claims. Accordingly, it is intended that the invention not be limited to the described embodiments, but that the invention have its full scope defined by the language of the following claims and their equivalents. [Explanation of symbols]

[0133] 1 catheter 2 First Needle 3. First location, first puncture site 4. First Tether 5 First expandable support, first expandable support structure 6 Second Tether 7. Second Place 8. Location 9 Introducer sheath 10 second expandable support, second expandable support structure 11. Plastic Bags 12 Skeleton, Arm 13 tube 21 Catheter 22 First Needle 23 Tether 24 First support plate 25 Support rod 25T through hole 26 Second support plate 27, 28 Curved support members 29 Curved support rod 34 Support plate 35 Support rod 43 Second Double Tether 51 Catheter 52 Second, smaller catheter 54 Rigid structural plate AO aortic valve B Tether fixing point CT chordae tendineae D deformation vector G Gap H1 Height of curved support member 27 H2 Height of support rod 29 L1, L2, L3 Tether 23 Length LA Left atrium LV left ventricle MV mitral valve PM papillary muscle R1 Radius of curved support member 27 R2 Radius of support rod 29 RA right atrium RV right ventricle TV Tricuspid valve

Claims

1. 1. A method for improving 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; creating a first passageway between the right atrium and the left ventricle at a septal portion of the tricuspid annulus immediately above the interventricular septum; creating a second passageway through the outer wall of the left ventricle near at least one of the left ventricular papillary muscles; positioning a support rod within the right atrium in contact with a septal portion of the tricuspid annulus; positioning a first support plate against the exterior wall of the left ventricle adjacent the second passageway; pulling the first support plate toward the support bar using a first tether under tension, the first tether extending between the first support plate and the support bar and passing through both the first passage and the second passage, with a first end of the first tether secured to the first support plate; A method comprising:

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

3. The method of claim 1 , wherein a second end of the first tether is fixed to the support bar.

4. The first support plate is 3 to 13 cm 2 and has an area of The method of claim 1, wherein the support rod has a length of 10 to 20 mm and a width of 3 to 8 mm.

5. The first support plate is 4 to 16 cm 2 and has an area of 2. The method of claim 1, wherein the support rod has a length of 15 to 25 mm and a width of 3 to 8 mm.

6. The first support plate is 7 to 20 cm 2 and has an area of 2. The method of claim 1, wherein the support rod has a length of 20 to 30 mm and a width of 3 to 8 mm.

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

8. creating a third passageway through the 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 the third passageway; pulling the second support plate toward the support bar using a second tether under tension, the second tether extending between the second support plate and the support bar, a first end of the second tether secured to the second support plate; The method of claim 1 further comprising:

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

10. positioning a second support member against the outer wall of the heart at a second location adjacent the posterior leaflet of the mitral valve; pulling the second support member toward the support bar using a second tether under tension, the second tether extending between the second support member and the support bar, a first end of the second tether secured to the second support member; The method of claim 1 further comprising:

11. 1. A method of improving 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; (a) introducing a first needle into the right atrium with a first advancement tether secured to the first needle; (b) creating a first passageway between the right atrium and the left ventricle through the cardiac skeleton at a location just above the interventricular septum and pushing the first needle through the first passageway into the left ventricle; (c) creating a second passageway through the exterior 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 distally until a distal portion of the first advancement tether exits the heart; (e) advancing the first advancement tether distally until a portion of the first advancement tether exits the subject's body; (f) securing a first support plate to a first retraction tether that is threaded through both the first passage and the second passage; (g) retracting the first retraction tether and moving the first support plate proximally between the subject's ribs until the first support plate reaches an outer surface of the outer wall of the left ventricle adjacent the second passageway; positioning a support rod within the right atrium adjacent the first passageway; After steps (a)-(g), pulling the first retraction tether proximally while the support bar is positioned adjacent the first passageway, and subsequently securing the first retraction tether to the support bar while under tension. A method comprising:

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

13. 12. The method of claim 11, wherein the first forward tether and the first retraction tether are separate from each other, and the first forward tether is used to thread the first retraction tether through both the first passage and the second passage.

14. introducing a second needle into the right ventricle with a second tether secured to the second needle; creating a third passageway through an outer wall of the right ventricle of the subject at a location between the right ventricular papillary muscles and pushing the second needle through the third passageway; advancing the second needle distally until a distal portion of the second tether exits the heart; advancing the second tether distally until a portion of the second tether exits the subject's body; advancing a second support plate proximally over the second tether until the second support plate reaches an outer surface of the outer wall of the right ventricle adjacent the third passageway; pressing the second support plate against the outer wall of the right ventricle; fixing a portion of the second tether to the second support plate and another portion of the second tether to the support rod so that the second tether is under tension; 12. The method of claim 11, further comprising:

15. introducing a second needle into the right ventricle with a second advancement tether secured to the second needle; creating a third passageway through an outer wall of the right ventricle of the subject at a location between the right ventricular papillary muscles and pushing the second needle through the third passageway; advancing the second needle distally until a distal portion of the second advancement tether exits the heart; advancing the second advancement tether distally until a portion of the second advancement tether exits the subject's body; securing a second support plate to a second retraction tether that is threaded through the third passage; retracting the second retraction tether and moving the second support plate proximally between the subject's ribs until the second support plate reaches an outer surface of the outer wall of the right ventricle adjacent the third passageway; pulling the second retraction tether proximally and subsequently securing the second retraction tether to the support bar while under tension; 12. The method of claim 11, further comprising:

16. introducing a second needle into the right atrium with a second tether secured to the second needle; creating a third passageway through the anterior lateral 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 distally until a distal portion of the second tether exits the heart; advancing the second tether distally until a portion of the second tether exits the subject's body; advancing a curved support member proximally over the second tether until the curved support member reaches an outer surface of the outer wall of the right atrium adjacent the third passageway, the curved support member having a curvature that conforms to the outer wall of the right atrium; pressing the curved support member against the outer wall of the right atrium; fixing a portion of the second tether to the curved support member and another portion of the second tether to the support bar so that the second tether is under tension; 12. The method of claim 11, further comprising:

17. introducing a second needle into the right atrium with a second advancement tether secured to the second needle; creating a third passageway through the anterior lateral 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 distally until a distal portion of the second advancement tether exits the heart; advancing the second advancement tether distally until a portion of the second advancement tether exits the subject's body; securing a curved support member to a second retraction tether threaded through the third passage, the curved support member having a curvature that conforms to the outer wall of the right atrium; retracting the second retraction tether and moving the curved support member proximally between the subject's ribs until the curved support member reaches an outer surface of the outer wall of the right atrium adjacent the third passageway; pulling the second retraction tether proximally and subsequently securing the second tether to the support bar while under tension; 12. The method of claim 11, further comprising:

18. introducing a second needle into the right atrium with a second tether secured to the second needle; advancing the second needle through the heart until the second needle enters the left atrium; creating a third passageway through the posterior lateral 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 distally until a distal portion of the second tether exits the heart; advancing the second tether distally until a portion of the second tether exits the subject's body; advancing a curved support member proximally over the second tether until the curved support member reaches an outer surface of the outer wall of the left atrium adjacent the third passageway, the curved support member having a curvature that conforms to the outer wall of the left atrium; pressing the curved support member against the outer wall of the left atrium; fixing a portion of the second tether to the curved support member and another portion of the second tether to the support bar so that the second tether is under tension; 12. The method of claim 11, further comprising:

19. introducing a second needle into the right atrium with a second advancement tether secured to the second needle; advancing the second needle through the heart until the second needle enters the left atrium; creating a third passageway through the posterior lateral 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 distally until a distal portion of the second advancement tether exits the heart; advancing the second advancement tether distally until a portion of the second advancement tether exits the subject's body; securing a curved support member to a second retraction tether threaded through the third passage, the curved support member having a curvature that conforms to the outer wall of the left atrium; retracting the second retraction tether and moving the curved support member proximally between the subject's ribs until the curved support member reaches an outer surface of the outer wall of the left atrium adjacent the third passageway; pulling the second retraction tether proximally and subsequently securing the second tether to the support bar while under tension; 12. The method of claim 11, further comprising:

20. 1. A device for ameliorating mitral valve regurgitation in a heart within the body of a subject, comprising: a support rod positioned within the subject's right atrium adjacent to a first passageway extending between the subject's right atrium and the subject's left ventricle, the first passageway being located immediately above the subject's interventricular septum; and a first support plate positioned against an outer surface of the subject's left ventricle adjacent to a second passageway extending through an outer wall of the subject's left ventricle, the second passageway being positioned between the subject's left ventricular papillary muscles; a first tether extending between the support rod and the first support plate and passing through both the first passage and the second passage; Equipped with a first portion of the first tether is fixed to the support rod, and a second portion of the first tether is fixed to the first support plate; The first tether is under tension such that the first support plate is pulled toward the support bar.

21. The first support plate is 3 to 13 cm 2 and has an area of The support rod has a length of 10 to 20 mm and a width of 3 to 8 mm; 21. The device of claim 20, wherein the first tether has a length of 60 to 85 mm.

22. The first support plate is 4 to 16 cm 2 and has an area of The support rod has a length of 15 to 25 mm and a width of 3 to 8 mm; 21. The device of claim 20, wherein the first tether has a length of 65 to 90 mm.

23. The first support plate is 7 to 20 cm 2 and has an area of The support rod has a length of 20 to 30 mm and a width of 3 to 8 mm; 21. The device of claim 20, wherein the first tether has a length of 70 to 95 mm.

24. a second support plate positioned against an outer surface of the outer wall of the right ventricle of the subject adjacent to a third passageway extending through the outer wall of the right ventricle of the subject, the second passageway being positioned between the right ventricular papillary muscles of the subject; a second tether extending between the support rod and the second support plate and passing through the third passage; Furthermore, a first portion of the second tether is fixed to the support rod, and a second portion of the second tether is fixed to the second support plate; 21. The apparatus of claim 20, wherein the second tether is under tension such that the second support plate is pulled toward the support bar.

25. a curved support member positioned against an outer surface of the outer wall of the subject's right atrium adjacent to a third passageway extending through the outer wall of the right atrium, the third passageway being positioned over the subject's tricuspid valve; a second tether extending between the support bar and the curved support member and passing through the third passage; Furthermore, a first portion of the second tether is secured to the support bar and a second portion of the second tether is secured to the curved support member; 21. The device of claim 20, wherein the second tether is under tension such that the curved support member is pulled toward the support bar.

26. a curved support member positioned against an outer surface of the outer wall of the subject's left atrium adjacent to a third passageway extending through the outer wall of the left atrium, the third passageway being positioned over the subject's mitral valve; a second tether extending between the support bar and the curved support member and passing through the third passage; Furthermore, a first portion of the second tether is secured to the support bar and a second portion of the second tether is secured to the curved support member; 21. The device of claim 20, wherein the second tether is under tension such that the curved support member is pulled toward the support bar.

27. 1. An apparatus for improving mitral valve regurgitation in a heart within a body of a subject, the heart having two left ventricular papillary muscles, each of the left ventricular papillary muscles having a respective center; a support plate positioned against the exterior surface of the posterior wall of the heart at a location within 3 cm of the midpoint between the centers of the two left ventricular papillary muscles; a support rod positioned within the right atrium of the heart against a surface of the tricuspid annulus of the heart adjacent the posterior wall of the right atrium; a tether extending between the support plate and the support rod, the tether being under tension so that the support plate is pulled toward the support rod; An apparatus comprising:

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

29. 28. 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. 30. The apparatus of claim 29, wherein the support rod is formed by injecting a second liquid material into a second polymer bag and allowing the second liquid material to solidify.

31. The area of ​​contact between the support plate and the outer surface of the rear wall is at least 2 cm 2 28. The device of claim 27, having an area of

32. The area of ​​contact between the support plate and the outer surface of the rear wall is at least 5 cm 2 28. The device of claim 27, having an area of

33. The area of ​​contact between the support plate and the outer surface of the rear wall is 6 cm 2 15cm from 2 28. The device of claim 27, having an area between

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