Equipment for mitral valve repair and its usage

Abstract

This invention provides an apparatus for repairing heart valves and a method for implanting anchors and repairing heart valves. The apparatus includes: a body; a component attached to the body at a first end and having a plurality of positioning cords extending laterally across a space between the component and away from a second end of the component opposite to the first end; a tube suspended from the plurality of positioning cords; and an adjustment cord extending through the tube. The method includes: implanting at least one annular anchor into the mitral valve annulus of a heart valve; implanting papillary anchors through each papillary muscle of the heart; delivering and positioning the apparatus for repairing the heart valve within the heart valve using at least one annular anchor and papillary anchors; and adjusting the apparatus to adjust the degree of atrial displacement of the mitral valve leaflets during ventricular systole.

Description

Technical Field

[0001] This invention relates to a device for repairing heart valves and a method of using the same. Specifically, this invention relates to a device for repairing the mitral valve and a method of using the same. Background Technology

[0002] The mitral valve is the most complex and frequently affected of the human heart valves. Conditions affecting normal mitral valve function include mitral regurgitation, mitral valve prolapse, and mitral stenosis. Mitral regurgitation occurs when the mitral valve leaflets fail to fully coapt during ventricular systole, leading to abnormal blood leakage from the left ventricle into the left atrium. Mitral valve prolapse occurs when the mitral valve leaflets become abnormally thickened and protrude into the left atrium, causing abnormal mitral valve function. Mitral stenosis occurs when the mitral valve narrows, obstructing normal blood flow. Many factors can affect the normal function of the mitral valve leaflets.

[0003] While moderate mitral valve dysfunction may not require treatment, severe mitral valve dysfunction can lead to symptoms such as shortness of breath, fatigue, and inability to exercise, and can threaten life expectancy. In such cases, invasive surgery is usually necessary to repair or replace the dysfunctional mitral valve.

[0004] Traditionally, repairing or replacing the mitral valve involves open-heart surgery. Open-heart surgery carries risks of morbidity and mortality and requires a recovery period that typically lasts several months. It carries contraindications and is not the optimal choice for certain patients, including some elderly patients and those with pre-existing health conditions. For these patients, an attractive alternative is to repair or replace the mitral valve without invasive open-heart surgery.

[0005] The foregoing examples and related limitations of the related art are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those skilled in the art upon their study of this specification and the accompanying drawings. Summary of the Invention

[0006] The following embodiments and aspects of the invention are described and illustrated by reference to exemplary and illustrative systems, tools, and methods, but the scope of the invention is not limiting. In various embodiments, one or more of the foregoing problems have been reduced or eliminated, while other embodiments involve other improvements.

[0007] One aspect of the present invention provides a device for repairing a heart valve. The device includes: a body; a component attached to the body at a first end and having a plurality of positioning cords extending laterally across a space between the component and away from a second end of the component opposite to the first end; a tube suspended from the plurality of positioning cords; and an adjusting cord extending through the tube. The plurality of positioning cords extend laterally across the tube space. The tube can be lengthened or shortened by adjusting the tension of the adjusting cord.

[0008] In some embodiments, the component has a mesh structure. The mesh structure may be defined by a plurality of cells. The plurality of cells extend radially and longitudinally from the body to the positioning rope. In some embodiments, the plurality of cells have a rhomboid shape. In some embodiments, the plurality of cells have a square or rectangular shape.

[0009] In some embodiments, adjusting the tension of the adjusting rope lengthens or shortens the tube, thus displacing the tube toward or away from the body, thereby causing a corresponding displacement of the component.

[0010] In some embodiments, the length of each positioning rope is selected to suspend the tube from the component in a parabolic or parabolic shape.

[0011] In some embodiments, the tube is thus extended such that the apex of the tube, which has a parabolic or parabolic shape, is displaced toward the body.

[0012] In some embodiments, the tube is thus shortened so that the vertex of the tube, which has a parabolic or quasi-parabolic shape, is thus displaced away from the body.

[0013] In some embodiments, the device includes a surrounding member that can be connected to the body for radially compressing and / or radially expanding the body.

[0014] In some embodiments, the body includes a plurality of peaks and a plurality of valleys, the peaks and valleys being interchangeably defined along the diameter of the body.

[0015] In some embodiments, the body includes a plurality of ring members, each of which is positioned on a corresponding peak.

[0016] In some embodiments, the surrounding member passes through multiple ring members.

[0017] In some embodiments, the body defines at least one anchoring portion.

[0018] In some embodiments, the body includes a skirt.

[0019] In some embodiments, the skirt defines at least one anchoring portion.

[0020] In some embodiments, the device is configured to extend from the atrial wall and mitral valve annulus to the anterolateral and posteromedial papillary muscles of the heart valve when the device is implanted in the heart valve.

[0021] In some embodiments, the component includes a front component attached to the front end of the body.

[0022] In some embodiments, the component includes a rear component attached to the rear end portion of the body.

[0023] In some embodiments, the anterior member is configured to cover the anterior leaflet of the mitral valve when the device is implanted into the heart valve.

[0024] In some embodiments, the rear member is configured to cover the posterior leaflet of the mitral valve when the device is implanted into the heart valve.

[0025] In some embodiments, the component includes a biocompatible and blood-permeable material that allows blood to pass through.

[0026] Another aspect of the invention provides a ring-shaped anchor comprising an anchoring pin, a tether connected to the anchoring pin, and a guidewire connected to the tether. The guidewire is at least long enough to traverse the patient's circulatory system from the mitral valve annulus to reach the entry and exit points of the patient's circulatory system.

[0027] In some embodiments, the anchor pin comprises a shape memory material.

[0028] In some embodiments, the anchoring pin includes a deformable configuration for advancing the anchor within the catheter through the patient's circulatory system.

[0029] In some embodiments, the anchoring pin includes a pre-deformed configuration for anchoring the anchor in the annular tissue of the heart.

[0030] Another aspect of the present invention provides an annular anchoring catheter, the annular anchoring catheter comprising a catheter body and a sensor attached to the body, the sensor being used to detect contact between the catheter and the annular wall of the mitral valve annulus of the heart.

[0031] In some embodiments, the catheter includes a needle that is housed within the catheter body and configured to retain an annular anchor.

[0032] Another aspect of the present invention provides a method for implanting an annular anchor. The method includes: advancing a catheter to an anchoring site located on the annular wall of the mitral valve annulus of the heart; detecting contact between the catheter and the anchoring site; and advancing the annular anchor from the catheter and embedding the annular anchor into the mitral valve annulus.

[0033] In some embodiments, advancing the annular anchor includes advancing a needle containing the annular anchor through the annular wall and advancing the annular anchor from the needle to embed the annular anchor into the mitral valve annulus.

[0034] Another aspect of the invention provides a nipple-shaped anchor comprising an anchoring pin, at least one ligature connected to the anchoring pin, and a guidewire connected to each ligature. Each guidewire is at least long enough to traverse the patient's circulatory system from the papillary muscle to reach the entry and exit points of the patient's circulatory system.

[0035] In some embodiments, the anchor pin comprises a shape memory material.

[0036] In some embodiments, the anchoring pin includes a deformable configuration for advancing the anchor within the catheter through the patient's circulatory system.

[0037] In some embodiments, the anchoring pin includes a pre-deformed configuration for securing the anchor through the papillary muscles of the heart.

[0038] Another aspect of the invention provides a nipple-like anchor conduit comprising: a body configured to receive a nipple-like anchor; an arm extending away from the body; and a receiver connected to the arm for receiving the nipple-like anchor. The body, arm, and receiver define an opening configured to receive a papillary muscle.

[0039] In some embodiments, the receiver is detachable from the arm.

[0040] In some embodiments, the arm is retractable within the body.

[0041] In some embodiments, the body includes a retaining pin that extends from the body to close the opening.

[0042] In some embodiments, the retaining pin can be retracted within the body to open the opening.

[0043] In some embodiments, the conduit includes a controller for externally operating one or more of the retaining pins and arms.

[0044] Another aspect of the present invention provides a method for implanting a nipple anchor. The method includes: advancing a nipple anchor catheter in a closed configuration through a patient's circulatory system to a nipple muscle; opening the catheter to receive the nipple muscle; positioning the nipple muscle within the opening; advancing the nipple anchor through the nipple muscle from the catheter; receiving the anchor pin of the nipple anchor by means of a receiver of the catheter; detaching the receiver from the catheter, thereby implanting the nipple anchor into the nipple muscle and securing it to the nipple muscle by means of the receiver; and withdrawing the catheter from the patient's circulatory system.

[0045] In some embodiments, the method includes: advancing a retaining pin at least partially through the nipple muscle to stabilize the nipple muscle before advancing the nipple-shaped anchor through the nipple muscle.

[0046] In some embodiments, the method includes retracting the retaining pin before withdrawing the catheter from the patient's circulatory system.

[0047] Another aspect of the invention provides a nipple-shaped anchor conduit comprising a body configured to receive a nipple-shaped anchor and a deformable arm extending away from the body.

[0048] In some embodiments, the body includes a needle for receiving a nipple-shaped anchor and for advancing the nipple-shaped anchor through the nipple muscle.

[0049] In some embodiments, the arm includes a tension line that extends longitudinally through the arm to deform the arm in deformable and extended configurations by applying tension to the line.

[0050] In some embodiments, the arm includes a plurality of linearly arranged modular members, wherein a tension line extends through the plurality of modular members to deform the arm by applying tension to the tension line.

[0051] In some embodiments, the catheter includes a controller for externally operating one or more of the needle and tension line.

[0052] Another aspect of the present invention provides a method for implanting a nipple anchor. The method includes: advancing a nipple anchor catheter in an extended configuration through a patient's circulatory system to a nipple muscle; deforming the catheter into a deformed configuration to at least partially surround the nipple muscle; advancing the nipple anchor from the catheter through the nipple muscle; extending the catheter into the extended configuration; and withdrawing the catheter from the patient's circulatory system in the extended configuration.

[0053] Another aspect of the present invention provides a nipple-shaped anchor conduit including a body, a deformable arm extending from the body, and an anchor housing extending through the body and the arm, wherein the anchor housing is configured to receive a nipple-shaped anchor.

[0054] In some embodiments, the catheter includes a guidewire that extends alongside the arm through the body, wherein the guidewire is extendable and retractable from the body.

[0055] In some embodiments, the guidewire is long enough to traverse the patient's circulatory system from the papillary muscle to the entry and exit points of the patient's circulatory system.

[0056] In some embodiments, the arm includes at least one deformable segment.

[0057] In some embodiments, the arm includes a first deformable segment deformable in a first plane and a second deformable segment deformable in a second plane.

[0058] In some embodiments, the first deformable segment can deform in a first plane along a first direction from about 0° to about 120°.

[0059] In some embodiments, the second deformable segment can deform in the second plane along the second direction from about 0° to about 90° and in the second plane along the third direction from about 0° to about -90°.

[0060] In some embodiments, the first direction and the second direction are not coplanar.

[0061] In some embodiments, the catheter includes a controller for externally manipulating one or more of a guidewire, a first deformable segment, and a second deformable segment.

[0062] Another aspect of the present invention provides a method for implanting a nipple anchor. The method includes: advancing a nipple anchor catheter in an extended configuration through a patient's circulatory system to the nipple muscle; deforming the catheter in a first direction into a deflection configuration; advancing a guidewire to at least partially surround the nipple muscle; deforming the catheter in a second direction into a deformed configuration; advancing the catheter along the guidewire to at least partially surround the nipple muscle by means of the catheter; advancing the nipple anchor from the catheter through the nipple muscle; and withdrawing the catheter from the patient's circulatory system in the extended configuration.

[0063] In some embodiments, advancing the nipple-shaped anchor through the papillary muscle includes advancing the nipple-shaped anchor from the entrance portion of the papillary muscle through the lateral dimension of the papillary muscle to the exit portion of the papillary muscle.

[0064] In some embodiments, advancing the nipple-shaped anchor through the papillary muscle further includes receiving the anchor tip of the nipple-shaped anchor via a receiver of a conduit adjacent to the outlet site.

[0065] In some embodiments, withdrawing the catheter includes extending the catheter into an extension configuration.

[0066] Another aspect of the present invention provides a method for repairing a heart valve. The method includes: implanting at least one annular anchor into the mitral valve annulus of the heart valve; implanting a papillary anchor through each papillary muscle of the heart; delivering and positioning a device for repairing the heart valve within the heart valve using at least one annular anchor and papillary anchors; and adjusting the device to adjust the degree of atrial displacement of the mitral valve leaflet during ventricular systole.

[0067] In some embodiments, the delivery device includes: externally connecting one or more guidewires for each annular anchor and one or more guidewires for each papillary anchor to the device, and advancing the device along the guidewires to the heart valve.

[0068] In some embodiments, the delivery device further includes: advancing one or more guidewires for each annular anchor through the body of the device from the outside, and advancing the body of the device into the atrial wall of the mitral valve annulus of the heart valve.

[0069] In some embodiments, the delivery device includes: at least one compressible tube that advances one or more guidewires for each papillary anchor from the outside through the device, and that advances at least one tube to extend in a parabolic or quasi-parabolic configuration between the papillary muscles of the heart valve.

[0070] In some embodiments, positioning the device within a heart valve includes adjusting the length of at least one tube to position the device to cover the atrial surface of at least one mitral leaflet of the heart valve.

[0071] In some embodiments, positioning the device within a heart valve further includes adjusting the length of at least one tube to adjust the position of at least one blood-permeable component of the device to adjust the degree of atrial displacement of at least one mitral valve leaflet during ventricular systole.

[0072] In some embodiments, the delivery device includes: a first compressible tube for advancing a first guidewire of each papillary anchor through the device from the outside and a second compressible tube for advancing a second guidewire of each papillary anchor through the device; and advancing the first tube and the second tube along the first guidewire and the second guidewire such that the first tube and the second tube extend in a parabolic or quasi-parabolic configuration between the papillary muscles of the heart valve.

[0073] In some embodiments, positioning the device within the heart valve further includes adjusting the length of the first tube to position the front component of the device to cover the atrial surface of the anterior leaflet of the heart valve.

[0074] In some embodiments, positioning the device within the heart valve further includes adjusting the length of the first tube to adjust the position of the anterior member to adjust the degree of atrial displacement of the anterior leaflet of the mitral valve during ventricular systole.

[0075] In some embodiments, positioning the device within the heart valve further includes adjusting the length of the second tube to position the rear component of the device to cover the atrial surface of the posterior leaflet of the heart valve.

[0076] In some embodiments, positioning the device within a heart valve includes adjusting the length of the second tube to adjust the position of the posterior member to adjust the degree of atrial displacement of the posterior leaflet of the mitral valve during ventricular systole.

[0077] In some embodiments, the method includes securing the device to the atrial wall of a heart valve.

[0078] In some embodiments, the method includes securing the device to each papillary muscle of the heart valve.

[0079] In some embodiments, securing the device to the atrial wall includes: advancing a locking member in an open configuration to an anchoring location of the device and positioning the locking member in a locked configuration adjacent to the atrial wall at each anchoring location.

[0080] In some embodiments, securing the device to the nipple muscle includes: advancing the locking member in the open configuration along each nipple-shaped anchor and positioning the locking member in the locked configuration adjacent to the nipple muscle.

[0081] Another aspect of the invention provides a locking member comprising: a body defining opposing jaws; and a channel extending longitudinally through the body between the jaws. The locking member is deformable in an open configuration by deflecting the jaws away from each other.

[0082] In some embodiments, the gripper defines a recess that is concentrically shaped around the channel and configured to receive a collar for retaining the locking member in a locking configuration.

[0083] In some embodiments, the collar includes at least one notch configured to engage the locking conduit.

[0084] In some embodiments, the body defines a groove that is concentrically shaped around the channel and configured to engage the locking conduit.

[0085] In some embodiments, each gripper includes a set of teeth.

[0086] Another aspect of the present invention provides a locking conduit, the locking conduit comprising a sleeve, a locking tube, and a deployment tube. The sleeve accommodates the locking tube, and the locking tube accommodates the deployment tube.

[0087] In some embodiments, the catheter includes a needle that extends through a channel defined by a deployment tube.

[0088] In some embodiments, the sleeve defines a notch for engaging the locking element.

[0089] Another aspect of the invention provides a method for securing a device within a heart valve. The method includes: advancing a locking member in an open configuration along a guidewire to a locking position; and advancing a collar along the locking member at the locking position to lock the locking member in a closed configuration.

[0090] In addition to the exemplary aspects and embodiments described above, further aspects and embodiments will become apparent from reference to the accompanying drawings and from studying the following detailed description. Attached Figure Description

[0091] Exemplary embodiments are illustrated in the accompanying drawings. The embodiments and drawings disclosed herein are intended to be illustrative rather than restrictive.

[0092] Figure 1 This is a top-section sectional view of the heart, showing the normal coaptation of the mitral valve.

[0093] Figure 2 yes Figure 1 The image shows a side sectional view of the heart.

[0094] Figure 3 This is a lateral sectional view of the heart, showing the prolapse of the posterior leaflet of the mitral valve.

[0095] Figure 4A This is a top rear perspective view of the device according to an exemplary embodiment of the present invention.

[0096] Figure 4B yes Figure 4A The device shown is a partial top-rear perspective view.

[0097] Figure 4C yes Figure 4A The device shown is a partial top-down front perspective view.

[0098] Figure 4D yes Figure 4A The rear view of the device shown.

[0099] Figure 4E yes Figure 4A The device shown is a side view.

[0100] Figure 4F yes Figure 4A The device shown is shown in top view.

[0101] Figure 4G yes Figure 4A The diagram shows a partial rear view of the device, where tension is released from the rope, thereby expanding and lengthening the tube.

[0102] Figure 4H yes Figure 4A The diagram shows a partial rear view of the device, in which the rope is tensioned, thereby compressing and shortening the tube.

[0103] Figure 5A yes Figure 1 The image shows a cross-sectional perspective view of the heart.

[0104] Figure 5B yes Figure 5A The image shows a cross-sectional perspective view of the heart, illustrating the normal mitral valve occlusion.

[0105] Figure 5C yes Figure 5A The cross-sectional perspective view of the heart shown, in which, Figure 4A The device shown advances into the mitral valve and is anchored to the papillary muscle.

[0106] Figure 5D yes Figure 5C The image shows a cross-sectional perspective view of the heart and the device, in which the device is adjusted to match the mitral valve.

[0107] Figure 5E yes Figure 5C The image shows a cross-sectional top view of the heart and the device, in which the device is anchored to the mitral valve annulus.

[0108] Figure 6A This is a side view of an annular anchor conduit according to an exemplary embodiment of the present invention, the annular anchor conduit facing... Figure 1 The annular wall of the heart is shown advancing.

[0109] Figure 6B yes Figure 6A The image shows a side view of the heart and catheter, with the needle advancing into the annular wall of the heart.

[0110] Figure 6C yes Figure 6A The image shows a side view of the heart and catheter, the catheter having an anchor according to an exemplary embodiment of the invention that extends from the needle.

[0111] Figure 6D yes Figure 6C The image shows a side view of the heart, catheter, and anchor, with the anchor advancing from the needle.

[0112] Figure 6E yes Figure 6C The image shows a side view of the heart, catheter, and anchor, with the anchor implanted in the mitral valve annulus of the heart.

[0113] Figure 6F yes Figure 6C The image shows a side view of the heart, catheter, and anchor, with the anchor inserted into the mitral valve annulus of the heart and the needle retracted into the catheter.

[0114] Figure 6G yes Figure 6C The image shows a side view of the heart, catheter, and anchor, with the anchor inserted into the mitral valve annulus of the heart and the catheter retracted from the annular wall of the heart.

[0115] Figure 7A This is a side view of an anchor according to an exemplary embodiment of the present invention.

[0116] Figure 7B yes Figure 7A A partial perspective view of the anchor shown.

[0117] Figure 7C yes Figure 7A A perspective view of the anchoring pin of the anchor shown.

[0118] Figure 7D yes Figure 7A A partial front view of the anchor shown.

[0119] Figure 7E yes Figure 7A A top view of the anchor shown.

[0120] Figure 7F yes Figure 7A A partial side view of the anchor shown.

[0121] Figure 8A This is a side view of an anchor according to an exemplary embodiment of the present invention.

[0122] Figure 8B yes Figure 8A The side perspective view of the anchor shown.

[0123] Figure 8C It is cut along line BB. Figure 8A The side sectional perspective view of the anchor shown.

[0124] Figure 8D yes Figure 8A The side view of the anchor shown.

[0125] Figure 8E It is intercepted along line DD. Figure 8D The side sectional view of the anchor shown.

[0126] Figure 9A This is a side perspective view of the tip of an anchor according to an exemplary embodiment of the present invention.

[0127] Figure 9B This is a side perspective view of the tip of an anchor according to an exemplary embodiment of the present invention.

[0128] Figure 9C This is a side perspective view of the tip of an anchor according to an exemplary embodiment of the present invention.

[0129] Figure 9D This is a side perspective view of the tip of an anchor according to an exemplary embodiment of the present invention.

[0130] Figure 10A This is a top view of an anchor fastener according to an exemplary embodiment of the present invention.

[0131] Figure 10B yes Figure 10A The side view of the anchor fastener shown.

[0132] Figure 10C yes Figure 10A The top side perspective view of the anchor fastener shown.

[0133] Figure 11A This is a perspective view of an anchor and anchor fastener according to an exemplary embodiment of the present invention.

[0134] Figure 11B This is a perspective view of an anchor and anchor fastener according to an exemplary embodiment of the present invention.

[0135] Figure 11C This is a perspective view of an anchor and anchor fastener according to an exemplary embodiment of the present invention.

[0136] Figure 11D This is a perspective view of an anchor and anchor fastener according to an exemplary embodiment of the present invention.

[0137] Figure 11E yes Figure 11D A perspective view of the anchor and anchor fastener shown.

[0138] Figure 12A This is a side view of a nipple-shaped anchor conduit according to an exemplary embodiment of the invention in a closed configuration, wherein the anchor extends through the nipple-shaped anchor conduit.

[0139] Figure 12B It is in an open configuration Figure 12A The side view of the conduit and anchor shown.

[0140] Figure 12C It is intercepted along line AA. Figure 12A The side sectional view of the conduit and anchor shown.

[0141] Figure 12D It is intercepted along line HH. Figure 12A The diagram shows a side sectional view of the catheter.

[0142] Figure 12E It is in an open configuration Figure 12A Rear perspective view of the conduit and anchor shown.

[0143] Figure 12F It is in an open configuration Figure 12AThe front perspective view of the conduit and anchor shown.

[0144] Figure 12G It is in an open configuration Figure 12A Partial rear perspective view of the conduit and anchor shown.

[0145] Figure 12H It is in an open configuration Figure 12A Partial front perspective view of the conduit and anchor shown.

[0146] Figure 13A It is intercepted along line AA. Figure 12A The diagram shows a side sectional view of the conduit and anchor, wherein the conduit accommodates the papillary muscle.

[0147] Figure 13B yes Figure 13A The diagram shows a side sectional view of the conduit, anchor, and papillary muscle, with the retaining pin of the conduit advancing through the papillary muscle.

[0148] Figure 13C yes Figure 13A The diagram shows a side sectional view of the conduit, anchor, and papillary muscle, with the retaining pin and anchoring pin advancing through the papillary muscle.

[0149] Figure 13D yes Figure 13A The diagram shows a side sectional view of the conduit, anchor, and papillary muscle, with the retaining pin retracting from the papillary muscle.

[0150] Figure 13E yes Figure 13A The image shows a side sectional view of the anchor and papillary muscle, where the conduit is retracted and the receiver is secured to the anchor.

[0151] Figure 14A This is a bottom front perspective view of a nipple-shaped anchor conduit according to an exemplary embodiment of the invention in a modified configuration, wherein the anchor extends through the nipple-shaped anchor conduit.

[0152] Figure 14B yes Figure 14A Top rear perspective view of the conduit and anchor shown.

[0153] Figure 14C yes Figure 14A The anterior perspective view of the catheter shown.

[0154] Figure 14D It is in an extended configuration Figure 14A The anterior perspective view of the catheter shown.

[0155] Figure 15AThis is a side view of a nipple-shaped anchoring conduit according to an exemplary embodiment of the present invention in a modified configuration.

[0156] Figure 15B It is in a deformed configuration Figure 15A The front view of the catheter shown.

[0157] Figure 15C It is in a deformed configuration Figure 15A The rear view of the catheter shown.

[0158] Figure 15D It is in a deformed configuration Figure 15A The top view of the catheter shown.

[0159] Figure 15E It is in the deflection configuration Figure 15A The front view of the catheter shown.

[0160] Figure 15F It is in the deflection configuration Figure 15A The rear view of the catheter shown.

[0161] Figure 15G It is in the deflection configuration Figure 15A The side view of the catheter shown.

[0162] Figure 15H It is in the deflection configuration Figure 15A The top view of the catheter shown.

[0163] Figure 15I It is in an extended configuration Figure 15A The front view of the catheter shown.

[0164] Figure 15J It is in an extended configuration Figure 15A The side view of the catheter shown.

[0165] Figure 15K It is in an extended configuration Figure 15A The top view of the catheter shown.

[0166] Figure 15L It is in an extended configuration Figure 15A The rear view of the catheter shown.

[0167] Figure 16A This is a perspective view of a nipple-shaped duct receiver according to an exemplary embodiment of the present invention.

[0168] Figure 16B This is a perspective view of a nipple-shaped duct receiver according to an exemplary embodiment of the present invention.

[0169] Figure 17AIt is in the deflection configuration Figure 15A The image shows a rear view of a papillary duct that allows a guidewire to extend around the papillary muscle.

[0170] Figure 17B yes Figure 17A The front view of the duct and papillary muscle shown.

[0171] Figure 17C yes Figure 17A The duct and papillary muscle shown are in a side view.

[0172] Figure 17D yes Figure 17A The top view of the ducts and papillary muscles shown.

[0173] Figure 17E It is in a deformed configuration Figure 15A The image shows a side view of a papillary duct that surrounds the papillary muscle.

[0174] Figure 17F yes Figure 17E The front view of the duct and papillary muscle shown.

[0175] Figure 17G yes Figure 17E The diagram shows a rear view of the ducts and papillary muscles.

[0176] Figure 17H yes Figure 17E The top view of the ducts and papillary muscles shown.

[0177] Figure 17I It is in a deformed configuration Figure 17A The image shows a front view of a papillary duct that allows a papillary anchor to advance through the papillary muscle.

[0178] Figure 17J yes Figure 17I The side view of the conduit, anchor, and papillary muscle shown.

[0179] Figure 17K yes Figure 17I The top view of the conduit, anchor, and papillary muscle shown.

[0180] Figure 18 This is a flowchart of a method for repairing the mitral valve according to an exemplary embodiment of the present invention.

[0181] Figure 19A This is a top view of a locking member according to an exemplary embodiment of the present invention.

[0182] Figure 19B yes Figure 19A The image shows a side view of the locking mechanism.

[0183] Figure 19C yes Figure 19A The top front perspective view of the locking element shown.

[0184] Figure 19D yes Figure 19A The front view of the locking element shown.

[0185] Figure 19E It is intercepted along line AA. Figure 19A The side sectional view of the locking element shown.

[0186] Figure 20A This is a top view of a locking conduit according to an exemplary embodiment of the present invention.

[0187] Figure 20B It is intercepted along line FF. Figure 20A The diagram shows a cross-sectional view of the catheter, in which the catheter contains... Figure 19A The locking element shown.

[0188] Figure 20C It is in an open configuration Figure 20A The top view of the catheter shown, the catheter making Figure 19A The locking element shown advances along the guide wire.

[0189] Figure 20D yes Figure 20C The side view of the conduit and locking device shown.

[0190] Figure 20E It is intercepted along line FF. Figure 20D A cross-sectional view of the conduit and locking element shown.

[0191] Figure 20F It is in an open configuration Figure 20A The top view of the catheter shown, the catheter making Figure 19A The locking element shown is further advanced along the guide wire.

[0192] Figure 20G yes Figure 20F The side view of the conduit and locking device shown.

[0193] Figure 20H It is intercepted along line FF. Figure 20G A cross-sectional view of the conduit and locking element shown.

[0194] Figure 20I It is in an open configuration Figure 20A The top view of the locking conduit shown, the locking conduit enabling... Figure 19A The locking element shown is further advanced along the guide wire.

[0195] Figure 20J yes Figure 20I The side view of the conduit and locking device shown.

[0196] Figure 20K It is intercepted along line DD. Figure 20I The side sectional view of the conduit and locking element shown.

[0197] Figure 20L yes Figure 20A The side view of the locking conduit shown indicates that the locking conduit will... Figure 19A The locking element shown is fixed to the guidewire in a closed configuration.

[0198] Figure 20M yes Figure 20L A top view of the conduit and locking mechanism shown.

[0199] Figure 20N It is intercepted along line FF. Figure 20L The side sectional view of the conduit and locking element shown.

[0200] Figure 21 This is a side view of a locking conduit according to an exemplary embodiment of the invention in an open configuration, the locking conduit allowing... Figure 18 The locking element shown in A advances along the guide wire.

[0201] Figure 22A This is a front perspective view of a device according to an exemplary embodiment of the present invention.

[0202] Figure 22B yes Figure 22A A partial side view of the device shown.

[0203] Figure 22C yes Figure 22A The device shown is shown in top view.

[0204] Figure 22D yes Figure 22A The rear view of the device shown.

[0205] Figure 22E yes Figure 22A The image shows an isolated enlarged view of the cell.

[0206] Figure 23A This is a schematic diagram showing a fully open mitral valve.

[0207] Figure 23B This is a schematic diagram showing a fully closed mitral valve. Detailed Implementation

[0208] Throughout the following description, specific details are set forth in order to provide a more thorough understanding to those skilled in the art. However, well-known elements may not have been shown or described in detail to avoid unnecessarily obscuring this disclosure. Therefore, the description and figures are to be considered illustrative rather than restrictive.

[0209] Unless the context otherwise indicates, the term “anterior” (as used herein with respect to the patient’s body and its parts) refers to the position closer to the anterior surface of the patient’s body or its parts than to the posterior surface of the patient’s body or its parts.

[0210] Unless the context otherwise indicates, the term “posterior” (as used herein with respect to the patient’s body and its parts) refers to the location closer to the posterior surface of the patient’s body or its parts than to the anterior surface of the patient’s body or its parts.

[0211] Unless the context otherwise requires, the terms “percutaneous,” “percutaneously,” and similar terms (as used herein) refer to methods of accessing and / or removing from a patient’s circulatory system and / or heart through the skin (e.g., through a needle).

[0212] Unless the context otherwise requires, the term “anterograde” (as used herein) refers to the percutaneous route to the mitral valve via the femoral vein, right atrium, atrial septum, and left atrium (i.e., along the normal direction of blood flow through the patient’s circulatory system).

[0213] Unless the context otherwise requires, the term “retrograde” (as used herein) refers to a percutaneous route via the femoral artery to the mitral valve, through which the blood enters and exits the left ventricle via the aortic valve (i.e., in the opposite direction to the normal direction of blood flow through the patient’s circulatory system).

[0214] Unless the context otherwise requires, the term “intravascular” (as used herein) refers to something located or present within a blood vessel or the circulatory system.

[0215] Unless the context otherwise requires, the term “external” (as used herein with respect to the patient’s body and its parts) means located outside the patient’s circulatory system or outside the patient’s body.

[0216] Unless the context otherwise requires, the term "transcatheter" (as used herein) refers to a method performed through the lumen of a catheter.

[0217] Unless the context otherwise requires, the term "circulatory system" (as used herein) refers to the system that circulates blood and / or lymph through a patient's body, and that system comprises one or more of the heart, blood vessels, blood, lymph, and lymphatic vessels and lymph nodes.

[0218] While the methods and devices of the present invention can be used for percutaneous repair of any heart valve, the following description will focus on mitral valve repair. Further, while the methods and devices of the present invention will preferably be percutaneous and intravascular, such methods and devices can also be used to perform open-heart surgery and / or in minimally invasive procedures, in which access to the heart is achieved through myocardial tissue, and in which access to the heart is achieved thoracoscopically. Further still, while the methods and devices of the present invention can be used with conventional transcatheter valve prostheses, such methods and devices can be used with prostheses implanted through myocardial tissue and / or prostheses implanted using minimally invasive procedures, in which access to the heart is achieved thoracoscopically. Further still, while the methods and devices of the present invention will use an antegrade approach (i.e., the patient's circulatory system entry and exit point is the femoral vein), in some embodiments the femoral artery may be more suitable as one or more of the least tortuous paths of its size, ease of insertion, and access to the heart.

[0219] like Figure 1 , Figure 5A and Figure 5B The human heart 10 shown is a muscular pump that relies on heart valves to achieve blood flow. Under normal physiological function, oxygen-rich blood returning from the lungs is collected in the left atrium 20 and then enters the left ventricle 40 (i.e., the pump chamber) through the mitral (inlet) valve 30. As the left ventricle 40 contracts, the increase in left ventricular pressure causes the mitral valve 30 to close. Figure 2 and Figure 5B This prevents blood from flowing back into the left atrium (20). When the ventricular pressure exceeds the aortic pressure, the aortic (outlet) valve (50) opens. Figure 1 and Figure 5A Blood is pumped forward into the aorta 60. When the left ventricle 40 relaxes, the ventricular pressure drops, and the mitral valve 30 reopens to allow blood to flow from the left atrium 20 to the left ventricle 40, and the entire process repeats.

[0220] The mitral valve 30 separates the left atrium 20 from the left ventricle 40. The mitral valve 30 comprises the mitral annulus 32, leaflets (anterior leaflet 34 and posterior leaflet 36), chordae tendineae 38, and papillary muscles 39, 39a, and 39b. During ventricular contraction (cardiac systole), the increased ventricular pressure forces the mitral valves 34 and 36 to shift towards the atrium 20 (i.e., atrial or leaflet displacement, commonly referred to as atrial or leaflet displacement). The length and integrity of the chordae tendineae 38 determine the degree of leaflet displacement. Under normal physiological function, equal displacement of the anterior leaflet 34 and the posterior leaflet 36 of the mitral valve promotes contact (occlusion) between the anterior and posterior leaflets and subsequent function of the mitral valve 30.

[0221] When the anterior mitral leaflet 34 and / or the posterior mitral leaflet 36 are supported by elongated or ruptured chordae tendineae 38, ventricular contraction causes excessive atrial displacement of one or more leaflets, which prevents apposition between the two leaflets. Figure 3 This is called mitral leaflet prolapse. In this case, the function of the mitral valve 30 is impaired, and blood leakage occurs. Leakage through the mitral valve is called mitral regurgitation, and when it is due to mitral valve prolapse, it is called degenerative mitral regurgitation. In other cases, the ventricular myocardium itself can be impaired by disease, leading to restricted ventricular contraction and persistent ventricular dilation. Because the mitral leaflets 34 and 36 are attached to the ventricular myocardium via the chordae tendineae 38, ventricular dilation can restrict the movement of the mitral leaflets toward the atrium 20 during systole, resulting in malalignment between the leaflets and causing mitral regurgitation. This condition is also known as functional mitral regurgitation.

[0222] exist Figures 4A to 4H The image shows a device 100 for repairing heart valves such as the mitral valve. Device 100 includes a radially compressible and radially expandable body 110, an anterior member 120, and a rear member 130. Although the term "radial" is most commonly used in conjunction with circular objects or features, for the purposes of this description and accompanying aspects, it should be understood that the term "radial" is used in a broader context and is not limited to describing strictly circular objects or features or objects or features having strictly circular cross-sections. In some embodiments, the anterior member 120 and the rear member 130 form a single member (not shown). In some other embodiments, device 100 includes either the anterior member 120 or the rear member 130, but not both.

[0223] exist Figures 4A to 4HIn the illustrated embodiment, the body 110 includes a radially compressible and radially expandable ring 112 attached to the skirt 114. The ring 112 includes a plurality of orifices 113, a plurality of peaks 115, and a plurality of valleys 117. The peaks 115 and valleys 117 are longitudinally spaced across the ring 112. The orifices 113 are positioned on the peaks 115 and / or valleys 117 for radial compression and / or radial expansion of the body 110. For radial compression and / or radial expansion of the body 110, a surrounding member (not shown) may be provided. The surrounding member extends through the ring member 113. The body 110 can be radially compressed by applying tension to a first end and a second end of the surrounding member. Full radial expansion of the body 110 is achieved by the complete release of tension from the surrounding element within the ring member 113. When tension is applied to the surrounding member to radially compress the body 110, a "purse-string" effect can be achieved. Those skilled in the art will recognize that the body 110 may comprise any suitable conventionally known radially compressible and radially expandable stent. In some embodiments, the surrounding element does not require radial compression and / or radial expansion of the body 110. For example, an inflatable balloon may be used to radially expand and contract the body 110.

[0224] An anterior member 120 is attached to the anterior end portion 119 of the body 110. A rear member 130 is attached to the rear end portion 118 of the body 110. Each member 120, 130 includes segments 122, 132 having a plurality of positioning cords 124, 134 for positioning each member to cover the atrial surface from the lateral commissure to its medial commissure of the mitral valve leaflets. Cords 124, 134 are laterally spaced across each segment 122, 132 and extend from the segments 122, 132 away from the body 110. In some embodiments, cords 124, 134 are integrally formed with the corresponding segments 122, 132. Cords 124, 134 each terminate in and connect to flexible, compressible tubes 140, 150. Cords 124, 134 are laterally spaced across the tubes 140, 150. In some embodiments, the lengths of each rope 124, 134 are designed to suspend the tubes 140, 150 from segments 122, 132 in a parabolic or near-parabolic shape. Thus, ropes 124, 134 connect the ventricular peripheries 126, 136 of segments 122, 132 to the corresponding tubes 140, 150. Figure 4G and Figure 4H In one embodiment, device 100 includes five ropes 124, 134 suspending tubes 140, 150 from components 120, 130. Those skilled in the art will recognize that device 100 may include any number of ropes 124, 134 adapted to position one or more components 120, 130 to cover the atrial surface of the mitral valve leaflets, as described elsewhere herein.

[0225] Tubes 140 and 150 each include adjusting cords 142 and 152, which are secured to the end of the tube and extend longitudinally through the tube. Each cord 142 and 152 is long enough to be secured to the tube at a first end, extend through the tube, and traverse the patient's circulatory system from the implantation site (e.g., papillary muscle 39) to the femoral vein puncture site (i.e., the entry and exit point of the patient's circulatory system). Thus, the second end of each cord 142 and 152 can be externally accessed by the patient for delivery of a device (e.g., a locking element) to each tube 140 and 150. Tubes 140 and 150 can be lengthened and shortened by applying tension to the cords 142 and 152 from the outside. By tensioning the cords 142 / 152, tubes 140 / 150 are compressed and shortened, thus displacing the apex of the parabolic or near-parabolic tube away from the body 110 and causing a corresponding displacement of segments 122 / 132. Figure 4H By releasing tension from ropes 142 / 152, tubes 140 / 150 are expanded and lengthened, thus causing the vertex of the parabolic or near-parabolic tube to shift toward the body 110 and resulting in a corresponding displacement of segments 122 / 132. Figure 4G Segments 122 and 132 are displaced via ropes 142 and 152 to position members 120 and 130 to cover the atrial surface of the mitral valve leaflets, as described elsewhere herein. When a desired amount of tension is applied to one or more ropes 142 and 152 to position one or more members 120 and 130 as desired, locking member 700 (described elsewhere herein) advances along one or more ropes 142 and 152 to abut against the ends of one or more tubes 140 and 150. In the locking configuration, and upon abutment against one or more tubes 140 and 150, the one or more tubes 140 and 150 are fixed to the desired length, and the one or more members 120 and 130 are fixed in the desired position to cover the atrial surface of the mitral valve leaflets.

[0226] In some embodiments, the anterior member 120 and / or the rear member 130 comprises a biocompatible and blood-permeable material that allows blood to pass through. In some embodiments, the anterior member 120 and / or the rear member 130 comprises a mesh or similar material having spaces that allow blood to pass through. In some embodiments, the anterior member 120 and / or the rear member 130 comprises a blood-permeable material made of one or more of polytetrafluoroethylene (PTFE), expanded PTFE, polyethylene, polypropylene, polyethylene terephthalate, extracellular matrix biomaterials, and tissue engineering materials. In some embodiments, the anterior member 120 and / or the rear member 130 comprises a blood-permeable material having tissue-inward growth qualities. Those skilled in the art will recognize that the anterior member 120 and / or the rear member 130 may be made of other biocompatible and blood-permeable materials routinely used in cardiac surgery.

[0227] In some embodiments, segment 122 and / or segment 132 comprises a biocompatible material that allows blood to pass through. In some embodiments, segment 122 and / or segment 132 comprises a mesh-like or similar material having spaces that allow blood to pass through. In some embodiments, segment 122 and / or segment 132 comprises a blood-permeable material made of one or more of polytetrafluoroethylene (PTFE), expanded PTFE, polyethylene, polypropylene, polyethylene terephthalate, extracellular matrix biomaterials, and tissue engineering materials. In some embodiments, segment 122 and / or segment 132 comprises a blood-permeable material having tissue-inward growth qualities. Those skilled in the art will recognize that segment 122 and / or segment 132 may be made of other biocompatible and blood-permeable materials routinely used in cardiac surgery.

[0228] In some embodiments, cord 124 and / or cord 134 comprises one or more of polytetrafluoroethylene (PTFE), expanded PTFE, polyethylene, polypropylene, polyethylene terephthalate, extracellular matrix biomaterials, and tissue engineering materials. In some embodiments, cord 124 and / or cord 134 comprises a material with tissue-inward growth qualities. Those skilled in the art will recognize that cord 124 and / or cord 134 can be made of other biocompatible materials routinely used in cardiac surgery.

[0229] In some embodiments, tube 140 and / or tube 150 comprise a biocompatible material, such as one or more of polytetrafluoroethylene (PTFE), expanded PTFE, polyethylene, polypropylene, polyethylene terephthalate, extracellular matrix biomaterials, and metal alloys, said metal alloys including (but not limited to) nickel and / or titanium and / or nitinol. TM One or more of the following. Those skilled in the art will recognize that tube 140 and / or tube 150 can be made of other biocompatible materials routinely used in cardiac surgery. In some embodiments, the material is braided, the braid defining an opening that extends longitudinally through the tube for receiving an adjustment cord.

[0230] In some embodiments, cord 142 and / or cord 152 comprises one or more of polytetrafluoroethylene (PTFE), expanded PTFE, polyethylene, polypropylene, polyethylene terephthalate, extracellular matrix biomaterials, and tissue engineering materials. In some embodiments, cord 142 and / or cord 152 comprises a material having tissue-inward growth qualities. Those skilled in the art will recognize that cord 142 and / or cord 152 can be made of other biocompatible materials routinely used in cardiac surgery.

[0231] In some embodiments, ring 112 comprises a biocompatible material, such as a biocompatible shape memory metal alloy, which includes (but is not limited to) nickel and / or titanium and / or Nitinol. TM In some embodiments, the skirt 114 comprises a biocompatible material, such as one or more selected from polytetrafluoroethylene (PTFE), expanded PTFE, polyethylene, polypropylene, polyethylene terephthalate, and extracellular matrix biomaterials. In some embodiments, the body 110 and / or ring 112 and / or skirt 114 are blood-permeable. In some embodiments, the body 110 and / or ring 112 and / or skirt 114 comprises a material with tissue-inward growth qualities. Those skilled in the art will recognize that the body 110 and / or ring 112 and / or skirt 114 can be made of other biocompatible materials routinely used in cardiac surgery.

[0232] Figures 5C to 5E A device 100 implanted in the heart 10 is shown, wherein anterior member 120 substantially prevents atrial displacement of the anterior mitral valve leaflet 34 and posterior member 130 substantially prevents atrial displacement of the posterior mitral valve leaflet 36. Anterior member 120 is configured to cover the atrial surface 35 of the anterior mitral valve leaflet 34 when the device 100 is implanted in the mitral valve. Figure 1 The posterior member 130 is configured to cover the atrial surface 37 of the posterior leaflet 36 of the mitral valve when the device 100 is implanted into the mitral valve. Figure 1 In some embodiments, the anterior member 120 is configured in size and / or shape to resemble the anterior leaflet 34 of the mitral valve. In some embodiments, the posterior member 130 is configured in size and / or shape to resemble the posterior leaflet 36 of the mitral valve.

[0233] Device 100 is delivered and positioned within the heart using an anchor (as described elsewhere herein). For implantation of device 100, a conventional endovascular guide (not shown) (or other device considered to be within the knowledge of a person skilled in the art of interventional cardiology) is inserted into the patient's circulatory system and advanced using a conventionally known transcatheter approach. In some embodiments, the guide is advanced using an antegrade transcatheter approach. In some other embodiments, the guide is advanced using a retrograde transcatheter approach. In cases where the guide is introduced into the patient's circulatory system via the femoral vein, the guide is advanced into the patient's right atrium and reaches the left atrium via the interatrial septum. Conventional transesophageal echocardiography (TEE) and / or fluoroscopy techniques may be used to guide the guide through the patient's circulatory system and position the guide within the heart.

[0234] Once a transatrial septal access for the guide is established, papillary anchors are implanted into each papillary muscle and one or more annular anchors are implanted into the mitral valve annulus. To implant the papillary anchors, the guide is advanced across the mitral valve into the left ventricle of the patient's heart. Using a catheter as described elsewhere in this document, the papillary anchors are introduced into each of the anterolateral and posteromedial papillary muscles. Routine transesophageal echocardiography (TEE) and / or fluoroscopy can be used to guide the catheter through the patient's circulatory system and position the papillary anchors within the papillary muscles.

[0235] To implant one or more annular anchors into the mitral annulus, a guide is positioned in the left atrium of the patient's heart. One or more annular anchors are introduced into the mitral annulus using a catheter as described elsewhere herein. Conventional transesophageal echocardiography (TEE) and / or fluoroscopy can be used to guide the catheter through the patient's circulatory system and position one or more annular anchors into the mitral annulus. Those skilled in the art will recognize that papillary anchors can be implanted into the papillary muscles before, after, or approximately simultaneously with the implantation of one or more annular anchors into the mitral annulus.

[0236] exist Figures 7A to 7C and Figures 7D to 7F An exemplary embodiment of the annular anchor is shown. Anchor 500 ( Figures 7A to 7F The device 100 includes an anchoring pin 510, a tether 520 connected to the anchoring pin, and a guidewire 530 connected to the tether. The guidewire is long enough to traverse the patient's circulatory system from the mitral valve annulus 32 to the femoral vein puncture site (i.e., the inlet and outlet of the patient's circulatory system) and to allow the device 100 and conventional transcatheter valve delivery systems (e.g., guides) to advance past the outer end of the guidewire 530. In some embodiments, the anchor 500 or one or more portions thereof comprise a biocompatible material, such as polytetrafluoroethylene (PTFE), expanded PTFE, polyethylene, polypropylene, polyethylene terephthalate, extracellular matrix biomaterials, and metal alloys including (but not limited to) nickel and / or titanium and / or Nitinol. TM In some embodiments, pin 510 includes biocompatible shape memory materials (e.g., SMA, smart metals, shape memory metals, shape memory alloys, muscle fibers, smart alloys, Nitinol). TM (one or more of stainless steel), having a pre-deformed shape, for example, such as Figure 7A or Figure 7DThe shape shown is for anchoring the anchor 500 within the mitral valve annulus 32. In a modified shape, the pin 510 may be retained in the catheter for advancing the anchor 500 into the mitral valve annulus. Those skilled in the art will recognize that the anchor 500 and portions thereof can be made of other biocompatible materials routinely used in cardiac surgery.

[0237] To secure each anchor 500 to the mitral annulus 32, a ring-shaped anchoring catheter is used. Conventional transesophageal echocardiography (TEE) and / or fluoroscopy can be used to advance the catheter through the patient's circulatory system and to the mitral annulus 32 via a guide. The catheter is deflectable and steerable. Figures 6A to 6G An exemplary embodiment of an annular anchor catheter 600 is shown. The catheter 600 includes a catheter body 610 and a sensor 620 attached to the body 610 for detecting contact between the catheter 600 and the annular wall of the mitral valve annulus 32. The body 610 houses a needle 630 for piercing the annular wall and implanting an anchor 500 into the annular wall tissue. The needle 630 is configured to receive a pin 510 of the anchor 500 and to advance the anchor 500 through the annular wall.

[0238] To secure each anchor 500, the catheter 600 advances to the desired anchoring site located on the annular wall of the mitral valve annulus 32. The sensor 620 detects the contact between the catheter 600 and the anchoring site. Figure 6A The needle 630 penetrated the annular wall and advanced into the mitral valve annulus tissue. Figure 6B Anchor 500 advances through needle 630 ( Figure 6C As the anchor moves away from the needle, pin 510 returns to its pre-deformed shape. Figure 6D and Figure 6E In its pre-deformed shape, pin 510 is embedded in the mitral annulus tissue and cannot be retracted from the mitral annulus 32. Figure 6F With the anchor 500 secured in the mitral annulus 32, the needle 630 can be retracted into the catheter 600, and the catheter 600 can be withdrawn from the patient's circulatory system via a guide. Figure 6G ).

[0239] In some embodiments, catheter 600 includes a controller (not shown) for extravascular operation of the device. When catheter 600 is intravascular, the controller is located outside the patient's body, as described elsewhere herein. In some embodiments, the controller includes a handle and devices for operating catheter 600 and portions thereof.

[0240] exist Figures 8A to 8E and Figures 11A to 11EAn exemplary embodiment of a nipple-shaped anchor is shown. Anchor 200 includes an anchor pin 210, a tether 220 connected to the anchor pin, and a guide wire 230 connected to the tether. Figures 8A to 8E In the illustrated embodiment, the anchor 200 includes a pair of frenulums 220, each frenulum 220 being connected to a guidewire 230. In some embodiments, the anchor includes a frenulum connected to the guidewire. Each guidewire 230 is long enough to traverse the patient's circulatory system from the papillary muscle to the femoral vein puncture site (i.e., the entry and exit point of the patient's circulatory system) and allow the device 100 and conventional transcatheter valve delivery systems (e.g., guides) to advance past the outer end of the guidewire 230. In some embodiments, the anchor 200 or one or more portions thereof comprise a biocompatible material, such as polytetrafluoroethylene (PTFE), expanded PTFE, polyethylene, polypropylene, polyethylene terephthalate, extracellular matrix biomaterials, and metal alloys including (but not limited to) nickel and / or titanium and / or Nitinol. TM In some embodiments, the pin includes a biocompatible shape memory material (e.g., SMA, smart metal, shape memory metal, shape memory alloy, muscle fiber, smart alloy, Nitinol). TM (one or more of stainless steel), which restores the pre-deformed shape, for example Figures 9A to 9D One of the shapes of pins 210A, 210B, 210C, and 210D is shown. Those skilled in the art will recognize that anchor 500 and portions thereof can be made of other biocompatible materials routinely used in cardiac surgery. Anchors 290, 291, 292, and 293 ( Figures 11A to 11E Many features and components of the anchor 500 are similar to those of the anchor 500, and the same reference numerals are used to indicate similar features and components.

[0241] In some embodiments, the anchor 200 includes fasteners for securing the anchor 200 to the papillary muscle 39. Figures 10A to 10C and Figures 11A to 11E An exemplary embodiment of the fastener is shown. The fastener 250 includes a body 260 defining an orifice 270. An anchor 200 advances through the papillary muscle 39 and through the orifice 270 of the fastener 250. When the pin 210 abuts against the fastener 250, the fastener 250 disperses any retraction force exerted by the anchor 200 on the papillary muscle, thereby preventing the anchor 200 from retracting through the papillary muscle 39. In some embodiments, the fastener 250 comprises a biocompatible material, such as polytetrafluoroethylene (PTFE), expanded PTFE, polyethylene, polypropylene, polyethylene terephthalate, extracellular matrix biomaterials, and metal alloys including (but not limited to) nickel and / or titanium and / or Nitinol. TM Fastener 280 ( Figures 11A to 11EMany features and components of the fastener are similar to those of the fastener 250, and the same reference numerals are used to indicate similar features and components.

[0242] To secure each anchor 200 to the papillary muscle, a papillary anchor conduit is used. Figures 12A to 12H 13A to Figure 13E , 14A to Figure 14D and Figure 18 A to Figure 18 L and Figures 20A to 20L Conventional transesophageal echocardiography (TEE) and / or fluoroscopy can be used to advance the catheter through the patient's circulatory system and reach the papillary muscles via a guide. The papillary anchor catheter is deflectable and steerable.

[0243] exist Figures 12A to 12H and Figures 13A to 13E An exemplary embodiment of a nipple-shaped anchoring conduit is shown. The conduit 300 includes a body 310 and a removable receiver 320, which is removably attached to the body 310 via an arm 330. The body 310, arm 330, and receiver 320 define an opening 340. The opening 340 is configured to receive a lateral dimension ( ) of a papillary muscle 39. Figures 13A to 13D The body 310 is configured to receive an anchor 200 having a pin 210 and to advance the anchor 200 through the papillary muscle. In some embodiments, the body 310 includes a retaining pin 350 for closing the opening 340. Figure 12A In the closed configuration shown, retaining pin 350 seals opening 340, and catheter 300 can advance through the patient's circulatory system and be positioned near the papillary muscle while minimizing entanglement and / or entanglement of surrounding tissues and / or valve structures. Figures 12B to 12H In the open configuration shown, the retaining pin 350 is at least partially retracted into the body 310, and the opening 340 is exposed for receiving the papillary muscle. To allow the retaining pin 350 to advance and retract across the opening 340, the retaining pin 350 includes a line 352 extending through the body 310. The line 352 is long enough to traverse the patient's circulatory system from the papillary muscle 39 to the femoral vein puncture site (i.e., the entry and exit point of the patient's circulatory system) and to allow for external manipulation of the retaining pin 350 outside the patient's body.

[0244] To secure the anchor 200 to the papillary muscle, the conduit 300 advances through the patient's circulatory system into the papillary muscle in a closed configuration. Near the papillary muscle, the retaining pin 350 retracts into the body 310 and the conduit 300 (in an open configuration) advances to position the lateral dimension of the papillary muscle within the opening 340. Figure 13AThe retaining pin 350 can extend (i.e., partially or completely closed) to contact or advance through the papillary muscle, thereby stabilizing the muscle while the anchor 200 is fixed therein. Figure 13B The pin 210 of the anchor 200 advances from the body 310 through the papillary muscle to contact and / or secure to the receiver 320. Figure 13C In some embodiments, the anchor 200 advances from the entrance portion 39e of the papillary muscle across the lateral dimension of the papillary muscle to the exit portion 39f of the papillary muscle. The pin 210 is received by a receiver 320 adjacent to the exit portion 39f. In some embodiments, the anchor 200 advances from the entrance portion 39e through the center of the papillary muscle to the exit portion 39f. In some embodiments, the anchor 200 advances from the entrance portion 39e through the papillary muscle to the exit portion 39f, thereby enhancing the grip on the papillary muscle and minimizing or preventing the anchor 200 from tearing from the papillary muscle.

[0245] In some embodiments, pin 210 is connected to receiver 320 via a flat-head screw-like mechanism. In some embodiments, receiver 320 receives fastener 250 for engagement with pin 210, as described elsewhere herein. However, those skilled in the art will recognize that other conventional means for securing pin 210 to receiver 320 can be used. When pin 210 is connected to receiver 320, pin 210 is not retractable via the papillary muscle. Laceration 220 extends through the papillary muscle, and anchor 200 is thus secured via the muscle.

[0246] With the anchor 200 secured to the papillary muscle, the catheter 300 can be withdrawn from the patient's circulatory system by retracting (i.e., loosening) the arm 330 (and retaining pin 350) into the body 310, thereby releasing the receiver 320. Figures 13D to 13E The catheter 300 is then withdrawn from the patient via a guide. To retract the arm 330 from the receiver 320, the arm 330 includes a line 332 extending through the body 310. The line 332 is long enough to traverse the patient's circulatory system from the papillary muscle 39 to the femoral vein puncture site (i.e., the entry and exit point of the patient's circulatory system) and to operate the arm 330 externally to the patient. In some embodiments, the line 352 and / or the line 332 are connected to a controller (not shown) external to the patient for internal manipulation of the catheter 300 and / or portions thereof. Figures 12A to 12H In the embodiment shown, arm 330 includes a threaded wire 330a and a pair of support posts 320b on either side of the wire 330a, the threaded wire 330a threadedly engaging receiver 320, and the pair of support posts 320b being released from receiver 320 when the wire 330a is unscrewed from receiver.

[0247] exist Figures 14A to 14DAn exemplary embodiment of a papillary anchor catheter is shown. The catheter 400 includes a body 410 and a deformable arm 420 extending away from the body 410. The body 410 is configured to receive a pin 210 of an anchor 200 and to advance the anchor 200 through the papillary muscle. In some embodiments, the body 410 includes a needle 440 for receiving the pin 210 within the body 410 and for advancing the anchor 200 through the papillary muscle. The needle 440 is long enough to traverse the patient's circulatory system from the papillary muscle 39 to the femoral vein puncture site (i.e., the entry and exit point of the patient's circulatory system) and to be operated outside the patient's body.

[0248] In the illustrated embodiment, arm 420 includes a plurality of linearly arranged modular members 422 and at least one tension line 450 extending through the modular members 422. Arm 420 is deformable into a hook-like or deformable configuration for receiving pin 210 as anchor 200 advances through the papillary muscle, as described elsewhere herein. To deform arm 420, tension is applied to tension line 450, bringing the edges of adjacent modular members 422 together and forming a recess 430 for receiving the papillary muscle. Thus, the shape of the modular members 422 is configured to provide a desired configuration for arm 420 when line 450 is tensioned. The length of line 450 is sufficient to traverse the patient's circulatory system from papillary muscle 39 to the femoral vein puncture site (i.e., the entry and exit point of the patient's circulatory system) and to operate arm 420 outside the patient's body.

[0249] exist Figures 14A to 14C The image shows conduit 400 in a deformed configuration. To allow conduit 400 to return to... Figure 14D The extended configuration shown removes tension from line 450. In this extended configuration, catheter 400 can advance through the patient's circulatory system and is positioned near the papillary muscle with minimal entanglement and / or entanglement of surrounding tissues and / or valve structures. Those skilled in the art will recognize that other conventional means of deforming arm 420 can be used.

[0250] To secure the anchor 200 to the papillary muscle, the catheter 400 advances through the patient's circulatory system to the papillary muscle in an extended configuration. A tension line 450 is then tensioned to position the papillary muscle within a recess 430 of the catheter 400. In this modified configuration, the arm 420 at least partially surrounds the papillary muscle. The pin 210 of the anchor 200 then advances from the body 410 through the papillary muscle to the contact arm 420. Thus, the catheter 400 in the modified configuration prevents the pin 210 from extending through the papillary muscle and prevents puncture and / or damage to the tissue of the left ventricle (i.e., the ventricular wall). In some embodiments, the anchor 200 advances from the entrance portion (not shown) of the papillary muscle through the lateral dimension of the papillary muscle to the exit portion (not shown). The pin 210 is received by the arm 420 adjacent to the exit portion 39d. In some embodiments, the anchor 200 advances from the entrance portion 39e through the center of the papillary muscle to the exit portion 39d. In some embodiments, the anchor 200 advances from the inlet portion 39e through the papillary muscle to the outlet portion 39d, thereby enhancing the grip on the papillary muscle and minimizing or preventing the anchor 200 from tearing from the papillary muscle.

[0251] Once pin 210 advances from body 410, pin 210 returns to its pre-deformed shape (e.g., Figures 9A to 9D and 11A to Figure 11E (One of the shapes shown). Thus, pin 210 cannot be retracted through the nipple muscle. The frenulum 220 extends through the nipple muscle, and anchor 200 is thus secured to the muscle. With anchor 200 secured to the nipple muscle, catheter 400 can be withdrawn from the patient's circulatory system by releasing tension from the line 450 and by withdrawing catheter 400 (in the extended configuration) from the patient's body via a guide.

[0252] In some embodiments, a guidewire (not shown) may be used to advance catheter 300 and / or catheter 400 to the papillary muscle. In some embodiments, the guidewire includes a J-shaped tip configured to engage the papillary muscle. The guidewire may be advanced through the patient's circulatory system via a guide to the papillary muscle. The papillary muscle is positioned around a recess defined by the tip. A balloon (not shown) may be advanced through the guide across the guidewire and inflated to stabilize the guidewire in place and prevent dislodgement if catheter 300 and / or catheter 400 advances across the guidewire. Thus, catheter 300 and / or catheter 400 may be advanced around the papillary muscle to the desired position.

[0253] In some embodiments, catheter 300 includes a controller (not shown) for operating the device outside the blood vessel. When catheter 300 is located inside the blood vessel, the controller is located outside the patient's body, as described elsewhere herein. In some embodiments, the controller includes a handle and devices for operating catheter 300 and portions thereof.

[0254] In some embodiments, catheter 400 includes a controller (not shown) for operating the device outside the blood vessel. When catheter 400 is located inside the blood vessel, the controller is located outside the patient's body, as described elsewhere herein. In some embodiments, the controller includes a handle and devices for operating catheter 400 and portions thereof.

[0255] In some embodiments, the catheter 300 and / or portions thereof comprise sterilized or sterilizable materials. In some embodiments, the catheter 300 and / or portions thereof comprise medical-grade plastics, thermoplastics, stainless steel, metals, or metal alloys (e.g., Nitinol). TM Or another nickel / titanium alloy) and one or more of titanium. Those skilled in the art will recognize that catheter 300 and / or portions thereof can be made of any sterile or sterilizable material conventionally used in the manufacture of tools used in cardiac surgery.

[0256] In some embodiments, catheter 400 and / or portions thereof comprise sterilized or sterilizable materials. In some embodiments, catheter 400 and / or portions thereof comprise medical-grade plastics, thermoplastics, stainless steel, metals, or metal alloys (e.g., Nitinol). TM Or another nickel / titanium alloy) and one or more of titanium. Those skilled in the art will recognize that catheter 400 and / or portions thereof can be made of any sterile or sterilizable material conventionally used in the manufacture of tools used in cardiac surgery.

[0257] exist Figures 15A to 15L and Figures 17A to 1 An exemplary embodiment of a nipple-shaped anchor catheter is shown in 7L. The catheter 1000 includes a body 1100, a deformable arm 1200 extending away from the body 1100, and an anchor housing 1300 connecting the body 1100 and the arm 1200. The anchor housing 1300 is configured to receive an anchor 200 as the catheter 1000 advances through a patient's circulatory system via a conventional intravascular guide (not shown) (or other device considered to be within the knowledge of a person skilled in the art of interventional cardiology). The anchor housing 1300 extends through a channel 1310A defined by the body 1100. Figure 15D And extends through the channel 1200A defined by arm 1200. Figure 15B The catheter 1000 also includes a guidewire 1400 extending from the body 1100 alongside the arm 1200 for guiding the catheter 1000 to the papillary muscle within the heart. The guidewire 1400 extends through a channel 1410A defined by the body 1100. Figure 15DThe guidewire 1400 is long enough to traverse the patient's circulatory system from the papillary muscle 39 to the femoral vein puncture site (i.e., the entry and exit point of the patient's circulatory system) and to be manipulated outside the patient's body. The guidewire 1400 can be soft and flexible for delivery around the papillary muscle without tangling or crossing adjacent ventricular walls.

[0258] The catheter 1000 is deformable, allowing the anchor 200 to advance through the papillary muscle while minimizing tangles and / or entanglements of tissue and / or valve structures in and around the heart and papillary muscle. In the illustrated embodiment, the arm 1200 includes at least one deformable segment 1210. In some embodiments, each deformable segment 1210 includes a plurality of linearly arranged modular elements and tension lines 1216, 1218 extending through these modular elements. Tension is applied to the lines 1216, 1218 to deform each segment 1210. In the illustrated embodiment, the arm 1200 includes a first deformable segment 1212 and a second deformable segment 1214. In some embodiments, the first deformable segment 1212 is deformable in a first plane along a direction of about 0° to about 120°. In some embodiments, the second deformable segment 1214 is deformable in a second plane along a first direction of about 0° to about 90°, and is deformable in a second plane along a second direction of about 0° to about -90°. In some embodiments, the first and second planes are not coplanar. In some embodiments, the first plane is perpendicular to the second plane. Those skilled in the art will recognize that each deformable segment can be deformable along multiple directions and / or in multiple planes. To deform the arm 1200, the conduit 1000 includes lines for manipulating each deformable segment. In the illustrated embodiment, the conduit 1000 includes a line 1217 for manipulating the first deformable segment 1212 and lines 1216, 1218 for manipulating the second deformable segment 1214. In some embodiments, line 1217 deforms the first deformable segment 1212 in the first plane along a first direction (e.g., about 0° to about 120°). In some embodiments, line 1216 deforms the second deformable segment 1214 in the second plane along a first direction (e.g., about 0° to about 90°), and line 1218 deforms the second deformable segment 1214 in the second plane along a second direction (e.g., about 0° to about -90°). In some embodiments, the first and second planes are not coplanar. In some embodiments, the first plane is perpendicular to the second plane. Lines 1216, 1217, and 1218 each extend through the corresponding channels 1216A, 1217A, and 1218A defined by the main body 1100. Figure 15DEach of the lines 1216, 1217, and 1218 is long enough to traverse the patient's circulatory system from the papillary muscle 39 to the femoral vein puncture site (i.e., the entry and exit point of the patient's circulatory system) and is operated on the external arm 1200. In some embodiments, one or more of the anchor housing 1300, guidewire 1400, lines 1216, 1217, and 1218 are connected to a controller (not shown) outside the patient's body for internal manipulation of the catheter 1000 and / or portions thereof.

[0259] exist Figures 15I to 15L The image shows catheter 1000 in an extended configuration. In the extended configuration, catheter 1000 can advance through the patient's circulatory system and is positioned near the papillary muscle while minimizing tangles and / or entanglements of tissue and / or valve structures in and around the heart and papillary muscle. For implantation of anchor 200, catheter 1000 is deformable, as described elsewhere herein.

[0260] like Figures 15E to 15H As shown, arm 1200 is deformable into a deflection configuration around the first deformable segment 1212. Catheter 1000 can deform into the deflection configuration within the left ventricle to facilitate entry and exit of the papillary muscle and implantation of the anchor 200. In the deflection configuration, guidewire 1400 can advance around the papillary muscle to guide catheter 1000 to the appropriate location for anchor 200 implantation, while minimizing entanglement and / or tangling of surrounding tissue and / or valve structures. Figures 17A to 17D The delivery of a catheter 1000 and a guidewire 1400, which deform around a first deformable segment 1212 into a deflection configuration, is illustrated to at least partially encircle the papillary muscle. With the guidewire 1400 at least partially encircling the papillary muscle, the catheter 1000 can be further advanced to implant an anchor 200 while minimizing entanglement and / or entanglement of tissue and / or valve structures surrounding the papillary muscle.

[0261] like Figures 15A to 15D As shown, arm 1200 is deformable into a hook-like or deformable configuration around the second deformable segment 1214. The catheter 1000 can deform into the deformable configuration within the left ventricle to facilitate access to the papillary muscle. For example, in the deformable configuration, the catheter 1000 can be positioned to allow the anchor 200 to advance through the papillary muscle and receive the pin 210, minimizing entanglement and / or entanglement of the tissue and / or valve structures surrounding the papillary muscle. In some embodiments, arm 1200 includes a receiver 1230 for receiving the pin 210. Figure 16A and Figure 16B An exemplary embodiment of the receiver is shown below. Receiver 1230 ( Figure 16A ) includes a recess 1232 for receiving pin 210. Receiver 1240 ( Figure 16BThe device includes an anchor fastener 1242 for receiving the pin 210 of the anchor 200. When the pin 210 is in its pre-deformed shape, the fastener 1242 disperses any retraction force exerted by the anchor 200 on the papillary muscle, thereby preventing the anchor 200 from retracting through the papillary muscle.

[0262] Figures 17E to 17K A catheter 1000 is shown deforming around a first deformable segment 1212 in a first plane along a first direction and around a second deformable segment 1214 in a second plane along a second direction, wherein the first plane is perpendicular to the second plane. With the catheter deformed around the first deformable segment 1212 and the second deformable segment 1214, the arm 1200 can advance along the guidewire 1400 to at least partially encircle the papillary muscle. With the arm 1200 at least partially encircling the papillary muscle, the anchor 200 can advance through the papillary muscle, and the pin 210 of the anchor 200 can be received by the receiver 1230. In some embodiments, the anchor 200 advances from the entrance portion 39e of the papillary muscle through the lateral dimension of the papillary muscle to the exit portion 39f of the papillary muscle. The pin 210 is received by the receiver 1230 adjacent to the exit portion 39f. This minimizes or avoids entanglement and / or entanglement of tissue and / or valve structures surrounding the papillary muscle. Therefore, the catheter 1000 prevents the pin 210 from extending through the papillary muscle and prevents puncture and / or damage to the tissue of the left ventricle (i.e., the ventricular wall). In some embodiments, the anchor 200 advances from the inlet portion 39e through the center of the papillary muscle to the outlet portion 39f. In some embodiments, the anchor 200 advances from the inlet portion 39e through the papillary muscle to the outlet portion 39f, thereby enhancing the grip on the papillary muscle and minimizing or avoiding tearing of the anchor 200 from the papillary muscle. In some embodiments, the anchor housing 1300 is configured to allow the anchor 200 to advance through the papillary muscle, thereby enhancing the grip on the papillary muscle and minimizing or avoiding tearing of the anchor 200 from the papillary muscle. For example, the diameter of the anchor housing 1300 may be selected to accommodate the rigid anchor 200 and allow the anchor to advance through the papillary muscle with optimal grip on the papillary muscle.

[0263] Once pin 210 advances from anchor housing 1300, pin 210 returns to its pre-deformed shape (e.g., Figures 9A to 9D and Figures 11A to 11D(One of the shapes shown). Thus, pin 210 cannot be retracted through the papillary muscle. The frenulum 220 extends through the papillary muscle, and the anchor 200 is thus secured to the muscle. With the anchor 200 secured to the papillary muscle, the catheter 1000 can be withdrawn from the patient's circulatory system via a guide to withdraw the catheter from the patient's body (in the extended configuration). Conventional transesophageal echocardiography (TEE) and / or fluoroscopy techniques can be used to advance and withdraw the catheter through the patient's circulatory system and to implant the anchor 200 through the papillary muscle.

[0264] In some embodiments, catheter 1000 includes a controller (not shown) for operating the device outside the blood vessel. When catheter 1000 is located inside a blood vessel, the controller is located outside the patient's body, as described elsewhere herein. In some embodiments, the controller includes a handle and devices for operating catheter 1000 and portions thereof.

[0265] In some embodiments, the catheter 1000 and / or a portion thereof comprises a sterilized or sterilizable material. In some embodiments, the catheter 1000 and / or a portion thereof comprises medical-grade plastic, thermoplastic, stainless steel, metal, or metal alloy (e.g., Nitinol). TM Or another nickel / titanium alloy) and one or more of titanium. Those skilled in the art will recognize that catheter 1000 and / or portions thereof can be made of any sterile or sterilizable material conventionally used in the manufacture of tools used in cardiac surgery.

[0266] For the implantation of device 100, one or more annular anchors are secured to the mitral valve annulus 32, as described elsewhere in this document. Figure 5E In the illustrated embodiment, three anchors 500 are secured to the mitral valve annulus 32. Papillary anchors are secured to each of the anterolateral papillary muscles 39a and posteromedial papillary muscles 39b, as described elsewhere herein. Once the first papillary anchor is implanted in the first papillary muscle, a second papillary anchor can be implanted in the second papillary muscle. Figures 5C to 5D In the illustrated embodiment, an anchor 200 is secured to each papillary muscle. Those skilled in the art will recognize that any suitable number of papillary and annular anchors can be used to position the device 100 in the desired location and place within the heart 10. Papillary anchors can be implanted into the papillary muscles before, after, or approximately simultaneously with the implantation of one or more annular anchors into the mitral valve annulus.

[0267] exist Figure 18The diagram illustrates a method 900 for repairing the mitral valve of the heart according to an exemplary embodiment. In block 910, a conventional transseptal guide (not shown) (or other device considered to be within the knowledge of a person skilled in the art of interventional cardiology) is inserted into the patient's circulatory system and advanced using a transcatheter approach as described elsewhere herein. In corresponding block diagrams 920 and 930, one or more papillary anchors and annular anchors are respectively implanted into the patient's mitral valve annulus and one or more papillary muscles, as described elsewhere herein.

[0268] Once the papillary anchors and annular anchors are implanted in the heart, the papillary anchors and one or more annular anchors are used to advance and guide the device 100 through the patient's circulatory system to the desired implantation site and to position the device 100 in the heart. In block 940, the device 100 is externally connected to guidewires of the papillary anchors and annular anchors. A guidewire 230, fixed to the anterolateral papillary muscle, advances externally through the first end 140A of the tube 140 of the anterior member 120 and / or the first end 150A of the tube 150 of the posterior member 130. A guidewire 230, fixed to the posteromedial papillary muscle, advances externally through the second end 140B of the tube 140 of the anterior member 120 and / or the second end 150B of the tube 150 of the posterior member 130. One or more guidewires 530, fixed to the mitral valve annulus, advance externally through the body 110 at one or more anchoring sites (not shown). In some embodiments, the guidewire of each anchor 500 advances through the skirt 114 at one or more anchoring sites (not shown). The anchoring sites can be positioned anywhere through the body 110 and / or the skirt 114, such that the body 110 can advance along one or more guidewires 530 to the mitral annulus 32, where it is positioned against the atrial muscle (not shown) adjacent to the mitral annulus. In some embodiments, the body 110 is shaped to resemble the mitral annulus of the heart for positioning the body 110 against the atrial muscle.

[0269] With guidewires 230, 530 externally connected to device 100, device 100 can then be inserted into the guide by radially compressing body 110 (as described elsewhere herein) to implant device 100 into the heart. In block 950, device 100 is advanced intravascularly to the implantation site to position device 100 within the heart 10. Once device 100 is positioned at the desired implantation site, device 100 is radially extended by releasing device 100 from the guide, as described elsewhere herein. In block 960, device 100 is adjusted to position anterior member 120 and / or posterior member 130 to regulate the degree of atrial displacement of the mitral valve leaflets during ventricular systole and to correct mitral valve leaflet prolapse and / or restore mitral valve function. Conventional transesophageal echocardiography (TEE) and / or fluoroscopy can be used to guide the device 100 along the guidewire through the patient's circulatory system to position the device 100 in the desired implantation site (e.g., mitral valve).

[0270] The body 110 is advanced along one or more guidewires 530 to the mitral annulus 32, where it is positioned against an atrial muscle (not shown) adjacent to the mitral annulus. In some embodiments, the body 110 is shaped to resemble the mitral annulus of the heart for positioning against the atrial muscle. To secure the body 110 to the mitral annulus 32, a locking member 700 (described elsewhere herein) is advanced in an open configuration along each guidewire 530 to a corresponding anchoring site (not shown) of the body 110 via a locking member conduit 800 (described elsewhere herein). In a locked configuration, the locking member 700 is secured to a frenulum 520 adjacent to each anchoring site. With the locking member 700 secured, the frenulum 520 can be cut and the guidewire 530 withdrawn from the patient's body.

[0271] Tube 140 and / or tube 150 advances along one or more guidewires 230 through the mitral valve and into the left ventricle near the corresponding papillary muscles. Thus, ends 140A and / or 150A of tube 140 are connected to the anterolateral papillary muscle 39a via a first anchor 200, and ends 140B and / or 150B of tube 150 are connected to the posteromedial papillary muscle 39b via a second anchor 200. Thus, tube 140 and / or tube 150 traverse from the anterolateral papillary muscle 39a to the posteromedial papillary muscle 39b. Figures 5C to 5DThe degree of atrial displacement of the mitral valve leaflets during ventricular systole can be adjusted by adjusting the lengths of tubes 140 and / or 150 as described elsewhere herein. The tension of cords 142 and / or 152 can be adjusted, as described elsewhere herein, to regulate the degree of atrial displacement of the mitral valve leaflets during ventricular systole. The lengths of tubes 140 and / or 150 and the tension of cords 142 and / or 152 can be adjusted using ultrasound guidance. As described elsewhere herein, locking member 700 can advance along one or more cords 142, 152 in an open configuration to abut against the ends of one or more tubes 140, 150. Locking member 700 is secured in a locked configuration to one or more cords 142, 152 adjacent to one or more tubes 140, 150, thereby securing one or more tubes 140, 150 to a desired length and securing one or more members 120, 130 in a desired position covering the atrial surface of the mitral valve leaflets. With the locking element 700 secured, one or more ropes 142, 152 can be cut near the locking element and the free ends withdrawn from the patient's body. When the device 100 is installed, it can correct mitral valve leaflet prolapse and / or restore mitral valve function.

[0272] In some embodiments, in order to optimize the degree of atrial displacement of the mitral valve leaflets during ventricular systole under tension as described elsewhere herein when the device 100 is implanted, conventional transesophageal echocardiography (TEE) and / or fluoroscopy techniques may be used to optimize the atrial margin 110a of the body 110. Figure 4A The distance between the anchor point in the nipple muscle 39 and the anchor point in the nipple muscle 39.

[0273] In box 960, one or more locking elements 700 (described elsewhere herein) may be advanced using a locking element catheter (described elsewhere herein) to secure the device 100 in a desired location and position. Conventional transesophageal echocardiography (TEE) and / or fluoroscopy techniques may be used to advance the locking elements 700 and locking element catheters through the patient's circulatory system to the desired location.

[0274] exist Figures 19A to 19E An exemplary embodiment of the locking member 700 is shown. The locking member 700 includes: a body 710 defining opposing grippers 720, 730; and a channel 740 extending longitudinally through the body for receiving guide wires and / or nipple-shaped anchors and / or annular anchors' ties. Figures 19A to 19EIn the illustrated embodiment, the locking member 700 is hairpin shaped, and the body 710 tapers from the grippers 720, 730 to the opposite end 712 to facilitate delivery of the locking member 700 via a locking member conduit (described elsewhere herein). In some embodiments, the body end 712 defines a recess 742 concentrically shaped around the channel 740 for engaging the conduit as described elsewhere herein.

[0275] Locking element 700 is biased in Figures 19A to 19E In the locking configuration shown, the jaws 720, 730 are operable to engage the guidewire and / or a tether extending therebetween. To increase the strength of the engagement on the guidewire or tether, the jaws 720, 730 may define teeth 722, 732 for gripping the guidewire or tether. In the open configuration (in... Figure 20C , Figure 20F , Figure 20J and Figure 20K In the best-illustrated configuration, grippers 720, 730 are deflected away from each other, and locking member 700 moves freely along guide wire or tether. Each gripper 720, 730 defines a flexible arm 724, 734. In some embodiments, pressure may be applied to arms 724, 734 to deflect grippers 720, 730 into an open configuration. In some embodiments, grippers 720, 730 may be deflected away from each other by inserting a needle or other similar device between the grippers.

[0276] To secure the locking element 700 to the guidewire and / or tether, a locking element conduit is used. Figures 20A to 20K This allows the locking element 700 to advance along the guide wire and / or strap in the open configuration. Figures 20A to 20N and Figure 21 An exemplary embodiment of the locking conduit is shown. Locking conduit 800 ( Figures 20A to 20N The device includes a sleeve 810 that houses a locking tube 820. The locking tube 820 is configured to engage a recess 742 of the locking member 700 to allow the locking member 700 to advance or retract along a guide wire and / or tether. The locking tube 820 houses a deployment tube 830 for disengaging the locking member 700 from the locking tube 820 by advancing the deployment tube 830 toward an end 712 of the locking member 700.

[0277] In some embodiments, the locking member tube 820 includes at least one cut (not shown) extending longitudinally from its locking member engaging end 820a through at least a portion of the locking member tube. In some embodiments, the deployment tube 830 includes at least one cut (not shown) extending longitudinally from its locking member abutment end 830a through at least a portion of the deployment tube. To deploy the locking member 700 from the conduit 800, force is applied to the deployment tube 830 to advance the locking member abutment end 830a against the end 712 of the locking member 700. As the end 830a abuts against the end 712, the deployment tube 830 splits along at least one cut, increasing the diameter of the locking member abutment end 830a and forcing the end 830a against the locking member tube 820. As end 830a abuts against locking tube 820, locking tube 820 splits along at least one cut, increasing the diameter of locking engagement end 820a, releasing locking tube 820 from recess 742 of locking member 700, and deploying locking member 700 from conduit 800.

[0278] In some embodiments, the locking member 700 can be retracted using the conduit 800 by forcing the locking member abutment end 830a of the deployment tube 830 against the locking member tube 820 to cause the locking member tube 820 to split, thereby increasing the diameter of the locking member engagement end 820a. The conduit 800 is advanced to position the locking member engagement end 820a of the locking member tube 820 against the recess 742 of the locking member 700. To engage the locking member engagement end 820a with the recess 742, the deployment tube 830 is retracted away from the locking member engagement end 820a. As the deployment tube 830 is retracted, the diameter of the ends 820a, 830a decreases and the locking member engagement end 820a mates with and engages with the recess 742.

[0279] In some embodiments, the catheter 800 includes a needle 840 (in... Figure 20B , Figure 20E , Figure 20H and Figure 20K (Best shown in the diagram) is used to hold the locking member 700 in the open configuration. A needle 840 extends through the channel 740 over the guide wire and / or tie and deflects the jaws 720, 730 away from the guide wire and / or tie. To secure the locking member 700 to the guide wire and / or tie, the needle 840 can be withdrawn from the channel 740, allowing the jaws 720, 730 to be biased toward each other and to bias the locking member 700 into the closed configuration.

[0280] In some embodiments, the locking member 700 includes an annular collar 750 for retaining the locking member 700 in a closed configuration. Figures 19A to 19EIn the exemplary embodiment shown, grippers 720, 730 define recesses 728, 738, concentrically formed around channel 740 for receiving collar 750 and retaining locking member 700 in a locked configuration. The collar 750, positioned in the recesses 728, 738, is operable to prevent grippers 720, 730 from deflecting away from each other. Figures 20L to 20N ).

[0281] In some embodiments, for the collar 750 to move along the locking member 700, the collar 750 includes at least one notch 752. The sleeve 810 of the conduit 800 defines at least one recess 812, said at least one recess 812 being configured to engage one or more notches 752. Figures 20A to 20N In the illustrated embodiment, the sleeve 810 includes a recess 812 configured to engage a notch 752 of the collar 750. To secure the locking member 700 to the guidewire / tether, the sleeve 810 advances past the locking member tube 820 toward the collar 750. The sleeve 810 rotates about the guidewire and / or tether to align the recess 812 with the notch 752. With the recess 812 and the notch 752 aligned, the collar 750 can move together with the sleeve 810. The sleeve 810 can advance across the locking member tube 820 to push the collar 750 toward the jaws 720, 730 and position the collar 750 within the recesses 728, 738. Thus, the collar 750 engages the jaws 720, 730 together to close and retain the locking member 700 in a locked configuration. Figures 20L to 20N In some embodiments, once the collar 750 advances along the grippers 720, 730 and is positioned within the recesses 728, 738, the locking member 700 is irreversibly locked in the closed configuration. With the locking member 700 locked in the closed configuration and thus secured to the guidewire and / or tether, the catheter 800 can be withdrawn from the patient's body.

[0282] Locking conduit 850 ( Figure 21 Many features and components of the locking conduit 800 are similar to those of the locking member conduit 850, and the same reference numerals are used to indicate similar features and components. The sleeve 810 of the conduit 850 defines at least one orifice 862, which is configured to receive at least one notch 752 of the locking member 700.

[0283] In some embodiments, catheter 800 includes a controller (not shown) for operating the device outside the blood vessel. When catheter 800 is located inside the blood vessel, the controller is located outside the patient's body, as described elsewhere herein. In some embodiments, the controller includes a handle and devices for operating catheter 800 and portions thereof.

[0284] In some embodiments, catheter 400 includes a controller (not shown) for operating the device outside the blood vessel. When catheter 400 is located inside the blood vessel, the controller is located outside the patient's body, as described elsewhere herein. In some embodiments, the controller includes a handle and devices for operating catheter 400 and portions thereof.

[0285] Locking element 700 and its portions may include medical-grade plastics, thermoplastics, stainless steel, metals, and metal alloys (e.g., Nitinol). TM Or another nickel / titanium alloy) and one or more of titanium.

[0286] The catheter 800 and its components may include medical-grade plastics, thermoplastics, stainless steel, metals, and metal alloys (e.g., Nitinol). TM Or another nickel / titanium alloy) and one or more of titanium. Those skilled in the art will recognize that catheter 1000 and / or portions thereof can be made of any sterile or sterilizable material conventionally used in the manufacture of tools used in cardiac surgery.

[0287] Figures 22A to 22D A device 900 for repairing a heart valve, such as the mitral valve, according to an exemplary embodiment of the present invention is shown. The device 900 includes a radially compressible and radially expandable body 910, a front member 920, and a rear member 930. In the illustrated embodiment, the body 910 is a tube. Alternatively, the body 910 has a shape similar to that of the body 110 of device 100, as in... Figure 4A As seen elsewhere, a radially compressible and radially expandable ring (not shown) having similar functionality and properties to ring 112 discussed elsewhere herein can be arranged on or within body 910 to facilitate its radial compression and expansion. The compressibility and expandability of the ring are not mandatory; body 910 can be provided, for example, in a self-expanding form (e.g., the body is constrained within a delivery device, such as a catheter, until the body is positioned and deployed). Body 910 can also be directly expanded and contracted using external devices such as inflatable balloons.

[0288] A front member 920 is connected to the front end 919 of the main body 910. A rear member 930 may be attached to the rear end 918 of the main body 910. Each member 920, 930 includes segments 922, 932. Segments 922, 932 may include a mesh structure defined by a plurality of cells 902. The plurality of cells 902 extend radially and longitudinally from the main body 910 to a plurality of positioning cords 924, 934. Cell 902 is a hollow space that allows blood to pass through.

[0289] Segments 922, 932 may include a plurality of positioning cords 924, 934 for positioning each component to cover the atrial surface from its lateral to medial commissure of the mitral valve leaflets. Cords 924, 934 are laterally spaced across each segment 922, 932 and extend from the segment 922, 932 away from the body 910. Cords 924, 934 may be integrally formed with the corresponding segment 922, 932. Each cord 924, 934 terminates in and connects to a flexible, compressible tube 940, 950. Cords 924, 934 are laterally spaced across tubes 940, 950. In some embodiments, cords 924, 934 are evenly spaced across tubes 940, 950. Tubes 940, 950 may each include adjusting cords 942, 952, which are attached to the end of the tube and extend longitudinally through the tube. In the illustrated embodiments, the compressible tubes 940 and 950 are circular hollow tubes constructed with braided threads. The threads may be made of one or more of polytetrafluoroethylene (PTFE), expanded PTFE, polyethylene, polypropylene, polyethylene terephthalate, extracellular matrix biomaterials, and tissue engineering materials. However, the compressible tubes 940 and 950 may be provided in other suitable forms known in the art. The compressible tubes 940 and 950 and the adjusting cords 942 and 952 are similar to tubes 140 and 150 and cords 142 and 152, respectively, which have been discussed elsewhere. Therefore, the functions and characteristics of the compressible tubes 940 and 950 and the adjusting cords 942 and 952 will not be repeated.

[0290] Cell 902 can be contractible between a relaxed position and an extended position. Cell 902 can be extended and / or contracted laterally and / or longitudinally relative to the body 910. In some embodiments, each cell 902 has a rhombus shape. A rhombus is a quadrilateral having four sides and four vertices, the four sides having substantially equal lengths, the four vertices having equal vertical angles (θ1 = θ2 and θ3 = θ4), and one set of angles being greater than another set of angles (θ1, θ2 are greater than θ3, θ4). Figure 22E A schematic diagram of rhomboid cell 902 is shown. In the illustrated embodiment ( Figures 22A to 22D In this configuration, the rhombus cell 902 is aligned such that vertices with smaller angles (θ3, θ4) are positioned longitudinally relative to the body 910, and vertices with larger angles (θ1, θ2) are positioned laterally relative to the body 910. However, this is not mandatory. In some embodiments, cell 902 may be aligned such that vertices with smaller angles (θ3, θ4) are positioned laterally and vertices with larger angles (θ1, θ2) are positioned longitudinally relative to the body 910.

[0291] When the device 900 is implanted in the heart 10, the shape of segments 922 and 932 changes in response to the opening and closing of the mitral valve 30 during ventricular systole. The mitral valve 30 changes shape during valve opening and closing. Figure 23A This is a schematic diagram showing the fully open mitral valve 30. The arrows indicate the direction of blood flow through the open mitral valve 30. Figure 23A As shown, a fully open mitral valve can be defined by a generally cylindrical shape. The cylindrical shape can be defined by two parallel circular bases connected by curved surfaces. Figure 23A This is a schematic diagram showing a fully closed mitral valve 30. The arrows indicate that blood cannot flow back into the atrium 20 through the mitral valve 30. Figure 23B As shown, a fully closed mitral valve can be defined by a generally hourglass shape. The hourglass shape can be defined by a convex front that tapers axially toward the bottom of a constricted waist.

[0292] In some embodiments, segments 922, 932 may change between a cylindrical configuration and an hourglass configuration in response to the corresponding opening and closing of the mitral valve 30. Segments 922, 932 conform to the shape of the mitral valve 30 through the transition of cell 902 between a relaxed position and an elongated position. The shape and size of cell 902 change between the relaxed position and the elongated position.

[0293] When the mitral valve 30 is open, segments 922 and 932 can be in a cylindrical configuration. In such an embodiment, cell 902 can be in a relaxed position. In the relaxed position, cell 902 can be substantially uniform in size and shape. For example, in an embodiment where cell 902 is rhomboid in shape, cells 902 have the same or substantially similar diagonal length p (i.e., the distance between opposite longitudinal vertices) and have the same or substantially similar diagonal length q (i.e., the distance between opposite transverse vertices), such as... Figure 22E As shown in the diagram.

[0294] When the mitral valve 30 is closed, segments 922 and 932 can be in an hourglass configuration. In such embodiments, some or all of the cells 902 can be in an elongated position. In the elongated position, the cells 902 may be inconsistent in size and shape. In some embodiments, the diagonal length p of the cells 902 increases from the rear end 918 and the front end 919 of the body 910 toward the compressible tubes 940 and 950. The diagonal length q of the cells 902 may decrease from the rear end 918 and the front end 919 of the body 910 toward the compressible tubes 940 and 950. In these embodiments, the cells 902 near the compressible tubes 940 and 950 are elongated and narrow. The elongated and narrow cells 902 generally conform to the bottom of the conical waist of a fully closed hourglass-shaped mitral valve.

[0295] Overlapping cells 902 during ventricular systole are undesirable. Some undesirable consequences include thrombosis, impaired mitral valve leaflet occlusion, and wear and tear on segments 922 and 932, which can eventually lead to device 900 failure over time. During ventricular systole, without overlapping cells 902, the rhomboid cells 902 can conform to the open cylindrical mitral valve 30 and the closed hourglass-shaped mitral valve 30, transitioning between them. As discussed herein, when device 900 is implanted in the heart 10, the rhomboid cells 902 at or near the bottom of the conical waist of the closed hourglass-shaped mitral valve 30 elongate longitudinally and contract laterally in response to the closure of the mitral valve 30. This elongation and narrowing of the rhomboid cells 902 at or near the bottom of the conical waist of the closed hourglass-shaped mitral valve 30 prevents overlap of cells 902.

[0296] It should be understood that cell 902 can have other suitable shapes that provide elongation and narrowing similar to the rhombus cells discussed herein. Other suitable shapes include other types of polygons, such as triangles, quadrilaterals other than rhombuses, pentagons, hexagons, etc. For example, in Figures 4A to 4H In the embodiments described, cell 102 of segments 122 and 132 has a square shape.

[0297] The device 900 is delivered and positioned inside the heart using the same method described elsewhere in this document for device 100.

[0298] Terminology Explanation

[0299] Unless the context clearly requires otherwise, throughout this specification and the claims:

[0300] • The terms “comprise, comprising” and similar terms should be interpreted as inclusive, not exclusive or exhaustive; that is, they should be interpreted as “including but not limited to”.

[0301] • “Connection”, “linkage” or any variation thereof means any direct or indirect connection or link between two or more elements; the connection or link between elements can be physical, logical or a combination thereof; elements formed as a whole can be considered connected or linked.

[0302] • The words “here,” “above,” “below,” and similar terms used to describe this specification should refer to the entire specification and not any particular part thereof;

[0303] • “Or” refers to a list containing two or more items, encompassing all of the following interpretations of the word: any item in the list, all items in the list, and any combination of items in the list;

[0304] • The singular forms of the indefinite and definite articles (“a”, “an”, “the”) also include the meaning of any appropriate plural form.

[0305] Terms used to indicate direction, such as “vertical,” “cross,” “horizontal,” “up,” “down,” “forward,” “backward,” “inward,” “outward,” “perpendicular,” “lateral,” “left,” “right,” “front,” “back,” “top,” “bottom,” “lower,” “above,” “below,” and similar terms, when used in this specification and any appended claims (if any), depend on the specific orientation of the described and illustrated device. Various alternative orientations may be assumed in the subject matter described herein. Therefore, these directional terms are not strictly defined and should not be interpreted narrowly.

[0306] Specific examples of systems, methods, and devices have been described herein for illustrative purposes. These are merely examples. The techniques provided herein can be applied to systems other than the exemplary systems described above. Many changes, modifications, additions, omissions, and arrangements are possible in the practice of this invention. This invention includes variations of the embodiments that will be apparent to those skilled in the art, including variations obtained by: replacing features, elements, and / or functions with equivalent features, elements, and / or functions; mixing and matching features, elements, and / or functions from different embodiments; combining features, elements, and / or functions from embodiments as described herein with features, elements, and / or functions from other technologies; and / or omitting combined features, elements, and / or functions from the described embodiments.

[0307] Therefore, the appended claims and the claims described below are intended to be interpreted as including all such modifications, arrangements, additions, omissions, and sub-combinations as can be reasonably inferred. The scope of the claims should not be limited to the preferred embodiments set forth in the examples, but should be given the broadest interpretation consistent with the entire description.

[0308] While this document discusses several exemplary aspects and embodiments, those skilled in the art will recognize certain modifications, arrangements, additions, and sub-combinations thereof.

[0309] While numerous exemplary aspects and embodiments have been discussed above, those skilled in the art will recognize certain modifications, arrangements, additions, and sub-combinations thereof. Therefore, the appended claims and the claims described below are intended to be interpreted as including all such modifications, arrangements, additions, and sub-combinations within their true spirit and scope.

Claims

1. An apparatus for repairing a heart valve, the apparatus comprising: a body that is radially compressible and expandable, the body having an anterior end and a posterior end; an anterior member connected to a posterior member, the anterior and posterior members being attached to the anterior and posterior ends of the body, respectively, wherein the anterior and posterior members each comprise a segment that extends radially around the body, and the segment extends longitudinally from the body to a plurality of positioning cords, wherein each segment comprises a mesh structure defined by a plurality of cells, and wherein the plurality of positioning cords are spaced laterally across the respective segment and arranged to extend longitudinally from the segment to their respective ends away from the body; an anterior tube and a posterior tube, each attached at their respective ends to the respective plurality of positioning cords; and a first adjustment cord and a second adjustment cord that extend through each of the anterior and posterior tubes, wherein the anterior and posterior tubes are lengthened or shortened by adjusting the tension of the respective adjustment cord, wherein the length of each positioning cord is selected to suspend the respective anterior and posterior tubes from the respective anterior and posterior members in a parabolic or parabolic-like shape.

2. The apparatus of claim 1, wherein, Adjusting the tension of the first and second adjustment cords lengthens or shortens the respective anterior and posterior tubes, thereby displacing the respective tubes toward or away from the body, causing a corresponding displacement of the respective anterior and posterior members.

3. The apparatus of claim 1, wherein, Lengthening the respective anterior and posterior tubes causes the apex of the parabolic or parabolic-like shape of the respective anterior and posterior tubes to be displaced toward the body.

4. The apparatus of claim 1, wherein, Shortening the respective anterior and posterior tubes causes the apex of the parabolic or parabolic-like shape of the respective anterior and posterior tubes to be displaced away from the body.

5. The apparatus of claim 1, further comprising a wrap-around member connectable to the body for radially compressing and / or radially expanding the body.

6. The apparatus of claim 5, wherein, The body comprises a plurality of peaks and a plurality of valleys, the peaks and valleys being interchangeably defined along a diameter of the body.

7. The apparatus of claim 6, wherein, The body comprises a plurality of ring members, each ring member being positioned on a corresponding peak.

8. The apparatus of claim 7, wherein, The wrap-around member passes through the plurality of ring members.

9. The apparatus of claim 1, wherein, The body defines at least one anchoring site.

10. The apparatus of claim 9, wherein, The body comprises a skirt.

11. The apparatus of claim 10, wherein, The skirt defines at least one anchoring site.

12. The apparatus of claim 1, wherein, The apparatus is configured to extend from the atrial wall and the mitral annulus to the anterior lateral papillary muscle and the posterior medial papillary muscle of the heart valve when the apparatus is implanted in the heart valve.

13. The apparatus of claim 1, wherein, The anterior member is configured to cover the anterior mitral leaflet of the heart valve when the apparatus is implanted in the heart valve.

14. The apparatus of claim 1, wherein, The posterior member is configured to cover the posterior mitral leaflet of the heart valve when the apparatus is implanted in the heart valve.

15. The apparatus of claim 1, wherein, The anterior and posterior members are each formed of a material comprising a biocompatible and blood-permeable material that allows blood to pass through.

16. The apparatus of claim 1, wherein, The plurality of cells have a diamond shape.

17. The apparatus of claim 1, wherein, The plurality of cells have a square or rectangular shape.

18. The apparatus of claim 16, wherein, The diamond shaped cells are contractible between a relaxed position and an elongated position.

19. The apparatus of claim 18, wherein, The diamond shaped cells are of uniform shape and size in the relaxed position.

20. The apparatus of claim 19, wherein, The diamond shaped cells are of non-uniform shape and size in the elongated position.

Images