Transcatheter Device and Method for Treating the Heart - Patent application

Abstract

The tether (10) can be advanced transluminally into a coronary vessel of the heart. At a first location (14a), a first end (10a) of the tether is advanced through the wall of the vessel into the heart chamber and then transluminally withdrawn from the heart chamber such that a first segment of the tether extends from the first location through the heart chamber. At a second location (14b), a second end (10b) of the tether is advanced through the wall into the heart chamber and then transluminally withdrawn from the heart chamber such that a second segment of the tether extends from the second location through the heart chamber. At least one anchor (50) is slid over and along at least one of the first and second ends and secured to tissue of the heart chamber. The heart chamber can then be reshaped by modifying the tension of the tether.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Application No. 63 / 181,565, entitled "Transcatheter devices and methods for treatment of a heart," by Hoffer et al., filed April 29, 2021, which is incorporated by reference herein for all purposes. [Background technology]

[0002] The function of the mammalian heart is based on the contraction of the cardiac muscle, exerting pressure within the ventricles of the heart, forcing blood to flow from the ventricles to the arteries. Blood from the body returns to the atria of the heart via the veins. Valves between each atrium of the heart and the corresponding ventricle of the heart, as well as between the ventricles of the heart and the corresponding arteries, inhibit the occurrence of backflow. The valves between the atria and ventricles of the heart are known as atrioventricular valves. At least in humans, the atrioventricular valve between the left atrium and the left ventricle is known as the mitral valve, and the atrioventricular valve between the right atrium and the right ventricle is known as the tricuspid valve. Each of these valves includes multiple valve leaflets that coapt when the valve is closed and have a space formed between them when the valve is open. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] US Patent Application Publication No. 2021 / 0145584 [Patent Document 2] U.S. Provisional Patent Application No. 63 / 147699 [Patent Document 3] International Application No. PCT / IB2022 / 051099 [Patent Document 4] US Patent Application Publication No. 2020 / 0015971 [Patent Document 5] US Patent Application Publication No. 2015 / 0272734 [Patent Document 6] US Patent Application Publication No. 2018 / 0049875 [Patent Document 7] International Publication No. 2021 / 084407 Summary of the Invention [Problem to be solved by the invention]

[0004] Proper closure of the mitral and tricuspid valves is important for proper functioning of the heart, and many medical conditions, some of which are life threatening, result from improper closure of the valves, resulting in regurgitation (backflow) from the ventricles into the corresponding atria. Annuloplasty may be required to reshape the annulus of a tricuspid or mitral valve that does not close properly. [Means for solving the problem]

[0005] This summary is intended to provide some examples and is not intended to limit the scope of the present invention in any way. For example, any features contained within an example of this summary are not required by the claims unless the claims explicitly recite those features. Also, features, components, steps, concepts, etc. described in the examples of this summary and elsewhere in this disclosure can be combined in various ways. Various features and steps described elsewhere in this disclosure can be included in the examples summarized herein.

[0006] According to some applications herein, a tether is advanced into a coronary vessel or artery, and two ends or ends of the tether are advanced through the wall of the coronary vessel or artery into an adjacent heart chamber at two different locations. The ends are withdrawn from the heart chamber (described in more detail below) for each of the locations such that a segment of the tether extends through the heart chamber from a respective one of the locations. A tissue anchor is slid over and along at least one of the ends and secured to the tissue of the heart chamber such that a portion of the tether extends between the wall of the coronary vessel or artery and the tissue anchor. The heart chamber is then reshaped, for example, by modifying the tension of the tether in the portion of the tether that extends between the coronary vessel or artery and the tissue anchor. The tension of the tether is then locked to maintain the newly achieved shape of the heart chamber. In some applications, the heart chamber is an atrium of the heart, and reshaping the heart chamber advantageously reshapes and improves the function of an atrioventricular valve disposed between the atrium of the heart and a ventricle of the heart downstream of the atrium.

[0007] According to some applications, a method of repairing a heart valve of a subject's heart is provided, the method including advancing a tether transluminally into a coronary vessel or artery of the subject's heart, the coronary vessel or artery may at least partially surround a chamber of the heart.

[0008] The method may include advancing a first end of the tether through a wall of a coronary vessel or artery into a heart chamber at a first location. The first end of the tether may be withdrawn transluminally from the heart chamber such that a first segment of the tether extends from the first location through the heart chamber.

[0009] The method may further include advancing a second end of the tether through a wall of the coronary vessel or artery and into the heart chamber at the second location. The second end of the tether may be withdrawn transluminally from the heart chamber such that a second segment of the tether extends from the second location through the heart chamber.

[0010] At least one tissue anchor can be slidably moved over at least one of the first end and the second end and secured to tissue of the heart chamber, such that a portion of the tether extends between the at least one tissue anchor and the coronary vessel or artery.

[0011] The heart chamber can be remodeled by modifying the tension of at least a portion of a tether extending between at least one tissue anchor and a coronary vessel or artery, and the tension of the tether can be locked after remodeling of the heart chamber.

[0012] In some applications, sliding the at least one anchor can include sliding one anchor over and along both the first end and the second end, hi some applications, locking the tension of the tether can include locking the tension adjacent one anchor.

[0013] In some applications, locking the tension may include locking a first end and a second end of the tether using a single lock.

[0014] In some applications, sliding the at least one anchor can include sliding the first tissue anchor over and along the first end to secure the first tissue anchor to tissue of the heart chamber in a first configuration, such that a first portion of the tether extends between the first tissue anchor and the coronary vessel or artery.

[0015] In some applications, the sliding can further include sliding a second tissue anchor over and along the second end and can include securing the second tissue anchor to tissue of the heart chamber in the second configuration such that a second portion of the tether extends between the second tissue anchor and the coronary vessel or artery.

[0016] In some applications, locking the tension can include locking first and second ends of the tether adjacent the first and second tissue anchors, respectively.

[0017] In some applications, locking the tension may include locking both the first and second ends of the tether using a single lock.

[0018] In some applications, the method may further include sliding a single lock over and along the first and second ends of the tether to a locking point prior to locking the tension.

[0019] In some applications, the sliding of the single lock onto the first and second ends of the tether can occur outside the subject's body, and the sliding of the single lock along the tether can occur, at least in part, transluminally.

[0020] In some applications, modifying the tension of the tether can include locking one of the first and second ends adjacent a corresponding one of the first and second tissue anchors and pulling the other of the first and second ends.

[0021] In some applications, locking the tension can include locking the other of the first and second ends adjacent to a corresponding other of the first and second tissue anchors.

[0022] In some applications, modifying the tension of the tether can include pulling a first end and a second end of the tether and then locking the first end of the tether adjacent to the first tissue anchor and the second end of the tether adjacent to the second tissue anchor.

[0023] In some applications, the heart chamber is the left atrium of the heart and the coronary vessel or artery is the left coronary artery of the subject.

[0024] In some applications, the left coronary artery is the left circumflex artery of the subject.

[0025] In some applications, remodeling the heart chamber includes remodeling the subject's mitral valve.

[0026] In some applications, at least one of transluminally withdrawing the first end and transluminally withdrawing the second end includes withdrawing the first end and the second end through at least one of a cardiac septum and a vena cava of the subject.

[0027] In some applications, the vena cava is the superior vena cava.

[0028] In some applications, the vena cava is the inferior vena cava, and the outlet of at least one of the first end and the second end may further pass through a femoral vein of the subject.

[0029] In some applications, the first end and the second end are both brought out through one of the superior vena cava and the inferior vena cava.

[0030] In some applications, one of the first end and the second end is brought out through the superior vena cava and the other of the first end and the second end is brought out through the inferior vena cava.

[0031] In some applications, advancement of the tether into a coronary vessel or artery passes through the subject's femoral artery and aorta.

[0032] In some applications, the heart chamber is the right atrium of the heart and the coronary vessel or artery is the right coronary artery of the subject.

[0033] In some applications, remodeling the heart chamber includes remodeling the subject's tricuspid valve.

[0034] For some applications, at least one of transluminally withdrawing the first end and transluminally withdrawing the second end includes withdrawing at least one of the first end and the second end through a vena cava of the subject.

[0035] In some applications, the vena cava is the superior vena cava.

[0036] In some applications, the vena cava is the inferior vena cava and the outlet of at least one of the first end and the second end can further pass through a femoral vein of the subject.

[0037] In some applications, the first end and the second end are both brought out through one of the superior vena cava and the inferior vena cava.

[0038] In some applications, one of the first end and the second end is brought out through the superior vena cava and the other of the first end and the second end is brought out through the inferior vena cava.

[0039] In some applications, withdrawing the first end and withdrawing the second end includes withdrawing the first end and the second end from within the subject's body. In some applications, sliding the at least one anchor onto at least one of the first end and the second end of the tether occurs outside the subject's body, and sliding the at least one anchor along the tether delivers the at least one anchor into the subject's body.

[0040] In some applications, withdrawing the first end and withdrawing the second end includes withdrawing the first end and the second end from a heart chamber within the subject's body. In some applications, sliding of the at least one anchor over and along at least one of the first end and the second end of the tether occurs within the subject's body.

[0041] In some applications, at least one of the first end withdrawal and the second end withdrawal may be accomplished using a snare.

[0042] In some applications, the withdrawal of the first end and the withdrawal of the second end are each accomplished using a snare.

[0043] In some applications, the snare used to pull the first end and the snare used to pull the second end are the same snare.

[0044] In some applications, the method may further include transluminally advancing a snare from the catheter into the heart chamber prior to at least one of retracting the first end and retracting the second end.

[0045] In some applications, at least one of the first end outlet and the second end outlet may be through a catheter.

[0046] In some applications, the method may further include a step of transluminally advancing a support tube defining a lumen into the coronary vessel or artery, the tether extending through the lumen of the support tube and being slidable relative to the support tube.

[0047] In some applications, transluminal advancement of the support tube may be performed prior to advancement of the first end of the tether through the wall of the coronary vessel or artery and into the heart chamber.

[0048] In some applications, transluminal advancement of the support tube may be performed after advancement of a first end of the tether through the wall of a coronary vessel or artery into the heart chamber and before advancement of a second end of the tether through the wall of a coronary vessel or artery into the heart chamber.

[0049] The above methods can be performed in a living animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (eg, a simulated body part, cardiac tissue), or the like.

[0050] According to some applications, there is further provided a system and / or device for use with a subject. The system / device may include a tether configured to be advanced transluminally into a coronary vessel or artery of a heart of the subject. In some applications, the coronary vessel or artery at least partially traverses a chamber of the heart. The tether may have a first end and a second end, the first end configured to be advanced through a wall of the coronary vessel or artery into the chamber at a first location, and the second end configured to be advanced through a wall of the coronary vessel or artery into the chamber at a second location.

[0051] The system / device may further include at least one device configured to transluminally withdraw the first and second ends of the tether from the heart chamber from the first and second locations, respectively, such that a first segment of the tether may extend through the heart chamber from the first location and a second segment of the tether may extend through the heart chamber from the second location.

[0052] The system / device may further include a support tube defining a lumen, the support tube configured to be advanced transluminally into the coronary vessel or artery. In some applications, the tether extends through the lumen of the support tube and is slidable relative to the support tube.

[0053] The system / apparatus may further include at least one tissue anchor configured to slide over and along at least one of the first end and the second end to secure at least one of the first end and the second end to tissue of the heart chamber such that a portion of the tether extends between the at least one tissue anchor and the coronary vessel or artery.

[0054] The system / device may further comprise at least one lock configured to lock the tension in the tether following tensioning of the tether.

[0055] In some applications, the at least one tissue anchor may include a single tissue anchor configured to slide over and along both the first end and the second end to secure the first end and the second end to tissue of the heart chamber such that two portions of the tether extend between the tissue anchor and the coronary vessel or artery.

[0056] For some applications, the at least one lock can include a single lock configured to lock the first and second ends of the tether adjacent to a single tissue anchor.

[0057] For some applications, the at least one tissue anchor can include a first tissue anchor configured to slide over a first end thereof such that a first portion of the tether extends between the first tissue anchor and the coronary vessel or artery, and to secure the first end to tissue of the heart chamber in a first configuration, and a second tissue anchor configured to slide over a second end thereof such that a second portion of the tether extends between the second tissue anchor and the coronary vessel or artery, and to secure the second end to tissue of the heart chamber in a second configuration.

[0058] For some applications, the at least one lock includes a single lock configured to slide over the first and second ends of the tether and lock the first and second ends of the tether to locking points adjacent one of the first and second tissue anchors.

[0059] For some applications, the at least one lock may include a first lock configured to slide over a first end of the tether and lock the first end of the tether to a first lock point adjacent to the first tissue anchor, and a second lock configured to slide over a second end of the tether and lock the second end of the tether to a second lock point adjacent to the second tissue anchor.

[0060] In some applications, the heart chamber is the left atrium of the heart and the coronary vessel or artery is the left coronary artery of the subject.

[0061] In some applications, the left coronary artery is the left circumflex artery of the subject.

[0062] For some applications, tension in the tether is configured to reshape the subject's mitral valve.

[0063] For some applications, the at least one device is configured to direct at least one of the first end and the second end through at least one of the septal space of the heart and the vena cava of the subject.

[0064] In some applications, the vena cava is the superior vena cava.

[0065] In some applications, the vena cava is the inferior vena cava, and the at least one device may be configured to further extend at least one of the first end and the second end through a femoral vein of the subject.

[0066] For some applications, the at least one device is configured to direct the first end and the second end through one of the superior vena cava and the inferior vena cava.

[0067] For some applications, the at least one device includes a first device configured to extend one of the first end and the second end through the superior vena cava and a second device configured to extend the other of the first end and the second end through the inferior vena cava.

[0068] For some applications, the tether is configured to be advanced through a subject's femoral artery and aorta and into a coronary vessel or artery.

[0069] In some applications, the heart chamber is the right atrium of the heart and the coronary vessel or artery is the right coronary artery of the subject.

[0070] For some applications, tension in the tether is configured to reshape the subject's tricuspid valve.

[0071] For some applications, the at least one device is configured to direct at least one of the first end and the second end through the vena cava of the subject.

[0072] In some applications, the vena cava is the superior vena cava.

[0073] In some applications, the vena cava is the inferior vena cava, and the at least one device may be configured to further extend at least one of the first end and the second end through a femoral vein of the subject.

[0074] For some applications, the at least one device is configured to direct the first end and the second end through one of the superior vena cava and the inferior vena cava.

[0075] For some applications, the at least one device includes a first device configured to extend one of the first end and the second end through the superior vena cava and a second device configured to extend the other of the first end and the second end through the inferior vena cava.

[0076] For some applications, the system may further include a first longitudinal catheter configured to be advanced transluminally into the coronary vessel or artery. The tether may be configured to be advanced distally from the first catheter into the coronary vessel or artery.

[0077] For some applications, the at least one device includes at least one snare.

[0078] For some applications, the at least one snare includes a single snare configured to withdraw the first end and the second end.

[0079] For some applications, the at least one snare includes a first snare configured to withdraw the first end and a second snare configured to withdraw the second end.

[0080] For some applications, the at least one snare is configured to be advanced transluminally from the catheter into the heart chamber prior to at least one of the first end retraction and the second end retraction.

[0081] For some applications, the system can further include at least one second catheter. The at least one device can be configured to extend the first end and the second end through the at least one second catheter.

[0082] For some applications, the support tube is configured to be advanced distally from the first catheter into the coronary vessel or artery.

[0083] According to a second aspect of the teachings herein, a method and apparatus are provided for protecting a coronary vessel or artery of a subject's heart during a medical procedure in the subject's heart. A compressed structure including a radiopaque material is expanded into an elongated structure within the coronary vessel or artery. The elongated structure is visible using fluoroscopic imaging. The medical procedure may include fixation of a tissue anchor within a heart chamber adjacent to the coronary vessel or artery in which the elongated structure is located. The heart is imaged using a fluoroscopy tool such that the elongated structure is visible. A location for fixation of the tissue anchor is selected based on the acquired images to avoid damage to the coronary vessel or artery during fixation. In some applications, the elongated structure is held within the coronary vessel or artery while fixation is performed, and fixation may be performed under real-time fluoroscopic guidance aided by visibility of the elongated structure.

[0084] In some cases, the elongate structure includes an electrically conductive material and an electrical signal (e.g., a voltage) is applied by the control subsystem between the elongate structure and the anchor and / or an anchor driver that delivers the anchor. Proximity or contact between the tissue anchor and the elongate structure is detected by the control subsystem (e.g., by detecting an electrical signal) and a signal, such as a visual, audio, or tactile signal, is provided to indicate the proximity and / or contact between the anchor and the elongate structure. In some applications, a different elongate structure (e.g., an elongate structure that is not expandable and / or does not include a radiopaque material) is used in a similar manner.

[0085] According to some applications, there is further provided a method of avoiding damage to a coronary vessel or artery of a subject's heart during a medical procedure, the coronary vessel or artery being adjacent to a chamber of the heart, the method including expanding within the coronary vessel or artery a compressed elongated tube comprising a radiopaque material.

[0086] The method may further include the step of securing a tissue anchor in a heart chamber adjacent the coronary vessel or artery.

[0087] In some applications, the placement of the tissue anchors during fixation may be selected based on at least one fluoroscopic image including the elongated tube to avoid damaging the coronary vessel or artery during fixation.

[0088] For some applications, the method may further include transluminally advancing the compressed elongate tube into a coronary vessel or artery prior to expanding the compressed elongate tube.

[0089] In some applications, the method may further include transluminally removing the elongate tube from the coronary vessel or artery after fixation of the tissue anchor.

[0090] In some applications, the transluminally removing step may include recompressing the elongate tube and transluminally removing the compressed elongate tube from the coronary vessel or artery.

[0091] In some applications, the heart chamber is the left atrium of the heart and the coronary vessel or artery is the left coronary artery of the subject.

[0092] In some applications, the left coronary artery is the left circumflex artery of the subject.

[0093] In some applications, the fixation is within the annulus of the target mitral valve.

[0094] For some applications, the elongate tube is long enough to extend around at least a majority of the mitral valve annulus.

[0095] In some applications, advancement of the compressed elongated tube into the coronary vessel or artery passes through the femoral artery and aorta of the subject.

[0096] In some applications, the heart chamber is the right atrium of the heart and the coronary vessel or artery is the right coronary artery of the subject.

[0097] In some applications, the fixation is within the annulus of the target tricuspid valve.

[0098] For some applications, the elongate tube is long enough to extend around at least a majority of the annulus of the tricuspid valve.

[0099] In some applications, advancement of the compressed elongate tube into a coronary vessel or artery is through a coronary ostium at the aortic root of the subject.

[0100] In some applications, advancing includes transluminally advancing a compressed elongate tube over a guidewire.

[0101] In some applications, the elongated tube includes a metal or mesh frame.

[0102] In some applications, the expansion may include retracting the outer sheath from the compressed elongate tube, thereby allowing the elongate tube to expand.

[0103] In some applications, the expanding may include pulling one end of the elongate tube from an opposing end of the elongate tube.

[0104] In some applications, the method may further include the step of transluminally advancing a tension element within the coronary vessel or artery at a distal end of the elongate tube prior to dilatation.

[0105] In some applications, there is no contrast agent within the subject's body during fixation.

[0106] In some applications, the elongate tube is made of a conductive material. In some applications, the anchor driver can be mechanically and electrically coupled to the tissue anchor such that contact between the anchor and the elongate tube generates a detectable signal, and is electrically coupled to the control subsystem.

[0107] For some applications, the method may further include monitoring a detectable signal indicative of contact between the tissue anchor and the elongate tube during fixation.

[0108] In some applications, the method may further include relocating the tissue anchor to another location in response to identifying the detectable signal.

[0109] The above methods can be performed in a living animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (eg, a simulated body part, cardiac tissue), or the like.

[0110] According to some applications, there is further provided a system for use in a subject. The system may include an elongated tube including a radiopaque and electrically conductive material. The elongated tube may be configured to be advanced transluminally in a compressed state into a coronary vessel or artery of a heart of the subject and expanded within the coronary vessel or artery.

[0111] The system may further include a tissue anchor configured to be secured within a heart chamber of the subject adjacent to the coronary vessel or artery.

[0112] The system may further include at least one fluoroscopic image capture device configured to capture at least one fluoroscopic image during fixation of the tissue anchor within the heart chamber. In some applications, the at least one fluoroscopic image includes the elongated tube.

[0113] The system may further include an anchor driver that may be mechanically and electrically coupled to the tissue anchor.

[0114] The control subsystem can be configured to generate a detectable signal when the tissue anchor contacts the elongate tube.

[0115] For some applications, the at least one fluoroscopic image is configured to assist the operator in avoiding damaging the coronary vessel or artery during fixation of the tissue anchor.

[0116] In some applications, the elongated tube is a compressible elongated tube having a compressed and an expanded operating orientation, hi some applications, the elongated tube may be configured to be advanced into a coronary vessel or artery when in the compressed operating orientation.

[0117] In some applications, the elongate tube may be further configured to be transluminally removed from the coronary vessel or artery following fixation of the tissue anchors.

[0118] In some applications, the heart chamber is the left atrium of the heart and the coronary vessel or artery is the left coronary artery of the subject.

[0119] In some applications, the left coronary artery is the left circumflex artery of the subject.

[0120] For some applications, the tissue anchor may be configured to be secured to the annulus of a subject's mitral valve.

[0121] For some applications, the elongate tube is long enough to extend around at least a majority of the mitral valve annulus.

[0122] In some applications, the elongate tube is configured to be advanced through the femoral artery and aorta of a subject and into a coronary vessel or artery.

[0123] In some applications, the heart chamber is the right atrium of the heart and the coronary vessel or artery is the right coronary artery of the subject.

[0124] For some applications, the tissue anchor is configured to be secured to the annulus of a tricuspid valve of a subject.

[0125] For some applications, the elongate tube is long enough to extend around at least a majority of the annulus of the tricuspid valve.

[0126] For some applications, the elongate tube is configured to be advanced into a coronary vessel or artery through the coronary ostium and aortic root of a subject.

[0127] For some applications, the system further includes a guidewire. In some applications, the compressed elongate tube is configured to be advanced transluminally over the guidewire into a coronary vessel or artery.

[0128] In some applications, the elongated tube includes a metal or mesh frame.

[0129] For some applications, the elongate tube may further include an outer sheath adapted to hold the elongate tube in a compressed operational orientation.

[0130] For some applications, the system may further include a tensioning element configured to pull the distal end of the elongated tube distally relative to the proximal end of the elongated tube when the elongated tube is in the compressed operating orientation, thereby expanding the elongated tube.

[0131] According to some applications, there is further provided a method of avoiding damage to a coronary vessel or artery of a subject's heart during a medical procedure, the coronary vessel or artery being adjacent to a chamber of the heart, the method including advancing an elongated structural element into the coronary vessel or artery, the elongated structural element being configured to emit an electrical signal.

[0132] The method may further include causing the elongated structural element to emit an electrical signal within the coronary vessel or artery and may include detecting the electrical signal adjacent the anchor driver using an anchor driver to drive the tissue anchor.

[0133] In some applications, the method may further include anchoring the tissue anchor in the heart chamber adjacent to the coronary vessel or artery at a fixed position where the electrical signal detected by the anchor driver is below a predetermined threshold, thereby avoiding damaging the coronary vessel or artery during anchoring.

[0134] In some applications, the fixation includes fixing the tissue anchor in a fixed position where the electrical signal detected by the anchor driver is an optimal electrical signal.

[0135] In some applications, the elongated structural element includes an elongated wire.

[0136] In some applications, the elongated structural element includes an elongated tube.

[0137] For some applications, the method may further include transluminally advancing the elongated tube into the coronary vessel or artery in the compressed position, and expanding the elongated tube within the coronary vessel or artery.

[0138] In some applications, the method may further include transluminally removing the elongated structural element from the coronary vessel or artery after fixation of the tissue anchor.

[0139] In some applications, the heart chamber is the left atrium of the heart and the coronary vessel or artery is the left coronary artery of the subject.

[0140] In some applications, the left coronary artery is the left circumflex artery of the subject.

[0141] In some applications, the fixation is within the annulus of the target mitral valve.

[0142] For some applications, the elongated structural element is long enough to extend around at least a majority of the mitral valve annulus.

[0143] In some applications, advancement of the elongated structural element into a coronary vessel or artery passes through the femoral artery and aorta of the subject.

[0144] In some applications, the heart chamber is the right atrium of the heart and the coronary vessel or artery is the right coronary artery of the subject.

[0145] In some applications, the fixation is within the annulus of the target tricuspid valve.

[0146] For some applications, the elongated structural element is long enough to extend around at least a majority of the annulus of the tricuspid valve.

[0147] In some applications, advancement of the elongated structural element into a coronary vessel or artery is through a coronary ostium at the aortic root of interest.

[0148] In some applications, there is no contrast agent within the subject's body during fixation.

[0149] The above methods can be performed in a living animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (eg, a simulated body part, cardiac tissue), or the like.

[0150] According to some applications, there is further provided a system for use in a subject, the system including an elongated structural element formed from an electrical signal emitting material, hi some applications, the elongated structure is configured to be advanced transluminally into a coronary vessel or artery of a heart of the subject and to emit an electrical signal within the coronary vessel or artery.

[0151] The system may further include a tissue anchor configured to be secured within a heart chamber of the subject adjacent to the coronary vessel or artery.

[0152] For some applications, the system further includes an anchor driver that may be mechanically and electrically coupled to the tissue anchor, the anchor driver configured to detect an electrical signal adjacent to the anchor driver.

[0153] For some applications, the anchor driver is configured to secure the tissue anchor to tissue of the heart chamber at a fixed position where the electrical signal detected by the anchor driver is below a predetermined threshold, thereby avoiding damaging the coronary vessel or artery during anchoring of the tissue anchor.

[0154] For some applications, the anchor driver is configured to secure the tissue anchor in a fixed position where the electrical signal detected by the anchor driver is a minimum electrical signal.

[0155] In some applications, the elongated structural element includes an elongated wire.

[0156] In some applications, the elongated structural element includes an elongated tube.

[0157] For some applications, the elongate tube is configured to be advanced transluminally into the coronary vessel or artery in a compressed position and then expanded within the coronary vessel or artery.

[0158] In some applications, the heart chamber is the left atrium of the heart and the coronary vessel or artery is the left coronary artery of the subject.

[0159] In some applications, the left coronary artery is the left circumflex artery of the subject.

[0160] For some applications, the tissue anchor is configured to be secured to the annulus of a subject's mitral valve.

[0161] For some applications, the elongated structural element is long enough to extend around at least a majority of the mitral valve annulus.

[0162] For some applications, the elongated structural element is configured to be advanced through the femoral artery and aorta of a subject and into a coronary vessel or artery.

[0163] In some applications, the heart chamber is the right atrium of the heart and the coronary vessel or artery is the right coronary artery of the subject.

[0164] For some applications, the tissue anchor is configured to be secured to the annulus of a tricuspid valve of a subject.

[0165] For some applications, the elongated structural element is long enough to extend around at least a majority of the annulus of the tricuspid valve.

[0166] For some applications, the elongated structural element is configured to be advanced into a coronary vessel or artery through a coronary ostium at the aortic root of a subject.

[0167] The foregoing discussion will be more readily understood from the following detailed description taken in conjunction with the accompanying drawings, in which: [Brief description of the drawings]

[0168] [Figure 1] FIG. 1 is a schematic illustration of an exemplary device according to one aspect of the teachings herein being delivered through a subject's aorta into the left coronary artery of a subject's heart according to an exemplary method. [Figure 2A] FIG. 2A is a schematic cross-sectional view of the steps of an example method for treating the mitral valve of a subject's heart. [Figure 2B] FIG. 2B is a schematic cross-sectional view of steps of an example method for treating the mitral valve of a subject's heart. [Figure 2C] 2A-2C are schematic cross-sectional views of steps of an example method for treating the mitral valve of a subject's heart. [Figure 2D] 2A-2D are schematic cross-sectional views of steps of an example method for treating the mitral valve of a subject's heart. [Figure 2E] 2E is a schematic cross-sectional view of an example method of treating the mitral valve of a subject's heart. [Figure 2F] 2F is a schematic cross-sectional view of an example method of treating the mitral valve of a subject's heart. [Figure 2G] 2A-2G are schematic cross-sectional views of steps of an example method for treating the mitral valve of a subject's heart. [Figure 2H] 2H is a schematic cross-sectional view of an example method of treating the mitral valve of a subject's heart. [Figure 2I] FIG. 2I is a schematic cross-sectional view of steps of an example method for treating the mitral valve of a subject's heart. [Figure 2J] 2J is a schematic cross-sectional view of steps of an example method for treating the mitral valve of a subject's heart. [Figure 2K] FIG. 2K is a schematic cross-sectional view of an example method of treating the mitral valve of a subject's heart. [Figure 2L] 2A-2L are schematic cross-sectional views of steps of an example method for treating the mitral valve of a subject's heart. [Figure 3A] FIG. 3A is a schematic cross-sectional view of an exemplary method that is similar to or includes similarities with the method of FIGS. 2A-2L. [Figure 3B]FIG. 3B is a schematic cross-sectional view of an exemplary method that is similar to or includes similarities with the method of FIGS. 2A-2L. [Figure 4] FIG. 4 is a schematic illustration of an exemplary device according to one aspect of the teachings herein being delivered through a subject's aorta into the right coronary artery of a subject's heart according to an exemplary method. [Figure 5A] FIG. 5A is a schematic cross-sectional view of the steps of an example method for treating the tricuspid valve of a subject's heart. [Figure 5B] 5A-5B are schematic cross-sectional views of steps of an example method for treating the tricuspid valve of a subject's heart. [Figure 5C] 5A-5C are schematic cross-sectional views of steps of an example method for treating the tricuspid valve of a subject's heart. [Figure 5D] 5A-5D are schematic cross-sectional views of steps of an example method for treating the tricuspid valve of a subject's heart. [Figure 5E] 5A-5E are schematic cross-sectional views of steps of an example method for treating the tricuspid valve of a subject's heart. [Figure 5F] 5F is a schematic cross-sectional view of steps of an example method for treating a tricuspid valve in a subject's heart. [Figure 5G] 5A-5G are schematic cross-sectional views of steps of an example method for treating the tricuspid valve of a subject's heart. [Figure 5H] 5H is a schematic cross-sectional view of an example method of treating the tricuspid valve of a subject's heart. [Figure 5I] FIG. 5I is a schematic cross-sectional view of steps of an example method for treating a tricuspid valve in a subject's heart. [Figure 5J] 5A-5J are schematic cross-sectional views of steps of an example method for treating a tricuspid valve in a subject's heart. [Figure 5K] FIG. 5K is a schematic cross-sectional view of steps of an example method for treating a tricuspid valve in a subject's heart. [Figure 5L] 5A-5L are schematic cross-sectional views of steps of an example method for treating a tricuspid valve in a subject's heart. [Figure 6A] FIG. 6A is a schematic cross-sectional view of an exemplary method that is similar to or includes similarities with the method of FIGS. 5A-5L. [Figure 6B]FIG. 6B is a schematic cross-sectional view of an exemplary method that is similar to or includes similarities with the method of FIGS. 5A-5L. [Figure 7] FIG. 7 is a schematic illustration of an exemplary device according to one aspect of the teachings herein being delivered through a subject's aorta into the left coronary artery of a subject's heart according to an exemplary method. [Figure 8A] FIG. 8A is a schematic cross-sectional view of an exemplary method step for preventing damage to a coronary vessel or artery during repair of a mitral valve of a subject's heart. [Figure 8B] FIG. 8B is a schematic cross-sectional view of an exemplary method step for preventing damage to a coronary vessel or artery during repair of a mitral valve of a subject's heart. [Figure 8C] FIG. 8C is a schematic cross-sectional view of an exemplary method step for preventing damage to a coronary vessel or artery during repair of a mitral valve of a subject's heart. [Figure 8D] FIG. 8D is a schematic cross-sectional view of an exemplary method step for preventing damage to a coronary vessel or artery during repair of a mitral valve of a subject's heart. [Figure 8E] FIG. 8E is a schematic cross-sectional view of an exemplary method step for preventing damage to a coronary vessel or artery during repair of a mitral valve of a subject's heart. [Figure 8F] FIG. 8F is a schematic cross-sectional view of an exemplary method step for preventing damage to a coronary vessel or artery during repair of a mitral valve of a subject's heart. [Figure 8G] FIG. 8G is a schematic cross-sectional view of an exemplary method step for preventing damage to a coronary vessel or artery during repair of a mitral valve of a subject's heart. [Figure 8H] FIG. 8H is a schematic cross-sectional view of an exemplary method step for preventing damage to a coronary vessel or artery during repair of a mitral valve of a subject's heart. [Figure 8I] FIG. 8I is a schematic cross-sectional view of an exemplary method step for preventing damage to a coronary vessel or artery during repair of a mitral valve of a subject's heart. [Figure 8J] FIG. 8J is a schematic cross-sectional view of an exemplary method step for preventing damage to a coronary vessel or artery during repair of a mitral valve of a subject's heart. [Figure 8K]FIG. 8K is a schematic cross-sectional view of an exemplary method step for preventing damage to a coronary vessel or artery during repair of a mitral valve of a subject's heart. [Figure 9A] FIG. 9A is a schematic cross-sectional view of an exemplary method step for preventing damage to a coronary vessel or artery during repair of a mitral valve of a subject's heart. [Figure 9B] FIG. 9B is a schematic cross-sectional view of an exemplary method step for preventing damage to a coronary vessel or artery during repair of a mitral valve of a subject's heart. [Figure 9C] FIG. 9C is a schematic cross-sectional view of an exemplary method step for preventing damage to a coronary vessel or artery during repair of a mitral valve of a subject's heart. [Figure 10A] FIG. 10A is a schematic cross-sectional view of an exemplary method step for preventing damage to a coronary vessel or artery during repair of a mitral valve of a subject's heart. [Figure 10B] FIG. 10B is a schematic cross-sectional view of an exemplary method step for preventing damage to a coronary vessel or artery during repair of a mitral valve of a subject's heart. [Figure 10C] FIG. 10C is a schematic cross-sectional view of an exemplary method step for preventing damage to a coronary vessel or artery during repair of a mitral valve of a subject's heart. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0169] Those skilled in the art will appreciate that the present invention is not limited to what has been particularly shown and described above, but rather the scope of the present invention includes both combinations and subcombinations of the various features described above and below, as well as variations and modifications thereof that would occur to a person skilled in the art upon reading the description herein and that are not in the prior art.

[0170] In the following description, various aspects of the present disclosure are described. For purposes of explanation, specific configurations and details are set forth to provide a thorough understanding of various aspects of the present disclosure. However, it will be apparent to one skilled in the art that the present disclosure may be practiced without the specific details presented herein. Furthermore, well-known features may be omitted or simplified so as not to obscure the present disclosure. Furthermore, to avoid undue confusion due to a large number of reference numbers or leads in a particular drawing, some elements may not be explicitly identified in all drawings that include that element.

[0171] It is to be understood that the scope of the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Moreover, it is to be understood that the phraseology and terminology employed in this disclosure are for the purpose of description and should not be regarded as limiting.

[0172] For the purposes of this application, the term subject relates to any mammal, particularly humans.

[0173] Referring now to the drawings, Figure 1 is a schematic diagram of an exemplary device according to one aspect of the teachings herein being delivered, according to an exemplary method, through a subject's aorta and into the coronary vessels of a subject's heart, in this example the left coronary artery (although various other vessels are possible). The method can be performed in a live animal or in a simulation, e.g., a cadaver, a cadaver heart, a simulator (e.g., a body part being simulated, heart tissue), etc.

[0174] 1, a device according to the teachings herein includes a tether 10 that may be surrounded by, and may be slidable relative to, a support tube 12. Tether 10 may be formed of any suitable material, such as a metal, polymer, biomaterial wire, ribbon, or cord. Support tube 12 is typically flexible.

[0175] For treatment of a subject's mitral valve, located between the left atrium and left ventricle of the heart (see reference numeral 20 in FIGS. 2A-2L), the tether 10 and support tube 12 are advanced transluminally into a coronary vessel, in this example into the left coronary artery 14, to at least partially surround the mitral valve (see, e.g., FIG. 2A). In some applications, as shown in FIG. 1, a catheter 16 delivers the tether 10 and support tube 12 into the left coronary artery 14 via the aorta 18 (e.g., transfemorally). In some applications, the left coronary artery may be or include the left circumflex artery of the subject's heart.

[0176] In the illustrated example, the distal portion of catheter 16 is advanced into the left coronary artery. Catheter 16 also has an extracorporeal proximal portion 19, which may include a handle (e.g., as shown in FIG. 2A ). The distal portion of catheter 16 is navigable to the anatomical site, such as by being actively steerable (e.g., operably coupled by one or more pull wires to proximal portion 19, such as its steering controller), or by being passively guided and / or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter).

[0177] 2A-2L, which are schematic cross-sectional views of steps in a method of treating a mitral valve 20 of a subject's heart using the apparatus of FIG. 1, according to some applications of the teachings herein. For example, the treatment of the mitral valve can be or include mitral valve annuloplasty. The method can be performed in a living animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., a body part being simulated, heart tissue), etc.

[0178] As shown in FIG. 2A, a catheter 16 is used to advance the tether 10, and typically the support tube 12, into the left coronary artery 14 via the aorta 18, as described above with respect to FIG. 1. As shown in the cross-sectional portion of FIG. 2A, the left coronary artery 14 at least partially surrounds (e.g., is disposed along) the mitral valve 20 of the subject's heart. As can be seen, the leaflets 22 and 24 of the mitral valve do not fully coapt, such that a gap 26 is formed therebetween. The therapeutic (e.g., annuloplasty) procedure described herein reshapes the mitral valve 20 (e.g., the annulus 28) such that the leaflets 22 and 24 coapt and the gap 26 is reduced or eliminated (see end result in FIG. 2L).

[0179] Referring to FIG. 2B, at a first puncture location 14a, a hole is punctured (eg, using a hollow needle) through the wall of the left coronary artery into the left atrium of the heart and a first end 10a of tether 10 is advanced into the atrium.

[0180] In some applications, the tether 10 is advanced into the left coronary artery 14 without the support tube 12, as shown in Figure 2A. In some applications, after the first end 10a of the tether 10 is advanced into the left atrium, the support tube 12 can be advanced over and around the tether.

[0181] As shown in FIG. 2C, a snare tool 30 having a snare 31 at its distal portion is introduced transluminally into the left atrium of the heart and engages with a first end 10a of the tether 10. In some applications, the snare tool 30 is advanced transluminally into the left atrium using a second catheter 32. For example, the snare tool 30 may be a component of the second catheter 32 or may be a separate device that is introduced via the second catheter 32.

[0182] In some applications, as shown, the snare tool 30 is introduced through the inferior vena cava 36 (e.g., transfemorally) and through an opening in the interstitial septum 38 of the subject's heart into the left atrium. In some applications, introduction of the snare tool may be via the superior vena cava.

[0183] In the illustrated example, a distal portion of catheter 32 is advanced through the vena cava. Catheter 32 also has an extracorporeal proximal portion 39 (e.g., as shown in FIG. 2C). The distal portion of catheter 32 is navigable to the anatomical site, such as by being actively steerable (e.g., operably coupled by one or more pull wires to proximal portion 39, such as its steering controller), or by being passively guided and / or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter).

[0184] As shown in FIG 2D, a snare 31 is then used to pull the first end 10a of the tether out of the left atrium, for example, such that a first segment 34 of the tether extends from the puncture location 14a across the left atrium, as described in more detail below. In some applications, the first end 10a is pulled through a catheter 32 (e.g., by withdrawing the snare tool 30 through the catheter), as shown in FIG 2D.

[0185] In some applications, as shown, the snare 31 withdraws the first end 10a from the left atrium, through an opening in the interstitial septum 38, and through the inferior vena cava 36 of the subject. In some applications, withdrawal may be via the superior vena cava.

[0186] As described in more detail below, in some applications of the process shown in Figure 2D, the first end 10a of the tether 10 is withdrawn completely from within the subject's body. In some applications of the process shown in Figure 2D, the first end 10a is withdrawn from the left atrium but remains within the subject's body.

[0187] 2E, at second location 14b, a second hole is punctured through the wall of the left coronary artery into the left atrium of the heart and second end 10b of the tether is advanced into the atrium. As can be seen, support tube 12 may be positioned between first location 14a and second location 14b, for example, may extend between the first location and the second location, or may terminate at each of the first location and the second location.

[0188] In some applications, such as the embodiment shown in Figures 2A-2L, first position 14a and second position 14b are selected to be near the ends of gap 26 between leaflets 22 and 24.

[0189] As shown in Figure 2F, a snare tool, which may be snare tool 30 of Figure 2C or may be a second snare tool, is introduced transluminally into the left atrium of the heart and engages the second end 10b of the tether. The snare tool may be advanced transluminally into the left atrium via a second catheter 32 (e.g., as described with respect to Figure 2C, mutatis mutandis) or out of a separate, third catheter.

[0190] Next, as shown in FIG. 2G, the snare 31 of the snare tool 30 (or another snare of another snare tool) is used to pull the second end 10b of the tether out of the left atrium so that a second segment 44 of the tether extends from the second puncture location 14b across the left atrium.

[0191] In some applications, as shown, the snare 31 of the snare tool 30 (or another snare of another snare tool) withdraws the second end 10b from the left atrium, through an opening in the cardiac septum 38, and through the inferior vena cava 36 of the subject. In some applications, withdrawal may be via the superior vena cava.

[0192] In some applications, for example when the same snare and catheter are used to withdraw both the first and second ends of tether 10, both the first and second ends are withdrawn from the heart chamber or left atrium via the same route, i.e., via the same one of the superior and inferior vena cava. As shown in FIG. 2G, in some applications, tether 10 forms a loop from catheter 32, across the left atrium, into left coronary artery 14, along left coronary artery 14, back through the atrium again, and back into the catheter. This loop includes (i) segment 34 that extends from catheter 32 across the atrium to location 14a, (ii) curved portion 10c of tether 10 that extends between locations 14a and 14b (e.g., within support tube 12), and (iii) segment 44 that extends from location 14b through the atrium and back into the catheter.

[0193] In some applications, each of the ends of tether 10 can be pulled out of the left atrium using a different route, for example, when snare tool 30 is used to pull first end 10a through catheter 32 and a separate snare is used to pull second end 10b through a separate catheter. For example, first end 10a can be pulled out through the superior vena cava, while second end 10b can be pulled out through the inferior vena cava.

[0194] As described in more detail below, in some applications of the process shown in FIG. 2G, the second end 10b of tether 10 is withdrawn completely from the subject's body. In some applications of the process shown in FIG. 2G, the second end 10b is withdrawn from the left atrium but remains within the subject's body. In some applications, the first and second ends of tether 10 are withdrawn from the left atrium to the same extent (i.e., both are withdrawn completely from the subject's body or both are withdrawn from the left atrium but remain within the subject's body).

[0195] In some applications, once both ends of tether 10 have been withdrawn from the left atrium, catheter 16 may be removed from left coronary artery 14, for example, by retraction of the catheter through aorta 18 in the direction of arrow 49.

[0196] 2H, for example, a first tissue anchor 50 driven by a driving tool 52 slides over and along the first end 10a toward the first segment 34. The first tissue anchor 50 is secured in tissue of the left atrium, for example, in the annulus 28, such that the first segment 34 extends between the left coronary artery 14 and the first tissue anchor 50, as shown in FIG. 2I. The first tissue anchor 50 may be secured across the mitral valve 20 from the left coronary artery 14 (for example, from the support tube 12), such as in the anterior region of the left atrium, proximate the anterior leaflet base 22 or the commissure where the anterior leaflet meets the posterior leaflet 24. At this stage, the first segment 34 may have slack.

[0197] As shown in FIG. 2J, the second tissue anchor 56 slides over and along the second end 10b toward the second segment 44. The second tissue anchor 56 is secured in tissue of the left atrium, e.g., in the annulus 28, such that the second segment 44 extends between the left coronary artery 14 and the second tissue anchor. The second tissue anchor 56 may be secured across the mitral valve 20 from the left coronary artery 14 (e.g., from the support tube 12), such as in the anterior region of the left atrium, proximate the anterior leaflet base 22 or the commissure where the anterior leaflet meets the posterior leaflet 24. At this stage, there may be slack in the second segment 44. The second tissue anchor 56 may be driven by the driving tool 52 or by a separate anchor driving tool.

[0198] Each of the anchors 50 and 56 can include a head that is slidably coupleable to the tether 10, for example, by the head comprising an eyelet that can be threaded onto the tether. Each of the anchors 50 and 56 can include a tissue-engaging element, which can be a helically threaded tissue-engaging element (as described herein) or can be another type of tissue-engaging element, such as a dart or staple. In some applications, each of the anchors 50 and 56 described above can include one or more of the anchors described below, each of which is incorporated by reference in its entirety for all purposes. No. 17 / 145,258, filed January 8, 2021, and published as PCT application Ser. No. 2020 / 01 / 02966, by Kasher et al. Patent document 2 by Shafigh et al., filed on February 9, 2021 Patent document 3 by Shafigh et al., filed on February 8, 2022

[0199] Driving tool 52 can be advanced through second catheter 32 (e.g., as shown in FIG. 2H) or through another catheter. In some applications, as shown, driving tool 52 is rotatable to secure the tissue anchors by threading them into the tissue of the annulus 28. Following securement of tissue anchors 50 and 56, driving tool 52 (and the separate driving tool, if used) can be retracted from the left atrium, e.g., through second catheter 32.

[0200] 2K, the tension in tether 10 is modified (e.g., tension is applied to the tether). In some applications, this is done by pulling on one or both of ends 10a and 10b. This pulling is indicated by arrow 58. Tension may be facilitated, for example, by one or more transluminally introduced tools 57, which may provide an opposing force against anchors 50 and 56. The application of tension to tether 10 may pull support tube 12 against the wall of left coronary artery 14 closest to the atrium (e.g., so that the tube pushes against the annulus and / or atrium).

[0201] Modifying the tension in tether 10 causes remodeling of mitral valve 20, e.g., in the direction of arrow 59, to close gap 26. As shown in Figures 2K-2L, remodeling of the mitral valve improves coaptation between valve leaflets 22 and 24, thereby reducing (e.g., closing) gap 26.

[0202] In some applications, support tube 12 is designed and configured to distribute the force applied by tether 10 across the wall of left coronary artery 14 so as to prevent the tether from damaging the wall of the left coronary artery and / or the wall of the atrium. In some applications, support tube 12 maintains puncture locations 14a and 14b at a fixed distance from one another, for example, by preventing tether 10 from cutting through the wall of the left coronary artery from one of the locations to the other (e.g., in a manner similar to a cheese slicer).

[0203] After modifying the tension of the tether and reforming the valve, the tension of the tether is locked. In the embodiment illustrated in FIG. 2L, a first lock 60 (which may be optionally referred to as a stopper) slides along a first end 10a of the tether 10 and is locked to the tether, often proximate to a first anchor 50. A second lock 66 slides along a second end 10b of the tether 10 and is locked to the tether, often proximate to a second anchor 56. The locks 60 and 66 can lock the tension of the tether 10 by preventing the tether (e.g., ends 10a and 10b) from sliding past the anchors 50 and 56, e.g., by the lock abutting the anchor. In some applications, the lock 60 has one or more features described in U.S. Patent Application Serial No. 16 / 534,875, filed August 7, 2019, by Brauon et al., which is published as U.S. Patent Application No. 6010 / 002999, which is incorporated herein by reference.

[0204] In some applications, the excess tether is then severed and removed from the left atrium, for example, by retraction of catheter 32. Advancement of locks 60 and 66 and severing of the excess tether may be performed using tool 57.

[0205] In some applications, modifying the tension of the tether 10 may be accomplished by pulling both ends 10a and 10b. In some applications, modifying the tension of the tether 10 may be accomplished by first locking one of ends 10a and 10b adjacent a respective one of tissue anchors 50 and 56, and then pulling the other of ends 10a and 10b to modify the tension of the tether. Once a desired tension of the tether is achieved, the other of ends 10a and 10b is locked adjacent a respective one of tissue anchors 50 and 56. For example, a first end 10a may be locked adjacent to tissue anchor 50, and then an end user or physician may pull end 10b to change the tension of the tether, and then lock the second end 10b adjacent to a second tissue anchor 56.

[0206] As mentioned above, in applications where tether ends 10a and 10b are pulled from within the user's body, tissue anchors 50 and 56 and locks 60 and 66 can be slid onto the tether ends extracorporeally. In some applications where tether ends 10a and 10b remain within the user's body until after excess tether has been cut, tissue anchors 50 and 56 and locks 60 and 66 can be slid onto the ends intracorporeally (e.g., transluminally).

[0207] 3A and 3B are schematic cross-sectional views of alternative implementations of the method of Figures 2A-2L in accordance with some application of the teachings herein. The method can be performed in a live animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., a body part being simulated, cardiac tissue), etc.

[0208] FIG. 3A illustrates a method similar to that described above with respect to FIGS. 2A-2L. However, the embodiment of FIG. 3A differs from the method described above in the locking step of FIG. 2L. In the embodiment of FIG. 3A, a single lock 70 is locked to both ends of the tether, for example, proximate one of the tissue anchors, shown here as tissue anchor 50. In some applications, during or after tensioning of the tether 10, the second end 10b of the tether is pulled around or through the second tissue anchor 56 to the first tissue anchor 50, resulting in a segment 72 of the tether extending between the first and second tissue anchors. The lock 70 then slides over and along both ends of the tether 10, locking the ends proximate the first tissue anchor 50. As described above, after locking the tension of the tether, the excess tether can be cut and removed. In some applications, the second end 10b may not be carried on anchor 50, but instead, lock 70 may be slid along and over both ends to a position partway between anchors 50 and 56 such that the ends converge at the lock partway between the anchors, locking the tension in the tether 10 by the lock being locked to both ends at this position.

[0209] FIG. 3B illustrates another method similar to that described above with respect to FIGS. 2A-2L. However, the embodiment of FIG. 3B differs from the method described above with respect to the anchoring and locking steps of FIGS. 2H-2L. In the embodiment of FIG. 3B, a single tissue anchor replaces the first tissue anchor 50 and the second tissue anchor 56 of FIGS. 2H-2L. Specifically, a single tissue anchor 80 slides over and along both ends of tether 10 such that first and second segments 82 and 84 of tether 10 extend from locations 14a and 14b, respectively, across the atrium and converge at tissue anchor 80 and are anchored in tissue of the left atrium, such as, for example, in annulus 28. Tissue anchor 80 can be driven out of the catheter by a driving tool, for example, substantially as described above with respect to driving tool 52.

[0210] The tension in the tether 10 is then modified substantially as described above, and the tension is locked using a lock 86 that slides over and locks onto the end of the tether. As described above, after locking the tension in the tether, the remaining portion of the tether can be cut and removed.

[0211] 4 is a schematic diagram of an exemplary device according to one aspect of the teachings herein being delivered through a subject's aorta into a coronary vessel of a subject's heart, in this example into the right coronary artery, according to an exemplary method. The method can be performed in a live animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., a body part being simulated, heart tissue), etc.

[0212] 4, a device according to the teachings herein includes a tether 110 that may be surrounded by, and may be slidable relative to, a support tube 112. Tether 110 may be formed of any suitable material, such as a metal, polymer, biomaterial wire, ribbon, or cord. Support tube 112 is typically flexible.

[0213] For treatment of a subject's tricuspid valve, located between the right atrium and right ventricle of the heart (see reference numeral 120 in FIGS. 5A-5L), the tether 110 and support tube 112 are advanced transluminally into the right coronary artery 114 to at least partially surround the tricuspid valve (see, e.g., FIG. 5A). In some applications, as shown in FIG. 4, a catheter 116 delivers the tether 110 and support tube 112 into the right coronary artery 114 via the aorta 18 (e.g., transfemorally).

[0214] In the illustrated example, a distal portion of the catheter 116 is advanced into the right coronary artery. The catheter 116 also has an extracorporeal proximal portion 119 (e.g., as shown in FIG. 5A ). The distal portion of the catheter 116 is navigable to the anatomical site, such as by being actively steerable (e.g., operably coupled by one or more pull wires to the proximal portion 119, such as a steering controller thereof), or by being passively guided and / or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter).

[0215] 5A-5L, which are schematic cross-sectional views of steps of a method of treating a tricuspid valve 120 of a subject's heart using the apparatus of FIG. 4, according to some applications of the teachings herein. For example, the tricuspid valve treatment can include tricuspid annuloplasty or mitral annuloplasty. The method can be performed in a living animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., a body part being simulated, heart tissue), etc.

[0216] As shown in FIG. 5A, a catheter 116 is used to advance the tether 110, and typically the support tube 112, through the aorta 18 and into the right coronary artery 114, as described above with respect to FIG. 4. As shown in the cross-sectional portion of FIG. 5A, the right coronary artery 114 at least partially surrounds (e.g., is disposed along the annulus of) the tricuspid valve 120 of the subject's heart. As can be seen, the leaflets 122, 123, and 124 of the tricuspid valve 120 do not fully coapt, such that a gap 126 is formed therebetween. The therapeutic (e.g., annuloplasty) procedure described herein reshapes the tricuspid valve 120 such that the leaflets 122, 123, and 124 coapt and the gap 126 is reduced or eliminated (see end result in FIG. 5L). The tricuspid valve 120 includes an annulus 128 that surrounds the leaflets 122, 123, and 124.

[0217] Referring to FIG. 5B, at a first location 114a, a hole is punctured (eg, using a hollow needle) through the wall of the right coronary artery into the right atrium of the heart and a first end 110a of tether 110 is advanced into the atrium.

[0218] In some applications, the tether 110 is advanced into the right coronary artery 114 without the support tube 112, as shown in Figure 5A. In some applications, after the first end 110a of the tether 110 is advanced into the right atrium, the support tube 112 can be advanced over and around the tether.

[0219] 5C, a snare tool 130, terminating in a snare 131, is introduced transluminally into the right atrium of the heart and engages the first end 10a of the tether 110. In some applications, the snare tool 130 is advanced transluminally into the right atrium using a second catheter 132. For example, the snare tool 130 may be a component of the second catheter 132 or may be a separate device that is introduced via the second catheter 132.

[0220] In some applications, as shown, the snare tool 130 is introduced into the subject's right atrium through the inferior vena cava 36 (e.g., transfemorally). In some applications, introduction of the snare tool may be via the superior vena cava.

[0221] In the illustrated example, a distal portion of catheter 132 is advanced into the vena cava. Catheter 132 also has an extracorporeal proximal portion 139 (e.g., as shown in FIG. 5C). The distal portion of catheter 132 is navigable to the anatomical site, such as by being actively steerable (e.g., operably coupled by one or more pull wires to proximal portion 139, such as a steering controller thereof), or by being passively guided and / or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter).

[0222] The snare 131 is then used to withdraw the first end 110a of the tether from the right atrium such that a first segment 134 of the tether extends from the puncture location 114a across the right atrium, as shown in FIG. 5D. In some applications, the first end 110a is withdrawn through a catheter 132 (e.g., by withdrawing the snare tool 130 through the catheter), as shown in FIG.

[0223] In some applications, as shown, the snare 131 withdraws the first end 110a from the subject's right atrium to the inferior vena cava 36. In some applications, withdrawal may be via the superior vena cava.

[0224] As described in more detail below, in some applications of the process shown in Figure 5D, first end 110a of tether 110 is withdrawn completely from within the subject's body. In some applications of the process shown in Figure 5D, first end 110a is withdrawn from the right atrium but remains within the subject's body.

[0225] Referring to FIGURE 5E, at second location 114b, a second hole is punctured through the wall of the right coronary artery into the right atrium of the heart, and second end 110b of the tether is advanced into the atrium. As shown, support tube 112 may be positioned between first location 114a and second location 114b. In some applications, such as the embodiment shown in FIGURES 5A-5L, first location 114a and second location 114b are selected to be near the ends of gap 126 between leaflets 122, 123, and 124, or near the ends of the leaflet coaptation.

[0226] As shown in Figure 5F, a snare tool, which may be snare tool 130 of Figure 5C or may be a second snare tool, is introduced transluminally into the right atrium of the heart and engages the second end 110b of the tether. The snare tool may be advanced transluminally out of a second catheter 132 (e.g., as described with respect to Figure 5C, mutatis mutandis) into the right atrium, or out of a separate, third catheter.

[0227] Next, as shown in FIG. 5G, the snare 131 of the snare tool 130 (or another snare of another snare tool) is used to pull the second end 110b of the tether out of the right atrium so that a second segment 144 of the tether extends from the second puncture location 114b across the right atrium.

[0228] In some applications, as shown, snare 131 (or another snare) withdraws first end 110b from the subject's right atrium to the inferior vena cava 36. In some applications, withdrawal may be via the superior vena cava.

[0229] In some applications, for example when the same snare and catheter are used to withdraw both the first and second ends of tether 110, both the first and second ends are withdrawn from the right atrium via the same route, i.e., via the same one of the superior and inferior vena cava. As shown in FIG. 5G, in such an embodiment, tether 110 forms a loop from catheter 132, across the right atrium, into and along right coronary artery 114, back through the atrium, and back into the catheter. This loop includes (i) segment 134 that extends from catheter 132 across the atrium to location 114a, (ii) curved portion 110c of tether 110 that extends between locations 114a and 114b (e.g., within support tube 112), and (iii) segment 144 that extends from location 114b through the atrium and back into the catheter.

[0230] In some applications, each of the ends of tether 110 can be pulled out of the right atrium using a different path, for example, when snare 131 is used to pull first end 110a through catheter 132 and a separate snare is used to pull second end 110b through a separate catheter. For example, first end 110a can be pulled out through the superior vena cava, while second end 110b can be pulled out through the inferior vena cava.

[0231] As described in more detail below, in some applications of the process shown in FIG. 5G, second end 110b of tether 110 is withdrawn completely from within the subject's body. In some applications of the process shown in FIG. 5G, second end 110b is withdrawn from the right atrium but remains within the subject's body. In some applications, the first and second ends of tether 110 are withdrawn from the right atrium to the same extent (i.e., both are withdrawn completely from the subject's body or both are withdrawn from the right atrium but remain within the subject's body).

[0232] In some applications, once both ends of tether 110 have been withdrawn from the right atrium, catheter 116 may be removed from right coronary artery 114, for example, by retraction of the catheter through aorta 18.

[0233] 5H, for example, a first tissue anchor 150 driven by a driving tool 152 slides over and along the first end 110a toward the first segment 134. The first tissue anchor 150 is secured in tissue of the right atrium, for example, in the annulus 128, such that the first segment 134 extends between the right coronary artery 114 and the first tissue anchor 150, as shown in FIG. 5I. The first tissue anchor 150 may be secured across the tricuspid valve 120 from the right coronary artery 114 (e.g., from the support tube 112) proximate the septal leaflet base 123 or the commissure where the septal leaflet meets the posterior leaflet 122 or anterior leaflet 124. At this stage, the first segment 134 may have slack.

[0234] As shown in FIG. 5J, the second tissue anchor 156 slides over and along the second end 110b toward the second segment 144. The second tissue anchor 156 is secured in tissue of the right atrium, e.g., the annulus 128, such that the second segment 144 extends between the right coronary artery 114 and the second tissue anchor. The second tissue anchor 156 may be secured across the tricuspid valve 120 from the right coronary artery 114 (e.g., from the support tube 112) proximate the septal leaflet base 123 or the commissure where the septal leaflet meets the posterior leaflet 122 or anterior leaflet 124. At this stage, there may be slack in the second segment 144. The second tissue anchor 156 may be driven by the driving tool 152 or by a separate anchor driving tool.

[0235] Each of anchors 150 and 156 can have a head that is slidably coupleable to tether 110, for example, by a head that includes an eyelet that can be threaded onto the tether. Each of anchors 150 and 156 can have a tissue-engaging element, which can be a helically threaded tissue-engaging element (as described herein) or can be another type of tissue-engaging element, such as a dart or staple. In some applications, each of anchors 150 and 156 described above can include one or more of the anchors described below, each of which is incorporated by reference in its entirety for all purposes. No. 17 / 145,258, filed January 8, 2021, and published as PCT application Ser. No. 2020 / 01 / 02966, by Kasher et al. Patent document 2 by Shafigh et al., filed on February 9, 2021 Patent document 3 by Shafigh et al., filed on February 8, 2022

[0236] Driving tool 152 may be advanced through second catheter 132 (e.g., as shown in FIG. 5H) or from a separate catheter. In some applications, as shown, driving tool 152 is rotatable to secure the tissue anchors by screwing them into the tissue of the annulus 128. Following securement of tissue anchors 150 and 156, driving tool 152 (and the separate driving tool, if used) may be retracted from the right atrium, e.g., via second catheter 132.

[0237] 5K, the tension in tether 110 is modified (e.g., tension is applied to the tether). In some applications, this is done by pulling on one or both of ends 110a and 110b. This pulling is indicated by arrow 158. Tension may be facilitated, for example, by one or more transluminally introduced tools 157, which may provide an opposing force against anchors 150 and 156. The application of tension to tether 110 may pull support tube 112 against the wall of right coronary artery 114 closest to the atrium.

[0238] Modifying the tension in tether 110 causes reformation of tricuspid valve 120, for example, in the direction of arrow 159. As shown in FIG. 5L, reformation of the tricuspid valve improves coaptation between leaflets 122, 123, and 124 of the valve, thereby reducing (e.g., closing) gap 126.

[0239] In some applications, support tube 112 is designed and configured to distribute the force applied by tether 110 across the wall of right coronary artery 114 so as to prevent the tether from damaging the wall of the right coronary artery and / or the wall of the atrium. In some applications, support tube 112 maintains puncture locations 114a and 114b at a fixed distance from one another, for example, by preventing tether 110 from cutting through the wall of the right coronary artery from one of the locations to the other (e.g., in a manner similar to a cheese slicer).

[0240] After modifying the tether tension and reforming the valve, the tension in the tether is locked. In the embodiment shown in FIG. 5L, a first lock 160 (which may optionally be referred to as a stopper) slides along a first end 110a of tether 110 and is locked to the tether, typically proximate to first anchor 150. A second lock 166 slides along a second end 110b of tether 110 and is locked to the tether, typically proximate to second anchor 156. Locks 160 and 166 can lock the tension in tether 110 by preventing the tether (e.g., ends 110a and 110b) from sliding past anchors 150 and 156, e.g., by the locks abutting the anchors.

[0241] In some applications, the excess tether is then severed and removed from the right atrium, for example, by retraction of catheter 132. Advancement of locks 160 and 166 and severing of the excess tether may be performed using tool 157.

[0242] In some applications, modifying the tension in tether 110 may be accomplished by pulling on both ends 110a and 110b.

[0243] In some applications, modifying the tension of tether 110 may be accomplished by first locking one of ends 110a and 110b adjacent one of tissue anchors 150 and 156, respectively, and then pulling the other of ends 110a and 110b to modify the tension of the tether. Once a desired tension in the tether is achieved, the other of ends 110a and 110b is locked adjacent one of tissue anchors 150 and 156, respectively. For example, first end 110a may be locked adjacent tissue anchor 150, after which an end user or physician may pull end 110b to change the tension of the tether, and then lock the second end 110b adjacent to a second tissue anchor 156.

[0244] As mentioned above, in applications where tether ends 110a and 110b are pulled from within the user's body, tissue anchors 150 and 156 and locks 160 and 166 can be slid onto the ends of the tether extracorporeally. In some applications where tether ends 110a and 110b remain within the user's body until after excess tether has been cut, tissue anchors 150 and 156 and locks 160 and 166 can be slid onto the ends intracorporeally (e.g., transluminally).

[0245] 6A and 6B are schematic cross-sectional views of alternative implementations of the method of Figures 5A-5L according to some application of the teachings herein. The method can be performed in a live animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., a simulated body part, cardiac tissue), etc.

[0246] FIG. 6A illustrates a method similar to that described above with respect to FIGS. 5A-5L. However, the embodiment of FIG. 6A differs from the method described above in the locking step of FIG. 5L. In the embodiment of FIG. 6A, a single lock 170 is locked to both ends of the tether, for example, proximate one of the tissue anchors, shown here as tissue anchor 150. In some applications, during or after tensioning of the tether 110, the first end 110a of the tether is pulled around or through the first tissue anchor 150 to the second tissue anchor 156, resulting in a segment 172 of the tether extending between the first and second tissue anchors. The lock 170 then slides over and along both ends of the tether 110, locking the ends proximate the second tissue anchor 156. As described above, after locking the tension of the tether, the excess tether can be cut and removed. In some applications, second end 110b may not be carried on anchor 150, but instead lock 170 may be slid along and over both ends to a position partway between anchors 150 and 156 such that the ends converge at the lock partway between the anchors, locking the tension in tether 110 by the lock being locked to both ends at this position.

[0247] FIG. 6B illustrates another method similar to that described above with respect to FIGS. 5A-5L. However, the embodiment of FIG. 6B differs from the method described above with respect to the anchoring and locking steps of FIGS. 5H-5L. In the embodiment of FIG. 6B, a single tissue anchor replaces first tissue anchor 150 and second tissue anchor 156 of FIGS. 5H-5L. Specifically, a single tissue anchor 180 slides over and along both ends of tether 110 such that segments 182 and 184 extend from locations 114a and 114b across the atrium and converge at tissue anchor 180 and are anchored in tissue of the right atrium, e.g., in annulus 128. Tissue anchor 180 can be driven out of the catheter by a driving tool, e.g., substantially as described above with respect to driving tool 152.

[0248] The tension in the tether 110 is then modified substantially as described above, and the tension is locked using a lock 186 that slides over and locks onto the end of the tether. As described above, after locking the tension in the tether, the excess tether can be cut and removed.

[0249] 7 and 8A-8K, which are schematic diagrams of devices and techniques for use therewith for protecting coronary vessels or arteries during treatment of a subject's atrioventricular heart valve, in accordance with some applications of the teachings herein.

[0250] As shown in FIG. 7, a device according to the teachings herein includes an elongated tube 210 that includes (e.g., is formed from) a radiopaque material. In some applications, the elongated tube 210 is flexible. In some applications, such as the one shown, the elongated tube 210 may include or be formed from a metal or mesh frame. For treatment of a target mitral valve located between the left atrium and left ventricle of the heart (see reference number 20 in FIGS. 8A-8K), the elongated tube 210 is advanced transluminally into a coronary vessel, for example, into the left coronary artery 14. In some applications, as shown in FIG. 7, a catheter 216 delivers the elongated tube 210 into the left coronary artery 14 via the aorta 18 (e.g., transfemorally).

[0251] In the illustrated example, a distal portion of catheter 216 is advanced into the left coronary artery. Catheter 216 also has an extracorporeal proximal portion 219, which may include a handle (e.g., as shown in FIG. 8A ). The distal portion of catheter 216 is navigable into the left coronary artery, such as by being actively steerable (e.g., operably coupled by one or more pull wires to proximal portion 219, such as a steering controller therefor), or by being passively guided and / or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter).

[0252] 8A-8K, which are schematic cross-sectional views of method steps for preventing damage to the left coronary artery during repair of the mitral valve 20 of a heart using the apparatus of FIG. 7, according to some applications of the teachings herein. For example, the repair of the mitral valve may be or include mitral valve annuloplasty. The method may be performed in a live animal or in a simulation, such as a cadaver, cadaver heart, simulator (e.g., simulated body part, heart tissue), etc.

[0253] As shown in the cross-sectional portion of Figure 8A, the left coronary artery 14 at least partially surrounds the mitral valve 20 of the subject's heart. As can be seen, the leaflets 22 and 24 of the mitral valve do not fully coapt, such that a gap 26 is formed therebetween. The therapeutic (e.g., annuloplasty) procedures described herein reshape the mitral valve 20 such that the leaflets 22 and 24 coapt and the gap 26 is reduced or eliminated (see final result in Figure 8K). The mitral valve 20 includes an annulus 28 that surrounds the leaflets 22 and 24.

[0254] The following description relates to a transluminal annuloplasty procedure in which a tether is secured in an arc around the valve to be treated by securing multiple tissue anchors to the tissue of the annulus in series around the valve, and the annulus is then contracted by applying tension to the tether to which the anchors are slidably coupled. Examples of such annuloplasty methods are described in U.S. Patent Application No. 14 / 437,373 to Sheps et al., filed April 21, 2015 and published as U.S. Patent Application No. 15 / 782,687 to Iflah et al., filed October 12, 2017 and published as U.S. Patent Application No. 16 / 534,875 to Brauon et al., filed August 7, 2019 and published as U.S. Patent Application No. 17 / 145,258 to Kasher et al., filed January 8, 2021 and published as U.S. Patent Application No. 17 / 145,258 to Kasher et al., filed January 8, 2021 and published as U.S. Patent Application No. 17 / 145,258, each of which is incorporated by reference in its entirety for all purposes. However, the elongated tube 210 of the disclosed technology may also be used to implement other techniques involving securing tissue anchors within the atrium, substantially as described. The above methods can be performed in a living animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (eg, a simulated body part, cardiac tissue), or the like.

[0255] As shown in Figure 8A, catheter 216 is used to advance elongate tube 210 into left coronary artery 14 in the direction of arrow 229, as described above with respect to Figure 7. In some applications, elongate tube 210 may be advanced transluminally over a guidewire.

[0256] The elongated tube 210 is advanced into the left coronary artery while the elongated tube is compressed, for example, by being enclosed within an outer sheath, shown as the body of catheter 216 .

[0257] Referring to FIG. 8B, outer sheath, or catheter 216, can be retracted proximally, indicated by arrow 230, allowing elongate tube 210 to radially expand.

[0258] In some applications, the radial expansion of the flexible tube 210 causes the tube to contract longitudinally. For example, the flexible tube 210 can be self-expanding. In some applications, the flexible tube 210 comprises a self-expanding structure, such as a stent, a stent-like structure, a braided structure, a woven structure, a balloon, or the like. Alternatively or additionally, the flexible tube 210 can be expanded by contracting the tube longitudinally, for example, by pulling one end of the flexible tube towards the other end. For example, the distal end of the flexible tube can be pulled while applying a reference force to the distal end of the flexible tube, thereby radially expanding the compressed structure (while contracting the tube longitudinally). In some applications, a tensioning element or tool is advanced transluminally into the left coronary artery 14 to pull one end of the flexible tube 210 against the opposite end.

[0259] In some applications, the flexible tube 210 is stent-like. In some applications, the flexible tube 210 has a cellular structure, for example, cut from a tube. In some applications, the flexible tube 210 has a braided structure.

[0260] In some applications, the outer diameter of the elongated tube 210 is substantially similar to the inner diameter of the left coronary artery 14 when expanded, for example, such that the elongated tube circumferentially contacts the inner surface of the left coronary artery. In some applications, the elongated tube 210 is long enough to extend at least one-quarter way around the annulus 28 of the mitral valve 20.

[0261] The introduction of elongated tube 210 into the left coronary artery as shown in Figures 7 and 8A, its expansion as shown in Figure 8B, and Figures 8C-8K are described below. Insertion of the tissue anchor is performed transluminally into subject 232 and is typically facilitated by imaging (e.g., fluoroscopy). For example, imaging device 234 can deliver real-time images of the procedure to a display screen 236 that is visible to end user or physician 238, who can also control catheter 216, and other catheters introduced at other stages of treatment. Elongated tube 210, which is radiopaque, is visible to end user or physician 238 in the images provided on display screen 236.

[0262] 8C, for example, a first tissue anchor 240 driven by a driven tool 242 extending distally from a second catheter 244 is advanced into the left atrium of the subject's heart, which is upstream of the mitral valve 20. The second catheter 244 can advance the driven tool 242 through the inferior vena cava 36 and then through an opening in the septum 38 into the left atrium. In some applications, advancement of the driven tool may be through the superior vena cava.

[0263] In the illustrated example, a distal portion of catheter 244 is advanced into the vena cava. Catheter 244 also has an extracorporeal proximal portion 249 that may include a handle (e.g., as shown in FIG. 8C). The distal portion of catheter 244 is navigable to the anatomical site, such as by being actively steerable (e.g., operably coupled by one or more pull wires to proximal portion 249, such as a steering controller therefor) or by being passively guided and / or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter).

[0264] Tissue anchor 240 can have a head that is slidably coupled to tether 255 (FIG. 8E), for example, by a head that comprises an eyelet that can be threaded onto the tether. Tissue anchor 240 can have a tissue engaging element, which can be a helical threaded tissue engaging element (as shown) or can be another type of tissue engaging element, such as a dart or staple. For some applications, tissue anchor 240 can comprise one or more of the anchors described below, each of which is incorporated by reference in its entirety for all purposes. No. 17 / 145,258, filed January 8, 2021, and published as PCT application Ser. No. 2020 / 01 / 02966, by Kasher et al. Patent document 2 by Shafigh et al., filed on February 9, 2021 Patent document 3 by Shafigh et al., filed on February 8, 2022

[0265] 8D, the driving tool 242 can be seen to secure the first tissue anchor 240 within the tissue of the annulus 28 of the mitral valve 20. In some applications, the driving tool 242 is rotatable such that a drive tool screw in the tissue engaging portion 240a of the first tissue anchor 240 is rotated into the tissue of the annulus 28.

[0266] As mentioned above, for applications in which the introduction and fixation of the first tissue anchor 240 is facilitated by fluoroscopic imaging of the heart, because the elongated tube 210 is radiopaque and typically substantially fills the diameter of the left coronary artery 14, the end user or physician 238 can identify the location and boundaries of the left coronary artery based on the location of the elongated tube as viewed on the display screen 236. Thus, the end user or physician can avoid the tissue anchor 240 contacting or puncturing the left coronary artery. In some applications, there is no fluid contrast agent within the subject's body during fixation of the first tissue anchor 240, and during fixation of the additional tissue anchors described below, e.g., the procedure may be performed without introducing a fluid contrast agent into the subject.

[0267] 8E, second tissue anchor 252 is anchored in the tissue of valve annulus 28 and third tissue anchor 254 is about to be anchored. Tissue anchors 252 and 254 are similar in construction to tissue anchor 240 described above and are slidably coupled to a tether 255 that extends distally from driving tool 242 or distally from second catheter 244. Placement of anchors 240, 252, and 254 is facilitated by fluoroscopic imaging of the subject's heart such that radiopaque elongated tube 210 is visible to the surgeon or end user so that the surgeon or end user can know the location and boundaries of left coronary artery 14 and avoid damage thereto.

[0268] In some applications, the elongated tube 210 is formed of a conductive material and the driving tool 242 is electrically coupled to the control subsystem 247 (e.g., disposed within or connected to the proximal portion 249). In some applications, contact between a tissue anchor, such as tissue anchor 254, and the elongated tube 210 is detected by the control subsystem 247, which provides a signal (e.g., on or via the display screen 236), such as an audible or visual signal shown in FIG. 8E by reference numeral 256. In such applications, the end user or physician 238 can monitor the signal 256 indicative of the proximity or contact between the tissue anchor and the elongated tube 210. In response to identifying the detectable signal 256, the end user or physician can reposition the tissue anchor, shown here as a third tissue anchor 254, to avoid damaging the left coronary artery 14 and drive the third tissue anchor into the tissue of the annulus 28 at a corrected position.

[0269] Figure 8F illustrates mitral valve 20 after fixation of previously described tissue anchors 240, 252, and 254, as well as a fourth additional tissue anchor 260, similar in structure to tissue anchor 240 and slidably coupled to tether 255. As shown in Figure 8F, a pair of tools 262 extend from catheter 244 along either end of tether 255. As described below, tools 262 are used to modify tension in tether 255, lock tension on the tether, and cut the tether.

[0270] After placement of all necessary tissue anchors, the elongate tube 210 may be removed from the left coronary artery. An exemplary method for removing the elongate tube 210 is shown in Figures 8G and 8H.

[0271] In Figure 8G, outer sheath, or catheter 216, is advanced distally over elongated tube 210 in the direction of arrow 270, compressing the elongated tube within the sheath. Other mechanisms for compression of elongated tube 210 may also be used. After compression of elongated tube 210, catheter 216 is retracted from the left coronary artery in the direction indicated by arrow 272 and removed from the subject's body via aorta 18, as shown in Figure 8H. Figure 8I shows the mitral valve of the subject's heart after removal of catheter 216 and prior to application of tension to tether 255 as described below.

[0272] With reference to FIG. 8J, the tension in tether 255 is modified (e.g., tension is applied to the tether). In some applications, this is done by pulling on the end of the tether. This pulling is indicated by arrow 274. The tension may be facilitated by, for example, one or more transluminally introduced tools 262, which may provide an opposing force against anchors 240 and 260. Modifying the tension in tether 255 causes reformation of mitral valve 20. As shown in FIG. 8K, reformation of the mitral valve results in complete coaptation of valve leaflets 22 and 24, and closing of gap 26 visible in FIGS. 8A-8I.

[0273] After modification of the tether tension and reformation of the valve, the tension in the tether is locked. In the embodiment shown in FIG. 8I, a first lock 276 (which may optionally be referred to as a stopper) slides along one end of tether 255 and is locked to the tether, typically adjacent tissue anchor 240. A second lock 278 slides along the other end of tether 255 and is locked to the tether, typically adjacent tissue anchor 260. Locks 276 and 278 can lock the tension in tether 255 by preventing the tether (e.g., ends 10a and 10b) from sliding past anchors 240 and 260, e.g., by the locks abutting the anchors.

[0274] In some applications, the excess tether is then cut and removed from the left atrium, for example, by retraction of catheter 244 through septum 38 and vena cava 36.

[0275] In some applications, modifying the tension in the tether 255 may be accomplished by pulling on both ends of the tether.

[0276] In some applications, modifying the tension of tether 255 may be accomplished by first locking one of the ends of the tether adjacent a respective one of tissue anchors 240 and 260, and then pulling the other of the ends of tether 255 to modify the tension of the tether. Once a desired tension in the tether is achieved, the other end of the tether is locked adjacent a respective one of tissue anchors 240 and 260. For example, a first end may be locked adjacent tissue anchor 240, after which an end user or physician may pull the second end to change the tension of the tether, and then lock the second end adjacent tissue anchor 260.

[0277] In some applications, the tether may be advanced into the body with a lock (e.g., a lock is pushed into the body with the tether and perhaps already locked to the tether). In some cases, a first anchor can be advanced with a first lock attached to the tether adjacent to the first anchor such that the end user or physician only interacts with the second end of the tether and the second lock.

[0278] It will be appreciated that while the description of Figures 7 and 8A-8K herein is provided with respect to the treatment of a mitral valve (e.g., annuloplasty), the methods and devices of the teachings herein may be used, with appropriate modifications, during the treatment of a tricuspid valve, for example, by advancing flexible tube 210 into a coronary vessel, for example, into the right coronary artery, and performing the tricuspid valve treatment via the vena cava, as described above with respect to Figures 4 and 5A-5L. In some applications, the flexible tube may be advanced into the right coronary artery via a coronary ostium at the aortic root of the subject's aorta 18. In some applications, elongated tube 210 is sufficiently long (see, e.g., Figures 4-5L) to extend around at least a majority of the tricuspid valve annulus, and fixation of tissue anchors 240, 252, 254, and 260, or any other number of tissue anchors, enters the tricuspid valve annulus.

[0279] 9A-9C, which are schematic cross-sectional views of method steps for preventing damage to coronary arteries during repair of a mitral valve in a subject's heart, according to some applications of the teachings herein. The method can be performed in a live animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., a body part being simulated, heart tissue), etc.

[0280] As shown in Figure 9A, an elongate tube 310, similar to elongate tube 210 of Figures 7-8K, is advanced and expanded into the left coronary artery 14 surrounding the mitral valve, substantially as described above with respect to Figures 7-8B. The following description relates to a transluminal annuloplasty procedure as described above, but may also be used when performing other annuloplasty methods and other treatments known in the art, provided such treatments require the insertion of tissue anchors.

[0281] The embodiment of Figures 9A-9C differs from the embodiment shown in Figures 8A-8K in that the elongated tube 310 is not necessarily sufficiently radiopaque to facilitate fluoroscopic guidance, but rather is configured to apply an electrical signal (e.g., a voltage) to cardiac tissue under the control of a controller or handle, similar to, for example, the proximal portion 219 of Figure 8A.

[0282] Typically, the elongated tube 310 is flexible. In some applications, such as that shown, the elongated tube 310 may include or be formed from a metal or mesh frame. For example, for treatment of the mitral valve (see reference number 20 in FIG. 9A) of a subject having the anatomy described above with respect to FIG. 8A, the elongated tube 310 is advanced transluminally into the left coronary artery 14 (e.g., the left circumflex artery) that at least partially surrounds the mitral valve (see, e.g., FIG. 9A).

[0283] As shown in FIG. 9A, for example, a first tissue anchor 340 driven by a driven tool 342 extending distally from a second catheter 344 is advanced into the left atrium of a subject's heart upstream of the mitral valve 20 substantially as described above with respect to FIG. 8C.

[0284] In the illustrated example, a distal portion of the catheter 344 is advanced into the vena cava. The catheter 344 also has an extracorporeal proximal portion 349, which may include a handle (e.g., as shown in FIG. 9A). The distal portion of the catheter 344 is navigable to the anatomical site, such as by being actively steerable (e.g., operably coupled by one or more pull wires to the proximal portion 349, such as a steering controller therefor), or by being passively guided and / or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter).

[0285] The tissue anchor 340 may have a head that is slidably coupled to a tether (see reference numeral 355 in FIG. 9B), for example, by the head comprising an eyelet that can be threaded onto the tether. The tissue anchor 340 may have a tissue engaging element, which may be a helical threaded tissue engaging element (as described herein) or may be another type of tissue engaging element, such as a dart or staple. For some applications, the tissue anchor 340 may comprise one or more of the anchors described below, each of which is incorporated by reference in its entirety for all purposes. No. 17 / 145,258, filed January 8, 2021, and published as PCT application Ser. No. 2020 / 01 / 02966, by Kasher et al. Patent document 2 by Shafigh et al., filed on February 9, 2021 Patent document 3 by Shafigh et al., filed on February 8, 2022

[0286] The actuation tool 342 is reversibly coupled to the tissue anchor and configured to detect the electrical signal applied by the tube 310. For example, the tool 342 can include a distal electrode or can be electrically coupled to the tissue anchor with the tissue anchor functioning as an electrode. The detected signal (e.g., its magnitude) is used to determine the proximity of the tool 324 and / or the tissue anchor to the tube 310 and therefore to the coronary artery 14. For example, a signal may be detected upon contact with tissue of the mitral valve 20. In some applications, if the amplitude of the signal exceeds a predetermined threshold indicating that the tissue anchor is too close to the elongated tube 310 and the left coronary artery 14, a new position is selected to reduce the chance of damaging the left coronary artery when securing the tissue anchor 340.

[0287] 9A-9C does not necessarily require contact between the tissue anchor and tube 310. That is, the technique does not merely alert the end user or physician after the tissue anchor has reached the coronary artery. Rather, the technique can provide general and / or proactive guidance to the end user's physician.

[0288] In some applications, the driving tool 342 controls the tissue anchor 340 such that the tissue engaging portion 340a engages the tissue of the mitral valve at several positions to detect an electrical signal at each position, and the position at which an optimal signal (e.g., a signal having a sufficiently low amplitude) is detected for fixation of the tissue anchor 340 is selected.

[0289] In some applications, a representation of the electrical signal detected by the driven tool 342 is shown on a proximal portion 349 of the catheter 344 that is visible to the end user or physician. In some applications, a representation of the electrical signal is displayed on a display screen that is visible to the end user or physician, as shown, for example, in FIG.

[0290] Once a suitable location sufficiently far from the coronary vessel or artery is detected, the driving tool 342 secures the first tissue anchor 340 to the tissue of the annulus 28 of the mitral valve 20. In some applications, the driving tool 342 is rotatable such that a driving tool screw in a tissue engaging portion 340a of the first tissue anchor 340 is rotated into the tissue of the annulus 28.

[0291] 9B, first tissue anchor 340 and second tissue anchor 352 are secured to tissue of valve annulus 28, and third tissue anchor 354 is in the process of being secured in a manner similar to that described above for the first tissue anchor. Tissue anchors 352 and 354 are similar in structure to tissue anchor 340 described above, and are slidably coupled to a tether 355 that extends distally from driving tool 342 or distally from second catheter 344.

[0292] FIG. 9C illustrates the mitral valve 20 after fixation of the previously described tissue anchors 340, 352, and 354, as well as a fourth additional tissue anchor 360, similar in structure to tissue anchor 340 and slidably coupled to tether 355. Once the four tissue anchors are attached, the treatment process proceeds in a manner similar to that described above with respect to FIGS. 8F-8K. It will be appreciated that while the description of FIGS. 9A-9C herein is provided with respect to treatment of a mitral valve (e.g., annuloplasty), the methods and apparatus of the teachings herein may be used, with appropriate modifications, during treatment of a tricuspid valve, for example, by advancing an elongated tube 310 into the right coronary artery and performing a treatment of the tricuspid valve via the vena cava, as described above with respect to FIGS. 4 and 5A-5L. In some applications, the elongated tube may be advanced into the right coronary artery via a coronary ostium in the aortic root of the aorta of interest. In some applications, elongate tube 310 is sufficiently long to extend around at least a majority of the tricuspid valve annulus (see, e.g., Figures 4-5L), and fixation of tissue anchors 340, 352, 354, and 360, or any other number of tissue anchors, enters the tricuspid valve annulus.

[0293] 10A-10C, which are schematic cross-sectional views of steps of another method for preventing damage to a coronary vessel or artery during repair of a mitral valve of a subject's heart, according to some applications of the teachings herein. The method can be performed in a live animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., a body part being simulated, heart tissue), etc.

[0294] 10A-10C illustrate a process for selecting an appropriate location for a tissue anchor that is substantially similar to that shown in FIGs. 9A-9C. However, in the embodiment of FIGs. 10A-10C, the elongated tube 310 is replaced by a wire 410, which typically does not fill the diameter of a coronary vessel or artery. In some applications, the elongated wire 410 is flexible. Those skilled in the art will appreciate that other elongated, electrical signal applying structures may be suitable for implementing the techniques described with reference to FIGs. 10A-10C.

[0295] Elongated wire 410 is introduced into the left coronary artery substantially as described above with respect to Figures 9A-9C. During fixation of the tissue anchor, elongated wire 410 functions similarly to elongated tube 310 shown in Figures 9A-9C, applying a detectable electrical signal during insertion of the tissue anchor.

[0296] Figure 10A is substantially similar to Figure 9A and illustrates the advancement and positioning of a first tissue anchor 440 driven by a drive tool 442 extending distally from a second catheter 444, e.g., as described above with respect to Figure 9A. The first tissue anchor 440, drive tool 442, and catheter 444 have similar structures to the structures of the first tissue anchor, drive tool, and catheter shown and described with respect to Figure 9A, and like numerals refer to like parts.

[0297] 9A, the driving tool 442 is mechanically and electrically coupled to the tissue anchors and configured to detect the applied electrical signal. Thus, when the tissue engaging portion 440a of the first tissue anchor 440 engages tissue of the mitral valve 20, e.g., when a desired anchoring position is reached, an electrical signal is detected by the driving tool 442. If the detected electrical signal has an extent that exceeds a predetermined threshold that indicates a position that is too close to the elongated wire 410 and the left coronary artery 14, a new position is selected to avoid damaging the coronary artery when anchoring the tissue anchor 440.

[0298] Once a suitable location sufficiently far from the coronary vessel or artery is detected, the driving tool 442 secures the first tissue anchor 440 to the tissue of the annulus 28 of the mitral valve 20. In some applications, the driving tool 442 is rotatable such that a driving tool screw in a tissue engaging portion 440a of the first tissue anchor 440 is rotated into the tissue of the annulus 28.

[0299] 10B, first tissue anchor 440 and second tissue anchor 452 are secured to tissue of valve annulus 28, and third tissue anchor 454 is in the process of being secured in a manner similar to that described above for the first tissue anchor. Tissue anchors 452 and 454 are similar in structure to tissue anchor 440 described above, and are slidably coupled to a tether 455 that extends distally from driving tool 442 or distally from second catheter 444.

[0300] 10C illustrates mitral valve 20 following fixation of previously described tissue anchors 440, 452, and 454, as well as a fourth additional tissue anchor 460, similar in structure to tissue anchor 340 and slidably coupled to tether 455. Once the four tissue anchors are attached, the healing process proceeds in a similar manner as described above with respect to FIGS.

[0301] 10A-10C herein are provided with respect to treating a mitral valve (e.g., annuloplasty), it should be noted that the methods and devices of the teachings herein may be used, with appropriate modifications, during treatment of a tricuspid valve, for example, by advancing an elongated wire 410 into the right coronary artery and performing a tricuspid valve treatment via the vena cava, as described above with respect to FIGS. 4 and 5A-5L. In some applications, the elongated wire may be advanced into the right coronary artery via a coronary ostium at the aortic root of the aorta of interest. In some applications, the elongated wire 410 is sufficiently long (see, e.g., FIGS. 4-5L) to extend around at least a majority of the tricuspid valve annulus, and the fixation of tissue anchors 440, 452, 454, and 460, or any other number of tissue anchors, enters the tricuspid valve annulus.

[0302] 9A-10C are described above as facilitating distancing of the tissue anchor from adjacent coronary vessels or arteries, for example, by anchoring only at tissue sites where the applied electrical signal is detected at a sufficiently low amplitude. However, it should be noted that it may be advantageous to position the tissue anchor within a certain proximity to the atrial wall, for example, so that the anchor is driven into the valve annulus rather than into the valve leaflets. Thus, in some applications, detection of the applied electrical signal at a sufficiently high degree is also desirable, and the anchor is anchored only at tissue sites where the applied electrical signal is detected at an amplitude above any predetermined threshold. Thus, in some applications, the anchor is anchored only at tissue sites where the applied electrical signal is detected at an amplitude between a predetermined lower threshold and a predetermined upper threshold.

[0303] Referring again to Figures 2L, 3A, 3B, 5L, 6A, 6B, and 8K, each of the locks described above can comprise a deformable structure (e.g., crimping), a spring-loaded element, and / or an actuatable mechanism. In some applications, each of the locks described above can comprise one or more of the locks or stoppers described below, each of which is incorporated by reference in its entirety for all purposes. U.S. Patent Application Serial No. 16 / 534,875, filed August 7, 2019, and published as U.S. Patent Application Publication No. 2019 / 0133636, by Brauon et al. International Patent Application No. PCT / IB2020 / 060044, filed October 27, 2020, and published as PCT Publication No. 7, by Kasher et al. No. 17 / 145,258, filed January 8, 2021, and published as PCT application Ser. No. 2020 / 01 / 02966, by Kasher et al.

[0304] The present invention is not limited to what has been specifically shown and described above. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described above, as well as variations and modifications thereof that are not present in the prior art and that would occur to one of ordinary skill in the art upon reading the above description. The treatment techniques, methods, acts, steps, etc. described or suggested herein may be performed on live animals or on non-living simulations such as cadavers, cadaver hearts, simulators (e.g., simulated body parts, tissues, etc.).

[0305] Although some operations of the disclosed embodiments are described in a specific sequential order for convenience of presentation, it should be understood that this method of description encompasses rearrangements, unless a specific order is required by the specific terms described above. For example, operations or steps described in a sequential manner may in some cases be rearranged or performed simultaneously. Furthermore, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods may be used in conjunction with other methods. Furthermore, terms such as "provide" or "achieve" are sometimes used in this specification to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the specific implementation and are recognizable by those skilled in the art.

Claims

1. 1. A system for use on a subject, comprising: a tether (10) configured to be transluminally advanced into a coronary vessel (36) of the subject's heart, the coronary vessel (36) at least partially traversing a chamber of the heart, the tether (10) having a first end (10a) and a second end (10b), the first end (10a) configured to be advanced through a wall of the coronary vessel (36) into the chamber at a first location (14a) and the second end (10b) configured to be advanced through the wall of the coronary vessel (36) into the chamber at a second location (14b); at least one device (30) configured to transluminally withdraw the first and second ends (10a) and (10b) of the tether (10) from the first and second locations (14a) and (14b), respectively, to outside of the heart chamber, such that a first segment (34) of the tether (10) extends from the first location (14a) through the heart chamber and a second segment (44) of the tether (10) extends from the second location (14b) through the heart chamber; a support tube (12) defining an internal lumen, the support tube (12) configured to be advanced transluminally into the coronary vessel (36), the tether (10) extending through the internal lumen of the support tube (12) and being slidable relative to the support tube (12); at least one tissue anchor (50, 56; 80) configured to slide along and over at least one of the first end (10a) and the second end (10b) such that a portion of the tether (10) extends between the at least one tissue anchor (50, 56; 80) and the coronary vessel (36) to secure the at least one of the first end (10a) and the second end (10b) to tissue of the heart chamber; and at least one lock (60, 66; 70) configured to lock the tension in the tether (10) following tensioning of the tether (10).

2. the at least one tissue anchor (50, 56; 80) comprises a single tissue anchor (80) configured to slide over and along both the first end (10a) and the second end (10b) to secure the first end (10a) and the second end (10b) to tissue of the heart chamber such that two portions of the tether (10) extend between the tissue anchor and the coronary vessel (36); 2. The system of claim 1, wherein the at least one lock (60, 66; 70) preferably includes a single lock (70) configured to lock the first end (10a) and the second end (10b) of the tether (10) adjacent to the single tissue anchor (80).

3. The at least one tissue anchor (50, 56; 80) a first tissue anchor (50) configured to slide over and along the first end (10 a) such that a first portion of the tether (10) extends between the first tissue anchor (50) and the coronary vessel (36) to secure the first end (10 a) to tissue of the heart chamber in a first configuration; a second tissue anchor (56) configured to slide over and along said second end (10b) such that a second portion of said tether (10) extends between said second tissue anchor (56) and said coronary vessel (36) and to secure said second end (10b) to tissue of the heart chamber in a second configuration, preferably the at least one lock (60, 66; 70) includes a single lock (70) configured to slide over the first end (10a) and the second end (10b) of the tether (10) and lock the first end (10a) and the second end (10b) of the tether (10) to a locking point adjacent one of the first tissue anchor and the second tissue anchor (56); Or alternatively, said at least one lock (60, 66; 70) a first lock (60) configured to slide onto the first end (10a) of the tether (10) and lock the first end (10a) of the tether (10) to a first lock (60) point adjacent the first tissue anchor (50); 2. The system of claim 1, further comprising: a second lock (66) configured to slide over the second end (10b) of the tether (10) and lock the second end (10b) of the tether (10) to a second locking point (66) adjacent the second tissue anchor (56).

4. the cardiac chamber being the left atrium of the heart and the coronary vessel being the left coronary artery of the subject, preferably the left coronary artery is the left circumflex artery of the subject; and / or The system of any one of claims 1 to 3, wherein the tension in the tether is configured to reshape the mitral valve (20) of the subject.

5. The at least one device (30) is configured to draw at least one of the first end (10a) and the second end (10b) through at least one of the septum (38) of the heart and the vena cava of the subject, preferably the vena cava is the superior vena cava, or alternatively 5. The system of claim 4, wherein the vena cava is the inferior vena cava (36), and the at least one device (30) is configured to withdraw at least one of the first end (10a) and the second end (10b) further through a femoral vein of the subject.

6. the at least one device (30) is configured to draw the first end (10a) and the second end (10b) through one of the superior vena cava and the inferior vena cava (36); or alternatively, 6. The system of claim 5, wherein the at least one device (30) includes a first device (30) configured to draw one of the first end (10a) and the second end (10b) through a superior vena cava, and a second device (30) configured to draw the other of the first end (10a) and the second end (10b) through an inferior vena cava (36).

7. The system of any one of claims 4 to 6, wherein the tether (10) is configured to be advanced through the subject's femoral artery and aorta and into the coronary vessel (36).

8. the cardiac chamber being the right atrium of the heart and the coronary vessel being the right coronary artery of the subject, preferably The system of any one of claims 1 to 3, wherein the tension in the tether (10) is configured to reshape the tricuspid valve (120) of the subject.

9. The at least one device (30) is configured to draw at least one of the first end (10a) and the second end (10b) through the vena cava of the subject, preferably the vena cava is the superior vena cava, or alternatively 9. The system of claim 8, wherein the vena cava is the inferior vena cava (36), and the at least one device (30) is configured to withdraw at least one of the first end (10a) and the second end (10b) further through a femoral vein of the subject.

10. the at least one device (30) is configured to draw the first end (10a) and the second end (10b) through one of the superior vena cava and the inferior vena cava (36); or alternatively, 10. The system of claim 9, wherein the at least one device (30) includes a first device (30) configured to draw one of the first end (10a) and the second end (10b) through a superior vena cava, and a second device (30) configured to draw the other of the first end (10a) and the second end (10b) through an inferior vena cava (36).

11. The system of any one of claims 1 to 10, further comprising a first longitudinal catheter (16) configured to be advanced transluminally into the coronary vessel (36), the tether (10) being configured to be advanced distally from the first catheter into the coronary vessel (36).

12. The at least one device (30) comprises at least one snare (31), preferably the at least one snare (31) comprises a single snare (31) configured to withdraw the first end (10a) and the second end (10b), or alternatively The system of any one of claims 1 to 11, wherein the at least one snare (31) comprises a first snare (31) configured to retract the first end (10a) and a second snare (31) configured to retract the second end (10b).

13. 13. The system of claim 12, wherein the at least one snare (31) is configured to be advanced transluminally from a catheter into the heart chamber prior to at least one of the withdrawal of the first end (10a) and the withdrawal of the second end (10b).

14. The system of claim 12 or 13, further comprising at least one second catheter (32), and the at least one device (30) is configured to draw the first end (10a) and the second end (10b) through the at least one second catheter (32).

15. The system of any one of claims 11 to 14, wherein the support tube (12) is configured to be advanced distally from the first catheter into the coronary vessel (36).

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