Transcatheter devices and methods for treating the heart

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first end (10a) of the tether is advanced through the wall of the vessel into the heart chamber and then transluminally withdrawn from the heart chamber such that a first segment of the tether extends from the first location through the heart chamber.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(14b), a second end (10b) of the tether is advanced through the wall into the heart chamber and then transluminally withdrawn from the heart chamber such that a second segment of the tether extends from the second location through the heart chamber.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 herein by reference 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 and 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 and its corresponding ventricle, as well as between the ventricles and their corresponding arteries, prevent 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 left ventricle is known as the mitral valve, and the atrioventricular valve between the right atrium and right ventricle is known as the tricuspid valve. Each of these valves contains multiple leaflets that coapt when the valve is closed and have a space between them when the valve is open. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] U.S. 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 a tricuspid or mitral valve annulus 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 included in an example of this Summary are not required for a claim unless the claim explicitly recites those features. Furthermore, features, components, steps, concepts, etc. described in the examples in this Summary and elsewhere in this disclosure can be combined in various ways. Various features and steps described elsewhere in this disclosure may 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 terminals of the tether are advanced through the wall of the coronary vessel or artery into an adjacent heart chamber at two different locations. For each of the locations, the terminals are withdrawn from the heart chamber (described in more detail below) so that a segment of the tether extends from a respective one of the locations through the heart chamber. A tissue anchor is slid over and along at least one of the terminals and secured to the tissue of the heart chamber so 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 by, for example, modifying the tension in the tether in the portion of the tether extending between the coronary vessel or artery and the tissue anchor. The tension in 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 located 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 in a subject's heart is provided, the method including transluminally advancing a tether 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 a 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 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 is slidable over at least one of the first end and the second end and can be 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 reshaped by modifying the tension in at least a portion of a tether extending between at least one tissue anchor and a coronary vessel or artery, and the tension in the tether can be locked after the heart chamber is reshaped.

[0012] For 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 on the tether can include locking the tension adjacent one anchor.

[0013] In some applications, locking the tension may include locking the first end and the 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 and securing the first tissue anchor to tissue of the heart chamber in a first configuration, such that the first portion of the tether extends between the first tissue anchor and the coronary vessel or artery.

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

[0016] For some applications, locking the tension may 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 involve locking both the first end and the second end of the tether using a single lock.

[0018] For 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, sliding of the single lock onto the first and second ends of the tether can occur outside the subject's body, and 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 may include locking one of the first end and the second end adjacent to a corresponding one of the first tissue anchor and the second tissue anchor, and pulling the other of the first end and the second end.

[0021] In some applications, locking the tension may include locking the other of the first end and the second end adjacent to a corresponding other of the first tissue anchor and the second tissue anchor.

[0022] In some applications, modifying the tension of the tether may include pulling the first end and the 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 interest.

[0025] In some applications, the remodeling of 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 the subject's femoral vein.

[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 led out through the superior vena cava and the other of the first end and the second end is led out through the inferior vena cava.

[0031] In some applications, advancement of the tether into the 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, the remodeling of 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 the subject's femoral vein.

[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 led out through the superior vena cava and the other of the first end and the second end is led 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 first end withdrawal and the second end withdrawal are each accomplished using a snare.

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

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

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

[0046] In some applications, the method may further include the 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 the first end of the tether through the wall of the coronary vessel or artery into the heart chamber and before advancement of the second end of the tether through the wall of the coronary vessel or artery into the heart chamber.

[0049] The above methods can be performed in live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, cardiac tissue), and 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 transluminally advanced into a coronary vessel or artery of the subject's heart. 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 the first segment of the tether can extend through the heart chamber from the first location and the second segment of the tether can 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 / device may further include at least one tissue anchor configured to slide over and along at least one of the first end and second end to secure at least one of the first end and 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 may include a single lock configured to lock the first end and the second end of the tether adjacent to a single tissue anchor.

[0057] For some applications, the at least one tissue anchor may include a first tissue anchor configured to slide over a first end thereof so 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 so 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 a 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 a 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 interest.

[0062] For some applications, the 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 extend at least one of the first end and the second end through at least one of the septum of the heart and the vena cava of the subject.

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

[0065] For 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 the subject's femoral vein.

[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 the subject's femoral artery and aorta 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, the 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 extend 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] For 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 the subject's femoral vein.

[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 transluminally advanced 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 retract the first end and a second snare configured to retract 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 withdrawal and the second end withdrawal.

[0081] For some applications, the system may further include at least one second catheter, and the at least one device may 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, methods and apparatus are provided for protecting a coronary vessel or artery of a subject's heart during a medical procedure on 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 positioned. The heart is imaged using a fluoroscopic tool so that the elongated structure is visible. A location for fixation of the tissue anchor is selected based on the acquired image 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 a 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 the 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 the 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 within a heart chamber adjacent to 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] For 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 interest.

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

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

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

[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 the coronary vessel or artery is through a coronary ostium at the aortic root of the subject.

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

[0101] In some applications, the elongated tube includes a metal frame or a 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, expanding may include pulling one end of the elongate tube from an opposite end of the elongate tube.

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

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

[0109] The above methods can be performed in live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, cardiac tissue), and 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 comprising a radiopaque and electrically conductive material. The elongated tube may be configured to be transluminally advanced in a compressed state into a coronary vessel or artery of the subject's heart and expanded within the coronary vessel or artery.

[0111] The system may further include a tissue anchor configured to be anchored within a cardiac 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, hi 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 may be configured to generate a detectable signal when the tissue anchor contacts the elongate tube.

[0115] In 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] For some applications, the elongate tube is a compressible elongate tube having a compressed working orientation and an expanded working orientation, hi some applications, the elongate tube may be configured to be advanced into a coronary vessel or artery when in the compressed working orientation.

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

[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 interest.

[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 annulus of the mitral valve.

[0122] In some applications, the elongate tube is configured to be advanced through the subject's femoral artery and aorta 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 subject's tricuspid valve.

[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. For 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 frame or a mesh frame.

[0129] For some applications, the elongate tube may further include an outer sheath adapted to hold the elongate tube in a compressed operating 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 using an anchor driver to drive the tissue anchor and detecting the electrical signal adjacent the anchor driver.

[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 an anchoring 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 optimum electrical signal.

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

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

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

[0138] For some applications, the method may further include transluminally removing the elongate 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 interest.

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

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

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

[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 elongate structural element into the 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 live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, cardiac tissue), and 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 anchored within a cardiac 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 securement 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 securement position where the electrical signal detected by the anchor driver is a minimum electrical signal.

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

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

[0157] For some applications, the elongate tube is configured to be transluminally advanced 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 interest.

[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 annulus of the mitral valve.

[0162] For some applications, the elongate structural element is configured to be advanced through the subject's femoral artery and aorta 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 subject's tricuspid valve.

[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 elongate 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. [Brief explanation 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 steps in 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 in an example method for treating the mitral valve of a subject's heart. [Figure 2C] FIG. 2C is a schematic cross-sectional view of steps in an example method for treating the mitral valve of a subject's heart. [Figure 2D] FIG. 2D is a schematic cross-sectional view of steps in an example method for treating the mitral valve of a subject's heart. [Figure 2E] 2E is a schematic cross-sectional view of steps in an example method for treating the mitral valve of a subject's heart. [Figure 2F] 2F is a schematic cross-sectional view of steps in an example method for treating the mitral valve of a subject's heart. [Figure 2G] FIG. 2G is a schematic cross-sectional view of steps in an example method for treating the mitral valve of a subject's heart. [Figure 2H] 2H is a schematic cross-sectional view of steps in an example method for treating the mitral valve of a subject's heart. [Figure 2I] FIG. 2I is a schematic cross-sectional view of steps in an example method for treating the mitral valve of a subject's heart. [Figure 2J] FIG. 2J is a schematic cross-sectional view of steps in 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] FIG. 2L is a schematic cross-sectional view of steps in 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 steps in an example method for treating the tricuspid valve of a subject's heart. [Figure 5B] FIG. 5B is a schematic cross-sectional view of steps in an example method for treating a tricuspid valve in a subject's heart. [Figure 5C] 5A-5C are schematic cross-sectional views of steps in an example method for treating a tricuspid valve in a subject's heart. [Figure 5D] FIG. 5D is a schematic cross-sectional view of steps in an example method for treating a tricuspid valve in a subject's heart. [Figure 5E] FIG. 5E is a schematic cross-sectional view of steps in an example method for treating a tricuspid valve in a subject's heart. [Figure 5F] FIG. 5F is a schematic cross-sectional view of steps in an example method for treating a tricuspid valve in a subject's heart. [Figure 5G] FIG. 5G is a schematic cross-sectional view of steps in an example method for treating a tricuspid valve in a subject's heart. [Figure 5H] 5H is a schematic cross-sectional view of steps in an example method for treating a tricuspid valve in a subject's heart. [Figure 5I] FIG. 5I is a schematic cross-sectional view of steps in an example method for treating a tricuspid valve in a subject's heart. [Figure 5J] FIG. 5J is a schematic cross-sectional view of steps in 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 in an example method for treating a tricuspid valve in a subject's heart. [Figure 5L] FIG. 5L is a schematic cross-sectional view of steps in 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 steps of an exemplary method for preventing damage to coronary vessels or arteries during repair of a mitral valve in a subject's heart. [Figure 8B] FIG. 8B is a schematic cross-sectional view of steps of an exemplary method for preventing damage to coronary vessels or arteries during repair of a mitral valve in a subject's heart. [Figure 8C] FIG. 8C is a schematic cross-sectional view of steps of an exemplary method for preventing damage to coronary vessels or arteries during repair of a mitral valve in a subject's heart. [Figure 8D] FIG. 8D is a schematic cross-sectional view of steps of an exemplary method for preventing damage to coronary vessels or arteries during repair of a mitral valve in a subject's heart. [Figure 8E] FIG. 8E is a schematic cross-sectional view of an exemplary method step for preventing damage to coronary vessels or arteries during repair of a mitral valve in a subject's heart. [Figure 8F] FIG. 8F is a schematic cross-sectional view of an exemplary method step for preventing damage to coronary vessels or arteries during repair of a mitral valve in a subject's heart. [Figure 8G] FIG. 8G is a schematic cross-sectional view of an exemplary method step for preventing damage to coronary vessels or arteries during repair of a mitral valve in a subject's heart. [Figure 8H] FIG. 8H is a schematic cross-sectional view of an exemplary method step for preventing damage to coronary vessels or arteries during repair of a mitral valve in a subject's heart. [Figure 8I] FIG. 8I is a schematic cross-sectional view of steps of an exemplary method for preventing damage to coronary vessels or arteries during repair of a mitral valve in a subject's heart. [Figure 8J] FIG. 8J is a schematic cross-sectional view of an exemplary method step for preventing damage to coronary vessels or arteries during repair of a mitral valve in a subject's heart. [Figure 8K]FIG. 8K is a schematic cross-sectional view of an exemplary method step for preventing damage to coronary vessels or arteries during repair of a mitral valve in a subject's heart. [Figure 9A] FIG. 9A is a schematic cross-sectional view of steps of an exemplary method for preventing damage to coronary vessels or arteries during repair of a mitral valve in a subject's heart. [Figure 9B] FIG. 9B is a schematic cross-sectional view of steps of an exemplary method for preventing damage to coronary vessels or arteries during repair of a mitral valve in a subject's heart. [Figure 9C] FIG. 9C is a schematic cross-sectional view of steps of an exemplary method for preventing damage to coronary vessels or arteries during repair of a mitral valve in a subject's heart. [Figure 10A] FIG. 10A is a schematic cross-sectional view of steps of an exemplary method for preventing damage to coronary vessels or arteries during repair of a mitral valve in a subject's heart. [Figure 10B] FIG. 10B is a schematic cross-sectional view of steps of an exemplary method for preventing damage to coronary vessels or arteries during repair of a mitral valve in a subject's heart. [Figure 10C] FIG. 10C is a schematic cross-sectional view of steps of an exemplary method for preventing damage to coronary vessels or arteries during repair of a mitral valve in a subject's heart. DETAILED DESCRIPTION OF THE INVENTION

[0169] Those skilled in the art will recognize 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 one skilled in the art upon reading the description herein and that are not in the prior art.

[0170] The following description describes various aspects of the present disclosure. 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 those 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 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 present 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 present 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 illustration 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 the left coronary artery (although various other vessels are possible), according to an exemplary method. 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 simulated body part, cardiac tissue), etc.

[0174] 1, a device according to the teachings herein includes a tether 10 that may be surrounded by and 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 transluminally advanced 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 may be navigated 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 for treating a mitral valve 20 of a subject's heart using the device of FIG. 1, according to some applications of the teachings herein. For example, the mitral valve treatment 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 simulated body part, cardiac tissue), etc.

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

[0179] Referring to FIG. 2B, at a first puncture location 14a, a hole is punctured (e.g., 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] 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 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 can be navigated 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] 2D, snare 31 is then used to pull first end 10a of the tether out of the left atrium, for example, as described in more detail below, so that first segment 34 of the tether extends from puncture location 14a across the left atrium. In some applications, first end 10a is pulled through catheter 32 (e.g., by withdrawing snare tool 30 through the catheter), as shown in FIG.

[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 subject's inferior vena cava 36. In some applications, withdrawal may also be via the superior vena cava.

[0186] As described in more detail below, in some applications of the process shown in Figure 2D, first end 10a of tether 10 is withdrawn completely from within the subject's body. In some applications of the process shown in Figure 2D, 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 and second locations, or may terminate at each of the first and second locations.

[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 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 can be transluminally advanced 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, snare 31 of snare tool 30 (or another snare of another snare tool) is used to pull second end 10b of the tether out of the left atrium so that second segment 44 of the tether extends from second puncture location 14b across the left atrium.

[0191] In some applications, as shown, snare 31 of snare tool 30 (or another snare of another snare tool) withdraws second end 10b from the left atrium through an opening in the cardiac septum 38 and through the subject's inferior vena cava 36. In some applications, withdrawal may also 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 a heart chamber or left atrium via the same route, i.e., via the same one of the superior vena cava 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, and back into the catheter. This loop includes (i) segment 34 extending from catheter 32 across the atrium to position 14a, (ii) curved portion 10c of tether 10 extending between positions 14a and 14b (e.g., within support tube 12), and (iii) segment 44 extending from position 14b through the atrium and back into the catheter.

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

[0194] As described in more detail below, in some applications of the process shown in Figure 2G, second end 10b of tether 10 is withdrawn completely from the subject's body. In some applications of the process shown in Figure 2G, second end 10b is withdrawn from the left atrium but remains within the subject's body. In some applications, first end and second end of tether 10 are withdrawn to the same extent from the left atrium (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 retracting 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 anchored in tissue of the left atrium, e.g., the annulus 28, so 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 anchored across the mitral valve 20 from the left coronary artery 14 (e.g., from the support vessel 12), such as in the anterior region of the left atrium, near the base of the anterior leaflet 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 anchored in tissue of the left atrium, e.g., the annulus 28, so that the second segment 44 extends between the left coronary artery 14 and the second tissue anchor. The second tissue anchor 56 can be anchored across the mitral valve 20 from the left coronary artery 14 (e.g., from the support vessel 12), such as in the anterior region of the left atrium, near the anterior leaflet base 22 or the commissure where the anterior leaflet meets the posterior leaflet 24. At this stage, the second segment 44 may have slack. The second tissue anchor 56 can be driven by the driving tool 52 or by a separate anchor driving tool.

[0198] Each of anchors 50 and 56 can include a head slidably coupleable to tether 10, for example, by the head comprising an eyelet that can be threaded onto the tether. Each of anchors 50 and 56 can include a tissue-engaging element, which can be a helical threaded tissue-engaging element (as described herein) or another type of tissue-engaging element, such as a dart or staple. For some applications, each of anchors 50 and 56 described above can comprise one or more of the anchors described below, each of which is incorporated by reference in its entirety for all purposes. U.S. Patent Application No. 17 / 145,258 to Kasher et al., filed January 8, 2021, and published as U.S. Patent Application No. 2021 / 012999 Patent Document 2 by Shafigh et al., filed February 9, 2021 Patent Document 3 by Shafigh et al., filed 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 valve annulus 28. Following securement of tissue anchors 50 and 56, driving tool 52 (and the other driving tool, if used) can be retracted from the left atrium, for example, 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. The 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 presses 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 tether tension and reforming the valve, the tension in the tether is locked. In the embodiment shown in FIG. 2L, a first lock 60 (optionally referred to as a stopper) slides along a first end 10a of the tether 10 and is locked to the tether, often adjacent 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 adjacent to a second anchor 56. Locks 60 and 66 can lock the tension in the tether 10 by preventing the tether (e.g., ends 10a and 10b) from sliding past anchors 50 and 56, e.g., by abutting the anchors. In some applications, lock 60 has one or more features described in U.S. Patent Application No. 16 / 534,875, filed August 7, 2019, by Brauon et al., and published as U.S. Patent Application No. 6087544, 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 tether 10 can be achieved by pulling on both ends 10a and 10b. In some applications, modifying the tension of tether 10 can be achieved by first locking one of ends 10a and 10b adjacent one of tissue anchors 50 and 56, respectively, and then pulling on the other of ends 10a and 10b to modify the tension of the tether. Once the desired tension of the tether is achieved, the other of ends 10a and 10b is locked adjacent one of tissue anchors 50 and 56, respectively. For example, first end 10a can be locked adjacent tissue anchor 50, after which the end user or physician can pull end 10b to change the tension of the tether and then lock the second end 10b adjacent to the 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 according to some application of the teachings herein. 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 simulated body part, 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, adjacent one of the tissue anchors, shown here as tissue anchor 50. In some applications, during or after tensioning of tether 10, second end 10b of the tether is pulled around or through second tissue anchor 56 to first tissue anchor 50, resulting in a tether segment 72 extending between the first and second tissue anchors. Lock 70 then slides over and along both ends of tether 10, locking the ends adjacent first tissue anchor 50. As described above, after locking the tension on the tether, excess tether can be cut and removed. In some applications, the second end 10b may not be carried on the anchor 50, but instead the lock 70 may slide 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 and the lock locks the tension in the tether 10 by locking 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 securing and locking steps of FIGS. 2H-2L. In the embodiment of FIG. 3B, a single tissue anchor replaces first tissue anchor 50 and 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, e.g., within valve annulus 28. Tissue anchor 80 can be driven out of the catheter by a driving tool, e.g., 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 the end of the tether and locks onto 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 illustration 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 simulated body part, cardiac tissue), etc.

[0212] 4, a device according to the teachings herein includes a tether 110 that may be surrounded by and 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 catheter 116 is advanced into the right coronary artery. Catheter 116 also has an extracorporeal proximal portion 119 (e.g., as shown in FIG. 5A ). The distal portion of catheter 116 can be navigated to the anatomical site, such as by being actively steerable (e.g., operably coupled by one or more pull wires to proximal portion 119, 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).

[0215] 5A-5L, which are schematic cross-sectional views of steps in a method of treating a tricuspid valve 120 of a subject's heart using the device of FIG. 4, according to some applications of the teachings herein. For example, the tricuspid valve treatment can include tricuspid valve annuloplasty or 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 simulated body part, cardiac 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 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 forms between them. A 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 final 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 (e.g., 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 with 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 introduced via the second catheter 132.

[0220] In some applications, as shown, the snare tool 130 is introduced into the right atrium of the subject 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 can be navigated 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 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).

[0222] Then, as shown in FIGURE 5D, snare 131 is used to pull first end 110a of the tether out of the right atrium so that first segment 134 of the tether extends from puncture location 114a across the right atrium. In some applications, first end 110a is pulled through catheter 132 (e.g., by withdrawing snare tool 130 through the catheter), as shown in FIGURE 5D.

[0223] In some applications, as shown, snare 131 withdraws 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 tether is advanced into the atrium. As shown, support tube 112 can be positioned between first location 114a and second location 114b. In some applications, such as the embodiments shown in FIGS. 5A-5L, first location 114a and second location 114b are selected to be near the ends of gap 126 between valve 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) and into the right atrium, or out of a separate, third catheter.

[0227] Next, as shown in FIG. 5G, snare 131 of snare tool 130 (or another snare of another snare tool) is used to pull second end 110b of the tether out of the right atrium so that second segment 144 of the tether extends from 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 vena cava and the 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 extending from catheter 132 across the atrium to position 114a, (ii) curved portion 110c of tether 110 extending between positions 114a and 114b (e.g., within support tube 112), and (iii) segment 144 extending from position 114b through the atrium and back into the catheter.

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

[0231] As described in more detail below, in some applications of the process shown in Figure 5G, second end 110b of tether 110 is withdrawn completely from the subject's body. In some applications of the process shown in Figure 5G, second end 110b is withdrawn from the right atrium but remains within the subject's body. In some applications, first end and second end of tether 110 are withdrawn to the same extent from the right atrium (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 anchored in tissue of the right atrium, e.g., the annulus 128, so 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 anchored across the tricuspid valve 120 from the right coronary artery 114 (e.g., from the support vessel 112) near 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 anchored in tissue of the right atrium, e.g., the annulus 128, so that the second segment 144 extends between the right coronary artery 114 and the second tissue anchor. The second tissue anchor 156 may be anchored across the tricuspid valve 120 from the right coronary artery 114 (e.g., from the support tube 112) near 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 helical threaded tissue-engaging element (as described herein) or another type of tissue-engaging element, such as a dart or staple. For some applications, each of anchors 150 and 156 described above can comprise one or more of the anchors described below, each of which is incorporated by reference in its entirety for all purposes. U.S. Patent Application No. 17 / 145,258 to Kasher et al., filed January 8, 2021, and published as U.S. Patent Application No. 2021 / 012999 Patent Document 2 by Shafigh et al., filed February 9, 2021 Patent Document 3 by Shafigh et al., filed February 8, 2022

[0236] Driving tool 152 may be advanced through second catheter 132 (e.g., as shown in FIG. 5H) or from another catheter. In some applications, as shown, driving tool 152 is rotatable to secure the tissue anchors by threading them into the tissue of valve annulus 128. Following securement of tissue anchors 150 and 156, driving tool 152 (and the other driving tool, if used) may be retracted from the right atrium, for example, 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. Tensioning 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, e.g., in the direction of arrow 159. As shown in FIG. 5L, reformation of the tricuspid valve improves coaptation between valve leaflets 122, 123, and 124, 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 location 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 typically locked to the tether proximate first anchor 150. A second lock 166 slides along a second end 110b of tether 110 and is typically locked to the tether proximate 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 cut and removed from the right atrium, for example, by retraction of catheter 132. Advancement of locks 160 and 166 and cutting of the excess tether can be performed using tool 157.

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

[0243] In some applications, modifying the tension of tether 110 may be achieved by first locking one of ends 110a and 110b adjacent one of tissue anchors 150 and 156, respectively, and then pulling on the other of ends 110a and 110b to modify the tension of the tether. Once the desired tension of 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 the end user or physician may pull on end 110b to change the tension of the tether and then lock the second end 110b adjacent 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 tether ends outside the body. 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 inside the body (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 living 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, adjacent one of the tissue anchors, shown here as tissue anchor 150. In some applications, during or after tensioning of tether 110, first end 110a of the tether is pulled around or through first tissue anchor 150 to second tissue anchor 156, resulting in a tether segment 172 extending between the first and second tissue anchors. Lock 170 then slides over and along both ends of tether 110, locking the ends adjacent second tissue anchor 156. As described above, after locking the tension on the tether, 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 slide 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 and the lock locks the tension in tether 110 by locking 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 securing 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, 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 secured within tissue of the right atrium, e.g., within 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 the end of the tether and locks onto the tether. As described above, after locking the tension in the tether, excess tether can be cut and removed.

[0249] Referring now to Figures 7 and 8A-8K, there are schematic illustrations 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 subject's mitral valve, located between the left atrium and left ventricle of the heart (see reference numeral 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 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).

[0252] 8A-8K, which are schematic cross-sectional views of method steps for preventing injury to the left coronary artery during repair of the mitral valve 20 of a heart using the device of FIG. 7, according to some applications of the teachings herein. For example, the mitral valve repair may be or include mitral valve annuloplasty. The method may be performed in a living animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., a 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 a 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 forms between them. The therapeutic (e.g., annuloplasty) procedures described herein reshape the mitral valve 20 so 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 annular tissue in a 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 Ser. 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. 15 / 782,687 to Iflah et al., filed August 7, 2019, 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, each of which is incorporated by reference in its entirety for all purposes. However, the elongate 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 live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, cardiac tissue), and 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, as 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 longitudinally contracting the tube, e.g., by pulling one end of the flexible tube toward 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 longitudinally contracting the tube). 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, for example, so that when expanded, the elongated tube 210 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 with respect to 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 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 driving tool 242 extending distally from a second catheter 244 is advanced into the left atrium of a subject's heart, the left atrium being upstream of the mitral valve 20. The second catheter 244 can advance the driving 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 driving tool may also be via 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 may be navigated 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 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).

[0264] Tissue anchor 240 can have a head that is slidably coupled to tether 255 (FIG. 8E), for example, by a head that includes 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. U.S. Patent Application No. 17 / 145,258 to Kasher et al., filed January 8, 2021, and published as U.S. Patent Application No. 2021 / 012999 Patent Document 2 by Shafigh et al., filed February 9, 2021 Patent Document 3 by Shafigh et al., filed February 8, 2022

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

[0266] As mentioned above, for applications in which the introduction and fixation of first tissue anchor 240 is facilitated by fluoroscopic imaging of the heart, because elongated tube 210 is radiopaque and typically substantially fills the diameter of left coronary artery 14, an 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 seen on display screen 236. Thus, the end user or physician can avoid contacting or puncturing the left coronary artery with tissue anchor 240. In some applications, during fixation of first tissue anchor 240, and during fixation of additional tissue anchors described below, there is no fluid contrast agent within the subject's body; for example, 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 structure to tissue anchor 240 described above and are slidably coupled to 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, thereby enabling the surgeon or end user to understand the location and boundaries of left coronary artery 14 and avoid damage thereto.

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

[0269] 8F illustrates mitral valve 20 after fixation of the 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 FIG. 8F, a pair of tools 262 extend from catheter 244 along opposite ends of tether 255. As described below, tools 262 are used to modify the 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 can 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 elongate tube 210 in the direction of arrow 270, compressing the elongate tube within the sheath. Other mechanisms for compressing elongate tube 210 may also be used. After compressing elongate tube 210, catheter 216 is withdrawn 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 81 shows the mitral valve of the subject's heart after removal of catheter 216 and before tensioning tether 255 as described below.

[0272] Referring 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, for example, by 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 has fully coapted valve leaflets 22 and 24, closing gap 26 visible in FIGS. 8A-8I.

[0273] After modifying the tether tension and reforming 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 achieved by first locking one of the ends of the tether adjacent to a respective one of tissue anchors 240 and 260, and then pulling on the other of the ends of tether 255 to modify the tension of the tether. Once the desired tension of the tether is achieved, the other end of the tether is locked adjacent to a respective one of tissue anchors 240 and 260. For example, a first end may be locked adjacent to tissue anchor 240, after which the end user or physician may pull on the second end to change the tension of the tether and then lock the second end adjacent to 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, 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 can be used, with appropriate modifications, during tricuspid valve treatment, for example, by advancing flexible tube 210 into a coronary vessel, e.g., 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 can be advanced into the right coronary artery via a coronary ostium in the aortic root of a subject's aorta 18. In some applications, elongated tube 210 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 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 living animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., a simulated body part, cardiac 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 that 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., 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 numeral 20 in FIG. 9A) in 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), which 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 driving 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 catheter 344 is advanced into the vena cava. Catheter 344 also has an extracorporeal proximal portion 349 that may include a handle (e.g., as shown in FIG. 9A ). The distal portion of catheter 344 can be navigated to the anatomical site, such as by being actively steerable (e.g., operably coupled by one or more pull wires to proximal portion 349, 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).

[0285] Tissue anchor 340 can 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. Tissue anchor 340 can have a tissue-engaging element, which can be a helical threaded tissue-engaging element (as described herein) or another type of tissue-engaging element, such as a dart or staple. For some applications, tissue anchor 340 can comprise one or more of the anchors described below, each of which is incorporated by reference in its entirety for all purposes. U.S. Patent Application No. 17 / 145,258 to Kasher et al., filed January 8, 2021, and published as U.S. Patent Application No. 2021 / 012999 Patent Document 2 by Shafigh et al., filed February 9, 2021 Patent Document 3 by Shafigh et al., filed February 8, 2022

[0286] The driving 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 the electrode. The detected signal (e.g., its magnitude) is used to determine the proximity of the tool 324 and / or 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 likelihood 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 so that the tissue engaging portion 340a engages with the tissue of the mitral valve at several positions, detects an electrical signal at each position, and selects the position where an optimal signal (e.g., a signal with a sufficiently low amplitude) is detected for fixation of the tissue anchor 340.

[0289] In some applications, a representation of the electrical signal detected by the driving tool 342 is displayed 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. 8B.

[0290] Once a suitable location sufficiently distant 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 the driving tool screw in the tissue engaging portion 340 a 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 anchored to tissue of valve annulus 28, and third tissue anchor 354 is in the process of being anchored in a manner similar to that described above for first tissue anchor 340. Tissue anchors 352 and 354 are similar in structure to tissue anchor 340 described above and are slidably coupled to 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 should be appreciated that while the description of FIGS. 9A-9C herein is provided with respect to a mitral valve treatment (e.g., annuloplasty), the methods and devices of the teachings herein can be used, with appropriate modifications, during tricuspid valve treatment, for example, by advancing the elongated tube 310 into the right coronary artery and performing the tricuspid valve treatment via the vena cava, as described above with respect to FIGS. 4 and 5A-5L. In some applications, the elongated tube can be advanced into the right coronary artery via a coronary ostium in the aortic root of the aorta of interest. In some applications, elongated tube 310 is long enough 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 coronary vessels or 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 living animal or in a simulation, such as a cadaver, a cadaver heart, a simulator (e.g., a simulated body part, cardiac 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, elongated tube 310 is replaced by wire 410, which typically does not fill the diameter of the coronary vessel or artery. In some applications, 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 those 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 anchor and configured to detect the applied electrical signal. Thus, when the tissue engaging portion 440 a of the first tissue anchor 440 engages the 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 a degree that exceeds a predetermined threshold that indicates a position that is too close to the elongate 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 distant 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 the driving tool screw in the tissue engaging portion 440 a 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 anchored to tissue of valve annulus 28, and third tissue anchor 454 is in the process of being anchored in a manner similar to that described above for first tissue anchor. Tissue anchors 452 and 454 are similar in structure to tissue anchor 440 described above, and are slidably coupled to tether 455 that extends distally from driving tool 442 or distally from second catheter 444.

[0300] 10C shows mitral valve 20 after fixation of the 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 manner similar to that described above with respect to FIGS. 8F-8K.

[0301] 10A-10C herein are provided with respect to mitral valve treatment (e.g., annuloplasty), it should be noted that the methods and devices of the teachings herein can be used, with appropriate modifications, during tricuspid valve treatment, for example, by advancing elongated wire 410 into the right coronary artery and performing tricuspid valve treatment via the vena cava, as described above with respect to FIGS. 4 and 5A-5L. In some applications, elongated wire 410 can be advanced into the right coronary artery via a coronary ostium in the aortic root of a target aorta. In some applications, elongated wire 410 is sufficiently long to extend around at least a majority of the tricuspid valve annulus (see, e.g., FIGS. 4-5L), and 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 some 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., crimp), a spring-loaded element, and / or an actuatable mechanism. For some applications, each of the locks described above can comprise one or more of the locks or stops described below, each of which is incorporated by reference in its entirety for all purposes. U.S. Patent Application No. 16 / 534,875, filed August 7, 2019, and published as U.S. Patent Application No. 2019 / 0129998, by Brauon et al. International Patent Application No. PCT / IB2020 / 060044, filed October 27, 2020, published as PCT International Publication No. PCT / IB2020 / 060044, by Kasher et al. U.S. Patent Application No. 17 / 145,258 to Kasher et al., filed January 8, 2021, and published as U.S. Patent Application No. 2021 / 012999

[0304] The present invention is not limited to what is 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 particular sequential order for convenience of presentation, it should be understood that this method of description encompasses rearrangements unless a particular order is required by specific terminology described above. For example, operations or steps described sequentially may, in some cases, be rearranged or performed simultaneously. Moreover, for simplicity, the accompanying drawings may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Furthermore, terms such as "provide" or "achieve" are sometimes used herein to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations corresponding to these terms may vary depending on the particular 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 end (10a) and the second end (10b) of the tether (10) from the first location (14a) and the second location (14b), respectively, to the 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 a lumen, the support tube (12) configured to be transluminally advanced into the coronary vessel (36), the tether (10) extending through the 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 over and along at least one of the first end (10 a) and the second end (10 b) such that a portion of the tether (10) extends between the at least one tissue anchor (50, 56; 80) and the coronary vessel (36), and to secure the at least one of the first end (10 a) and the second end (10 b) 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. said at least one tissue anchor (50, 56; 80); a first tissue anchor (50) configured to slide over and along the first end (10 a) so that a first portion of the tether (10) extends between the first tissue anchor (50) and the coronary vessel (36) and 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 the second end (10b) so that a second portion of the tether (10) extends between the second tissue anchor (56) and the coronary vessel (36) and to secure the second end (10b) to tissue of the heart chamber in a second configuration, preferably the at least one lock (60, 66; 70) comprises 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) at 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 onto the second end (10b) of the tether (10) and lock the second end (10b) of the tether (10) to a second lock (66) point adjacent to the second tissue anchor (56).

4. the cardiac chamber is the left atrium of the heart and the coronary vessel (36) is the left coronary artery of the subject, preferably the left coronary artery is the subject's left circumflex artery; and / or The system of any one of claims 1 to 3, wherein the tension in the tether is configured to reshape the subject's mitral valve (20).

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 cardiac septum (38) and the subject's vena cava, 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 the subject's femoral vein.

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 withdraw one of the first end (10a) and the second end (10b) through a superior vena cava, and a second device (30) configured to withdraw the other of the first end (10a) and the second end (10b) through an inferior vena cava (36).

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

8. the cardiac chamber is the right atrium of the heart and the coronary vessel (36) is 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 subject's vena cava, 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 the subject's femoral vein.

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 withdraw one of the first end (10a) and the second end (10b) through a superior vena cava, and a second device (30) configured to withdraw 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 3, further comprising a first longitudinal catheter (16) configured to be transluminally advanced into the coronary vessel (36), and the tether (10) configured to be advanced distally from the first longitudinal 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 3, 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. 13. The system of claim 12, further comprising at least one second catheter (32), wherein the at least one device (30) is configured to pull the first end (10a) and the second end (10b) through the at least one second catheter (32).

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

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