Patent Description:
A function of mammalian hearts is based on heart muscle contracting and creating pressure within ventricles of the heart, causing the blood to flow from the ventricles into arteries. The blood from the body returns to atria of the heart via veins. Valves, between each heart atrium and the corresponding heart ventricle, as well as between the heart ventricles and the corresponding arteries, inhibit backflow from occurring. The valves between the atria and the ventricles of the heart are known as the atrioventricular valves. At least in humans, the atrioventricular valve between the left atrium and the left ventricle is known as the mitral valve, and the atrioventricular valve between the right atrium and the right ventricle is known as the tricuspid valve. Each of these valves includes of a plurality of leaflets that coapt with each other when the valve is closed and have a space formed therebetween when the valve is open.

Proper closing of the mitral and tricuspid valves is critical for proper function of the heart, and many medical conditions, some life threatening, result from improper closing of the valves which creates backflow (regurgitation) from the ventricles into the corresponding atria. An annuloplasty procedure may be needed to reshape the annulus of a tricuspid or mitral valve that does not close properly.

<CIT> (US'<NUM>) discloses a coronary sinus ring apparatus, including an elongated body for deployment in a coronary sinus, an aperture in a long side of the body, at least a partial lumen extending from one end of the elongated body to at least the aperture, and a guide within the elongated body positioned and shaped to guide an element inserted along the lumen to the aperture. US'<NUM> also discloses an apparatus for treating a heart, including a delivery tube sized for and adapted for insertion into a body, a sharp tip adapted to be pushed through cardiac muscle, an elongate tensioning element, and a foldable anchor adapted to couple the elongate tension element to cardiac muscle tissue, wherein the delivery tube encloses one or both of the elongate tensioning element and the foldable anchor.

<CIT> discloses an apparatus for reducing mitral regurgitation comprising: a plication assembly comprising a first anchoring element, a second anchoring element, and a linkage construct connecting the first anchoring element to the second anchoring element; and a catheter adapted to deliver the first anchoring element to the coronary sinus.

<CIT> discloses a medical device which comprises a generally cylindrical treatment element for location between a pair of valve leaflets situated between an atrium and a ventricle of a heart.

The claimed invention is defined in independent claim <NUM> and relates to a system for use with a subject. Some preferred configurations of the claimed invention are defined in dependent claims <NUM> to <NUM>. Also described herein are related aspects, examples, embodiments and arrangements useful for understanding the claimed invention, and which do not necessarily constitute embodiments of the claimed invention. The subject-matter for which protection is sought is defined by the claims.

This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure can be included in the examples summarized here.

In accordance with some applications herein, a tether is advanced into a coronary blood vessel or artery, and the two termini, or ends, of the tether are advanced through the wall of the coronary blood vessel or artery into an adjacent chamber of the heart, at two different locations. The termini are drawn out of the heart chamber (as described in more detail hereinbelow), such that, for each of the locations, a segment of the tether extends through the heart chamber, from a respective one of the locations. A tissue anchor is slid over and along at least one of the termini and is anchored to the tissue of the heart chamber, such that a part of the tether extends between the wall of the coronary blood vessel or artery and the tissue anchor. The heart chamber is then reshaped by modifying tension in the tether, e.g., in the part of the tether that extends between the coronary blood 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. For some applications, the chamber is an atrium of the heart, and reshaping the chamber advantageously reshapes and improves the function of the atrioventricular valve disposed between the atrium and the ventricle of the heart that is downstream of the atrium.

There is provided, in accordance with some applications, a method of repairing a heart valve of a heart of a subject. The method includes transluminally advancing a tether into a coronary blood vessel or artery of the heart of the subject. The coronary blood vessel or artery may at least partly circumscribe a heart chamber of the heart.

The method can include advancing a first terminus of the tether through a wall of the coronary blood vessel or artery into the heart chamber at first location. The first terminus of the tether can be transluminally drawn out of the heart chamber such that a first segment of the tether extends from the first location through the heart chamber.

The method can further include advancing a second terminus of the tether, through the wall of the coronary blood vessel or artery, into the heart chamber at a second location. The second terminus of the tether can be transluminally drawn out of the heart chamber such that a second segment of the tether extends from the second location through the heart chamber.

At least one tissue anchor can be slid over and along at least one of the first and second termini and can be anchored to tissue of the heart chamber. As such, a part of the tether extends between the at least one tissue anchor and the coronary blood vessel or artery.

The heart chamber can be reshaped by modifying tension of at least one part of the tether extending between the at least one tissue anchor and the coronary blood vessel or artery, and the tension of the tether can be locked, following the reshaping of the heart chamber.

In some applications, the sliding of the at least one anchor can include sliding one anchor over and along both the first and second termini. In some applications, the locking of the tension in the tether can include locking the tension adjacent the one anchor.

In some applications, the locking of the tension can include locking the first and second termini of the tether using a single lock.

In some applications, the sliding of the at least one anchor can include sliding a first tissue anchor over and along the first terminus and can include anchoring the first tissue anchor to tissue of the heart chamber at a first placement. As such, a first part of the tether extends between the first tissue anchor and the coronary blood vessel or artery.

In some applications, the sliding can further include sliding a second tissue anchor over and along the second terminus and can include anchoring the second tissue anchor to tissue of the heart chamber at a second placement. As such second part of the tether extends between the second tissue anchor and the coronary blood vessel or artery.

In some applications, the locking of the tension can include locking the first and second termini of the tether adjacent the first and second tissue anchors, respectively.

In some applications, the locking of the tension can include locking both the first and second termini of the tether using a single lock.

In some applications, the method can further include, prior to the locking of the tension, sliding the single lock onto the first and second termini of the tether, and along the tether, to a locking point.

In some applications, sliding of the single lock onto the first and second termini of the tether can occur outside the subject's body, and the sliding of the single lock along the tether can occur, at least partially, transluminally.

In some applications, modifying of tension in the tether can include locking one of the first and second termini adjacent a corresponding one of the first and second tissue anchors; and pulling the other one of the first and second termini.

In some applications, the locking of the tension can include locking the other one of the first and second termini adjacent a corresponding other one of the first and second tissue anchors.

In some applications, the modifying of the tension in the tether can include pulling on the first and second termini of the tether, and subsequently locking the first terminus of the tether adjacent the first tissue anchor and the second terminus of the tether adjacent the second tissue anchor.

In some applications, the heart chamber is a left atrium of the heart, and the coronary blood vessel or artery is a left coronary artery of the subject.

In some applications, the left coronary artery is a left circumflex artery of the subject.

In some applications, the reshaping of the heart chamber includes reshaping of a mitral valve of the subject.

In some applications, at least one of the transluminally drawing the first terminus and the transluminally drawing the second terminus includes drawing the first and the second termini through at least one of an interspatial septum of the heart and a vena cava of the subject.

In some applications, the vena cava is a superior vena cava.

In some applications, the vena cava is an inferior vena cava, and the drawing of at least one of the first terminus and the second terminus may further be through a femoral vein of the subject.

In some applications, the first and second termini are both drawn through one of the superior vena cava and the inferior vena cava.

In some applications, one of the first and second termini is drawn through the superior vena cava, and the other of the first and second termini is drawn through the inferior vena cava.

In some applications, the advancing of the tether into the coronary blood vessel or artery is through a femoral artery and an aorta of the subject.

In some applications, the heart chamber is a right atrium of the heart, and the coronary blood vessel or artery is a right coronary artery of the subject.

In some applications, the reshaping of the heart chamber includes reshaping of a tricuspid valve of the subject.

In some applications, at least one of the transluminally drawing the first terminus and the transluminally drawing the second terminus includes drawing at least one of the first and the second termini through a vena cava of the subject.

In some applications, the vena cava is an inferior vena cava, and the drawing of at least one of the first terminus and the second terminus can further be through a femoral vein of the subject.

In some applications, one of the first and second termini is drawn through the superior vena cava, and the other of the first and second termini is drawn through the inferior vena cava.

In some applications, the drawing of the first terminus and the drawing of the second terminus includes drawing the first and second termini out of the subject's body. In some applications, the sliding of the at least one anchor onto the at least one of the first and second termini of the tether occurs outside of the subject's body, and the sliding of the at least one anchor along the tether causes the at least one anchor to be delivered into the subject's body.

In some applications, the drawing of the first terminus and the drawing of the second terminus includes drawing the first and second termini out of the heart chamber within the subject's body. In some applications, the sliding of the at least one anchor onto the at least one of the first and second termini of the tether and along the tether occurs within the subject's body.

In some applications, at least one of the drawing of the first terminus and the drawing of the second terminus can be accomplished using a snare.

In some applications, the drawing of the first terminus and the drawing of the second terminus are each accomplished using a snare.

In some applications, the snare used for drawing the first terminus and the snare used for drawing of the second terminus are the same snare.

In some applications, the method can further include, prior to at least one of the drawing of the first terminus and the drawing of the second terminus, transluminally advancing the snare, out of a catheter, to the heart chamber.

In some applications, at least one of the drawing of the first terminus and the drawing of the second terminus can be through the catheter.

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

In some applications, the transluminally advancing of the support tube can be carried out prior to the advancing of the first terminus of the tether through the wall of the coronary blood vessel or artery into the heart chamber.

In some applications, the transluminally advancing of the support tube can be carried out following the advancing of the first terminus of the tether through the wall of the coronary blood vessel or artery into the heart chamber, and prior to the advancing of the second terminus of the tether through the wall of the coronary blood vessel or artery into the heart chamber.

The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc..

There is further provided, in accordance with claim <NUM>, a system for use with a subject. The system includes a tether configured to be transluminally advanced into a coronary blood vessel or artery of the heart of the subject. The coronary blood vessel or artery at least partially transcribing a heart chamber of the heart. The tether has a first terminus and a second terminus, the first terminus configured to be advanced through a wall of the coronary blood vessel or artery into the heart chamber at a first location and the second terminus configured to be advanced through the wall of the coronary blood vessel or artery into the heart chamber at a second location.

As defined in claim <NUM>, the system further includes at least one device configured to transluminally draw the first and second termini of the tether, from the first and second locations, respectively, out of the heart chamber. As such, a first segment of the tether extends from the first location through the heart chamber and a second segment of the tether extends from the second location through the heart chamber.

As defined in claim <NUM>, the system further includes a support tube defining a lumen, the support tube being configured to be transluminally advanced into the coronary blood vessel or artery. The tether extends through the lumen of the support tube and being slidable relative to the support tube.

As defined in claim <NUM>, the system further includes at least one tissue anchor, configured to be slid over and along at least one of the first and second termini, and to anchor the at least one of the first and second termini to tissue of the heart chamber, such that a part of the tether extends between the at least one tissue anchor and the coronary blood vessel or artery.

As defined in claim <NUM>, the system further includes at least one lock, configured, following tensioning of the tether, to lock tension in the tether.

In some applications, the at least one tissue anchor can include a single tissue anchor, configured to be slid over and along both the first and second termini, and to anchor the first and second termini to tissue of the heart chamber, such that two parts of the tether extend between the tissue anchor and the coronary blood vessel or artery.

In some applications, the at least one lock can include a single lock configured to lock the first and second termini of the tether adjacent the single tissue anchor.

In some applications, the at least one tissue anchor can include a first tissue anchor configured to be slid over and along the first terminus and to anchor the first terminus to tissue of the heart chamber at a first placement, such that a first part of the tether extends between the first tissue anchor and the coronary blood vessel or artery. In some applications, a second tissue anchor can be configured to be slid over and along the second terminus and to anchor the second terminus to tissue of the heart chamber at a second placement, such that a second part of the tether extends between the second tissue anchor and the coronary blood vessel or artery.

In some applications, the at least one lock includes a single lock configured to be slid onto the first and second termini of the tether and to lock the first and second termini of the tether to a locking point adjacent one of the first and second tissue anchors.

In some applications, the at least one lock can include a first lock configured to be slid onto the first terminus of the tether and to lock the first terminus of the tether to a first locking point adjacent the first tissue anchor, and a second lock configured to be slid onto the second terminus of the tether and to lock the second terminus of the tether to a second locking point adjacent the second tissue anchor.

In some applications, the tension in the tether is configured to reshape a mitral valve of the subject.

In some applications, the at least one device is configured to draw at least one of the first and second termini through at least one of an interspatial septum of the heart and a vena cava of the subject.

In some applications, the vena cava is an inferior vena cava, and the at least one device can be configured to draw at least one of the first terminus and the second terminus further through a femoral vein of the subject.

In some applications, the at least one device is configured to draw the first and second termini through one of the superior vena cava and the inferior vena cava.

In some applications, the at least one device includes a first device configured to draw one of the first and second termini through the superior vena cava, and a second device configured to draw the other of the first and second termini through the inferior vena cava.

In some applications, the tether is configured to be advanced into the coronary blood vessel or artery through a femoral artery and an aorta of the subject.

In some applications, the tension in the tether is configured to reshape a tricuspid valve of the subject.

In some applications, the at least one device is configured to draw at least one of the first and second termini through a vena cava of the subject.

In some applications, the vena cava is an inferior vena cava, and the at least one device can be configured to draw at least one of the first and second termini further through a femoral vein of the subject.

In some applications, the at least one device includes a first device configured to draw one of the first and second termini through the superior vena cava, and a second device configured to draw the other of the first and second termini through the inferior vena cava.

In some applications, the system can further include a first longitudinal catheter configured to be transluminally advanced to the coronary blood vessel or artery. The tether can be configured to be advanced to the coronary blood vessel or artery distally out of the first catheter.

In some applications, the at least one device includes at least one snare.

In some applications, the at least one snare includes a single snare configured to draw the first and second termini.

In some applications, the at least one snare includes a first snare configured to draw the first terminus and a second snare configured to draw the second terminus.

In some applications, the at least one snare is configured to be transluminally advanced out of a catheter, to the heart chamber, prior to at least one of the drawing of the first terminus and the drawing of the second terminus.

In some applications, the system can further include at least one second catheter. The at least one device can be configured to draw the first and second termini through the at least one second catheter.

In some applications, the support tube is configured to be advanced into the coronary blood vessel or artery distally out of the first catheter.

In accordance with a second aspect of the teachings herein, methods and devices are provided to protect a coronary blood vessel or artery of the heart of a subject during a medical procedure in the heart of the subject. A compressed structure, comprising a radiopaque material, is expanded within the coronary blood vessel or artery into an elongate structure. The elongate structure is visible using fluoroscopic imaging. The medical procedure can include anchoring of a tissue anchor within the heart chamber adjacent the coronary blood vessel or artery in which the elongate structure is disposed. The heart is imaged using fluoroscopic tools, such that the elongate structure is visible. The location for anchoring of the tissue anchor is selected, based on the obtained image(s), to avoid damage to the coronary blood vessel or artery during the anchoring. For some applications, the elongate structure is retained in the coronary blood vessel or artery while the anchoring is performed, and the anchoring can be performed under real-time fluoroscopic guidance, aided by the visibility of the elongate structure.

In some cases, the elongate structure comprises an electrically conductive material, and an electrical signal (e.g., a voltage) is applied, by a control subsystem, between the elongate structure and the anchor and/or an anchor driver that is delivering 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, audible, or haptic signal is provided to indicate the proximity and/or contact between the anchor and the elongate structure. For some applications, a different elongate structure (e.g., an elongate structure that is not expandable and/or does not comprise a radiopaque material) is used in a similar manner.

There is further provided, in accordance with some applications, a method of avoiding damage to a coronary blood vessel or artery of a heart of a subject during a medical procedure, the coronary blood vessel or artery being adjacent to a heart chamber of the heart. The method includes, within the coronary blood vessel or artery, expanding a compressed elongate tube that includes a radiopaque material.

The method can further include anchoring a tissue anchor within the heart chamber adjacent the coronary blood vessel or artery.

In some applications, placement of the tissue anchor during the anchoring can be selected, based on at least one fluoroscopic image that includes the elongate tube, to avoid damaging the coronary blood vessel or artery during the anchoring.

In some applications, the method can further include, prior to the expanding, transluminally advancing the compressed elongate tube to the coronary blood vessel or artery.

In some applications, the method can further include, following the anchoring of the tissue anchor, transluminally removing the elongate tube from the coronary blood vessel or artery.

In some applications, the transluminally removing can include recompressing the elongate tube, and transluminally removing the compressed elongate tube from the coronary blood vessel or artery.

In some applications, the anchoring is into an annulus of a mitral valve of the subject.

In some applications, the elongate tube is sufficiently long to extend around at least majority of the annulus of the mitral valve.

In some applications, the advancing of the compressed elongate tube into the coronary blood vessel or artery is through a femoral artery and an aorta of the subject.

In some applications, the anchoring is into an annulus of a tricuspid valve of the subject.

In some applications, the elongate tube is sufficiently long to extend around at least majority of the annulus of the tricuspid valve.

In some applications, the advancing of the compressed elongate tube into the coronary blood vessel or artery is through a coronary ostia at an aortic root of the subject.

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

In some applications, the elongate tube includes a metal frame or a mesh frame.

In some applications, the expanding can include retracting an external sheath from the compressed elongate tube, thereby allowing the elongate tube to expand.

In some applications, the expanding can include pulling one end of the elongate tube away from the opposing end of the elongate tube.

In some applications, the method can further include, prior to the expanding, transluminally advancing a pulling element to the distal end of the elongate tube, within the coronary blood vessel or artery.

In some applications, during the anchoring, the body of the subject is devoid of contrast agents.

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

In some applications, the method can further include, during the anchoring, monitoring for a detectable signal indicative of contact between the tissue anchor and the elongate tube.

In some applications, the method can further include, in response to identification of the detectable signal, repositioning the tissue anchor in another location.

There is further provided, in accordance with some applications, a system for use with a subject. The system can include an elongate tube including a radiopaque and electrically conductive material. The elongate tube can be configured to be transluminally advanced into a coronary blood vessel or artery in a heart of the subject, in a compressed state, and expanded within the coronary blood vessel or artery.

The system can further include a tissue anchor configured to be anchored within a heart chamber of the subject, adjacent the coronary blood vessel or artery.

The system can further include at least one fluoroscopic image capturing device, configured to capture at least one fluoroscopic image during anchoring of the tissue anchor within the heart chamber. In some applications, the at least one fluoroscopic image includes the elongate tube.

The system can further include an anchor driver, which can be mechanically and electrically coupled to the tissue anchor.

A control subsystem can be configured to generate a detectable signal when the tissue anchor contacts the elongate tube.

In some applications, the at least one fluoroscopic image is configured to assist an operator in avoiding damaging the coronary blood vessel or artery during anchoring of the tissue anchor.

In some applications, the elongate tube is a compressible elongate tube having a compressed operative orientation and an expanded operative orientation. In some applications, the elongate tube can be configured to be advanced into the coronary blood vessel or artery when in the compressed operative orientation.

In some applications, the elongate tube can further be configured to be transluminally removed from the coronary blood vessel or artery, following the anchoring of the tissue anchor.

In some applications, the tissue anchor can be configured to be anchored into an annulus of a mitral valve of the subject.

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

In some applications, the tissue anchor is configured to be anchored into an annulus of a tricuspid valve of the subject.

In some applications, the elongate tube is configured to be advanced into the coronary blood vessel or artery is through a coronary ostia at an aortic root of the subject.

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

In some applications, the elongate tube can further include an external sheath adapted to hold the elongate tube in the compressed operative orientation.

In some applications, the system can further include a pulling element configured to pull a distal end of the elongate tube distally with respect to a proximal end of the elongate tube, when the elongate tube is in the compressed operative orientation, thereby to expand the elongate tube.

There is further provided, in accordance with some applications, a method of avoiding damage to a coronary blood vessel or artery of a heart of a subject during a medical procedure, the coronary blood vessel or artery being adjacent to a heart chamber of the heart. The method includes advancing an elongate structural element into the coronary blood vessel or artery, the elongate structural element being configured to emit an electrical signal.

The method can further include causing elongate structural element to emit an electrical signal within the coronary blood vessel or artery, and can include, using an anchor driver driving a tissue anchor, detecting the electrical signal adjacent the anchor driver.

In some applications, the method can further include anchoring the tissue anchor within the heart chamber adjacent the coronary blood vessel or artery, at an anchoring position at which the electrical signal detected by the anchor driver is below a predetermined threshold, thereby to avoid damaging the coronary blood vessel or artery during the anchoring.

In some applications, the anchoring includes anchoring the tissue anchor at an anchoring position at which the electrical signal detected by the anchor driver is an optimal electrical signal.

In some applications, the elongate structural element includes an elongate wire.

In some applications, the elongate structural element includes an elongate tube.

In some applications, the method can further include transluminally advancing the elongate tube, in a compressed position, to the coronary blood vessel or artery, and expanding the elongate tube in the coronary blood vessel or artery.

In some applications, the method can further include, following the anchoring of the tissue anchor, transluminally removing the elongate structural element from the coronary blood vessel or artery.

In some applications, the elongate structural element is sufficiently long to extend around at least majority of the annulus of the mitral valve.

In some applications, the advancing of elongate structural element into the coronary blood vessel or artery is through a femoral artery and an aorta of the subject.

In some applications, the elongate structural element is sufficiently long to extend around at least majority of the annulus of the tricuspid valve.

In some applications, the advancing of the elongate structural element into the coronary blood vessel or artery is through a coronary ostia at an aortic root of the subject.

There is further provided, in accordance with some applications, a system for use with a subject, the system including an elongate structural element formed of an electrical signal emitting material. In some applications, the elongate structure is configured to be transluminally advanced into a coronary blood vessel or artery in a heart of the subject and to emit an electrical signal within the coronary blood vessel or artery.

In some applications, the system further includes an anchor driver, which can be mechanically and electrically coupled to the tissue anchor, the anchor driver being configured to detect an electrical signal adjacent the anchor driver.

In some applications, the anchor driver is configured to anchor the tissue anchor to tissue of the heart chamber at an anchoring position at which the electrical signal detected by the anchor driver is below a predetermined threshold, thereby to avoid damaging the coronary blood vessel or artery during anchoring of the tissue anchor.

In some applications, the anchor driver is configured to anchor the tissue anchor at an anchoring position at which the electrical signal detected by the anchor driver is a minimum electrical signal.

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

In some applications, the tissue anchor is configured to be anchored into an annulus of a mitral valve of the subject.

In some applications, the elongate structural element is configured to be advanced into the coronary blood vessel or artery through a femoral artery and an aorta of the subject.

In some applications, the elongate structural element is configured to be advanced into the coronary blood vessel or artery through a coronary ostia at an aortic root of the subject.

The foregoing discussion will be understood more readily from the following detailed description, when taken in conjunction with the accompanying Figures, in which:.

The invention relates to a system as illustrated in <FIG>.

It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention is defined by the appended claims.

In the following description, various aspects of the disclosure will be described. For the purpose of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the different aspects of the disclosure. However, it will also be apparent to one skilled in the art that the disclosure may be practiced without specific details being presented herein. Furthermore, well-known features may be omitted or simplified in order not to obscure the disclosure. Additionally, in order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some elements may not be explicitly identified in every drawing that contains that element.

It is to be understood that the scope of the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. Furthermore, it is to be understood that the phraseology and terminology employed in the disclosure is for the purpose of description and should not be regarded as limiting.

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

Referring now to the drawings, <FIG> is a schematic illustration of an example device according to an aspect of the teachings herein being delivered through the aorta of a subject into a coronary blood vessel, in this example a left coronary artery (although various other blood vessels are also possible), of the heart of the subject, according to an example method. The method can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc..

As seen in <FIG>, a device according to the teachings herein includes a tether <NUM>, which is surrounded by a support tube <NUM> and is slidable relative to the support tube. Tether <NUM> can be formed of any suitable material, such as metal, polymer, biomaterial wire, ribbon, or cord. Support tube <NUM> is typically flexible.

For treatment of the mitral valve (see reference numeral <NUM> in <FIG>) of the subject, which is located between the left atrium and the left ventricle of the heart, tether <NUM> and support tube <NUM> are transluminally advanced into a coronary blood vessel, in this example a left coronary artery <NUM>, which at least partially circumscribes the mitral valve (see for example <FIG>). For some applications, and as shown in <FIG>, a catheter <NUM> delivers tether <NUM> and support tube <NUM> via aorta <NUM> (e.g., transfemorally) and into left coronary artery <NUM>. In some applications, the left coronary artery may be or include the left circumflex artery of the heart of the subject.

In the illustrated example, a distal part of catheter <NUM> is advanced to the left coronary artery. Catheter <NUM> also has an extracorporeal proximal part <NUM> that can comprise a handle (e.g., as shown in <FIG>). The distal part of catheter <NUM> is guidable to the anatomical site, such as by being actively steerable (e.g., by being operatively coupled by one or more pullwires to proximal part <NUM>, such as to a steering controller thereof), or by being passively guided and/or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter).

Reference is now made to <FIG>, which are schematic sectional view illustrations of steps of a method of treatment of mitral valve <NUM> of the heart of the subject using the device of <FIG>, in accordance with some applications of the teachings herein. For example, the treatment of the mitral valve can be or include annuloplasty of the mitral valve. The method can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc..

As seen in <FIG>, catheter <NUM> is used to advance tether <NUM>, and typically support tube <NUM>, via aorta <NUM> into left coronary artery <NUM>, as described hereinabove with respect to <FIG>. As seen in the sectional portion of <FIG>, left coronary artery <NUM> at least partially circumscribes the mitral valve <NUM> of the subject's heart (e.g., is disposed alongside an annulus <NUM> of the mitral valve). As seen, leaflets <NUM> and <NUM> of the mitral valve do not fully coapt, such that a gap <NUM> is formed therebetween. The treatment (e.g., annuloplasty) procedure described herein reshapes the mitral valve <NUM> (e.g., annulus <NUM>), such that the leaflets <NUM> and <NUM> coapt and gap <NUM> is reduced or eliminated (see the end result in <FIG>).

Turning to <FIG>, 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 at a first puncture location 14a, and a first terminus 10a of tether <NUM> is advanced into the atrium.

In some applications, tether <NUM> is advanced into left coronary artery <NUM> as shown in <FIG>, without support tube <NUM>. In some applications, following advancement of first terminus 10a of tether <NUM> into the left atrium, support tube <NUM> can be advanced onto, and around, the tether.

As seen in <FIG>, a snare tool <NUM>, having a snare <NUM> at a distal part thereof, is transluminally introduced into the left atrium of the heart, and engages first terminus 10a of tether <NUM>. In some applications, snare tool <NUM> is transluminally advanced into the left atrium using a second catheter <NUM>. For example, snare tool <NUM> can be a component of second catheter <NUM> or can be a discrete device that is introduced via second catheter <NUM>.

In some applications, and as shown, snare tool <NUM> is introduced into the left atrium through an inferior vena cava <NUM> (e.g., transfemorally) and through an opening in the interspatial septum <NUM> of the heart of the subject. In some applications, introduction of the snare tool can be via the superior vena cava.

In the illustrated example, a distal part of catheter <NUM> is advanced through the vena cava. Catheter <NUM> also has an extracorporeal proximal part <NUM> (e.g., as shown in <FIG>). The distal part of catheter <NUM> is guidable to the anatomical site, such as by being actively steerable (e.g., by being operatively coupled by one or more pullwires to proximal part <NUM>, such as to a steering controller thereof), or by being passively guided and/or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter).

Snare <NUM> is then used to draw first terminus 10a of the tether out of the left atrium, e.g., as described in more detail hereinbelow, such that a first segment <NUM> of the tether extends from puncture location 14a across the left atrium, as seen in <FIG>. In some applications, first terminus 10a is drawn through catheter <NUM> (e.g., by withdrawing snare tool <NUM> through the catheter), as shown in <FIG>.

In some applications, and as shown, snare <NUM> draws first terminus 10a from the left atrium through the opening in the interspatial septum <NUM> and through inferior vena cava <NUM> of the subject. In some applications, withdrawal can be via the superior vena cava.

As explained in further detail hereinbelow, in some applications of the step shown in <FIG>, first terminus 10a of tether <NUM> is drawn fully out of the subject's body. In some applications of the step shown in <FIG>, first terminus 10a is drawn out of the left atrium, but remains within the subject's body.

Turning to <FIG>, a second hole is punctured through the wall of the left coronary artery into the left atrium of the heart at a second location 14b, and a second terminus 10b of the tether is advanced into the atrium. As seen, support tube <NUM> can be disposed between first location 14a and second location 14b - e.g., can extend between the first and second locations, terminating at each of the first and second locations.

In some applications, such as the example illustrated in <FIG>, first location 14a and second location 14b are selected to be near ends of gap <NUM> between leaflets <NUM> and <NUM>.

As seen in <FIG>, a snare tool, which can be snare tool <NUM> of <FIG> or can be a second snare tool, is transluminally introduced into the left atrium of the heart and engages second terminus 10b of the tether. The snare tool can be transluminally advanced into the left atrium via second catheter <NUM> (e.g., as described with respect to <FIG>, mutatis mutandis), or out of another, third, catheter.

Snare <NUM> of snare tool <NUM> (or another snare of another snare tool) is then used to draw second terminus 10b of the tether out of the left atrium, such that a second segment <NUM> of the tether extends from second puncture location 14b across the left atrium, as seen in <FIG>.

In some applications, and as shown, snare <NUM> of snare tool <NUM> (or another snare of another snare tool) draws second terminus 10b from the left atrium through the opening in interspatial septum <NUM> of the heart and through inferior vena cava <NUM> of the subject. In some applications, withdrawal can be via the superior vena cava.

In some applications, for example when the same snare and catheter are used for drawing both the first and second termini of tether <NUM>, the first and second termini are both drawn from the heart chamber, or the left atrium, via the same route, i.e., via the same one of the superior and inferior vena cava. As shown in <FIG>, for some applications, tether <NUM> forms a loop from catheter <NUM>, across the left atrium, into and along left coronary artery <NUM>, back through the atrium, and into the catheter. This loop includes (i) segment <NUM> extending from catheter <NUM> across the atrium to location 14a, (ii) a bight 10c of tether <NUM> extending between location 14a and location 14b (e.g., within support tube <NUM>), and (iii) segment <NUM> extending from location 14b back through the atrium and into the catheter.

In some applications, for example when snare tool <NUM> is used to draw first terminus 10a through catheter <NUM>, and a separate snare is used to draw second terminus 10b through a separate catheter, each of the termini of tether <NUM> can be drawn out of the left atrium using a different route. For example, first terminus 10a may be drawn through the superior vena cava, while second terminus 10b may be drawn through the inferior vena cava.

As explained in further detail hereinbelow, in some applications of the step shown in <FIG>, second terminus 10b of tether <NUM> is drawn fully out of the subject's body. In some applications of the step shown in <FIG>, second terminus 10b is drawn out of the left atrium but remains within the subject's body. In some applications, the first and second termini of tether <NUM> are drawn out of the left atrium to the same extent (i.e., both are pulled fully out of the subject's body, or both are pulled out of the left atrium but remain in the subject's body).

In some applications, once both termini of tether <NUM> are drawn from the left atrium, catheter <NUM> can be removed from left coronary artery <NUM>, for example by retraction of the catheter in the direction of arrow <NUM>, through aorta <NUM>.

Turning to <FIG>, a first tissue anchor <NUM>, e.g., driven by a driving tool <NUM>, is slid over and along first terminus 10a toward first segment <NUM>. First tissue anchor <NUM> is anchored into tissue of the left atrium, for example into annulus <NUM>, such that first segment <NUM> now extends between left coronary artery <NUM> and first tissue anchor <NUM>, as seen in <FIG>. First tissue anchor <NUM> can be anchored across mitral valve <NUM> from left coronary artery <NUM> (e.g., from support tube <NUM>), such as at an anterior region of the left atrium, e.g., in proximity to the root of anterior leaflet <NUM> or a commissure at which the anterior leaflet meets posterior leaflet <NUM>. At this stage, first segment <NUM> may be slack.

As seen in <FIG>, a second tissue anchor <NUM> is slid over and along second terminus 10b toward second segment <NUM>. Second tissue anchor <NUM> is anchored into tissue of the left atrium, for example into annulus <NUM>, such that second segment <NUM> now extends between left coronary artery <NUM> and the second tissue anchor. Second tissue anchor <NUM> can be anchored across mitral valve <NUM> from left coronary artery <NUM> (e.g., from support tube <NUM>), such as at an anterior region of the left atrium, e.g., in proximity to the root of anterior leaflet <NUM> or a commissure at which the anterior leaflet meets posterior leaflet <NUM>. At this stage, second segment <NUM> may be slack. Second tissue anchor <NUM> can be driven by driving tool <NUM>, or by another anchor driving tool.

Each of anchors <NUM> and <NUM> can include a head that is slidably couplable to tether <NUM>, e.g., by the head comprising an eyelet that is threadable onto the tether. Each of anchors <NUM> and <NUM> can include a tissue-engaging element, which can be a helical screw-in tissue-engaging element (as described herein) or can be another type of tissue-engaging element, such as a dart or a staple. For some applications, each of anchors <NUM> and <NUM> can comprise an anchor described in one or more of the following:.

Driving tool <NUM> can be advanced via second catheter <NUM> (e.g., as shown in <FIG>), or via another catheter. In some applications, and as shown, driving tool <NUM> is rotatable, and anchors the tissue anchor(s) by screwing the tissue anchor(s) into the tissue of annulus <NUM>. Following anchoring of tissue anchors <NUM> and <NUM>, driving tool <NUM> (and, if one is used, another driving tool) can be retracted from the left atrium, for example via second catheter <NUM>.

Turning to <FIG>, the tension in tether <NUM> is modified (e.g., tension is applied to the tether). In some applications, this is done by pulling on one or both of termini 10a and 10b. This pulling is indicated by arrows <NUM>. Tensioning may be facilitated by one or more transluminally introduced tools <NUM> that can, for example, provide an opposing force against anchors <NUM> and <NUM>. The application of tension to tether <NUM> may pull support tube <NUM> against the wall of left coronary artery <NUM> that is closest to the atrium (e.g., such that the tube presses against the annulus and/or atrium).

Modification of the tension in tether <NUM> causes reshaping of the mitral valve <NUM>, for example in the direction of arrows <NUM>, so as to close the gap <NUM>. As shown in <FIG>, the reshaping of the mitral valve improves coaptation between leaflets <NUM> and <NUM> of the valve, thereby reducing (e.g., closing) gap <NUM>.

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

Following modification to the tension of the tether and reshaping of the valve, the tension in the tether is locked. In the example illustrated in <FIG>, a first lock <NUM> (which can optionally be referred to as a stopper) is slid along first terminus 10a of tether <NUM> and is locked to the tether, often in proximity to first anchor <NUM>. A second lock <NUM> is slid along second terminus 10b of tether <NUM>, and is locked to the tether, often in proximity to second anchor <NUM>. Locks <NUM> and <NUM> can lock the tension in tether <NUM> by inhibiting the tether (e.g., termini 10a and 10b) from sliding past anchors <NUM> and <NUM>, e.g., by the locks abutting the anchors. For some applications, lock <NUM> has one or more features described in <CIT>, which published as <CIT>.

In some applications, excess tether is then cut and removed from the left atrium, for example by retraction of catheter <NUM>. The advancement of locks <NUM> and <NUM>, and the cutting of excess tether, can be performed using tools <NUM>.

In some applications, the modification of the tension in tether <NUM> can be accomplished by pulling on both termini 10a and 10b. In some applications, the modification of the tension in tether <NUM> can be accomplished by initially locking one of termini 10a and 10b adjacent the respective one of tissue anchors <NUM> and <NUM>, and subsequently pulling on the other one of termini 10a and 10b to modify the tension in the tether. Once the desired tension of the tether is achieved, the other of termini 10a and 10b is locked adjacent the respective one of tissue anchors <NUM> and <NUM>. For example, first terminus 10a can be locked adjacent tissue anchor <NUM>, following which an end user or physician can pull on terminus 10b to change the tension in the tether, and then locks second terminus 10b adjacent second tissue anchor <NUM>.

In applications in which the termini 10a and 10b of the tether are drawn out of the user's body, as described hereinabove, the tissue anchors <NUM> and <NUM>, as well as locks <NUM> and <NUM>, can be slid onto the termini of the tether extracorporeally. In some applications, in which the termini 10a and 10b of the tether remain within the user's body until after the excess tether has been cut, tissue anchors <NUM> and <NUM> and locks <NUM> and <NUM> can be slid onto the termini intracorporeally (e.g., transluminally).

<FIG> and <FIG> are schematic sectional view illustrations of alternative implementations of the method of <FIG>, in accordance with some applications of the teachings herein. The method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc..

<FIG> demonstrates a method similar to that described hereinabove with respect to <FIG>. However, the example of <FIG> differs from the method previously described in the locking step of <FIG>. In the example of <FIG>, a single lock <NUM> is locked to both termini of the tether, e.g., in proximity to one of the tissue anchors, here shown as tissue anchor <NUM>. In some applications, during or following tensioning of tether <NUM>, second terminus 10b of the tether is drawn around or through second tissue anchor <NUM> to first tissue anchor <NUM>, resulting in a segment <NUM> of the tether extending between the first and second tissue anchors. Lock <NUM> is then slid onto and along both termini of tether <NUM>, to lock the termini adjacent first tissue anchor <NUM>. As described hereinabove, following locking of the tension in the tether, excess tether can be cut and removed. In some applications, second terminus 10b may not be brought to anchor <NUM>, but instead lock <NUM> may be slid over and along both termini to a location partway between anchors <NUM> and <NUM>, such that the termini converge at the lock partway between the anchors, and the lock locks the tension in tether <NUM> by being locked to both termini in this position.

<FIG> demonstrates another method similar to that described hereinabove with respect to <FIG>. However, the example of <FIG> differs from the method previously described in the anchoring and locking steps of <FIG>. In the example of <FIG>, a single tissue anchor replaces the first and second tissue anchors <NUM> and <NUM> of <FIG>. Specifically, a single tissue anchor <NUM> is slid over and along both termini of tether <NUM>, and is anchored into tissue of the left atrium, for example into annulus <NUM>, such that a first segment <NUM> and a second segment <NUM> of tether <NUM> extend from locations 14a and 14b, respectively, and across the atrium to converge at tissue anchor <NUM>. Tissue anchor <NUM> can be driven by a driving tool, for example out of a catheter, substantially as described hereinabove with respect to driving tool <NUM>.

Subsequently, the tension in tether <NUM> is modified substantially as described hereinabove, and the tension is locked using a lock <NUM> that is slid over and along the termini of the tether and is locked to the tether. As described hereinabove, following locking of the tension in the tether, the remainder of the tether can be snipped and removed.

<FIG> is a schematic illustration of an example device according to an aspect of the teachings herein being delivered through the aorta of a subject into a coronary blood vessel, in this example a right coronary artery, of the heart of the subject, according to an example method. The method can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc..

For treatment of the tricuspid valve (see reference numeral <NUM> in <FIG>) of the subject, which is located between the right atrium and the right ventricle of the heart, tether <NUM> and support tube <NUM> are transluminally advanced into a right coronary artery <NUM> which at least partially circumscribes the tricuspid valve (see for example <FIG>). For some applications, and as shown in <FIG>, a catheter <NUM> delivers tether <NUM> and support tube <NUM> via aorta <NUM> (e.g., transfemorally) and into right coronary artery <NUM>.

In the illustrated example, a distal part of catheter <NUM> is advanced to the right coronary artery. Catheter <NUM> also has an extracorporeal proximal part <NUM> (e.g., as shown in <FIG>). The distal part of catheter <NUM> is guidable to the anatomical site, such as by being actively steerable (e.g., by being operatively coupled by one or more pullwires to proximal part <NUM>, such as to a steering controller thereof), or by being passively guided and/or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter).

Reference is now made to <FIG>, which are schematic sectional view illustrations of steps of a method of treatment of tricuspid valve <NUM> of the heart of the subject using the device of <FIG>, in accordance with some applications of the teachings herein. For example, the treatment of the tricuspid valve may be or include annuloplasty of the tricuspid valve. The method can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc..

As seen in <FIG>, catheter <NUM> is used to advanced tether <NUM>, and typically support tube <NUM>, via aorta <NUM> into right coronary artery <NUM>, as described hereinabove with respect to <FIG>. As seen in the sectional portion of <FIG>, right coronary artery <NUM> at least partially circumscribes the tricuspid valve <NUM> of the subject's heart (e.g., is disposed alongside the annulus of the tricuspid valve). As seen, leaflets <NUM>, <NUM>, and <NUM> of the tricuspid valve <NUM> do not fully coapt, such that a gap <NUM> is formed therebetween. The treatment (e.g., annuloplasty) procedure described herein reshapes the tricuspid valve <NUM>, such that the leaflets <NUM>, <NUM>, and <NUM> coapt and gap <NUM> is reduced or eliminated (see the end result in <FIG>). Tricuspid valve <NUM> includes an annulus <NUM>, surrounding leaflets <NUM>, <NUM>, and <NUM>.

Turning to <FIG>, 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 at a first location 114a, and a first terminus 110a of tether <NUM> is advanced into the atrium.

In some applications, tether <NUM> is advanced into right coronary artery <NUM> as shown in <FIG>, without support tube <NUM>. In some applications, following advancement of first terminus 110a of tether <NUM> into the right atrium, support tube <NUM> can be advanced onto, and around, the tether.

As seen in <FIG>, a snare tool <NUM> terminating in a snare <NUM> is transluminally introduced into the right atrium of the heart and engages first terminus 10a of tether <NUM>. In some applications, snare tool <NUM> is transluminally advanced into the right atrium using a second catheter <NUM>. For example, snare tool <NUM> can be a component of second catheter <NUM> or can be a discrete device that is introduced via second catheter <NUM>.

In some applications, and as shown, snare tool <NUM> is introduced into the right atrium through inferior vena cava <NUM> of the subject (e.g., transfemorally). In some applications, introduction of the snare tool can be via the superior vena cava.

In the illustrated example, a distal part of catheter <NUM> is advanced to the vena cava. Catheter <NUM> also has an extracorporeal proximal part <NUM> (e.g., as shown in <FIG>). The distal part of catheter <NUM> is guidable to the anatomical site, such as by being actively steerable (e.g., by being operatively coupled by one or more pullwires to proximal part <NUM>, such as to a steering controller thereof), or by being passively guided and/or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter).

Snare <NUM> is then used to draw first terminus 110a of the tether out of the right atrium, such that a first segment <NUM> of the tether extends from puncture location 114a across the right atrium, as seen in <FIG>. In some applications, first terminus 110a is drawn through catheter <NUM>, (e.g., by withdrawing snare tool <NUM> through the catheter) as shown in <FIG>.

In some applications, and as shown, snare <NUM> draws first terminus 110a from the right atrium through inferior vena cava <NUM> of the subject. In some applications, withdrawal can be via the superior vena cava.

As explained in further detail hereinbelow, in some applications of the step shown in <FIG>, first terminus 110a of tether <NUM> is drawn fully out of the subject's body. In some applications of the step shown in <FIG>, first terminus 110a is drawn out of the right atrium, but remains within the subject's body.

Turning to <FIG>, a second hole is punctured through the wall of the right coronary artery into the right atrium of the heart at a second location 114b, and a second terminus 110b of the tether is advanced into the atrium. As seen, support tube <NUM> can be disposed between first location 114a and second location 114b. In some applications, such as the example illustrated in <FIG>, first location 114a and second location 114b are selected to be near ends of gap <NUM> between leaflets <NUM>, <NUM>, and <NUM>, or near ends of the coapting portion of the leaflets.

As seen in <FIG>, a snare tool, which can be snare tool <NUM> of <FIG> or can be a second snare tool, is transluminally introduced into the right atrium of the heart and engages second terminus 110b of the tether. The snare tool can be transluminally advanced into the right atrium out of second catheter <NUM> (e.g., as described with respect to <FIG>, mutatis mutandis), or out of another, third, catheter.

Snare <NUM> of snare tool <NUM> (or another snare of another snare tool) is then used to draw second terminus 110b of the tether out of the right atrium, such that a second segment <NUM> of the tether extends from second puncture location 114b across the right atrium, as seen in <FIG>.

In some applications, and as shown, snare <NUM> (or another snare) draws first terminus 110b from the right atrium through inferior vena cava <NUM> of the subject. In some applications, withdrawal can be via the superior vena cava.

In some applications, for example when the same snare and catheter are used for drawing both the first and second termini of tether <NUM>, the first and second termini are both drawn from the right atrium via the same route, i.e., via the same one of the superior and inferior vena cava. As shown in <FIG>, for such examples, tether <NUM> forms a loop from catheter <NUM>, across the right atrium, into and along right coronary artery <NUM>, back through the atrium, and into the catheter. This loop includes (i) segment <NUM> extending from catheter <NUM> across the atrium to location 114a, (ii) a bight 110c of tether <NUM> extending between location 114a and location 114b (e.g., within support tube <NUM>), and (iii) segment <NUM> extending from location 114b back through the atrium and into the catheter.

In some applications, for example when snare <NUM> is used to draw first terminus 110a through catheter <NUM>, and a separate snare is used to draw second terminus 110b through a separate catheter, each of the termini of tether <NUM> can be drawn out of the right atrium using a different route. For example, first terminus 110a may be drawn through the superior vena cava, while second terminus 110b may be drawn through the inferior vena cava.

As explained in further detail hereinbelow, in some applications of the step shown in <FIG>, second terminus 110b of tether <NUM> is drawn fully out of the subject's body. In some applications of the step shown in <FIG>, second terminus 110b is drawn out of the right atrium, but remains within the subject's body. In some applications, the first and second termini of tether <NUM> are drawn out of the right atrium to the same extent (i.e., both are pulled fully out of the subject's body, or both are pulled out of the right atrium but remain in the subject's body).

In some applications, once both termini of tether <NUM> are drawn from the right atrium, catheter <NUM> can be removed from right coronary artery <NUM>, for example by retraction of the catheter through aorta <NUM>.

Turning to <FIG>, a first tissue anchor <NUM>, e.g., driven by a driving tool <NUM>, is slid over and along first terminus 110a toward first segment <NUM>. First tissue anchor <NUM> is anchored into tissue of the right atrium, for example into annulus <NUM>, such that first segment <NUM> now extends between right coronary artery <NUM> and first tissue anchor <NUM>, as seen in <FIG>. First tissue anchor <NUM> can be anchored across tricuspid valve <NUM> from right coronary artery <NUM> (e.g., from support tube <NUM>), such as in proximity to the root of septal leaflet <NUM> or a commissure at which the septal leaflet meets posterior leaflet <NUM> or anterior leaflet <NUM>. At this stage, first segment <NUM> may be slack.

As seen in <FIG>, a second tissue anchor <NUM> is slid over and along second terminus 110b toward second segment <NUM>. Second tissue anchor <NUM> is anchored into tissue of the right atrium, for example into annulus <NUM>, such that second segment <NUM> now extends between right coronary artery <NUM> and the second tissue anchor. Second tissue anchor <NUM> can be anchored across tricuspid valve <NUM> from right coronary artery <NUM> (e.g., from support tube <NUM>), such as in proximity to the root of septal leaflet <NUM> or a commissure at which the septal leaflet meets posterior leaflet <NUM> or anterior leaflet <NUM>. At this stage, second segment <NUM> may be slack. Second tissue anchor <NUM> can be driven by driving tool <NUM>, or by another anchor driving tool.

Each of anchors <NUM> and <NUM> can have a head that is slidably couplable to tether <NUM>, e.g., by the head comprising an eyelet that is threadable onto the tether. Each of anchors <NUM> and <NUM> can have a tissue-engaging element, which can be a helical screw-in tissue-engaging element (as described herein) or can be another type of tissue-engaging element, such as a dart or a staple. For some applications, each of anchors <NUM> and <NUM> can comprise an anchor described in one or more of the following:.

Driving tool <NUM> can be advanced via second catheter <NUM> (e.g., as shown in <FIG>), or from another catheter. In some applications, and as shown, driving tool <NUM> is rotatable, and anchors the tissue anchor(s) by screwing the tissue anchor(s) into the tissue of annulus <NUM>. Following anchoring of tissue anchors <NUM> and <NUM>, driving tool <NUM> (and, if one is used, another driving tool) can be retracted from the right atrium, for example via second catheter <NUM>.

Turning to <FIG>, the tension in tether <NUM> is modified (e.g., tension is applied to the tether). In some applications, this is done by pulling on one or both of termini 110a and 110b. This pulling is indicated by arrows <NUM>. Tensioning can be facilitated by one or more transluminally introduced tools <NUM> that can, for example, provide an opposing force against anchors <NUM> and <NUM>. The application of tension to tether <NUM> can pull support tube <NUM> against the wall of right coronary artery <NUM> that is closest to the atrium.

Modification of the tension in tether <NUM> causes reshaping of the tricuspid valve <NUM>, for example in the direction of arrows <NUM>. As shown in <FIG>, the reshaping of the tricuspid valve improves coaptation between leaflets <NUM>, <NUM>, and <NUM> of the valve, thereby reducing (e.g., closing) gap <NUM>.

In some applications, support tube <NUM> is designed and configured to distribute force, applied by tether <NUM>, across the wall of right coronary artery <NUM>, 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 <NUM> maintains puncture locations 114a and 114b at a fixed distance from one another, for example by preventing tether <NUM> from cutting (e.g., in a similar manner to a cheese wire) through the wall of the right coronary artery from one of the locations toward the other.

Following modification to the tension of the tether and reshaping of the valve, the tension in the tether is locked. In the example illustrated in <FIG>, a first lock <NUM> (which can optionally be referred to as a stopper) is slid along first terminus 110a of tether <NUM>, and is locked to the tether, typically in proximity to first anchor <NUM>. A second lock <NUM> is slid along second terminus 110b of tether <NUM>, and is locked to the tether, typically in proximity to second anchor <NUM>. Locks <NUM> and <NUM> can lock the tension in tether <NUM> by inhibiting the tether (e.g., termini 110a and 110b) from sliding past anchors <NUM> and <NUM>, e.g., by the locks abutting the anchors.

In some applications, excess tether is then cut and removed from the right atrium, for example by retraction of catheter <NUM>. The advancement of locks <NUM> and <NUM>, and cutting of excess tether, can be performed using tools <NUM>.

In some applications, the modification of the tension in tether <NUM> can be accomplished by pulling on both termini 110a and 110b.

In some applications, the modification of the tension in tether <NUM> can be accomplished by initially locking one of termini 110a and 110b adjacent the respective one of tissue anchors <NUM> and <NUM>, and subsequently pulling on the other one of termini 110a and 110b to modify the tension in the tether. Once the desired tension of the tether is achieved, the other of termini 110a and 110b is locked adjacent the respective one of tissue anchors <NUM> and <NUM>. For example, first terminus 110a can be locked adjacent tissue anchor <NUM>, following which the end user or physician cab pull on terminus 110b to change the tension in the tether, and then locks second terminus 110b adjacent second tissue anchor <NUM>.

In applications in which the termini 110a and 110b of the tether are drawn out of the user's body, as described hereinabove, the tissue anchors <NUM> and <NUM>, as well as locks <NUM> and <NUM>, can be slid onto the termini of the tether extracorporeally. In some applications, in which the termini 110a and 110b of the tether remain within the user's body until after the excess tether has been cut, tissue anchors <NUM> and <NUM> and locks <NUM> and <NUM> can be slid onto the termini intracorporeally (e.g., transluminally).

<FIG> demonstrates a method similar to that described hereinabove with respect to <FIG>. However, the example of <FIG> differs from the method previously described in the locking step of <FIG>. In the example of <FIG>, a single lock <NUM> is locked to both termini of the tether, e.g., in proximity to one of the tissue anchors, here shown as tissue anchor <NUM>. In some applications, during or following tensioning of tether <NUM>, first terminus 110a of the tether is drawn around or through first tissue anchor <NUM> to second tissue anchor <NUM>, resulting in a segment <NUM> of the tether extending between the first and second tissue anchors. Lock <NUM> is then slid onto and along both termini of tether <NUM>, to lock the termini adjacent second tissue anchor <NUM>. As described hereinabove, following locking of the tension in the tether, excess tether can be cut and removed. In some applications, second terminus 110b may not be brought to anchor <NUM>, but instead lock <NUM> can be slid over and along both termini to a location partway between anchors <NUM> and <NUM>, such that the termini converge at the lock partway between the anchors, and the lock locks the tension in tether <NUM> by being locked to both termini in this position.

<FIG> demonstrates another method similar to that described hereinabove with respect to <FIG>. However, the example of <FIG> differs from the method previously described in the anchoring and locking steps of <FIG>. In the example of <FIG>, a single tissue anchor replaces the first and second tissue anchors <NUM> and <NUM> of <FIG>. Specifically, a single tissue anchor <NUM> is slid over and along both termini of tether <NUM>, and is anchored into tissue of the right atrium, for example into annulus <NUM>, such that segments <NUM> and <NUM> extend from locations 114a and 114b and across the atrium to converge at tissue anchor <NUM>. Tissue anchor <NUM> can be driven by a driving tool, for example out of a catheter, substantially as described hereinabove with respect to driving tool <NUM>.

Subsequently, the tension in tether <NUM> is modified substantially as described hereinabove, the tension is locked using a lock <NUM> that is slid over and along the termini of the tether and is locked to the tether. As described hereinabove, following locking of the tension in the tether, excess tether can be cut and removed.

Reference is now made to <FIG> and <FIG>, which are schematic illustrations of a device, and techniques for use therewith, for protecting a coronary blood vessel or artery during treatment of an atrioventricular heart valve of a subject, according to some applications of the teachings herein.

As seen in <FIG>, a device according to the teachings herein includes an elongate tube <NUM> comprising (e.g., formed of) a radiopaque material. In some applications, elongate tube <NUM> is flexible. In some applications, such as that shown, elongate tube <NUM> can include, or be formed of, a metal frame or a mesh frame. For treatment of the mitral valve (see reference numeral <NUM> in <FIG>) of the subject, which is located between the left atrium and the left ventricle of the heart, elongate tube <NUM> is transluminally advanced into a coronary blood vessel, for example, a left coronary artery <NUM>. For some applications, and as shown in <FIG>, a catheter <NUM> delivers the elongate tube <NUM> via aorta <NUM> (e.g., transfemorally) and into left coronary artery <NUM>.

In the illustrated example, a distal part of catheter <NUM> is advanced to the left coronary artery. Catheter <NUM> also has an extracorporeal proximal part <NUM> that can comprise a handle (e.g., as shown in <FIG>). The distal part of catheter <NUM> is guidable to the left coronary artery, such as by being actively steerable (e.g., by being operatively coupled by one or more pullwires to proximal part <NUM>, such as to a steering controller thereof), or by being passively guided and/or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter).

<FIG> are schematic sectional view illustrations of steps of a method of preventing damage to the left coronary artery during treatment of mitral valve <NUM> of the heart using the device of <FIG>, in accordance with some applications of the teachings herein. For example, the treatment of the mitral valve may be or include annuloplasty of the mitral valve. The method can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc..

As seen in the sectional portion of <FIG>, left coronary artery <NUM> at least partially circumscribes the mitral valve <NUM> of the subject's heart. As seen, leaflets <NUM> and <NUM> of the mitral valve do not fully coapt, such that a gap <NUM> is formed therebetween. The treatment (e.g., annuloplasty) procedure described herein, reshapes the mitral valve <NUM>, such that the leaflets <NUM> and <NUM> coapt and gap <NUM> is reduced or eliminated (see the end result in <FIG>). Mitral valve <NUM> includes an annulus <NUM>, surrounding leaflets <NUM> and <NUM>.

The following description relates to a transluminal annuloplasty procedure, in which a tether is secured in an arc around the valve being treated by anchoring multiple tissue anchors to the tissue of the annulus in a series around the valve. The annulus is then contracted by tensioning the tether, to which the anchors are slidably coupled. Examples of such annuloplasty methods are described in <CIT>, which published as <CIT>; <CIT>, which published as <CIT>; <CIT>, which published as <CIT>; and <CIT>, which published as <CIT>. However, elongate tube <NUM> of the disclosed technology can be used, substantially as described, also when implementing other techniques that include anchoring a tissue anchor within the atrium. These method can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc..

As seen in <FIG>, catheter <NUM> is used to advanced elongate tube <NUM> into left coronary artery <NUM>, in the direction of arrows <NUM>, as described hereinabove with respect to <FIG>. In some applications, elongate tube <NUM> can be advanced transluminally over a guide wire.

Elongate tube <NUM> is advanced to the left coronary artery while the elongate tube is compressed, for example by being enclosed within an external sheath, here shown as the body of catheter <NUM>.

Turning to <FIG>, the external sheath, or catheter <NUM>, can be retracted in a proximal direction, indicated by arrows <NUM>, allowing elongate tube <NUM> to expand radially.

In some applications, radial expansion of flexible tube <NUM> causes the tube to become longitudinally contracted. For example, flexible tube <NUM> can be self-expanding. In some applications, the flexible tube <NUM> comprises a self-expanding structure, such as a stent, stent-like structure, braided structure, woven structure, balloon, etc. Alternatively or additionally, flexible tube <NUM> can be expanded by longitudinally contracting the tube, e.g., by pulling one end of the flexible tube toward to 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 to radially expand the compressed structure (while longitudinally contracting the tube). In some applications, a pulling element or tool is transluminally advanced into left coronary artery <NUM> in order to pull one end of flexible tube <NUM> relative to the opposing end.

In some applications, flexible tube <NUM> is stent-like. In some applications, flexible tube <NUM> has a cellular structure, e.g., cut from a tube. In some applications, flexible tube <NUM> has a braided structure.

In some applications, the outer diameter of elongate tube <NUM>, when expanded, is substantially similar to the inner diameter of left coronary artery <NUM>, e.g., such that the elongate tube is in circumferential contact with the inner surface of the left coronary artery. In some applications, elongate tube <NUM> is sufficiently long to extend at least a quarter of the way around annulus <NUM> of mitral valve <NUM>.

The introduction of elongate tube <NUM> into the left coronary artery as shown in <FIG>, the expansion thereof shown in <FIG>, and the insertion of tissue anchors as described hereinbelow with respect to <FIG>, are performed on the subject <NUM> transluminally, typically facilitated by imaging (e.g., fluoroscopy). For example, an imaging device <NUM> can deliver real time images of the procedure to a display screen <NUM>, visible to an end user or physician <NUM> who can also be controlling catheter <NUM>, and other catheters introduced at other stages of the treatment. Elongate tube <NUM>, being radiopaque, is visible to end user or physician <NUM> in the images provided on display screen <NUM>.

As seen in <FIG>, a first tissue anchor <NUM>, e.g., driven by a driving tool <NUM> extending distally out of a second catheter <NUM>, is advanced to the left atrium of the heart of the subject, the left atrium being upstream of mitral valve <NUM>. Second catheter <NUM> can advance the driving tool <NUM> to the left atrium via an inferior vena cava <NUM> and then via an opening in the interspatial septum <NUM>. In some applications, advancement of the driving tool can be via the superior vena cava.

In the illustrated example, a distal part of catheter <NUM> is advanced to the vena cava. Catheter <NUM> also has an extracorporeal proximal part <NUM>, which can include a handle (e.g., as shown in <FIG>). The distal part of catheter <NUM> is guidable to the anatomical site, such as by being actively steerable (e.g., by being operatively coupled by one or more pullwires to proximal part <NUM>, such as to a steering controller thereof), or by being passively guided and/or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter).

Tissue anchor <NUM> can have a head that is slidably coupled to a tether <NUM> (<FIG>), e.g., by the head comprising an eyelet that is threadable onto the tether. Tissue anchor <NUM> can have a tissue-engaging element, which can be a helical screw-in tissue-engaging element (as shown) or can be another type of tissue-engaging element, such as a dart or a staple. For some applications, tissue anchor <NUM> can comprise an anchor described in one or more of the following:.

Turning to <FIG>, it is seen that driving tool <NUM> anchors first tissue anchor <NUM> into tissue of annulus <NUM> of mitral valve <NUM>. In some applications, driving tool <NUM> is rotatable, such that rotation of the driving tool screws in a tissue-engaging portion of 240a of first tissue anchor <NUM> into the tissue of annulus <NUM>.

For applications in which the introduction and anchoring of first tissue anchor <NUM> is facilitated by fluoroscopic imaging of the heart, as described above, because elongate tube <NUM> is radiopaque and typically substantially fills the diameter of left coronary artery <NUM>, end user or physician <NUM> can identify the location and bounds of the left coronary artery based on the location of the elongate tube, visible on display <NUM>. Thus, the end user or physician can avoid tissue anchor <NUM> contacting or piercing the left coronary artery. In some applications, during anchoring of first tissue anchor <NUM>, and of additional tissue anchors as described hereinbelow, the body of the subject is devoid of fluid contrast agents, e.g., the procedure can be performed without the introduction of a fluid contrast agent into the subject.

Turning to <FIG>, a second tissue anchor <NUM> has been anchored into the tissue of annulus <NUM>, and a third tissue anchor <NUM> is about to be anchored. Tissue anchors <NUM> and <NUM> are similar in structure to tissue anchor <NUM> described hereinabove, and are slidably coupled to tether <NUM>, which extends distally out of driving tool <NUM> or out of second catheter <NUM>. The placement of anchors <NUM>, <NUM>, and <NUM> is facilitated by fluoroscopic imaging of the heart of the subject, so that the radiopaque elongate tube <NUM> is visible to the operating physician or end user, and thus the physician or end user knows the location and bounds of left coronary artery <NUM> and can avoid damage thereto.

In some applications, elongate tube <NUM> is formed of an electrically conductive material, and driving tool <NUM> is electrically coupled to a control subsystem <NUM>, (for example disposed in or connected to proximal part <NUM>). In some applications, contact between a tissue anchor, such as tissue anchor <NUM>, and elongate tube <NUM>, is detected by control subsystem <NUM>, which provides a signal (e.g., on or via display <NUM>) such as an audible or visual signal, indicated in <FIG> by reference numeral <NUM>. In such applications, the end user or physician <NUM> can monitor for signal <NUM>, indicating proximity or contact between a tissue anchor and elongate tube <NUM>. In response to identification of detectable signal <NUM>, the end user or operating physician may reposition the tissue anchor, here shown as third tissue anchor <NUM>, in order to avoid damaging left coronary artery <NUM>, and drives the third tissue anchor into the tissue of annulus <NUM> at a modified location.

<FIG> shows mitral valve <NUM> following anchoring of tissue anchors <NUM>, <NUM>, and <NUM> shown previously, and of a fourth, additional tissue anchor <NUM>, similar in structure to tissue anchor <NUM> and slidably coupled to tether <NUM>. As seen in <FIG>, a pair of tools <NUM> extend out of catheter <NUM> along both ends of tether <NUM>. As is explained hereinbelow, tools <NUM> will be used to modify the tension in tether <NUM>, lock the tension in the tether, and cut the tether.

Following installation of all the required tissue anchors, elongate tube <NUM> can be removed from the left coronary artery. An exemplary method for removing elongate tube <NUM> is shown in <FIG>.

In <FIG>, the external sheath, or catheter <NUM>, is advanced distally over elongate tube <NUM>, in the direction of arrow <NUM>, causing the elongate tube to compress within the sheath. Other mechanisms of compression of elongate tube <NUM> can also be employed. Following compression of elongate tube <NUM>, catheter <NUM> is retracted from the left coronary artery in a direction indicated by arrow <NUM>, as seen in <FIG>, and is removed from the body of the subject via the aorta <NUM>. <FIG> shows the mitral valve of the subject's heart following removal of catheter <NUM>, and prior to tensioning of tether <NUM>, as explained hereinbelow.

Turning to <FIG>, the tension in tether <NUM> is modified (e.g., tension is applied to the tether). In some applications, this is done by pulling ends of the tether. This pulling is indicated by arrows <NUM>. Tensioning can be facilitated by one or more transluminally introduced tools <NUM> that can, for example, provide an opposing force against anchors <NUM> and <NUM>. Modification of the tension in tether <NUM> causes reshaping of mitral valve <NUM>. As shown in <FIG>, the reshaping of the mitral valve causes leaflets <NUM> and <NUM> of the valve to fully coapt, and gap <NUM>, which is visible in <FIG>, is closed.

Following modification to the tension of the tether and reshaping of the valve, the tension in the tether is locked. In the example illustrated in <FIG>, a first lock <NUM> (which can optionally be referred to as a stopper), is slid along one end of tether <NUM>, and is locked to the tether, typically in proximity to tissue anchor <NUM>. A second lock <NUM> is slid along an opposing end of tether <NUM>, and is locked to the tether, typically in proximity to tissue anchor <NUM>. Locks <NUM> and <NUM> can lock the tension in tether <NUM> by inhibiting the tether (e.g., termini 10a and 10b) from sliding past anchors <NUM> and <NUM>, e.g., by the locks abutting the anchors.

In some applications, excess tether is then cut and removed from the left atrium, for example by retraction of catheter <NUM> via the septum <NUM> and vena cava <NUM>.

In some applications, the modification of the tension in tether <NUM> can be accomplished by pulling on both ends of the tether.

In some applications, the modification of the tension in tether <NUM> can be accomplished by initially locking one of the ends of the tether adjacent the respective one of tissue anchors <NUM> and <NUM>, and subsequently pulling on the other end of tether <NUM> to modify the tension in the tether. Once the desired tension of the tether is achieved, the other end of the tether is locked adjacent the respective one of tissue anchors <NUM> and <NUM>. For example, the first end can be locked adjacent tissue anchor <NUM>, following which the end user or physician can pull on the second end to change the tension in the tether, and then locks the second end adjacent tissue anchor <NUM>.

In some applications, the tether can be advanced into the body together with one lock (e.g., one lock is pushed into the body along with the tether, possibly already locked to the tether). In some cases, the first anchor can be advanced together with the first lock attached to the tether adjacent the first anchor, such that the end user or physician only interacts with the second end of the tether, and with the second lock.

It is appreciated that while the description of <FIG> and <FIG> herein is provided with respect to treatment of the mitral valve (e.g., annuloplasty), the method and device of the teachings herein can be used, mutatis mutandis, during treatment of the tricuspid valve, by advancing flexible tube <NUM> into coronary blood vessel, for example, a right coronary artery, and carrying out treatment of the tricuspid valve via the vena cava, for example as described hereinabove with respect to <FIG> and <FIG>. In some applications, the flexible tube can be advanced into the right coronary artery via a coronary ostia at the aortic root of aorta <NUM> of the subject. In some applications, elongate tube <NUM> is sufficiently long to extend around at least a majority of the annulus of the tricuspid valve (see for example <FIG>), and the anchoring of tissue anchors <NUM>, <NUM>, <NUM>, and <NUM>, or any other number of tissue anchors, is into the annulus of the tricuspid valve.

<FIG> are schematic sectional view illustrations of steps of a method of preventing damage to the coronary artery during treatment of a mitral valve of the heart of the subject, in accordance with some applications of the teachings herein. The method can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc..

As seen in <FIG>, an elongate tube <NUM>, similar to elongate tube <NUM> of <FIG>, is advanced into and expanded within left coronary artery <NUM> surrounding the mitral valve, substantially as described hereinabove with respect to <FIG>. The following description relates to a transluminal annuloplasty procedure, as described hereinabove, but can be used also when implementing other annuloplasty methods and other treatments known in the art, provided that such treatments require insertion of a tissue anchor.

The example of <FIG> is distinct from that of <FIG> in that the elongate tube <NUM> is not necessarily sufficiently radiopaque to facilitate fluoroscopic guidance, but rather is configured to apply an electrical signal (e.g., a voltage) to the tissue of the heart, for example from under the control of a controller or handle, similar to proximal part <NUM> of <FIG>.

Typically, elongate tube <NUM> is flexible. In some applications, such as that shown, elongate tube <NUM> can include, or be formed of, a metal frame or a mesh frame. For treatment of the mitral valve (see reference numeral <NUM> in <FIG>) of the subject, for example having the anatomy described hereinabove with respect to <FIG>, elongate tube <NUM> is transluminally advanced into left coronary artery <NUM> (e.g., left circumflex artery) which at least partially circumscribes the mitral valve (see for example <FIG>).

As seen in <FIG>, a first tissue anchor <NUM>, e.g., driven by a driving tool <NUM> extending distally out of a second catheter <NUM>, is advanced to the left atrium of the heart of the subject, upstream of mitral valve <NUM>, substantially as described hereinabove with respect to <FIG>.

Tissue anchor <NUM> can have a head that is slidably coupled to a tether (see reference numeral <NUM> in <FIG>), e.g., by the head comprising an eyelet that is threadable onto the tether. Tissue anchor <NUM> can have a tissue-engaging element, which can be a helical screw-in tissue-engaging element (as described herein) or can be another type of tissue-engaging element, such as a dart or a staple. For some applications, tissue anchor <NUM> can comprise an anchor described in one or more of the following:.

Driving tool <NUM> is reversibly coupled to the tissue anchor and is configured to detect the electrical signal applied by tube <NUM>. For example, tool <NUM> can comprise a distal electrode, or can be electrically coupled to the tissue anchor with the tissue anchor serving as an electrode. The detected signal (e.g., its magnitude) is used to determine the proximity of tool <NUM> and/or the tissue anchor to tube <NUM>, and thereby to coronary artery <NUM>. For example, the signal can be detected when contact is made with tissue of mitral valve <NUM>. For some applications, if an amplitude of the signal is above a predetermined threshold, that is indicative of the tissue anchor being too close to elongate tube <NUM> and to left coronary artery <NUM>, and a new position is selected, so as to reduce a likelihood of damaging of the left coronary artery when anchoring the tissue anchor <NUM>.

It is to be noted that the technique described with reference to <FIG> does not necessarily require contact between the tissue anchor and tube <NUM>. That is, the technique does not only alert the end user or physician once the tissue anchor has reached the coronary artery. Rather, the technique can provide general and/or preemptive guidance to the end user physician.

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

In some applications, an indication of the electrical signal detected by driving tool <NUM> is indicated on the proximal part <NUM> of catheter <NUM> that is visible to an end user or physician. In some applications, the indication of the electrical signal is displayed on a display screen that is visible to the end user or physician, for example as shown in <FIG>.

When a suitable position, which is sufficiently distant from the coronary blood vessel or artery, is detected, driving tool <NUM> anchors first tissue anchor <NUM> into tissue of annulus <NUM> of mitral valve <NUM>. In some applications, driving tool <NUM> is rotatable, such that rotation of the driving tool screws in a tissue-engaging portion of 340a of first tissue anchor <NUM> into the tissue of annulus <NUM>.

Turning to <FIG>, the first tissue anchor <NUM> and a second tissue anchor <NUM> have been anchored into the tissue of annulus <NUM>, and a third tissue anchor <NUM> is in the process of being anchored, in a similar manner to that described above for the first tissue anchor. Tissue anchors <NUM> and <NUM> are similar in structure to tissue anchor <NUM> described hereinabove, and are slidably coupled to tether <NUM>, which extends distally out of driving tool <NUM> or out of second catheter <NUM>.

<FIG> shows mitral valve <NUM> following anchoring of tissue anchors <NUM>, <NUM>, and <NUM> shown previously, and of a fourth, additional tissue anchor <NUM>, similar in structure to tissue anchor <NUM> and slidably coupled to tether <NUM>. Once the four tissue anchors are installed, the treatment process proceeds in the manner described hereinabove with respect to <FIG>. It is appreciated that while the description of <FIG> herein is provided with respect to treatment (e.g., annuloplasty) of the mitral valve, the method and device of the teachings herein can be used, mutatis mutandis, during treatment of the tricuspid valve, by advancing elongate tube <NUM> into a right coronary artery and carrying out treatment of the tricuspid valve via the vena cava, for example as described hereinabove with respect to <FIG> and <FIG>. In some applications, the elongate tube can be advanced into the right coronary artery via a coronary ostia at the aortic root of the aorta of the subject. In some applications, elongate tube <NUM> is sufficiently long to extend around at least a majority of the annulus of the tricuspid valve (see for example <FIG>), and the anchoring of tissue anchors <NUM>, <NUM>, <NUM>, and <NUM>, or any other number of tissue anchors, is into the annulus of the tricuspid valve.

<FIG> are schematic sectional view illustrations of steps of another method of preventing damage to the coronary blood vessel or artery during treatment of a mitral valve of the heart of the subject, in accordance with some applications of the teachings herein. The method can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc..

<FIG> demonstrate a process of selecting suitable locations for tissue anchors that is substantially similar to that shown in <FIG>. However, in the example of <FIG>, elongate tube <NUM> is replaced by a wire <NUM>, which typically does not fill the diameter of the coronary blood vessel or artery. In some applications, elongate wire <NUM> is flexible. It will be appreciated by a people skilled in the art that other elongate, electrical signal-applying structures, may be suitable for implementing the techniques described with reference to <FIG>.

Elongate wire <NUM> is introduced into the left coronary artery substantially as described hereinabove with respect to <FIG>. During anchoring of tissue anchors, elongate wire <NUM> functions similarly to elongate tube <NUM> of <FIG> and applies an electrical signal which is detectable during insertion of tissue anchors.

<FIG> is substantially similar to <FIG> and shows advancement and positioning of a first tissue anchor <NUM>, e.g., driven by a driving tool <NUM> extending distally out of a second catheter <NUM>, substantially as described hereinabove with respect to <FIG>. First tissue anchor <NUM>, driving tool <NUM>, and catheter <NUM> have structures similar to those of the first tissue anchor, driving tool, and catheter shown and described with respect to <FIG>, with like numbers indicating like portions.

As discussed hereinabove with respect to <FIG>, driving tool <NUM> is mechanically and electrically coupled to the tissue anchor, and is configured to detect the applied electrical signal. As such, when a tissue-engaging portion 440a of first tissue anchor <NUM> engages tissue of mitral valve <NUM>, for example when arriving at a desired anchoring position, the electrical signal is detected by driving tool <NUM>. If the detected electrical signal has a magnitude above a predetermined threshold, that is indicative of the position being too close to elongate wire <NUM> and to left coronary artery <NUM>, and a new position is selected, so as to avoid damaging of the coronary artery when anchoring the tissue anchor <NUM>.

When a suitable position, which is sufficiently distant from the coronary blood vessel or artery, is detected, driving tool <NUM> anchors first tissue anchor <NUM> into tissue of annulus <NUM> of mitral valve <NUM>. In some applications, driving tool <NUM> is rotatable, such that rotation of the driving tool screws in a tissue-engaging portion of 440a of first tissue anchor <NUM> into the tissue of annulus <NUM>.

<FIG> shows mitral valve <NUM> following anchoring of tissue anchors <NUM>, <NUM>, and <NUM> shown previously, and of a fourth, additional tissue anchor <NUM>, similar in structure to tissue anchor <NUM> and slidably coupled to tether <NUM>. Once the four tissue anchors are installed, the treatment process proceeds in the manner described hereinabove with respect to <FIG>.

It is to be noted that, although the description of <FIG> herein is provided with respect to treatment (e.g., annuloplasty) of the mitral valve, the method and device of the teachings herein can be used, mutatis mutandis, during treatment of the tricuspid valve, by advancing elongate wire <NUM> into a right coronary artery and carrying out treatment of the tricuspid valve via the vena cava, for example as described hereinabove with respect to <FIG> and <FIG>. In some applications, the elongate wire can be advanced into the right coronary artery via a coronary ostia at the aortic root of the aorta of the subject. In some applications, elongate wire <NUM> is sufficiently long to extend around at least a majority of the annulus of the tricuspid valve (see for example <FIG>), and the anchoring of tissue anchors <NUM>, <NUM>, <NUM>, and <NUM>, or any other number of tissue anchors, is into the annulus of the tricuspid valve.

The techniques of <FIG> are described hereinabove as facilitating distancing of tissue anchors from an adjacent coronary blood vessel or artery, e.g., by anchoring only to tissue sites at which the applied electrical signal is detected at a sufficiently low amplitude. However, it is to be noted that locating tissue anchors within a certain proximity to the atrial wall can be advantageous, e.g., so that the anchors are driven into the annulus of the valve, rather than into the leaflets of the valve. Therefore, for some applications, detection of the applied electrical signal at a sufficiently high magnitude is also desirable, and anchors are only anchored to tissue sites at which the applied electrical signal is detected at an amplitude that is above a given predetermined threshold. Therefore, for some applications, anchors are only anchored to tissue sites at which the applied electrical signal is detected at an amplitude that is between a predetermined lower threshold and a predetermined upper threshold.

Reference is again made to <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG>. Each of the locks described hereinabove can comprise deformable structure (e.g., a crimp), a spring-loaded element, and/or an actuatable mechanism. For some applications, each of the locks described hereinabove can comprise a lock or a stopper described in one or more of the following:.

The present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention is defined by the appended claims. The treatment techniques, methods, operations, steps, etc. described or suggested herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, tissue, etc. being simulated), etc..

Claim 1:
A system for use with a subject, the system comprising:
a tether (<NUM>) configured to be transluminally advanced into a coronary blood vessel (<NUM>) of the heart of the subject, the coronary blood vessel (<NUM>) at least partially transcribing a heart chamber of the heart, the tether (<NUM>) having a first terminus (10a) and a second terminus (10b), the first terminus (10a) configured to be advanced through a wall of the coronary blood vessel (<NUM>) into the heart chamber at a first location (14a) and the second terminus (10b) configured to be advanced through the wall of the coronary blood vessel (<NUM>) into the heart chamber at a second location (14b);
at least one device (<NUM>) configured to transluminally draw the first and second termini (10a, 10b) of the tether (<NUM>), from the first and second locations (14a, 14b), respectively, out of the heart chamber, such that a first segment (<NUM>) of the tether (<NUM>) extends from the first location (14a) through the heart chamber and a second segment (<NUM>) of the tether (<NUM>) extends from the second location (14b) through the heart chamber;
a support tube (<NUM>) defining a lumen, the support tube (<NUM>) being configured to be transluminally advanced into the coronary blood vessel (<NUM>), the tether (<NUM>) extending through the lumen of the support tube (<NUM>) and being slidable relative to the support tube (<NUM>);
at least one tissue anchor (<NUM>, <NUM>; <NUM>), configured to be slid over and along at least one of the first and second termini (10a, 10b), and to anchor the at least one of the first and second termini (10a, 10b) to tissue of the heart chamber, such that a part of the tether (<NUM>) extends between the at least one tissue anchor (<NUM>, <NUM>; <NUM>) and the coronary blood vessel (<NUM>); and
at least one lock (<NUM>, <NUM>; <NUM>), configured, following tensioning of the tether (<NUM>), to lock tension in the tether (<NUM>).