JP2007514502A - Device for changing the shape of a body organ - Google Patents

Abstract

【Task】
One form of the present invention is a method of treating mitral regurgitation in a patient. The method comprises delivering the tissue shaping device to a patient's coronary sinus in an unexpanded configuration within a catheter having an outer diameter of 9 or 10 French or less, the tissue shaping device comprising a flexible wire And a connector disposed between the proximal expandable anchor with the flexible wire, e.g., the distal expandable anchor is naturally expanded. Allowing or applying an actuating force to the distal expandable anchor and, after performing the actuating force step, locking the distal expandable anchor to lock the distal expandable anchor The step of deploying the device to reduce mitral regurgitation, such as by anchoring the distal expandable anchor by placing a flexible wire in contact with the wall of the coronary sinus It is equipped with a. The invention also includes an apparatus for performing the method.

Description

  The present invention relates generally to an apparatus and method for shaping tissue by deploying one or more devices in a body cavity adjacent to the tissue. One particular application according to the present invention relates to treating mitral regurgitation by deploying a tissue shaping device in a patient's coronary sinus or great cardiac vein.

  The mitral valve is the part of the heart that is located between the left atrial chamber and the left ventricular chamber. When the left ventricle contracts and pumps blood throughout the body, the mitral valve closes to prevent blood from being pumped back into the left atrium. In some patients, whether due to congenital abnormalities, disease or injury, the mitral valve fails to close properly, resulting in a condition known as regurgitation, which causes blood to Each time it contracts, it is pumped into the atria. Backflow is a serious and often rapidly deteriorating condition that reduces circulation efficiency and must be repaired.

  Two relatively common techniques for restoring the function of a damaged mitral valve are to surgically replace the valve with a mechanical valve or sew a flexible ring around the valve. Support the valve. Each of these methods is extremely invasive because access to the heart is made through an opening in the patient's chest. Patients with mitral regurgitation are often relatively weak and thus increase the risk associated with surgery.

  One non-invasive method for helping to close the mitral valve includes placing a tissue shaping device in the cardiac sinus and in a blood vessel passing through the mitral valve. The tissue shaping device is designed to help close the valve by pressing the blood vessel and surrounding tissue against the valve. This technique has an advantageous effect over other mitral valve repair methods in that it can be performed percutaneously without opening the chest wall. Examples of such devices are described in the following US patent application. That is, US patent application specification S.F. filed on May 8, 2002. N. No. 10 / 142,637, “Body Lumen Device Anchor, Device and Assembly”, U.S. Patent Application Specification S.P. N. No. 10 / 331,143, “System and Method to Effect the Little Valve Annulus of a Heart”, US patent application filed May 2, 2003 Description S.M. N. No. 10 / 429,172, “Devices and Methods for Modifying the Shape of a Body Organ”. The disclosures of these patent application specifications are incorporated herein by reference.

  When deploying a tissue shaping device in a vein or artery to modify adjacent tissue, care must be taken not to compress nearby arteries. For example, when treating mitral regurgitation, a tissue shaping device can be deployed in the coronary sinus to alter the shape of the adjacent mitral annulus. However, coronary arteries such as the rotating artery traverse between the coronary sinus and the heart, and deploying a support restricts perfusion to a portion of the heart by compressing one of these arteries. Increase the risk that it may be. For example, reference may be made to the following patent application specifications which are incorporated herein by reference for the disclosure thereof. That is, US patent application specification S.F. filed on May 14, 2001 and published as US Patent Application Publication No. US 2002/0169504 Al on November 14, 2002. N. No. 09 / 855,945, filed May 14, 2001, US patent dated November 14, 2002, “Mittal Valve Therapeutic Device, System and Method”. U.S. Patent Application Specification S.A. filed as published US 2002/0169502 Al. N. 09 / 855,946, “Mittal Valve Therapy Assembly and Method”, U.S. Patent Application Specification S.N. N. No. 10 / 003,910, “Focused Compression Mitral Valve Device and Method”. For this reason, it is desirable to monitor cardiac perfusion during and after treatment of such mitral regurgitation. For example, U.S. patent application specification S.D. filed on Feb. 12, 2003, the disclosure of which is incorporated herein by reference. N. See "Method of Implanting a Mitral Valve Therapy Device" of 10 / 366,585.

  The anatomy of the heart and surrounding blood vessels varies from patient to patient. For example, the location of the rotating artery and other important arteries relative to the coronary sinus is different. Specifically, the distance along the coronary sinus from the ostium to the intersection with the rotating artery varies from patient to patient. Furthermore, the diameter and length of the coronary sinus varies from patient to patient.

  We have a set of tissue shaping devices that maximize therapeutic effects (ie, reduced mitral regurgitation) while minimizing adverse effects, such as unacceptable compression of the rotating artery or other coronary arteries. Invented a tissue shaping device and method. The tissue shaping devices, device sets and methods of the present invention allow the practitioner to adapt the treatment to the patient's anatomy.

  One form of the invention is a method of treating mitral regurgitation in a patient. The method comprises a tissue shaping device having a connector disposed between a distal expandable anchor comprising a flexible wire and a proximal expandable anchor comprising a flexible wire. Delivering the device having a length of 60 mm or less into a patient's coronary sinus in a non-expanded configuration in a catheter having an outer diameter of 9 or 10 French; and, for example, a distal expandable anchor The distal side, such as by allowing natural expansion or by applying an actuating force to the distal expandable anchor and performing the step of applying this force, locking the distal expandable anchor, etc. Place the device by anchoring the distal expandable anchor, such as by placing the flexible wire of the expandable anchor in contact with the coronary sinus wall. And a, a step of decreasing mitral regurgitation by. Deploying may include anchoring the distal expandable anchor with a anchoring force of at least 1 to 2 pounds.

  In some embodiments, the deploying step of the method may include distal expansion, perhaps via a connector from outside the patient's body, such as by moving the proximal anchor proximally relative to the coronary sinus. The method can further include applying a proximal force to the possible anchor. The method also includes anchoring the proximal anchor either before or after applying the proximal force to the distal expandable anchor and either before or after the moving step. You can also. The proximal anchor is proximal after allowing the proximal expandable anchor to spontaneously expand or after performing an actuating force and applying a force to the proximal expandable anchor. It can be fixed by locking the expandable anchor.

  The distal expandable anchor also includes a flexible wire connection of the distal expandable anchor that substantially restricts proximal and distal movement of the connection relative to the distal expandable anchor. In some embodiments, such as those having, the step of delivering is a non-expanded configuration in which none of the distal expandable anchor flexible wire extends proximally along the connector within the catheter. Delivering the tissue shaping device to the coronary sinus at.

  In other embodiments, such as embodiments in which the distal expandable anchor has a flexible wire connection of the distal expandable anchor that is movable distally and proximally, the step of delivering comprises: Delivering the tissue shaping device to the coronary sinus in a non-expanded configuration in which at least a portion of the flexible wire of the distal expandable anchor extends proximally or distally along the connector within the catheter. be able to. Deploying in these embodiments includes locking the distal expandable anchor after moving the connection distally to actuate and move the distal expandable anchor. be able to.

  Another aspect of the present invention is a tissue shaping device adapted to be delivered to the coronary sinus in a non-expanded configuration within a catheter having an outer diameter of 9 to 10 French or less, which reduces mitral regurgitation Distal expandable anchors (such as natural expandable anchors or actuated anchors with actuators and locking members) that are adapted for further deployment within the coronary sinus and thus include flexible wires and flexible It is the said tissue shaping apparatus which has a connector arrange | positioned between the expandable anchors of the proximal end provided with a property wire, and has a length of 60 mm or less. In some embodiments, the distal expandable anchor is expanded into contact with the coronary sinus wall portion, such as an anchoring force of at least 0.453 to 0.907 kg (1 to 2 pounds). By providing sufficient anchoring force to settle within the coronary sinus, it can accommodate a range of coronary sinus diameters.

  In some embodiments, the device has an expanded configuration and the distal expandable anchor has at least one or two bending points and first and second arms extending from the bending points. The first and second arms are adapted to be deformable about a bending point as the device moves from an expanded configuration to an unexpanded configuration. The bending point can be disposed at the uppermost point of the distal expandable anchor when the distal expandable anchor is in the expanded configuration. The first and second arms can extend generally proximally or generally distally when the tissue shaping device is in an unexpanded configuration. The bending point may be, for example, a flexible wire portion or a loop formed on the flexible wire having a larger radius of curvature compared to the adjacent wire portion, and on the distal side or proximal side of the anchor. It can be arranged.

  The apparatus also includes a distal expandable anchor flexible wire connection that substantially restricts the proximal and distal movement of the connection relative to the distal expandable anchor. Alternatively, it can have a distally and proximally movable connection between the distal expandable anchor and the connector. The device may be re-restrained from an expanded configuration within the coronary sinus to a non-expanded configuration within the catheter within the coronary sinus and may be redeployed within the coronary sinus after re-restraint. .

  In some embodiments, the proximal anchor expands the device into contact with the wall portion of the coronary sinus with sufficient anchoring force to anchor the device within the coronary sinus. It can be adapted to the diameter of the sinus. In embodiments where the device has an expanded configuration, the proximal anchor can have at least one bending point and first and second arms extending from the bending point, wherein the first and second arms are When the device moves from the expanded configuration to the non-expanded configuration, it can be deformed around the bending point. The proximal anchor may be a natural expandable anchor or an actuated anchor, in which case the actuated anchor may have an actuator and a locking member adapted to be locked at the position where the actuator is deployed. it can.

  The anatomy of the heart and surrounding blood vessels varies from patient to patient. For example, the location of the rotating artery and other important arteries relative to the coronary sinus is different. Specifically, the distance along the coronary sinus from the ostium to the intersection with the rotating artery varies from patient to patient. Furthermore, the diameter and length of the coronary sinus varies from patient to patient.

  We have a set of tissue shaping devices that maximize the therapeutic effect (ie, reduced mitral regurgitation) while minimizing adverse effects such as unacceptable compression of the rotating artery or other coronary arteries. Invented the tissue shaping apparatus and method. The tissue shaping devices, device sets and methods of the present invention allow the practitioner to adapt the treatment to the patient's anatomy.

  One aspect of the present invention is a tissue shaping device adapted to be deployed within a blood vessel to reshape tissue adjacent to the blood vessel, the first and second anchors, and the first and second And a connector disposed between the anchors, the connector providing a tissue shaping device that is integral with at least a portion of the first anchor. In some embodiments, the first anchor has a flexible wire and a crimp portion that holds a portion of the flexible wire, the crimp portion being optionally integrated with the connector. The The connector may have a semicircular cross section with a radius substantially equal to the radius of the crimp.

  In some embodiments, each of the first and second anchors of the device has a flexible wire and a crimp portion that holds a portion of the flexible wire, and the crimp portion of the first anchor The crimp portion of the second anchor can be integrated with the connector.

  Another aspect of the present invention is a tissue comprising scraping material from a blank to form a connector and an integral anchor portion and attaching a non-integral anchor portion to the integral anchor portion. A method of manufacturing a shaping device is provided. In embodiments where the integral anchor portion has a crimp tube and the non-integral portion has a flexible wire, the method further comprises disposing a portion of the flexible wire within the crimp tube. Can do. In embodiments where the blank has a substantially cylindrical cross-section, the scraping step can include scraping a portion of the cylinder to leave a connector having a substantially semi-circular cross-section.

  In embodiments where the integral anchor portion is the first integral anchor portion, the scraping step scrapes material from the blank to form a second integral anchor portion, and the connector is the first integral anchor portion. And further including a step of being disposed between the flexible anchor portion and the second integral anchor portion. In embodiments in which each of the first and second anchor portions has a crimp tube and the non-integral anchor portion has a flexible wire, the method includes allocating a portion of the flexible wire to the first anchor. The method may further include disposing in the crimp tube.

  In embodiments where the non-integral anchor portion is a first non-integral anchor portion, the method further comprises attaching a second non-integral anchor portion to the second integral anchor portion. Can be included. In some embodiments, each of the first and second integral anchor portions has a crimp tube and each of the first and second non-integral anchor portions has a flexible wire, The method includes disposing a portion of the first anchor flexible wire in the first anchor crimp tube and disposing a portion of the second anchor flexible wire in the second anchor crimp tube. Further comprising the steps of:

  The anatomy of the heart and surrounding blood vessels varies from patient to patient. For example, the location of the rotating artery and other important arteries relative to the coronary sinus is different. Specifically, the distance along the coronary sinus from the ostium to the intersection with the rotating artery varies from patient to patient. Furthermore, the diameter and length of the coronary sinus varies from patient to patient.

  We have a set of tissue shaping devices that maximize the therapeutic effect (ie, reduced mitral regurgitation) while minimizing adverse effects such as unacceptable compression of the rotating artery or other coronary arteries. Invented the tissue shaping apparatus and method. The tissue shaping devices, device sets and methods of the present invention allow the practitioner to adapt the treatment to the patient's anatomy.

  One form of the present invention is a tissue shaping device adapted to be deployed within a blood vessel to reshape tissue adjacent to the blood vessel. In some embodiments, the apparatus comprises a flexible wire having at least one bending point and first and second arms extending from the bending point, wherein the first and second arms are bending points. A first anchor and a second arm extending from the bending point, and a first and a second arm extending from the bending anchor. The arm includes a proximal anchor that can be deformed around a bending point, and a connector disposed between the distal anchor and the proximal anchor. The bending point of the distal anchor can be disposed on the proximal side of the distal anchor, and the bending point of the proximal anchor can be disposed on the distal side of the proximal anchor.

  In some embodiments, the flexible wire of the distal anchor is arranged in a substantially 8-shaped configuration. In this case, the flexible wire of the distal anchor has a second bending point and third and fourth arms extending from the second bending point, and the third and fourth arms are the second. It can be bent around the bending point. The flexible wire of the distal anchor also has first and second proximal struts, the first and second bending points being formed on the first and second proximal struts, respectively. . Each of the bending points can be, for example, a portion of a flexible wire having a larger radius of curvature compared to an adjacent wire portion or a loop formed by a flexible wire. The first and second bending points of the distal anchor flexible wire may also be disposed at the uppermost point of the distal anchor.

  In some embodiments, the flexible wire of the proximal anchor is arranged in a substantially 8-shaped configuration. In this case, the flexible wire of the proximal anchor has a second bending point and third and fourth arms extending from the second bending point, and the third and fourth arms are the first and second arms. It is designed to bend around the second bending point. The proximal anchor flexible wire also has first and second proximal struts, the first and second bending points being formed in the first and second proximal struts, respectively. . Each of the bending points can be, for example, a portion of a flexible wire that has a large radius of curvature compared to an adjacent wire portion or a loop formed in the flexible wire. The first and second bend points of the proximal anchor flexible wire can also be disposed at the uppermost point of the proximal anchor.

  In some embodiments, the distal anchor is a naturally expandable anchor, and in some embodiments, the proximal anchor is an actuated anchor. The connector can have a moment of inertia that varies along its length. The distal anchor and the proximal anchor can have a crimp tube, and the connector can be integral with the crimp tube.

  The anatomy of the heart and surrounding blood vessels varies from patient to patient. For example, the location of the rotating artery and other important arteries relative to the coronary sinus is different. Specifically, the distance along the coronary sinus from the ostium to the intersection with the rotating artery varies from patient to patient. Furthermore, the diameter and length of the coronary sinus varies from patient to patient.

  We have a set of tissue shaping devices that maximize therapeutic effects (ie, reduced mitral regurgitation) while minimizing adverse effects such as unacceptable compression of the rotating artery or other coronary arteries. Invented a tissue shaping device and method. The tissue shaping devices, device sets and methods of the present invention allow the practitioner to adapt the treatment to the patient's anatomy.

  In one embodiment, the present invention is a method of treating mitral regurgitation in a patient's heart, delivering the tissue shaping device to the coronary sinus, such as in a catheter having an outer diameter of 9 or 10 France or less And deploying a tissue shaping device to reduce mitral regurgitation, the deploying step comprising a base of an intersection where the coronary artery passes between the coronary sinus and the mitral valve A treatment method comprising the step of applying force through the wall of the coronary sinus only towards the mitral valve on the end side. In some embodiments, the device is deployed such that its distal end is proximal to the intersection, and in some embodiments, the distal end is deployed distal to the intersection. The method can also include determining an intersection.

  In some embodiments, the tissue shaping device has a distal anchor, wherein the deploying step includes distal anchors such as by expanding the distal anchors by natural expansion or by applying an actuating force. Can be included on the proximal side of the intersection. The fixing force may be 0.453 to 0.907 kg (1 to 2 pounds).

  In some embodiments, the deploying step includes applying a proximally directed force to the distal anchor (in some embodiments, from outside the patient, such as by moving the proximal anchor proximally). And a further step of adding. The tissue shaping device further comprises a proximal anchor and a connector deployed between the distal anchor and the proximal anchor, the deploying step being proximal by natural expansion or by applying an actuation force. The method further includes anchoring the proximal anchor (eg, within the coronary sinus or at least partially outside the coronary sinus), such as by expanding the side anchor. The step of anchoring the proximal anchor can be performed before or after the step of applying a proximal force to the distal anchor.

  Deploying in the method can include deploying the distal anchor of the device from the distal end of the catheter. The method can also include re-restraining the distal anchor into the catheter and optionally redeploying the distal anchor. Deploying in the method includes deploying the proximal anchor of the device from the distal end of the catheter, and re-constraining the proximal anchor into the catheter and selectively redeploying the distal anchor. be able to. The entire device can be reconstrained and redeployed from the catheter.

  The method also includes selecting a tissue shaping device from a set of tissue shaping devices including a plurality of lengths of tissue shaping device and / or a plurality of anchor size tissue shaping devices prior to the delivering step. You can also.

  The present invention is also a set of devices used in treating mitral regurgitation, the set of devices including a plurality of tissue shaping devices having different lengths, each of which includes 9 Or it is set as the form which can be delivered to a patient's sinus in the catheter which has an outer diameter of 10 France or less. In some embodiments, each of the tissue shaping devices has an anchor (such as a distal anchor or a proximal anchor) having an expanded configuration and an unexpanded configuration that is delivered through a catheter. In some embodiments, at least one tissue shaping device in the set has a length of 60 mm or less, and at least one tissue shaping device in the set has a length of 60 mm or more. In some embodiments, the distal anchor in each of the tissue shaping devices in the assembly has a diameter that is greater than the diameter of the coronary sinus at the location of the distal anchor in an expanded configuration (eg, about 7 mm to about 16 mm). Also, the proximal anchor of each tissue shaping device in the assembly, in the expanded configuration, has a diameter (eg, about 9 mm to about 20 mm) that is greater than or equal to the diameter of the coronary sinus at the location of the proximal anchor. In some sets, the anchor is naturally expandable and in other sets, the anchor is actuated, while still other sets have at least one device having a naturally expandable anchor and an actuated anchor. One device. The set can also include a catheter having an outer diameter of 9 to 10 French.

  Another aspect of the present invention is a set of devices used when treating mitral regurgitation, the set comprising a plurality of tissue shaping devices each comprising an anchor having an unexpanded configuration and an expanded configuration. The anchors have different diameters when in their expanded configuration, and each of the tissue shaping devices is configured to be delivered to the patient's coronary sinus via a catheter having an outer diameter of 9 to 10 French. ing. In some embodiments, the anchor is a distal anchor (such as a naturally expandable anchor or actuated anchor) and the device is a proximal anchor (naturally expandable anchor) having an unexpanded configuration and an expanded configuration. Or a proximal anchor, such that the proximal anchor has a different diameter when in the expanded configuration. In some embodiments, the diameter of the distal anchor of the tissue shaping device in the set is in the range of about 7 mm to about 16 mm in their expanded configuration, and in some embodiments, the tissue shaping device in the set. The proximal anchor diameter is in the range of about 9 mm to about 20 mm in the expanded configuration. The set can also include a catheter having an outer diameter of 9 to 10 French.

  The anatomy of the heart and surrounding blood vessels varies from patient to patient. For example, the location of the rotating artery and other important arteries relative to the coronary sinus is different. Specifically, the distance along the coronary sinus from the ostium to the intersection with the rotating artery varies from patient to patient. Furthermore, the diameter and length of the coronary sinus varies from patient to patient.

  We have a set of tissue shaping devices that maximize the therapeutic effect (ie, reduced mitral regurgitation) while minimizing adverse effects such as unacceptable compression of the rotating artery or other coronary arteries. Invented the tissue shaping apparatus and method. The tissue shaping devices, device sets and methods of the present invention allow the practitioner to adapt the treatment to the patient's anatomy.

  One form of the present invention allows the patient's heart to be placed in a nearby blood vessel (such as a coronary sinus) to reshape at least a portion of the patient's heart (such as a mitral valve). The tissue shaping device. In the present invention, the tissue shaping device includes a proximal anchor, a distal anchor, and a connector disposed between the proximal anchor and the distal anchor, and the connector extends along its length. Moment of inertia. In some embodiments, the connector has a proximal anchor portion, a distal anchor portion, and a central portion disposed between the proximal anchor portion and the distal anchor portion, and a moment of inertia. Is the smallest at one point in the center. Each of the proximal anchor and the distal anchor has a fastener, and the moment of inertia of the proximal end of the proximal fastener or the proximal proximal end of the distal fastener is the inertia at a point in the central portion of the connector. Greater than moment.

  In some embodiments, the connector has a substantially uniform width and a substantially non-uniform thickness over the length of the connector. In embodiments where the connector has a proximal anchor portion, a distal anchor portion, and a central portion disposed between the proximal anchor portion and the distal anchor portion, the thickness of the connector is that of the central portion. One point will be the smallest. In embodiments where the proximal anchor has a proximal anchor fastener or the distal anchor has a distal anchor fastener, either the proximal anchor fastener or the distal anchor fastener. The thickness of the connector at a point just proximal to the end will be greater than the thickness of the connector at the central portion.

  The connector can include at least a portion having a thickness that varies as a function of the distance from its proximal end to its distal end. This function can be, for example, a linear function or a quadratic function of distance. In an embodiment in which the connector includes a proximal anchor portion, a distal anchor portion, and a central portion disposed between the proximal anchor portion and the distal anchor portion, the connector portion whose thickness varies. Can be in the middle part. The central portion will include a portion having a substantially uniform thickness.

The present invention may also include embodiments in which the connector has an integral proximal anchor actuation element, an integral deployment attachment element, and / or an integral anchor position stop.
The anatomy of the heart and surrounding blood vessels varies from patient to patient. For example, the location of the rotating artery and other important arteries relative to the coronary sinus is different. Specifically, the distance along the coronary sinus from the ostium to the intersection with the rotating artery varies from patient to patient. In addition, the diameter and length of the coronary sinus varies from patient to patient.

  We have a set of tissue shaping devices that maximize the therapeutic effect (ie, reduced mitral regurgitation) while minimizing adverse effects such as unacceptable compression of the rotating artery or other coronary arteries. Invented the tissue shaping apparatus and method. The tissue shaping devices, device sets and methods of the present invention allow the practitioner to adapt the treatment to the patient's anatomy.

  One form of the present invention provides a tissue shaping device adapted to be placed in a blood vessel near a patient's heart to reshape the patient's heart, wherein the tissue shaping device comprises: It has an expandable anchor adapted to come into contact with the vessel wall by a radially outward force and preferably provides an anchoring force of at least 0.43 to 0.907 kg (1 to 2 pounds). The anchor, in some embodiments, has an expansion energy absorbing element adapted to limit the radially outward force on the vessel wall. In some embodiments, the anchor comprises a flexible wire, where the expansion energy absorbing element can be the bending point of the flexible wire. The bend point may have a portion of the flexible wire with an increased curvature compared to the adjacent wire portion or may be a loop formed in the flexible wire. The flexible wire of the anchor can be arranged in a substantially figure eight shape, in which case there are at least two expansion energy absorbing elements, such as the two bending points of the flexible wire. Can be.

  In some embodiments, the anchor can be a naturally expandable anchor, and in other embodiments, the anchor is optionally an actuated anchor having a movable actuator and a locking member. be able to. The actuator can be used to expand the anchor as the actuator moves distally. In the case of an anchor made of flexible wire, distal movement can move at least a portion of the flexible wire distally when the anchor is expanded.

  The present invention also includes a method of deploying a tissue shaping device having an anchor and an expansion energy absorbing element within a blood vessel. The method includes delivering a tissue shaping device to a treatment site in a blood vessel, expanding the anchor with the expansion energy of the anchor, and applying a radially outward force against the vessel wall (eg, at least 0.453 to Providing a force, such as a fixing force of 0.907 kg (1 to 2 pounds), and absorbing at least a portion of the extended energy within the absorbing element of the extended energy. In some embodiments, the absorbing step includes limiting a radially outward force applied to the wall.

  In embodiments where the anchor has a flexible wire and the expansion energy absorbing element has a bending point in the flexible wire, the step of absorbing includes bending the flexible wire about the bending point. In embodiments where the flexible wire is disposed in a substantially 8-shaped configuration, the anchor has a second extension energy absorbing element, such as a second bending point in the flexible wire; Also, the step of absorbing can include bending the flexible wire about the first and second bending points.

  In some embodiments, the expanding step can include applying an actuation force to the actuator to provide the expansion energy of the anchor, such as by moving the actuator (eg, moving the actuator distally). . The expanding step can also include allowing the anchor to naturally expand.

  In some embodiments, the delivering step can include delivering the tissue shaping device through the catheter to the treatment site in an unexpanded configuration, and allowing the natural expansion extends the anchor from the catheter. Steps may be included. The method can also include compressing the tissue shaping device to an unexpanded configuration and placing the tissue shaping device within the catheter prior to the delivering step.

Hereinafter, the present invention will be described in more detail with reference to the drawings.
FIG. 1 shows a partial view of a human heart 10 and several surrounding anatomical structures. The main coronary venous vessel is defined as starting from the opening to the ostium 14 or right atrium and extending through the great cardiac vein to the anterior ventricular (“AIV”) groove or groove 16. It is. Also shown is the mitral valve 20 surrounded by the mitral annulus 22 and adjacent to at least a portion of the coronary sinus 12. The rotating artery 24 shown in FIG. 1 extends between the coronary sinus 12 and the heart. The relative dimensions and positions of each of these structures vary from individual to individual.

  A tissue shaping device 30 is disposed in the coronary sinus 12. As shown in FIG. 1, the distal end 32 of the device 30 is disposed proximal to the circumflex artery 24 to reshape the adjacent mitral annulus 22 and thereby reduce mitral valve regurgitation. As shown in FIG. 1, the device 30 includes a distal anchor 34, a proximal anchor 36, and a connector 38.

  In the embodiment of FIG. 1, the proximal anchor 36 is deployed completely within the coronary sinus. In the alternative embodiment shown in FIG. 2, the proximal anchor is at least partially deployed outside the coronary sinus.

  3 to 6 show the method according to the invention. As shown in FIG. 3, the catheter 50 is manipulated as known in the art through the ostium 14 and into the coronary sinus 12. For guidance through the patient's venous system, the catheter 50 preferably has an outer diameter of 10 French or less, most preferably 9 French or less. A non-expanded device 30 is disposed within the catheter 50 and a tether or control wire 52 extends rearwardly through the catheter 50 from the device 30 to the outside of the patient's body. In some embodiments, the control wire 52 is a U.S. patent application S.A. N. It may include multiple tethers and control wire elements, such as those described in 10 / 331,143.

  According to one preferred embodiment, the device is deployed as distally as possible without applying significant compressive force to the rotating artery or other coronary aorta. Thus, the distal end of the catheter 50 is disposed at the position of the distal anchor located proximal to the intersection between the rotating artery 24 and the coronary sinus 12, as shown in FIG. At this point, while the device 30 is held stationary by the control wire 52, the catheter 50 is withdrawn proximally, exposing the distal anchor 34 at the location of the distal anchor within the coronary sinus 12. . Alternatively, the catheter may be held stationary while the device 30 is advanced distally to expose the distal anchor.

  The distal anchor 34 is either a natural expandable anchor or an actuated anchor or a combination of a naturally expandable anchor and an actuated anchor. Once uncovered, the distal anchor 34 expands by natural expansion or expands by applying an actuating force (such as the force transmitted through the control wire 52), as shown in FIG. Engage with the inner wall of the coronary sinus 12. The anchoring force of the distal anchor, that is, the force that resists movement of the distal anchor in response to the proximal force, is not only to maintain the position of the device within the coronary sinus but also to be adjacent as described below. It must also be sufficient to allow the device to be used to reshape the tissue that it does. In a preferred embodiment, the distal anchor 34 engages the wall of the coronary sinus to provide a fixing force of at least 0.43 kg (1 lb) and most preferably at least 0.907 kg (2 lb). . Depending on the anchor design, the expansion energy of the anchor supplying the anchoring force is obtained by strain energy and / or actuating force stored in the anchor due to the compressive force for delivering the catheter.

  While the device 30 is held in place by the anchoring force of the distal anchor 34, the catheter 50 is further pulled proximally to a position just distal to the proximal anchor 36, as shown in FIG. Next, a proximal force is applied to the distal anchor 34 via the connector 38 by the control wire 52. In this embodiment, the distance between the distal anchor and the proximal anchor along the connector is constant, so that the proximal anchor 34 is stationary relative to the coronary sinus by the proximal force. The proximal anchor 36 moves proximally relative to the coronary sinus. This tightening action straightens the portion of the coronary sinus 12, thereby changing its shape and the shape of the adjacent mitral valve 20, moving the mitral valve cusp into the larger bone and reducing mitral regurgitation Let In some embodiments of the invention, the proximal anchor moves proximally by about 1 to 6 cm, most preferably at least 2 cm, in response to a force applied in the proximal direction. In other embodiments, such as embodiments where the distance between the distal anchor and the proximal anchor is not constant (such as when the connector length is variable), the proximal anchor is Despite the proximal force applied to the side anchor, it can remain substantially stationary relative to the coronary sinus.

  After a reasonable degree of mitral regurgitation has been achieved (eg, as determined by looking at a Doppler enhanced echocardiogram), a proximal anchor is deployed. US patent specification S.R. N. Other patient vital signs, such as cardiac perfusion, can also be monitored during this procedure, as described in US 10 / 366,585.

  In a preferred embodiment, the anchoring force of the proximal anchor, i.e., the force that resists the proximal anchor moving in response to the distal force, will not only keep the device in the coronary sinus but also It must be sufficient to make it possible to maintain a firm shape of the tissue. In one preferred embodiment, the proximal anchor engages the wall of the coronary sinus to provide a fixing force of at least 0.453 kg (1 pound), most preferably at least 0.907 kg (2 pounds). provide. As with the distal anchor, the expansion energy of the proximal anchor that provides anchoring force depends on the strain energy, actuation force or stored in the anchor due to compression to deliver the catheter depending on the anchor design. Obtained from a combination of both.

  In one preferred embodiment, the catheter 50 is withdrawn proximally to expose the proximal anchor 36, and then the proximal anchor 36 is allowed to apply an actuation force that naturally expands to expand the anchor. Or a combination of both, the proximal anchor is deployed. Next, the control wire 52 is removed and the catheter 50 is removed from the patient. The position and configuration of the device when deployed according to this method is shown in FIG.

  Alternatively, as shown in FIG. 2, proximal anchor 36 may be deployed at least partially outside the coronary sinus after tightening to alter the shape of the mitral valve tissue. it can. In both embodiments, the distal anchor 34 is disposed proximally from the intersection between the coronary sinus 12 and the circumflex artery 24 so that the anchoring force applied to the coronary sinus by the device 30 and All of the tissue reshaping force acts only on the proximal side of the intersection.

  In an alternative embodiment, the proximal anchor may be deployed before applying the proximal force to tighten the device and reshape the mitral valve tissue. An example of a device according to the invention is shown in FIG. The device 60 includes a naturally expandable distal anchor 62, a naturally expandable proximal anchor 64, and a connector 66. The design of the distal anchor 62 allows the anchor to retain its anchoring force when a proximal force is applied to the anchor to tighten, while the design of the proximal anchor 64 is distal after tightening. The proximal anchor is allowed to move proximally after deployment, while resisting movement toward the The tightening after deployment of the proximal anchor is described in US patent application specification S.D. filed Jan. 30, 2002, which is incorporated herein by reference. N. 10 / 066,426 for further details. Also in this embodiment, the distal anchor 62 is placed proximally from the intersection between the coronary sinus 12 and the rotating artery 24, so that any anchoring force applied to the coronary sinus by the device 30. The tissue shaping force acts only on the proximal side with respect to the intersection.

  After deployment, it may be desirable to move and / or remove or initially tighten the tissue shaping device and then retighten. Thus, in accordance with certain embodiments of the present invention, the device or one of its anchors can be re-constrained. For example, in the embodiment of FIG. 1, after the proximal anchor 36 is deployed, but before the control wire 52 is disengaged, the catheter 50 is moved distally to place the proximal anchor 36 in the catheter. For example, the configuration shown in FIG. 5 can be obtained. From this position, the tightening force along the connector 38 can be increased or decreased, after which the proximal anchor 36 can be redeployed.

  Alternatively, the catheter 50 may be advanced distally to reconstrain both the proximal anchor 36 and the distal anchor 34, for example in the form shown in FIG. From this position, the distal anchor 34 can be redeployed, a tightening force can be applied, and the proximal anchor 36 can be deployed as described above. In this state, the device 30 can be completely removed from the patient by simply withdrawing the catheter from the patient.

  X-ray fluoroscopy (eg, angiograms and venograms) is used to determine the relative position of the coronary sinus and the coronary artery, such as the convolution artery, including the intersection between the blood vessels, and the artery is coronary Whether it is between the sinus and the heart can be determined. While the heart is observed with a fluoroscope, radiopaque dye can be injected into the coronary sinus and artery in a known manner.

  One alternative method of determining the relative position of the blood vessels is shown in FIG. In this method, guide wires 70 and 72 are inserted into the coronary sinus 12 and the rotating artery 24 or other coronary arteries, and the relative positions of the guide wires are observed with a fluoroscope to identify the intersection 74.

  FIG. 8 shows one embodiment of a tissue shaping device according to the present invention. The tissue shaping device 100 includes a connector or support wire 102 having a proximal end 104 and a distal end 106. The support wire 102 is made of a biocompatible material such as stainless steel or a shape memory material such as Nitinol wire.

  In one embodiment of the present invention, the connector 102 comprises a double length nitinol wire disposed within the distal crimp tube 108 at both ends. On the proximal side of the proximal end of the crimp tube 108, a distal-side locking projection 110 formed by a support wire bent away from the longitudinal axis of the support wire 102 is provided. Is bent parallel to the longitudinal axis of the support and then bent again towards the longitudinal axis of the support to form one half 110a of the locking projection 110 on the distal side. From the distal projection 110, the wire continues through the proximal crimp tube 112 in the proximal direction. When exiting from the proximal end of the proximal crimp tube 112, the wire is bent to form an arrowhead proximal projection 114. The support wire 102 then passes back proximally through the proximal crimp tube 112 and reaches a position just proximal to the proximal end of the distal crimp tube 108 where the wire bends distally. A second half 110b of the locking projection 110 is formed.

  At the distal end of the connector 102 is an actuable distal anchor 120 formed by a flexible wire such as Nitinol or some other shape memory material. As shown in FIG. 8, one end of the wire forming the distal anchor is disposed in the distal clamp tube 108. After exiting the end of the crimp tube 108, the wire is bent upward and radially outward from the longitudinal axis of the crimp tube 108 to form an eight-shaped configuration. The wire then bends back in the proximal direction and forms one leg of the eight shape across the longitudinal axis of the crimp tube 108. The wire is then bent to form a double loop eyelet or loop 122 around the longitudinal axis of the support wire 102, after which the outer circumference of the longitudinal axis of the crimp tube 108 is radially outward and Extending rearwardly from the distal end, the other leg of the figure 8 is formed. Finally, the wire bends proximally and enters the distal end of the crimp tube 108 to complete the distal anchor 120.

  The distal anchor is expanded using a catheter or locking tool and an actuating force is applied to move the distal anchor eye 122 from the proximal position of the distal locking projection 110 in the connector to the distal engagement. Slide to the position on the end side of the stop projection 110. The bent portions 110a, 110b of the connector 110 are spaced wider than the width of the eye 122 and provide a camming surface for engagement. The distal movement of the eyelets 122 pushes these camming surfaces inwardly, causing the eyelets 122 to advance toward the distal end of the locking projection 110 and then into their original spaced position. Return and hold the eye 122 in the locked position.

  The actuating proximal anchor 140 is formed and acted in the same manner by moving the eyelet 142 over the locking projection 114. Both the distal anchor and the proximal anchor provide an anchoring force of at least 0.453 kg (1 lb), most preferably 0.907 kg (2 lb).

  FIG. 9 illustrates one method of delivering tissue shaping device 100 according to the present invention to a desired location in the body, such as a coronary sinus, to treat mitral regurgitation. As described above, the device 100 is preferably loaded and positioned at a desired location within the catheter 200 such that the proximal and distal anchors are in an unexpanded or deformed state. That is, the eyelet 122 of the distal anchor 120 is disposed on the proximal end side of the distal locking projection 110, and the eye 142 of the proximal anchor 140 is the proximal locking projection. It is arranged on the base end side of 114. The surgeon pushes the end of the device from the catheter 200 into the coronary sinus by advancing the device or retracting the catheter or combination thereof. A pusher (not shown) provides distal movement of the device relative to the catheter 200 and a tether 201 provides proximal movement of the device relative to the catheter 200.

  Due to the inherent elasticity of the material forming the distal anchor, the distal anchor begins to expand as soon as it exits the catheter. Once the device is properly positioned, the catheter 200 is advanced to apply an actuation force to the distal anchor's eye 122 and push the eye distally over the distal locking projection 110. The distal anchor 120 is further expanded and locked in place to securely engage the coronary sinus wall. Next, a proximal force is applied to the connector 102 and distal anchor 120 via a tether or control wire 201 extending within the catheter outside the patient to provide sufficient pressure on the tissue adjacent to the connector. In addition, the shape of the tissue is modified. In the case of a mitral valve, when the device provides sufficient pressure on the mitral valve using fluoroscopy, ultrasound imaging techniques or other imaging techniques, the ventricle is not affected without any other adverse effects on the patient. It can be seen that each contraction helps the mitral valve to close completely.

  The proximal-side anchor 140 moves in the proximal direction by the reshaping force in the proximal direction. For example, in one embodiment, the proximal anchor 140 can be moved proximally by about 1 to 6 cm, most preferably at least 2 cm, to reshape the mitral valve tissue. The proximal anchor 140 is then allowed to be deployed from within the catheter and begin to expand. The locking tool applies an actuating force to the proximal anchor's eyelet 142 to advance it distally over the proximal locking projection 114 to expand the proximal anchor and Lock and thereby firmly engage the coronary sinus wall to maintain the position of the proximal anchor and maintain the reshaping pressure of the connector against the coronary sinus wall. Alternatively, the catheter 200 may be advanced so that the proximal anchor 140 can be locked.

  Finally, the mechanism that secures the proximal end of the device can be released. In one embodiment, fixation is achieved by a braided loop 202 and a locking wire 204 at the end of the tether 201. The locking wire 204 is withdrawn, thereby releasing the loop 202 so that the loop can be pulled through the proximal locking projection 114 at the proximal end of the device 100.

  The effect of reducing mitral regurgitation using the device of the present invention can be maximized by deploying the distal anchor as far distally as possible in the coronary sinus. In some cases, for example, if the patient's circumflex artery crosses the coronary sinus relatively close to the ostium, or if the coronary sinus itself is shorter than normal, a relatively short tissue shaping device may be used. It would be desirable to transplant. As can be seen from FIG. 9, the anchor 120 extends proximally along the connector 102 within the catheter 200 when in its unexpanded configuration. However, by shortening the device by only shortening the connector, the proximal portion of the eyelet 122 and distal anchor 120 overlaps the portion of the proximal anchor when the device is loaded into the catheter, This requires that the catheter diameter be longer than required for longer types of devices. For mitral regurgitation applications, the preferred catheter diameter is 10 French or less (most preferably 9 France) and the tissue shaping device fits within the catheter when in the unexpanded configuration. You must

  10-23, an implementation of the device of the present invention having a flexible and expandable wire anchor that allows a tissue shaping device 60 mm or less in length to be delivered by a 10 French (or less) catheter. The form is shown. In some embodiments, one or both anchors are provided with a bend point, and the anchor is centered on this bend point when placed in an unexpanded configuration for delivery by the catheter or re-restraint within the catheter. Is deformed. These bend points allow the anchor to be configured to minimize the extent to which it overlaps with other elements of the device. In other embodiments, the distal anchor expands naturally, thereby proximally in the unexpanded form of the anchor that will overlap the unexpanded proximal anchor in the delivery and / or reconstraint catheter. Elongation makes eyes unnecessary.

  FIG. 10 shows an actuated anchor design suitable for a relatively short tissue shaping device similar to that shown in FIGS. In this embodiment, the distal anchor 300 is disposed on the distal side of the connector 302. As in the embodiment of FIG. 8, the anchor 300 is formed in an eight-shaped form by a flexible wire such as nitinol held by a crimp tube 304. The eyelet 306 is formed around the longitudinal axis of the connector 302. Due to the actuating force in the distal direction with respect to the eyelet 306, the eyelet moves above the locking projection 308 formed on the connector 302 to operate and lock the anchor 300.

  FIG. 10 shows the anchor 300 in an expanded configuration. When the anchor 300 and other parts of the tissue shaping device are loaded into the catheter and initially deployed and in a non-expanded configuration, such as a configuration suitable for treating mitral regurgitation, the eyelet 306 is engaged. It arrange | positions in the base end side of the stop protrusion 308, and compresses the 8-shaped loop of the anchor 300 with respect to the crimp part 304. FIG. A bending point 310 is formed in the distal strut of the anchor 300 to limit the proximal distance that the eyelet 306 must be moved along the connector to compress the anchor 300 into an unexpanded configuration. . The bending point 310 is an essentially twisted portion, that is, a portion having a large curvature formed in the wire. When the anchor 300 is compressed to the unexpanded configuration, the bend point 310 deforms and the upper arm 312 of the end strut bends about the bend point 310 and moves toward the lower arm 314 of the end strut, thereby The eyelet 306 and the proximal strut of the anchor limit the distance that it must move proximally along the connector to compress the anchor.

  Similarly, when the distal anchor is re-constrained in the catheter for redeployment or removal from the patient, the anchor 300 deforms about the bend point 310 and the eyelet 306 is used for locking during the re-restraint procedure. Even if it does not move in the proximal direction above the protrusion 308, the contour outline of the cross section of the anchor in the catheter is limited. The bending point can be provided on the proximal anchor in the same manner.

  As described above, the distal anchor 300 can be part of a tissue shaping device (such as that shown in FIGS. 8 and 9) having a proximal anchor and a connector disposed between the anchors. . To treat mitral regurgitation, the distal anchor 300 is deployed through the catheter and expanded by actuation force and anchored against the wall of the coronary sinus, preferably at least 1 pound. A anchoring force of at least 0.907 kg (2 pounds) can be provided and the anchor 300 can be locked in the expanded configuration. Proximal force is transmitted through the connector 302 distally, such as by moving the proximal anchor from about 1 to 6 cm, preferably at least 2 cm proximally, by pulling a tether or control wire that is manipulated from outside the patient. Added to the side anchor 300. A proximal anchor can then be deployed to maintain the reshaping force of the device.

  One feature of anchor 300 is the ability to adapt and adapt to a wide variety of vessel dimensions. For example, when the anchor 300 is expanded in a blood vessel such as a coronary sinus, the anchor's wire arm may cause the coronary sinus wall to move before the eyelet 306 is advanced distally over the locking projection 308. And the anchor can be locked in place. As the eyepiece 306 continues to advance distally, some outward force is generated in the coronary sinus wall, and much of the energy applied into the anchor by the actuation force of the anchor is absorbed by the distal struts. Absorbed by deformation about bend point 310, this distal strut will act as an absorbing element for the expansion energy and limit the radially outward force applied to the coronary sinus wall. This feature allows the anchor to be used in a wider range of vessel sizes while reducing the risk of vascular overdilation.

  FIG. 11 shows another anchor design suitable for a shorter tissue shaping device similar to that shown in FIGS. In this embodiment, the distal anchor 320 is disposed on the distal side of the connector 322. As in the embodiment of FIG. 8, the anchor 320 is formed in a figure eight shape from a flexible wire such as nitinol held by a crimp tube 324. However, unlike the embodiment of FIG. 10, the anchor 320 is naturally expanded and not actuated. The eyelet 326 is held in place by the second crimp portion 325 to limit or eliminate the proximal proximal end of the anchor from moving proximally or distally along the connector 322, for example. .

  FIG. 11 shows the anchor 320 in the expanded configuration. The anchor 320 and other parts of the tissue shaping device are loaded into the catheter, initially deployed, and in an unexpanded configuration, such as a configuration suitable for treating mitral regurgitation, the eight-shaped loop of anchor 320 Is compressed. Bend point 330 is formed on the end strut of anchor 320. When the anchor 320 is compressed to the unexpanded configuration, the bending point 330 deforms, causing the upper arm 332 of the distal strut to bend about the bending point 330 and move toward the lower arm 334 of the distal strut. . Depending on the exact location of the bend point 330, when the anchor 320 is in its unexpanded configuration, it is likely that the proximal portion of the wire portion of the anchor 320 will be disposed along the crimp 325 or connector 322. There are few or no parts to be arranged.

  Similarly, if the end anchor is deployed or re-restrained within the catheter for removal from the patient, the anchor 320 will deform about the bend point 330 to limit the cross-sectional profile of the anchor within the catheter. Become. The bending point may be provided on the proximal anchor in the same manner.

  The distal anchor 320 can be part of a tissue shaping device (such as that shown in FIGS. 8 and 9) having a proximal anchor and a connector disposed between the anchors. Due to the superelastic properties of the constituent shape memory material, the distal anchor 320 is deployed through the catheter and spontaneously expands and settles against the wall of the coronary sinus, preferably at least 1 pound. A fixing force of at least 0.907 kg (2 pounds) can be provided. The proximal force is then applied to the connector by moving the proximal anchor, eg, about 1 to 6 cm, more preferably at least 2 cm proximally, by pulling a tether or control wire that can be actuated from the outside of the patient. It can be added to the distal anchor 320 via 322. The proximal anchor can then be deployed to maintain the reshaping force of the device.

  FIG. 12 shows another embodiment of an anchor suitable for use in a shorter tissue shaping device. In this embodiment, the distal anchor 340 is disposed on the distal side of the connector 342. As in the embodiment of FIG. 11, the anchor 340 is formed in an 8-shaped form from a flexible wire such as nitinol held by a crimp tube 344. As in this embodiment, the anchor 340 is a natural expansion type and not an operation type. The anchor 340 loop forming the anchor proximal strut extends through a loop 346 extending distally from the second crimp 345 so that the anchor proximal strut is proximal, eg, along the connector 342. Restrict or eliminate movement in the direction or in the distal direction.

  FIG. 12 shows the anchor 340 in an expanded configuration. Similar to the device of FIG. 11, the anchor 340 and other portions of the tissue shaping device are initially loaded into the catheter and deployed in a non-expanded configuration, such as a configuration suitable for treating mitral regurgitation. The 8-shaped loop of anchor 340 is compressed. However, unlike the embodiment of FIG. 11, the bending point 350 is formed on the proximal column of the anchor 340. As anchor 340 is compressed to the unexpanded configuration, bend point 350 deforms, causing distal strut upper arm 352 to bend about bend point 350 and move toward lower strut lower arm 354. The amount of wire portion of anchor 340 that extends proximally along crimp portion 345 and connector 342 in its unexpanded configuration depends on the location of bend point 350. In one embodiment, the bending point is formed on the uppermost and widest portion of the proximal column.

  The distal anchor 340 can be part of a tissue shaping device (such as that shown in FIGS. 8 and 9) having a proximal anchor and a connector disposed between the anchors. Due to the superelastic properties of the shape memory material, the distal anchor 340 is deployed through the catheter and spontaneously expands and settles against the wall of the coronary sinus and is at least 0.43 kg (1 lb), preferably at least 0. A fixing force of .907 kg (2 pounds) can be provided. The proximal force is then applied by pulling a tether or control wire that is actuated from outside the patient, for example, by moving the proximal anchor proximally by about 1 to 6 cm, more preferably at least 2 cm. It can be added to the distal anchor 340 via a connector 342. The proximal anchor can then be deployed to maintain the reshaping force of the device.

  For example, the bending point 350 adds anchoring force to the distal anchor 340 by increasing the height of the anchor as the proximal strut becomes more perpendicular to the connector in response to proximal forces. To increase the fixing power. In the same manner, the anchoring force of the proximal anchor can be increased by adding a bending point to the distal strut of the proximal anchor in response to the distal force.

  FIG. 13 shows yet another embodiment of an anchor suitable for use in a shorter tissue shaping device. In this embodiment, the distal anchor 360 is disposed on the distal side of the connector 362. As in the embodiment of FIG. 12, the anchor 360 is formed in an 8-shaped form from a flexible wire such as nitinol held by a crimp tube 364. As in this embodiment, the anchor 360 is a natural expansion type and not an operation type. The anchor 360 loop forming the anchor proximal strut passes through a loop 366 extending distally from the second crimp portion 365 and the anchor proximal strut proximally along the connector 362, for example. Or restrict or eliminate movement in the distal direction.

  FIG. 13 shows the anchor 360 in an expanded configuration. Similar to the device of FIG. 12, the anchor 360 and other parts of the tissue shaping device are loaded into the catheter and initially deployed, and are in an unexpanded configuration, such as a configuration suitable for treating mitral regurgitation. When the anchor 360's 8-shaped loop is compressed. However, unlike the embodiment of FIG. 12, bend points 370 are formed on both the proximal and distal struts of anchor 360.

The anchor 360 can be used as a part of the tissue shaping device as in the above-described embodiment.
FIG. 14 shows an actuated anchor design suitable for a shorter tissue shaping device similar to that shown in FIGS. In this embodiment, the distal anchor 380 is disposed on the distal side of the connector 382. As in other embodiments, the anchor 380 is formed in a figure eight shape from a flexible wire such as nitinol held by a crimp tube 384. Unlike the embodiment of FIG. 10, eyelets 386, 387 are formed on each of the anchor proximal struts about the longitudinal axis of the connector 382. This arrangement reduces the radially outward force of the anchor. The distal actuation force applied to the eyelets 386, 387 moves these eyelets over the locking projections 388 formed on the connector 382 to actuate and lock the anchor 380.

  FIG. 14 shows the anchor 380 in an expanded configuration. In a non-expanded configuration, such as a configuration suitable for first loading the anchor 380 and other portions of the tissue shaping device into a catheter and treating mitral regurgitation, the eyelets 386, 387 are locked The eight-shaped loop of the anchor 380 is compressed with respect to the crimp 384. Bend point 390 is formed in the distal strut of anchor 380 to limit the proximal distance that eyepieces 386, 387 must move to compress anchor 380 into an unexpanded configuration. When the anchor 380 is compressed into the unexpanded configuration, the bend point 390 deforms and the upper arm 392 of the distal strut bends about the bend point 390 and moves toward the lower arm 394 of the distal strut, In order to compress the eye, the distance that the eyes 386, 387 and the proximal strut of the anchor must move proximally along the connector is limited.

  If the distal anchor is to be reconstrained within the catheter for redeployment or removal from the patient, the anchor 380 deforms about the bend point 390 and the eyelets 386, 387 are locked during the reconstraination procedure. Limits the cross-sectional geometry of the anchor in the catheter even when it does not move proximally over the protuberance 388. The bending point may also be provided on the proximal anchor in the same manner.

  Similar to the other embodiments described above, the distal anchor 380 is a tissue shaping device (such as that shown in FIGS. 8 and 9) having a proximal anchor and a connector disposed between the anchors. Can be part. To treat mitral regurgitation, distal anchor 380 is deployed from the catheter and expanded by actuation force and anchored against the wall of the coronary sinus, at least 1 pound, preferably at least 0. Provides anchoring force of 907 kg (2 pounds) and locks anchor 380 in an expanded configuration. Proximal force is distal through the connector 388, such as by moving the proximal anchor proximally by pulling a tether or control wire actuated from outside of the patient by about 1 to 6 cm, preferably at least 2 cm. Added to anchor 380. The proximal anchor can then be deployed to maintain the reshaping force of the device.

  As in other embodiments, one feature of anchor 380 is the ability to adapt and adapt to a wide variety of vessel dimensions. For example, when the anchor 380 is expanded within a blood vessel such as a coronary sinus, the anchor's wire arms have their eyes 386, 387 advanced distally over the locking projections 388 to bring the anchor into position. The wall of the coronary sinus can be contacted prior to locking. As the eye 386 continues to advance distally, some outward force is generated against the wall of the coronary sinus, and much of the energy applied into the anchor by the actuation force of the anchor is bent by the distal strut. It will be absorbed by deforming around the point 390.

  FIG. 15 illustrates yet another embodiment of an actuation anchor for use within a shorter tissue shaping device. The proximal anchor 400 is disposed on the proximal end side of the connector 402. As in other embodiments, the anchor 400 is formed in a figure eight shape from a flexible wire such as Nitinol held by a crimp tube 404. The eyelet 406 is formed around a locking projection 408 extending from the crimp portion 404 in the proximal direction. The actuating force in the distal direction applied to the eyelet 406 moves the eyelet above the locking projection 408 to operate and lock the anchor 400.

  FIG. 15 shows the anchor 400 in an expanded configuration. When the anchor 400 is compressed to the unexpanded configuration, the bending point 410 formed as a loop in the anchor wire deforms, the upper arm 412 of the distal strut bends about the bending point 410 and the lower arm of the distal strut Move towards 414. As in other embodiments, proximal anchor 400 is a portion of a tissue shaping device (such as that shown in FIGS. 8 and 9) having a distal anchor and a connector disposed between the anchors. It can be.

  As in other embodiments, one feature of anchor 400 is the ability to adapt and adapt to a wide variety of vessel dimensions. For example, when the anchor 400 is expanded in a blood vessel such as a coronary sinus, the anchor wire arm causes the eyelet 406 to advance distally over the locking projection 408 to engage the anchor in place. Before stopping, the wall of the coronary sinus can be contacted. As the eye 406 continues to advance distally, some outward force is generated in the coronary sinus wall, and much of the energy input into the anchor by the actuator actuation force is bent by the distal strut. It will be absorbed by deformation about point 410, and the distal strut acts as an expansion energy absorbing element and limits the radially outward force applied to the coronary sinus wall.

  In other embodiments, the loop bend point of the embodiment of FIG. 15 can be formed on the proximal strut of the anchor in addition to or instead of the bend point on the distal strut. The loop bend embodiment can also be used at the distal anchor (without a crimp or connector) as shown in FIG. In the embodiment of FIG. 16, it should be noted that the proximal and distal struts, as well as the eyelets 422 and bend points 424 of the anchor 420 are formed from a single wire.

  FIG. 17 shows one embodiment of a distal anchor 440 similar to that shown in FIG. 10 that is suitable for use with a shorter tissue shaping device. However, in this embodiment, an additional twist 442 is added to the apex of the anchor's 8-shaped pattern. As in the embodiment of FIG. 10, the bend point 444 is formed on the anchor's distal strut. As shown, the anchor 440 is operable by moving the eyelet 446 distally over a locking projection 448 formed on the connector 450. The anchor 440 can also be formed as a naturally expandable anchor by limiting or eliminating the movement of the proximal strut of the anchor 440 along the connector 450 as in the embodiment shown in FIG. As in other embodiments, the bend point helps the anchor 440 adapt and adapt to different vessel dimensions. In addition, the additional twist 442 also helps the anchor adapt to different vessel diameters by keeping the anchor vertices aligned with each other.

  As in other embodiments, the anchor 440 is preferably formed of nitinol wire. The anchor 440 is used as a part of the tissue shaping device in the same manner as the anchor of FIG. 10 (in the case of the actuated anchor embodiment) or the anchor of FIG. 11 (in the case of the naturally expandable anchor embodiment). Is possible. The anchor 440 may be used as a proximal anchor.

  FIG. 18 shows one embodiment of a distal anchor 460 similar to the anchor of FIG. However, in this embodiment, the bend point 462 is formed on the proximal strut of the anchor as in the naturally expandable anchor shown in FIG. As in the embodiment of FIG. 17, an additional twist 464 is added to the apex of the anchor's 8-shaped pattern. As shown, the anchor 460 can be actuated by moving the eyelet 466 distally over a locking projection 468 formed in the connector 470. The anchor 460 can also be a naturally expandable anchor by limiting or eliminating movement of the proximal connection point of the anchor 460 along the connector 470, as in the embodiment shown in FIG. As in the embodiment of FIG. 17, the bend points help the anchor 460 adapt and adapt to different vessel dimensions. In addition, the additional twist 464 also helps the anchor adapt to different vessel diameters by keeping the anchor vertices aligned with each other.

  As in other embodiments, the anchor 460 is preferably formed of nitinol wire. Anchor 460 is used as part of the tissue shaping device in a manner similar to that of FIG. 10 (for the actuated anchor embodiment) or FIG. 11 (for the naturally expandable anchor embodiment). can do. The anchor 460 can also be used as a proximal anchor.

  FIG. 19 shows one embodiment of a naturally expandable distal anchor 480 suitable for use in a shorter tissue shaping device. As in other embodiments, the anchor 480 is formed in a figure eight shape from a flexible wire, such as nitinol, held by a crimp tube 482. However, the base of the figure eight pattern is relatively narrow in this embodiment and the anchor proximal strut 484 extends through the crimp 482.

  The distal anchor 480 can be part of a tissue shaping device (such as that shown in FIGS. 8 and 9) having a proximal anchor and a connector disposed between the anchors. To treat mitral regurgitation, the distal anchor 480 is deployed from the catheter and spontaneously expands and settles against the wall of the coronary sinus and is at least 0.453 kg (1 pound), preferably at least 0.907 kg ( 2 pounds) of fixing power can be provided. By pulling a tether or control wire that is actuated from outside the patient, the proximal force is moved distally through the connector 486, such as by moving the proximal anchor proximally by about 1 to 6 cm, more preferably at least 2 cm. Added to anchor 480. The proximal anchor can then be deployed to maintain the reshaping force of the device.

  FIG. 20 shows one embodiment of a distal anchor that is suitable for use in a shorter tissue shaping device and is similar to the anchor of FIG. In this embodiment, the distal anchor 500 is deployed on the distal side of the connector 502. As in other embodiments, the anchor 500 is formed in a figure eight shape from a flexible wire such as nitinol held by a crimp tube 504. The eyelet 506 is formed around the longitudinal axis of the connector 502. By the actuating force in the distal direction with respect to the eyelet 506, the eyelet moves above the locking protrusion 508 formed on the connector 502 to operate and lock the anchor 500.

  However, the angle of the proximal strut 501 and the angle of the distal strut 503 are larger than the corresponding angles of the embodiment of FIG. 10, and the anchor 500 is wider than the height when expanded as shown. Expand. When the anchor 500 and other portions of the tissue shaping device are initially loaded into the anchor and are in a non-expanded configuration, such as a configuration suitable for treating mitral regurgitation, the eye 506 Deployed on the proximal end side of the locking projection 508, the 8-shaped loop of the anchor 500 is compressed into the crimp portion 504. In order to limit the proximal distance that the eye 506 must move along the connector in order to compress the anchor 500 to the unexpanded configuration, the bend point 510, as in the embodiment of FIG. 503 to limit the width of the device in the non-expanded configuration within the catheter.

  The distal anchor 500 can be part of a tissue shaping device (such as that shown in FIGS. 8 and 9) having a proximal anchor and a connector disposed between the anchors. To treat mitral regurgitation, the distal anchor 500 is deployed from the catheter and expanded by actuation force and settles against the wall of the coronary sinus, at least 0.43 kg (1 lb), preferably at least 0. 0. Provides anchoring force of 907 kg (2 pounds) and locks anchor 500 in an expanded configuration. Proximal force is transmitted through the connector 502 by pulling a tether or control wire that is actuated from outside the patient, such as by moving the proximal anchor proximally about 1 to 6 cm, more preferably at least 2 cm. Added to the side anchor 500. The proximal anchor can then be deployed to maintain the reshaping force of the device.

The anchor shown in FIG. 20 can be used as a proximal anchor. This anchor may be formed as a naturally expandable anchor.
FIG. 21 shows a tandem distal anchor according to another embodiment according to the present invention. The naturally expandable anchor 520 is formed in a figure eight shape from a flexible wire such as nitinol held by a crimp tube 522. The eyelet 524 is held in place by the distal end of the actuating anchor 540 to limit or eliminate movement of the proximal strut of the anchor 520 in the proximal and distal directions. As in the anchor shown in FIG. 11, a bending point 530 is formed on the distal strut of the anchor 520. Depending on the exact location of the bend point 530, there is very little or no wire portion of the anchor 520 disposed on the proximal proximal side of the anchor 540 when the anchor 520 is in its unexpanded configuration.

  Similarly, if the distal anchor is re-restrained within the catheter for redeployment or removal from the patient, the anchor 520 deforms about the bend point 530 and the cross-sectional profile of the anchor within the catheter. It will limit the external shape. The bending point may also be provided on the proximal anchor in the same manner.

  The anchor 540 is the same as the anchor 120 shown in FIG. The anchor 540 is formed in an 8-shaped form from a flexible wire such as nitinol held by a crimp tube 544. The eyelet 546 is formed around the longitudinal axis of the connector 542. Due to the actuating force applied to the eyelet 546 in the distal direction, the eyelet moves above the locking protrusion 548 formed on the connector 542 to actuate and lock the anchor 540.

  Tandem anchors 520, 540 can be part of a tissue shaping device (such as those shown in FIGS. 8 and 9) having a proximal anchor and a connector disposed between the anchors. Anchors 520, 540 can be formed from a single wire or separate pieces of wire. To treat mitral regurgitation, distal anchors 520, 540 can be deployed from the catheter. Next, the naturally expandable anchor 520 is naturally expanded and the actuatable anchor 540 is expanded and locked by actuating force to anchor both anchors to the coronary sinus wall, at least 0. It provides a fusing power of 453 kg (1 lb), preferably at least 0.907 kg (2 lb). By pulling a tether or control wire actuated from the outside of the patient, the proximal force is moved through the connector 542, such as by moving the proximal anchor proximally about 1 to 6 cm, more preferably at least 2 cm. To the anchors 520 and 540. A proximal anchor can then be deployed to maintain the reshaping force of the device.

Although the anchor designs described above have been described as part of a shorter tissue shaping device, these anchors can be used in any length of tissue shaping device.
22 and 23 show one alternative embodiment in which the device connector 560 is integrated with the distal and proximal crimp tubes 562, 564. FIG. In this embodiment, the connector 560 is formed by scraping a portion of a blank such as a Nitinol cylinder or tube, leaving the crimp tube portions 562, 564 intact. For this reason, the radius of the semicircular cross-section connector is equal to the radius of the two anchor crimp tubes.

  Of course, other connector shapes for the integral connector and crimp designs are possible. For example, the device removes the rectangular edge portion from the central portion and forms an I-shaped sheet (eg, nitinol or stainless steel) having a wider width at the end and a narrower width at the central connector portion. The device can be formed from a blank in the form of a flat ribbon or sheet. The ends can then be rolled to form a crimp tube so that the connector remains substantially flat. Furthermore, in an alternative embodiment, the connector can be integrated with one anchor.

  As shown in FIG. 23, the distal anchor 566 is formed in a figure eight shape from a flexible wire such as Nitinol. The distal anchor 566 is a natural expansion type, and the proximal strut 568 is held in a required position by a crimp tube 562. Selective bending points can be formed on the proximal strut 568 or the distal strut 570 of the anchor 566.

  Proximal anchor 572 is also formed in a figure eight shape from a flexible wire, such as Nitinol, which has an eye 574 at the proximal end. The distal actuating force applied to the eyelet 574 moves the eyelet above the locking projection 576 extending proximally from the crimp tube 564 to actuate and lock the anchor 572. . The locking projection 576 also acts as a connection point for the tether or control wire, deploying and operating the device in the manner described above with respect to FIGS. Selective bending points can be formed on the proximal or distal struts of anchor 572.

  When deployed in the coronary sinus to treat mitral regurgitation, the tissue shaping device of the present invention is subject to periodic bending and tension loads as the patient's heart beats. FIG. 24 shows an alternative connector for use with the tissue shaping device of the present invention that distributes all strain due to bending and pulling loads between beats over a wider area of the device.

  The connector 600 has a proximal anchor region 602, a distal anchor region 604, and a central region 606. The distal anchor region is longer than the distal anchor attached to the distal anchor region, and the proximal anchor region is longer than the proximal anchor attached to the proximal anchor region. be able to. An optional locking projection 608 can be formed at the proximal end of the connector 600 for use with the actuated proximal anchor and for connection to a tether or control wire, as described above. An optional extension 610 can be formed at the distal end of the connector 600 to prevent the distal anchor from accidentally sliding distally.

  In order to reduce material fatigue due to loading and unloading of the tissue shaping device between heart beats, the moment of inertia of connector 600 is a connector disposed along its length, particularly between two anchors. It changes in the part. For example, in this embodiment, the connector 600 is preferably formed of nitinol formed as a ribbon or sheet and having a rectangular cross-sectional area. The thickness of the connector 600 is preferably constant in the proximal anchor region 602 and the distal anchor region 604, so that the crimp portion and other components of the anchor can be easily attached. The central region 606 has a thickness that decreases from the boundary between the central region 606 and the proximal anchor region 602 to approximately the center point of the central region 606 (thus reducing the moment of inertia), and , Having a thickness (the moment of inertia increases) that increases from that point to the boundary between the central region 606 and the distal anchor region 604. The changing thickness and changing cross-sectional shape of the connector 600 changes the moment of inertia along its length, thereby allowing all distortions due to loading and unloading of the device between heartbeats over a wider area. And helps reduce the chance of fatigue failure of the connector material.

  FIG. 25 shows another embodiment of the connector. Similar to the previous embodiment, the connector 620 has a proximal anchor region 622, a distal anchor region 624, and a central region 626. Proximal anchor region 622 has two optional crotch bifurcations 628 formed at its proximal end to facilitate attachment of crimps and other anchor elements. A bent branch 629 can be formed at the proximal end of the branch to prevent accidental slipping of the proximal anchor. The optional extension 630 can prevent accidental slipping of the distal anchor formed at the distal end of the connector 620.

  Similar to the embodiment of FIG. 24, the connector 620 is formed as a ribbon or sheet and is preferably formed of nitinol having a rectangular cross-sectional area. The thickness of the connector 620 is preferably constant within the proximal anchor region 622 and the distal anchor region 624 to facilitate attachment of the crimp and other anchor components. The central region 626 has a thickness (the moment of inertia decreases) that decreases from the boundary between the central region 626 and the proximal anchor region 622 to approximately the center point of the central region 626, and at that location. To a boundary between the central region 626 and the distal anchor region 624 (the moment of inertia increases). The changing thickness and changing cross-sectional shape of the connector 620 changes the moment of inertia along its length, thereby allowing all distortions due to the load and unloading of the device between heartbeats over a wider area. And helps reduce the chance that the connector material will fatigue.

  FIG. 26 shows the outline of the connector 640. The connector 640 can be formed like the connectors 600, 620 shown in FIG. 24 or FIG. 25, respectively, or can have several other forms. Connector 640 includes a proximal anchor region 642, a distal anchor region 644, and a central region 646. Connector 640 is preferably formed as a ribbon or sheet, and is preferably formed of nitinol having a rectangular cross-sectional area.

  In the embodiment shown in FIG. 26, the thickness of the proximal anchor region 642 and the distal anchor region 644 is constant. The thickness of the central region 646 decreases from the boundary between the central region 646 and the proximal anchor region 642 to a location distal to the boundary and the boundary region between the distal anchor region 644 and the central region 646. It increases from the proximal end to the boundary. The locations in the central region where the thickness decrease stops and the thickness increase begins can be matched or separated to form a uniform thickness region in the central region 646. In this embodiment, the thickness of the central region varies as a function of the square root of the distance from the boundary between the central region and the proximal anchor region and the distal anchor region.

  FIG. 27 shows still another embodiment of the connector. As in the embodiment of FIG. 26, the connector 650 can be formed similar to the connectors 600, 620 of FIGS. 24, 25, respectively, or can have several other forms. Connector 650 has a proximal anchor region 652, a distal anchor region 654, and a central region 656. Connector 650 is preferably formed as a ribbon or sheet, and is preferably formed of nitinol having a rectangular cross-sectional area.

  In the embodiment shown in FIG. 27, the thickness of the proximal anchor region 652 and the distal anchor region 654 is constant. The thickness of the proximal portion 658 of the central region 656 decreases linearly from the boundary between the central region 656 and the proximal anchor region 652 to a constant thickness central portion 662 of the central region 656, and The thickness of the distal region 600 of the central region 656 increases linearly from the central region 662 to the boundary between the distal anchor region 654 and the central region 656.

  In other embodiments, the thickness of the connector varies in other ways. Furthermore, the cross-sectional shape of the connector may be a shape other than a rectangle, and may change along the length of the connector.

  28 and 29 show still another embodiment of the present invention. The tissue shaping device 700 has a connector 706 disposed between the proximal anchor 702 and the distal anchor 704. The connector 706 can be formed as a ribbon or sheet, such as the tapered connector shown in FIGS. The actuated proximal anchor 702 is formed from a flexible wire such as Nitinol in the shape of an eight and is fastened to the connector 706 by a crimp tube 708. Similarly, the naturally expandable distal anchor 704 is formed in a figure eight shape by a flexible wire such as Nitinol and fastened to the connector 706 by a crimp tube 710. Proximal locking projections 716 are used to actuate and lock the proximal anchor 702 and from the proximal anchor 702 to connect to a tether or control wire as described above. It extends in the proximal direction.

  Bend point 712 is formed in the loop of proximal anchor 702 and bend point 714 is formed in the loop of distal anchor 704. When compressed to its unexpanded form for delivery and deployment by the catheter, or to re-restraint within the catheter for deployment or removal, the wire portions of the anchors 702, 704 are centered about the bend points 712, 714, respectively. Bend and limit the cross-sectional profile of the anchor in the catheter. As described above, the bending point also affects the anchor strength of the anchor and the adaptability of the anchor to different vessel diameters.

  In addition to varying coronary sinus length and distance from the ostium to the intersection between the coronary sinus and the rotating artery, the diameter of the coronary sinus at the distal and proximal anchor locations is Is different. The above-mentioned anchor can be formed at various heights and can be combined with connectors having different lengths to cope with differences among patients. For example, a tissue shaping device deployed in the coronary sinus to treat mitral regurgitation has a distal anchor height in the range of about 7 mm to about 16 mm and a base in the range of about 9 mm to about 20 mm. And the height of the end anchor.

  When treating a patient with mitral regurgitation, the proper length of the tissue shaping device and the proper anchor height relative to the distal and proximal anchors can be estimated. The clinician then selects a tissue shaping device having the proper length and anchor size from a set or sets of devices having different lengths and different anchor dimensions formed, eg, according to the above-described embodiments. be able to. These sets of devices can be assembled into multiple sets or kits, or simply a collection or inventory of different tissue shaping devices.

  One method for estimating the proper length and anchor size of the tissue shaping device for mitral regurgitation is to observe a fluoroscopic image of the coronary sinus with a catheter with a marker visible by fluoroscopy. It is to be. The intersection between the coronary sinus and the rotating artery is determined as described above, and the screen size of the coronary sinus length proximal to the location and the diameter of the coronary sinus at the intended anchor location. Can be measured. Thus, by measuring the distance of the catheter marker on the screen and comparing that distance with the actual distance between the catheter markers, the length and diameter measurements can be adjusted to the actual dimensions. A tissue shaping device having the proper length and anchor size can be selected from a set of devices or in-stock devices deployed in the patient's body to treat mitral regurgitation.

  FIG. 30 shows still another embodiment of the method of the present invention. In this embodiment, a tissue shaping device 800 formed from a substantially straight rigid member 802 is disposed within the coronary sinus 804 to treat mitral regurgitation. When deployed as shown, the central portion of rigid member 802 applies a remodeling force forward through the coronary sinus toward mitral valve 806, while the proximal end 808 and distal end of rigid member 802 Each 810 applies a posterior force to the wall of the coronary sinus. In accordance with the present invention, the device 800 is disposed relative to the rotating artery 812, so that the distal end 810 of the device 800 and the guidewire portion 814 are distal to the intersection, but from the rigid member 802. All of the forward force is behind the intersection between the artery 812 and the coronary sinus 804.

  The device of FIG. 30 can also have a less rigid portion at the distal end 810 of member 802 to further relieve any force directed at the mitral valve distal to the intersection. Further details of the apparatus (other than the method of the present invention) can be found in U.S. Patent Application Specification No. S.S. 2002/018838, which is incorporated herein by reference. N. 10 / 112,354.

  FIG. 31 shows another embodiment of the method according to the invention. The device 900 has a substantially straight rigid portion 902 disposed within the coronary sinus 908 between the proximal angled portion 904 and the distal angled portion 906. As shown, proximal angled portion 904 extends through coronary sinus ostium 910 within a catheter (not shown). The distal angled portion 906 extends distally to a hooked portion 912 that is preferably disposed on the AIV.

  To treat mitral regurgitation, the straight portion 902 of the device reshapes the coronary sinus and adjacent tissue and applies an anterior force toward the mitral valve 914 through the coronary sinus wall. . Because of the design of the device, this reshaping force is applied to the coronary sinus 908 and the patient's circumflex artery 916, even though at least a portion of the device distal portion 906 and hooked portion 912 are disposed distal to the intersection. Is added only in the proximal direction to the intersection between and.

  Other variations of the invention described in the claims will be apparent to those skilled in the art and are intended to be encompassed by the claims.

1 is a schematic diagram illustrating a tissue shaping device according to a preferred embodiment deployed in a coronary sinus. FIG. FIG. 6 is a schematic diagram illustrating a tissue shaping device according to one alternative embodiment deployed in a coronary sinus. It is the schematic which shows the tissue shaping apparatus sent out to a coronary sinus within a catheter. 1 is a schematic diagram illustrating a tissue shaping device partially deployed in a coronary sinus. 1 is a schematic diagram illustrating a tissue shaping device partially deployed and tightened in a coronary sinus. FIG. It is a top view which shows another embodiment of the tissue shaping apparatus according to this invention. FIG. 6 is a schematic diagram illustrating a method for determining an intersection between a rotating artery and a coronary sinus. 1 is a perspective view showing a tissue shaping device according to one embodiment of the present invention. FIG. 9 is a partial cross-sectional view of the tissue shaping device of FIG. 8 in an unexpanded configuration within the catheter. 1 is a perspective view showing an anchor used with a tissue shaping device according to the present invention. FIG. FIG. 6 is a perspective view of another anchor used with a tissue shaping device according to the present invention. FIG. 6 is a perspective view showing yet another anchor used with a tissue shaping device according to the present invention. FIG. 6 is a perspective view of yet another anchor for use with a tissue shaping device according to the present invention. FIG. 6 is a perspective view showing yet another anchor used with a tissue shaping device according to the present invention. FIG. 6 is a perspective view showing yet another anchor used with a tissue shaping device according to the present invention. FIG. 3 is a perspective view of a portion of an anchor used with a tissue shaping device according to the present invention. FIG. 6 is a perspective view showing yet another anchor used with a tissue shaping device according to the present invention. FIG. 6 is a perspective view showing yet another anchor used with a tissue shaping device according to the present invention. FIG. 6 is a perspective view showing yet another anchor used with a tissue shaping device according to the present invention. FIG. 6 is a perspective view showing yet another anchor used with a tissue shaping device according to the present invention. 1 is a perspective view showing a tandem anchor used with a tissue shaping device according to the present invention. FIG. It is a perspective view which shows the connector with the integral anchor crimp part used in the tissue shaping apparatus according to this invention. It is a perspective view which shows the tissue shaping apparatus which employ | adopts the connector of FIG. FIG. 6 is a perspective view showing another connector used with a tissue shaping device according to the present invention. FIG. 6 is a perspective view showing still another connector used with the tissue shaping device according to the present invention. 1 is a side view showing a connector used with a tissue shaping device according to the present invention. FIG. FIG. 6 is a side view of another connector used with a tissue shaping device according to the present invention. FIG. 6 is a perspective view showing still another tissue shaping device according to the present invention. It is a side view of the tissue shaping apparatus shown in FIG. FIG. 3 is a schematic diagram illustrating another embodiment demonstrating the method of the present invention. FIG. 6 is a schematic diagram illustrating yet another embodiment demonstrating the method of the present invention.

Claims (172)

  In a device configured to treat mitral regurgitation in a patient's heart, deployed in the coronary sinus, the coronary artery passes between the coronary sinus and the mitral valve through the coronary sinus wall An apparatus including a tissue shaping device configured to be able to apply a force toward a mitral valve on a proximal side of an intersection that is a place.   The apparatus of claim 1, wherein the intersection is determined before or after the tissue shaping device is delivered to the coronary sinus.   The device of claim 1, wherein the tissue shaping device is configured to be delivered to the coronary sinus in a catheter having an outer diameter of 10 France or less.   4. The device of claim 3, wherein the tissue shaping device is configured to be delivered to the coronary sinus in a catheter having an outer diameter of 9 France or less.   The device of claim 1, wherein the distal end of the tissue shaping device is deployed proximal to the intersection.   The device of claim 1, wherein the distal end of the tissue shaping device is deployed distal to the intersection.   The apparatus of claim 1, wherein the tissue shaping device further comprises a distal anchor configured to be deployed proximal to the intersection.   8. The device of claim 7, wherein the distal anchor is deployed by expanding the distal anchor.   9. The device according to claim 8, wherein the distal anchor is configured to be naturally expandable.   9. The device of claim 8, wherein the distal anchor is expanded by an actuating force applied to the distal anchor.   8. The apparatus of claim 7, wherein the distal anchor is anchored with an actuation force of at least 1 pound.   12. The apparatus of claim 11, wherein the distal anchor is anchored with an actuation force of at least 2 pounds.   8. The device of claim 7, wherein a proximal force is applied to the distal anchor.   14. The device of claim 13, wherein a proximal force is applied to the distal anchor from outside the patient.   14. The device of claim 13, wherein the tissue shaping device further comprises a proximal anchor, a distal anchor, and a connector disposed between the proximal anchor.   16. The device of claim 15, wherein the proximal anchor is configured to be deployed and established within the coronary sinus.   16. The device of claim 15, wherein the proximal anchor is configured to be at least partially anchored outside the coronary sinus.   16. The apparatus of claim 15, wherein the proximal anchor is anchored after a proximal force is applied to the distal anchor.   16. The device of claim 15, wherein the proximal anchor moves proximally after the distal anchor is anchored.   20. The apparatus of claim 19, wherein the proximal anchor is anchored after the proximal anchor is moved.   16. The device of claim 15, wherein the proximal anchor is deployed by expanding the distal anchor.   24. The device of claim 21, wherein the proximal anchor is configured to be naturally expandable.   24. The device of claim 21, wherein the proximal anchor is deployed by applying an actuation force to the proximal anchor.   The device of claim 1, wherein the tissue shaping device comprises a distal anchor configured to be deployable from the distal end of the catheter.   25. The device of claim 24, wherein the distal anchor is reconstrained within the distal end of the catheter.   26. The apparatus of claim 25, wherein the distal anchor is anchored after reconstraining the distal anchor.   The apparatus of claim 1, wherein the tissue shaping device comprises a proximal anchor configured to be deployable from a distal end of a catheter.   28. The device of claim 27, wherein the proximal anchor is reconstrained within the distal end of the catheter.   30. The apparatus of claim 28, wherein the proximal anchor is anchored after reconstraining the distal anchor.   The apparatus of claim 1, wherein the tissue shaping device is selected from a set of tissue shaping devices of a plurality of lengths.   The apparatus of claim 1, wherein the tissue shaping device comprises an anchor selected from a set of tissue shaping devices comprising a plurality of anchor size tissue shaping devices. In the set of devices used when treating mitral regurgitation,
Treating mitral regurgitation comprising a plurality of tissue shaping devices having different lengths, each configured to be delivered to a patient's coronary sinus in a catheter having an outer diameter of 10 French or less A set of equipment sometimes used.   33. The set of devices of claim 32, further comprising a catheter having an outer diameter of 9 France or less.   33. The set of devices of claim 32, wherein each of the tissue shaping devices comprises an anchor having a non-expanded configuration and an expanded configuration, each of the tissue shaping devices having its distal anchor in its unexpanded configuration. A set of devices that are further configured to be delivered to the patient's coronary sinus in a catheter having an outer diameter of 10 French or less. The set of devices according to claim 32, wherein the tissue shaping device in each set is
A proximal anchor having an unexpanded configuration and an expanded configuration;
A distal anchor having an unexpanded configuration and an expanded configuration;
A connector disposed between the proximal anchor and the distal anchor;
Each of the tissue shaping devices can be delivered to the patient's coronary sinus in a catheter having an outer diameter of 10 French or less when its proximal and distal anchors are in their unexpanded configuration. A set of devices in the form.   36. The device set of claim 35, wherein at least one tissue shaping device in the set has a length of 60 mm or less, and at least one tissue shaping device in the set has a length of 60 mm or more. Pairs.   36. The device set of claim 35, wherein each distal anchor of the tissue shaping device in the set has a diameter greater than or equal to the diameter of the coronary sinus at the distal anchor location when in its expanded configuration. Pairs.   38. The set of devices of claim 37, wherein the diameter of the distal anchor of the tissue shaping device in the set is in the range of about 7 mm to about 16 mm when in its expanded configuration.   36. The set of devices of claim 35, wherein each proximal anchor of the tissue shaping device in the set has a diameter greater than or equal to the diameter of the coronary sinus at the proximal anchor location when in its expanded configuration. , A set of equipment.   40. The set of devices of claim 39, wherein the diameter of the distal anchor of the tissue shaping device in the set is in the range of about 9 mm to about 20 mm when in its expanded configuration.   36. The set of devices of claim 35, wherein each distal anchor of the tissue shaping device in the set comprises a naturally expandable anchor.   36. The set of devices of claim 35, wherein each proximal anchor of the tissue shaping device in the set comprises a naturally expandable anchor.   36. The set of devices of claim 35, wherein each distal anchor of the tissue shaping device in the set comprises an actuated anchor.   36. The set of devices of claim 35, wherein each proximal anchor of the tissue shaping device in the set comprises an actuated anchor.   36. The set of devices of claim 35, wherein the distal anchor of at least one tissue shaping device in the set comprises a naturally expandable anchor, and the distal anchor of at least one tissue shaping device in the set is actuated. A set of devices comprising an anchor.   36. The set of devices of claim 35, wherein the proximal anchor of at least one tissue shaping device in the set comprises a naturally expandable anchor, and the proximal anchor of at least one tissue shaping device in the set is: A set of devices comprising actuated anchors.   33. The set of devices of claim 32, wherein each of the tissue shaping devices is configured to be delivered to a patient's coronary sinus in a catheter having an outer diameter of 9 French or less. In the set of devices used when treating mitral regurgitation,
A plurality of tissue shaping devices each comprising an anchor having an unexpanded configuration and an expanded configuration, the anchors having different diameters when in the expanded configuration, each of the tissue shaping devices is 10 French A set of devices used in treating mitral regurgitation configured to be delivered to a patient's coronary sinus in a catheter having the following outer diameter:   49. The device set of claim 48, wherein each anchor of the device is a distal anchor, each of the devices further comprising a proximal anchor having an unexpanded configuration and an expanded configuration, A set of devices in which the anchor has a different diameter when in its expanded configuration.   50. The set of devices of claim 49, wherein the diameter of the distal anchor of the tissue shaping device in the set is in the range of about 7 mm to about 16 mm when in its expanded configuration.   50. The set of devices of claim 49, wherein the diameter of the proximal anchor of the tissue shaping device in the set is in the range of about 9 mm to about 20 mm when in its expanded configuration.   52. The set of devices of claim 51, wherein each distal anchor of the tissue shaping device in the set comprises a naturally expandable anchor.   52. The set of devices of claim 51, wherein each proximal anchor of the tissue shaping device in the set comprises a naturally expandable anchor.   52. The set of devices of claim 51, wherein each distal anchor of the tissue shaping device in the set comprises an actuated anchor.   52. The set of devices of claim 51, wherein each proximal anchor of the tissue shaping device in the set comprises an actuated anchor.   52. The set of devices of claim 51, wherein the distal anchor of at least one tissue shaping device in the set comprises a naturally expandable anchor, and the distal anchor of at least one tissue shaping device in the set is actuated. A set of devices comprising an anchor.   52. The set of devices of claim 51, wherein the proximal anchor of at least one tissue shaping device in the set comprises a naturally expandable anchor, and the proximal anchor of at least one tissue shaping device in the set is A set of devices comprising actuated anchors.   49. The set of devices of claim 48, further comprising a catheter having an outer diameter of 10 French or less.   49. The set of devices of claim 48, wherein each of the tissue shaping devices is configured to be delivered from within a catheter having an outer diameter of 9 French or less to a patient's coronary sinus.   In a tissue shaping device adapted to be placed in a blood vessel near the patient's heart to reshape the patient's heart, expandable to allow contact with the vessel wall with a radially outward force A tissue shaping device, comprising an expansion energy absorbing element.   61. The tissue shaping device of claim 60, wherein the expansion energy absorbing element is adapted to limit a radially outward force on the vessel wall.   61. The tissue shaping device of claim 60, wherein the anchor is adapted to provide an anchoring force of at least 1 pound.   64. The tissue shaping device of claim 62, wherein the anchor is adapted to provide an anchoring force of at least 2 pounds.   61. The tissue shaping device according to claim 60, wherein the anchor comprises a flexible wire.   65. The tissue shaping device of claim 64, wherein the expansion energy absorbing element comprises a flex point on the flexible wire.   66. The tissue shaping apparatus according to claim 65, wherein the bending point comprises a flexible wire portion having a greater curvature compared to an adjacent wire portion.   66. The tissue shaping apparatus according to claim 65, wherein the bending point comprises a loop formed on a flexible wire.   65. The tissue shaping device according to claim 64, wherein the flexible wire is disposed in a substantially 8-shaped form.   69. The tissue shaping apparatus according to claim 68, wherein the expansion energy absorbing element comprises a flex point on the flexible wire.   69. The tissue shaping apparatus according to claim 68, wherein the expansion energy absorption element is a first expansion energy absorption element and further comprises a second expansion energy absorption element.   71. The tissue shaping apparatus according to claim 70, wherein the first and second extension energy absorbing elements comprise first and second bending points on the flexible wire, respectively.   61. The tissue shaping device according to claim 60, wherein the anchor comprises a naturally expandable anchor.   61. The tissue shaping device according to claim 60, wherein the anchor comprises an actuated anchor.   74. The tissue shaping apparatus according to claim 73, further comprising a movable anchor actuator.   The tissue shaping device according to claim 74, further comprising an anchor locking member.   75. The tissue shaping device according to claim 74, wherein the actuator is adapted to expand the anchor when the actuator moves distally.   75. The tissue shaping device of claim 74, wherein the anchor comprises a flexible wire, and at least a portion of the flexible wire is adapted to be moved distally by a movable actuator when the anchor is expanded. Tissue shaping device.   78. The tissue shaping apparatus of claim 77, wherein the expansion energy absorbing element comprises a bending point on a flexible wire.   61. A tissue shaping device according to claim 60, wherein the device is configured to be deployed from the distal end of the catheter.   80. The tissue shaping device of claim 79, wherein the tissue shaping device is held in a compressed form within the lumen of the catheter.   81. The tissue shaping device of claim 80, wherein the device is expanded after being deployed from the distal end of the catheter.   Tissue shaping adapted to be delivered to the coronary sinus in a non-expanded configuration within a catheter having an outer diameter of 10 French or less and to be deployed within the coronary sinus to reduce mitral regurgitation The device comprises a connector disposed between a distal expandable anchor comprising a flexible wire and a proximal expandable anchor comprising a flexible wire, the device having a length of 60 mm or less. A tissue shaping device.   83. The tissue shaping device of claim 82, wherein the tissue shaping device is adapted to be delivered to the coronary sinus in a non-expanded configuration within a catheter having an outer diameter of 9 France or less.   83. The tissue shaping device of claim 82, wherein the distal expandable anchor expands to contact the wall portion of the coronary sinus and provides sufficient anchoring force to anchor the device within the coronary sinus. A tissue shaping device adapted to accommodate a range of coronary sinus diameters.   85. The tissue shaping apparatus according to claim 84, wherein the anchoring force is at least 1 pound.   86. The tissue shaping apparatus according to claim 85, wherein the anchoring force is at least 0.907 kg (2 pounds).   83. The tissue shaping device of claim 82, having an expanded configuration, wherein the distal expandable anchor comprises at least one bending point and first and second arms extending from the bending point, The tissue shaping device, wherein the first and second arms are adapted to deform about a bending point as the device moves from an expanded configuration to an unexpanded configuration.   90. The tissue shaping device of claim 87, wherein the bending point is a first bending point and the distal expandable anchors extend from the second bending point and the second bending point. A tissue shaping device, wherein the third and fourth arms are adapted to deform about a second bending point when the device moves from an expanded configuration to an unexpanded configuration.   90. The tissue shaping device of claim 88, wherein the first and second bend points are disposed at an uppermost portion of the distal expandable anchor when the distal expandable anchor is in an expanded configuration. A tissue shaping device.   90. The tissue shaping apparatus according to claim 87, wherein the first and second arms generally extend proximally when the tissue shaping apparatus is in an unexpanded configuration.   90. The tissue shaping device according to claim 87, wherein the first and second arms extend generally distally when the tissue shaping device is in an unexpanded configuration.   90. The tissue shaping device of claim 87, wherein the distal expandable anchor flexible wire has a pre-formed shape.   90. The tissue shaping apparatus according to claim 87, wherein the bending point comprises a portion of a flexible wire having a large radius of curvature compared to an adjacent wire portion.   88. The tissue shaping apparatus according to claim 87, wherein the bending point comprises a loop formed in a flexible wire shape.   88. The tissue shaping device of claim 87, wherein the distal expandable anchor has a distal side and a proximal side, and the bending point is disposed on the distal side.   88. The tissue shaping device of claim 87, wherein the distal expandable anchor has a distal side and a proximal side, and the bending point is disposed on the proximal side.   83. The tissue shaping device of claim 82, further comprising a flexible wire connection of the distal expandable anchor, the connection being proximal and distal to the distal expandable anchor. A tissue shaping device that substantially limits movement.   83. The tissue shaping device according to claim 82, further comprising a distally and proximally movable connection between the distal expandable anchor and the connector.   83. The tissue shaping device of claim 82, wherein the distal expandable anchor comprises a naturally expandable anchor.   83. The tissue shaping device of claim 82, wherein the distal expandable anchor comprises an actuated anchor.   101. The tissue shaping device according to claim 100, wherein the actuated anchor further comprises an actuator and a locking member adapted to be locked at a position where the actuator is deployed.   83. The tissue shaping device according to claim 82, having an expanded configuration and further reconstrained from an expanded configuration within the coronary sinus to an unexpanded configuration within the catheter within the coronary sinus. A tissue shaping device.   103. The tissue shaping device according to claim 102, wherein the tissue shaping device is adapted to be further redeployed within the coronary sinus after being reconstrained.   83. The tissue shaping device of claim 82, wherein the proximal anchor contacts the wall portion of the coronary sinus with sufficient anchoring force to expand and anchor the device in the coronary sinus. A tissue shaping device adapted to accommodate a range of coronary sinus diameters.   85. The tissue shaping device of claim 82, having an expanded configuration, wherein the proximal anchor comprises at least one bending point and first and second arms extending from the bending point, the first and first The tissue shaping device, wherein the two arms are adapted to deform about a bending point as the device moves from an expanded configuration to an unexpanded configuration.   83. The tissue shaping apparatus according to claim 82, wherein the proximal anchor comprises a naturally expandable anchor.   83. The tissue shaping device according to claim 82, wherein the proximal anchor comprises an actuated anchor.   108. The tissue shaping device according to claim 107, wherein the actuated anchor further comprises an actuator and a locking member adapted to be locked at a position where the actuator is deployed.   83. The tissue shaping device of claim 82, wherein none of the distal expandable anchor flexible wires extend proximally along the connector within the catheter.   83. The tissue shaping device of claim 82, wherein at least a portion of the flexible wire of the anchor of the distal expandable member is delivered to the coronary sinus with the catheter extending proximally along the connector within the catheter. Tissue shaping device.   111. The tissue shaping device of claim 110, wherein the distal expandable member is configured to substantially limit movement of the connection proximally and distally relative to the distal expandable anchor. The tissue shaping device further comprising a flexible wire connection of the distal expandable anchor.   112. The tissue shaping device of claim 111, wherein the distal expandable member further comprises a distal anchor flexible wire connection that is expandable distally and proximally.   113. The tissue shaping device of claim 112, wherein the tissue shaping device is deployed in the coronary sinus by actuating the connection distally to actuate the distal expandable anchor.   114. The tissue shaping device of claim 113, wherein the distal expandable member can be locked after actuating the distal expandable anchor.   83. The tissue shaping device of claim 82, wherein the distal expandable member further comprises a distal anchor flexible wire connection that is expandable in the distal and proximal directions.   118. The tissue shaping device of claim 115, wherein at least a portion of the distal expandable anchor flexible wire is delivered to the coronary sinus extending distally along the connector with the catheter. apparatus.   117. The tissue shaping device according to claim 116, deployed in the coronary sinus by actuating a distal expandable anchor.   118. The tissue shaping device of claim 117, wherein the distal expandable anchor can be locked after actuating the distal expandable member.   A tissue shaping device adapted to be deployed within a blood vessel to reshape tissue adjacent to a blood vessel, the first and second anchors, and a connector disposed between the first and second anchors, A tissue shaping device, wherein the connector is integral with at least a portion of the first anchor   120. The tissue shaping apparatus according to claim 119, wherein the first anchor includes a flexible wire and a crimp portion that holds a portion of the flexible wire.   123. The tissue shaping device according to claim 120, wherein the crimp portion is integral with the connector.   123. The tissue shaping apparatus according to claim 120, wherein the connector has a semicircular cross section.   123. The tissue shaping device according to claim 122, wherein the connector has a radius substantially equal to the radius of the crimp portion.   120. The tissue shaping apparatus according to claim 119, wherein each of the first and second anchors includes a flexible wire and a crimp portion that holds a portion of the flexible wire.   125. The tissue shaping device according to claim 124, wherein the crimp portion of the first anchor and the crimp portion of the second anchor are integral with the connector.   125. The tissue shaping apparatus according to claim 124, wherein the connector has a semicircular cross section.   127. The tissue shaping apparatus according to claim 126, wherein the connector has a radius substantially equal to the radius of the crimp portion of the first anchor.   In a tissue shaping device adapted to be deployed within a blood vessel to reshape tissue adjacent to a blood vessel, a connector and integral anchor portion formed by removing material from the blank material, and an integral anchor A tissue shaping device comprising a non-integral anchor portion attached to the portion.   129. The tissue shaping device of claim 128, wherein the integral anchor portion comprises a crimp tube and the non-integral portion is a flexible having at least a portion of the flexible wire disposed within the crimp tube. A tissue shaping device comprising a wire.   129. The tissue shaping apparatus according to claim 128, wherein the blank has a substantially cylindrical cross section and the connector has a substantially semicircular cross section.   129. The tissue shaping device of claim 128, wherein the integral anchor portion comprises a first integral anchor portion formed by removing material from the blank and a second integral anchor portion. A tissue shaping device.   132. The tissue shaping apparatus according to claim 131, wherein the connector is disposed between the first and second integral anchor portions.   135. The tissue shaping device according to claim 132, wherein each of the first and second anchor portions comprises a crimp tube, and the non-integral anchor portion is disposed within the crimp tube of the first anchor. A tissue shaping device comprising a flexible wire having at least a portion of the flexible wire.   135. The tissue shaping device of claim 132, wherein the non-integral anchor portion is a first non-integral anchor portion and a second non-integral anchor portion attached to the second integral anchor portion. A tissue shaping device further comprising an anchor portion.   135. The tissue shaping device of claim 134, wherein each of the first and second integral anchor portions comprises a crimp tube, and each of the first and second non-integral anchor portions is flexible. A tissue shaping device comprising a wire.   135. The tissue shaping device of claim 135, wherein at least a portion of the first anchor flexible wire is disposed within the crimp tube of the first anchor and a portion of the second anchor flexible wire is the first anchor. A tissue shaping device disposed in a crimp tube of a second anchor.   132. The tissue shaping device according to claim 131, wherein the blank has a substantially cylindrical cross section and the connector has a substantially semicircular cross section. In a tissue shaping device adapted to be deployed within a blood vessel to reshape tissue adjacent to the blood vessel,
A distal end comprising a flexible wire having at least one bending point and first and second arms extending from the bending point, the first and second arms being adapted to be deformable about the bending point Side anchors,
A flexible wire having at least one bending point and first and second arms extending from the bending point, wherein the first and second arms are adapted to be deformable about the bending point. An end anchor,
A tissue shaping device comprising a connector disposed between a distal anchor and a proximal anchor.   138. The tissue shaping device according to claim 138, wherein the bending point of the distal anchor is disposed on the proximal side of the distal anchor.   138. The tissue shaping apparatus according to claim 138, wherein the bending point of the proximal anchor is disposed on the distal side of the proximal anchor.   138. The tissue shaping device of claim 138, wherein the distal anchor flexible wire is disposed in a substantially 8-shaped configuration.   142. The tissue shaping device according to claim 141, wherein the bending point of the flexible wire of the distal anchor comprises a first bending point, and the flexible wire of the distal anchor comprises the second bending point and the second bending point. A tissue shaping device, further comprising third and fourth arms extending from the bending point, wherein the third and fourth arms are adapted to bend about the second bending point.   143. The tissue shaping device of claim 142, wherein the flexible wire of the distal anchor further comprises first and second proximal struts, each of the first and second bending points being first and second A tissue shaping device shaped into the second proximal strut.   144. The tissue shaping device of claim 143, wherein each of the first and second bend points of the flexible wire of the distal anchor is a flexible wire having a larger radius of curvature compared to the adjacent wire portion. A tissue shaping device comprising a portion.   146. The tissue shaping device according to claim 144, wherein each of the first and second bending points of the flexible wire of the distal anchor comprises a loop formed in the flexible wire.   144. The tissue shaping apparatus according to claim 143, wherein the first and second bending points of the flexible wire of the distal anchor are disposed at the uppermost point of the distal anchor.   140. The tissue shaping device of claim 139, wherein the flexible wire of the proximal anchor is disposed in a substantially 8-shaped configuration.   148. The tissue shaping device according to claim 148, wherein the bending point of the flexible wire of the proximal anchor includes a first bending point, and the flexible wire of the proximal anchor includes the second bending point and the first bending point. And a third and fourth arm extending from the second bending point, wherein the third and fourth arm are adapted to bend about the second bending point.   149. The tissue shaping device of claim 149, wherein the proximal anchor flexible wire further comprises first and second proximal struts, each of the first and second bending points being the first. And a tissue shaping device formed on the second proximal strut.   The tissue shaping device according to claim 150, wherein each of the first and second bending points of the flexible wire of the proximal anchor has a large radius of curvature compared to the adjacent wire portion. A tissue shaping device comprising a portion of   The tissue shaping device according to claim 150, wherein each of the first and second bending points of the flexible wire of the proximal anchor includes a loop formed in a flexible wire shape.   149. The tissue shaping device according to claim 149, wherein the first and second bending points of the flexible wire of the proximal anchor are disposed at the uppermost point of the proximal anchor.   140. The tissue shaping device according to claim 139, wherein the distal anchor is a naturally expandable anchor.   140. The tissue shaping device according to claim 139, wherein the proximal anchor is an actuated anchor.   140. The tissue shaping apparatus according to claim 139, wherein the connector has a moment of inertia that varies along its length.   140. The tissue shaping device according to claim 139, wherein the distal anchor further comprises a distal anchor crimp tube and the proximal anchor further comprises a proximal anchor crimp tube.   158. The tissue shaping device of claim 157, wherein the connector is integral with the distal tube anchor crimp tube and the proximal anchor crimp tube.   A tissue shaping device adapted to be placed in a blood vessel near a patient's heart to reshape the patient's heart, comprising: a proximal anchor, a distal anchor, a proximal anchor, and a distal anchor; And a connector disposed therebetween, the connector having a moment of inertia that varies along its length.   159. The tissue shaping device of claim 158, wherein the connector comprises a proximal anchor portion, a distal anchor portion, and a central portion disposed between the proximal anchor portion and the distal anchor portion. The tissue shaping device has a minimum moment of inertia at one point in the central portion.   159. The tissue shaping device of claim 158, wherein the connector comprises a proximal anchor portion, a distal anchor portion, and a central portion disposed between the proximal anchor portion and the distal anchor portion. The proximal anchor has a proximal anchor fastener, and the moment of inertia of the connector at a point just distal to the proximal anchor fastener is greater than the moment of inertia at a point in the central portion of the connector, tissue Shaping device.   159. The tissue shaping device of claim 158, wherein the connector comprises a proximal anchor portion, a distal anchor portion, and a central portion disposed between the proximal anchor portion and the distal anchor portion. The distal anchor has a distal anchor fastener, and the moment of inertia of the connector at a point just proximal to the distal anchor fastener is greater than the moment of inertia at a point in the central portion of the connector, the tissue shaping device .   159. The tissue shaping apparatus according to claim 158, wherein the connector has a connector length, and the connector has a substantially uniform width and a non-uniform thickness along the length of the connector. .   163. The tissue shaping device according to claim 162, wherein the connector comprises a proximal anchor portion, a distal anchor portion, and a central portion disposed between the proximal anchor portion and the distal anchor portion. The tissue shaping device, wherein the thickness of the connector is minimal at one point in the central portion.   163. The tissue shaping device according to claim 162, wherein the connector comprises a proximal anchor portion, a distal anchor portion, and a central portion disposed between the proximal anchor portion and the distal anchor portion. The tissue shaping device, wherein the proximal anchor comprises a proximal anchor fastener, and the thickness of the connector at a point immediately proximal to the proximal anchor fastener is greater than the thickness of the connector at the central portion.   159. The tissue shaping apparatus according to claim 158, wherein the connector has a proximal end and a distal end, and the connector further comprises at least a portion having a thickness that varies as a function of distance from the proximal or distal end. .   166. The tissue shaping apparatus according to claim 165, wherein the function is a linear function.   166. The tissue shaping apparatus according to claim 165, wherein the function is a quadratic function.   166. The tissue shaping device of claim 165, wherein the connector comprises a proximal anchor portion, a distal anchor portion, and a central portion disposed between the proximal anchor portion and the distal anchor portion. The tissue shaping device, wherein the thickness of the portion varies in the central portion.   169. The tissue shaping apparatus according to claim 168, wherein the central portion further comprises a portion having a substantially uniform thickness.   159. The tissue shaping device of claim 158, wherein the connector comprises an integral proximal anchor actuation element.   159. The tissue shaping apparatus of claim 158, wherein the connector comprises an integral deployment attachment element.   159. The tissue shaping apparatus according to claim 158, wherein the connector comprises an integral anchor position stopper.

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