ES2804730T3 - Device to modify the shape of an organ of the body - Google Patents

Abstract

A tissue shaping device adapted to be deployed in a vessel to reshape tissue adjacent to the vessel, comprising: a first expandable anchor (440, 460, 320) comprising a flexible wire; a second expandable anchor comprising a flexible wire; and a connector (450, 470) disposed between the first and second anchors; characterized in that the first anchor includes additional twists (442, 464) formed by the flexible wire at a vertex of the first anchor to hold the vertex of the anchor together.

Description

DESCRIPTION

Device to modify the shape of an organ of the body

Background of the invention

The present invention generally relates to devices for shaping tissue by deploying one or more devices in body lumens adjacent to tissue. A particular application of the invention relates to a treatment for mitral valve regurgitation by deploying a tissue shaping device in the patient's coronary sinus or large coronary vein.

The mitral valve is a portion of the heart that lies between the chambers of the left atrium and the left ventricle. When the left ventricle contracts to pump blood throughout the body, the mitral valve closes to prevent blood from pumping back into the left atrium. In some patients, whether due to a genetic defect, disease or injury, the mitral valve does not close properly, causing an abnormality known as valve regurgitation, in which blood is pumped into the atrium each time the muscle contracts. cardiac. Valvular regurgitation is a serious, often rapidly deteriorating abnormality that reduces circulatory efficiency and must be corrected.

Two of the most common techniques for restoring function of a damaged mitral valve are to surgically replace the valve with a mechanical valve or suture a flexible ring around the valve for support. Each of these procedures is highly invasive, as access to the heart is obtained through an opening in the patient's chest. Patients with mitral valve regurgitation are often relatively fragile, which increases the risks associated with such an operation.

A less invasive approach to assist mitral valve closure involves placement of a tissue-shaping device in the cardiac sinus and the vessel that passes adjacent to the mitral valve. The tissue shaping device is designed to push the vessel and surrounding tissue against the valve to aid in its closure. This technique has the advantage over other methods of mitral valve repair, since it can be performed percutaneously without opening the chest wall. Examples of such devices are shown in US Patent Application No. 10 / 142,637, "Body Lumen Device Anchor, Device and Assembly" filed May 8, 2002; US Patent Application No. 10 / 331,143, "System and Method to Effect the Mitral Valve Annulus of a Heart" filed December 26, 2002; and US Patent Application No. 10 / 429,172, "Device and Method for Modifying the Shape of a Body Organ," filed May 2, 2003.

When deploying a tissue shaping device into a vein or artery to modify adjacent tissue, care must be taken to avoid constricting nearby arteries. For example, when treating mitral valve regurgitation, a tissue shaping device can be deployed in the coronary sinus to reshape the adjacent mitral valve annulus. However, coronary arteries such as the circumflex artery can cross between the coronary sinus and the heart, increasing the danger that deployment of the support may limit perfusion to a portion of the heart by contracting one of those arteries. See, for example, the following applications: US Patent Application SN 09 / 855,945, "Mitral Valve Therapy Device, System and Method", filed May 14, 2001 and published November 14, 2002, as US 2002/0169504 A1; US Patent Application No. 09 / 855,946, "Mitral Valve Therapy Assembly and Method", filed May 14, 2001 and published November 14, 2002, as US 2002/0169502 A1; and US patent application S. N.

10 / 003,910, "Focused Compression Mitral Valve Device and Method," filed November 1, 2001. Therefore, it is advisable to monitor cardiac perfusion during and after such treatment of mitral valve regurgitation. See, for example, US Patent Application SN 10 / 366,585, "Method of Implanting a Mitral Valve Therapy Device", filed February 12, 2003. WO 03/094801 discloses an intravascular support device which includes a support or reshaping wire, a proximal anchor, and a distal anchor. The support wire is attached to a wall of the vessel to reshape the tissue adjacent to the vessel in which the intravascular support is placed. The anchors and support wire are designed so that the vein in which the support is placed remains open and can be accessed by other devices if necessary.

Brief summary of the invention

The anatomical structure of the heart and its surrounding vessels varies from patient to patient. For example, the location of the circumflex artery and other essential arteries with respect to the coronary sinus can vary. Specifically, the distance along the coronary sinus from the foramen to the point of intersection with the circumflex artery can vary from patient to patient. Also, the diameter and length of the coronary sinus can vary from patient to patient.

We have invented a tissue shaping device, a set of tissue shaping devices that maximize the therapeutic effect (i.e., reduction of mitral valve regurgitation) while minimizing side effects such as a unacceptable contraction of the circumflex artery or other coronary arteries. The tissue shaping device, set of devices, and method of the present invention allow the user to tailor treatment to the anatomical structure of the patient.

The present disclosure details a method of treating mitral valve regurgitation in a patient, the method being outside the scope of the present invention. The method includes the steps of administering a tissue-shaping device to the coronary sinus of the patient in an unexpanded configuration within a catheter having an outside diameter of a gauge no greater than nine or ten Fr, including the shaping device. of tissue a connector disposed between a distal expandable anchor comprising flexible wire and a proximal expandable anchor comprising flexible wire, the device having a length of 60 mm or less; and deploying the device to reduce mitral valve regurgitation, such as by anchoring the expandable distal anchor by placing the flexible expandable distal anchor wire in contact with a wall of the coronary sinus, for example, allowing the distal expandable anchor to automatically expand or applying a driving force to the distal expandable anchor and possibly locking the distal expandable anchor after performing the application step. The deployment step may include the step of anchoring the distal expandable anchor with an anchoring force of at least 4.44822 N to 8.89644 N (one to two pounds).

The method implementation step further includes the step of applying a proximally directed force on the distal expandable anchor through the connector, possibly from outside the patient, such as moving the proximal anchor proximally with respect to the coronary sinus. The method may also include the step of anchoring the proximal anchor, before or after the step of applying a proximally directed force on the distal expandable anchor and before or after the movement step. The proximal anchor may be anchored by allowing the proximal expandable anchor to self-expand or by applying a driving force to the proximal expandable anchor and possibly locking the proximal expandable anchor after the application step is performed.

In some examples, such as embodiments where the distal expandable anchor also includes a distal expandable anchor flexible wire connection that substantially limits proximal and distal movement of the connection relative to the distal expandable anchor, the administration step includes the step of delivering the tissue shaping device to the coronary sinus in an unexpanded configuration in which none of the flexible distal expandable anchor wires extend proximally along the connector within the catheter.

In other examples, such as embodiments in which the distal expandable anchor also includes a distally and proximally movable expandable flexible anchor wire connection, the step of delivery may include the step of delivering the tissue-shaping device to the coronary sinus. in an unexpanded configuration in which at least a portion of the expandable distal anchor flexible wire extends proximally or distally along the connector within the catheter. The deployment step in those embodiments may include the steps of moving the connection distally to actuate the distal expandable anchor and locking the distal expandable anchor after the movement step is performed.

Another disclosure of the invention is a tissue shaping device adapted to be delivered to a coronary sinus in an unexpanded configuration within a catheter having an outer diameter of no greater than nine or ten Fr and adapted to be deployed in the coronary sinus to reduce mitral valve regurgitation, the device including a connector disposed between a distal expandable anchor comprising a flexible wire (such as a self-expanding anchor or a drivable anchor possibly having an actuator and a lock) and a proximal expandable anchor comprising a flexible wire, the device having a length of 60mm or less. In some cases, the distal expandable anchor is adapted to fit a range of diameters of the coronary sinus by expanding to contact a portion of the coronary sinus wall to provide sufficient anchoring force to anchor the device within the coronary sinus, such as a Anchor force of at least 4.44822 N to 8.89644 N (one to two pounds).

In some examples, the device has an expanded configuration, with the distal expandable anchor having at least one or two points of flexion and the first and second arms extending from the flexion points, the first and second arms being adapted to deform around the points. flex when the device is moved from the expanded configuration to the unexpanded configuration. The flexion points may be arranged at the highest point of the distal expandable anchor when the distal expandable anchor is in the expanded configuration.

The first and second arms may extend generally proximally or generally distally when the tissue shaping device is in the unexpanded configuration. The point of flexure may be, for example, a section of the flexible wire that has an increased radius of curvature compared to adjacent wire sections or a loop formed in the flexible wire, and may be disposed on the distal or proximal side of the anchorage.

The device may also include a distal expandable anchor flexible wire connection that substantially limits proximal and distal movement of the connection relative to the distal expandable anchor or a distal and proximally movable connection between the distal expandable anchor and the connector. The device may also be adapted to be recaptured from its expanded configuration within the coronary sinus to an unexpanded configuration within a catheter within the coronary sinus and possibly redeployed into the coronary sinus after being recaptured. In some examples, the proximal anchor is adapted to fit a range of coronary sinus diameters expanding to contact a wall portion of the coronary sinus with sufficient anchoring force to anchor the device within the coronary sinus. In examples where the device has an expanded configuration, the proximal anchor may include at least one point of flexion and first and second arms that extend from the point of flexion, the first and second arms being adapted to deform over the point. flex when the device is moved from the expanded configuration to the unexpanded configuration. The proximal anchor may be a self-expanding anchor or an operable anchor, in which case the operable anchor may include an actuator and a lock adapted to lock the actuator in a deployed position.

The anatomical structure of the heart and its surrounding vessels varies from patient to patient. For example, the location of the circumflex artery and other essential arteries with respect to the coronary sinus can vary. Specifically, the distance along the coronary sinus from the foramen to the point of intersection with the circumflex artery can vary from patient to patient. Also, the diameter and length of the coronary sinus can vary from patient to patient.

We have invented a tissue shaping device and a set of tissue shaping devices that maximize the therapeutic effect (i.e. reduction of mitral valve regurgitation) while minimizing side effects such as a unacceptable contraction of the circumflex artery or other coronary arteries. The tissue shaping device and set of devices of the present invention allow the user to tailor the treatment to the anatomical structure of the patient.

One aspect of the invention provides a tissue shaping device adapted to be deployed in a vessel to reshape tissue adjacent to the vessel, the device including a first expandable anchor comprising a flexible wire and a second expandable anchor comprising a wire flexible and a connector disposed between the first and second anchors, the first anchor including additional twists formed by the flexible wire at an apex of the first anchor to hold the apex of the anchor together. The connector can be integrated with at least a portion of the first anchor. In some embodiments, the first anchor has a flexible wire and a crimp that supports a portion of the flexible wire, the crimp optionally being integrated with the connector. The connector may have a semi-circular cross section with a radius substantially equal to a crimp radius.

In some embodiments, the first and second anchors of the device each have a flexible wire and crimp that supports a portion of the flexible wire, and the first anchor crimp and the second anchor crimp may be integrated with the connector.

The invention also discloses a method of manufacturing a tissue shaping device, the method including the steps of: removing material from a blank to form a connector and an integrated anchoring portion; and attaching a non-integrated anchoring portion to the integrated anchoring portion. In embodiments where the integrated anchoring portion includes a crimped tube and the non-integrated portion includes a flexible wire, the method may further include the step of disposing a portion of the flexible wire in the crimped tube. In examples where the blank has a substantially cylindrical cross section, the extraction step may include the step of removing a portion of the cylinder to leave a connector having a substantially semicircular cross section.

In examples where the integrated anchoring portion is a first integrated anchoring portion, the extraction step may further include the step of extracting material from the blank to form a second integrated anchoring portion, the connector being disposed between the first integrated anchoring portion and the second integrated anchoring portion. In the examples where the first and second anchor portions have a crimp tube and the non-integrated anchor portion includes a flexible wire, the method may further include the step of arranging a portion of the flexible wire in the first crimp anchor tube. .

In examples where the non-integrated anchoring portion is a non-integrated first anchoring portion, the method may further include the step of attaching a non-integrated second anchoring portion to the integrated second anchoring portion. In some examples, the first and second integrated anchor portions have a crimped tube and the first and second non-integrated anchor portions each include a flexible wire, the method further including the steps of disposing a portion of the first flexible anchor wire in the first crimp anchor tube and disposing a portion of the second flexible anchor wire in the second crimp anchor tube.

The anatomical structure of the heart and its surrounding vessels varies from patient to patient. For example, the location of the circumflex artery and other essential arteries with respect to the coronary sinus can vary. Specifically, the distance along the coronary sinus from the foramen to the point of intersection with the circumflex artery can vary from patient to patient. Also, the diameter and length of the coronary sinus can vary from patient to patient.

We have invented a tissue shaping device, a set of tissue shaping devices, and a method that maximizes the therapeutic effect (i.e. reduction of mitral valve regurgitation) while minimizing side effects, such as unacceptable contraction of the circumflex artery or other coronary arteries. The device for tissue shaping, the set of devices and the method of the present invention allow the user to adapt the treatment to the anatomical structure of the patient.

One aspect of the invention is a tissue shaping device adapted to be deployed in a vessel to reshape tissue adjacent to the vessel. The device includes: a first preferably distal expandable anchor having a flexible wire with at least one point of flexion and first and second arms extending from the point of flexion, the first and second arms being adapted to deform around the point of flexion. flexion; a preferably proximal expandable anchor having a flexible wire with at least one point of flexion and first and second arms extending from the point of flexion, the first and second arms being adapted to deform around the point of flexion; and a connector disposed between the distal anchor and the proximal anchor. The flexion point of the distal anchor may be disposed on a proximal side of the distal anchor, and the flexion point of the proximal anchor may be disposed on a distal side of the proximal anchor.

In some embodiments, the flexible wire of the distal anchor is arranged in a substantially figure-eight configuration. The flexible distal anchor wire may include a second point of flexion and third and fourth arms extending from the second point of flexion, the third and fourth arms being adapted to bend around the second point of flexion. The flexible wire of the distal anchor may also include first and second proximal struts, with the first and second flex points being formed on the first and second proximal struts, respectively. The bending points can each be, for example, a section of the flexible wire having an increased radius of curvature compared to adjacent wire sections or a loop formed in the flexible wire. The first and second flexure points of the flexible wire of the distal anchor may also be arranged at a higher point of the distal anchor.

In some embodiments, the flexible proximal anchor wire is arranged in a substantially figure-eight configuration. The flexible wire of the proximal anchor may include a second point of flexion and third and fourth arms extending from the second point of flexion, the third and fourth arms being adapted to bend around the second point of flexion. The flexible wire of the proximal anchor may also include first and second proximal struts, with the first and second flex points being formed on the first and second proximal struts, respectively. The bending points can each be, for example, a section of the flexible wire having an increased radius of curvature compared to adjacent wire sections or a loop formed in the flexible wire. The first and second flexible wires of the proximal anchor may also be disposed higher than the proximal anchor.

In some embodiments, the distal anchor is a self-expanding anchor, and in some embodiments, the proximal anchor is a drivable anchor. The connector may have a moment of inertia that varies along its length. The distal and proximal anchors can also include crimped tubes, and the connector may be integrated with the crimped tubes.

The anatomical structure of the heart and its surrounding vessels varies from patient to patient. For example, the location of the circumflex artery and other essential arteries with respect to the coronary sinus can vary. Specifically, the distance along the coronary sinus from the foramen to the point of intersection with the circumflex artery can vary from patient to patient. Also, the diameter and length of the coronary sinus can vary from patient to patient.

We have invented tissue shaping devices, device sets, and tissue shaping methods that maximize therapeutic effect (i.e., reduction of mitral valve regurgitation) while minimizing side effects, such as a unacceptable contraction of the circumflex artery or other coronary arteries. The tissue shaping devices, device assemblies and methods of the present invention allow the user to tailor treatment to the anatomical structure of the patient.

A method of treating valve regurgitation of a mitral valve in the heart of a patient is outside the scope of the invention, the method including the steps of administering a tissue-shaping device to the coronary sinus, such as in a catheter having an outside diameter no larger than nine or ten Fr; and deploying the tissue shaping device to reduce mitral valve regurgitation, the deployment step including the step of applying a force through the coronary sinus wall toward the mitral valve only proximal to a crossing point where a Coronary artery passes between a coronary sinus and the mitral valve. In some examples, the device is deployed with its distal end proximal to the crossover point, and in some examples, the distal end is deployed distal to the crossover point. The method may also include the step of determining the crossover point.

In some examples, the tissue shaping device includes a distal anchor, in which case the deployment step may include the step of anchoring the distal anchor proximal to the crossing point, such as expanding the distal anchor by self-expansion or by applying of an actuation force. The anchor force can be 4.44822 N - 8.89644 N (one - two pounds).

In some examples, the deployment step further includes the step of applying a proximally directed force on the distal anchor, in some embodiments from outside the patient, such as moving the proximal anchor proximally. The tissue shaping device may further include a proximal anchor and connector disposed between the distal anchor and the proximal anchor, the deployment step further including the step of anchoring the proximal anchor (eg, in the coronary sinus or at least partially outside the coronary sinus), such as expanding the proximal anchor by self-expansion or by applying an actuating force. The step of anchoring the proximal anchor may be performed before or after the step of applying a proximally directed force on the distal anchor.

The method deployment step may include the step of deploying a distal anchor of the device from a distal end of a catheter. The method may also include the step of recapturing the distal anchor in a catheter and optionally redeploying the distal anchor. The method deployment step may also include the step of deploying a proximal anchor of the device from a distal end of a catheter and may include the step of recapturing the proximal anchor in a catheter and optionally redeploying the distal anchor. The entire device can also be recaptured by a catheter and redeployed from the catheter.

The method may also include the step of selecting the tissue-forming device from a set of tissue-forming devices that includes tissue-forming devices of a plurality of lengths and / or tissue-forming devices of a plurality of anchor sizes prior to the administration step.

The invention is also a set of devices for use in the treatment of mitral valve regurgitation, the set including a plurality of tissue shaping devices having different lengths, each of the devices being configured for shaping tissue. tissue to be delivered to a coronary sinus of a patient within a catheter having an outside diameter of a gauge no greater than nine or ten Fr. In some examples, the tissue shaping devices each include an anchor (such as a distal anchor or a proximal anchor) having an expanded configuration and an unexpanded configuration for delivery through a catheter. In some examples, at least one tissue shaping device in the set has a length of 60mm or less and at least one tissue shaping device in the set has a length of more than 60mm. In some examples, the distal anchor of each tissue-shaping device in the assembly in its expanded configuration has a diameter equal to or greater than a diameter of the coronary sinus at a distal anchor location (e.g., from about 7mm to about 16 mm), and the proximal anchor of each tissue shaping device in the set in its expanded configuration has a diameter equal to or greater than a diameter of the coronary sinus at a proximal anchor location (e.g., approximately 9 mm to about 20 mm). In some assemblies, the anchors are self-expanding, in other assemblies the anchors are operable, while other assemblies have at least one device with a self-expanding anchor and one with a operable anchor. The kit can also include a catheter with an outside diameter no larger than nine or ten Fr.

Also disclosed is a set of devices for use in treating mitral valve regurgitation, the set including a plurality of tissue-shaping devices, each with an anchor having an unexpanded configuration and an expanded configuration. the anchors having different diameters when in their expanded configurations, and each of the tissue shaping devices is configured to be delivered to a coronary sinus of a patient within a catheter having an outer diameter of no greater than nine gauge or ten Fr. In some examples, the anchor is a distal anchor (such as a self-expanding anchor or a drivable anchor), and the devices further include a proximal anchor (such as a self-expanding anchor or a drivable anchor) that has an unexpanded configuration and an expanded configuration, the proximal anchors having different diameters when in their configuration expanded ones. In some examples, the diameters of the distal anchors of the tissue shaping devices in the array in their expanded configurations range from about 7 mm to about 16 mm and, in some embodiments, the diameters of the proximal anchors of the devices for the tissue conformation in the assembly in its expanded configurations ranges from about 9mm to about 20mm. The kit can also include a catheter with an outside diameter no larger than nine or ten Fr.

The anatomical structure of the heart and its surrounding vessels varies from patient to patient. For example, the location of the circumflex artery and other essential arteries with respect to the coronary sinus can vary. Specifically, the distance along the coronary sinus from the foramen to the point of intersection with the circumflex artery can vary from patient to patient. Also, the diameter and length of the coronary sinus can vary from patient to patient.

We have invented a tissue shaping device, a set of tissue shaping devices, and a method that maximizes the therapeutic effect (i.e. reduction of mitral valve regurgitation) while minimizing side effects, such as unacceptable contraction of the circumflex artery or other coronary arteries. The tissue shaping device, set of devices, and method of the present invention allow the user to tailor treatment to the anatomical structure of the patient.

Also disclosed herein is a tissue shaping device adapted to be disposed in a vessel near a patient's heart (such as the coronary sinus) to reshape at least part of the patient's heart (such as the mitral valve). In that invention, the tissue shaping device includes a proximal anchor, a distal anchor, and a connector disposed between the proximal anchor and the distal anchor, the connector a moment of inertia that varies along its length. In some examples, the connector has a proximal anchoring portion, a distal anchoring portion, and a central portion disposed between the proximal anchoring portion and the distal anchoring portion, with the moment of inertia being smallest at a point on the central portion. . The proximal and distal anchors can each include a clamp, and the moment of inertia just distal to the proximal clamp or just proximal to the distal clamp is greater than the moment of inertia at a point in the central portion of the connector.

In some examples, the connector has a width that is substantially uniform and a thickness that is not uniform, over the length of the connector. In embodiments where 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 thickness of the connector may be less at a point on the portion. central. In embodiments where the proximal anchor includes a proximal anchor grip or the distal anchor includes a distal anchor grip, the thickness of the connector at a point just distal to the proximal anchor grip or just proximal to the distal anchor grip may be greater than the thickness of the connector in the central portion.

The connector can include at least a portion that has a thickness that varies as a function of distance from its proximal end or its distal end. This function can be, for example, a linear function or a square distance function. In embodiments where the connector includes a proximal anchoring portion, a distal anchoring portion, and a central portion disposed between the proximal anchoring portion and the distal anchoring portion, the portion of the connector whose thickness varies may be in the central portion. . The central portion may also include a portion having a substantially uniform thickness.

The invention also includes embodiments in which the connector includes an integrated proximal anchor actuation element, an integrated deployment fixation element, and / or an integrated anchor position stop.

The anatomical structure of the heart and its surrounding vessels varies from patient to patient. For example, the location of the circumflex artery and other essential arteries with respect to the coronary sinus can vary. Specifically, the distance along the coronary sinus from the foramen to the point of intersection with the circumflex artery can vary from patient to patient. Also, the diameter and length of the coronary sinus can vary from patient to patient.

We have invented a tissue shaping device, a set of tissue shaping devices, and a method that maximizes the therapeutic effect (i.e. reduction of mitral valve regurgitation) while minimizing side effects, such as unacceptable contraction of the circumflex artery or other coronary arteries. The tissue shaping device, set of devices, and method of the present invention allow the user to tailor treatment to the anatomical structure of the patient.

Also disclosed herein is a tissue shaping device adapted to be disposed in a vessel near the heart of a patient to reshape the heart of the patient, wherein the tissue shaping device includes an expandable anchor adapted to contact a vessel wall with an outward radial force, providing an anchoring force of preferably at least 4.44822 N to 8.89644 N (one to two pounds). The anchor includes an expanding energy absorbing element which, in some embodiments, is adapted to limit the radially outward force on the vessel wall. In some embodiments, the anchor includes a flexible wire, in which case the expansion energy absorbing element may be a point of flexure in the flexible wire. The flex point may include a section of the flexible wire that has an increased curvature compared to adjacent wire sections or it may be a loop formed in the flexible wire. The flexible anchor wire may be arranged in a substantially eight-shaped configuration, in which case there may be at least two expansion energy absorbing elements, such as two bending points in the flexible wire.

In some embodiments, the anchor can be a self-expanding anchor, in other embodiments, the anchor can be an operable anchor, optionally with a movable actuator and lock. The actuator can be used to expand the anchor as the actuator moves distally. With flexible wire anchors, the distal movement can move at least a portion of the flexible wire distally when the anchor is expanded.

Also disclosed herein, but outside the scope of the invention, is a method for deploying a tissue shaping device in a vessel, the tissue shaping device including an anchor and an energy absorbing element. expansion. The method includes the steps of delivering the tissue-shaping device to a treatment location within the vessel, expanding the anchor with the expansion energy of the anchor to place a radially outward force on a vessel wall (providing, for example , an anchoring force of at least 4.44822 N to 8.89644 N (one to two pounds)) and absorb at least a part of the expansion energy in the expansion energy absorbing element. In some examples, the absorption step includes the step of limiting the radially outward force on the wall.

In examples where the anchor includes flexible wire and the expansion energy absorbing element includes a flex point in the flexible wire, the absorbing step includes the step of bending the flexible wire around the flex point. In examples where the flexible wire is arranged in a substantially In the shape of a figure of eight, the anchor may include a second expansion energy absorbing element such as a second point of bending in the flexible wire, and the absorption step may include the step of bending the flexible wire around the bending points. first and second.

In some examples, the expansion step may include the step of applying an actuating force to the anchor to supply the expansion energy of the anchor, such as moving an actuator (eg, moving the actuator distally). The expansion stage may also include the stage of allowing the anchor to expand automatically.

In some examples, the delivery step may include the step of delivering the tissue-shaping device to the treatment location on a catheter in an unexpanded configuration, and the permitting step may include the step of expelling the anchor from the catheter. . The method may also include, prior to the administration step, the steps of compressing the tissue shaping device into the unexpanded configuration and placing the tissue shaping device on the catheter.

The invention will be described in more detail below with reference to the drawings.

Brief description of the figures

Figure 1 is a schematic view of a tissue shaping device according to one disclosure of the invention deployed within a coronary sinus.

Figure 2 is a schematic view of a tissue shaping device in accordance with an alternative disclosure of the invention deployed within a coronary sinus.

Figure 3 is a schematic view of a tissue shaping device delivered to a coronary sinus within a catheter.

Figure 4 is a schematic view of a partially deployed tissue shaping device within a coronary sinus.

Figure 5 is a schematic view of a partially deployed and cinched tissue shaping device within a coronary sinus.

Figure 6 is an elevational view of yet another disclosure of a tissue shaping device. Fig. 7 is a schematic drawing showing a method for determining the crossing point between a circumflex artery and a coronary sinus.

Figure 8 is a perspective drawing of a tissue shaping device in accordance with one disclosure.

Figure 9 is a partial sectional view of the tissue shaping device of Figure 8 in an unexpanded configuration within a catheter.

Figure 10 is a perspective view of an anchor for use with a tissue shaping device in accordance with this disclosure.

Figure 11 is a perspective view of another anchor for use with a tissue shaping device in accordance with this disclosure.

Figure 12 is a perspective view of yet another anchor for use with a tissue shaping device in accordance with this disclosure.

Figure 13 is a perspective view of yet another anchor for use with a tissue shaping device in accordance with this disclosure.

Figure 14 is a perspective view of another anchor for use with a tissue shaping device in accordance with this disclosure.

Figure 15 is a perspective view of yet another anchor for use with a tissue shaping device in accordance with this disclosure.

Figure 16 is a perspective view of part of an anchor for use with a tissue shaping device in accordance with this disclosure.

Figure 17 is a perspective view of an anchor for use with a tissue shaping device in accordance with one embodiment of this invention.

Figure 18 is a perspective view of another anchor for use with a tissue shaping device in accordance with another embodiment of this invention.

Figure 19 is a perspective view of yet another anchor for use with a tissue shaping device in accordance with this disclosure.

Figure 20 is a perspective view of yet another anchor for use with a tissue shaping device in accordance with this disclosure.

Figure 21 is a perspective view of a tandem anchor for use with a tissue shaping device in accordance with this disclosure.

Figure 22 is a perspective view of a connector with integrated anchor crimps for use in a tissue shaping device in accordance with this invention.

Figure 23 is a perspective view of a tissue shaping device employing the connector of Figure 22.

Figure 24 is a perspective view of another connector for use with a tissue shaping device in accordance with this disclosure.

Figure 25 is a perspective view of yet another connector for use with a tissue shaping device in accordance with this disclosure.

Figure 26 is a side view of a connector for use with a tissue shaping device in accordance with this disclosure.

Figure 27 is a side view of another connector for use with a tissue shaping device in accordance with this disclosure.

Figure 28 is a perspective view of another tissue shaping device in accordance with this disclosure.

Figure 29 is a side view of the tissue shaping device shown in Figure 28.

Figure 30 is a schematic view of another example showing the method of this invention.

Figure 31 is a schematic view of yet another example showing the method of this invention.

Detailed description of the invention

Figure 1 shows a partial view of a human heart 10 and some surrounding anatomical structures. The main coronary venous vessel is the coronary sinus 12, defined as beginning at orifice 14 or opening into the right atrium and extending through the great coronary vein to the anterior interventricular sulcus ("AIS") 16. It is also shows mitral valve 20 surrounded by mitral valve annulus 22 and adjacent to at least a portion of coronary sinus 12. The circumflex artery 24 shown in Figure 1 passes between coronary sinus 12 and the heart. The relative size and location of each of these structures vary from person to person.

Disposed within coronary sinus 12 is a tissue shaping device 30. As shown in Figure 1, distal end 32 of device 30 is disposed proximal to circumflex artery 24 to re-shape the valve annulus. 22 adjacent mitral valve and thereby reduce mitral valve regurgitation. As shown in Figure 1, device 30 has a distal anchor 34, a proximal anchor 36, and a connector 38.

In the example of Figure 1, proximal anchor 36 is fully deployed within the coronary sinus. In the alternate example shown in Figure 2, the proximal anchor is deployed at least partially out of the coronary sinus.

Figures 3-6 show a method in accordance with this disclosure. As shown in Figure 3, a catheter 50 is oriented in a manner known in the art through port 14 into coronary sinus 12. In order to navigate the venous system of the patient, catheter 50 preferably has a diameter No greater than ten Fr gauge outside, most preferably no greater than nine Fr gauge outside diameter. Disposed within catheter 50 is device 30 in an unexpanded configuration, and extending rearwardly through catheter 50 from device 30 to the exterior of the patient is a tie or control wire 52. At In some embodiments, the control wire 52 may include multiple control and tie elements, such as those described in US Patent Application SN 10 / 331,143.

In accordance with the disclosure, the device is deployed as distally as possible without applying substantial compressive force to the circumflex or other major coronary artery. Thus, the distal end of catheter 50 is disposed at a distal anchoring location proximal to the crossing point between circumflex artery 24 and coronary sinus 12, as shown in Figure 3. At this point, the catheter 50 is withdrawn proximally while device 30 is held stationary with control wire 52 to uncover distal anchor 34 at the distal anchor location within coronary sinus 12. Alternatively, the catheter can be kept stationary while device 30 is advanced distally to uncover the distal anchor.

Distal anchor 34 is a self-expanding anchor or a drivable anchor or a combination of a self-expanding and operable anchor. Once discovered, distal anchor 34 automatically expands, or expands by application of a driving force (such as a force transmitted through control wire 52), to engage the inner wall of coronary sinus 12, as as shown in figure 4. The anchoring force of the distal anchor, that is, the force with which the distal anchor resists movement in response to a proximally directed force, must be sufficient not only to maintain the position of the device within the coronary sinus, but also to allow the device to be used to reshape the adjacent tissue in the manner described below. In a preferred embodiment, distal anchor 34 engages the coronary sinus wall to provide an anchoring force of at least 4.44822 N (one pound), most preferably an anchoring force of at least 8.89644 N (Two pounds). The anchor expansion energy to supply the anchor force comes from the deformation energy stored in the anchor due to its compression for delivery of the catheter, from an actuation force, or a combination of both, depending on the design of the anchor.

While device 30 is held in place by the anchoring force of distal anchor 34, catheter 50 is withdrawn more proximally to a point just distal of proximal anchor 36, as shown in Figure 5. Next, exerts a proximally directed force on distal anchor 34 via control wire 52 through connector 38. In this example, the distance between the distal and proximal anchors along the connector is fixed, so the proximally directed force moves the anchor Proximal 36 proximal to the coronary sinus while distal anchor 34 remains stationary with respect to the coronary sinus. This cinching action straightens that section of coronary sinus 12, thereby modifying its shape and the shape of the adjacent mitral valve 20, moving the mitral valve leaflets toward greater coaptation, and reducing mitral valve regurgitation. In some examples of the invention, the proximal anchor moves proximally between about 1-6 cm, most preferably at least 2 cm, in response to proximally directed force. In others, such as examples where the distance between the distal and proximal anchors is not fixed (for example, where the length of the connector is variable), the proximal anchor may remain substantially stationary with respect to the coronary sinus despite application. of a proximally directed force on the distal anchor.

After adequate mitral valve regurgitation reduction has been achieved (as determined, for example, by viewing enhanced Doppler echocardiograms), the proximal anchor is deployed. Other vital signs of the patient, such as cardiac perfusion, can also be monitored during this procedure, as described in US Patent Application No. 10 / 366,585.

In preferred examples, the anchoring force of the proximal anchor, that is, the force with which the proximal anchor resists movement in response to a distally directed force, should be sufficient not only to maintain the position of the device within the coronary sinus, but also to allow the device to maintain the cinched shape of the adjacent tissue. In a preferred example, the proximal anchor is applied to the wall of the coronary sinus to provide an anchoring force of at least 4.44822 N (one pound), most preferably an anchoring force of at least 8.89644 N ( Two pounds). As with the distal anchor, the expansion energy of the proximal anchor to supply the anchoring force comes from the deformation energy stored in the anchor due to its compression for delivery of the catheter, from an actuation force, or a combination of both, depending on the design of the anchor.

In a preferred example, the proximal anchor is deployed by withdrawing catheter 50 proximally to uncover proximal anchor 36, then allowing proximal anchor 36 to self-expand, applying an actuation force to expand the anchor, or a combination of both. Control wire 52 is dislodged and catheter 50 is removed from the patient. The location and configuration of the device deployed according to this method are as shown in Figure 1.

Alternatively, the proximal anchor 36 can be deployed at least partially out of the coronary sinus after cinching to modify the shape of the mitral valve tissue, as shown in Figure 2. In both examples, because the distal anchor 34 is disposed proximal to the crossing point between coronary sinus 12 and circumflex artery 24, all anchoring and tissue reshaping force applied to the coronary sinus by device 30 is only proximal to the crossing point.

In alternative examples, the proximal anchor can be deployed prior to the application of proximally directed force to cinch the device to reshape the mitral valve tissue. An example of such a device is shown in Figure 6. Device 60 includes a self-expanding distal anchor 62, a self-expanding proximal anchor 64, and a connector 66. The design of the distal anchor 62 allows it to maintain its anchoring force when a force is applied. directed proximally over it to cinch it, while the design of the proximal anchor 64 allows it to move proximally after deployment while resisting distal movement after cinching. Strapping after deployment of the proximal anchor is described in greater detail in US Patent Application No. 10 / 066,426, filed January 30, 2002.

In this example too, distal anchor 62 is disposed proximal to the crossing point between coronary sinus 12 and circumflex artery 24, so that all anchoring and tissue remodeling force applied to the coronary sinus by device 30 is only proximal. to the crossing point.

It may be desirable to move and / or remove the tissue shaping device after deployment or to re-cinch after initial cinching. According to some examples of the invention, therefore, the device or one of its anchors can be recaptured. For example, in the example of Figure 1, after deployment of proximal anchor 36 but before disengagement of control wire 52, catheter 50 can be moved distally to position proximal anchor 36 back into catheter 50, for example, to the configuration shown in Figure 5. From this position, the cinching force along the connector 38 can increase or decrease, and the proximal anchor 36 can then be redeployed.

Alternatively, catheter 50 can be advanced distally to retrieve both proximal anchor 36 and distal anchor 34, for example, to the configuration shown in Figure 3. From this position, distal anchor 34 can be redeployed, having applied a cinching force and having deployed proximal anchor 36 as discussed above. Also from this position, device 30 can be completely removed from the patient simply by withdrawing the catheter from the patient.

A fluoroscopy (eg, angiograms and venograms) can be used to determine the relative positions of the coronary sinus and coronary arteries such as the circumflex artery, including the crossing point between the vessels and whether the artery is between the coronary sinus and the heart. A radiopaque dye can be injected into the coronary sinus and arteries in a known way while looking at the heart under a fluoroscope.

An alternative method of determining the relative positions of the vessels is shown in Figure 7. In this method, the guide wires 70 and 72 are inserted into the coronary sinus 12 and the circumflex artery 24 or other coronary artery, and the relative positions of the guide wires are viewed on a fluoroscope to identify the crossing point 74 Figure 8 illustrates an example of a tissue shaping device in accordance with this disclosure. 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. like nitinol wire.

In one example, connector 102 comprises a double length of nitinol wire that has both ends positioned within a distal crimp tube 108. Proximal to the proximal end of crimp tube 108 is a distal locking boss 110 that is formed by the crimp wire. bracket that bends from the longitudinal axis of the bracket 102 and then bends parallel to the longitudinal axis of the bracket before bending back towards the longitudinal axis of the bracket to form one half 110a of the distal locking boss 110. From the distal boss lock 110, the wire continues proximally through proximal crimp tube 112. As it exits the proximal end of proximal crimp tube 112, the wire bends to form a proximal locking boss 114 in the shape of an arrowhead. The wire of the holder 102 then returns distally through the proximal crimp tube 112 to a position just proximal to the proximal end of the distal crimp tube 108 where the wire is bent to form a second half 11 Ob of the distal lock 110.

At the distal end of connector 102 is an operable distal anchor 120 which is formed of a flexible wire such as nitinol or some other shape memory material. As shown in Figure 8, the wire that forms the distal anchor has one end positioned within the distal crimp tube 108. After exiting the distal end of the crimp tube 108, the wire forms a figure-eight configuration at the bottom. which bends upward and radially outward from the longitudinal axis of the crimp tube 108. The wire is bent back proximally and crosses the longitudinal axis of the crimp tube 108 to form a figure-eight leg. The wire is then bent to form a double loop eyelet or loop 122 around the long axis of support wire 102 before extending radially outward and distally backward over the long axis of crimp tube 108 to form the other leg shaped. Eight. Finally, the wire is bent proximally at the distal end of crimp tube 108 to complete distal anchor 120.

The distal anchor is expanded using a catheter or locking tool to exert a driving force that slides the distal anchor eye 122 from a position that is proximal to the distal locking boss 110 on the connector to a position that is distal to distal locking boss 110. The outwardly bent portions 11 Oa and 11 Ob of connector 110 are spaced wider than the width of eyelet 122 and provide Cam surfaces for locking action. The distal movement of eyelet 122 pushes these cam surfaces inward to allow eyelet 122 to pass distally to locking boss 110, and then return to its original space to maintain eyelet 122 in the locked position.

The operable proximal anchor 140 is formed and actuated in a similar manner by moving the eyelet 142 over the locking boss 114. Both the distal and proximal anchors provide anchoring forces of at least 4.44822 N (one pound), and the most being preferably 8.89644 N (two pounds).

Figure 9 illustrates a method of delivering a tissue shaping device 100 in accordance with the present disclosure to a desired location in the body, such as the coronary sinus, to treat mitral valve regurgitation. As noted above, device 100 is preferably loaded and oriented at a desired location within catheter 200 with the proximal and distal anchors in an unexpanded or deformed condition. That is, eyelet 122 of distal anchor 120 is positioned proximal to distal locking boss 110 and eyelet 142 of proximal anchor 140 is positioned proximal to proximal locking boss 114. The physician ejects the distal end of the device from the catheter. 200 toward the coronary sinus by advancing the device or retracting the catheter or a combination thereof. A pusher (not shown) provides distal movement of the device relative to catheter 200, and a clamp 201 provides proximal movement of the device relative to catheter 200.

Due to the inherent elasticity of the material from which it is formed, the distal anchor begins to expand as soon as it is out of the catheter. Once the device is properly positioned, catheter 200 is advanced to place a driving force on distal anchor eye 122 to push it distally onto distal locking boss 110 so that distal anchor 120 expands and becomes lock further in place to securely engage the coronary sinus wall. Next, a proximally directed force is applied to connector 102 and distal anchor 120 through a tie or control wire 201 that extends through the catheter outside the patient to apply sufficient pressure to the tissue adjacent to the connector to modify the shape of that tissue. In the case of the mitral valve, fluoroscopy, ultrasound, or other imaging technology can be used to see when the device delivers enough pressure to the mitral valve to help close it completely with each ventricular contraction without adversely affecting the patient. .

The proximally directed reshaping force causes the proximal anchor 140 to move proximally. In one embodiment, for example, proximal anchor 140 can be moved 1-6 cm, most preferably at least 2 cm, proximally to reshape mitral valve tissue. The proximal anchor 140 is then deployed from the catheter and allowed to begin its expansion. The locking tool applies an actuation force on proximal anchor eye 142 to advance distally over proximal locking boss 114 to expand and lock the proximal anchor, thereby securely engaging the coronary sinus wall to maintain sinus position the proximal anchor and maintain the remodeling pressure of the connector against the wall of the coronary sinus. Alternatively, catheter 200 can be advanced to lock proximal anchor 140.

Finally, the mechanism to secure the proximal end of the device can be released. In one embodiment, the fixation is done with a braided loop 202 at the end of the tie 201 and a locking wire 204. The locking wire 204 is removed thereby releasing the loop 202 so that it can be traversed through the protrusion. proximal locking device 114 at the proximal end of device 100.

Reduction of mitral valve regurgitation using the devices of this invention can be maximized by deploying the distal anchor as far distally into the coronary sinus as possible. In some cases, it may be desirable to implant a device for shorter tissue shaping, such as situations where the patient's circumflex artery crosses the coronary sinus relatively closer to the orifice or situations where the coronary sinus is shorter than the normal. As can be seen in FIG. 9, anchor 120 in its unexpanded configuration extends proximally along connector 102 within catheter 200. However, shortening the device simply by shortening the connector can cause eyelet 122 and the proximal portion of the distal anchor 120 overlaps with portions of the proximal anchor when the device is loaded into a catheter, thereby requiring that the diameter of the catheter be larger than is necessary for longer versions of the device. For mitral valve regurgitation applications, a preferred catheter diameter is ten Fr or less gauge (most preferably nine Fr), and the tissue shaping device in its unexpanded configuration should fit within the catheter. .

Figures 10-23 show examples and embodiments of the device of this invention having flexible and expandable wire anchors that allow the delivery of tissue-shaping devices 60mm or less in length with a ten-Fr (or less). In some examples and embodiments, one or both anchors are provided with flex points over which the anchors deform when placed in their unexpanded configuration for administration with a catheter or recapture in a catheter. These flex points allow the anchors to deform into configurations that minimize overlap with other elements of the device. In other embodiments, the distal anchor expands automatically, thereby avoiding the need for a proximally extending eyelet in the unexpanded anchor configuration that can overlap with the unexpanded proximal anchor within the delivery and / or recapture catheter.

Figure 10 shows a suitable operable anchor design for a shorter tissue shaping device similar to the device shown in Figures 8 and 9. In this example, distal anchor 300 is distal to a connector 302. As in FIG. As an example of Figure 8, the anchor 300 is formed in a figure-eight configuration from flexible wire such as nitinol held by a crimp tube 304. An eyelet 306 is formed around the longitudinal axis of the connector 302. A force of Distally directed actuation on eyelet 306 moves it over a locking boss 308 formed on connector 302 to actuate and lock anchor 300.

Figure 10 shows anchor 300 in an expanded configuration. In an unexpanded configuration, such as a configuration suitable for loading anchor 300 and the remainder of the tissue-shaping device into a catheter for initial deployment to treat mitral valve regurgitation, eyelet 306 is disposed proximally to lock boss 308, and the eight-shaped loops of anchor 300 are compressed against crimp 304. To limit the proximal distance, eyelet 306 must move along the connector to compress anchor 300 into an unexpanded configuration, the points Flexion points 310 are formed in the distal struts of anchor 300. Flexion points 310 are essentially kinks, that is, points of greater curvature, formed in the wire. When the anchor 300 is compressed into an unexpanded configuration, the flex points 310 deform so that the upper arms 312 of the distal struts bend around the flex points 310 and move toward the lower arms 314 of the struts. distal, thereby limiting the distance of the eyelet 306 and the proximal struts of the anchor must move proximally along the connector to compress the anchor.

Similarly, if the distal anchor were recaptured in a catheter for redeployment or removal from the patient, the anchor 300 would deform over the flex points 310 to limit the cross-sectional profile of the anchor within the catheter, even if eyelet 306 did not move proximally over locking boss 308 during the recapture procedure. Flexion points can also be provided on the proximal anchor in a similar manner.

As noted above, the distal anchor 300 may be part of a tissue shaping device (such as that shown in Figures 8 and 9) that has a proximal anchor and a connector disposed between the anchors. To treat mitral valve regurgitation, the distal anchor 300 can be deployed from a catheter and expanded with an actuation force to anchor against the coronary sinus wall to provide an anchor force of at least 4.44822 N (one pound) , preferably at least 8.89644 N (two pounds) and to lock anchor 300 in an expanded configuration. A force directed proximally to distal anchor 300 is applied through connector 302, such as by moving the proximal anchor proximally between about 1-6 cm, more preferably at least 2 cm, by pulling on a control wire or tie operated from outside the patient. . The proximal anchor can be deployed to maintain the reshaping force of the device.

One aspect of the anchor 300 is its ability to fit and accommodate a variety of cup sizes. For example, when anchor 300 expands within a vessel such as the coronary sinus, the wire arms of the anchor may contact the wall of the coronary sinus before eyelet 306 has been advanced distally over locking boss 308. to lock the anchor in place. Although continued distal advancement of eyelet 306 will create an external force on the coronary sinus wall, much of the energy put into the anchor by the anchor actuation force will be absorbed by the deformation of the distal struts over the flexion points. 310, which serve as expansion energy absorbing elements and thereby limit the radially outward force on the coronary sinus wall. This feature allows the anchor to be used in a wider range of vessel sizes while reducing the risk of excessive vessel expansion.

Figure 11 shows another suitable anchor design for a shorter tissue shaping device similar to the device shown in Figures 8 and 9. In this example, distal anchor 320 is distally distal to a connector 322. As in In the example of Figure 8, anchor 320 is formed in a figure-eight configuration from flexible wire such as nitinol supported by a crimp tube 324.

Unlike the example of Figure 10, however, the anchor 320 is self-expanding and is not operable. Eyelet 326 is held in place by a second crimp 325 to limit or eliminate movement of the proximal connection point of the anchor proximally or distally, for example, along connector 322.

Figure 11 shows anchor 320 in an expanded configuration. In an unexpanded configuration, such as a configuration suitable for loading anchor 320 and the remainder of the tissue-shaping device into a catheter for initial deployment to treat mitral valve regurgitation, the eight-shaped loops of the anchor 320 are compressed. Flexion points 330 are formed on the distal struts of anchor 320. When anchor 320 is compressed into an unexpanded configuration, flexure points 330 deform such that upper arms 332 of the distal struts bend around flex points 330 and move toward lower arms 334 of the distal struts. Depending on the exact location of the flex points 330, little or none of the wire portion of the anchor 320 is disposed proximally along the crimp. 325 or connector 322 when anchor 320 is in its unexpanded configuration.

Similarly, if the distal anchor were recaptured in a catheter for redeployment or removal from the patient, the anchor 320 would deform over the flex points 330 to limit the cross-sectional profile of the anchor within the catheter. Flexion points can also be provided on the proximal anchor in a similar manner.

The distal anchor 320 may be part of a tissue shaping device (such as that shown in Figures 8 and 9) having a proximal anchor and a connector disposed between the anchors. Due to the superelastic properties of its shape memory material, the distal anchor 320 can be deployed from a catheter to self-expand to anchor against the coronary sinus wall to provide an anchoring force of at least 4.44822 N (one pound), preferably at least 8.89644 N (two pounds). Then, a force directed proximally to distal anchor 320 can be applied through connector 322, such as by moving the proximal anchor proximally between about 1-6 cm, more preferably at least 2 cm, by pulling a tie or control wire operated from outside the patient. The proximal anchor can be deployed to maintain the reshaping force of the device.

Figure 12 shows another example of an anchor suitable for use in a shorter tissue shaping device. In this case, the distal anchor 340 is disposed distal to a connector 342. As in the embodiment of Figure 11, the anchor 340 is formed in a figure-eight configuration from flexible wire such as nitinol held by a crimped tube 344. Also like that example, anchor 340 is self-expanding and non-operable. The anchor loop 340 that forms the proximal anchor struts passes through a loop 346 that extends distally from a second crimp 345 to limit or eliminate movement of the proximal anchor struts proximally or distally, for example, along connector 342.

Figure 12 shows anchor 340 in an expanded configuration. Like the device of Figure 11, in an unexpanded configuration, such as a configuration suitable for loading anchor 340 and the remainder of the tissue-shaping device into a catheter for initial deployment to treat valve insufficiency. mitral, the eight-shaped loops of anchor 340 are compressed. Unlike the example in Figure 11, however, flex points 350 are formed on the proximal struts of anchor 340. When anchor 340 is compressed into an unexpanded configuration, flex points 350 are deformed such that the upper arms 352 of the distal struts bend around the flexion points 350 and move toward the lower arms 354 of the distal struts. The amount of the wire portion of the anchor 340 that extends proximally along the crimp 345 and the connector 342 in their unexpanded configuration depends on the location of the flex points 350. In one example, the flex points are formed at the highest and widest part of the proximal struts.

Distal anchor 340 may be part of a tissue shaping device (such as that shown in Figures 8 and 9) that has a proximal anchor and a connector disposed between the anchors.

Due to the superelastic properties of its shape memory material, the distal anchor 340 can be deployed from a catheter to self-expand to anchor against the coronary sinus wall to provide an anchoring force of at least 4.44822 N (one pound), preferably at least 8.89644 N (two pounds). Then, a force directed proximally to distal anchor 340 may be applied through connector 342, such as by moving the proximal anchor proximally between about 1-6 cm, more preferably at least 2 cm, by pulling a tie or control wire operated from outside the patient. The proximal anchor can be deployed to maintain the reshaping force of the device.

The flexion points 350 also add to the anchoring force of the distal anchor 340, for example, causing the height of the anchor to increase as the proximal struts become more perpendicular to the connector in response to a proximally directed force, increasing from thereby the anchoring force. In the same way, flex points can be added to the distal struts of a proximal anchor to increase the anchoring force of the proximal anchor in response to a distally directed force.

Figure 13 shows yet another example of an anchor suitable for use in a shorter tissue shaping device. In this case, the distal anchor 360 is distally distal to a connector 362. As in the example of Figure 12, the anchor 360 is formed in a figure-eight configuration from flexible wire such as nitinol supported by a tube. crimp 364. Also like that example, anchor 360 is self-expanding and non-operable. The anchor loop 360 that forms the proximal anchor struts passes through a loop 366 that extends distally from a second crimp 365 to limit or eliminate movement of the proximal anchor struts proximally or distally, for example, along connector 362.

Figure 13 shows anchor 360 in an expanded configuration. Like the device of Figure 12, in an unexpanded configuration, such as a configuration suitable for loading anchor 360 and the remainder of the tissue-shaping device into a catheter for initial deployment to treat valve insufficiency. mitral, the eight-shaped loops of anchor 360 are compressed. Unlike the example in figure 12, however, flexion points 370 are formed on both the proximal and distal struts of the anchor 360.

Anchor 360 can be used as part of a tissue shaping device like the examples discussed above.

Figure 14 shows a suitable operable anchor design for a shorter tissue shaping device similar to the device shown in Figures 8 and 9. In this example, the distal anchor 380 is distally distal to a connector 382. As in the FIGS. In other examples, anchor 380 is formed in a figure-eight configuration from flexible wire such as nitinol supported by a crimp tube 384. In contrast to the example of Figure 10, eyelets 386 and 387 are formed at each one of the proximal struts of the anchor around the longitudinal axis of connector 382 . This arrangement reduces the radially outward force on the anchor. A distally directed actuation force on eyelets 386 and 387 moves them over a locking boss 388 formed on connector 382 to actuate and lock anchor 380.

Figure 14 shows anchor 380 in an expanded configuration. In an unexpanded configuration, such as a configuration suitable for loading anchor 380 and the remainder of the tissue-shaping device into a catheter for initial deployment to treat mitral valve regurgitation, eyelets 386 and 387 are arranged proximally. To lock protrusion 388 and the eight-shaped loops of anchor 380 are compressed against crimp 384. To limit proximal distance, eyelets 386 and 387 must move to compress anchor 380 into an unexpanded configuration, the flex points 390 are formed on the distal struts of the anchor 380. When the anchor 380 is compressed into an unexpanded configuration, the flexion points 390 deform so that the upper arms 392 of the distal struts bend around the flexure points 390 and move toward the lower arms 394 of the distal struts, thereby limiting the distance of the eyelets 386 and 387 and the struts The proximal pieces of the anchor must be moved proximally along the connector to compress the anchor.

If the distal anchor were recaptured in a catheter for redeployment or removal from the patient, the anchor 380 would deform over flex points 390 to limit the cross-sectional profile of the anchor within the catheter, even if the eyelets 386 and 387 will not move proximally over locking boss 388 during the recapture procedure. Flexion points can also be provided on the proximal anchor in a similar manner.

As with the other examples above, the distal anchor 380 can be part of a tissue shaping device (such as that shown in Figures 8 and 9) that has a proximal anchor and a connector disposed between the anchors. To treat mitral valve regurgitation, distal anchor 380 can be deployed from a catheter and expanded with an actuation force to anchor against the coronary sinus wall to provide an anchor force of at least 4.44822 N (one pound) , preferably at least 8.89644 N (two pounds) and to lock anchor 380 in an expanded configuration. A force directed proximally to distal anchor 380 is applied through connector 382, such as by moving the proximal anchor proximally between about 1-6 cm, more preferably at least 2 cm, pulling on a control wire or tie operated from outside the patient . The proximal anchor can be deployed to maintain the reshaping force of the device.

As with other examples, one aspect of the anchor 380 is its ability to fit and accommodate a variety of cup sizes. For example, when anchor 380 is expanded within a vessel such as the coronary sinus, the wire arms of the anchor may contact the coronary sinus wall before eyelets 386 and 387 have advanced distally over the locking boss. 388 to lock the anchor in place. While continued distal advancement of eyelet 386 will create an external force on the coronary sinus wall, much of the energy put into the anchor by the anchor actuation force will be absorbed by the deformation of the distal struts over the flexure points. 390.

Figure 15 shows yet another example of an operable anchor for use in a shorter tissue shaping device. Proximal anchor 400 is disposed proximal to connector 402. As in other cases, anchor 400 is formed in a figure-eight configuration from flexible wire such as nitinol held by crimp tube 404. An eyelet 406 is formed. around a locking boss 408 extending proximally from the crimp 404. A distally directed drive force on the eyelet 406 moves it over the locking boss 408 to drive and lock the anchor 400.

Figure 15 shows anchor 400 in an expanded configuration. When the anchor 400 is compressed into an unexpanded configuration, the flex points 410 formed as loops in the anchor wire deform so that the upper arms 412 of the distal struts bend around the flex points 410 and move toward the lower arms 414 of the distal struts. As with the other examples, proximal anchor 400 can be part of a tissue shaping device (such as that shown in Figures 8 and 9) that has a distal anchor and a connector disposed between the anchors.

As other examples, one aspect of the anchor 400 is its ability to fit and accommodate a variety of cup sizes. For example, when anchor 400 expands within a vessel such as the coronary sinus, the wire arms of the anchor may contact the wall of the coronary sinus before eyelet 406 has been advanced distally over locking boss 408 to lock the anchor in place. Although continued distal advancement of eyelet 406 will create an external force on the coronary sinus wall, much of the energy put into the anchor by the anchor actuation force will be absorbed by deformation of the distal struts over the flexion points 410 , which serve as expansion energy absorbing elements and thereby limit the radially outward force on the coronary sinus wall.

In other examples, the looped flex points of the embodiment of Figure 15 may be formed on the proximal struts of the anchor in addition to or in place of the distal struts. The example of the looped flex point can also be used on a distal anchor, as shown in Figure 16 (without the crimp or connector). It should be noted that in the example of Figure 16, the proximal and distal struts of anchor 420, as well as eyelet 422 and flex points 424 are formed from a single wire.

Figure 17 shows an embodiment of the present invention of a distal anchor 440 similar to that of Figure 10 suitable for use in a device for shorter tissue shaping. In this embodiment, however, additional twists 442 are added at the apex of the figure-eight pattern of the anchor. As in the example of Figure 10, flex points 444 are formed on the distal struts of the anchor. As shown, anchor 440 can be actuated by moving eyelet 446 distally over a locking boss 448 formed in connector 450. Anchor 440 can also be made as a self-expanding anchor by limiting or eliminating movement of the proximal struts of anchor 440 along the way. length of the connector 450, as in the example shown in Figure 11. As with other examples and embodiments, the flex points help the anchor 440 to adjust and accommodate different vessel sizes. In addition, the additional twists 442 also help the anchor adapt to different vessel diameters by holding the apex of the anchor together.

As in the other examples, the anchor 440 is preferably formed from nitinol wire. Anchor 440 can be used as part of a tissue shaping device in a similar manner to the anchor of Figure 10 (for the actuation anchor) or the anchor of Figure 11 (for the self-expanding anchor). Anchor 440 can also be used as a proximal anchor.

Figure 18 shows another embodiment of the present invention having a distal anchor 460 similar to that of Figure 17. In this embodiment, however, the flex points 462 are formed in the proximal struts of the anchor, as in the self-expanding anchor that shown in Figure 12. As in the embodiment of Figure 17, additional twists 464 are added at the apex of the eight-shaped pattern of the anchor. As shown, anchor 460 can be actuated by moving eyelet 466 distally over a locking boss 468 formed on connector 470. Anchor 460 can also be made as a self-expanding anchor by limiting or eliminating movement of the proximal connection point of anchor 460 along the connector 470, as in the embodiment shown in Figure 11. As with the embodiment of Figure 17, the flex points help the anchor 460 adjust and accommodate different vessel sizes. In addition, the additional twists 464 also help the anchor adapt to different vessel diameters by holding the apex of the anchor together.

As in the other embodiments and examples, the anchor 460 is preferably formed from nitinol wire. Anchor 460 can be used as part of a tissue shaping device in a similar manner to the anchor of FIG. 10 (for the actuation anchor) or the anchor of FIG. 11 (for the self-expanding anchor). Anchor 460 can also be used as a proximal anchor.

Figure 19 shows an example of a self-expanding distal anchor 480 suitable for use in a device for shorter tissue shaping. As in the other examples and embodiments, the anchor 480 is formed in a figure-eight configuration from flexible wire such as nitinol supported by a crimp tube 482. The base of the figure-eight pattern is narrower in this example. , however, with the proximal struts of anchor 484 passing through crimp 482.

The distal anchor 480 may be part of a tissue shaping device (such as that shown in Figures 8 and 9) that has a proximal anchor and a connector disposed between the anchors. To treat mitral valve regurgitation, the distal anchor 480 can be deployed from a catheter and allowed to self-expand to anchor against the coronary sinus wall to provide an anchoring force of at least 4.44822 N (one pound), preferably at least 8.89644 N (two pounds). A force directed proximally to distal anchor 480 is applied through connector 486, such as by moving the proximal anchor proximally between about 1-6 cm, more preferably at least 2 cm, by pulling on a control wire or tie operated from outside the patient . The proximal anchor can be deployed to maintain the reshaping force of the device.

Figure 20 shows another example of a distal anchor suitable for use in a device for shorter tissue shaping and similar to that of Figure 10. In this example, the distal anchor 500 is distally distal to a connector 502. As in In other examples and embodiments, anchor 500 is formed in a figure-eight configuration from flexible wire such as nitinol supported by a crimp tube 504. An eyelet 506 is formed around of the longitudinal axis of connector 502. A distally directed actuation force on eyelet 506 moves it over a locking boss 508 formed in connector 502 to actuate and lock anchor 500.

The angle of the proximal struts 501 and the angle of the distal struts 503 are wider than the corresponding angles in the example of Figure 10, however, causing the anchor 500 to stretch more wide than high when expand, as shown. In an unexpanded configuration, such as a configuration suitable for loading anchor 500 and the remainder of the tissue-shaping device into a catheter for initial deployment to treat mitral valve regurgitation, eyelet 506 is disposed proximally to lock Boss 508 and the eight-shaped loops of anchor 500 are compressed against crimp 504. To limit proximal distance, eyelet 506 must move along the connector to compress anchor 500 into an unexpanded configuration, the points of attachment flexion 510 are formed in the distal struts 503, as in the example of Figure 10, to limit the width of the device in its unexpanded configuration within a catheter.

The distal anchor 500 may be part of a tissue shaping device (such as that shown in Figures 8 and 9) that has a proximal anchor and a connector disposed between the anchors. To treat mitral valve regurgitation, distal anchor 500 can be deployed from a catheter and expanded with an actuation force to anchor against the coronary sinus wall to provide an anchor force of at least 4.44822 N (one pound), preferably of at least 8.89644 N (two pounds) and to lock anchor 500 in an expanded configuration. A force directed proximally to distal anchor 500 is applied through connector 502, such as by moving the proximal anchor proximally between about 1-6 cm, more preferably at least 2 cm, by pulling on a control wire or tie operated from outside the patient . The proximal anchor can be deployed to maintain the reshaping force of the device.

The anchor shown in Figure 20 can be used as a proximal anchor. This anchor can also be formed as a self-expanding anchor.

Figure 21 shows a tandem distal anchor in accordance with another example of the present invention. Self-expanding anchor 520 is formed in a figure-eight configuration from flexible wire such as nitinol supported by crimp tube 522. Eyelet 524 is held in place by the distal end of operable anchor 540 to limit or eliminate strain. Proximal and distal movement of the proximal struts of the anchor 520. As in the anchor shown in Figure 11, the flex points 530 are formed on the distal struts of the anchor 520. Depending on the exact location of the flexion points 530 Very little or none of the wire portion of anchor 520 is disposed proximal to the distal end of anchor 540 when anchor 520 is in its unexpanded configuration.

Similarly, if the distal anchor were recaptured in a catheter for redeployment or removal from the patient, the anchor 520 would deform over the flex points 530 to limit the cross-sectional profile of the anchor within the catheter. Flexion points can also be provided on the proximal anchor in a similar manner.

Anchor 540 is similar to anchor 120 shown in Figure 8. Anchor 540 is formed in a figure-eight configuration from flexible wire such as nitinol supported by a crimp tube 544. An eyelet 546 is formed around from the longitudinal axis of connector 542. A distally directed actuating force on eyelet 546 moves it over a locking boss 548 formed on connector 542 to actuate and lock anchor 540.

Tandem anchors 520 and 540 may be part of a tissue shaping device (such as that shown in Figures 8 and 9) having a proximal anchor and a connector disposed between the anchors. Anchors 520 and 540 can be made from a single wire or separate pieces of wire. To treat mitral valve regurgitation, distal anchors 520 and 540 can be deployed from a catheter. The self-expanding anchor 520 will self-expand, and the operable anchor 540 can expand and lock with an actuation force, to anchor both anchors against the coronary sinus wall to provide an anchor force of at least 4.44822 N (one pound), preferably of at least 8.89644 N (two pounds). A proximally directed force is applied to anchors 520 and 540 through connector 542, such as by moving the proximal anchor proximally between about 1-6 cm, more preferably at least 2 cm, by pulling on an externally operated control wire or tie of the patient. The proximal anchor can be deployed to maintain the reshaping force of the device.

While the above anchor designs were described as part of shorter tissue shaping devices, these anchors can be used in tissue shaping devices of any length.

Figures 22 and 23 show an alternate example in which the device connector 560 is integrated with the distal and proximal crimp tubes 562 and 564. In this example, the connector 560 is formed by cutting a section of a blank, such as a cylinder or tube of nitinol (or other suitable material such as stainless steel), leaving the crimped tube portions 562 and 564 intact. The radius of the semi-circular cross-section connector is therefore the same as the radius of the two anchor tubes.

Other connector shapes are possible for an integrated connector and crimp design, of course. For example, the device can be formed from a flat sheet or ribbon-shaped blank by removing rectangular edge sections from a center section, creating an I-shaped sheet (e.g. nitinol or stainless steel) that have greater widths at the ends and a narrower width at the center connector portion. The ends can be rolled to form the crimped tubes, leaving the connector substantially flat. Also, in alternative examples, the connector can be integrated with just one of the anchors.

As shown in Figure 23, a distal anchor 566 is formed in a figure-eight configuration from flexible wire such as nitinol. The distal anchor 566 is self-expanding, and its proximal struts 568 are held in place by the crimp tube 562. Optional flex points can be formed on the proximal struts 568 or distal struts 570 of the anchor 566.

A proximal anchor 572 is also formed in a figure-eight configuration from flexible wire such as nitinol with an eyelet 574 at its proximal end. A distally directed actuation force on eyelet 574 moves it over a locking boss 576 extending proximally from crimp tube 564 to actuate and lock anchor 572. Locking boss 576 also serves as a connection point for a tie down. or a control wire deploy and activate the device in the manner previously described with respect to Figures 8 and 9. Optional flex points may be formed on the proximal or distal struts of anchor 572.

When deployed in the coronary sinus to treat mitral valve regurgitation, the tissue shaping devices of the present invention are subjected to cyclic flexure and tensile loading as the patient's heart beats. Figure 24 shows an alternative connector for use with the tissue shaping devices of the present invention that distributes any stress caused by beat-to-beat flexion and tensile load over the device.

Connector 600 has a proximal anchor area 602, a distal anchor area 604, and a central area 606. The distal anchor area can be longer than the distal anchor attached to it, and the proximal anchor area can be longer. than the proximal anchor attached to it. An optional locking boss 608 may be formed on the proximal end of the connector 600 for use with a operable proximal anchor and for connection to a tie or control wire, as described above. An optional knob 610 may be formed on the distal end of connector 600 to prevent accidental distal slippage of a distal anchor.

In order to reduce material fatigue caused by the loading and unloading of the heartbeat to the tissue shaping device, the moment of inertia of the connector 600 varies along its length, particularly in the connector portion disposed between the two anchors. In this example, the connector 600 is formed as a tape or sheet and is preferably formed from nitinol having a rectangular cross-sectional area. The thickness of the connector 600 is preferably constant across the proximal anchor area 602 and the distal anchor area 604 to facilitate the attachment of crimps and other anchor components. Central area 606 has a decreasing thickness (and therefore decreasing moment of inertia) from the border between central area 606 and proximal anchoring area 602 to a point approximately in the center of central area 606, and a increasing thickness (and increasing moment of inertia) from that point to the boundary between central area 606 and distal anchoring area 604. The variable thickness and variable cross-sectional shape of the connector 600 changes its moment of inertia along its length, thereby helping to distribute any stress from heartbeat to device loading and unloading over a wider area and reducing the potential for connector material fatigue failure.

Figure 25 shows another example of the connector. Like the previous one, the connector 620 has a proximal anchor area 622, a distal anchor area 624, and a central area 626. The proximal anchor area 622 has an optional two-barbed tip 628 formed at its proximal end to facilitate attachment. of a crimp and other anchoring elements. Bent tip portions 629 may be formed at the proximal end of the tip to prevent accidental slippage of a proximal anchor. An optional knob 630 may be formed on the distal end of connector 620 to prevent accidental distal slippage of a distal anchor.

As the example of FIG. 24, connector 620 is formed as a tape or sheet and is preferably formed from nitinol having a rectangular cross-sectional area. The thickness of the connector 620 is preferably constant in the proximal anchoring area 622 and the distal anchoring area 624 to facilitate the attachment of crimps and other anchor components. Central area 626 has a decreasing thickness (decreasing moment of inertia) from the border between central area 626 and proximal anchoring area 622 to a point approximately in the center of central area 626, and increasing thickness (increasing moment of inertia ) from that point to the edge between central area 626 and distal anchoring area 624. The variable thickness and variable cross-sectional shape of the connector 620 changes its moment of inertia along its length, thereby helping to distribute in a wider area any stress from heartbeat to device loading and unloading and reducing the chance of connector material fatigue failure.

Figure 26 shows a connector 640 in profile. Connector 640 can be formed like connectors 600 and 620 or Figures 24 and 25, respectively, or it may have some other configuration. Connector 640 has a proximal anchor area 642, a distal anchor area 644, and a central area 646. Connector 640 is preferably formed as a tape or sheet and is preferably formed from nitinol having a rectangular cross-sectional area. .

In the example shown in FIG. 26, the thicknesses of the proximal anchoring area 642 and the distal anchoring area 644 are constant. The thickness of central area 646 decreases from the border between central area 646 and proximal anchoring area 642 to a point distal of that border and increases from a point proximal to the border between distal anchoring area 644 and central area 646 to that edge. The points in the central area where the decrease in thickness ends and the increase in thickness begins may be coincident or may be separated to form an area of uniform thickness within the central area 646. In this embodiment, the thickness of the central area changes as a function of the square root of the distance from the edges between the central area and the proximal and distal anchoring areas.

Figure 27 shows yet another example of the connector. As in Figure 26, connector 650 may be formed like connectors 600 and 620 or Figures 24 and 25, respectively, or it may have some other configuration. Connector 650 has a proximal anchor area 652, a distal anchor area 654, and a central area 656. Connector 650 is preferably formed as a tape or sheet and is preferably formed from nitinol having a rectangular cross-sectional area. .

In the example shown in FIG. 27, the thicknesses of the proximal anchoring area 652 and the distal anchoring area 654 are constant. The thickness of a proximal portion 658 of the central area 656 decreases linearly from the border between the central area 656 and the proximal anchoring area 652 to a central portion of constant thickness 662 of the central area 656, and the thickness of a distal portion 660 of the Central area 656 increases linearly from central portion 662 to the border between distal anchoring area 654 and central area 656.

In other examples, the thickness of the connector may vary in other ways. Also, the cross-sectional shape of the connector may be different from rectangular and may change along the length of the connector.

Figures 28 and 29 show yet another example of the invention. The tissue shaping device 700 has a connector 706 disposed between a proximal anchor 702 and a distal anchor 704. The connector 706 may be formed as a tape or sheet, like the tapered connectors shown in Figures 24-27. Operable proximal anchor 702 is formed in a figure-eight configuration from flexible wire such as nitinol and is secured to connector 706 with crimp tube 708. Likewise, self-expanding distal anchor 704 is formed in a figure-eight from a flexible wire such as nitinol and is secured to connector 706 with a crimp tube 710. A proximal locking boss 716 extends proximally from proximal anchor 702 for use in actuating and locking the proximal anchor 702 and to connect to a control wire or tie, as described above.

Flexion points 712 are formed in the loops of the proximal anchor 702, and the flexure points 714 are formed in the loops of the distal anchor 704. When compressed into their unexpanded configurations for delivery and deployment as a function of catheters or For recapture into a catheter for redeployment or removal, the wire portions of anchors 702 and 704 bend around flex points 712 and 714, respectively, to limit the cross-sectional profile of the anchors within the catheter. The flex points also affect the anchor strength of the anchors and the adaptability of the anchors to different vessel diameters, as discussed above.

In addition to different coronary sinus lengths and varying distances from the orifice to the crossing point between the coronary sinus and the circumflex artery, the diameter of the coronary sinus at the distal and proximal anchor points can vary from patient to patient. The anchors described above can be manufactured in a variety of heights and combined with connectors of different lengths to accommodate this variation from patient to patient. For example, tissue shaping devices deployed in the coronary sinus to treat mitral valve regurgitation may have distal anchoring heights ranging from about 7mm to about 16mm and proximal anchoring heights ranging from about 9mm. to about 20 mm.

When treating a patient for mitral valve regurgitation, estimates can be made of the appropriate length for a device for tissue shaping, as well as the appropriate anchor heights for distal and proximal anchors. The physician can then select a tissue shaping device having the appropriate anchor length and sizes from a set or sets of devices with different lengths and different anchor sizes, made, for example, according to the embodiments and examples described above. These sets of devices can be added in sets or kits or they can simply be a collection or inventory of different devices for tissue shaping.

One way to estimate the appropriate length and anchor sizes of a tissue shaping device for mitral valve regurgitation is to view a fluoroscopic image of a coronary sinus into which a catheter with fluoroscopically visible markings has been inserted. The crossing point between the coronary sinus and the circumflex artery can be determined as described above, and the screen size of the length can be measured of the coronary sinus proximal to that point and the diameter of the coronary sinus at the intended anchoring locations. By also measuring the screen distance of the catheter markings and comparing them to the actual distance between the catheter markings, the length and diameter measurements can be scaled to actual size. A tissue shaping device with the appropriate length and anchor sizes can be selected from a set or inventory of devices to be deployed to the patient to treat mitral valve regurgitation.

Figure 30 shows yet another example of the method of the present invention. In this case, a tissue shaping device 800 formed from a substantially straight rigid member 802 is disposed in coronary sinus 804 to treat mitral valve regurgitation. When deployed as shown, the central portion of the rigid member 802 exerts an anterior remodeling force through the coronary sinus wall toward the mitral valve 806, while the proximal and distal ends 808 and 810, respectively, of the rigid member 802 exerts posteriorly directed forces on the coronary sinus wall. In accordance with the present invention, device 800 is disposed relative to circumflex artery 812 so that all forces directed anteriorly from rigid member 802 are posterior to the crossing point between artery 812 and coronary sinus 804, regardless of the fact that the distal end 810 of the device 800 and a guidewire portion 814 are distal to the crossover point.

The device of Figure 30 may also include a less rigid portion at the distal end 810 of the member 802 to further eliminate any forces directed toward the mitral valve distal to the crossover point. More details of the device (other than the method of the present invention) can be found in US patent application S.N.

10 / 112,354, published as US Patent Application Publication No. 2002/0183838.

Figure 31 shows another example of the method of this invention. Device 900 has a substantially straight rigid portion 902 disposed between a proximal angled portion 904 and a distal angled portion 906 within coronary sinus 908. As shown, proximal angled portion 904 extends through the orifice of the coronary sinus 910 within a catheter (not shown). The distal angled portion 906 extends distally to an engaged portion 912 that is preferably disposed in the SIA.

To treat mitral valve regurgitation, the straight portion 902 of the device reshapes the coronary sinus and adjacent tissue to apply a force directed anteriorly through the coronary sinus wall toward the mitral valve 914. Due to the design of the device , this reshaping force is applied only proximal to the crossing point between the coronary sinus 908 and the circumflex artery 916 of the patient, despite the fact that at least a portion of the distal portion 906 of the device and the hooked portion 912 are disposed distally to the crossover point.

The invention is disclosed in the appended claims.

Claims (9)

A tissue shaping device adapted to be deployed in a vessel to reshape tissue adjacent to the vessel, comprising: a first expandable anchor (440, 460, 320) comprising a flexible wire; a second expandable anchor comprising a flexible wire; Y a connector (450, 470) disposed between the first and second anchors; characterized in that the first anchor includes additional twists (442, 464) formed by the flexible wire at a vertex of the first anchor to hold the vertex of the anchor together. The device according to claim 1, wherein the second anchor includes additional twists formed by the flexible wire. The device according to claim 2, wherein the additional twists of the second anchor are formed at an apex of the second anchor. The device according to claim 1, wherein the flexible wire forms an 8-shaped configuration and the additional twists are formed at a crossover location between wire segments in the 8-shaped configuration. The device according to claim 4, wherein the second anchor includes additional twists formed by the flexible wire. The device according to claim 5, wherein the flexible wire of the second anchor forms an 8-shaped configuration and the additional twists of the second anchor are formed at a crossing location between wire segments in the 8-shaped configuration of the second anchor. The device according to claim 1, wherein one or both anchors comprise at least one bending point (462, 444) over which the anchor (s) deforms when placed in an unexpanded condition. The device according to any preceding claim, wherein the anchor wires are arranged within a crimped tube. The device according to any preceding claim, wherein the device includes a locking boss (448, 468) formed on the connector to lock the first anchor or the second anchor in an expanded configuration.