ES2581321T3 - Device to modify the shape of an organ of the body - Google Patents

Abstract

A set of separate devices (30) for use in mitral valve regurgitation treatment, the set comprises: a plurality of separate tissue forming devices (30) having different lengths, each device comprises an anchor (34, 36) comprising twisted wires to each other and having an unexpanded configuration and an expanded configuration, the anchors (34, 36) have different diameters when they are in their expanded configurations, each of the separate tissue forming devices (30) is configured to be administered to a coronary sinus of a patient within a catheter (50) that has an outside diameter not greater than ten french; where there are extra twists (442 or 464) at an apex of a pattern in figure of 8 formed by the anchor.

Description

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DESCRIPTION

Device to modify the shape of an organ of the body

This invention is generally related to devices and methods for forming tissue by deploying one or more devices in body lights adjacent to the tissue. A particular application is related to a treatment for mitral valve regurgitation through the deployment of a tissue-forming device in the coronary sinus or the patient's major cardiac vein.

The mitral valve is a part of the heart that is located between the chambers of the left atrium and the left ventricle. When the left vent is contracted to pump blood throughout the body, the mitral valve closes to prevent blood from being pumped back to the left atrium. In some patients, whether due to genetic malformation, disease or injury, the mitral valve does not close properly, causing a state known as regurgitation, whereby blood is pumped to the atrium at each contraction of the heart muscle. Regurgitation is a serious condition, which often deteriorates rapidly, which reduces circulatory efficiency and must be corrected.

Two of the best known techniques to restore the function of a damaged mitral valve are to surgically replace the valve with a mechanical valve or suture a flexible ring around the valve to support it. Each of these procedures is highly invasive because access to the heart is obtained through an opening in the patient's chest. Patients with mitral valve regurgitation are often relatively weak, thereby increasing the risks associated with such an operation. A less invasive approach to assist in the closure of the mitral valve involves the placement of a tissue-forming 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 its closure. This technique has an advantage over other mitral valve repair methods because it can be performed percutaneously without opening the thoracic wall. Examples of devices of this type are shown in the US patent application. UU. Serial No. 10 / 142,637, "Body Lumen Device Anchor, Device and Assembly" filed May 8, 2002; U.S. patent application UU. Serial No. 10 / 331,143, "System and Method to Effect the Mitral Valve Annulus of a Heart" presented on December 26, 2002; and the US patent application. UU. Serial No. 10 / 429,172, "Device and Method for Modifying the Shape of a Body Organ," filed May 2, 2003. When a tissue shaping device is deployed in a vein or artery to modify adjacent tissue, it should be Be careful to avoid building nearby arteries. For example, when mitral valve regurgitation is treated, a tissue shaping device can be deployed in the coronary sinus to modify the shape of the adjacent mitral valve ring ring. Coronary arteries, such as the circumflex artery, can pass between the coronary sinus and the heart, however, increasing the danger that the deployment of the support may limit perfusion to a part of the heart by building one of those arteries. See, p. eg, the following applications, US patent application. UU. Serial No. 09 / 855,945, "Mitral Valve Therapy Device, System and Method," filed May 14, 2001 and published November 14, 2002 as US 2002/0169504 A1; U.S. patent application UU. Serial No. 09 / 855,946, "Mitral Valve Therapy Assembly and Method," published May 14, 2001 and published November 14, 2002 as US 2002/0169502 A1; and the US patent application. UU. Serial No. 10 / 003.910, "Focused Compression Mitral Valve Device and Method" presented on November 1, 2001. It is therefore advisable to monitor cardiac perfusion during and after such mitral valve regurgitation therapy. See, p. eg, the US patent application. UU. Serial No. 10 / 366,585, "Method of Implanting a Mitral Valve Therapy Device," filed on February 12, 2003. WO 03/094801 refers to an intravascular support device that includes a support or reformer wire, a proximal anchor and a distal anchor.

Brief compendium of the invention

The anatoirna of the heart and its surrounding vessels varies from one patient to another. For example, the location of the circumflex artery and other key arteries with respect to the coronary sinus may vary. Specifically, the distance along the coronary sinus from the ostium to the crossing point with the circumflex artery may vary from one patient to another. Additionally, the diameter and length of the coronary sinus may vary from one patient to another.

We have invented a set of tissue shaping devices according to claim 1 for use in mitral valve regurgitation treatment. The tissue shaping device, the set of devices and the method of this invention allow the user to adapt the therapy to the patient's anatomy.

A method for treating mitral valve regurgitation in a patient is described. The method includes the steps of administering a tissue shaping device to the patient's coronary sinus in an unexpanded configuration within a catheter having an outside diameter of no more than nine or ten French, the tissue shaping device includes a connector arranged between a distal expandable anchor comprising flexible wire and a proximal expandable anchor comprising flexible wire, the device has a length of 60 mm or less; and deploying the device to reduce mitral valve regurgitation, such as anchoring the expandable distal anchor by placing the expandable distal anchor flexible wire in contact with a coronary sinus wall, e.g. eg, allowing the expandable distal anchor to self expand or applying a driving force to the expandable distal anchor and possibly locking the expandable distal anchor after performing the application stage. The phase

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Deployment may include the step of anchoring the distal expandable anchor with an anchor force of at least 0.45 to 0.90 kg (one to two pounds).

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

In some examples, in which the distal expandable anchor also includes a flexible wire connection of the distal expandable anchor, which substantially limits the proximal and distal movement of the connection with respect to the distal expandable anchor, the administration stage includes the administering stage. the coronary sinus tissue shaping device in an unexpanded configuration in which none of the flexible distal expandable anchor wire extends proximally along the connector within the catheter.

In other examples, in which the distal expandable anchor also includes a distal and proximally movable distal expandable flexible wire connection, the administration step may include the step of administering the tissue forming device to the coronary sinus in an unexpanded configuration. wherein at least a portion of the distal expandable flexible anchor wire extends proximally or distally along the connector within the catheter. The deployment stage may include the steps of moving the connection distally to actuate the distal expandable anchor and lock the distal expandable anchor after performing the movement stage.

A tissue shaping device adapted to be administered to a coronary sinus in an unexpanded configuration within a catheter having an outside diameter of no more than nine to ten french and also adapted to be deployed in the coronary sinus to reduce is also described. mitral valve regurgitation, the device includes a connector disposed between a distal expandable anchor comprising a flexible wire (such as a self-expanding anchor or an operable anchor that possibly has an actuator and a lock) and a proximal expandable anchor comprising a flexible wire , the device has a length of 60 mm or less. In some examples the distal expandable anchor is adapted to conform to a range of coronary sinus diameters by expansion to contact with a wall part of the coronary sinus to provide sufficient anchoring force to anchor the device within the coronary sinus, such as an anchor force of at least 0.45 to 0.90 kg (one to two pounds).

In some examples the device has an expanded configuration, the expandable distal anchor has at least one or two bending points and first and second arms extending from the bending points, the first and second arms are adapted to deform around the points bending when the device moves from the expanded configuration to the non-expanded configuration. The bending points can 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 generally extend proximally or generally distally when the tissue shaping device is in the unexpanded configuration. The bending point can be, e.g. eg, 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, and can be arranged on the distal or proximal side of the anchor.

The device may also include a flexible expandable anchor anchor wire connection that substantially limits the proximal and distal movement of the connection with respect to the distal expandable anchor or a distal and proximally movable connection between the distal expandable anchor and the connector. The device can 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 conform to a range of coronary sinus diameters by expansion until contact with a part of the coronary sinus wall with an anchoring force sufficient to anchor the device within the coronary sinus. Where the device has an expanded configuration, the proximal anchor may include at least one bending point and first and second arms extending from the bending point, the first and second arms are adapted to deform around the bending point when the device moves from expanded configuration to non-expanded configuration. The proximal anchor may be a self-expanding anchor or an operable anchor, in which case the actionable anchor may include an actuator and a lock adapted to lock the actuator in a deployment position.

A tissue shaping device is adapted to be deployed in a vessel to reform tissue adjacent to the vessel, the device includes first and second anchors and a connector arranged between the first and second anchors, the integral connector being at least a part of the first anchor . In some examples the first anchor has a flexible wire and corrugated pressing element that holds a part of the flexible wire,

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the corrugated pressing element being optionally integral with the connector. The connector may have a semicircular cross section with a radius substantially equal to a radius of corrugated pressing element.

In some examples each of the first and second anchors of the device has a flexible wire and a corrugated pressing element that holds a part of the flexible wire, and the first corrugated anchoring pressing element and the second corrugated anchoring pressing element can be integral with the connector.

A method for making a fabric shaping device includes the steps of: removing material from an initial piece to form a connector and an integral anchoring part; and connect a non-integral anchor part to the integral anchor part. In examples where the integral anchoring part includes a corrugated pressing tube and the non-integral part includes a flexible wire, the method may also include the step of arranging a part of the flexible wire in the corrugated pressing tube. In examples where the initial part has a substantially cylindrical cross section, the withdrawal stage may include the step of removing a part of the cylinder to leave a connector having a substantially semicircular cross section.

In examples where the integral anchoring part is a first integral anchoring part, the withdrawal stage may also include the step of removing material from the initial part to form a second integral anchoring part, with the connector arranged between the first integral part of anchorage and the second integral part of anchorage. In examples where the first and second anchoring parts have a corrugated pressing tube and the non-integral anchoring part includes a flexible wire, the method may also include the step of arranging a portion of the flexible wire in the first pressing tube. wavy anchor.

In examples where the non-integral anchoring part is a first non-integral anchoring part, the method may also include the step of connecting a second non-integral anchoring part to the second integral anchoring part. In some examples each of the first and second integral anchoring parts has a corrugated pressing tube and each of the first and second non-integral anchoring parts includes a flexible wire, the method also includes the steps of arranging a portion of the first flexible anchor wire in the first corrugated anchor pressing tube and disposing a part of the second flexible anchor wire in the second corrugated anchor pressing tube.

A tissue shaping device is adapted to be deployed in a vessel to reform tissue adjacent to the vessel. In some examples the device includes: a distal anchor that has a flexible wire with at least one bending point and first and second arms extending from the bending point, the first and second arms are adapted to deform around the bending point ; a proximal anchor having a flexible wire with at least one bending point and first and second arms extending from the bending point, the first and second arms are adapted to deform around the bending point; and a connector disposed between the distal anchor and the proximal anchor. The distal anchor bending point can be arranged on a proximal side of the distal anchor, and the proximal anchor bending point can be arranged on a distal side of the proximal anchor. In some examples the flexible distal anchor wire is arranged in a substantially eight figure configuration. The flexible distal anchor wire can then include a second bending point and third and fourth arms extending from the second bending point, the third and fourth arms are adapted to bend around the second bending point. The flexible distal anchor wire can also include first and second proximal struts, with the first and second bend points formed in the first and second proximal struts, respectively. Each of the bending points can be, e.g. eg, 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 bending points of distal anchor flexible wire can also be arranged at the highest point of the distal anchor.

In some examples the flexible proximal anchor wire is arranged in a substantially eight figure configuration. The flexible proximal anchoring wire can then include a second bending point and third and fourth arms extending from the second bending point, the third and fourth arms are adapted to bend around the second bending point. The flexible proximal anchor wire may also include first and second proximal struts, with the first and second bend points formed in the first and second proximal struts, respectively. Each of the bending points can be, e.g. eg, 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 bending points of proximal anchor flexible wire can also be arranged at the highest point of the proximal anchor.

In some examples the distal anchor is a self-expanding anchor, and in some examples the proximal anchor is an actionable anchor. The connector can have a moment of inertia that varies along its length. Distal and proximal anchors can also include corrugated pressing tubes, and the connector can be integral with corrugated pressing tubes.

An example is a method to treat regurgitation of a mitral valve in the heart of a patient, the method includes the steps of administering a tissue forming device in the coronary sinus, such as in a catheter that has an outside diameter of no more than new or ten french; and deploying the tissue shaping device to reduce mitral valve regurgitation, the deployment stage includes the stage of applying a force through

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the coronary sinus wall towards 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 crossing point, and in some examples the distal end is deployed distal to the crossing point. The method may also include the step of determining the crossing point.

In some examples the tissue shaping device includes a distal anchor, in which case the deployment stage may include the stage of anchoring the distal anchor proximal to the crossing point, such as by expanding the distal anchor through self-expansion or through the application of a driving force. The anchoring force can be from 0.45 to 0.90 kg (one or two pounds).

In some examples, the deployment stage also includes the stage of applying a proximally directed force on the distal anchor - in some examples from outside the patient - such as moving the proximal anchor proximally. The tissue shaping device may also include a proximal anchor and a connector arranged between the distal anchor and the proximal anchor, the deployment stage also includes the stage of anchoring the proximal anchor (e.g., in the coronary sinus or at least partially outside the coronary sinus), such as by expansion of the proximal anchor through self-expansion or through the application of a driving force. The step of anchoring the proximal anchor can be performed before or after the stage of applying a proximally directed force on the distal anchor.

The method deployment stage may include the stage 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 stage may also include the stage 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 shaping device from a set of tissue shaping devices that includes tissue shaping devices of a plurality of lengths and / or tissue shaping devices of a plurality of anchoring sizes before the administration stage

The invention is a set of devices for use in mitral valve regurgitation treatment, the set includes a plurality of tissue shaping devices that have different lengths, each of the tissue shaping devices is configured to be administrable to a coronary sinus of a patient inside a catheter that has an outside diameter no larger than ten french. Each of the tissue shaping devices includes an anchor (such as a distal anchor or a proximal anchor) that has an expanded configuration and an unexpanded configuration for administration by catheterization.

In some embodiments, the distal anchor of each tissue shaping device in the set in its expanded configuration has a diameter equal to or greater than the diameter of a coronary sinus at a distal anchor location (e.g., from about 7 mm 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 coronary sinus diameter at a proximal anchor location (eg, approximately 9 mm to approximately 20 mm).

In some sets, the anchors are self-expanding, in other sets the anchors are operable, while other sets still have at least one device with a self-expanding anchor and one with an actionable anchor. The set can also include a catheter that has an outside diameter no larger than ten french.

A set of devices for use in mitral valve regurgitation treatment is described, the set includes a plurality of tissue shaping devices each with an anchor that has an unexpanded configuration and an expanded configuration, the anchors have different diameters when they are in its expanded configurations, and each of the tissue shaping devices is configured to be administrable to a coronary sinus of a patient within a catheter having an outside diameter of no more than ten french. In some examples, the anchor is a distal anchor (such as a self-expanding anchor or an actionable anchor), and the devices also include a proximal anchor (such as a self-expanding anchor or an actionable anchor) that has an unexpanded configuration and an expanded configuration. , the proximal anchors have different diameters when they are in their expanded configurations. In some examples the diameters of the distal anchors of the tissue shaping devices in the set in their expanded configurations range from about 7 mm to about 16 mm, and in some examples the diameters of the proximal anchors of the tissue shaping devices in the set set in its expanded configurations range from approximately 9 mm to approximately 20 mm. The set can also include a catheter that has an outside diameter no larger than nine to ten French. A tissue shaping device is adapted to be placed in a vessel near a patient's heart (such as the coronary sinus) to reform at least part of the patient's heart (such as the mitral valve). 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 has a moment of inertia that spans its length. In some examples, the connector has a proximal anchor part, a distal anchor part and a central part disposed between the proximal anchor part and the distal anchor part, the

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smallest moment of inertia at a point in the central part. Each of the proximal and distal anchors may include a fastener, and the moment of inertia just distal to the fastener proximal or just proximal to the distal fastener is greater than the moment of inertia at a point in the central part of the connector.

In some examples, the connector has a width that is substantially uniform, and a thickness that is not uniform, in the connector length. In examples where the connector includes a proximal anchoring part, a distal anchoring part and a central part disposed between the proximal anchoring part and the distal anchoring part, the connector thickness may be smaller at a point in the central part. In examples where the proximal anchor includes a proximal anchor bra or the distal anchor includes a distal anchor brace, the thickness of the connector at a point just distal to the anchor brace proximal or just proximal to the distal anchor brace may be greater than the thickness of the connector in the central part.

The connector may include at least one part that has a thickness that is as a function of the distance from its proximal end or its distal end. This function can be, p. eg, a linear function or a square function of distance. In examples where the connector includes a proximal anchoring part, a distal anchoring part and a central part disposed between the proximal anchoring part and the distal anchoring part, the connector part whose vain thickness may be in the central part . The central part may also include a part that has substantially uniform thickness. The description also includes examples in which the connector includes an integral proximal anchor drive element, an integral deployment connection element and / or an integral anchor position stop.

A tissue shaping device adapted to be arranged in a vessel near the heart of a patient to reshape the patient's heart, in which the tissue shaping device includes an expandable anchor adapted to contact a wall of the vessel with a force radially toward outside, providing an anchor force of preferably at least 0.45 to 0.90 kg (one to two pounds). The anchor includes an expansion energy absorbing element that, in some examples, is adapted to limit the force radially outwardly on the vessel wall. In some examples, the anchor includes a flexible wire, in which case the expansion energy absorbing element may be a bending point in the flexible wire. The bending point may include a section of the flexible wire having 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 figure 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 examples the anchor can be a self-expanding anchor, in other examples the anchor can be an operable anchor, optionally with a movable actuator and a lock. The actuator can be used to expand the anchor when 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 expands.

The description also includes a method for deploying a tissue shaping device in a vessel, the tissue shaping device includes an anchor and an expansion energy absorbing element. The method includes the steps of administering the tissue shaping device to a treatment location within the vessel, expanding the anchor with anchor expansion energy to place a force radially outwardly on a vessel wall (providing, e.g., an anchor force of at least 0.45 to 0.90 kg (one to two pounds), and to absorb at least a portion of the expansion energy in the expansion energy absorption element. In some examples, the step of Absorption includes the step of limiting the force radially outward on the wall.

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

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

In some examples the administration stage may include the stage of administering the tissue shaping device to the treatment location in a catheter in an unexpanded configuration, and the permitting stage may include the stage of ejection of the anchor from the catheter. The method may also include, before the administration stage, the steps of compressing the tissue shaping device to the unexpanded configuration and placing the tissue shaping device in the catheter.

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

Brief description of the figures

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Figure 1 is a schematic view of a tissue forming device deployed within a coronary sinus.

Figure 2 is a schematic view of a tissue shaping device according to an alternative example deployed within a coronary sinus.

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

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

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

Figure 6 is an elevation view of even another example of a tissue shaping device.

Figure 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 according to an example.

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.

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

Figure 12 is a perspective view of even another anchor for use with a tissue shaping device.

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

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

Figure 15 is a perspective view of even another anchor for use with a fabric shaper.

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

Figure 17 is a perspective view of yet another anchor for use with a tissue shaping device according to this invention.

Figure 18 is a perspective view of another anchor for use with a tissue shaping device according to this invention.

Figure 19 is a perspective view of even another anchor for use with a tissue shaping device.

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

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

Figure 22 is a perspective view of a connector with integral corrugated anchoring press elements for use in a fabric shaping device.

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

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

Figure 25 is a perspective view of even another connector for use with a tissue shaping device. Figure 26 is a side view of a connector for use with a tissue shaping device.

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

Figure 28 is a perspective view of even another tissue forming device.

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

Figure 30 is a schematic view of another example demonstrating the method.

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Figure 31 is a schematic view of even another example demonstrating the method.

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 coronary sinus 12, defined as starting at ostium 14 or opening to the right atrium and extending through the cardiac vena magna to the anterior interventricular groove ("AN") 16. Also shown mitral valve 20 surrounded by mitral valve ring 22 and adjacent to at least a part of the coronary sinus 12. The circumflex artery 24 shown in Figure 1 passes between the coronary sinus 12 and the heart. The relative size and location of each of these structures vary from one person to another.

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

In Figure 1, the proximal anchor 36 is fully deployed within the coronary sinus. In Figure 2, the proximal anchor is at least partially deployed outside the coronary sinus.

Figures 3-6 show a method. As shown in Figure 3, a catheter 50 is maneuvered in a manner known in the art through the ostium 14 inside the coronary sinus 12. In order to be navigable through the patient's venous system, the catheter 50 preferably has an outside diameter of no more than ten french, most preferably with an outside diameter of no more than nine french. Arranged within catheter 50 is device 30 in an unexpanded configuration, and extending backward through catheter 50 from device 30 to the outside of the patient is a tie or control wire 52. In some examples, control wire 52 it can include multiple tie and control wire elements, such as those described in the US patent application. UU. Serial No. 10 / 331,143.

According to a preferred example, the device is deployed as far as possible distally without applying substantial compressive force on the circumflex artery or other main coronary artery. Thus, the distal end of catheter 50 is disposed at a location of proximal distal anchor of the crossing point between circumflex artery 24 and coronary sinus 12 as shown in Figure 3. At this point, catheter 50 is removed proximally while the device 30 is held stationary by the control wire 52 to discover the distal anchor 34 at the location of the distal anchor within the coronary sinus 12. Alternatively, the catheter can be held stationary while the device 30 is advanced distally to discover the anchor distal

The distal anchor 34 is a self-expanding anchor or an actionable anchor or a combination of self-expanding and actionable anchor. Once discovered, the distal anchor 34 is self-expanding, or expanded by the application of a driving force (such as a force transmitted through the control wire 52), to couple the inner wall of the coronary sinus 12, as shown in Fig. 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 not only sufficient to maintain the position of the device within the coronary sinus. but also to allow the device to be used to reshape adjacent tissue in a manner as described below. In a preferred example, the distal anchor 34 is coupled to the coronary sinus wall to provide an anchor force of at least 0.45 kg (one pound), most preferably an anchor force of at least 0.90 kg ( Two pounds). The anchor expansion energy to supply the anchor force comes from strain energy stored in the anchor due to its compression for catheter administration, a driving force, or a combination of both, depending on the anchor design.

While the device 30 is held in place by the anchoring force of the distal anchor 34, the catheter 50 is removed even more proximally to a just distal point of the proximal anchor 36, as shown in Figure 5. Then a force is exerted directed proximally over the distal anchor 34 by the control wire 52 through the connector 38. In this example, the distance between the distal and proximal anchors along the connector is fixed, whereby the proximally directed force moves the proximal anchor 36 proximally with respect to the coronary sinus while the distal anchor 34 remains stationary with respect to the coronary sinus. This ligation action straightens that section of the coronary sinus 12, thereby modifying its shape and the shape of the adjacent mitral valve 20, moving the mitral valve leaflets to greater coaptation and reducing mitral valve regurgitation. In some examples the proximal anchor moves approximately 1-6 cm proximally, most preferably at least 2 cm, in response to the proximally directed force. In other examples, in which the distance between the distal and proximal anchors is not fixed (e.g., where the connector length is variable), the proximal anchor may remain substantially stationary with respect to the coronary sinus despite the application of a force directed proximally over the distal anchor.

After the appropriate amount of reduction in mitral valve regurgitation has been achieved (determined, e.g., by visualization of echocardiograms enhanced by doppler effect), 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 the US patent application. UU. serial number 10 / 366,585.

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In preferred examples, the anchoring force of the proximal anchor, is dedr, the force with which the proximal anchor resists movement in response to a distally directed force, should not be sufficient not only to maintain the position of the device within the coronary sinus but also to allow the device to maintain the bound form of the adjacent tissue. In preferred examples, the proximal anchor is coupled to the coronary sinus wall to provide an anchor force of at least 0.45 kg (one pound), most preferably an anchor force of at least 0.90 kg (two pounds) ). As with the distal anchor, the expansion energy of the proximal anchor to supply the anchor force comes from strain energy stored in the anchor due to its compression for catheter administration, a driving force, or a combination of both, depending of the anchor design.

In a preferred example, the proximal anchor is deployed by removing the catheter 50 proximally to discover the proximal anchor 36, either allowing the proximal anchor 36 to self-expand, applying a driving force to expand the anchor, or a combination of both. The control wire 52 is then connected, and the catheter 50 is removed from the patient. The location and configuration of the device, deployed according to this method, is as shown in Figure 1.

Alternatively, the proximal anchor 36 can be deployed at least partially outside the coronary sinus after ligation to modify the shape of the mitral valve tissue, as shown in Figure 2. In both examples, as the distal anchor 34 is arranged proximally At the crossing point between coronary sinus 12 and circumflex artery 24, any anchoring and tissue reforming force applied to the coronary sinus by device 30 is only proximal to the crossing point.

In alternative examples, the proximal anchor may be deployed prior to the application of the proximally directed force to ligate the device to reshape the mitral valve tissue. An example of 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 on it for ligation, while the design of the proximal anchor 64 allows it to move proximally after deployment while resisting distal movement after ligation. Ligation after deployment of the proximal anchor is described in more detail in the US patent application. UU. Serial No. 10 / 066,426, filed on January 30, 2002. In this example, in addition, the distal anchor 62 is disposed proximal to the crossing point between coronary sinus 12 and circumflex artery 24 so that all anchoring and reforming force of tissue 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 bind in bull after initial ligation. The device or one of its anchors can be recaptured. For example, in Figure 1, after the deployment of the proximal anchor 36 but before the decoupling of the control wire 52, the catheter 50 can be moved distally to place the proximal anchor 36 back inside the catheter 50, p. eg, to the configuration shown in Figure 5. From this position, the bonding force along the connector 38 can be increased or decreased, and the proximal anchor 36 can then be redeployed.

Alternatively, the catheter 50 can be advanced distally to recapture the proximal anchor 36 and the distal anchor 34, p. eg, to the configuration shown in Figure 3. From this position, the distal anchor 34 can be redeployed, apply a ligation force and deploy the proximal anchor 36 as discussed above. Also from this position, the device 30 can be removed entirely from the patient simply by removing the catheter from the patient.

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 if the artery is between the coronary sinus and the heart. Radiopaque dye can be injected into the coronary sinus and arteries in a known way while viewing the heart in a fluoroscope.

An alternative method for determining the relative positions of the vessels is shown in Figure 7. In this method, wires 70 and 72 are inserted into the coronary sinus 12 and into the circumflex artery 24 or other coronary artery, and the relative positions of The grna wires are seen in a fluoroscope to identify the crossing point 74.

Figure 8 illustrates a tissue shaping device. The fabric forming device 100 includes a connector or support wire 102 having a proximal end 104 and a distal end 106. The support wire 102 is made of a biocompatible material such as stainless steel or a shape memory material such as nitinol wire

The connector 102 comprises a double length of nitinol wire having both ends placed within a distal corrugated pressing tube 108. Proximal to the proximal end of the corrugated pressing tube 108 is a distal locking package 110 formed by the wire support when bending away from the longitudinal axis of the support 102 and then bending parallel to the longitudinal axis of the support before bending again towards the longitudinal axis of the support to form a half 110a of the distal locking package 110. From the distal locking package 110 , the wire continues proximally through a proximal corrugated pressing tube 112. Upon exiting the end

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proximal of the proximal corrugated pressing tube 112, the wire bends to form an proximal locking package in the form of an arrowhead 114. The support wire 102 then returns distally through the proximal corrugated pressing tube 112 to a position just proximal to the proximal end or the distal corrugated pressing tube 108 where the wire bends to form a second half 110b of the distal lock 110.

At the distal end of the connector 102 there is an actionable distal anchor 120 that is formed of a flexible wire such as nitinol or some other shape memory material. As shown in Figure 8, the wire forming the distal anchor has one end placed inside the distal corrugated pressing tube 108. After exiting the distal end of the corrugated pressing tube 108, the wire forms a figure configuration of eight by which bends up and radially outward from the longitudinal axis of the corrugated pressing tube 108. The wire is then bent back proximally and crosses the longitudinal axis of the corrugated pressing tube 108 to form a leg of figure eight. The wire is then bent to form a double loop or loop eyelet 122 about the longitudinal axis of the support wire 102 before extending radially outwardly and distally backward on the longitudinal axis of the corrugated pressing tube 108 to form the other leg of The figure of eight. Finally, the wire bends proximally inside the distal end of the corrugated pressing tube 108 to complete the distal anchor 120.

The distal anchor is expanded using a catheter or locking tool to exert a driving force by sliding the eyelet 122 of the distal anchor from a position that is proximal to the distal locking package 110 over the connector to a position that is distal to the locking package. distal 110. The bent portions 110a and 110b of the connector 110 are spaced wider than the width of the buttonhole 122 and provide cam surfaces for the locking action. The distal movement of the buttonhole 122 pushes these cam surfaces inwardly to allow the buttonhole 122 to distally pass the locking package 110, then returning to its original spacing to keep the buttonhole 122 in the locked position.

The actionable proximal anchor 140 is formed and operated in a similar manner by moving the eyelet 142 over the locking package 114. Both the distal and the proximal anchor provide anchoring forces of at least 0.45 kg (one pound), and the most preferably 0.90 kg (two pounds).

Figure 9 illustrates a method for administering a tissue shaping device 100 to a desired location in the body, such as the coronary sinus for treating mitral valve regurgitation. As indicated above, the device 100 is preferably loaded into, and is directed to, a desired location within a catheter 200 with the proximal and distal anchors in an unexpanded or deformed state. That is, the buttonhole 122 of the distal anchor 120 is positioned proximal to the distal locking package 110 and the buttonhole 142 of the proximal anchoring 140 is positioned proximal to the proximal locking package 114. The doctor ejects the distal end of the device from the catheter 200 to 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 with respect to catheter 200, and a tie 201 provides proximal movement of the device with respect 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 outside the catheter. Once the device is properly positioned, the catheter 200 is advanced to place a driving force on the distal anchor eye 122 to push it distally over the distal lock package 110 so that the distal anchor 120 expands further and It locks in place to securely attach to the wall of the coronary sinus. Next, a force directed proximally to the connector 102 and to the distal anchor 120 is applied by means of a tie or control wire 201 that extends through the catheter out of the patient to apply sufficient pressure on 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 supplies enough pressure on the mitral valve to help its complete closure with each ventricular contraction without negatively affecting the patient.

The proximally directed reforming force causes the proximal anchor 140 to move proximally. In one example, the proximal anchor 140 can be moved approximately 1-6 cm, most preferably at least 2 cm, proximally to reshape the mitral valve tissue. The proximal anchor 140 is then deployed from the catheter and allowed to begin its expansion. The locking tool applies a driving force on the proximal anchor eyelet 142 to advance it distally over the proximal locking package 114 to expand and lock the proximal anchor, thereby safely engaging the coronary sinus wall to maintain the position. of the anchor and to maintain the reforming pressure of the connector against the coronary sinus wall. Alternatively, the catheter 200 can be advanced to lock the proximal anchor 140. Finally, the mechanism can be released to secure the proximal end of the device.

In one example, the fixation is made with a twisted loop 202 at the end of the tie 201 and a wire lock 204. The locking wire 204 is removed thereby releasing the loop 202 so that it can be attracted through the bulk proximal lock 114 at the proximal end of the device 100. Reduction of mitral valve regurgitation using devices can be maximized by deploying the distal anchor as far as possible distally in the coronary sinus. In some cases it may be desirable to implant a shorter tissue shaping device, such as situations in which the patient's circumflex artery crosses the coronary sinus relatively closer to the ostium or situations in which the coronary sinus itself is shorter than normal .

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As can be seen in Figure 9, the anchor 120 in its unexpanded configuration extends proximally along the connector 102 inside the catheter 2O0. Making the device shorter by simply shortening the connector, however, may cause the buttonhole 122 and the proximal part of the distal anchor 120 to overlap with parts of the proximal anchor when the device is loaded into a catheter, thereby requiring that the diameter Catheter is larger than necessary for longer versions of the device. For mitral valve regurgitation applications, a preferred catheter diameter is ten French or less (most preferably nine French), and the tissue shaping device in its unexpanded configuration should fit into the catheter.

Figures 10-23 show in a device that has flexible and expandable wire anchors that allow the administration of tissue forming devices 60 mm or less in length by a catheter of ten french (or less). In some examples, one or both anchors are provided with bending points around which the anchors are deformed when placed in their unexpanded configuration for administration by means of a catheter or recapture in a catheter. These bending points allow the anchors to deform to configurations that minimize overlap with other elements of the device. In other examples, the distal anchor is self-expanding, thereby avoiding the need for a buttonhole that extends proximally in the unexpanded configuration of the anchor that could overlap with the unexpanded proximal anchor within the administration and / or recapture catheter.

Figure 10 shows an actionable anchor design suitable for a shorter tissue forming device similar to the device shown in Figures 8 and 9. In this example, the distal anchor 300 is disposed distal to a connector 302. As in Figure 8 , the anchor 300 is formed in an eight figure configuration from flexible wire such as nitinol supported by a corrugated pressing tube 304. A buttonhole 306 is formed around the longitudinal axis of the connector 302. A driving force directed distally over the eyelet 306 moves it over a lock package 308 formed in the connector 302 to actuate and lock the anchor 300. Figure 10 shows the anchor 300 in an expanded configuration. In an unexpanded configuration, such as a configuration suitable for loading the anchor 300 and the rest of the tissue shaping device into a catheter for initial deployment to treat mitral valve regurgitation, the eyelet 306 is disposed proximal to the locking package 308, and the loops in figure eight of the anchor 300 are compressed against the corrugated pressing element 304. In order to limit the proximal distance, the eyelet 306 must be moved along the connector to compress the anchor 300 to an unexpanded configuration. , the bending points 310 are formed in the distal struts of the anchor 300. The bending points 310 are essentially twists, that is, points of greater curvature, formed in the wire. When anchor 300 is compressed to an unexpanded configuration, the bend points 310 are deformed so that the upper arms 312 of the distal struts bend around the bend points 310 and move toward the lower arms 314 of the struts distal, thereby limiting the distance that the eyelet 306 and proximal anchor struts must be moved proximally along the connector to compress the anchor.

Similarly, if the distal anchor was to be recaptured in a catheter to be redeployed or removed from the patient, the anchor 300 deforms around the bending points 310 to limit the cross-sectional profile of the anchor within the catheter, even if the buttonhole 306 did not move proximally on the lock package 308 during the recapture procedure. Bending points can also be provided in the proximal anchor in a similar manner.

As indicated 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 actuating force for anchoring against the coronary sinus wall to provide an anchoring force of at least 0.45 kg (one pound), preferably at least 0.90 kg (two pounds), and lock anchor 300 in an expanded configuration. A force directed proximally to the distal anchor 300 is applied through the connector 302, such as by proximally moving the proximal anchor approximately 1-6 cm, more preferably at least 2 cm, by pulling a tie or control wire driven from outside the patient. The proximal anchor can then be deployed to maintain the reforming force of the device.

An aspect of anchor 300 is the ability to conform and adapt to a variety of vessel sizes. For example, when the anchor 300 expands into a vessel, such as the coronary sinus, the anchor wire arms may contact the coronary sinus wall before the eyelet 306 has advanced distally on the lock package 308 to lock the anchor in place. While a continuous distal advance of the eyelet 306 will create some force outwardly over the coronary sinus wall, much of the energy put into the anchor by the anchoring driving force will be absorbed by the deformation of the distal struts around the points bending 310, which serve as expansion energy absorbing elements and thereby limit the force radially outwardly on the coronary sinus wall. This feature allows the anchor to be used over a wider range of vessel sizes while reducing the risk of vessel overexpansion. Figure 11 shows another anchor design suitable for a shorter tissue forming device similar to the device shown in Figures 8 and 9. In this example, the distal anchor 320 is disposed distal to a connector 322. As in Figure 8, anchor 320 is formed in an eight figure configuration from flexible wire such as nitinol supported by a corrugated pressing tube 324. Unlike figure 10, however, anchor 320 is self-expanding and is not operable. Buttonhole 326 is held on site by a second pressing element.

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corrugated 325 to limit or eliminate the proximal or distal movement of the proximal anchor connection point, e.g. e.g., along connector 322.

Figure 11 shows anchor 320 in an expanded configuration. In an unexpanded configuration, such as a suitable configuration for loading anchor 320 and the rest of the tissue shaping device into a catheter for initial deployment to treat mitral valve regurgitation, the eight-figure loops of anchor 320 are compressed. The bending points 330 are formed in the distal struts of the anchor 320. When the anchor 320 is compressed to an unexpanded configuration, the bending points 330 are deformed so that the upper arms 332 of the distal struts are bent around the bending points 330 and move towards the lower arms 334 of the distal struts. Depending on the exact location of the bending points 330, very little or nothing of the wire part of the anchor 320 is disposed proximally along the corrugated pressing element 325 or connector 322 when the anchor 320 is in its expanded configuration.

Similarly, if the distal anchor was to be recaptured in a catheter to be redeployed or removed from the patient, the anchor 320 deforms around the bending points 330 to limit the cross-sectional profile of the anchor within the catheter. Bending points can also be provided in 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) 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 320 can be deployed from a catheter to self-expand for anchoring against the coronary sinus wall to provide an anchor force of at least 0.45 kg (one pound) , preferably at least 0.90 kg (two pounds). A force directed proximally to the distal anchor 320 can then be applied through the connector 322, such as by proximally moving the proximal anchor approximately 1-6 cm, more preferably at least 2 cm, by pulling a tie or control wire driven from outside the patient. The proximal anchor can then be deployed to maintain the reforming force of the device.

Figure 12 shows another example of an anchor suitable for use in a shorter tissue shaping device. In this example, the distal anchor 340 is disposed distal to a connector 342. As in Figure 11, the anchor 340 is formed in an eight figure configuration from flexible wire such as nitinol held by a corrugated pressing tube 344 In addition, anchor 340 is self-expanding and not operable. The anchor loop 340 that forms the proximal anchor struts passes through a loop 346 that extends distally from a second corrugated pressing element 345 to limit or eliminate the movement of the proximal or distal anchor proximal struts, e.g. e.g., 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 rest of the tissue shaping device into a catheter for initial deployment to treat mitral valve regurgitation, the loops in figure of eight of anchor 340 are compressed. However, unlike Figure 11, the bending points 350 are formed in the proximal struts of the anchor 340. When the anchor 340 is compressed to an unexpanded configuration, the bending points 350 are deformed so that the upper arms 352 of the distal struts are folded around the bending points 350 and move towards the lower arms 354 of the distal struts. The amount of the wire portion of the anchor 340 that extends proximally along the corrugated pressing element 345 and the connector 342 in its unexpanded configuration depends on the location of the bending points 350. The bending points are formed in the highest and widest part of the proximal struts.

The 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 for anchoring against the coronary sinus wall to provide an anchor force of at least 0.45 kg (one pound) , preferably at least 0.90 kg (two pounds). A force directed proximally to the distal anchor 340 can then be applied through the connector 342, such as by proximally moving the proximal anchor approximately 1-6 cm, more preferably at least 2 cm, by pulling a tie or control wire driven from outside the patient. The proximal anchor can then be deployed to maintain the reforming force of the device.

The bending points 350 are also added to the anchoring force of the distal anchor 340, p. eg, causing the anchor height to increase as the proximal struts become more perpendicular to the connector in response to a proximally directed force, thereby increasing the anchoring force. In the same way, the bending points can be added to the distal struts of a proximal anchor to increase the anchor strength of the proximal anchor in response to a distally directed force.

Figure 13 shows even another anchor suitable for use in a shorter tissue shaping device. The distal anchor 360 is disposed distal to a connector 362. As in Figure 12, the anchor 360 is formed in a figure configuration of eight from flexible wire such as nitinol held by a pressing tube

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corrugated 364. In addition, the anchor 360 is self-expanding and is not operable. The anchor loop 360 that forms the proximal anchor struts passes through a loop 366 that extends distally from a second corrugated pressing element 365 to limit or eliminate the movement of the proximal or distal anchor proximal struts, e.g. e.g., 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 the anchor 360 and the rest of the tissue shaping device into a catheter for initial deployment to treat mitral valve regurgitation, the loops in figure of eight of the 360 anchor are compressed. Unlike Figure 12, however, the bending points 370 are formed both in the proximal struts and in the distal struts of the anchor 360.

Anchor 360 can be used as part of a previously treated tissue forming device.

Figure 14 shows an actuation anchor design suitable for a shorter tissue-forming device similar to the device shown in Figures 8 and 9. In this example, the distal anchor 380 is disposed distal to a connector 382. The anchor 380 is formed in an eight figure configuration from flexible wire such as nitinol held by a corrugated pressing tube 384. Unlike figure 10, the eyelets 386 and 387 are formed in each of the proximal anchor struts around the axis length of connector 382. This arrangement reduces the force radially outward from the anchor. A drive force directed distally over the eyelets 386 and 387 moves them over a lock package 388 formed in the connector 382 to drive and lock the anchor 380.

Figure 14 shows anchor 380 in an expanded configuration. In an unexpanded configuration, such as a suitable configuration for loading anchor 380 and the rest of the tissue shaping device into a catheter for initial deployment to treat mitral valve regurgitation, eyelets 386 and 387 are arranged proximal to the locking bulk 388, and the eight-figure loops of anchor 380 are compressed against the corrugated pressing element 384. In order to limit the proximal distance, the eyelets 386 and 387 must be moved to compress the anchor 380 to an unexpanded configuration, the bending points 390 are formed in the distal struts of the anchor 380. When the anchor 380 is compressed to an unexpanded configuration, the bending points 390 are deformed so that the upper arms 392 of the distal struts are bent around the bending points 390 and move towards the lower arms 394 of the distal struts, thereby limiting the distance that the eyelets should move proximally 386 and 387 and the proximal anchor struts along the connector to compress the anchor.

If the distal anchor was to be recaptured in a catheter to be redeployed or removed from the patient, the anchor 380 deforms around the bending points 390 to limit the cross-sectional profile of the anchor within the catheter, even if the eyelets 386 and 387 did not move proximally over lock package 388 during the recapture procedure. Bending points can also be provided in the proximal anchor in a similar manner.

As before, the distal anchor 380 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 380 can be deployed from a catheter and expanded with an actuating force for anchoring against the coronary sinus wall to provide an anchoring force of at least 0.45 kg (one pound), preferably at least 0.90 kg (two pounds), and lock anchor 380 in an expanded configuration. A force directed proximally to the distal anchor 380 is applied through the connector 382, such as by proximally moving the proximal anchor approximately 1-6 cm, more preferably at least 2 cm, by pulling a tie or control wire driven from outside the patient. The proximal anchor can then be deployed to maintain the reforming force of the device.

An aspect of anchor 380 is the ability to conform and adapt to a variety of vessel sizes. For example, when anchor 380 expands inside a vessel, such as the coronary sinus, the anchor wire arms may contact the coronary sinus wall before the eyelets 386 and 387 have advanced distally over the bulk of locked 388 to lock the anchor in place. While a continuous distal advance of the eyelet 386 will create some force outwardly over the coronary sinus wall, much of the energy put into the anchor by the anchoring driving force will be absorbed by the deformation of the distal struts around the points fold 390.

Figure 15 shows even another actionable anchor for use in a shorter tissue shaping device. The proximal anchor 400 is disposed proximal to a connector 402. The anchor 400 is formed in an eight figure configuration from flexible wire such as nitinol supported by a corrugated pressing tube 404. A buttonhole 406 is formed around a bulge of locking 408 extending proximally of the corrugated pressing element 404. An actuating force directed distally over the buttonhole 406 moves it on a locking package 408 to actuate and lock the anchor 400.

Figure 15 shows anchor 400 in an expanded configuration. When anchor 400 is compressed to an unexpanded configuration, the bending points 410 formed as loops in the anchor wire deform

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so that the upper arms 412 of the distal struts bend around the bend points 410 and move towards the lower arms 414 of the distal struts. The proximal anchor 400 may be part of a tissue forming device (such as that shown in Figures 8 and 9) that has a distal anchor and a connector disposed between the anchors.

An aspect of anchor 400 is the ability to conform and adapt to a variety of vessel sizes. For example, when the anchor 400 expands into a vessel, such as the coronary sinus, the anchor wire arms may contact the coronary sinus wall before the eyelet 406 has advanced distally over the locking package 408 to lock the anchor in place. While a continuous distal advance of the eyelet 406 will create some force outwardly over the coronary sinus wall, much of the energy put into the anchor by the anchoring force will be absorbed by the deformation of the distal struts around the points bending 410, which serve as expansion energy absorption elements and thereby limit the force radially outward on the coronary sinus wall.

In other examples, the loop bending points of Figure 15 can be formed at the proximal anchor struts in addition to or instead of at the distal struts. The loop bending point can also be used in a distal anchor, as shown in Figure 16 (without the wavy pressing element or the connector). Note that in Figure 16 the proximal and distal struts of the anchor 420 as well as the eyelet 422 and bending points 424 are formed from a single wire.

Figure 17 shows an embodiment of the invention of a distal anchor 440 similar to that of Figure 10 suitable for use in a shorter tissue shaping device. In this embodiment, however, extra twists 442 are added at the apex of the pattern in figure eight of the anchor. As in Figure 10, the bending point 444 is formed at the distal struts of the anchor. As shown, the anchor 440 is operable by moving the eyelet 446 distally over a lock package 448 in the connector 450. The anchor 440 can also be made as a self-expanding anchor by limiting or eliminating the movement of the proximal struts of the anchor 440 to along connector 450, as shown in Figure 11. As with other examples, the bending points help anchor 440 to adapt and conform to different vessel sizes. In addition, the extra twists 442 also help the anchor to adapt to different vessel diameters by keeping the anchor apex together.

The anchor 440 is preferably formed from nitinol wire. Anchor 440 can be used as part of a fabric shaping device in a manner similar to the anchor of Figure 10 (for the actionable 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 an embodiment of a distal anchor 460 similar to that of Figure 17. In this embodiment, however, the bending points 462 are formed in the proximal anchor struts, as in the self-expanding anchor shown in Figure 12. As in the embodiment of Figure 17, extra twists 464 are added at the apex of the pattern in figure eight of the anchor. As shown, the anchor 460 is operable by moving the eyelet 466 distally over a lock package 468 formed in the connector 470. The anchor 460 can also be made as a self-expanding anchor by limiting or eliminating the movement of the proximal connection point of the anchor 460 along connector 470, as shown in figure 11. As with the embodiment of figure 17, the bending points help anchor 460 to adapt and conform to different vessel sizes. In addition, the extra twists 464 also help the anchor adapt to different vessel diameters by keeping the anchor apex together.

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

Figure 19 shows a self-expanding distal anchor 480 suitable for use in a shorter tissue shaping device. An anchor 480 is formed in an eight figure configuration from flexible wire such as nitinol supported by a corrugated pressing tube 482. The base of the pattern in figure eight is narrower in this embodiment, however, with the struts proximal 484 of the anchor through the corrugated pressing element 482.

The distal anchor 480 may be part of a tissue shaping device (such as 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 for anchoring against the coronary sinus wall to provide an anchor force of at least 0.45 kg (one pound), preferably at minus 0.90 kg (two pounds). A force directed proximally to the distal anchor 480 is applied through the connector 486, such as by proximally moving the proximal anchor approximately 1-6 cm, more preferably at least 2 cm, by pulling a tie or control wire driven from outside the patient. The proximal anchor can then be deployed to maintain the reforming force of the device.

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Figure 20 shows a distal anchor suitable for use in a shorter tissue shaping device and similar to that of Figure 10. The distal anchor 500 is disposed distal to a connector 502. An anchor 500 is formed in an eight figure configuration from flexible wire such as nitinol supported by a corrugated pressing tube 504. A buttonhole 506 is formed around the longitudinal axis of the connector 502. A driving force directed distally over the buttonhole 506 moves it over a lock package 508 formed in the connector 502 for actuating and locking the anchor 500.

The angle of the proximal struts 501 and the angle of the distal struts 503 are wider than the corresponding angles in Figure 10, however, causing the anchor 500 to distend more in width than in height when it expands, as shown. . In an unexpanded configuration, such as a configuration suitable for loading the anchor 500 and the rest of the tissue shaping device into a catheter for initial deployment to treat mitral valve regurgitation, the eyelet 506 is disposed proximal to the lock package 508, and the loops in figure eight of the anchor 500 are compressed against the wavy pressing element 504. In order to limit the proximal distance, the buttonhole 506 must be moved along the connector to compress the anchor 500 to an unexpanded configuration , the bending points 510 are formed in the distal struts 503, as in Figure 10, to limit the width of the device in its non-expanded configuration within the 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, the distal anchor 500 can be deployed from a catheter and expanded with an actuating force for anchoring against the coronary sinus wall to provide an anchoring force of at least 0.45 kg (one pound), preferably at least 0.90 kg (two pounds), and lock anchor 500 in an expanded configuration. A force directed proximally to the distal anchor 500 is applied through the connector 502, such as by proximally moving the proximal anchor approximately 1-6 cm, more preferably at least 2 cm, by pulling a tie or control wire driven from outside the patient. The proximal anchor can then be deployed to maintain the reforming 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 distal anchorage in tandem. Self-expanding anchor 520 is formed in an eight figure configuration from flexible wire such as nitinol supported by a corrugated pressing tube 522. Buttonhole 524 is held in place by the distal end of the operable anchor 540 to limit or eliminate proximal and distal movement of the proximal struts of the anchor 520. As in the anchor shown in Figure 11, the bending points 530 are formed in the distal struts of the anchor 520. Depending on the exact location of the bending points 530, very Little or nothing of the wire part of the anchor 520 is disposed proximal to the distal end of the anchor 540 when the anchor 520 is in its unexpanded configuration.

Similarly, if the distal anchor was to be recaptured in a catheter to be redeployed or removed from the patient, the anchor 520 deforms around the bending points 530 to limit the cross-sectional profile of the anchor within the catheter. Bending points can also be provided in the proximal anchor in a similar manner.

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

Tandem anchors 520 and 540 may be part of a fabric shaping device (such as shown in Figures 8 and 9) that has a proximal anchor and a connector disposed between the anchors. The anchors 520 and 540 can be made of 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 then self-expand, and the actionable anchor 540 can be expanded and locked with a driving force, to anchor both anchors against the coronary sinus wall to provide an anchor force of at least 0.45 kg (one pound ), preferably at least 0.90 kg (two pounds). A force directed proximally to anchors 520 and 540 is applied through connector 542, such as by proximally moving the proximal anchor approximately 1-6 cm, more preferably at least 2 cm, by pulling a tie or control wire driven from outside the patient. The proximal anchor can then be deployed to maintain the reforming force of the device.

While the above anchor designs have been 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 alternative example in which the connector 560 of the device is made integral with the distal and proximal corrugated pressing tubes 562 and 564. In this example, the connector 560 is formed by cutting a section of such an initial piece. as a nitinol cylinder or tube (or other suitable material such as steel

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stainless), leaving parts 562 and 564 of corrugated pressing tube intact. The radius of the semicircular cross-section connector is therefore the same as the radii of the two anchor corrugated pressing tubes.

Of course other forms of connector are possible for an integral connector design and corrugated pressing element. For example, the device can be formed from an initial piece in the form of a ribbon or flat sheet by removing rectangular edge sections from a central section, creating an I-shaped sheet (e.g., nitinol or stainless steel) that has larger widths at the ends and a narrower width at the central connector part. The ends can then be rolled to form the corrugated pressing tubes, leaving the connector substantially flat. In addition, the connector can be made integral with only one of the anchors.

As shown in Figure 23, the distal anchor 566 is formed in an eight figure 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 corrugated pressing tube 562. Optional bending 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 an eight figure configuration from flexible wire such as nitinol with an eyelet 574 at its proximal end. A drive force distally directed on the eyelet 574 moves it over a locking package 576 that extends proximally from the corrugated pressing tube 564 to actuate and lock the anchor 572. The locking package 576 also serves as the connection point for a tie or control wire for deploying and operating the device in the manner described above with respect to Figures 8 and 9. Optional bending points can be formed at the proximal or distal struts of the anchor 572.

When deployed in the coronary sinus to treat mitral valve regurgitation, the tissue-forming devices of this invention are subjected to cyclic bending and tension loads as the patient's heart beats. Figure 24 shows a connector for use with the tissue forming devices that distributes in any of the device any deformation caused by the beating from beat to beat and tension load.

The connector 600 has a proximal anchor zone 602, a distal anchor zone 604 and a central zone 606. The distal anchor zone may be longer than the distal anchor connected to it, and the proximal anchor zone may be longer that the proximal anchor connected to it. An optional lock package 608 can be formed at the proximal end of the connector 600 for use with an actuated proximal anchor and to connect to a tie or control wire, as described above. An optional bulb 610 can be formed at the distal end of the connector 600 to prevent accidental distal sliding of a distal anchor.

In order to reduce material fatigue caused by the loading and unloading from beat to beat of the tissue shaping device, the moment of inertia of the connector 600 varies along its length, particularly in the part of the connector arranged between the two anchors For example, connector 600 is formed as a tape or sheet and preferably is formed of nitinol having a rectangular cross-sectional area. The thickness of the connector 600 is preferably constant in the proximal anchor zone 602 and the distal anchor zone 604 to facilitate the connection of corrugated pressing elements and other components of the anchors. The central zone 606 has a decreasing thickness (and therefore a decreasing moment of inertia) from the border between the central zone 606 and the anchor zone 602 proximal to a point approximately in the center of the central zone 606, and a thickness increasing (and increasing moment of inertia) from that point to the border between central zone 606 and zone 604 of distal anchor. The variable thickness and the variable cross-sectional shape of the connector 600 change its moment of inertia along its length, thereby helping to distribute over a wider area any deformation by the load and discharge from beat to beat of the device and reduce the possibility of fatigue failure of the connector material.

Figure 25 shows another connector 620 with a proximal anchor zone 622, a distal anchor zone 624 and a central zone 626. The proximal anchor zone 622 has an optional tip 628 with two prongs formed at its proximal end to facilitate connection of a corrugated pressing element and other anchoring elements. Bent tip portions 629 can be formed at the proximal end of the tip to prevent accidental sliding of a proximal anchor. An optional bulb 630 can be formed at the distal end of connector 620 to prevent accidental distal sliding of a distal anchor.

Like Figure 24, the connector 620 is formed as a tape or sheet and preferably is formed of nitinol having a rectangular cross-sectional area. The thickness of the connector 620 is preferably constant in the proximal anchor zone 622 and the distal anchor zone 624 to facilitate the connection of corrugated pressing elements and other components of the anchors. The central zone 626 has a decreasing thickness (moment of decreasing inertia) from the border between the central zone 626 and the anchor zone 622 proximal to a point approximately in the center of the central zone 626, and an increasing thickness (moment of inertia increasing) from that point to the border between central zone 626 and zone 624 of distal anchor. The variable thickness and the variable cross-sectional shape of the connector 620 change its moment of inertia along its length, thereby helping to distribute over a wider area any deformation by the load and discharge from beat to beat of the device and reduce the possibility of fatigue failure of the connector material.

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

In Figure 26, the thicknesses of the proximal anchor zone 642 and the distal anchor zone 644 are constant. The thickness of central zone 646 decreases from the border between central zone 646 and anchor zone 642 proximal to a distal point of that border and increases from a point proximal to the border between zone 644 of distal anchor and central zone 646 to that border . The points in the central zone at which the thickness decrease ends and the thickness increase begins may be coincident or may be separated to form an area of uniform thickness within the central zone 646. The thickness of the central zone changes as a function of the square root of the distance from the borders between the central zone and the proximal and distal anchor zones.

Figure 27 shows even another connector. As in Figure 26, connector 650 may be formed as connectors 600 and 620 in Figure 24, respectively, or may have some other configuration. The connector 650 has a proximal anchor zone 652, a distal anchor zone 654 and a central zone 656. The connector 650 is preferably formed as a tape or sheet and preferably is formed of nitinol having a rectangular cross-sectional area.

In Figure 27, the thicknesses of the proximal anchor zone 652 and the distal anchor zone 654 are constant. The thickness of a proximal part 658 of the central zone 656 decreases linearly from the border between central zone 656 and zone 652 of proximal anchorage to a central part of constant thickness 662 of the central zone 656, and the thickness of a distal part 660 of the central zone 656 increases linearly from the central part 662 to the border between zone 654 of distal anchor and central zone 656.

The thickness of the connector may vary in other ways. Additionally, the cross-sectional shape of the connector may be different from rectangular and may change in the length of the connector.

Figures 28 and 29 show even another example. The fabric forming device 700 has a connector 706 disposed between a proximal anchor 702 and a distal anchor 704. The connector 706 can be formed as a tape or sheet, such as the diminishing connectors shown in Figures 24-27. The actionable proximal anchor 702 is formed in an eight figure configuration from flexible wire such as nitinol and is secured to the connector 706 with a corrugated pressing tube 708. Similarly, the self-expanding distal anchor 704 is formed in a configuration Figure eight made from flexible wire such as nitinol and attached to connector 706 with a corrugated pressing tube 710. A proximal locking package 716 extends proximally from the proximal anchor 702 for use to drive and lock the proximal anchor 702 and to connect to a tie or control wire, as described above.

Bending points 712 are formed in the loops of the proximal anchor 702, and bending points 714 are formed in the loops of the distal anchor 704. When compressed to their non-expanded configurations for catheter-based deployment or administration or for recapture in a catheter to redeploy or remove, the wire parts of the anchors 702 and 704 are folded around bending points 712 and 714, respectively, to limit the cross-sectional profile of the anchors within the catheter. The bending 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 ostium 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 may vary from one patient to another. The anchors described above can be made in a variety of heights and combined with connectors of varying lengths to accommodate this variation between patients. For example, tissue forming devices deployed in the coronary sinus to treat mitral valve regurgitation may have distal anchor heights ranging from about 7 mm to about 16 mm and proximal anchor heights ranging from about 9 mm to about 20 mm.

When treating a patient for mitral valve regurgitation, estimates of the appropriate length can be made for a tissue shaping device as well as anchor heights for the distal and proximal anchors. The chemist may then select a tissue shaping device that has the appropriate length and anchor sizes of a set or sets of devices with different lengths and different anchor sizes, made, e.g. eg, according to the above. These sets of devices can be added to sets or kits or they can simply be a collection or inventory of different weaving devices.

One way to estimate the appropriate length and anchoring sizes of a tissue shaping device for mitral valve regurgitation is to see a fluoroscopic image of a coronary sinus into which a catheter with fluoroscopically visible marks 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 coronary sinus length proximal to that point and the coronary sinus diameter at the anchor locations can be measured. pretended. Also measuring the distance on the screen of the catheter marks and comparing them with the real distance between the marks of

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catheter, length and diameter measurements can be scaled to real size. A tissue shaping device with the appropriate length and anchor sizes can be selected from a set or inventory of devices for deployment in the patient to treat mitral valve regurgitation.

Figure 30 shows even another method. A tissue shaping device 800 formed of a substantially straight nested member 820 is disposed in the coronary sinus 804 to treat mitral valve regurgitation. When deployed as shown, the central part of the nested member 802 exerts a remodeling force above through the coronary sinus wall towards the mitral valve 806, while the proximal and distal ends 808 and 810, respectively, of the nested member 802 exert forces directed subsequently on the coronary sinus wall. The device 800 is disposed in relation to the circumflex artery 812 so that all the forces previously directed from the nested member 802 are posterior to the crossing point between artery 812 and coronary sinus 804, despite the fact that the distal end 810 of the device 800 and a part 814 of large wire are distal to the crossing point.

The device of Figure 30 may also include a less sharp part at the distal end 810 of the member 802 to further eliminate any force directed towards the mitral valve distal to the crossing point. Additional details of the device (apart from the method of this invention) can be found in the US patent application. UU. Serial No. 10 / 112,354, published as a US patent application. UU. Publication No. 2002/0183838.

Figure 31 shows another method. The device 900 has a substantially straight nested portion 902 disposed between a proximal angled portion 904 and a distal angled portion 906 within the coronary sinus 908. As shown, the proximal angled portion 904 extends through the ostium 910 of the coronary sinus within a catheter (not shown). The angled distal part 906 distally to a hooked part 912 which is preferably arranged in the AIV.

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

Other modifications will be apparent to those skilled in the art.

Claims (11)

5 10 fifteen twenty 25 30 35 1. A set of separate devices (30) for use in mitral valve regurgitation treatment, the set comprises: a plurality of separate tissue forming devices (30) having different lengths, each device comprises an anchor (34, 36) comprising twisted wires between each other and having an unexpanded configuration and an expanded configuration, the anchors (34, 36 ) have different diameters when they are in their expanded configurations, each of the separate tissue forming devices (30) is configured to be able to be administered to a coronary sinus of a patient within a catheter (50) that has an outside diameter no larger than ten french; where there are extra twists (442 or 464) on an apex of a pattern in figure of 8 formed by the anchor. 2. The set of claim 1 wherein the anchor of each device is a distal anchor (34), each of the devices further comprises a proximal anchor (36) having an unexpanded configuration and an expanded configuration, the proximal anchors (36) have different diameters when they are in their expanded configurations. 3. The set of claim 2 wherein the diameters of the distal anchors (34) of the separate tissue forming devices (30) of the set in their expanded configurations range from about 7 mm to about 16 mm. 4. The set of claim 2 wherein the diameters of the proximal anchors (36) of the separate tissue forming devices (30) of the set in their expanded configurations range from about 9 mm to about 20 mm. 5. The set of claim 4 wherein the distal anchor (62) or the proximal anchor (64) of each separate tissue forming device (60) of the set comprises a self-expanding anchor. 6. The set of claim 4 wherein the distal anchor (120) or the proximal anchor (140) of each separate tissue-forming device (100) of the set comprises an actionable anchor. 7. The set of claim 4 wherein the distal anchor (62) of at least one tissue shaping device (60) of the set comprises a self-expanding anchor and the distal anchor (120) of at least one tissue shaping device (100 ) of the set comprises an actionable anchor. 8. The set of claim 4 wherein the proximal anchor (64) of at least one tissue forming device (60) of the set comprises a self-expanding anchor and the proximal anchor (140) of at least one tissue forming device (100 ) of the set comprises an actionable anchor. 9. The set of claim 1 further comprising a catheter (50) having an outside diameter of not more than ten french. 10. The set of claim 1 wherein each of the separate tissue forming devices (30) is configured to be able to be administered to a coronary sinus of a patient within a catheter (50) having an outside diameter not greater than nine french 11. The set of any preceding claim, wherein the anchor wires twist each other at the apex (442 or 464) of the pattern in figure 8.