US20050027351A1 - Mitral valve regurgitation treatment device and method - Google Patents
Mitral valve regurgitation treatment device and method Download PDFInfo
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- US20050027351A1 US20050027351A1 US10/742,747 US74274703A US2005027351A1 US 20050027351 A1 US20050027351 A1 US 20050027351A1 US 74274703 A US74274703 A US 74274703A US 2005027351 A1 US2005027351 A1 US 2005027351A1
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- anchor
- tissue shaping
- proximal
- distal
- shaping device
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2451—Inserts in the coronary sinus for correcting the valve shape
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
- Y10S623/902—Method of implanting
- Y10S623/904—Heart
Definitions
- This invention relates generally to devices and methods for shaping tissue by deploying one or more devices in body lumens adjacent to the tissue.
- One particular application of the invention relates to a treatment for mitral valve regurgitation through deployment of a tissue shaping device in the patient's coronary sinus or great cardiac vein.
- the mitral valve is a portion of the heart that is located between the chambers of the left atrium and the left ventricle. When the left ventricle contracts to pump blood throughout the body, the mitral valve closes to prevent the blood being pumped back into the left atrium. In some patients, whether due to genetic malformation, disease or injury, the mitral valve fails to close properly causing a condition known as regurgitation, whereby blood is pumped into the atrium upon each contraction of the heart muscle. Regurgitation is a serious, often rapidly deteriorating, condition that reduces circulatory efficiency and must be corrected.
- Two of the more common techniques for restoring the function of a damaged mitral valve are to surgically replace the valve with a mechanical valve or to 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 frail thereby increasing the risks associated with such an operation.
- tissue shaping device in the cardiac sinus and vessel that passes adjacent 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 the advantage over other methods of mitral valve repair because it can be performed percutaneously without opening the chest wall. Examples of such devices are shown in U.S. patent appl. Ser. No. 10/142,637, “Body Lumen Device Anchor, Device and Assembly” filed May 8, 2002; U.S. patent appl. Ser. No. 10/331,143, “System and Method to Effect the Mitral Valve Annulus of a Heart” filed Dec. 26, 2002; and U.S. patent appl. Ser. No. 10/429,172, “Device and Method for Modifying the Shape of a Body Organ,” filed May 2, 2003. The disclosures of these patent applications are incorporated herein by reference.
- a tissue shaping device When deploying a tissue shaping device in a vein or artery to modify adjacent tissue, care must be taken to avoid constricting nearby arteries.
- a tissue shaping device may be deployed in the coronary sinus to modify the shape of the adjacent mitral valve annulus.
- Coronary arteries such as the circumflex artery may cross between the coronary sinus and the heart, however, raising the danger that deployment of the support may limit perfusion to a portion of the heart by constricting one of those arteries. See, e.g., the following applications, the disclosures of which are incorporated herein by reference: U.S. patent appl. Ser. No. 09/855,945, “Mitral Valve Therapy Device, System and Method,” filed May 14, 2001 and published Nov.
- the anatomy of the heart and its surrounding vessels varies from patient to patient.
- the location of the circumflex artery and other key arteries with respect to the coronary sinus can vary.
- the distance along the coronary sinus from the ostium to the crossing point with the circumflex artery can vary from patient to patient.
- the diameter and length of the coronary sinus can vary from patient to patient.
- tissue shaping devices, sets of tissue shaping devices and methods that maximize the therapeutic effect (i.e., reduction of mitral valve regurgitation) while minimizing adverse effects, such as an unacceptable constriction of the circumflex artery or other coronary arteries.
- the tissue shaping devices, sets of devices and methods of this invention enable the user to adapt the therapy to the patient's anatomy.
- the invention is a method of treating regurgitation of a mitral valve in a patient's heart, the method including the steps of delivering a tissue shaping device to the coronary sinus, such as in a catheter having an outer diameter no more than nine or ten french; and deploying the tissue shaping device to reduce mitral valve regurgitation, with the deploying step including the step of applying a force through the coronary sinus wall toward the mitral valve solely proximal to a crossover point where a coronary artery passes between a coronary sinus and the mitral valve.
- the device is deployed with its distal end proximal to the crossover point, and in some embodiments the distal end is deployed distal to the crossover point.
- the method may also include the step of determining the crossover point.
- the tissue shaping device includes a distal anchor
- the deploying step may include the step of anchoring the distal anchor proximal to the crossover point, such as by expanding the distal anchor through self-expansion or through the application of an actuation force.
- the anchoring force may be one-two pounds.
- the deploying step further includes the step of applying a proximally directed force on the distal anchor—in some embodiments from outside the patient—such as by moving the proximal anchor proximally.
- the tissue shaping device may further include a proximal anchor and a connector disposed between the distal anchor and the proximal anchor, with the deploying step further including the step of anchoring the proximal anchor (e.g., in the coronary sinus or at least partially outside the coronary sinus), such as by expanding the proximal anchor through self-expansion or through the application of an actuation force.
- the step of anchoring the proximal anchor may be performed before or after the step of applying a proximally directed force on the distal anchor.
- the deploying step of the method may include the step of deploying a distal anchor of the device from a distal end of a catheter.
- the method may also include the step of recapturing the distal anchor into a catheter and optionally redeploying the distal anchor.
- the deploying step of the method may also include the step of deploying a proximal anchor of the device from a distal end of a catheter, and the may include the step of recapturing the proximal anchor into a catheter and optionally redeploying the distal anchor.
- the entire device may 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 anchor sizes prior to the delivering step.
- the invention is also a set of devices for use in treating mitral valve regurgitation, with the set including a plurality of tissue shaping devices having different lengths, each of the tissue shaping devices being configured to be deliverable to a coronary sinus of a patient within a catheter having an outer diameter no greater than nine or ten french.
- the tissue shaping devices each include an anchor (such as a distal anchor or a proximal anchor) having an expanded configuration and an unexpanded configuration for delivery via catheter.
- at least one tissue shaping device in the set has a length 60 mm or less and at least one tissue shaping device in the set has a length more than 60 mm.
- the distal 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 distal anchor location (e.g., 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 (e.g., about 9 mm. to about 20 mm.)
- the anchors are self-expanding, in other sets the anchors are actuatable, while still other sets have at least one device with a self-expanding anchor and one with an actuatable anchor.
- the set may also include a catheter having an outer diameter no greater than nine to ten french.
- Another aspect of the invention is a set of devices for use in treating mitral valve regurgitation, with the set including a plurality of tissue shaping devices each with an anchor having an unexpanded configuration and an expanded configuration, the anchors having different diameters when in their expanded configurations, and each of the tissue shaping devices being configured to be deliverable to a coronary sinus of a patient within a catheter having an outer diameter no greater than nine to ten french.
- the anchor is a distal anchor (such as a self-expanding anchor or an actuatable anchor), and the devices further include a proximal anchor (such as a self-expanding anchor or an actuatable anchor) having an unexpanded configuration and an expanded configuration, the proximal anchors having different diameters when in their expanded configurations.
- 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.
- the diameters of the proximal anchors of the tissue shaping devices in the set in their expanded configurations range from about 9 mm. to about 20 mm.
- the set may also include a catheter having an outer diameter no greater than nine to ten french.
- FIG. 1 is a schematic view of a tissue shaping device according to a preferred embodiment as deployed within a coronary sinus.
- FIG. 2 is a schematic view of a tissue shaping device according to an alternative embodiment as deployed within a coronary sinus.
- FIG. 3 is a schematic view of a tissue shaping device being delivered to a coronary sinus within a catheter.
- FIG. 4 is a schematic view of a partially deployed tissue shaping device within a coronary sinus.
- FIG. 5 is a schematic view of a partially deployed and cinched tissue shaping device within a coronary sinus.
- FIG. 6 is an elevational view of yet another embodiment of a tissue shaping device according to this invention.
- FIG. 7 is a schematic drawing showing a method of determining the crossover point between a circumflex artery and a coronary sinus.
- FIG. 8 is a perspective drawing of a tissue shaping device according to one embodiment of this invention.
- FIG. 9 is a partial sectional view of the tissue shaping device of FIG. 8 in an unexpanded configuration within a catheter.
- FIG. 10 is a perspective view of an anchor for use with a tissue shaping device according to this invention.
- FIG. 11 is a perspective view of another anchor for use with a tissue shaping device according to this invention.
- FIG. 12 is a perspective view of yet another anchor for use with a tissue shaping device according to this invention.
- FIG. 13 is a perspective view of still another anchor for use with a tissue shaping device according to this invention.
- FIG. 14 is a perspective view of another anchor for use with a tissue shaping device according to this invention.
- FIG. 15 is a perspective view of yet another anchor for use with a tissue shaping device according to this invention.
- FIG. 16 is a perspective view of part of an anchor for use with a tissue shaping device according to this invention.
- FIG. 17 is a perspective view of still another anchor for use with a tissue shaping device according to this invention.
- FIG. 18 is a perspective view of another anchor for use with a tissue shaping device according to this invention.
- FIG. 19 is a perspective view of yet another anchor for use with a tissue shaping. device according to this invention.
- FIG. 20 is a perspective view of still another anchor for use with a tissue shaping device according to this invention.
- FIG. 21 is a perspective view of a tandem anchor for use with a tissue shaping device according to this invention.
- FIG. 22 is a perspective view of a connector with integral anchor crimps for us in a tissue shaping device according to this invention.
- FIG. 23 is a perspective view of a tissue shaping device employing the connector of FIG. 22 .
- FIG. 24 is a perspective view of another connector for use with a tissue shaping device according to this invention.
- FIG. 25 is a perspective view of yet another connector for use with a tissue shaping device according to this invention.
- FIG. 26 is a side view of a connector for use with a tissue shaping device according to this invention.
- FIG. 27 is a side view of another connector for use with a tissue shaping device according to this invention.
- FIG. 28 is a perspective view of yet another tissue shaping device according to this invention.
- FIG. 29 is a side view of the tissue shaping device shown in FIG. 28 .
- FIG. 30 is a schematic view of another embodiment demonstrating the method of this invention.
- FIG. 31 is a schematic view of yet another embodiment demonstrating the method of this invention.
- FIG. 1 shows a partial view of a human heart 10 and some surrounding anatomical structures.
- the main coronary venous vessel is the coronary sinus 12 , defined as starting at the ostium 14 or opening to the right atrium and extending through the great cardiac vein to the anterior interventricular (“AIV”) sulcus or groove 16 .
- AIV anterior interventricular
- FIG. 1 shows a partial view of a human heart 10 and some surrounding anatomical structures.
- the main coronary venous vessel is the coronary sinus 12 , defined as starting at the ostium 14 or opening to the right atrium and extending through the great cardiac vein to the anterior interventricular (“AIV”) sulcus or groove 16 .
- AIV anterior interventricular
- the mitral valve 20 surrounded by the mitral valve annulus 22 and adjacent to at least a portion of the coronary sinus 12 .
- the circumflex artery 24 shown in FIG. 1 passes between the coronary sinus 12 and the heart. The relative size and location of each of these structures vary from person to person
- tissue shaping device 30 Disposed within the coronary sinus 12 is a tissue shaping device 30 . As shown in FIG. 1 , the distal end 32 of device 30 is disposed proximal to circumflex artery 24 to reshape the adjacent mitral valve annulus 22 and thereby reduce mitral valve regurgitation. As shown in FIG. 1 , device 30 has a distal anchor 34 , a proximal anchor 36 and a connector 38 .
- proximal anchor 36 is deployed completely within the coronary sinus. In the alternative embodiment shown in FIG. 2 , proximal anchor is deployed at least partially outside the coronary sinus.
- FIGS. 3-6 show a method according to this invention.
- a catheter 50 is maneuvered in a manner known in the art through the ostium 14 into coronary sinus 12 .
- catheter 50 preferably has an outer diameter no greater than ten french, most preferably with an outer diameter no more than nine french.
- device 30 Disposed within catheter 50 is device 30 in an unexpanded configuration, and extending back through catheter 50 from device 30 to the exterior of the patient is a tether or control wire 52 .
- control wire 52 may include multiple tether and control wire elements, such as those described in U.S. patent application Ser. No. 10/331,143.
- the device is deployed as far distally as possible without applying substantial compressive force on the circumflex or other major coronary artery.
- the distal end of catheter 50 is disposed at a distal anchor location proximal of the crossover point between the circumflex artery 24 and the coronary sinus 12 as shown in FIG. 3 .
- catheter 50 is withdrawn proximally while device 30 is held stationary by control wire 52 to uncover distal anchor 34 at the distal anchor location within coronary sinus 12 .
- the catheter may be held stationary while device 30 is advanced distally to uncover the distal anchor.
- Distal anchor 34 is either a self-expanding anchor or an actuatable anchor or a combination self-expanding and actuatable anchor. Once uncovered, distal anchor 34 self-expands, or is expanded through the application of an actuation force (such as a force transmitted through control wire 52 ), to engage the inner wall of coronary sinus 12 , as shown in FIG. 4 .
- the distal anchor's anchoring force i.e., the force with which the distal anchor resists moving in response to a proximally-directed force, must be sufficient not only to maintain the device's position within the coronary sinus but also to enable the device to be used to reshape adjacent tissue in a manner such as that described below.
- distal anchor 34 engages the coronary sinus wall to provide an anchoring force of at least one pound, most preferably an anchoring force of at least two pounds.
- the anchor's expansion energy to supply the anchoring force comes from strain energy stored in the anchor due to its compression for catheter delivery, from an actuation force, or a combination of both, depending on anchor design.
- catheter 50 While device 30 is held in place by the anchoring force of distal anchor 34 , catheter 50 is withdrawn further proximally to a point just distal of proximal anchor 36 , as shown in FIG. 5 .
- a proximally directed force is then exerted on distal anchor 34 by control wire 52 through connector 38 .
- the distance between the distal and proximal anchors along the connector is fixed, so the proximally directed force moves proximal anchor 36 proximally with respect to the coronary sinus while distal anchor 34 remains stationary with respect to the coronary sinus.
- the proximal anchor is moved proximally about 1-6 cm., most preferably at least 2 cm., in response to the proximally directed force.
- the proximal anchor may stay substantially stationary with respect to the coronary sinus despite the application of a proximally directed force on the distal anchor.
- the proximal anchor is deployed.
- Other patient vital signs such as cardiac perfusion, may also be monitored during this procedure as described in U.S. patent application Ser. No. 10/366,585.
- the proximal anchor's anchoring force i.e., the force with which the proximal anchor resists moving in response to a distally-directed force, must be sufficient not only to maintain the device's position within the coronary sinus but also to enable the device to maintain the adjacent tissue's cinched shape.
- the proximal anchor engages the coronary sinus wall to provide an anchoring force of at least one pound, most preferably an anchoring force of at least two pounds.
- the proximal anchor's expansion energy to supply the anchoring force comes from strain energy stored in the anchor due to its compression for catheter delivery, from an actuation force, or a combination of both, depending on anchor design.
- the proximal anchor is deployed by withdrawing catheter 50 proximally to uncover proximal anchor 36 , then either permitting proximal anchor 36 to self-expand, applying an actuation force to expand the anchor, or a combination of both.
- the control wire 52 is then detached, and catheter 50 is removed from the patient.
- the device location and configuration as deployed according to this method is as shown in FIG. 1 .
- proximal anchor 36 may be deployed at least partially outside of the coronary sinus after cinching to modify the shape of the mitral valve tissue, as shown in FIG. 2 .
- distal anchor 34 is disposed proximal to the crossover point between coronary sinus 12 and circumflex artery 24 , all of the anchoring and tissue reshaping force applied to the coronary sinus by device 30 is solely proximal to the crossover point.
- the proximal anchor may be deployed prior to the application of the proximally directed force to cinch the device to reshape the mitral valve tissue.
- FIG. 6 One example of a device according to this embodiment is shown in FIG. 6 .
- Device 60 includes a self-expanding distal anchor 62 , a self-expanding proximal anchor 64 and a connector 66 .
- the design of distal anchor 62 enables it to maintain its anchoring force when a proximally directed force is applied on it to cinch, while the design of proximal anchor 64 permits it to be moved proximally after deployment while resisting distal movement after cinching. Cinching after proximal anchor deployment is described in more detail in U.S.
- distal anchor 62 is disposed proximal to the crossover point between coronary sinus 12 and circumflex artery 24 so that all of anchoring and tissue reshaping force applied to the coronary sinus by device 30 is solely proximal to the crossover point.
- the device or one of its anchors may be recaptured.
- catheter 50 may be moved distally to place proximal anchor 36 back inside catheter 50 , e.g., to the configuration shown in FIG. 5 . From this position, the cinching force along connector 38 may be increased or decreased, and proximal anchor 36 may then be redeployed.
- catheter 50 may be advanced distally to recapture both proximal anchor 36 and distal anchor 34 , e.g., to the configuration shown in FIG. 3 . From this position, distal anchor 34 may be redeployed, a cinching force applied, and proximal anchor 36 deployed as discussed above. Also from this position, device 30 may be removed from the patient entirely by simply withdrawing the catheter from the patient.
- Fluoroscopy e.g., angiograms and venograms
- Fluoroscopy may be used to determine the relative positions of the coronary sinus and the coronary arteries such as the circumflex artery, including the crossover point between the vessels and whether or not the artery is between the coronary sinus and the heart.
- Radiopaque dye may be injected into the coronary sinus and into the arteries in a known manner while the heart is viewed on a fluoroscope.
- FIG. 7 An alternative method of determining the relative positions of the vessels is shown in FIG. 7 .
- guide 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 guide wires are viewed on a fluoroscope to identify the crossover point 74 .
- FIG. 8 illustrates one embodiment of a tissue shaping device in accordance with the present invention.
- the tissue shaping device 100 includes a connector or support wire 102 having a proximal end 104 and a distal end 106 .
- the support wire 102 is made of a biocompatible material such as stainless steel or a shape memory material such as nitinol wire.
- connector 102 comprises a double length of nitinol wire that has both ends positioned within a distal crimp tube 108 .
- Proximal to the proximal end of the crimp tube 108 is a distal lock bump 110 that is formed by the support wire bending away from the longitudinal axis of the support 102 and then being bent parallel to the longitudinal axis of the support before being bent again towards the longitudinal axis of the support to form one half 110 a of distal lock bump 110 .
- the wire continues proximally through a proximal crimp tube 112 .
- the wire On exiting the proximal end of the proximal crimp tube 112 , the wire is bent to form an arrowhead-shaped proximal lock bump 114 .
- the wire of the support 102 then returns distally through the proximal crimp tube 112 to a position just proximal to the proximal end of the distal crimp tube 108 wherein the wire is bent to form a second half 110 b of the distal lock 110 .
- an actuatable distal anchor 120 that is formed of a flexible wire such as nitinol or some other shape memory material.
- the wire forming the distal anchor has one end positioned within the distal crimp tube 108 .
- the wire After exiting the distal end of the crimp tube 108 , the wire forms a figure eight configuration whereby it bends upward and radially outward from the longitudinal axis of the crimp tube 108 . The wire then bends back proximally and crosses the longitudinal axis of the crimp tube 108 to form one leg of the figure eight.
- the wire is then bent to form a double loop eyelet or loop 122 around the longitudinal axis of the support wire 102 before extending radially outwards and distally back over the longitudinal axis of the crimp tube 108 to form the other leg of the figure eight. Finally, the wire is bent proximally into the distal end of the crimp tube 108 to complete the distal anchor 120 .
- the distal anchor is expanded by using a catheter or locking tool to exert an actuation force sliding eyelet 122 of the distal anchor from a position that is proximal to distal lock bump 110 on the connector to a position that is distal to distal lock bump 110 .
- the bent-out portions 110 a and 110 b of connector 110 are spaced wider than the width of eyelet 122 and provide camming surfaces for the locking action. Distal movement of eyelet 122 pushes these camming surfaces inward to permit eyelet 122 to pass distally of the lock bump 110 , then return to their original spacing to keep eyelet 122 in the locked position.
- Actuatable proximal anchor 140 is formed and actuated in a similar manner by moving eyelet 142 over lock bump 114 . Both the distal and the proximal anchor provide anchoring forces of at least one pound, and most preferably two pounds.
- FIG. 9 illustrates one method for delivering a tissue shaping device 100 in accordance with the present invention to a desired location in the body, such as the coronary sinus to treat mitral valve regurgitation.
- device 100 is preferably loaded into and routed to a desired location within a catheter 200 with the proximal and distal anchors in an unexpanded or deformed condition. That is, eyelet 122 of distal anchor 120 is positioned proximal to the distal lock bump 110 and the eyelet 142 of the proximal anchor 140 is positioned proximal to the proximal lock bump 114 .
- the physician ejects the distal end of the device from the catheter 200 into 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
- a tether 201 provides proximal movement of the device with respect to catheter 200 .
- the distal anchor begins to expand as soon as it is outside the catheter.
- catheter 200 is advanced to place an actuation force on distal anchor eyelet 122 to push it distally over the distal lock bump 110 so that the distal anchor 120 further expands and locks in place to securely engage the wall of the coronary sinus.
- a proximally-directed force is applied to connector 102 and distal anchor 120 via a tether or control wire 201 extending through catheter outside the patient to apply sufficient pressure on the tissue adjacent the connector to modify the shape of that tissue.
- fluoroscopy, ultrasound or other imaging technology may be used to see when the device supplies sufficient pressure on the mitral valve to aid in its complete closure with each ventricular contraction without otherwise adversely affecting the patient.
- proximal anchor 140 moves proximally.
- proximal anchor 140 can be moved about 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 an actuation force on proximal anchor eyelet 142 to advance it distally over the proximal lock bump 114 to expand and lock the proximal anchor, thereby securely engaging the coronary sinus wall to maintain the proximal anchor's position and to maintain the reshaping pressure of the connector against the coronary sinus wall.
- catheter 200 may be advanced to lock proximal anchor 140 .
- the mechanism for securing the proximal end of the device can be released.
- the securement is made with a braided loop 202 at the end of tether 201 and a lock wire 204 .
- the lock wire 204 is withdrawn thereby releasing the loop 202 so it can be pulled through the proximal lock bump 114 at the proximal end of device 100 .
- Reduction in mitral valve regurgitation using devices of this invention can be maximized by deploying the distal anchor as far distally in the coronary sinus as possible.
- anchor 120 in its unexpanded configuration extends proximally along connector 102 within catheter 200 .
- a preferred catheter diameter is ten french or less (most preferably nine french), and the tissue shaping device in its unexpanded configuration must fit within the catheter.
- FIGS. 10-23 show embodiments of the device of this invention having flexible and expandable wire anchors which permit the delivery of tissue shaping devices 60 mm or less in length by a ten french (or less) catheter.
- one or both of the anchors are provided with bending points about which the anchors deform when placed in their unexpanded configuration for delivery by a catheter or recapture into a catheter. These bending points enable the anchors to deform into configurations that minimize overlap with other elements of the device.
- the distal anchor is self-expanding, thereby avoiding the need for a proximally-extending eyelet in the anchor's unexpanded configuration that might overlap with the unexpanded proximal anchor within the delivery and/or recapture catheter.
- FIG. 10 shows an actuatable anchor design suitable for a shorter tissue shaping device similar to the device shown in FIGS. 8 and 9 .
- distal anchor 300 is disposed distal to a connector 302 .
- anchor 300 is formed in a figure eight configuration from flexible wire such as nitinol held by a crimp tube 304 .
- An eyelet 306 is formed around the longitudinal axis of connector 302 . A distally directed actuation force on eyelet 306 moves it over a lock bump 308 formed in connector 302 to actuate and lock anchor 300 .
- FIG. 10 shows anchor 300 in an expanded configuration.
- eyelet 306 is disposed proximal to lock bump 308 , and the figure eight loops of anchor 300 are compressed against crimp 304 .
- eyelet 306 In order to limit the proximal distance eyelet 306 must be moved along the connector to compress anchor 300 into an unexpanded configuration, bending points 310 are formed in the distal struts of anchor 300 . Bending points 310 are essentially kinks, i.e., points of increased curvature, formed in the wire.
- bending points 310 deform such that the upper arms 312 of the distal struts bend around bending points 310 and move toward the lower arms 314 of the distal struts, thereby limiting the distance eyelet 306 and the anchor's proximal struts must be moved proximally along the connector to compress the anchor.
- anchor 300 would deform about bending points 310 to limit the cross-sectional profile of the anchor within the catheter, even if eyelet 306 were not moved proximally over lock bump 308 during the recapture procedure. Bending points may also be provided on the proximal anchor in a similar fashion.
- distal anchor 300 may be part of a tissue shaping device (such as that shown in FIGS. 8 and 9 ) having a proximal anchor and a connector disposed between the anchors.
- tissue shaping device such as that shown in FIGS. 8 and 9
- distal anchor 300 may be deployed from a catheter and expanded with an actuation force to anchor against the coronary sinus wall to provide an anchoring force of at least one pound, preferably at least two pounds, and to lock anchor 300 in an expanded configuration.
- a proximally directed force is applied to distal anchor 300 through connector 302 , such as by moving the proximal anchor proximally about 1-6 cm., more preferably at least 2 cm., by pulling on a tether or control wire operated from outside the patient.
- the proximal anchor may then be deployed to maintain the reshaping force of the device.
- anchor 300 is its ability to conform and adapt to a variety of vessel sizes. For example, when anchor 300 is expanded inside a vessel such as the coronary sinus, the anchor's wire arms may contact the coronary sinus wall before the eyelet 306 has been advanced distally over lock bump 308 to lock the anchor in place. While continued distal advancement of eyelet 306 will create some outward force on the coronary sinus wall, much of the energy put into the anchor by the anchor actuation force will be absorbed by the deformation of the distal struts about bending points 310 , which serve as expansion energy absorption elements and thereby limit the radially outward force on the coronary sinus wall. This feature enables the anchor to be used in a wider range of vessel sizes while reducing the risk of over-expanding the vessel.
- FIG. 11 shows another anchor design suitable for a shorter tissue shaping device similar to the device shown in FIGS. 8 and 9 .
- distal anchor 320 is disposed distal to a connector 322 .
- anchor 320 is formed in a figure eight configuration from flexible wire such as nitinol held by a crimp tube 324 .
- anchor 320 is self-expanding and is not actuatable.
- Eyelet 326 is held in place by a second crimp 325 to limit or eliminate movement of the anchor's proximal connection point proximally or distally, e.g., along connector 322 .
- FIG. 11 shows anchor 320 in an expanded configuration.
- an unexpanded configuration such as a configuration suitable for loading anchor 320 and the rest of the tissue shaping device into a catheter for initial deployment to treat mitral valve regurgitation
- the figure eight loops of anchor 320 are compressed.
- Bending points 330 are formed in the distal struts of anchor 320 .
- bending points 330 deform such that the upper arms 332 of the distal struts bend around bending points 330 and move toward the lower arms 334 of the distal struts.
- very little or none of the wire portion of anchor 320 is disposed proximally along crimp 325 or connector 322 when anchor 320 is in its unexpanded configuration.
- anchor 320 would deform about bending points 330 to limit the cross-sectional profile of the anchor within the catheter. Bending points may also be provided on the proximal anchor in a similar fashion.
- Distal anchor 320 may be part of a tissue shaping device (such as that shown in FIGS. 8 and 9 ) having a proximal anchor and a connector disposed between the anchors. Due to the superelastic properties of its shape memory material, distal anchor 320 may be deployed from a catheter to self-expand to anchor against the coronary sinus wall to provide an anchoring force of at least one pound, preferably at least two pounds. A proximally directed force may then be applied to distal anchor 320 through connector 322 , such as by moving the proximal anchor proximally about 1-6 cm., more preferably at least 2 cm., by pulling on a tether or control wire operated from outside the patient. The proximal anchor may then be deployed to maintain the reshaping force of the device.
- FIG. 12 shows another embodiment of an anchor suitable for use in a shorter tissue shaping device.
- distal anchor 340 is disposed distal to a connector 342 .
- anchor 340 is formed in a figure eight configuration from flexible wire such as nitinol held by a crimp tube 344 .
- anchor 340 is self-expanding and is not actuatable.
- the loop of anchor 340 forming the anchor's proximal struts passes through a loop 346 extending distally from a second crimp 345 to limit or eliminate movement of the anchor's proximal struts proximally or distally, e.g., along connector 342 .
- FIG. 12 shows anchor 340 in an expanded configuration.
- 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 figure eight loops of anchor 340 are compressed.
- bending points 350 are formed in the proximal struts of anchor 340 .
- anchor 340 is compressed into an unexpanded configuration
- bending points 350 deform such that the upper arms 352 of the distal struts bend around bending points 350 and move toward the lower arms 354 of the distal struts.
- the amount of the wire portion of anchor 340 extending proximally along crimp 345 and connector 342 in its unexpanded configuration depends on the location of bending points 350 .
- the bending points are formed at the tallest and widest part of the proximal struts.
- Distal anchor 340 may be part of a tissue shaping device (such as that shown in FIGS. 8 and 9 ) having a proximal anchor and a connector disposed between the anchors. Due to the superelastic properties of its shape memory material, distal anchor 340 may be deployed from a catheter to self-expand to anchor against the coronary sinus wall to provide an anchoring force of at least one pound, preferably at least two pounds. A proximally directed force may then be applied to distal anchor 340 through connector 342 , such as by moving the proximal anchor proximally about 1-6 cm., more preferably at least 2 cm., by pulling on a tether or control wire operated from outside the patient. The proximal anchor may then be deployed to maintain the reshaping force of the device.
- Bending points 350 also add to the anchoring force of distal anchor 340 , e.g., by 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.
- bending points may be added to the distal struts of a proximal anchor to increase the proximal anchor's anchoring force in response to a distally directed force.
- FIG. 13 shows yet another embodiment of an anchor suitable for use in a shorter tissue shaping device.
- distal anchor 360 is disposed distal to a connector 362 .
- anchor 360 is formed in a figure eight configuration from flexible wire such as nitinol held by a crimp tube 364 .
- anchor 360 is self-expanding and is not actuatable.
- the loop of anchor 360 forming the anchor's proximal struts passes through a loop 366 extending distally from a second crimp 365 to limit or eliminate movement of the anchor's proximal struts proximally or distally, e.g., along connector 362 .
- FIG. 13 shows anchor 360 in an expanded configuration.
- an unexpanded configuration such as a configuration suitable for loading anchor 360 and the rest of the tissue shaping device into a catheter for initial deployment to treat mitral valve regurgitation
- the figure eight loops of anchor 360 are compressed.
- bending points 370 are formed in both the proximal struts and the distal struts of anchor 360 .
- Anchor 360 may be used as part of a tissue shaping device like the embodiments discussed above.
- FIG. 14 shows an actuatable anchor design-suitable for a shorter tissue shaping device similar to the device shown in FIGS. 8 and 9 .
- distal anchor 380 is disposed distal to a connector 382 .
- anchor 380 is formed in a figure eight configuration from flexible wire such as nitinol held by a crimp tube 384 .
- eyelets 386 and 387 are formed in each of the anchor's proximal struts around the longitudinal axis of connector 382 . This arrangement reduces the radially outward force of the anchor.
- a distally directed actuation force on eyelets 386 and 387 move them over a lock bump 388 formed in connector 382 to actuate and lock anchor 380 .
- FIG. 14 shows anchor 380 in an expanded configuration.
- an unexpanded configuration such as a configuration suitable 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 disposed proximal to lock bump 388 and the figure eight loops of anchor 380 are compressed against crimp 384 .
- bending points 390 are formed in the distal struts of anchor 380 .
- bending points 390 deform such that the upper arms 392 of the distal struts bend around bending points 390 and move toward the lower arms 394 of the distal struts, thereby limiting the distance eyelets 386 and 387 and the anchor's proximal struts must be moved proximally along the connector to compress the anchor.
- anchor 380 would deform about bending points 390 to limit the cross-sectional profile of the anchor within the catheter, even if eyelets 386 and 387 were not moved proximally over lock bump 388 during the recapture procedure. Bending points may also be provided on the proximal anchor in a similar fashion.
- distal anchor 380 may be part of a tissue shaping device (such as that shown in FIGS. 8 and 9 ) having a proximal anchor and a connector disposed between the anchors.
- tissue shaping device such as that shown in FIGS. 8 and 9
- distal anchor 380 may be deployed from a catheter and expanded with an actuation force to anchor against the coronary sinus wall to provide an anchoring force of at least one pound, preferably at least two pounds, and to lock anchor 380 in an expanded configuration.
- a proximally directed force is applied to distal anchor 380 through connector 382 , such as by moving the proximal anchor proximally about 1-6 cm., more preferably at least 2 cm., by pulling on a tether or control wire operated from outside the patient.
- the proximal anchor may then be deployed to maintain the reshaping force of the device.
- one aspect of anchor 380 is its ability to conform and adapt to a variety of vessel sizes.
- the anchor's wire arms may contact the coronary sinus wall before the eyelets 386 and 387 have been advance distally over lock bump 388 to lock the anchor in place. While continued distal advancement of eyelet 386 will create some outward force on the coronary sinus wall, much of the energy put into the anchor by the anchor actuation force will be absorbed by the deformation of the distal struts about bending points 390 .
- FIG. 15 shows yet another embodiment of an actuatable anchor for use in a shorter tissue shaping device.
- Proximal anchor 400 is disposed proximal to a connector 402 .
- anchor 400 is formed in a figure eight configuration from flexible wire such as nitinol held by a crimp tube 404 .
- An eyelet 406 is formed around a lock bump 408 extending proximally from crimp 404 . A distally directed actuation force on eyelet 406 moves it over lock bump 408 to actuate and lock anchor 400 .
- FIG. 15 shows anchor 400 in an expanded configuration.
- bending points 410 formed as loops in the anchor wire deform such that the upper arms 412 of the distal struts bend around bending points 410 and move toward the lower arms 414 of the distal struts.
- proximal anchor 400 may be part of a tissue shaping device (such as that shown in FIGS. 8 and 9 ) having a distal anchor and a connector disposed between the anchors.
- one aspect of anchor 400 is its ability to conform and adapt to a variety of vessel sizes.
- the anchor's wire arms may contact the coronary sinus wall before the eyelet 406 has been advanced distally over lock bump 408 to lock the anchor in place. While continued distal advancement of eyelet 406 will create some outward force on the coronary sinus wall, much of the energy put into the anchor by the anchor actuation force will be absorbed by the deformation of the distal struts about bending points 410 , which serve as expansion energy absorption elements and thereby limit the radially outward force on the coronary sinus wall.
- the looped bending points of the FIG. 15 embodiment may be formed on the anchor's proximal struts in addition to or instead of on the distal struts.
- the looped bending point embodiment may also be used in a distal anchor, as shown in FIG. 16 (without the crimp or connector). Note that in the embodiment of FIG. 16 the proximal and distal struts of anchor 420 as well as the eyelet 422 and bending points 424 are formed from a single wire.
- FIG. 17 shows an embodiment of a distal anchor 440 similar to that of FIG. 10 suitable for use in a shorter tissue shaping device.
- extra twists 442 are added at the apex of the anchor's figure eight pattern.
- bending points 444 are formed in the anchor's distal struts.
- anchor 440 is actuatable by moving eyelet 446 distally over a lock bump 448 formed in connector 450 .
- Anchor 440 may also be made as a self-expanding anchor by limiting or eliminating movement of the proximal struts of anchor 440 along connector 450 , as in the embodiment shown in FIG. 11 .
- the bending points help anchor 440 adapt and conform to different vessel sizes.
- the extra twists 442 also help the anchor adapt to different vessel diameters by keeping the anchor's apex together.
- anchor 440 is preferably formed from nitinol wire.
- Anchor 440 may be used as part of a tissue shaping device in a manner similar to the anchor of FIG. 10 (for the actuatable anchor embodiment) or the anchor of FIG. 11 (for the self-expanding anchor embodiment).
- Anchor 440 may also be used as a proximal anchor.
- FIG. 18 shows an embodiment of a distal anchor 460 similar to that of FIG. 17 .
- the bending points 462 are formed in the anchor's proximal struts, as in the self-expanding anchor shown in FIG. 12 .
- extra twists 464 are added at the apex of the anchor's figure eight pattern.
- anchor 460 is actuatable by moving eyelet 466 distally over a lock bump 468 formed in connector 470 .
- Anchor 460 may also be made as a self-expanding anchor by limiting or eliminating movement of the proximal connection point of anchor 460 along connector 470 , as in the embodiment shown in FIG. 11 .
- the bending points help anchor 460 adapt and conform to different vessel sizes.
- the extra twists 464 also help the anchor adapt to different vessel diameters by keeping the anchor's apex together.
- anchor 460 is preferably formed from nitinol wire.
- Anchor 460 may be used as part of a tissue shaping device in a manner similar to the anchor of FIG. 10 (for the actuatable anchor embodiment) or the anchor of FIG. 11 (for the self-expanding anchor embodiment).
- Anchor 460 may also be used as a proximal anchor.
- FIG. 19 shows an embodiment of a self-expanding distal anchor 480 suitable for use in a shorter tissue shaping device.
- anchor 480 is formed in a figure eight configuration from flexible wire such as nitinol held by a crimp tube 482 .
- the base of the figure eight pattern is narrower in this embodiment, however, with the anchor's proximal struts 484 passing through crimp 482 .
- Distal anchor 480 may be part of a tissue shaping device (such as that shown in FIGS. 8 and 9 ) having a proximal anchor and a connector disposed between the anchors.
- tissue shaping device such as that shown in FIGS. 8 and 9
- distal anchor 480 may be deployed from a catheter and allowed to self-expand to anchor against the coronary sinus wall to provide an anchoring force of at least one pound, preferably at least two pounds.
- a proximally directed force is applied to distal anchor 480 through connector 486 , such as by moving the proximal anchor proximally about 1-6 cm., more preferably at least 2 cm., by pulling on a tether or control wire operated from outside the patient.
- the proximal anchor may then be deployed to maintain the reshaping force of the device.
- FIG. 20 shows an embodiment of a distal anchor suitable for use in a shorter tissue shaping device and similar to that of FIG. 10 .
- distal anchor 500 is disposed distal to a connector 502 .
- anchor 500 is formed in a figure eight configuration from flexible wire such as nitinol held by a crimp tube 504 .
- An eyelet 506 is formed around the longitudinal axis of connector 502 .
- a distally directed actuation force on eyelet 506 moves it over a lock bump 508 formed in connector 502 to actuate and lock anchor 500 .
- proximal struts 501 and the angle of distal struts 503 are wider than corresponding angles in the FIG. 10 embodiment, however, causing anchor 500 to distend more in width than in height when expanded, as shown.
- eyelet 506 is disposed proximal to lock bump 508 and the figure eight loops of anchor 500 are compressed against crimp 504 .
- bending points 510 are formed in the distal struts 503 , as in the FIG. 10 embodiment, to limit the width of the device in its unexpanded configuration within a catheter.
- Distal anchor 500 may be part of a tissue shaping device (such as that shown in FIGS. 8 and 9 ) having a proximal anchor and a connector disposed between the anchors.
- tissue shaping device such as that shown in FIGS. 8 and 9
- distal anchor 500 may be deployed from a catheter and expanded with an actuation force to anchor against the coronary sinus wall to provide an anchoring force of at least one pound, preferably at least two pounds, and to lock anchor 500 in an expanded configuration.
- a proximally directed force is applied to distal anchor 500 through connector 502 , such as by moving the proximal anchor proximally about 1-6 cm., more preferably at least 2 cm., by pulling on a tether or control wire operated from outside the patient.
- the proximal anchor may then be deployed to maintain the reshaping force of the device.
- the anchor shown in FIG. 20 may be used as a proximal anchor. This anchor may also be formed as a self-expanding anchor.
- FIG. 21 shows a tandem distal anchor according to another embodiment of this invention.
- Self-expanding anchor 520 is formed in a figure eight configuration from flexible wire such as nitinol held by a crimp tube 522 .
- Eyelet 524 is held in place by the distal end of actuatable anchor 540 to limit or eliminate proximal and distal movement of the proximal struts of anchor 520 .
- bending points 530 are formed in the distal struts of anchor 520 . Depending upon the exact location of bending points 530 , very little or none of the wire portion of anchor 520 is disposed proximal to the distal end of anchor 540 when anchor 520 is in its unexpanded configuration.
- anchor 520 would deform about bending points 530 to limit the cross-sectional profile of the anchor within the catheter. Bending points may also be provided on the proximal anchor in a similar fashion.
- Anchor 540 is similar to anchor 120 shown in FIG. 8 .
- Anchor 540 is formed in a figure eight configuration from flexible wire such as nitinol held by a crimp tube 544 .
- An eyelet 546 is formed around the longitudinal axis of connector 542 .
- a distally directed actuation force on eyelet 546 moves it over a lock bump 548 formed in connector 542 to actuate and lock anchor 540 .
- Tandem anchors 520 and 540 may be part of a tissue shaping device (such as that shown in FIGS. 8 and 9 ) having a proximal anchor and a connector disposed between the anchors.
- Anchors 520 and 540 may be made from a single wire or from separate pieces of wire.
- distal anchors 520 and 540 may be deployed from a catheter.
- Self-expanding anchor 520 will then self-expand, and actuatable anchor 540 may be expanded and locked with an actuation force, to anchor both anchors against the coronary sinus wall to provide an anchoring force of at least one pound, preferably at least two pounds.
- a proximally directed force is applied to anchors 520 and 540 through connector 542 , such as by moving the proximal anchor proximally about 1-6 cm., more preferably at least 2 cm., by pulling on a tether or control wire operated from outside the patient.
- the proximal anchor may then be deployed to maintain the reshaping force of the device.
- FIGS. 22 and 23 show an alternative embodiment in which the device's connector 560 is made integral with the distal and proximal crimp tubes 562 and 564 .
- connector 560 is formed by cutting away a section of a blank such as a nitinol (or other suitable material such as stainless steel) cylinder or tube, leaving crimp tube portions 562 and 564 intact.
- the radius of the semi-circular cross-section connector is therefore the same as the radii of the two anchor crimp tubes.
- the device may be formed from a blank shaped as a flat ribbon or sheet by removing rectangular edge sections from a central section, creating an I-shaped sheet (e.g., nitinol or stainless steel) having greater widths at the ends and a narrower width in the center connector portion. The ends can then be rolled to form the crimp tubes, leaving the connector substantially flat.
- the connector can be made integral with just one of the anchors.
- a distal anchor 566 is formed in a figure eight configuration from flexible wire such as nitinol.
- Distal anchor 566 is self-expanding, and its proximal struts 568 are held in place by crimp tube 562 .
- Optional bending points may be formed in the proximal struts 568 or distal struts 570 of anchor 566 .
- a proximal anchor 572 is also formed in a figure eight configuration from flexible wire such as nitinol with an eyelet 574 on its proximal end.
- a distally directed actuation force on eyelet 574 moves it over a lock bump 576 extending proximally from crimp tube 564 to actuate and lock anchor 572 .
- Lock bump 576 also serves as the connection point for a tether or control wire to deploy and actuate device in the manner described above with respect to FIGS. 8 and 9 .
- Optional bending points may be formed in the proximal or distal struts of anchor 572 .
- FIG. 24 shows an alternative connector for use with the tissue shaping devices of this invention that distributes over more of the device any strain caused by the beat to beat bending and tensile loading.
- Connector 600 has a proximal anchor area 602 , a distal anchor area 604 and a central area 606 .
- the distal anchor area may be longer than the distal anchor attached to it, and the proximal anchor area may be longer than the proximal anchor attached to it.
- An optional lock bump 608 may be formed at the proximal end of connector 600 for use with an actuatable proximal anchor and for connecting to a tether or control wire, as described above.
- An optional bulb 610 may be formed at the distal end of connector 600 to prevent accidental distal slippage of a distal anchor.
- connector 600 In order to reduce material fatigue caused by the heartbeat to heartbeat loading and unloading of the tissue shaping device, the moment of inertia of connector 600 varies along its length, particularly in the portion of connector disposed between the two anchors.
- connector 600 is formed as a ribbon or sheet and is preferably formed from nitinol having a rectangular cross-sectional area.
- the thickness of connector 600 is preferably constant in the proximal anchor area 602 and the distal anchor area 604 to facilitate attachment of crimps and other components of the anchors.
- the central area 606 has a decreasing thickness (and therefore a decreasing moment of inertia) from the border between, central area 606 and proximal anchor area 602 to a point about at the center of central area 606 , and an increasing thickness (and increasing moment of inertia) from that point to the border between central area 606 and distal anchor area 604 .
- the varying thickness and varying cross-sectional shape of connector 600 change its moment of inertia along its length, thereby helping distribute over a wider area any strain from the heartbeat to heartbeat loading and unloading of the device and reducing the chance of fatigue failure of the connector material.
- FIG. 25 shows another embodiment of the connector.
- connector 620 has a proximal anchor area 622 , a distal anchor area 624 and a central area 626 .
- Proximal anchor area 622 has an optional two-tined prong 628 formed at its proximal end to facilitate attachment of a crimp and other anchor elements.
- Bent prong portions 629 may be formed at the proximal end of the prong to prevent accidental slippage of a proximal anchor.
- An optional bulb 630 may be formed at the distal end of connector 620 to prevent accidental distal slippage of a distal anchor.
- connector 620 is formed as a ribbon or sheet and is preferably formed from nitinol having a rectangular cross-sectional area.
- the thickness of connector 620 is preferably constant in the proximal anchor area 622 and the distal anchor area 624 to facilitate attachment of crimps and other components of the anchors.
- the central area 626 has a decreasing thickness (decreasing moment of inertia) from the border between central area 626 and proximal anchor area 622 to a point about at the center of central area 626 , and an increasing thickness (increasing moment of inertia) from that point to the border between central area 626 and distal anchor area 624 .
- the varying thickness and varying cross-sectional shape of connector 620 change its moment of inertia along its length, thereby helping distribute over a wider area any strain from the heartbeat to heartbeat loading and unloading of the device and reducing the chance of fatigue failure of the connector material.
- FIG. 26 shows a connector 640 in profile.
- Connector 640 may be formed like the connectors 600 and 620 or FIGS. 24 and 25 , respectively, or may have some other configuration.
- Connector 640 has a proximal anchor area 642 , a distal anchor area 644 and a central area 646 .
- Connector 640 is preferably formed as a ribbon or sheet and is preferably formed from nitinol having a rectangular cross-sectional area.
- the thicknesses of proximal anchor area 642 and distal anchor area 644 are constant.
- the thickness of central area 646 decreases from the border between central area 646 and proximal anchor area 642 to a point distal of that border and increases from a point proximal to the border between distal anchor area 644 and central area 646 to that border.
- the points in the central area where the thickness decrease ends and the thickness increase begins may be coincident or may be separated to form an area of uniform thickness within central area 646 .
- the thickness of the central area changes as a function of the square root of the distance from the borders between the central area and the proximal and distal anchor areas.
- FIG. 27 shows yet another embodiment of the connector.
- connector 650 may be formed like the connectors 600 and 620 or FIGS. 24 and 25 , respectively, or may have some other configuration.
- Connector 650 has a proximal anchor area 652 , a distal anchor area 654 and a central area 656 .
- Connector 650 is preferably formed as a ribbon or sheet and is preferably formed from nitinol having a rectangular cross-sectional area.
- proximal anchor area 652 and distal anchor area 654 are constant.
- the thickness of a proximal portion 658 of central area 656 decreases linearly from the border between central area 656 and proximal anchor area 652 to a constant thickness center portion 662 of central area 656
- the thickness of a distal portion 660 of central area 656 increases linearly from center portion 662 to the border between distal anchor area 654 and central area 656 .
- the thickness of the connector may vary in other ways.
- the cross-sectional shape of the connector may be other than rectangular and may change over the length of the connector.
- FIGS. 28 and 29 show yet another embodiment of the invention.
- Tissue shaping device 700 has a connector 706 disposed between a proximal anchor 702 and a distal anchor 704 .
- Connector 706 may be formed as a ribbon or sheet, such as the tapered connectors shown in FIGS. 24-27 .
- Actuatable proximal anchor 702 is formed in a figure eight configuration from flexible wire such as nitinol and is fastened to connector 706 with a crimp tube 708 .
- self-expanding distal anchor 704 is formed in a figure eight configuration from flexible wire such as nitinol and is fastened to connector 706 with a crimp tube 710 .
- a proximal lock bump 716 extends proximally from proximal anchor 702 for use in actuating and locking proximal anchor 702 and for connecting to a tether or control wire, as described above.
- Bending points 712 are formed in the loops of proximal anchor 702
- bending points 714 are formed in the loops of distal anchor 704 .
- the wire portions of anchors 702 and 704 bend about 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.
- the diameter of the coronary sinus at the distal and proximal anchor points can vary from patient to patient.
- the anchors described above may be made in a variety of heights and combined with connectors of varying lengths to accommodate this patient to patient variation.
- tissue shaping devices deployed in the coronary sinus to treat mitral valve regurgitation can 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.
- tissue shaping device When treating a patient for mitral valve regurgitation, estimates can be made of the appropriate length for a tissue shaping device as well as appropriate anchor heights for the distal and proximal anchors. The clinician can then select a tissue shaping device having the appropriate length and anchor sizes from a set or sets of devices with different lengths and different anchor sizes, made, e.g., according to the embodiments described above. These device sets may be aggregated into sets or kits or may simply be a collection or inventory of different tissue shaping devices.
- One way of estimating the appropriate length and anchor sizes of a tissue shaping device for mitral valve regurgitation is to view a fluoroscopic image of a coronary sinus into which a catheter with fluoroscopically viewable markings has been inserted.
- the crossover 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 intended anchor locations can be measured.
- the length and diameter measures can be scaled to actual size.
- a tissue shaping device with the appropriate length and anchor sizes can be selected from a set or inventory of devices for deployment in the patient to treat mitral valve regurgitation.
- FIG. 30 shows yet another embodiment of the method of this invention.
- a tissue shaping device 800 formed from a substantially straight rigid member 802 is disposed in the coronary sinus 804 to treat mitral valve regurgitation.
- the central portion of rigid member 802 exerts a remodeling force anteriorly through the coronary sinus wall toward the mitral valve 806 , while the proximal and distal ends 808 and 810 , respectively, of rigid member 802 exert posteriorly-directed forces on the coronary sinus wall.
- device 800 is disposed in relation to the circumflex artery 812 so that all of the anteriorly-directed forces from rigid member 802 are posterior to the crossover point between artery 812 and coronary sinus 804 , despite the fact that distal end 810 of device 800 and a guidewire portion 814 are distal to the crossover point.
- the device of FIG. 30 may also include a less rigid portion at the distal end 810 of member 802 to further eliminate any force directed toward the mitral valve distal to the crossover point. Further details of the device (apart from the method of this invention) may be found in U.S. patent application Ser. No. 10/112,354, published as U.S. patent appl. Publ. No. 2002/0183838, the disclosure of which is incorporated herein by reference.
- FIG. 31 shows another embodiment of the method of this invention.
- Device 900 has a substantially straight rigid portion 902 disposed between a proximal angled portion 904 and a distal angled portion 906 within coronary sinus 908 .
- proximal angled portion 904 extends through the coronary sinus ostium 910 within a catheter (not shown).
- Distal angled portion 906 extends distally to a hooked portion 912 that is preferably disposed in the AIV.
- the device's straight portion 902 reshapes the coronary sinus and adjacent tissue to apply an anteriorally directed force through the coronary sinus wall toward the mitral valve 914 . Due to the device's design, this reshaping force is applied solely proximal to the crossover point between coronary sinus 908 and the patient's circumflex artery 916 , despite the fact at least a part of the device's distal portion 906 and hooked portion 912 are disposed distal to the crossover point.
Abstract
A method of treating regurgitation of a mitral valve in a patient's heart. The method includes the steps of: delivering a tissue shaping device to the coronary sinus; and deploying the tissue shaping device to reduce mitral valve regurgitation, the deploying step comprising applying a force through the coronary sinus wall toward the mitral valve solely proximal to a crossover point where a coronary artery passes between a coronary sinus and the mitral valve. The invention is also a set of devices for use in treating mitral valve regurgitation. The set includes a plurality of tissue shaping devices having different lengths, each of the tissue shaping devices being configured to be deliverable to a coronary sinus of a patient within a catheter having an outer diameter no greater than ten french.
Description
- This application is a continuation-in-part of U.S. patent appl. Ser. No. 09/855,945, filed May 14, 2001, the disclosure of which is incorporated herein by reference.
- This invention relates generally to devices and methods for shaping tissue by deploying one or more devices in body lumens adjacent to the tissue. One particular application of the invention relates to a treatment for mitral valve regurgitation through deployment of a tissue shaping device in the patient's coronary sinus or great cardiac vein.
- The mitral valve is a portion of the heart that is located between the chambers of the left atrium and the left ventricle. When the left ventricle contracts to pump blood throughout the body, the mitral valve closes to prevent the blood being pumped back into the left atrium. In some patients, whether due to genetic malformation, disease or injury, the mitral valve fails to close properly causing a condition known as regurgitation, whereby blood is pumped into the atrium upon each contraction of the heart muscle. Regurgitation is a serious, often rapidly deteriorating, condition that reduces circulatory efficiency and must be corrected.
- Two of the more common techniques for restoring the function of a damaged mitral valve are to surgically replace the valve with a mechanical valve or to 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 frail thereby increasing the risks associated with such an operation.
- One less invasive approach for aiding the closure of the mitral valve involves the placement of a tissue shaping device in the cardiac sinus and vessel that passes adjacent 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 the advantage over other methods of mitral valve repair because it can be performed percutaneously without opening the chest wall. Examples of such devices are shown in U.S. patent appl. Ser. No. 10/142,637, “Body Lumen Device Anchor, Device and Assembly” filed May 8, 2002; U.S. patent appl. Ser. No. 10/331,143, “System and Method to Effect the Mitral Valve Annulus of a Heart” filed Dec. 26, 2002; and U.S. patent appl. Ser. No. 10/429,172, “Device and Method for Modifying the Shape of a Body Organ,” filed May 2, 2003. The disclosures of these patent applications are incorporated herein by reference.
- When deploying a tissue shaping device in a vein or artery to modify adjacent tissue, care must be taken to avoid constricting nearby arteries. For example, when treating mitral valve regurgitation, a tissue shaping device may be deployed in the coronary sinus to modify the shape of the adjacent mitral valve annulus. Coronary arteries such as the circumflex artery may cross between the coronary sinus and the heart, however, raising the danger that deployment of the support may limit perfusion to a portion of the heart by constricting one of those arteries. See, e.g., the following applications, the disclosures of which are incorporated herein by reference: U.S. patent appl. Ser. No. 09/855,945, “Mitral Valve Therapy Device, System and Method,” filed May 14, 2001 and published Nov. 14, 2002, as US 2002/0169504 A1; U.S. patent appl. Ser. No. 09/855,946, “Mitral Valve Therapy Assembly and Method,” filed May 14, 2001 and published Nov. 14, 2002, as US 2002/0169502 A1; and U.S. patent appl. Ser. No. 10/003,910, “Focused Compression Mitral Valve Device and Method” filed Nov. 1, 2001. It is therefore advisable to monitor cardiac perfusion during and after such mitral valve regurgitation therapy. See, e.g., U.S. patent appl. Ser. No. 10/366,585, “Method of Implanting a Mitral Valve Therapy Device,” filed Feb. 12, 2003, the disclosure of which is incorporated herein by reference.
- The anatomy of the heart and its surrounding vessels varies from patient to patient. For example, the location of the circumflex artery and other key arteries with respect to the coronary sinus can vary. Specifically, the distance along the coronary sinus from the ostium to the crossing point with the circumflex artery can vary from patient to patient. In addition, the diameter and length of the coronary sinus can vary from patient to patient.
- We have invented tissue shaping devices, sets of tissue shaping devices and methods that maximize the therapeutic effect (i.e., reduction of mitral valve regurgitation) while minimizing adverse effects, such as an unacceptable constriction of the circumflex artery or other coronary arteries. The tissue shaping devices, sets of devices and methods of this invention enable the user to adapt the therapy to the patient's anatomy.
- In one embodiment, the invention is a method of treating regurgitation of a mitral valve in a patient's heart, the method including the steps of delivering a tissue shaping device to the coronary sinus, such as in a catheter having an outer diameter no more than nine or ten french; and deploying the tissue shaping device to reduce mitral valve regurgitation, with the deploying step including the step of applying a force through the coronary sinus wall toward the mitral valve solely proximal to a crossover point where a coronary artery passes between a coronary sinus and the mitral valve. In some embodiments, the device is deployed with its distal end proximal to the crossover point, and in some embodiments the distal end is deployed distal to the crossover point. The method may also include the step of determining the crossover point.
- In some embodiments the tissue shaping device includes a distal anchor, in which case the deploying step may include the step of anchoring the distal anchor proximal to the crossover point, such as by expanding the distal anchor through self-expansion or through the application of an actuation force. The anchoring force may be one-two pounds.
- In some embodiments, the deploying step further includes the step of applying a proximally directed force on the distal anchor—in some embodiments from outside the patient—such as by moving the proximal anchor proximally. The tissue shaping device may further include a proximal anchor and a connector disposed between the distal anchor and the proximal anchor, with the deploying step further including the step of anchoring the proximal anchor (e.g., in the coronary sinus or at least partially outside the coronary sinus), such as by expanding the proximal anchor through self-expansion or through the application of an actuation force. The step of anchoring the proximal anchor may be performed before or after the step of applying a proximally directed force on the distal anchor.
- The deploying step of the method may include the step of deploying a distal anchor of the device from a distal end of a catheter. The method may also include the step of recapturing the distal anchor into a catheter and optionally redeploying the distal anchor. The deploying step of the method may also include the step of deploying a proximal anchor of the device from a distal end of a catheter, and the may include the step of recapturing the proximal anchor into a catheter and optionally redeploying the distal anchor. The entire device may 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 anchor sizes prior to the delivering step.
- The invention is also a set of devices for use in treating mitral valve regurgitation, with the set including a plurality of tissue shaping devices having different lengths, each of the tissue shaping devices being configured to be deliverable to a coronary sinus of a patient within a catheter having an outer diameter no greater than nine or ten french. In some embodiments the tissue shaping devices each include an anchor (such as a distal anchor or a proximal anchor) having an expanded configuration and an unexpanded configuration for delivery via catheter. In some embodiments, at least one tissue shaping device in the set has a
length 60 mm or less and at least one tissue shaping device in the set has a length more than 60 mm. 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 a coronary sinus diameter at a distal anchor location (e.g., 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 (e.g., about 9 mm. to about 20 mm.) In some sets, the anchors are self-expanding, in other sets the anchors are actuatable, while still other sets have at least one device with a self-expanding anchor and one with an actuatable anchor. The set may also include a catheter having an outer diameter no greater than nine to ten french. - Another aspect of the invention is a set of devices for use in treating mitral valve regurgitation, with the set including a plurality of tissue shaping devices each with an anchor having an unexpanded configuration and an expanded configuration, the anchors having different diameters when in their expanded configurations, and each of the tissue shaping devices being configured to be deliverable to a coronary sinus of a patient within a catheter having an outer diameter no greater than nine to ten french. In some embodiments the anchor is a distal anchor (such as a self-expanding anchor or an actuatable anchor), and the devices further include a proximal anchor (such as a self-expanding anchor or an actuatable anchor) having an unexpanded configuration and an expanded configuration, the proximal anchors having different diameters when in their expanded configurations. In some embodiments 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 embodiments the diameters of the proximal anchors of the tissue shaping devices in the set in their expanded configurations range from about 9 mm. to about 20 mm. The set may also include a catheter having an outer diameter no greater than nine to ten french.
- The invention will be described in more detail below with reference to the drawings.
-
FIG. 1 is a schematic view of a tissue shaping device according to a preferred embodiment as deployed within a coronary sinus. -
FIG. 2 is a schematic view of a tissue shaping device according to an alternative embodiment as deployed within a coronary sinus. -
FIG. 3 is a schematic view of a tissue shaping device being delivered to a coronary sinus within a catheter. -
FIG. 4 is a schematic view of a partially deployed tissue shaping device within a coronary sinus. -
FIG. 5 is a schematic view of a partially deployed and cinched tissue shaping device within a coronary sinus. -
FIG. 6 is an elevational view of yet another embodiment of a tissue shaping device according to this invention. -
FIG. 7 is a schematic drawing showing a method of determining the crossover point between a circumflex artery and a coronary sinus. -
FIG. 8 is a perspective drawing of a tissue shaping device according to one embodiment of this invention. -
FIG. 9 is a partial sectional view of the tissue shaping device ofFIG. 8 in an unexpanded configuration within a catheter. -
FIG. 10 is a perspective view of an anchor for use with a tissue shaping device according to this invention. -
FIG. 11 is a perspective view of another anchor for use with a tissue shaping device according to this invention. -
FIG. 12 is a perspective view of yet another anchor for use with a tissue shaping device according to this invention. -
FIG. 13 is a perspective view of still another anchor for use with a tissue shaping device according to this invention. -
FIG. 14 is a perspective view of another anchor for use with a tissue shaping device according to this invention. -
FIG. 15 is a perspective view of yet another anchor for use with a tissue shaping device according to this invention. -
FIG. 16 is a perspective view of part of an anchor for use with a tissue shaping device according to this invention. -
FIG. 17 is a perspective view of still another anchor for use with a tissue shaping device according to this invention. -
FIG. 18 is a perspective view of another anchor for use with a tissue shaping device according to this invention. -
FIG. 19 is a perspective view of yet another anchor for use with a tissue shaping. device according to this invention. -
FIG. 20 is a perspective view of still another anchor for use with a tissue shaping device according to this invention. -
FIG. 21 is a perspective view of a tandem anchor for use with a tissue shaping device according to this invention. -
FIG. 22 is a perspective view of a connector with integral anchor crimps for us in a tissue shaping device according to this invention. -
FIG. 23 is a perspective view of a tissue shaping device employing the connector ofFIG. 22 . -
FIG. 24 is a perspective view of another connector for use with a tissue shaping device according to this invention. -
FIG. 25 is a perspective view of yet another connector for use with a tissue shaping device according to this invention. -
FIG. 26 is a side view of a connector for use with a tissue shaping device according to this invention. -
FIG. 27 is a side view of another connector for use with a tissue shaping device according to this invention. -
FIG. 28 is a perspective view of yet another tissue shaping device according to this invention. -
FIG. 29 is a side view of the tissue shaping device shown inFIG. 28 . -
FIG. 30 is a schematic view of another embodiment demonstrating the method of this invention. -
FIG. 31 is a schematic view of yet another embodiment demonstrating the method of this invention. -
FIG. 1 shows a partial view of ahuman heart 10 and some surrounding anatomical structures. The main coronary venous vessel is thecoronary sinus 12, defined as starting at theostium 14 or opening to the right atrium and extending through the great cardiac vein to the anterior interventricular (“AIV”) sulcus orgroove 16. Also shown is themitral valve 20 surrounded by themitral valve annulus 22 and adjacent to at least a portion of thecoronary sinus 12. Thecircumflex artery 24 shown inFIG. 1 passes between thecoronary sinus 12 and the heart. The relative size and location of each of these structures vary from person to person. - Disposed within the
coronary sinus 12 is atissue shaping device 30. As shown inFIG. 1 , thedistal end 32 ofdevice 30 is disposed proximal tocircumflex artery 24 to reshape the adjacentmitral valve annulus 22 and thereby reduce mitral valve regurgitation. As shown inFIG. 1 ,device 30 has adistal anchor 34, aproximal anchor 36 and aconnector 38. - In the embodiment of
FIG. 1 ,proximal anchor 36 is deployed completely within the coronary sinus. In the alternative embodiment shown inFIG. 2 , proximal anchor is deployed at least partially outside the coronary sinus. -
FIGS. 3-6 show a method according to this invention. As shown inFIG. 3 , acatheter 50 is maneuvered in a manner known in the art through theostium 14 intocoronary sinus 12. In order to be navigable through the patient's venous system,catheter 50 preferably has an outer diameter no greater than ten french, most preferably with an outer diameter no more than nine french. Disposed withincatheter 50 isdevice 30 in an unexpanded configuration, and extending back throughcatheter 50 fromdevice 30 to the exterior of the patient is a tether orcontrol wire 52. In some embodiments,control wire 52 may include multiple tether and control wire elements, such as those described in U.S. patent application Ser. No. 10/331,143. - According to one preferred embodiment, the device is deployed as far distally as possible without applying substantial compressive force on the circumflex or other major coronary artery. Thus, the distal end of
catheter 50 is disposed at a distal anchor location proximal of the crossover point between thecircumflex artery 24 and thecoronary sinus 12 as shown inFIG. 3 . At this point,catheter 50 is withdrawn proximally whiledevice 30 is held stationary bycontrol wire 52 to uncoverdistal anchor 34 at the distal anchor location withincoronary sinus 12. Alternatively, the catheter may be held stationary whiledevice 30 is advanced distally to uncover the distal anchor. -
Distal anchor 34 is either a self-expanding anchor or an actuatable anchor or a combination self-expanding and actuatable anchor. Once uncovered,distal anchor 34 self-expands, or is expanded through the application of an actuation force (such as a force transmitted through control wire 52), to engage the inner wall ofcoronary sinus 12, as shown inFIG. 4 . The distal anchor's anchoring force, i.e., the force with which the distal anchor resists moving in response to a proximally-directed force, must be sufficient not only to maintain the device's position within the coronary sinus but also to enable the device to be used to reshape adjacent tissue in a manner such as that described below. In a preferred embodiment,distal anchor 34 engages the coronary sinus wall to provide an anchoring force of at least one pound, most preferably an anchoring force of at least two pounds. The anchor's expansion energy to supply the anchoring force comes from strain energy stored in the anchor due to its compression for catheter delivery, from an actuation force, or a combination of both, depending on anchor design. - While
device 30 is held in place by the anchoring force ofdistal anchor 34,catheter 50 is withdrawn further proximally to a point just distal ofproximal anchor 36, as shown inFIG. 5 . A proximally directed force is then exerted ondistal anchor 34 bycontrol wire 52 throughconnector 38. In this embodiment, the distance between the distal and proximal anchors along the connector is fixed, so the proximally directed force movesproximal anchor 36 proximally with respect to the coronary sinus whiledistal anchor 34 remains stationary with respect to the coronary sinus. This cinching action straightens that section ofcoronary sinus 12, thereby modifying its shape and the shape of the adjacentmitral valve 20, moving the mitral valve leaflets into greater coaptation and reducing mitral valve regurgitation. In some embodiments of the invention, the proximal anchor is moved proximally about 1-6 cm., most preferably at least 2 cm., in response to the proximally directed force. In other embodiments, such as embodiments 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 stay substantially stationary with respect to the coronary sinus despite the application of a proximally directed force on the distal anchor. - After the appropriate amount of reduction in mitral valve regurgitation has been achieved (as determined, e.g., by viewing doppler-enhanced echocardiograms), the proximal anchor is deployed. Other patient vital signs, such as cardiac perfusion, may also be monitored during this procedure as described in U.S. patent application Ser. No. 10/366,585.
- In preferred embodiments, the proximal anchor's anchoring force, i.e., the force with which the proximal anchor resists moving in response to a distally-directed force, must be sufficient not only to maintain the device's position within the coronary sinus but also to enable the device to maintain the adjacent tissue's cinched shape. In a preferred embodiment, the proximal anchor engages the coronary sinus wall to provide an anchoring force of at least one pound, most preferably an anchoring force of at least two pounds. As with the distal anchor, the proximal anchor's expansion energy to supply the anchoring force comes from strain energy stored in the anchor due to its compression for catheter delivery, from an actuation force, or a combination of both, depending on anchor design.
- In a preferred embodiment, the proximal anchor is deployed by withdrawing
catheter 50 proximally to uncoverproximal anchor 36, then either permittingproximal anchor 36 to self-expand, applying an actuation force to expand the anchor, or a combination of both. Thecontrol wire 52 is then detached, andcatheter 50 is removed from the patient. The device location and configuration as deployed according to this method is as shown inFIG. 1 . - Alternatively,
proximal anchor 36 may be deployed at least partially outside of the coronary sinus after cinching to modify the shape of the mitral valve tissue, as shown inFIG. 2 . In both embodiments, becausedistal anchor 34 is disposed proximal to the crossover point betweencoronary sinus 12 andcircumflex artery 24, all of the anchoring and tissue reshaping force applied to the coronary sinus bydevice 30 is solely proximal to the crossover point. - In alternative embodiments, the proximal anchor may be deployed prior to the application of the proximally directed force to cinch the device to reshape the mitral valve tissue. One example of a device according to this embodiment is shown in
FIG. 6 .Device 60 includes a self-expandingdistal anchor 62, a self-expandingproximal anchor 64 and aconnector 66. The design ofdistal anchor 62 enables it to maintain its anchoring force when a proximally directed force is applied on it to cinch, while the design ofproximal anchor 64 permits it to be moved proximally after deployment while resisting distal movement after cinching. Cinching after proximal anchor deployment is described in more detail in U.S. patent application Ser. No. 10/066,426, filed Jan. 30, 2002, the disclosure of which is incorporated herein by reference. In this embodiment as well,distal anchor 62 is disposed proximal to the crossover point betweencoronary sinus 12 andcircumflex artery 24 so that all of anchoring and tissue reshaping force applied to the coronary sinus bydevice 30 is solely proximal to the crossover point. - It may be desirable to move and/or remove the tissue shaping device after deployment or to re-cinch after initial cinching. According to certain embodiments of the invention, therefore, the device or one of its anchors may be recaptured. For example, in the embodiment of
FIG. 1 , after deployment ofproximal anchor 36 but prior to disengagement ofcontrol wire 52,catheter 50 may be moved distally to placeproximal anchor 36 back insidecatheter 50, e.g., to the configuration shown inFIG. 5 . From this position, the cinching force alongconnector 38 may be increased or decreased, andproximal anchor 36 may then be redeployed. - Alternatively,
catheter 50 may be advanced distally to recapture bothproximal anchor 36 anddistal anchor 34, e.g., to the configuration shown inFIG. 3 . From this position,distal anchor 34 may be redeployed, a cinching force applied, andproximal anchor 36 deployed as discussed above. Also from this position,device 30 may be removed from the patient entirely by simply withdrawing the catheter from the patient. - Fluoroscopy (e.g., angiograms and venograms) may be used to determine the relative positions of the coronary sinus and the coronary arteries such as the circumflex artery, including the crossover point between the vessels and whether or not the artery is between the coronary sinus and the heart. Radiopaque dye may be injected into the coronary sinus and into the arteries in a known manner while the heart is viewed on a fluoroscope.
- An alternative method of determining the relative positions of the vessels is shown in
FIG. 7 . In this method, guidewires coronary sinus 12 and into thecircumflex artery 24 or other coronary artery, and the relative positions of the guide wires are viewed on a fluoroscope to identify the crossover point 74. -
FIG. 8 illustrates one embodiment of a tissue shaping device in accordance with the present invention. Thetissue shaping device 100 includes a connector orsupport wire 102 having aproximal end 104 and a distal end 106. Thesupport wire 102 is made of a biocompatible material such as stainless steel or a shape memory material such as nitinol wire. - In one embodiment of the invention,
connector 102 comprises a double length of nitinol wire that has both ends positioned within adistal crimp tube 108. Proximal to the proximal end of thecrimp tube 108 is adistal lock bump 110 that is formed by the support wire bending away from the longitudinal axis of thesupport 102 and then being bent parallel to the longitudinal axis of the support before being bent again towards the longitudinal axis of the support to form one half 110 a ofdistal lock bump 110. Fromdistal lock bump 110, the wire continues proximally through aproximal crimp tube 112. On exiting the proximal end of theproximal crimp tube 112, the wire is bent to form an arrowhead-shapedproximal lock bump 114. The wire of thesupport 102 then returns distally through theproximal crimp tube 112 to a position just proximal to the proximal end of thedistal crimp tube 108 wherein the wire is bent to form a second half 110 b of thedistal lock 110. - At the distal end of
connector 102 is an actuatabledistal anchor 120 that is formed of a flexible wire such as nitinol or some other shape memory material. As shown inFIG. 8 , the wire forming the distal anchor has one end positioned within thedistal crimp tube 108. After exiting the distal end of thecrimp tube 108, the wire forms a figure eight configuration whereby it bends upward and radially outward from the longitudinal axis of thecrimp tube 108. The wire then bends back proximally and crosses the longitudinal axis of thecrimp tube 108 to form one leg of the figure eight. The wire is then bent to form a double loop eyelet orloop 122 around the longitudinal axis of thesupport wire 102 before extending radially outwards and distally back over the longitudinal axis of thecrimp tube 108 to form the other leg of the figure eight. Finally, the wire is bent proximally into the distal end of thecrimp tube 108 to complete thedistal anchor 120. - The distal anchor is expanded by using a catheter or locking tool to exert an actuation
force sliding eyelet 122 of the distal anchor from a position that is proximal todistal lock bump 110 on the connector to a position that is distal todistal lock bump 110. The bent-out portions 110 a and 110 b ofconnector 110 are spaced wider than the width ofeyelet 122 and provide camming surfaces for the locking action. Distal movement ofeyelet 122 pushes these camming surfaces inward to permiteyelet 122 to pass distally of thelock bump 110, then return to their original spacing to keepeyelet 122 in the locked position. - Actuatable
proximal anchor 140 is formed and actuated in a similar manner by movingeyelet 142 overlock bump 114. Both the distal and the proximal anchor provide anchoring forces of at least one pound, and most preferably two pounds. -
FIG. 9 illustrates one method for delivering atissue shaping device 100 in accordance with the present invention to a desired location in the body, such as the coronary sinus to treat mitral valve regurgitation. As indicated above,device 100 is preferably loaded into and routed to a desired location within acatheter 200 with the proximal and distal anchors in an unexpanded or deformed condition. That is,eyelet 122 ofdistal anchor 120 is positioned proximal to thedistal lock bump 110 and theeyelet 142 of theproximal anchor 140 is positioned proximal to theproximal lock bump 114. The physician ejects the distal end of the device from thecatheter 200 into 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 tocatheter 200, and atether 201 provides proximal movement of the device with respect tocatheter 200. - Because of 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,
catheter 200 is advanced to place an actuation force ondistal anchor eyelet 122 to push it distally over thedistal lock bump 110 so that thedistal anchor 120 further expands and locks in place to securely engage the wall of the coronary sinus. Next, a proximally-directed force is applied toconnector 102 anddistal anchor 120 via a tether orcontrol wire 201 extending through catheter outside the patient to apply sufficient pressure on the tissue adjacent the connector to modify the shape of that tissue. In the case of the mitral valve, fluoroscopy, ultrasound or other imaging technology may be used to see when the device supplies sufficient pressure on the mitral valve to aid in its complete closure with each ventricular contraction without otherwise adversely affecting the patient. - The proximally directed reshaping force causes the
proximal anchor 140 to move proximally. In one embodiment, for example,proximal anchor 140 can be moved about 1-6 cm., most preferably at least 2 cm., proximally to reshape the mitral valve tissue. Theproximal anchor 140 is then deployed from the catheter and allowed to begin its expansion. The locking tool applies an actuation force onproximal anchor eyelet 142 to advance it distally over theproximal lock bump 114 to expand and lock the proximal anchor, thereby securely engaging the coronary sinus wall to maintain the proximal anchor's position and to maintain the reshaping pressure of the connector against the coronary sinus wall. Alternatively,catheter 200 may be advanced to lockproximal anchor 140. - Finally, the mechanism for securing the proximal end of the device can be released. In one embodiment, the securement is made with a
braided loop 202 at the end oftether 201 and alock wire 204. Thelock wire 204 is withdrawn thereby releasing theloop 202 so it can be pulled through theproximal lock bump 114 at the proximal end ofdevice 100. - Reduction in mitral valve regurgitation using devices of this invention can be maximized by deploying the distal anchor as far distally in the coronary sinus as possible. In some instances it may be desirable to implant a shorter tissue shaping device, such as situations where 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. As can be seen from
FIG. 9 ,anchor 120 in its unexpanded configuration extends proximally alongconnector 102 withincatheter 200. Making the device shorter by simply shortening the connector, however, may cause theeyelet 122 and proximal portion of thedistal anchor 120 to overlap with portions of the proximal anchor when the device is loaded into a catheter, thereby requiring the catheter diameter to be larger than is needed 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 must fit within the catheter. -
FIGS. 10-23 show embodiments of the device of this invention having flexible and expandable wire anchors which permit the delivery oftissue shaping devices 60 mm or less in length by a ten french (or less) catheter. In some embodiments, one or both of the anchors are provided with bending points about which the anchors deform when placed in their unexpanded configuration for delivery by a catheter or recapture into a catheter. These bending points enable the anchors to deform into configurations that minimize overlap with other elements of the device. In other embodiments, the distal anchor is self-expanding, thereby avoiding the need for a proximally-extending eyelet in the anchor's unexpanded configuration that might overlap with the unexpanded proximal anchor within the delivery and/or recapture catheter. -
FIG. 10 shows an actuatable anchor design suitable for a shorter tissue shaping device similar to the device shown inFIGS. 8 and 9 . In this embodiment,distal anchor 300 is disposed distal to aconnector 302. As in the embodiment ofFIG. 8 ,anchor 300 is formed in a figure eight configuration from flexible wire such as nitinol held by acrimp tube 304. Aneyelet 306 is formed around the longitudinal axis ofconnector 302. A distally directed actuation force oneyelet 306 moves it over alock bump 308 formed inconnector 302 to actuate and lockanchor 300. -
FIG. 10 shows anchor 300 in an expanded configuration. In an unexpanded configuration, such as a configuration suitable forloading anchor 300 and the rest of the tissue shaping device into a catheter for initial deployment to treat mitral valve regurgitation,eyelet 306 is disposed proximal to lockbump 308, and the figure eight loops ofanchor 300 are compressed againstcrimp 304. In order to limit theproximal distance eyelet 306 must be moved along the connector to compressanchor 300 into an unexpanded configuration, bendingpoints 310 are formed in the distal struts ofanchor 300. Bending points 310 are essentially kinks, i.e., points of increased curvature, formed in the wire. Whenanchor 300 is compressed into an unexpanded configuration, bendingpoints 310 deform such that theupper arms 312 of the distal struts bend around bendingpoints 310 and move toward thelower arms 314 of the distal struts, thereby limiting thedistance eyelet 306 and the anchor's proximal struts must be moved proximally along the connector to compress the anchor. - Likewise, if distal anchor were to be recaptured into a catheter for redeployment or removal from the patient,
anchor 300 would deform about bendingpoints 310 to limit the cross-sectional profile of the anchor within the catheter, even ifeyelet 306 were not moved proximally overlock bump 308 during the recapture procedure. Bending points may also be provided on the proximal anchor in a similar fashion. - As stated above,
distal anchor 300 may be part of a tissue shaping device (such as that shown inFIGS. 8 and 9 ) having a proximal anchor and a connector disposed between the anchors. To treat mitral valve regurgitation,distal anchor 300 may be deployed from a catheter and expanded with an actuation force to anchor against the coronary sinus wall to provide an anchoring force of at least one pound, preferably at least two pounds, and to lockanchor 300 in an expanded configuration. A proximally directed force is applied todistal anchor 300 throughconnector 302, such as by moving the proximal anchor proximally about 1-6 cm., more preferably at least 2 cm., by pulling on a tether or control wire operated from outside the patient. The proximal anchor may then be deployed to maintain the reshaping force of the device. - One aspect of
anchor 300 is its ability to conform and adapt to a variety of vessel sizes. For example, whenanchor 300 is expanded inside a vessel such as the coronary sinus, the anchor's wire arms may contact the coronary sinus wall before theeyelet 306 has been advanced distally overlock bump 308 to lock the anchor in place. While continued distal advancement ofeyelet 306 will create some outward force on the coronary sinus wall, much of the energy put into the anchor by the anchor actuation force will be absorbed by the deformation of the distal struts about bendingpoints 310, which serve as expansion energy absorption elements and thereby limit the radially outward force on the coronary sinus wall. This feature enables the anchor to be used in a wider range of vessel sizes while reducing the risk of over-expanding the vessel. -
FIG. 11 shows another anchor design suitable for a shorter tissue shaping device similar to the device shown inFIGS. 8 and 9 . In this embodiment,distal anchor 320 is disposed distal to aconnector 322. As in the embodiment ofFIG. 8 ,anchor 320 is formed in a figure eight configuration from flexible wire such as nitinol held by acrimp tube 324. Unlike the embodiment ofFIG. 10 , however,anchor 320 is self-expanding and is not actuatable.Eyelet 326 is held in place by asecond crimp 325 to limit or eliminate movement of the anchor's proximal connection point proximally or distally, e.g., alongconnector 322. -
FIG. 11 shows anchor 320 in an expanded configuration. In an unexpanded configuration, such as a configuration suitable forloading anchor 320 and the rest of the tissue shaping device into a catheter for initial deployment to treat mitral valve regurgitation, the figure eight loops ofanchor 320 are compressed. Bending points 330 are formed in the distal struts ofanchor 320. Whenanchor 320 is compressed into an unexpanded configuration, bendingpoints 330 deform such that theupper arms 332 of the distal struts bend around bendingpoints 330 and move toward thelower arms 334 of the distal struts. Depending upon the exact location of bendingpoints 330, very little or none of the wire portion ofanchor 320 is disposed proximally alongcrimp 325 orconnector 322 whenanchor 320 is in its unexpanded configuration. - Likewise, if distal anchor were to be recaptured into a catheter for redeployment or removal from the patient,
anchor 320 would deform about bendingpoints 330 to limit the cross-sectional profile of the anchor within the catheter. Bending points may also be provided on the proximal anchor in a similar fashion. -
Distal anchor 320 may be part of a tissue shaping device (such as that shown inFIGS. 8 and 9 ) having a proximal anchor and a connector disposed between the anchors. Due to the superelastic properties of its shape memory material,distal anchor 320 may be deployed from a catheter to self-expand to anchor against the coronary sinus wall to provide an anchoring force of at least one pound, preferably at least two pounds. A proximally directed force may then be applied todistal anchor 320 throughconnector 322, such as by moving the proximal anchor proximally about 1-6 cm., more preferably at least 2 cm., by pulling on a tether or control wire operated from outside the patient. The proximal anchor may then be deployed to maintain the reshaping force of the device. -
FIG. 12 shows another embodiment of an anchor suitable for use in a shorter tissue shaping device. In this embodiment,distal anchor 340 is disposed distal to aconnector 342. As in the embodiment ofFIG. 11 ,anchor 340 is formed in a figure eight configuration from flexible wire such as nitinol held by acrimp tube 344. Also like that embodiment,anchor 340 is self-expanding and is not actuatable. The loop ofanchor 340 forming the anchor's proximal struts passes through aloop 346 extending distally from asecond crimp 345 to limit or eliminate movement of the anchor's proximal struts proximally or distally, e.g., alongconnector 342. -
FIG. 12 shows anchor 340 in an expanded configuration. Like the device ofFIG. 11 , in an unexpanded configuration, such as a configuration suitable forloading anchor 340 and the rest of the tissue shaping device into a catheter for initial deployment to treat mitral valve regurgitation, the figure eight loops ofanchor 340 are compressed. Unlike theFIG. 11 embodiment, however, bendingpoints 350 are formed in the proximal struts ofanchor 340. Whenanchor 340 is compressed into an unexpanded configuration, bendingpoints 350 deform such that theupper arms 352 of the distal struts bend around bendingpoints 350 and move toward thelower arms 354 of the distal struts. The amount of the wire portion ofanchor 340 extending proximally alongcrimp 345 andconnector 342 in its unexpanded configuration depends on the location of bendingpoints 350. In one embodiment, the bending points are formed at the tallest and widest part of the proximal struts. -
Distal anchor 340 may be part of a tissue shaping device (such as that shown inFIGS. 8 and 9 ) having a proximal anchor and a connector disposed between the anchors. Due to the superelastic properties of its shape memory material,distal anchor 340 may be deployed from a catheter to self-expand to anchor against the coronary sinus wall to provide an anchoring force of at least one pound, preferably at least two pounds. A proximally directed force may then be applied todistal anchor 340 throughconnector 342, such as by moving the proximal anchor proximally about 1-6 cm., more preferably at least 2 cm., by pulling on a tether or control wire operated from outside the patient. The proximal anchor may then be deployed to maintain the reshaping force of the device. - Bending points 350 also add to the anchoring force of
distal anchor 340, e.g., by 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 manner, bending points may be added to the distal struts of a proximal anchor to increase the proximal anchor's anchoring force in response to a distally directed force. -
FIG. 13 shows yet another embodiment of an anchor suitable for use in a shorter tissue shaping device. In this embodiment,distal anchor 360 is disposed distal to aconnector 362. As in the embodiment ofFIG. 12 ,anchor 360 is formed in a figure eight configuration from flexible wire such as nitinol held by acrimp tube 364. Also like that embodiment,anchor 360 is self-expanding and is not actuatable. The loop ofanchor 360 forming the anchor's proximal struts passes through aloop 366 extending distally from asecond crimp 365 to limit or eliminate movement of the anchor's proximal struts proximally or distally, e.g., alongconnector 362. -
FIG. 13 shows anchor 360 in an expanded configuration. Like the device ofFIG. 12 , in an unexpanded configuration, such as a configuration suitable forloading anchor 360 and the rest of the tissue shaping device into a catheter for initial deployment to treat mitral valve regurgitation, the figure eight loops ofanchor 360 are compressed. Unlike theFIG. 12 embodiment, however, bendingpoints 370 are formed in both the proximal struts and the distal struts ofanchor 360. -
Anchor 360 may be used as part of a tissue shaping device like the embodiments discussed above. -
FIG. 14 shows an actuatable anchor design-suitable for a shorter tissue shaping device similar to the device shown inFIGS. 8 and 9 . In this embodiment,distal anchor 380 is disposed distal to aconnector 382. As in the other embodiments,anchor 380 is formed in a figure eight configuration from flexible wire such as nitinol held by acrimp tube 384. In contrast to the embodiment ofFIG. 10 ,eyelets connector 382. This arrangement reduces the radially outward force of the anchor. A distally directed actuation force oneyelets lock bump 388 formed inconnector 382 to actuate and lockanchor 380. -
FIG. 14 shows anchor 380 in an expanded configuration. In an unexpanded configuration, such as a configuration suitable forloading 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 disposed proximal to lockbump 388 and the figure eight loops ofanchor 380 are compressed againstcrimp 384. In order to limit the proximal distance eyelets 386 and 387 must be moved to compressanchor 380 into an unexpanded configuration, bendingpoints 390 are formed in the distal struts ofanchor 380. Whenanchor 380 is compressed into an unexpanded configuration, bendingpoints 390 deform such that theupper arms 392 of the distal struts bend around bendingpoints 390 and move toward thelower arms 394 of the distal struts, thereby limiting the distance eyelets 386 and 387 and the anchor's proximal struts must be moved proximally along the connector to compress the anchor. - If distal anchor were to be recaptured into a catheter for redeployment or removal from the patient,
anchor 380 would deform about bendingpoints 390 to limit the cross-sectional profile of the anchor within the catheter, even ifeyelets lock bump 388 during the recapture procedure. Bending points may also be provided on the proximal anchor in a similar fashion. - As with the other embodiments above,
distal anchor 380 may be part of a tissue shaping device (such as that shown inFIGS. 8 and 9 ) having a proximal anchor and a connector disposed between the anchors. To treat mitral valve regurgitation,distal anchor 380 may be deployed from a catheter and expanded with an actuation force to anchor against the coronary sinus wall to provide an anchoring force of at least one pound, preferably at least two pounds, and to lockanchor 380 in an expanded configuration. A proximally directed force is applied todistal anchor 380 throughconnector 382, such as by moving the proximal anchor proximally about 1-6 cm., more preferably at least 2 cm., by pulling on a tether or control wire operated from outside the patient. The proximal anchor may then be deployed to maintain the reshaping force of the device. - As with other embodiments, one aspect of
anchor 380 is its ability to conform and adapt to a variety of vessel sizes. For example, whenanchor 380 is expanded inside a vessel such as the coronary sinus, the anchor's wire arms may contact the coronary sinus wall before theeyelets lock bump 388 to lock the anchor in place. While continued distal advancement ofeyelet 386 will create some outward force on the coronary sinus wall, much of the energy put into the anchor by the anchor actuation force will be absorbed by the deformation of the distal struts about bendingpoints 390. -
FIG. 15 shows yet another embodiment of an actuatable anchor for use in a shorter tissue shaping device.Proximal anchor 400 is disposed proximal to aconnector 402. As in other embodiments,anchor 400 is formed in a figure eight configuration from flexible wire such as nitinol held by acrimp tube 404. Aneyelet 406 is formed around alock bump 408 extending proximally fromcrimp 404. A distally directed actuation force oneyelet 406 moves it overlock bump 408 to actuate and lockanchor 400. -
FIG. 15 shows anchor 400 in an expanded configuration. Whenanchor 400 is compressed into an unexpanded configuration, bendingpoints 410 formed as loops in the anchor wire deform such that theupper arms 412 of the distal struts bend around bendingpoints 410 and move toward thelower arms 414 of the distal struts. As with the other embodiments,proximal anchor 400 may be part of a tissue shaping device (such as that shown inFIGS. 8 and 9 ) having a distal anchor and a connector disposed between the anchors. - Like other embodiments, one aspect of
anchor 400 is its ability to conform and adapt to a variety of vessel sizes. For example, whenanchor 400 is expanded inside a vessel such as the coronary sinus, the anchor's wire arms may contact the coronary sinus wall before theeyelet 406 has been advanced distally overlock bump 408 to lock the anchor in place. While continued distal advancement ofeyelet 406 will create some outward force on the coronary sinus wall, much of the energy put into the anchor by the anchor actuation force will be absorbed by the deformation of the distal struts about bendingpoints 410, which serve as expansion energy absorption elements and thereby limit the radially outward force on the coronary sinus wall. - In other embodiments, the looped bending points of the
FIG. 15 embodiment may be formed on the anchor's proximal struts in addition to or instead of on the distal struts. The looped bending point embodiment may also be used in a distal anchor, as shown inFIG. 16 (without the crimp or connector). Note that in the embodiment ofFIG. 16 the proximal and distal struts ofanchor 420 as well as theeyelet 422 and bendingpoints 424 are formed from a single wire. -
FIG. 17 shows an embodiment of adistal anchor 440 similar to that ofFIG. 10 suitable for use in a shorter tissue shaping device. In this embodiment, however,extra twists 442 are added at the apex of the anchor's figure eight pattern. As in theFIG. 10 embodiment, bendingpoints 444 are formed in the anchor's distal struts. As shown,anchor 440 is actuatable by movingeyelet 446 distally over alock bump 448 formed inconnector 450.Anchor 440 may also be made as a self-expanding anchor by limiting or eliminating movement of the proximal struts ofanchor 440 alongconnector 450, as in the embodiment shown inFIG. 11 . As with other embodiments, the bending points help anchor 440 adapt and conform to different vessel sizes. In addition, theextra twists 442 also help the anchor adapt to different vessel diameters by keeping the anchor's apex together. - As in the other embodiments,
anchor 440 is preferably formed from nitinol wire.Anchor 440 may be used as part of a tissue shaping device in a manner similar to the anchor ofFIG. 10 (for the actuatable anchor embodiment) or the anchor ofFIG. 11 (for the self-expanding anchor embodiment).Anchor 440 may also be used as a proximal anchor. -
FIG. 18 shows an embodiment of adistal anchor 460 similar to that ofFIG. 17 . In this embodiment, however, the bending points 462 are formed in the anchor's proximal struts, as in the self-expanding anchor shown inFIG. 12 . As in theFIG. 17 embodiment,extra twists 464 are added at the apex of the anchor's figure eight pattern. As shown,anchor 460 is actuatable by movingeyelet 466 distally over alock bump 468 formed inconnector 470.Anchor 460 may also be made as a self-expanding anchor by limiting or eliminating movement of the proximal connection point ofanchor 460 alongconnector 470, as in the embodiment shown inFIG. 11 . As with the embodiment ofFIG. 17 , the bending points help anchor 460 adapt and conform to different vessel sizes. In addition, theextra twists 464 also help the anchor adapt to different vessel diameters by keeping the anchor's apex together. - As in the other embodiments,
anchor 460 is preferably formed from nitinol wire.Anchor 460 may be used as part of a tissue shaping device in a manner similar to the anchor ofFIG. 10 (for the actuatable anchor embodiment) or the anchor ofFIG. 11 (for the self-expanding anchor embodiment).Anchor 460 may also be used as a proximal anchor. -
FIG. 19 shows an embodiment of a self-expandingdistal anchor 480 suitable for use in a shorter tissue shaping device. As in the other embodiments,anchor 480 is formed in a figure eight configuration from flexible wire such as nitinol held by acrimp tube 482. The base of the figure eight pattern is narrower in this embodiment, however, with the anchor's proximal struts 484 passing throughcrimp 482. -
Distal anchor 480 may be part of a tissue shaping device (such as that shown inFIGS. 8 and 9 ) having a proximal anchor and a connector disposed between the anchors. To treat mitral valve regurgitation,distal anchor 480 may be deployed from a catheter and allowed to self-expand to anchor against the coronary sinus wall to provide an anchoring force of at least one pound, preferably at least two pounds. A proximally directed force is applied todistal anchor 480 throughconnector 486, such as by moving the proximal anchor proximally about 1-6 cm., more preferably at least 2 cm., by pulling on a tether or control wire operated from outside the patient. The proximal anchor may then be deployed to maintain the reshaping force of the device. -
FIG. 20 shows an embodiment of a distal anchor suitable for use in a shorter tissue shaping device and similar to that ofFIG. 10 . In this embodiment,distal anchor 500 is disposed distal to aconnector 502. As in other embodiments,anchor 500 is formed in a figure eight configuration from flexible wire such as nitinol held by acrimp tube 504. Aneyelet 506 is formed around the longitudinal axis ofconnector 502. A distally directed actuation force oneyelet 506 moves it over alock bump 508 formed inconnector 502 to actuate and lockanchor 500. - The angle of
proximal struts 501 and the angle ofdistal struts 503 are wider than corresponding angles in theFIG. 10 embodiment, however, causinganchor 500 to distend more in width than in height when expanded, as shown. In an unexpanded configuration, such as a configuration suitable forloading anchor 500 and the rest of the tissue shaping device into a catheter for initial deployment to treat mitral valve regurgitation,eyelet 506 is disposed proximal to lockbump 508 and the figure eight loops ofanchor 500 are compressed againstcrimp 504. In order to limit theproximal distance eyelet 506 must be moved along the connector to compressanchor 500 into an unexpanded configuration, bendingpoints 510 are formed in thedistal struts 503, as in theFIG. 10 embodiment, to limit the width of the device in its unexpanded configuration within a catheter. -
Distal anchor 500 may be part of a tissue shaping device (such as that shown inFIGS. 8 and 9 ) having a proximal anchor and a connector disposed between the anchors. To treat mitral valve regurgitation,distal anchor 500 may be deployed from a catheter and expanded with an actuation force to anchor against the coronary sinus wall to provide an anchoring force of at least one pound, preferably at least two pounds, and to lockanchor 500 in an expanded configuration. A proximally directed force is applied todistal anchor 500 throughconnector 502, such as by moving the proximal anchor proximally about 1-6 cm., more preferably at least 2 cm., by pulling on a tether or control wire operated from outside the patient. The proximal anchor may then be deployed to maintain the reshaping force of the device. - The anchor shown in
FIG. 20 may be used as a proximal anchor. This anchor may also be formed as a self-expanding anchor. -
FIG. 21 shows a tandem distal anchor according to another embodiment of this invention. Self-expandinganchor 520 is formed in a figure eight configuration from flexible wire such as nitinol held by acrimp tube 522.Eyelet 524 is held in place by the distal end ofactuatable anchor 540 to limit or eliminate proximal and distal movement of the proximal struts ofanchor 520. As in the anchor shown inFIG. 11 , bendingpoints 530 are formed in the distal struts ofanchor 520. Depending upon the exact location of bendingpoints 530, very little or none of the wire portion ofanchor 520 is disposed proximal to the distal end ofanchor 540 whenanchor 520 is in its unexpanded configuration. - Likewise, if distal anchor were to be recaptured into a catheter for redeployment or removal from the patient,
anchor 520 would deform about bendingpoints 530 to limit the cross-sectional profile of the anchor within the catheter. Bending points may also be provided on the proximal anchor in a similar fashion. -
Anchor 540 is similar to anchor 120 shown inFIG. 8 .Anchor 540 is formed in a figure eight configuration from flexible wire such as nitinol held by acrimp tube 544. Aneyelet 546 is formed around the longitudinal axis ofconnector 542. A distally directed actuation force oneyelet 546 moves it over alock bump 548 formed inconnector 542 to actuate and lockanchor 540. - Tandem anchors 520 and 540 may be part of a tissue shaping device (such as that shown in
FIGS. 8 and 9 ) having a proximal anchor and a connector disposed between the anchors.Anchors distal anchors anchor 520 will then self-expand, andactuatable anchor 540 may be expanded and locked with an actuation force, to anchor both anchors against the coronary sinus wall to provide an anchoring force of at least one pound, preferably at least two pounds. A proximally directed force is applied toanchors connector 542, such as by moving the proximal anchor proximally about 1-6 cm., more preferably at least 2 cm., by pulling on a tether or control wire operated from outside the patient. The proximal anchor may then be deployed to maintain the reshaping force of the device. - While the anchor designs above were described as part of shorter tissue shaping devices, these anchors may be used in tissue shaping devices of any length.
-
FIGS. 22 and 23 show an alternative embodiment in which the device'sconnector 560 is made integral with the distal andproximal crimp tubes connector 560 is formed by cutting away a section of a blank such as a nitinol (or other suitable material such as stainless steel) cylinder or tube, leavingcrimp tube portions - Other connector shapes are possible for an integral connector and crimp design, of course. For example, the device may be formed from a blank shaped as a flat ribbon or sheet by removing rectangular edge sections from a central section, creating an I-shaped sheet (e.g., nitinol or stainless steel) having greater widths at the ends and a narrower width in the center connector portion. The ends can then be rolled to form the crimp tubes, leaving the connector substantially flat. In addition, in alternative embodiments, the connector can be made integral with just one of the anchors.
- As shown in
FIG. 23 , adistal anchor 566 is formed in a figure eight configuration from flexible wire such as nitinol.Distal anchor 566 is self-expanding, and itsproximal struts 568 are held in place bycrimp tube 562. Optional bending points may be formed in the proximal struts 568 ordistal struts 570 ofanchor 566. - A
proximal anchor 572 is also formed in a figure eight configuration from flexible wire such as nitinol with aneyelet 574 on its proximal end. A distally directed actuation force oneyelet 574 moves it over alock bump 576 extending proximally fromcrimp tube 564 to actuate and lockanchor 572.Lock bump 576 also serves as the connection point for a tether or control wire to deploy and actuate device in the manner described above with respect toFIGS. 8 and 9 . Optional bending points may be formed in the proximal or distal struts ofanchor 572. - When deployed in the coronary sinus to treat mitral valve regurgitation, the tissue shaping devices of this invention are subjected to cyclic bending and tensile loading as the patient's heart beats.
FIG. 24 shows an alternative connector for use with the tissue shaping devices of this invention that distributes over more of the device any strain caused by the beat to beat bending and tensile loading. -
Connector 600 has aproximal anchor area 602, adistal anchor area 604 and acentral area 606. The distal anchor area may be longer than the distal anchor attached to it, and the proximal anchor area may be longer than the proximal anchor attached to it. Anoptional lock bump 608 may be formed at the proximal end ofconnector 600 for use with an actuatable proximal anchor and for connecting to a tether or control wire, as described above. Anoptional bulb 610 may be formed at the distal end ofconnector 600 to prevent accidental distal slippage of a distal anchor. - In order to reduce material fatigue caused by the heartbeat to heartbeat loading and unloading of the tissue shaping device, the moment of inertia of
connector 600 varies along its length, particularly in the portion of connector disposed between the two anchors. In this embodiment, for example,connector 600 is formed as a ribbon or sheet and is preferably formed from nitinol having a rectangular cross-sectional area. The thickness ofconnector 600 is preferably constant in theproximal anchor area 602 and thedistal anchor area 604 to facilitate attachment of crimps and other components of the anchors. Thecentral area 606 has a decreasing thickness (and therefore a decreasing moment of inertia) from the border between,central area 606 andproximal anchor area 602 to a point about at the center ofcentral area 606, and an increasing thickness (and increasing moment of inertia) from that point to the border betweencentral area 606 anddistal anchor area 604. The varying thickness and varying cross-sectional shape ofconnector 600 change its moment of inertia along its length, thereby helping distribute over a wider area any strain from the heartbeat to heartbeat loading and unloading of the device and reducing the chance of fatigue failure of the connector material. -
FIG. 25 shows another embodiment of the connector. Like the previous embodiment,connector 620 has aproximal anchor area 622, adistal anchor area 624 and acentral area 626.Proximal anchor area 622 has an optional two-tined prong 628 formed at its proximal end to facilitate attachment of a crimp and other anchor elements.Bent prong portions 629 may be formed at the proximal end of the prong to prevent accidental slippage of a proximal anchor. Anoptional bulb 630 may be formed at the distal end ofconnector 620 to prevent accidental distal slippage of a distal anchor. - Like the
FIG. 24 embodiment,connector 620 is formed as a ribbon or sheet and is preferably formed from nitinol having a rectangular cross-sectional area. The thickness ofconnector 620 is preferably constant in theproximal anchor area 622 and thedistal anchor area 624 to facilitate attachment of crimps and other components of the anchors. Thecentral area 626 has a decreasing thickness (decreasing moment of inertia) from the border betweencentral area 626 andproximal anchor area 622 to a point about at the center ofcentral area 626, and an increasing thickness (increasing moment of inertia) from that point to the border betweencentral area 626 anddistal anchor area 624. The varying thickness and varying cross-sectional shape ofconnector 620 change its moment of inertia along its length, thereby helping distribute over a wider area any strain from the heartbeat to heartbeat loading and unloading of the device and reducing the chance of fatigue failure of the connector material. -
FIG. 26 shows aconnector 640 in profile.Connector 640 may be formed like theconnectors FIGS. 24 and 25 , respectively, or may have some other configuration.Connector 640 has aproximal anchor area 642, adistal anchor area 644 and acentral area 646.Connector 640 is preferably formed as a ribbon or sheet and is preferably formed from nitinol having a rectangular cross-sectional area. - In the embodiment shown in
FIG. 26 , the thicknesses ofproximal anchor area 642 anddistal anchor area 644 are constant. The thickness ofcentral area 646 decreases from the border betweencentral area 646 andproximal anchor area 642 to a point distal of that border and increases from a point proximal to the border betweendistal anchor area 644 andcentral area 646 to that border. The points in the central area where the thickness decrease ends and the thickness increase begins may be coincident or may be separated to form an area of uniform thickness withincentral area 646. In this embodiment, the thickness of the central area changes as a function of the square root of the distance from the borders between the central area and the proximal and distal anchor areas. -
FIG. 27 shows yet another embodiment of the connector. As in the embodiment ofFIG. 26 ,connector 650 may be formed like theconnectors FIGS. 24 and 25 , respectively, or may have some other configuration.Connector 650 has aproximal anchor area 652, adistal anchor area 654 and acentral area 656.Connector 650 is preferably formed as a ribbon or sheet and is preferably formed from nitinol having a rectangular cross-sectional area. - In the embodiment shown in
FIG. 27 , the thicknesses ofproximal anchor area 652 anddistal anchor area 654 are constant. The thickness of aproximal portion 658 ofcentral area 656 decreases linearly from the border betweencentral area 656 andproximal anchor area 652 to a constantthickness center portion 662 ofcentral area 656, and the thickness of adistal portion 660 ofcentral area 656 increases linearly fromcenter portion 662 to the border betweendistal anchor area 654 andcentral area 656. - In other embodiments, the thickness of the connector may vary in other ways. In addition, the cross-sectional shape of the connector may be other than rectangular and may change over the length of the connector.
-
FIGS. 28 and 29 show yet another embodiment of the invention.Tissue shaping device 700 has aconnector 706 disposed between aproximal anchor 702 and adistal anchor 704.Connector 706 may be formed as a ribbon or sheet, such as the tapered connectors shown inFIGS. 24-27 . Actuatableproximal anchor 702 is formed in a figure eight configuration from flexible wire such as nitinol and is fastened toconnector 706 with acrimp tube 708. Likewise, self-expandingdistal anchor 704 is formed in a figure eight configuration from flexible wire such as nitinol and is fastened toconnector 706 with acrimp tube 710. Aproximal lock bump 716 extends proximally fromproximal anchor 702 for use in actuating and lockingproximal anchor 702 and for connecting to a tether or control wire, as described above. - Bending points 712 are formed in the loops of
proximal anchor 702, and bendingpoints 714 are formed in the loops ofdistal anchor 704. When compressed into their unexpanded configurations for catheter-based delivery and deployment or for recapture into a catheter for redeployment or removal, the wire portions ofanchors points - In addition to different coronary sinus lengths and varying distances from the ostium to the crossover point between the coronary sinus and the circumflex artery, the diameter of the coronary sinus at the distal and proximal anchor points can vary from patient to patient. The anchors described above may be made in a variety of heights and combined with connectors of varying lengths to accommodate this patient to patient variation. For example, tissue shaping devices deployed in the coronary sinus to treat mitral valve regurgitation can 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 can be made of the appropriate length for a tissue shaping device as well as appropriate anchor heights for the distal and proximal anchors. The clinician can then select a tissue shaping device having the appropriate length and anchor sizes from a set or sets of devices with different lengths and different anchor sizes, made, e.g., according to the embodiments described above. These device sets may be aggregated into sets or kits or may simply be a collection or inventory of different tissue shaping devices.
- One way of estimating the appropriate length and anchor sizes of a tissue shaping device for mitral valve regurgitation is to view a fluoroscopic image of a coronary sinus into which a catheter with fluoroscopically viewable markings has been inserted. The crossover 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 intended anchor locations can be measured. By also measuring the screen distance of the catheter markings and comparing them to the actual distance between the catheter marking, the length and diameter measures can be scaled to actual size. A tissue shaping device with the appropriate length and anchor sizes can be selected from a set or inventory of devices for deployment in the patient to treat mitral valve regurgitation.
-
FIG. 30 shows yet another embodiment of the method of this invention. In this embodiment, atissue shaping device 800 formed from a substantially straightrigid member 802 is disposed in thecoronary sinus 804 to treat mitral valve regurgitation. When deployed as shown, the central portion ofrigid member 802 exerts a remodeling force anteriorly through the coronary sinus wall toward themitral valve 806, while the proximal anddistal ends rigid member 802 exert posteriorly-directed forces on the coronary sinus wall. According to this invention,device 800 is disposed in relation to thecircumflex artery 812 so that all of the anteriorly-directed forces fromrigid member 802 are posterior to the crossover point betweenartery 812 andcoronary sinus 804, despite the fact thatdistal end 810 ofdevice 800 and a guidewire portion 814 are distal to the crossover point. - The device of
FIG. 30 may also include a less rigid portion at thedistal end 810 ofmember 802 to further eliminate any force directed toward the mitral valve distal to the crossover point. Further details of the device (apart from the method of this invention) may be found in U.S. patent application Ser. No. 10/112,354, published as U.S. patent appl. Publ. No. 2002/0183838, the disclosure of which is incorporated herein by reference. -
FIG. 31 shows another embodiment of the method of this invention.Device 900 has a substantially straightrigid portion 902 disposed between a proximalangled portion 904 and a distalangled portion 906 withincoronary sinus 908. As shown, proximalangled portion 904 extends through thecoronary sinus ostium 910 within a catheter (not shown). Distalangled portion 906 extends distally to a hookedportion 912 that is preferably disposed in the AIV. - To treat mitral valve regurgitation, the device's
straight portion 902 reshapes the coronary sinus and adjacent tissue to apply an anteriorally directed force through the coronary sinus wall toward themitral valve 914. Due to the device's design, this reshaping force is applied solely proximal to the crossover point betweencoronary sinus 908 and the patient'scircumflex artery 916, despite the fact at least a part of the device'sdistal portion 906 and hookedportion 912 are disposed distal to the crossover point. - Other modifications to the inventions claimed below will be apparent to those skilled in the art and are intended to be encompassed by the claims.
Claims (60)
1. A method of treating regurgitation of a mitral valve in a patient's heart, the method comprising:
delivering a tissue shaping device to the coronary sinus; and
deploying the tissue shaping device to reduce mitral valve regurgitation, the deploying step comprising applying a force through the coronary sinus wall toward the mitral valve solely proximal to a crossover point where a coronary artery passes between a coronary sinus and the mitral valve.
2. The method of claim 1 further comprising determining the crossover point.
3. The method of claim 1 wherein the delivering step comprises delivering the tissue shaping device to the coronary sinus in a catheter having an outer diameter no more than ten french.
4. The method of claim 3 wherein the delivering step comprises delivering the tissue shaping device to the coronary sinus in a catheter having an outer diameter no more than nine french.
5. The method of claim 1 wherein the deploying step comprises placing a distal end of the tissue shaping device proximal to the crossover point.
6. The method of claim 1 wherein the deploying step comprises placing a distal end of the tissue shaping device distal to the crossover point.
7. The method of claim 1 wherein the tissue shaping device comprises a distal anchor, the deploying step comprising anchoring the distal anchor proximal to the crossover point.
8. The method of claim 7 wherein the anchoring step comprises expanding the distal anchor.
9. The method of claim 8 wherein the anchoring step comprises permitting the distal anchor to self-expand.
10. The method of claim 8 wherein the anchoring step comprises applying an actuation force to the distal anchor.
11. The method of claim 7 wherein the anchoring step comprises anchoring the distal anchor with an anchoring force of at least one pound.
12. The method of claim 11 wherein the anchoring step comprises anchoring the distal anchor with an anchoring force of at least two pounds.
13. The method of claim 7 wherein the deploying step further comprises applying a proximally directed force on the distal anchor.
14. The method of claim 13 wherein the step of applying a proximally directed force comprises applying a proximally directed force on the distal anchor from outside the patient.
15. The method of claim 13 wherein the tissue shaping device further comprises a proximal anchor and a connector disposed between the distal anchor and the proximal anchor, the deploying step further comprising anchoring the proximal anchor.
16. The method of claim 15 wherein the step of anchoring the proximal anchor comprises anchoring the proximal anchor in the coronary sinus.
17. The method of claim 15 wherein the step of anchoring the proximal anchor comprises anchoring the proximal anchor at least partially outside the coronary sinus.
18. The method of claim 15 wherein the step of anchoring the proximal anchor is performed after the step of applying a proximally directed force on the distal anchor.
19. The method of claim 15 wherein the applying step comprises moving the proximal anchor proximally after the step of anchoring the distal anchor.
20. The method of claim 19 wherein the step of anchoring the proximal anchor is performed after the moving step.
21. The method of claim 15 wherein the step of anchoring the proximal anchor comprises expanding the proximal anchor.
22. The method of claim 21 wherein the anchoring step comprises permitting the proximal anchor to self-expand.
23. The method of claim 21 wherein the anchoring step comprises applying an actuating force to the proximal anchor.
24. The method of claim 1 wherein the tissue shaping device comprises a distal anchor, the deploying step further comprising deploying the distal anchor from a distal end of a catheter.
25. The method of claim 24 further comprising recapturing the distal anchor into a catheter.
26. The method of claim 25 further comprising anchoring the distal anchor after recapturing the distal anchor.
27. The method of claim 1 wherein the tissue shaping device comprises a proximal anchor, the deploying step further comprising deploying the proximal anchor from a distal end of a catheter.
28. The method of claim 27 further comprising recapturing the proximal anchor into a catheter.
29. The method of claim 28 further comprising anchoring the proximal anchor after recapturing the proximal anchor.
30. The method of claim 1 wherein the delivering step comprises delivering the tissue shaping device to the coronary sinus in a catheter, the deploying step further comprising deploying the tissue shaping device from a distal end of the catheter, the method further comprising recapturing the tissue shaping device into a catheter.
31. The method of claim 1 further comprising selecting the tissue shaping device from a set of tissue shaping devices comprising tissue shaping devices of a plurality of lengths prior to the delivering step.
32. The method of claim 1 wherein the tissue shaping device comprises an anchor, the method further comprising selecting the tissue shaping device from a set of tissue shaping devices comprising tissue shaping devices of a plurality of anchor sizes prior to the delivering step.
33. A set of devices for use in treating mitral valve regurgitation, the set comprising:
a plurality of tissue shaping devices having different lengths, each of the tissue shaping devices being configured to be deliverable to a coronary sinus of a patient within a catheter having an outer diameter no greater than ten french.
34. The set of claim 33 further comprising a catheter having an outer diameter no greater than nine french.
35. The set of claim 33 wherein the tissue shaping devices each comprise an anchor having an unexpanded configuration and an expanded configuration, each tissue shaping device being further configured to be deliverable to a coronary sinus of a patient within a catheter having an outer diameter no greater than ten french when its distal anchor is in its unexpanded configuration.
36. The set of claim 33 wherein the tissue shaping devices in the set each comprise:
a proximal anchor having an unexpanded configuration and an expanded configuration;
a distal anchor having an unexpanded configuration and an expanded configuration; and
a connector disposed between the proximal anchor and the distal anchor,
each tissue shaping device being further configured to be deliverable to a coronary sinus of a patient within a catheter having an outer diameter no greater than ten french when its proximal anchor and distal anchor are in their unexpanded configurations.
37. The set of claim 36 wherein at least one tissue shaping device in the set has a length 60 mm or less and at least one tissue shaping device in the set has a length more than 60 mm.
38. The set of claim 36 wherein the distal anchor of each tissue shaping device in the set has a diameter in its expanded configuration equal to or greater than a coronary sinus diameter at a distal anchor location.
39. The set of claim 38 wherein 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.
40. The set of claim 36 wherein the proximal anchor of each tissue shaping device in the set has a diameter in its expanded configuration equal to or greater than a coronary sinus diameter at a proximal anchor location.
41. The set of claim 40 wherein the diameters of the proximal anchors of the tissue shaping devices in the set in their expanded configurations range from about 9 mm. to about 20 mm.
42. The set of claim 36 wherein the distal anchor of each tissue shaping device in the set comprises a self-expanding anchor.
43. The set of claim 36 wherein the proximal anchor of each tissue shaping device in the set comprises a self-expanding anchor.
44. The set of claim 36 wherein the distal anchor of each tissue shaping device in the set comprises an actuatable anchor.
45. The set of claim 36 wherein the proximal anchor of each tissue shaping device in the set comprises an actuatable anchor.
46. The set of claim 36 wherein the distal anchor of at least one tissue shaping device in the set comprises a self-expanding anchor and the distal anchor of at least one tissue shaping device in the set comprises an actuatable anchor.
47. The set of claim 36 wherein the proximal anchor of at least one tissue shaping device in the set comprises a self-expanding anchor and the proximal anchor of at least one tissue shaping device in the set comprises an actuatable anchor.
48. The set of claim 33 wherein each of the tissue shaping devices is configured to be deliverable to a coronary sinus of a patient within a catheter having an outer diameter no greater than nine french.
49. A set of devices for use in treating mitral valve regurgitation, the set comprising:
a plurality of tissue shaping devices each comprising an anchor having an unexpanded configuration and an expanded configuration, the anchors having different diameters when in their expanded configurations, each of the tissue shaping devices being configured to be deliverable to a coronary sinus of a patient within a catheter having an outer diameter no greater than ten french.
50. The set of claim 49 wherein the anchor of each device is a distal anchor, the devices each further comprising a proximal anchor having an unexpanded configuration and an expanded configuration, the proximal anchors having different diameters when in their expanded configurations.
51. The set of claim 50 wherein 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.
52. The set of claim 50 wherein the diameters of the proximal anchors of the tissue shaping devices in the set in their expanded configurations range from about 9 mm. to about 20 mm.
53. The set of claim 52 wherein the distal anchor of each tissue shaping device in the set comprises a self-expanding anchor.
54. The set of claim 52 wherein the proximal anchor of each tissue shaping device in the set comprises a self-expanding anchor.
55. The set of claim 52 wherein the distal anchor of each tissue shaping device in the set comprises an actuatable anchor.
56. The set of claim 52 wherein the proximal anchor of each tissue shaping device in the set comprises an actuatable anchor.
57. The set of claim 52 wherein the distal anchor of at least one tissue shaping device in the set comprises a self-expanding anchor and the distal anchor of at least one tissue shaping device in the set comprises an actuatable anchor.
58. The set of claim 52 wherein the proximal anchor of at least one tissue shaping device in the set comprises a self-expanding anchor and the proximal anchor of at least one tissue shaping device in the set comprises an actuatable anchor.
59. The set of claim 49 further comprising a catheter having an outer diameter no greater than ten french.
60. The set of claim 49 wherein each of the tissue shaping devices is configured to be deliverable to a coronary sinus of a patient within a catheter having an outer diameter no greater than nine french.
Priority Applications (12)
Application Number | Priority Date | Filing Date | Title |
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US10/742,747 US20050027351A1 (en) | 2001-05-14 | 2003-12-19 | Mitral valve regurgitation treatment device and method |
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US7270676B2 (en) | 2007-09-18 |
US20050033419A1 (en) | 2005-02-10 |
EP1395202A4 (en) | 2006-06-21 |
WO2002100240A2 (en) | 2002-12-19 |
US20050038507A1 (en) | 2005-02-17 |
WO2002100240A3 (en) | 2003-12-04 |
CA2447689A1 (en) | 2002-12-19 |
DE60227514D1 (en) | 2008-08-21 |
JP4255374B2 (en) | 2009-04-15 |
ES2310210T3 (en) | 2009-01-01 |
US20020169504A1 (en) | 2002-11-14 |
EP1395202B1 (en) | 2008-07-09 |
CA2447689C (en) | 2009-07-21 |
US7828843B2 (en) | 2010-11-09 |
US20050027353A1 (en) | 2005-02-03 |
EP1395202A2 (en) | 2004-03-10 |
US6800090B2 (en) | 2004-10-05 |
ATE400235T1 (en) | 2008-07-15 |
JP2004530484A (en) | 2004-10-07 |
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