Devices and methods provide enhanced treatment of a cardiac valve annulus. Methods generally involve contacting an anchor delivery device with the valve annulus and releasing a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus. Anchors, which in some e
Devices and methods provide enhanced treatment of a cardiac valve annulus. Methods generally involve contacting an anchor delivery device with the valve annulus and releasing a plurality of coupled anchors from the anchor delivery device to secure the anchors to the annulus. Anchors, which in some embodiments are super-elastic or shape memory self-securing anchors, are then drawn together to tighten the annulus. Devices generally include an elongate catheter having a housing at or near the distal end for releasably housing a plurality of coupled anchors. The housing may be flexible, may conform to a valve annulus, and in some embodiments may be coupled with an expandable member to enhance contact of the housing with annular tissue. In one embodiment, self-securing anchors lie approximately flat within the delivery device housing, allowing anchors with relatively large deployed shapes to be housed in and deployed from a relatively narrow delivery device.
대표청구항▼
1. A method of constricting tissue in a heart, the method comprising: advancing an operational device such that a distal end of the operational device is entirely within a ventricle to contact a length of tissue at an intersection of an interior side of a ventricular wall and an underside of a valve
1. A method of constricting tissue in a heart, the method comprising: advancing an operational device such that a distal end of the operational device is entirely within a ventricle to contact a length of tissue at an intersection of an interior side of a ventricular wall and an underside of a valve leaflet, wherein the operational device comprises a lumen and a plurality of apertures in communication with the lumen for delivering a plurality of anchors therethrough,wherein contacting the length of tissue comprises simultaneously positioning the plurality of coupled anchors along the length of the tissue;delivering the simultaneously positioned plurality of coupled anchors from the lumen of device through the plurality of apertures to secure the anchors to the tissue; anddrawing the anchors together to constrict the tissue. 2. A method as in claim 1, wherein contacting, delivering and drawing are performed on a tricuspid valve annulus of the heart. 3. A method as in claim 1, wherein contacting, delivering and drawing are performed as part of an open heart surgical procedure. 4. A method as in claim 1, wherein advancing, delivering and drawing are performed without stopping the heart. 5. A method as in claim 1, wherein advancing, delivering and drawing are performed through one or more minimally invasive incisions. 6. A method as in claim 1, wherein delivering the plurality of anchors comprises crimping the anchors to secure them to the valve annulus. 7. A method as in claim 1, wherein delivering the plurality of anchors comprises driving the anchors out of the operational device using at least one expandable member disposed within the operational device. 8. A method as in claim 1, further comprising: contacting a stabilizing member with the valve annulus on a side of the valve opposite the operational device; andapplying force to the stabilizing member to immobilize the annulus between the stabilizing member and the anchor delivery device to facilitate delivery of the anchors. 9. A method as in claim 1, wherein drawing the anchors together comprises allowing a self-deforming coupling member coupled with the anchors to deform to constrict the tissue. 10. A method as in claim 1, further comprising stabilizing the tissue with the anchor delivery device prior to delivering the anchors. 11. A method as in claim 1, wherein delivering the plurality of anchors from the operational device acts to secure at least one heart valve prosthesis to the tissue. 12. A method as in claim 1, wherein the method is performed on annular tissue of a mitral valve. 13. A method as in claim 12, wherein the operational device is contacted with the length of the annular tissue from within a left ventricle of the heart. 14. A method as in claim 12, wherein the anchor delivery device is contacted with the mitral valve annulus from within a left atrium of the heart. 15. A method as in claim 1, wherein advancing, delivering and drawing are performed via intravascular access to the heart. 16. A method as in claim 15, wherein the tissue is annular tissue of a mitral valve, the method further comprising advancing the operational device through an aorta and into a left ventricle of the heart. 17. A method as in claim 15, wherein the tissue is a mitral valve annulus, the method further comprising advancing the operational device through a central vein and into a right atrium of the heart, across an interatrial septum, and into a left ventricle of the heart to contact a length of the mitral valve annulus on an inferior side of an intersection of a left ventricular wall and at least one mitral valve leaflet of the heart. 18. A method as in claim 15, wherein the tissue is a mitral valve annulus, the method further comprising advancing the operational device into a coronary sinus of the heart to contact a length of the mitral valve annulus through the coronary sinus. 19. A method as in claim 1, further comprising deforming a flexible distal portion of the operational device to conform the distal portion to the length of tissue prior to contacting the anchor delivery device with the tissue. 20. A method as in claim 19, further comprising advancing the flexible distal portion within a space between a left ventricular wall, at least one mitral valve leaflet and at least one chordae tendineae of the heart. 21. A method as in claim 20, further comprising expanding an expandable member coupled with the flexible distal portion to urge the flexible distal portion against an intersection of the left ventricular wall and the at least one mitral valve leaflet. 22. A method as in claim 19, wherein deforming the flexible distal portion comprises expanding a shaped expandable member to deform the distal portion. 23. A method as in claim 19, wherein deforming the flexible distal portion comprises articulating the distal portion in at least two directions. 24. A method as in claim 19, wherein deforming the flexible distal portion comprises applying tension to at least a first tensioning cord to cause a first bend in the distal portion. 25. A method as in claim 24, wherein deforming the flexible distal portion further comprises applying tension to at least a second tensioning cord to cause a second bend in the distal portion. 26. A method as in claim 25, wherein the first bend comprises approximately a C-shaped bend to conform the distal portion to the annulus, and the second bend comprises an upwardly directed bend. 27. A method as in claim 19, wherein deforming the flexible distal portion comprises introducing a fluid into a shape-memory distal portion. 28. A method as in claim 19, further comprising locking the shape of the flexible distal portion. 29. A method as in claim 1, wherein delivering the plurality of anchors comprises releasing the anchors to allow them to change from an undeployed shape to a deployed shape to secure to the tissue. 30. A method as in claim 29, wherein the anchors are constrained in their undeployed shape and elastically expand to their deployed shape when released from constraint. 31. A method as in claim 30, wherein the deployed shape of each of the plurality of anchors has a radius of at least about 3 mm, and wherein the operational device has a cross-sectional diameter of about 1.67 mm or less. 32. A method as in claim 30, wherein releasing the plurality of coupled anchors from constraint comprises applying force to each of the anchors with an anchor contacting member, wherein the applied force causes each anchor to exit the operational device through each of the plurality of apertures. 33. A method as in claim 32, wherein the force is applied sequentially to the anchors by the anchor contacting member to cause the anchors to exit the operational device sequentially. 34. A method as in claim 32, wherein applying force to each of the anchors comprises retracting the anchor contacting member proximally relative to the operational device. 35. A method as in claim 32, wherein each anchor comprises two arms with sharpened tips, and wherein the arms curve in opposite directions when each anchor is released from the operational device. 36. A method as in claim 30, wherein the anchors are released from the operational device simultaneously. 37. A method as in claim 30, wherein releasing the plurality of coupled anchors from constraint comprises retracting at least one anchor retaining mandrel of the operational device. 38. A method as in claim 37, wherein retracting the at least one mandrel comprises retracting two mandrels, each mandrel positioned to retain an arm of each anchor. 39. A method as in claim 38, wherein each anchor has an opened arcuate undeployed shape and assumes a closed shape with overlapping ends after release from constraint. 40. A method as in claim 39, wherein the undeployed shape is approximately a C-shape or semicircle having two sharpened ends, and the deployed shape is a closed circle in which the two ends overlap, wherein upon release from the operational device the anchors secure to the annulus by penetrating the annulus with the ends and subsequently assuming the closed circle shape. 41. A method as in claim 1, wherein drawing the anchors together comprises cinching a tether coupled with the anchors. 42. A method as in claim 41, wherein cinching the tether comprises applying tensile force to a tether disposed between each of the plurality of anchors and the tissue. 43. A method as in claim 41, wherein cinching the tether comprises applying tensile force to a tether extending through at least one eyelet on each of the plurality of anchors. 44. A method as in claim 41, further comprising: securing the tether to at least a terminal anchor of the plurality of anchors; and cutting the tether to leave the cinched anchors secured to the tissue. 45. A method as in claim 44, wherein securing the tether comprises attaching a nitinol knot on the tether to at least the terminal anchor. 46. A method as in claim 44, wherein the cinching, securing and cutting steps are performed using a termination catheter advanced over the tether to a location adjacent the coupled anchors. 47. A method as in claim 41, wherein the anchors are further drawn together by a self-deforming coupling member coupled with the anchors. 48. A method as in claim 47, wherein the coupling member is coupled with the tether. 49. A method as in claim 1, wherein the advancing, delivering and drawing steps cause a first length of the tissue to be constricted, the method further comprising: contacting the device with a second length of tissue; delivering a plurality of coupled anchors from the device to secure the anchors to the second length of tissue; anddrawing the anchors together to circumferentially constrict the second length of tissue. 50. A method as in claim 49, wherein the first length of tissue comprises an anterior length and the second length of tissue comprises a posterior length. 51. A method as in claim 1, further comprising visualizing the tissue. 52. A method as in claim 51, wherein visualizing is performed using a visualization device selected from the group consisting of an ultrasound device, an angioscopic device, a transesophageal echocardiogram device and a fluoroscopic device. 53. A method as in claim 52, wherein the ultrasound device comprises a gel-containing cone for enhancing ultrasound visualization. 54. A method as in claim 53, wherein visualizing comprises using a real-time ultrasound device to visualize a regurgitant flow across the heart valve during at least the drawing step. 55. A method as in claim 51, wherein drawing the anchors together comprises cinching a tether slidably coupled with the anchors, the method further comprising: visualizing a reduction in the regurgitant flow during the cinching step; and selecting an amount of cinching based on the reduction in the regurgitant flow. 56. A method as in claim 51, wherein the at least one visualization device is coupled with the operational device. 57. A method as in claim 56, wherein the at least one visualization device comprises an angioscope having a viewing end within or adjacent to a lens, bubble or inflatable balloon which displaces blood to permit viewing in the beating heart.
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