Source: http://www.google.com/patents/US20040243227?dq=5359317
Timestamp: 2017-08-19 12:09:19
Document Index: 616959661

Matched Legal Cases: ['art.\n3', 'art.\n17', 'art.\n18', 'art.\n20', 'art.\n21', 'art.\n41', 'art.\n54', 'art.\n55', 'art.\n57', 'art.\n58', 'art.\n89', 'art.\n106', 'art.\n114']

Patent US20040243227 - Delivery devices and methods for heart valve repair - Google Patents
Devices, systems and methods facilitate positioning of a cardiac valve annulus treatment device, thus enhancing treatment of the annulus. Methods generally involve advancing an anchor delivery device through vasculature of the patient to a location in the heart for treating the valve annulus, contacting...http://www.google.com/patents/US20040243227?utm_source=gb-gplus-sharePatent US20040243227 - Delivery devices and methods for heart valve repair
Publication number US20040243227 A1
Application number US 10/792,681
Publication number 10792681, 792681, US 2004/0243227 A1, US 2004/243227 A1, US 20040243227 A1, US 20040243227A1, US 2004243227 A1, US 2004243227A1, US-A1-20040243227, US-A1-2004243227, US2004/0243227A1, US2004/243227A1, US20040243227 A1, US20040243227A1, US2004243227 A1, US2004243227A1
Inventors Niel Starksen, John To, Rodolfo Morales
Patent Citations (98), Referenced by (248), Classifications (25), Legal Events (1)
US 20040243227 A1
1. A method for advancing one or more devices into a left ventricle of a heart to contact a mitral valve annulus, the method comprising:
advancing a steerable guide catheter into the left ventricle and around at least a portion of the mitral valve annulus;
passing a guide sheath over the steerable guide catheter;
withdrawing the steerable guide catheter out of the guide sheath; and
advancing one or more devices through the guide sheath to contact the mitral valve annulus.
2. A method as in claim 1, wherein the steerable guide catheter is advanced through an aorta into a space in the left ventricle formed by a left ventricular wall, at least one mitral valve leaflet and chordae tendiniae of the heart.
3. A method as in claim 2, further comprising deforming a flexible distal portion of the steerable guide catheter to conform the distal portion to the mitral valve annulus.
4. A method as in claim 3, wherein deforming the flexible distal portion comprises applying tension to at least one tensioning member to cause at least one bend in the distal portion.
5. A method as in claim 4, further comprising, before advancing the steerable guide catheter, advancing a shaped guide catheter through the aorta to a position within or adjacent the space in the left ventricle, wherein the steerable guide catheter is advanced through the shaped guide catheter.
6. A method as in claim 5, wherein deforming the flexible distal portion further comprises passing the distal portion through at least one bend in the shaped guide catheter.
7. A method as in claim 6, wherein passing the distal portion through the at least one bend in the shaped guide catheter comprises:
passing the portion through a first bend to direct it approximately into a plane with a plane of the mitral valve annulus; and
passing the portion through a second bend approximately perpendicular to the first bend and having a radius of curvature approximately the same as a radius of curvature of the mitral valve annulus.
8. A method as in claim 7, wherein applying tension to the at least one tensioning member causes the flexible distal portion to continue to bend in an arc with a radius of curvature approximately the same as the radius of curvature of the mitral valve annulus.
9. A method as in claim 4, wherein tension is applied to two tensioning members to articulate the flexible distal portion in at least two directions.
10. A method as in claim 3, wherein deforming the flexible distal portion comprises expanding a shaped expandable member to deform the distal portion.
11. A method as in claim 3, wherein deforming the flexible distal portion comprises introducing a fluid into a lumen of the distal portion.
12. A method as in claim 3, wherein deforming the flexible distal portion comprises releasing a shape-memory material from constraint.
13. A method as in claim 3, wherein deforming the flexible distal portion comprises articulating the distal portion in at least two directions.
14. A method as in claim 3, further comprising locking the shape of the flexible distal portion.
15. A method as in claim 3, further comprising urging the steerable guide catheter against the mitral valve annulus.
16. A method as in claim 15, wherein urging the steerable guide catheter comprises expanding an expandable member coupled with the steerable guide catheter within a space in the left ventricle formed by a left ventricular wall, at least one mitral valve leaflet and chordae tendiniae of the heart.
17. A method as in claim 15, wherein urging the steerable guide catheter comprises applying an attractive magnetic force between a first magnetic member coupled with the steerable guide catheter and a second magnetic member disposed within a coronary sinus of the heart.
18. A method as in claim 1, further comprising urging the guide sheath against the mitral valve annulus.
19. A method as in claim 18, wherein urging the guide sheath comprises expanding an expandable member coupled with the guide sheath within a space in the left ventricle formed by a left ventricular wall, at least one mitral valve leaflet and chordae tendiniae of the heart.
20. A method as in claim 18, wherein urging the guide sheath comprises applying an attractive magnetic force between a first magnetic member coupled with the guide sheath and a second magnetic member disposed within a coronary sinus of the heart.
21. A method as in claim 1, wherein a delivery device is advanced through the guide sheath for contacting and delivering a therapy to the mitral valve annulus.
22. A method as in claim 21, wherein the delivery device comprises a device for delivering coupled anchors to the mitral valve annulus, the method further comprising:
delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the mitral valve annulus; and
drawing the anchors together to circumferentially tighten the annulus.
23. A method as in claim 22, further comprising expanding an expandable member coupled with the anchor delivery device to urge the delivery device against the length of valve annulus.
24. A method as in claim 22, further comprising applying an attractive magnetic force between a first magnetic member coupled with the delivery device and a second magnetic member disposed within a coronary sinus of the heart to urge the delivery device against the length of valve annulus.
25. A method as in claim 22, wherein the anchors are delivered from the anchor delivery device through a distal portion of the guide sheath to attach the distal portion to the mitral valve annulus, wherein the distal portion of the guide sheath is detachable from a proximal portion of the guide sheath to remain attached to the annulus.
26. A method as in claim 25, further comprising cinching the attached distal portion of the guide sheath to circumferentially tighten the valve annulus.
27. A method as in claim 22, wherein the anchors are delivered from the anchor delivery device through a detachable, biocompatible strip coupled with the anchor delivery device to attach the strip to the mitral valve annulus.
28. A method as in claim 27, further comprising cinching the attached strip to circumferentially tighten the valve annulus.
29. A method as in claim 22, further comprising:
30. A method as in claim 22, further comprising stabilizing the annulus with the anchor delivery device prior to delivering the anchors.
31. A method as in claim 30, wherein stabilizing the annulus with the anchor delivery device comprises expanding an expandable member coupled with the anchor delivery device to move the delivery device into enhanced contact with the valve annulus and stabilize the annulus.
32. A method as in claim 22, wherein the delivering and drawing steps cause a first length of the valve annulus to be tightened, the method further comprising:
33. A method as in claim 21, further comprising delivering energy from the delivery device to tighten the valve annulus.
34. A method as in claim 33, wherein delivering energy comprises delivering a form of energy selected from the group consisting of radio frequency, ultrasound, microwave and laser energy.
35. A method as in claim 21, further comprising delivering at least one pharmacological agent from the delivery device to tighten the valve annulus.
36. A method as in claim 1, wherein a visualization device is advanced through the guide sheath for enhancing visualization of the mitral valve annulus.
37. A method as in claim 36, wherein the visualization device is selected from the group consisting of an ultrasound device, a camera, an endoscope and a fiber optic device.
38. A method as in claim 1, wherein all steps are performed while the heart is beating.
39. A method for advancing one or more devices into a left ventricle of a heart to contact a mitral valve annulus, the method comprising:
advancing a shaped guide catheter through an aorta into the left ventricle;
passing a steerable guide catheter through the shaped guide catheter and around at least a portion of the length of the mitral valve annulus;
passing a guide sheath over the steerable guide catheter, within the shaped guide catheter;
40. A method as in claim 39, wherein the steerable guide catheter is advanced into a space in the left ventricle formed by a left ventricular wall, at least one mitral valve leaflet and chordae tendiniae of the heart.
41. A method as in claim 39, further comprising deforming a flexible distal portion of the steerable guide catheter to conform the distal portion to the mitral valve annulus.
42. A method as in claim 41, wherein deforming the flexible distal portion comprises applying tension to at least one tensioning member to cause at least one bend in the distal portion.
43. A method as in claim 42, wherein deforming the flexible distal portion further comprises passing the distal portion through at least one bend in the shaped guide catheter.
44. A method as in claim 43, wherein passing the distal portion through the at least one bend in the shaped guide catheter comprises:
45. A method as in claim 44, wherein applying tension to the at least one tensioning member causes the flexible distal portion to continue to bend in an arc with a radius of curvature approximately the same as the radius of curvature of the mitral valve annulus.
46. A method as in claim 42, wherein tension is applied to two tensioning members to articulate the flexible distal portion in at least two directions.
47. A method as in claim 41, wherein deforming the flexible distal portion comprises expanding a shaped expandable member to deform the distal portion.
48. A method as in claim 41, wherein deforming the flexible distal portion comprises introducing a fluid into a lumen of the distal portion.
49. A method as in claim 41, wherein deforming the flexible distal portion comprises releasing a shape-memory material from constraint.
50. A method as in claim 41, wherein deforming the flexible distal portion comprises articulating the distal portion in at least two directions.
51. A method as in claim 41, further comprising locking the shape of the flexible distal portion.
52. A method as in claim 41, further comprising urging the steerable guide catheter against the mitral valve annulus.
53. A method as in claim 52, wherein urging the steerable guide catheter comprises expanding an expandable member coupled with the steerable guide catheter within a space in the left ventricle formed by a left ventricular wall, at least one mitral valve leaflet and chordae tendiniae of the heart.
54. A method as in claim 52, wherein urging the steerable guide catheter comprises applying an attractive magnetic force between a first magnetic member coupled with the steerable guide catheter and a second magnetic member disposed within a coronary sinus of the heart.
55. A method as in claim 39, further comprising urging the guide sheath against the mitral valve annulus.
56. A method as in claim 55, wherein urging the guide sheath comprises expanding an expandable member coupled with the guide sheath within a space in the left ventricle formed by a left ventricular wall, at least one mitral valve leaflet and chordae tendiniae of the heart.
57. A method as in claim 55, wherein urging the guide sheath comprises applying an attractive magnetic force between a first magnetic member coupled with the guide sheath and a second magnetic member disposed within a coronary sinus of the heart.
58. A method as in claim 39, wherein a delivery device is advanced through the guide sheath for contacting and delivering a therapy to the mitral valve annulus.
59. A method as in claim 58, wherein the delivery device comprises a device for delivering coupled anchors to the mitral valve annulus, the method further comprising:
60. A method as in claim 59, further comprising expanding an expandable member coupled with the anchor delivery device to urge the delivery device against the length of valve annulus.
61. A method as in claim 59, further comprising applying an attractive magnetic force between a first magnetic member coupled with the delivery device and a second magnetic member disposed within a coronary sinus of the heart to urge the delivery device against the length of valve annulus.
62. A method as in claim 59, wherein the anchors are delivered from the anchor delivery device through a distal portion of the guide sheath to attach the distal portion to the mitral valve annulus, wherein the distal portion of the guide sheath is detachable from a proximal portion of the guide sheath to remain attached to the annulus.
63. A method as in claim 62, further comprising cinching the attached distal portion of the guide sheath to circumferentially tighten the valve annulus.
64. A method as in claim 59, wherein the anchors are delivered from the anchor delivery device through a detachable, biocompatible strip coupled with the anchor delivery device to attach the strip to the mitral valve annulus.
65. A method as in claim 64, further comprising cinching the attached strip to circumferentially tighten the valve annulus.
67. A method as in claim 59, further comprising stabilizing the annulus with the anchor delivery device prior to delivering the anchors.
68. A method as in claim 59, wherein the delivering and drawing steps cause a first length of the valve annulus to be tightened, the method further comprising:
69. A method as in claim 58, further comprising delivering energy from the delivery device to tighten the valve annulus.
70. A method as in claim 69, wherein delivering energy comprises delivering a form of energy selected from the group consisting of radio frequency, ultrasound, microwave and laser energy.
71. A method as in claim 58, further comprising delivering at least one pharmacological agent from the delivery device to tighten the valve annulus.
72. A method as in claim 39, wherein a visualization device is advanced through the guide sheath for enhancing visualization of the mitral valve annulus.
73. A method as in claim 72, wherein the visualization device is selected from the group consisting of an ultrasound device, a camera, an endoscope and a fiber optic device.
74. A method as in claim 39, wherein all steps are performed while the heart is beating.
75. A method for treating a mitral valve annulus of a heart, the method comprising:
advancing a steerable guide catheter into a left ventricle of the heart and around at least a portion of the mitral valve annulus;
withdrawing the steerable guide catheter out of the guide sheath;
advancing an anchor delivery device through the guide sheath to contact the mitral valve annulus;
76. A method as in claim 75, further comprising, before advancing the steerable guide catheter, advancing a shaped guide catheter through the aorta to a position within or adjacent the space in the left ventricle, wherein the steerable guide catheter is advanced through the shaped guide catheter.
77. A device for facilitating placement of one or more devices in contact with a heart valve annulus, the device comprising:
an elongate catheter body having a proximal portion and a distal portion;
at least one tensioning member coupled with the proximal portion of the catheter body and extending to the distal portion; and
at least one tensioning actuator coupled with the proximal portion and the tensioning member for applying tension to the tensioning member to deform the distal portion to allow it to conform generally to a shape of the valve annulus.
78. A device as in claim 77, wherein the catheter body may be advanced intravascularly to the heart to contact the annulus.
79. A device as in claim 78, wherein the catheter body may be advanced through an aorta and into a left ventricle of the heart to contact the valve annulus.
80. A device as in claim 78, wherein the proximal portion of the catheter body is relatively stiff compared to the distal portion.
81. A device as in claim 78, wherein the catheter body further comprises a rounded, atraumatic distal tip.
82. A device as in claim 81, wherein the catheter body further comprises at least one radiopaque portion at or near the distal tip for enhancing visualization.
83. A device as in claim 77, wherein the catheter body further comprises at least one lumen extending through the proximal and distal portions for passing one or more fluids.
84. A device as in claim 77, wherein the at least one tensioning member comprises two tensioning members, allowing the distal portion to be deformed in at least two different directions.
85. A device as in claim 77, wherein the at least one tensioning member comprises at least one tensioning cord comprising a material selected from the group consisting of Nitinol, polyester, nylon, polypropylene and other polymers.
86. A device as in claim 77, wherein the at least one tensioning actuator comprises a knob coupled with the tensioning member, wherein turning the knob in one direction applies tension to the tensioning member to deform the distal portion, and wherein turning the knob in an opposite direction releases tension from the tensioning member to return to the distal portion to a less deformed configuration.
87. A device as in claim 77, further comprising at least one urging member coupled with the distal portion of the catheter body for urging the distal portion into contact with the valve annulus.
88. A device as in claim 87, wherein the at least one urging member comprises an expandable member for expanding within a space in a left ventricle formed by a left ventricular wall, at least one mitral valve leaflet and chordae tendiniae of the heart.
89. A device as in claim 87, wherein the at least one urging member comprises at least one magnet coupled with the distal portion for applying attractive magnetic force between itself and an oppositely charged magnet disposed in a coronary sinus adjacent the valve annulus.
90. A device as in claim 77, further comprising a housing coupled with the proximal end, wherein the tensioning actuator is coupled with the housing.
91. A device as in claim 90, wherein the housing further comprises at least one fluid inlet port in fluid communication with at least one lumen in the elongate shaft for introducing one or more fluids into the lumen(s).
92. A system for facilitating placement of one or more devices in contact with a heart valve annulus, the system comprising:
a shaped guide catheter having at least one curve toward a distal end for positioning the distal end in a position below the mitral valve;
a steerable guide catheter passable through the shaped guide catheter and having a steerable distal end for advancing around a length of the valve annulus below the mitral valve; and
a guide sheath passable over the steerable guide catheter through the shaped guide catheter, wherein the one or more devices are passable through the guide sheath to contact the mitral valve annulus.
93. A system as in claim 92, wherein the at least one curve of the shaped guide catheter comprises:
a proximal curve approximately perpendicular to a central axis of the shaped guide catheter for bringing the distal end of the catheter into a plane approximately parallel with a plane of the mitral valve; and
a distal curve having a radius of curvature approximately the same as a radius of curvature of the mitral valve annulus.
94. A system as in claim 92, wherein the steerable guide catheter comprises:
95. A system as in claim 94, wherein the catheter body may be advanced intravascularly to the heart to contact the annulus.
96. A system as in claim 95, wherein the catheter body may be advanced through an aorta and into a left ventricle of the heart to contact the valve annulus.
97. A system as in claim 95, wherein the proximal portion of the catheter body is stiffer than the distal portion.
98. A system as in claim 95, wherein the catheter body further comprises a rounded, atraumatic distal tip.
99. A system as in claim 98, wherein the catheter body further comprises at least one radiopaque portion at or near the distal tip for enhancing visualization.
100. A system as in claim 94, wherein the catheter body further comprises at least one lumen extending through the proximal and distal portions for passing one or more fluids.
101. A system as in claim 94, wherein the at least one tensioning member comprises two tensioning members, allowing the distal portion to be deformed in at least two different directions.
102. A system as in claim 94, wherein the at least one tensioning member comprises at least one tensioning cord comprising a material selected from the group consisting of Nitinol, polyester, nylon, polypropylene and other polymers.
103. A system as in claim 94, wherein the at least one tensioning actuator comprises a knob coupled with the tensioning member, wherein turning the knob in one direction applies tension to the tensioning member to deform the distal portion, and wherein turning the knob in an opposite direction releases tension from the tensioning member to return to the distal portion to a less deformed configuration.
104. A system as in claim 94, further comprising at least one urging member coupled with the distal portion of the catheter for urging the distal portion into contact with the valve annulus.
105. A system as in claim 104, wherein the at least one urging member comprises an expandable member for expanding within a space in a left ventricle formed by a left ventricular wall, at least one mitral valve leaflet and chordae tendiniae of the heart.
106. A system as in claim 104, wherein the at least one urging member comprises at least one magnet coupled with the distal portion for applying attractive magnetic force between itself and an oppositely charged magnet disposed in a coronary sinus adjacent the valve annulus.
107. A system as in claim 94, further comprising a housing coupled with the proximal end, wherein the tensioning actuator is coupled with the housing.
108. A system as in claim 107, wherein the housing further comprises at least one fluid inlet port in fluid communication with at least one lumen in the elongate shaft for introducing one or more fluids into the lumen(s).
109. A system as in claim 92, wherein a distal portion of the guide sheath is detachable from a proximal portion of the guide sheath to remain in attached to the valve annulus after an annulus treatment procedure.
110. A system as in claim 109, wherein the detachable distal portion comprises a tubular member comprising Dacron.
111. A system as in claim 109, wherein the detachable distal portion is cinchable to tighten the mitral valve annulus.
112. A system as in claim 92, further comprising at least one urging member coupled with at least one of the shaped guide catheter, the steerable guide catheter and the guide sheath.
113. A device as in claim 112, wherein the at least one urging member comprises an expandable member for expanding within a space in a left ventricle formed by a left ventricular wall, at least one mitral valve leaflet and chordae tendiniae of the heart.
114. A device as in claim 112, wherein the at least one urging member comprises at least one magnet coupled with at least one of the shaped guide catheter, the steerable guide catheter and the guide sheath for applying attractive magnetic force between itself and an oppositely charged magnet disposed in a coronary sinus adjacent the valve annulus.
115. A system as in claim 92, further comprising an anchor delivery device passable through the guide sheath contact and apply coupled anchors to the mitral valve annulus.
116. A system as in claim 92, further comprising a visualization device passable through the sheath guide to facilitate visualization of the mitral valve annulus.
117. A system as in claim 116, wherein the visualization device is selected from the group consisting of an ultrsound device, a camera, an endoscope and a fiber optic device.
The present application is a Continuation-in-Part of U.S. patent application Ser. No. 10/741,130 (Attorney Docket No. 016886-001320), filed on Dec. 19, 2003, which is a Continuation-in-Part of U.S. patent application Ser. Nos. 10/656,797 (Attorney Docket No. 16886-001300), filed on Sep. 4, 2003, and 10/461,043 (Attorney Docket No. 16886-000310), filed on Jun. 13, 2003, the latter of which claims the benefit of Provisional Application Nos. 60/388,935 (Attorney Docket No. 016886-000300US), filed on Jun. 13, 2002; 60/429,288 (Attorney Docket No. 016886-000700US), filed on Nov. 25, 2002; 60/445,890 (Attorney Docket No. 016886-000800US), filed on Feb. 6, 2003, and 60/462,502 (Attorney Docket No. 016886-001100US), filed on Apr. 10, 2003, the full disclosures of which are all incorporated herein by reference.
The present application claims the benefit of Provisional Application Nos.: 60/459,735 (Attorney Docket No. 16886-000900US), filed on Apr. 1, 2003; 60/462,502 (Attorney Docket No. 16886-001100US), filed on Apr. 10, 2003; and 60/524,622 (Attorney Docket No. 16886-001310US), filed Nov. 24, 2003, the full disclosures of which are hereby incorporated by reference.
Devices and methods that address these difficulties are described in U.S. patent application Ser. Nos. 60/445,890, 60/459,735, 60/462,502, 60/524,622, 10/461043, 10/656797 and 10/741,130, which were previously incorporated by reference. For example, these references describe devices and methods for exposing, stabilizing and/or performing a procedure on a heart valve annulus, such as a mitral valve annulus. Many of the devices and methods previously described by the inventors have been found to be highly effective, but improvements are still being sought.
Published U.S. application Ser. No. 2002/0156526 describes a catheter-based method for performing annuloplasty. Published U.S. application Ser. No. 2002/0042621 describes a heart valve annuloplasty system with constrictable plication bands which are optionally attached to a linkage strip. Published U.S. application Ser. No. 2002/0087169 describes a remote controlled catheter system which can be used to deliver anchors and a tether for performing an annuloplasty procedure. Other patent publications of interest include WO01/26586; US2001/0005787; US2001/0014800; US2002/0013621; US2002/0029080; US2002/0035361; US2002/0042621; US2002/0095167; and US2003/0074012. U.S. patents of interest include 4,014,492; 4,042,979; 4,043,504; 4,055,861; 4,700,250; 5,366,479; 5,450,860; 5,571,215; 5,674,279; 5,709,695; 5,752,518; 5,848,969;5,860,992; 5,904,651; 5,961,539; 5,972,004; 6,165,183; 6,197,017; 6,250,308; 6,260,552; 6,283,993; 6,269,819; 6,312,447; 6,332,893; and 6,524,338. Publications of interest include De Simone et al. (1993) Am. J. Cardiol. 73:721-722, and Downing et al. (2001) Heart Surgery Forum, Abstract 7025. All of the above cited references are hereby incorporated by reference in the present application.
In one aspect of the present invention, a method for advancing one or more devices into a left ventricle of a heart to contact a mitral valve annulus involves: advancing a steerable guide catheter into the left ventricle and around at least a portion of the mitral valve annulus; passing a guide sheath over the steerable guide catheter; withdrawing the steerable guide catheter out of the guide sheath; and advancing one or more devices through the guide sheath to contact the mitral valve annulus. In some embodiments, the steerable guide catheter is advanced through an aorta into a space in the left ventricle formed by a left ventricular wall, at least one mitral valve leaflet and chordae tendiniae of the heart.
Some embodiments of the method further include deforming a flexible distal portion of the steerable guide catheter to conform the distal portion to the mitral valve annulus. For example, in some embodiments deforming the flexible distal portion comprises applying tension to at least one tensioning member to cause at least one bend in the distal portion. Some embodiments further involve, before advancing the steerable guide catheter, advancing a shaped guide catheter through the aorta to a position within or adjacent the space in the left ventricle, wherein the steerable guide catheter is advanced through the shaped guide catheter. In such embodiments, deforming the flexible distal portion may optionally further involve passing the distal portion through at least one bend in the shaped guide catheter. For example, passing the distal portion through the shaped guide catheter may include passing the portion through a first bend to direct it approximately into a plane with a plane of the mitral valve annulus and passing the portion through a second bend approximately perpendicular to the first bend and having a radius of curvature approximately the same as a radius of curvature of the mitral valve annulus. In some embodiments, applying tension to the at least one tensioning member may cause the flexible distal portion to continue to bend in an arc with a radius of curvature approximately the same as the radius of curvature of the mitral valve annulus. In some embodiments, tension may be applied to two tensioning members to articulate the flexible distal portion in at least two directions.
In alternative embodiments, deforming the flexible distal portion may comprise expanding a shaped expandable member to deform the distal portion. Alternatively, deforming the flexible distal portion may comprise introducing a fluid into a lumen of the distal portion. In yet other embodiments, deforming the flexible distal portion comprises releasing a shape-memory material from constraint. In these and other embodiments, deforming the flexible distal portion may involve articulating the distal portion in at least two directions. Some embodiments may also optionally involve comprising locking the shape of the flexible distal portion.
Some embodiments of the method further comprise urging the steerable guide catheter against the mitral valve annulus. In some embodiments, for example, urging the steerable guide catheter comprises expanding an expandable member coupled with the steerable guide catheter within a space in the left ventricle formed by a left ventricular wall, at least one mitral valve leaflet and chordae tendiniae of the heart. In other embodiments, urging the steerable guide catheter comprises applying an attractive magnetic force between a first magnetic member coupled with the steerable guide catheter and a second magnetic member disposed within a coronary sinus of the heart. These or other embodiments may optionally further include urging the guide sheath against the mitral valve annulus. Again, urging the guide sheath may involve expanding an expandable member coupled with the guide sheath within a space in the left ventricle formed by a left ventricular wall, at least one mitral valve leaflet and chordae tendiniae of the heart. Alternatively, urging the guide sheath may comprise applying an attractive magnetic force between a first magnetic member coupled with the guide sheath and a second magnetic member disposed within a coronary sinus of the heart.
In some embodiments, a delivery device is advanced through the guide sheath for contacting and delivering a therapy to the mitral valve annulus. In one embodiment, the delivery device comprises a device for delivering coupled anchors to the mitral valve annulus. In such an embodiment, the method generally includes delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the mitral valve annulus and drawing the anchors together to circumferentially tighten the annulus. The method my optionally also include expanding an expandable member coupled with the anchor delivery device to urge the delivery device against the length of valve annulus. Alternatively, the method may include applying an attractive magnetic force between a first magnetic member coupled with the delivery device and a second magnetic member disposed within a coronary sinus of the heart to urge the delivery device against the length of valve annulus.
In one embodiment, the anchors are delivered from the anchor delivery device through a distal portion of the guide sheath to attach the distal portion to the mitral valve annulus. In this embodiment, the distal portion of the guide sheath is detachable from a proximal portion of the guide sheath to remain attached to the annulus. Some embodiments may also include cinching the attached distal portion of the guide sheath to circumferentially tighten the valve annulus. In an alternative embodiment, the anchors are delivered from the anchor delivery device through a detachable, biocompatible strip coupled with the anchor delivery device to attach the strip to the mitral valve annulus. Some embodiments include cinching the attached strip to circumferentially tighten the valve annulus.
Some embodiments of the method include contacting a stabilizing member with the valve annulus on a side of the valve opposite the anchor delivery device and applying force to the stabilizing member to immobilize the annulus between the stabilizing member and the anchor delivery device to facilitate delivery of the anchors. Alternatively or additionally, one embodiment may include stabilizing the annulus with the anchor delivery device prior to delivering the anchors. In some embodiments, the delivering and drawing steps cause a first length of the valve annulus to be tightened, and the method further includes contacting the anchor delivery device with a second length of the valve annulus; delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the second length of the annulus; and drawing the anchors together to circumferentially tighten the second length of the annulus.
In other embodiments, the method may include delivering energy from the delivery device to tighten the valve annulus. For example, delivered energy may include but is not limited to radio frequency, ultrasound, microwave or laser energy. Other embodiments may include delivering at least one pharmacological agent from the delivery device to tighten the valve annulus. In yet other embodiments, a visualization device is advanced through the guide sheath for enhancing visualization of the mitral valve annulus. For example, the visualization device may include but is not limited to an ultrasound device, a camera, an endoscope or a fiber optic device.
In various embodiments, any of the method steps described above may be performed while the heart is beating. Alternatively, embodiments may be performed on a stopped heart.
In another aspect of the invention, a method for advancing one or more devices into a left ventricle of a heart to contact a mitral valve annulus comprises: advancing a shaped guide catheter through an aorta into the left ventricle; passing a steerable guide catheter through the shaped guide catheter and around at least a portion of the length of the mitral valve annulus; passing a guide sheath over the steerable guide catheter, within the shaped guide catheter; withdrawing the steerable guide catheter out of the guide sheath; and advancing one or more devices through the guide sheath to contact the mitral valve annulus. Various embodiments of this method may include any of the features or steps described above.
In another aspect of the invention, a method for treating a mitral valve annulus of a heart includes: advancing a steerable guide catheter into a left ventricle of the heart and around at least a portion of the mitral valve annulus; passing a guide sheath over the steerable guide catheter; withdrawing the steerable guide catheter out of the guide sheath; advancing an anchor delivery device through the guide sheath to contact the mitral valve annulus; delivering a plurality of coupled anchors from the anchor delivery device to secure the anchors to the mitral valve annulus; and drawing the anchors together to circumferentially tighten the annulus. Some embodiments further include, before advancing the steerable guide catheter, advancing a shaped guide catheter through the aorta to a position within or adjacent the space in the left ventricle, wherein the steerable guide catheter is advanced through the shaped guide catheter. Various embodiments of this method, too, may include any of the features or steps described above.
In another aspect of the present invention, a device for facilitating placement of one or more devices in contact with a heart valve annulus comprises: an elongate catheter body having a proximal portion and a distal portion; at least one tensioning member coupled with the proximal portion of the catheter body and extending to the distal portion; and at least one tensioning actuator coupled with the proximal portion and the tensioning member for applying tension to the tensioning member to deform the distal portion to allow it to conform generally to a shape of the valve annulus. Typically, the catheter body may be advanced intravascularly to the heart to contact the annulus. In some embodiments, for example, the catheter body may be advanced through an aorta and into a left ventricle of the heart to contact the valve annulus.
In some embodiments, the proximal portion of the catheter body is relatively stiff compared to the distal portion. Also in some embodiments, the catheter body further comprises a rounded, atraumatic distal tip. The catheter body may optionally further include at least one radiopaque portion at or near the distal tip for enhancing visualization. The catheter body may also include at least one lumen extending through the proximal and distal portions for passing one or more fluids.
In some embodiments, the at least one tensioning member comprises two tensioning members, allowing the distal portion to be deformed in at least two different directions. The at least one tensioning member may be made of an suitable material, such as but not limited to Nitinol, polyester, nylon, polypropylene and/or other polymers. The at least one tensioning actuator, in some embodiments, comprises a knob coupled with the tensioning member, wherein turning the knob in one direction applies tension to the tensioning member to deform the distal portion, and wherein turning the knob in an opposite direction releases tension from the tensioning member to return to the distal portion to a less deformed configuration.
Some embodiments of the device further include at least one urging member coupled with the distal portion of the catheter body for urging the distal portion into contact with the valve annulus. For example, the at least one urging member may comprise an expandable member for expanding within a space in a left ventricle formed by a left ventricular wall, at least one mitral valve leaflet and chordae tendiniae of the heart. In an alternative embodiment, the at least one urging member comprises at least one magnet coupled with the distal portion for applying attractive magnetic force between itself and an oppositely charged magnet disposed in a coronary sinus adjacent the valve annulus.
Some embodiments further include a housing coupled with the proximal end of the catheter body, wherein the tensioning actuator is coupled with the housing. Optionally, the housing may further comprise at least one fluid inlet port in fluid communication with at least one lumen in the elongate shaft for introducing one or more fluids into the lumen(s).
In another aspect of the present invention, a system for facilitating placement of one or more devices in contact with a heart valve annulus includes: a shaped guide catheter having at least one curve toward a distal end for positioning the distal end in a position below the mitral valve; a steerable guide catheter passable through the shaped guide catheter and having a steerable distal end for advancing around a length of the valve annulus below the mitral valve; and a guide sheath passable over the steerable guide catheter through the shaped guide catheter, wherein the one or more devices are passable through the guide sheath to contact the mitral valve annulus. Generally, the shaped guide catheter, steerable guide catheter and guide sheath may have any of the various functions and features described above, in various embodiments.
In one embodiment, for example, the shaped guide catheter includes a proximal curve approximately perpendicular to a central axis of the shaped guide catheter for bringing the distal end of the catheter into a plane approximately parallel with a plane of the mitral valve and a distal curve having a radius of curvature approximately the same as a radius of curvature of the mitral valve annulus. In one embodiment, the steerable guide catheter comprises: an elongate catheter body having a proximal portion and a distal portion; at least one tensioning member coupled with the proximal portion of the catheter body and extending to the distal portion; and at least one tensioning actuator coupled with the proximal portion and the tensioning member for applying tension to the tensioning member to deform the distal portion to allow it to conform generally to a shape of the valve annulus. In various embodiment, this steerable guide catheter may have any of the features of the catheter device described above.
In some embodiments of the system, a distal portion of the guide sheath is detachable from a proximal portion of the guide sheath to remain in attached to the valve annulus after an annulus treatment procedure. For example, the detachable distal portion may comprise a tubular member comprising Dacron or the like. In some embodiments, the detachable distal portion is cinchable to tighten the mitral valve annulus.
In some embodiments, the system may further include at least one urging member coupled with at least one of the shaped guide catheter, the steerable guide catheter and the guide sheath. For example, the urging member may comprise an expandable member for expanding within a space in a left ventricle formed by a left ventricular wall, at least one mitral valve leaflet and chordae tendiniae of the heart. Alternatively, the urging member may comprise at least one magnet coupled with at least one of the shaped guide catheter, the steerable guide catheter and the guide sheath for applying attractive magnetic force between itself and an oppositely charged magnet disposed in a coronary sinus adjacent the valve annulus.
Any suitable device or combination of devices may be advanced into contact with the mitral valve annulus in various embodiments. In some embodiments, for example, the system includes an anchor delivery device passable through the guide sheath to contact and apply coupled anchors to the mitral valve annulus. The system may additionally or alternatively include a visualization device passable through the guide sheath to facilitate visualization of the mitral valve annulus. For example, the visualization device may comprises, but is not limited to, an ultrasound device, a camera, an endoscope or a fiber optic device.
[0039]FIG. 1 is a cross-sectional view of a heart with a flexible anchor delivery device being positioned for treatment of a mitral valve annulus, according to one embodiment of the present invention;
[0040]FIGS. 2A and 2B are cross-sectional views of a portion of a heart, schematically showing positioning of a flexible device for treatment of a mitral valve annulus, according to one embodiment of the present invention;
[0041]FIGS. 2C and 2D are cross-sectional views of a portion of a heart, showing positioning of a flexible anchor delivery device for treatment of a mitral valve annulus, according to one embodiment of the present invention;
[0042]FIG. 3 is a perspective view of a distal portion of an anchor delivery device, according to one embodiment of the invention;
[0043]FIG. 4. is a perspective view of a segment of a distal portion of an anchor delivery device, with anchors in an undeployed shape and position;
[0044]FIG. 5 is a different perspective view of the segment of the device shown in FIG. 4;
[0045]FIG. 6. is a perspective view of a segment of a distal portion of an anchor delivery device, with anchors in a deployed shape and position;
[0046]FIGS. 7A-7E are cross-sectional views of an anchor delivery device, illustrating a method for delivering anchors to valve annulus tissue, according to one embodiment of the invention;
[0047]FIGS. 8A and 8B are top-views of a plurality of anchors coupled to a self-deforming coupling member or “backbone,” with the backbone shown in an undeployed shape and a deployed shape;
[0048]FIGS. 9A-9C are various perspective views of a distal portion of a flexible anchor delivery device according to one embodiment of the present invention;
[0049]FIGS. 10A-10F demonstrate a method for applying anchors to a valve annulus and cinching the anchors to tighten the annulus, using an anchor delivery device according to an embodiment of the invention;
[0050]FIG. 11 shows a heart in cross-section with a guide catheter device advanced through the aorta into the left ventricle according to an embodiment of the invention;
[0051]FIGS. 12A-12F demonstrate a method for advancing an anchor delivery device to a position for treating a heart vavle according to an embodiment of the invention; and
[0052]FIGS. 13A and 13B are side cross-sectional views of a guide catheter device for facilitating positioning of an anchor delivery device according to an embodiment of the invention.
Referring now to FIG. 10E, anchors 526 are seen in their fully deployed or nearly fully deployed shape, with each pointed tip (or “arm”) of each anchor 526 having curved to form a circle or semi-circle. Of course, in various embodiments anchors 526 may have any other suitable deployed and undeployed shapes, as described more fully above. FIG. 10F shows anchors 526 deployed into the valve annulus VA and coupled with tether 534, with the distal-most anchor 526 coupled attached fixedly to tether 524 at attachment point 536. At this stage, tether 534 may be cinched to tighten the annulus, thus reducing valve regurgitation. In some embodiments, valve finction may be monitored by means such as echocardiogram and/or fluoroscopy, and tether 534 may be cinched, loosened, and adjusted to achieve a desired amount of tightening as evident via the employed visualization technique(s). When a desired amount of tightening is achieved, tether 534 is then attached to a most-proximal anchor 526 (or two or more most-proximal anchors 526), using any suitable technique, and tether 534 is then cut proximal to the most-proximal anchor 526, thus leaving the cinched, tethered anchors 526 in place along the valve annulus VA. Attachment of tether 534 to the most-proximal anchor(s) 526 may be achieved via adhesive, knotting, crimping, tying or any other technique, and cutting tether 534 may also be performed via any technique, such as with a cutting member coupled with housing 522.
With reference now to FIGS. 13A and 13B, one embodiment of a steerable catheter device 560 is shown. Steerable catheter device 560 may be used in a method such as that just described in reference to FIGS. 12A-12F, for example in performing a function similar to that performed by second guide catheter 554. In other embodiments, catheter device 560 may perform any other suitable finction. As shown, catheter device 560 suitably includes an elongate catheter body having a proximal portion 562 and a distal portion 564. At least one tensioning member 568, such as but not limited to a tensioning cord, extends from proximal portion 562 to distal portion 564 and is coupled with the distal portion 564 and at least one tensioning actuator 570/572 on the proximal portion. Tensioning actuator 570/572 may include, for example, a knob 570 and a barrel 572 for wrapping and unwrapping tensioning member 568 to apply and remove tension. Tensioning member 568 is coupled with distal portion 564 at one or more connection points 580. In some embodiments, catheter device 560 includes a proximal housing 571, handle or the like, coupled to the proximal end of proximal portion 562 via a hub 576 or other means. Housing 571 may be coupled with tensioning actuator 570/572 and may include one or more arms 574 for infusing fluid or for other functions. In the embodiment shown, arm 574 and housing 571 include a lumen 567 that is in fluid communication with a fluid lumen 566 of the catheter body. Fluid may be introduced through arm 574 to pass through fluid lumen 566 to provide, for example, for contrast material at the distal tip of catheter device 560 to enhance visualization of device 560 during a procedure. Any other suitable fluid(s) may be passed through lumens 567/566 for any other purpose. Another lumen 578 may be included in distal portion 564, through which tensioning member 568 passes before attaching at a distal location along distal portion 564.
[0094]FIG. 13B shows catheter device 560 in a deformed/bent configuration, after tension has been applied to distal portion 564 by applying tension to tensioning member 568, via knob 570 and barrel 572. The bend in distal portion 564 will allow it to conform more readily to a valve annulus, while catheter device 560 in its straight configuration will be more amenable to passage through vasculature of the patient. Tensioning member 568 may be manufactured from any suitable material or combination of materials, such as but not limited to Nitinol, polyester, nylon, polypropylene and/or other polymers. Some embodiments may include two or more tensioning members 568 and/or two or more tensioning actuators 570/572 to provide for changes in shape of distal portion 564 in multiple directions. In alternative embodiments, knob 570 and barrel 572 may be substituted with any suitable devices, such as a pull cord, button, lever or other actuator. Various alternatives may also be substituted for tensioning member 568 in various embodiments. For example, shaped expandable members, shape memory members and/or the like may be used to change the shape of distal portion 564.
Although the foregoing is a complete and accurate description of the present invention, the description provided above is for exemplary purposes only, and variations may be made to the embodiments described without departing from the scope of the invention. Thus, the above described should not be construed to limit the scope of the invention as described in the appended claims.
US7713298 * May 6, 2005 May 11, 2010 Micardia Corporation Methods for treating cardiac valves with adjustable implants
CN103271782A * May 17, 2013 Sep 4, 2013 中国人民解放军第二军医大学 Adjustable type tricuspid-valve forming device
EP1790318A1 * Nov 16, 2006 May 30, 2007 Micardia Corporation Magnetic engagement of catheter to implantable device
WO2006002492A1 * Jul 6, 2005 Jan 12, 2006 Baker Medical Research Institute Treating valvular insufficiency
WO2006116129A2 * Apr 21, 2006 Nov 2, 2006 Micardia Corporation Dynamically adjustable implants and methods for reshaping tissue
WO2006116129A3 * Apr 21, 2006 Apr 19, 2007 Micardia Corp Dynamically adjustable implants and methods for reshaping tissue
WO2016204954A1 * May 26, 2016 Dec 22, 2016 Evalve, Inc. Catheter guiding system
International Classification A61B17/064, A61F2/24, A61B17/08, A61B17/04, A61B17/00, A61B17/068
Cooperative Classification A61B17/064, A61F2/2466, A61B2017/0409, A61F2/2451, A61B2017/00867, A61F2/2445, A61B17/0401, A61B2017/00243, A61B17/068, A61B17/0682, A61B17/00234, A61B2017/00783, A61B2017/0414
European Classification A61F2/24R14, A61F2/24R2, A61B17/068B, A61B17/064
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:STARKSEN, NIEL F.;TO, JOHN;MORALES, RODOLFO A.;REEL/FRAME:014907/0851