Devices and methods for heart valve repair

• US 20060025787A1
• Filed: 09/27/2005
• Published: 02/02/2006
• Est. Priority Date: 06/13/2002
• Status: Abandoned Application

• Current Assignee: Guided Delivery Systems, Inc.
• Original Assignee: Guided Delivery Systems, Inc.
• Inventors: Starksen, Niel F., Morales, Rodolfo A.
• Application Number:
  US11/237,461
• Publication Number:
  US 20060025787A1
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00096 Optical elements
• CPC Class Codes: A61B 1/04 combined with photographic or television appliances
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/0684 having a forming anvil staying above the tissue during stapling
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06023 Multiple eyelets
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61F 2/2445 : Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2451 : Inserts in the coronary sinus for correcting the valve shape

Abstract

Methods and devices provide constriction of a heart valve annulus to treat cardiac valve regurgitation and other conditions. Embodiments typically include a device for attaching a cinching or tightening apparatus to a heart valve annulus to reduce the circumference of the annulus, thus reducing valve regurgitation. Tightening devices may include multiple tethered clips, multiple untethered crimping clips, stabilizing devices, visualization devices, and the like. In one embodiment, a plurality of tethered clips is secured circumferentially to a valve annulus, and the tether coupling the clips is cinched to reduce the circumference of at least a portion of the annulus. Methods and devices may be used in open heart surgical procedures, minimally invasive procedures, catheter-based procedures, and/or procedures on beating hearts or stopped hearts.

Claims

1-78. -78. (canceled)

79. A method of tightening tissue comprising:

attaching a plurality of clips comprising a first clip, an intermediate clip and a terminal clip to the tissue, wherein the clips are coupled to a tether before attaching to the tissue;

shortening the length of the tether between the clips;

securing a proximal end of the tether to the terminal clip.

80. The method of claim 79, wherein shortening the length of the tether between the clips comprises cinching the tether by drawing the tether in the proximal direction through an eyelet of at least the intermediate clip and the terminal clip.

81. The method of claim 80, wherein cinching comprises applying tensile force to the tether.

82. The method of claim 81, wherein applying tensile force comprises pulling the tether proximally through an applicator which has introduced the terminal clip

83. The method of claim 79, wherein attaching a plurality of clips comprises attaching the first clip to the tissue wherein the first clip is secured near the distal end of the tether.

84. The method of claim 79, wherein the individual clips are secured successively to the tissue.

85. The method of claim 79, further comprising coupling individual clips to the tether immediately before attaching the individual clip to the tissue.

86. The method of claim 79, wherein the individual clips are simultaneously secured to the tissue.

87. The method of claim 79, wherein securing a proximal end of the tether to the terminal clip comprises deforming the terminal clip so that the terminal clip becomes fixed to the tether.

88. The method of claim 79, wherein securing a proximal end of the tether to the terminal clip comprises attaching a clamping device to the proximal end of the tether.

89. The method of claim 79, further comprising visualizing the tissue.

90. The method of claim 89, wherein visualizing is performed using a visualization device comprising at least one of an ultrasound device, an angioscopic device, a transesophageal echocardiogram device and a fluoroscopic device

91. The method of claim 89, wherein visualization is performed using an ultrasound device comprising a gel-containing cone for enhancing ultrasound visualization.

92. The method of claim 89, further comprising determining the amount to shorten the length of the tether between the clips based on the visualization of the tissue.

93. The method of claim 79, wherein the attaching and shortening steps are performed as part of a minimally invasive surgery.

94. The method of claim 79, wherein the attaching and shortening steps are performed intravascularly.

95. A method of cinching an annulus comprising:

attaching a plurality of clips comprising a first clip, an intermediate clip and a terminal clip spaced at least partly around the annulus, wherein the clips are coupled to a tether before attaching;

cinching by shortening the length of the tether between the clips;

securing a proximal end of the tether to the terminal clip.

96. The method of claim 95, wherein the cinching comprises applying tensile force to the tether.

97. The method of claim 96, wherein applying tensile force comprises pulling the tether proximally through an applicator which has introduced the terminal clip.

98. The method of claim 95, wherein securing a proximal end of the tether to the terminal clip comprises attaching a clamping device to the proximal end of the tether.

100. A method as in claim 97, wherein the method is performed intravascularly.

99. A method for constricting a valve annulus in a beating heart, said method comprising:

viewing at least a portion of the annulus;

securing individual clips at circumferentially spaced-apart locations about at least a portion of the annulus while viewing; and

cinching a tether through the clips to circumferentially tighten the annulus.