APPARATUS AND METHOD FOR THE LIGATION OF TISSUE

• US 20080147097A1
• Filed: 02/26/2008
• Published: 06/19/2008
• Est. Priority Date: 10/09/2003
• Status: Active Grant

• Current Assignee: SentreHeart, LLC (Atricure, Inc.)
• Original Assignee: SentreHEART Incorporated (Atricure, Inc.)
• Inventors: LIDDICOAT, John R., Cohn, William E., Laham, Roger
• Granted Patent: US 8,795,297 B2
• Time in Patent Office: Days
• US Class Current: 606/148
• 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 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/12018 Elastic band ligators
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2576/023 for the heart
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0127 Magnetic means; Magnetic markers
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A novel catheter-based system which ligates the left atrial appendage (LAA) on the outside of the heart, preferably using a combination of catheters and/or instruments, e.g., a guide catheter positioned inside the left atrial appendage which may assist in locating the left atrial appendage and/or assist in the optimal placement of a ligature on the outside of the appendage, and a ligating catheter and/or instrument outside the heart in the pericardial space to set a ligating element at the neck of the left atrial appendage.

Claims

1-62. -62. (canceled)

63. A device configured for use in a left atrial appendage procedure comprising:

an elongate body having a proximal end, a distal end, and a lumen therethrough, wherein the elongate body has a diameter of approximately 24 French or smaller; and

an expandable member slidably disposed within the distal end of the elongate member, wherein the elongate member comprises a plurality of arms and wherein the expandable member is capable of displacing tissue in proximity to the left atrial appendage.

64. The device of claim 63, wherein the expandable member is capable of expanding to a size corresponding to the exterior of the left atrial appendage.

65. The device of claim 63, wherein the expandable member is self-expandable.

66. The device of claim 63, wherein the plurality of arms are coupled to one another with springs.

67. The device of claim 63, further comprising one or more control wires for advancing or retracting the expandable member through the lumen of the elongate body.

68. The device of claim 63, wherein the elongate body has a deflectable tip.

69. The device of claim 63, wherein the expandable member has the shape of a bell-shaped crown in its expanded configuration.

70. The device of claim 63, wherein the expandable member is made from a shape memory material.

71. The device of claim 70, wherein the shape memory material is Nitinol.

72. A system for facilitating ligation of a left atrial appendage comprising:

a device comprising an elongate body and an expandable member, wherein the elongate body has a proximal end, a distal end, a lumen therethrough, and a diameter of approximately 24 French or smaller, and wherein the expandable member comprises a plurality of arms and is slidably disposed within the distal end of the elongate member; and

a gripping apparatus for gripping tissue of the left atrial appendage.

73. The system of claim 72, wherein the gripping apparatus comprises a suction tube.

74. The system of claim 72, wherein the device further comprises an alignment element.

75. The system of claim 72, further comprising a ligating element.

76. The system of claim 75, wherein the ligating element comprises a suture.

77. The system of claim 75, wherein the ligating element comprises a loop.

78. The system of claim 75, wherein the ligating element comprises polypropylene.

79. The system of claim 75, wherein the ligating element comprises PTFE.

80. A system for facilitating ligation of a left atrial appendage comprising:

a device comprising an elongate body and an expandable member, wherein the elongate body has a proximal end, a distal end, a lumen therethrough, and a diameter of approximately 24 French or smaller, and wherein the expandable member comprises a plurality of arms and is slidably disposed within the distal end of the elongate member; and

a ligating element for ligating tissue of the left atrial appendage.

81. The system of claim 80, wherein the ligating element comprises a suture.

82. The system of claim 80, wherein the ligating element comprises a loop.

83. The system of claim 80, wherein the ligating element comprises polypropylene.

84. The system of claim 80, wherein the ligating element comprises PTFE.

85. A system for facilitating ligation of a left atrial appendage comprising:

a device comprising an elongate body and an expandable member, wherein the elongate body has a proximal end, a distal end, a lumen therethrough, and a diameter of approximately 24 French or smaller, and wherein the expandable member comprises a plurality of arms and is slidably disposed within the distal end of the elongate member; and

a guide catheter.

86. The system of claim 85, wherein the guide catheter comprises an alignment element.

87. The system of claim 86, wherein the alignment element comprises one or more magnets.

88. The system of claim 85, wherein the guide catheter comprises a radio-opaque material.

89. The system of claim 85, wherein the guide catheter comprises an expandable balloon.

90. A method for ligating tissue of a left atrial appendage comprising:

advancing a device in the proximity to tissue of the left atrial appendage, wherein the device comprises an elongate body having a proximal end, a distal end, and a lumen therebetween, wherein the elongate body has a diameter of approximately 24 French or smaller, and an expandable member slidably disposed within the distal end of the elongate member, wherein elongate member comprises a plurality of arms; and

positioning a ligating element about the neck of the left atrial appendage.

91. The method of claim 90, further comprising ligating the left atrial appendage.

92. The method of claim 90, further comprising gripping tissue of the left atrial appendage.

93. The method of claim 90, further comprising visualizing the advancing or positioning under fluoroscopy.

94. The method of claim 90, further comprising visualizing the advancing or positioning using ultrasound.

95. The method of claim 90, further comprising visualizing the advancing or positioning under direct visualization.

96. The method of claim 90, further comprising visualizing the advancing or positioning using CT guidance.

97. The method of claim 90, further comprising advancing a guide catheter into the left atrium and into the left atrial appendage prior to advancing the device in proximity to tissue of the left atrial appendage.

98. The method of claim 97, wherein the guide catheter is advanced transseptally.

99. The method of claim 97, wherein the guide catheter comprises an expandable balloon.

100. The method of claim 97, wherein the guide catheter comprises an alignment element.