PFO CLOSURE DEVICES AND RELATED METHODS OF USE

• US 20100234881A1
• Filed: 03/17/2010
• Published: 09/16/2010
• Est. Priority Date: 05/06/2002
• Status: Abandoned Application

• Current Assignee: St. Jude Medical, Cardiology Division, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Ressemann, Thomas V., Blaeser, David J., Keith, Peter T., Wahr, Dennis W., Phillips, Joel D., Hackett, Steven S., Olson, Scott A., Christianson, Mark R., Grudem, Jerome K. JR.
• Application Number:
  US12/725,886
• Publication Number:
  US 20100234881A1
• Time in Patent Office: Days
• US Class Current: 606/213
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0474 Knot pushers
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence

Abstract

Devices and methods for sealing a passageway formed by a patent foramen ovale (PFO track) in the heart are provided. One method includes providing an abrading device to the PFO track and abrading the tissue within the PFO track. The abraded tissue forming the PFO track is then held together under pressure, either via lowering right atrial pressure or via applying suction to the septum primum to pull it into apposition against the septum secundum. After a sufficient period of time, the pressure is released and the abraded tissue heals to form a robust seal over the PFO track. Additionally, several devices are provided which can be placed into the PFO track to apply adhesive to the walls of the PFO track. The devices may or may not be left within the PFO track. If the devices are not left within the PFO track, the walls of the PFO track, covered with adhesive, are brought into apposition with one another and adhered together. If the device is left within the PFO track, the device is flattened from an expanded configuration to a flattened configuration, and the walls of the PFO track, adhering to the outer surface of the device, are pulled toward each other as the device flattens. The device may also include interior structure to hold the device in a flattened configuration.

Claims

1-87. -87. (canceled)

88. A method of sealing a passageway in a heart, comprising:

advancing a delivery device having an expandable end into the passageway, the delivery device including at least two suture lumens, each suture lumen having an open end positioned in the passageway when the delivery device is advanced into the passageway;

expanding the expandable end;

advancing a suture-anchor assembly out of the open end of each suture lumen;

penetrating the tissue forming the passageway with an anchor of each suture-anchor assembly; and

pulling the passageway closed with the anchored sutures.

89. The method of claim 88, wherein the pulling step includes tying the sutures in a knot.

90. The method of claim 88, further comprising abrading portions of the tissue surfaces forming the passageway prior to advancing the delivery device.

91. The method of claim 88, wherein the expanding step includes inflating a balloon inside of the expandable end.

92-98. -98. (canceled)

99. A method of sealing a passageway in a heart, comprising:

introducing a suture delivery system to the passageway, the suture delivery system including at least two suture lumens, each suture lumen containing a suture-anchor assembly;

advancing the suture-anchor assemblies out of the at least two suture lumens;

penetrating the tissue forming the passageway with an anchor of each suture-anchor assembly; and

pulling the passageway closed with the anchored sutures.

100. The method of claim 99, wherein the pulling step includes tying the sutures in a knot.

101. The method of claim 99, wherein the passageway to be sealed is a patent foramen ovale, and the penetrating step includes penetrating the septum secundum with one of the anchors and penetrating the septum primum with another of the anchors.

102. A system for sealing a passageway in a human body, the system comprising:

a suture delivery device having at least two suture lumens; and

at least one suture positioned within each of the suture lumens.

103. The system of claim 102, further comprising an anchor at an end of each suture.

104. The system of claim 103, wherein each anchor includes a barbed end.

105. The system of claim 102, wherein one of the at least two suture lumens is positioned on a first side of the suture delivery device and the other of the at least two suture lumens is positioned on an opposite side of the suture delivery device.

106. The system of claim 105, wherein the at least two suture lumens are spaced about 180°

apart.

107. The system of claim 102, wherein each of the two suture lumens has an open end.

108. The system of claim 102, wherein the suture delivery device includes an expandable distal portion.

109. The system of claim 108, wherein the expandable distal portion of the suture delivery device includes a balloon.

110. The system of claim 102, further comprising a lock device.

111. The system of claim 110, wherein the lock device is configured to engage the suture and move in only one direction along the suture.

112. The system of claim 102, wherein the passageway is a patent foramen ovale.