Method and septostomy device for creating an interatrial aperture
Inventors
Assignees
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Publication Number
US-12471948-B2
Publication Date
2025-11-18
Expiration Date
Abstract
A septostomy device 10 with a cutting structure or means 140 and tissue capture mechanisms 240, 250 is disclosed, along with a medical procedure for using the device. The system 10 is configured in such a way as to create a permanent interatrial aperture in the heart, including creating a permanent interatrial hole and/or removing tissue.
Core Innovation
A septostomy assembly includes a catheter assembly with a catheter shaft having a catheter lumen and a tissue retention assembly located at least partially in the catheter lumen. The catheter includes a shaped blade oriented at a substantially right angle to the longitudinal axis of the catheter. The tissue retention assembly includes a proximal tissue retention device and a distal tissue retention device designed to apply a force between them.
An actuator reduces a gap between the proximal and distal tissue retention devices to grasp tissue. The distal tissue retention device tents the tissue into the catheter lumen to create a shunt in the tissue that is larger in diameter than the tissue retention device. This arrangement defines an interatrial aperture via tissue grasping and cutting with the right-angle shaped blade.
The disclosed approach further specifies expandable tissue retention devices that expand from a first cross section that fits within a catheter central lumen to a second expanded cross section that exceeds the diameter of the catheter. In treating a heart, a catheter is inserted into the right atrium and moved so a portion of the device extends into the left atrium, where the proximal and distal tissue retention devices are expanded and an aperture is cut in the interatrial septum, followed by removing a cut tissue from the right atrium.
Claims Coverage
The document includes three independent claims defining a septostomy assembly and a method of treating a heart. Across the independent claims, there are two principal inventive feature themes: a right-angle oriented shaped cutting blade with a proximal and distal tissue retention assembly that grasps tissue and tents it to create a shunt larger than the retention device, and expandable proximal and distal retention devices that transition from a lumen-fitting cross section to an expanded cross section that exceeds the catheter diameter.
Right-angle shaped blade for septostomy
A catheter assembly with a shaped blade oriented at a substantially right angle to the longitudinal axis of the catheter.
Proximal and distal tissue retention to grasp tissue
A tissue retention assembly located at least partially in the catheter lumen comprising a proximal tissue retention device and a distal tissue retention device, the tissue retention devices designed to apply a force between them; and an actuator designed to reduce a gap between the proximal and distal tissue retention devices to grasp a tissue.
Distal tissue tenting to create shunt larger than retention device
The distal tissue retention device tents the tissue into a catheter lumen to create a shunt in the tissue larger in diameter than the tissue retention device.
Expandable retention devices exceeding catheter diameter
The proximal tissue retention device and the distal tissue retention device each expandable from a first cross section that fits within the catheter central lumen to a second expanded cross section that exceeds the diameter of the catheter.
Heart treatment using right and left atrial positioning with expansion and cutting
Inserting a catheter into the right atrium and moving a portion of the device into the left atrium; expanding the proximal and distal tissue retention devices; actuating an actuator to grasp the tissue retention devices in place with a portion of the interatrial septum held between them; cutting an aperture in the interatrial septum between the right atrium and the left atrium; and removing a cut tissue from the right atrium.
Taken together, the independent claims define a septostomy assembly where a substantially right-angle shaped blade is used with a proximal and distal tissue retention assembly driven by an actuator to grasp tissue and tent the tissue to create a larger-diameter shunt, and where the retention devices can expand from a lumen-fitting cross section to an expanded cross section exceeding catheter diameter to enable cutting an aperture in the interatrial septum during heart treatment.
Stated Advantages
Documented Applications
No documented applications found
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