Method and catheter for creating an interatrial aperture
Inventors
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-10993735-B2
Publication Date
2021-05-04
Expiration Date
Abstract
A catheter device 10 with a cutting structure or means 16 on the distal portion 14 is disclosed, along with a medical procedure for using the device. The catheter 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
The invention relates to a catheter-based medical device assembly for treating a heart by creating a durable permanent interatrial aperture between the right atrium and the left atrium. The system includes a catheter shaft with a central lumen and a radiopaque marker, a sharp shaped blade, and steering elements configured to orient the shaped blade toward tissue. The sharp shaped blade has a blade cutting edge oriented at a substantially right angle to a longitudinal axis of the catheter shaft.
The device further includes a proximal tissue retention device and a distal tissue retention device, together with an actuator configured to reduce a gap between the proximal and distal tissue retention devices. When the gap is reduced, the proximal and distal tissue retention devices are configured to retain cut tissue between them. The invention also includes mechanisms to lock tissue retention devices in place and to coordinate blade orientation and tissue retention to manage formation of an aperture in the interatrial septum between the right atrium and the left atrium.
In embodiments, the shaped blade is re-oriented by a first steering element between positions that are substantially orthogonal and substantially parallel relative to the longitudinal axis of the catheter shaft. The durable permanent interatrial aperture is supported by capturing and removing septal tissue while using tissue holding and monitoring concepts to reduce risk of unwanted tearing, spontaneous closure, embolization, and loss of cut tissue.
Claims Coverage
The provided independent claims cover a catheter device assembly with a right-angle cutting edge and proximal/distal tissue retention with steering, an assembly that adds locking and re-orientation of the shaped blade between orthogonal and parallel positions, and a method of treating a heart by inserting the catheter into the right atrium, moving a portion into the left atrium, actuating tissue retention to hold septum tissue, cutting an aperture, and removing cut tissue. Across these claims, the core inventive features number at least four: right-angle blade cutting edge, proximal/distal tissue retention with an actuator, steering to orient/re-orient the blade, and locking the tissue retention devices in place.
Right-angle cutting edge oriented to a catheter longitudinal axis
A sharp shaped blade having a blade cutting edge oriented at a substantially right angle to a longitudinal axis of the catheter shaft.
Proximal and distal tissue retention devices actuated by a gap-reducing actuator
A proximal tissue retention device and a distal tissue retention device; an actuator configured to reduce a gap between the proximal and distal tissue retention devices; wherein the proximal tissue retention device and the distal tissue retention device are configured to retain a cut tissue between them when the gap is reduced.
Steering element to orient the shaped blade toward tissue
A first steering element configured to orient the shaped blade toward a tissue.
Locking mechanism for proximal and distal tissue retention devices
A locking mechanism configured to lock the proximal and distal tissue retention devices in place.
Re-orienting shaped blade from orthogonal to parallel positions
A first steering element configured to re-orient the shaped blade from a first position substantially orthogonal to the longitudinal axis of the catheter shaft to a second position substantially parallel to the longitudinal axis of the catheter shaft.
Method steps for interatrial septum aperture formation
Inserting a catheter into the right atrium; while the catheter is in the right atrium, moving a portion of the catheter into the left atrium; actuating the actuator to lock 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; removing a cut tissue from the right atrium.
The independent claims collectively define a catheter assembly with a shaped blade having a substantially right-angle cutting edge relative to the catheter longitudinal axis, proximal and distal tissue retention devices actuated to hold cut tissue, and steering elements that orient and re-orient the blade. One independent claim adds a locking mechanism for retaining the tissue retention devices in place, and the method claim requires catheter positioning across the interatrial septum, septum tissue retention during aperture cutting, and removal of the cut tissue.
Stated Advantages
To reduce risk of unwanted tearing, spontaneous closure, embolization, and loss of cut tissue.
Documented Applications
Treating a heart by creating a durable permanent interatrial aperture between the right atrium and the left atrium.
Formation of an aperture in the interatrial septum between the right atrium and the left atrium.
Interested in licensing this patent?