Method and catheter for creating an interatrial aperture
Inventors
Assignees
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Publication Number
US-11957374-B2
Publication Date
2024-04-16
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 is a medical device assembly that includes a sheath and a catheter arranged to form a durable inter atrial septal aperture without leaving an implant. The sheath includes an elongated sheath shaft having a first bend region, a central lumen, and a distal end, and a first steering wire with a first position and a second position. When the steering wire is in the second position, the distal end of the sheath is substantially perpendicular to a longitudinal axis of the sheath.
Inside the sheath is a catheter comprising a catheter shaft with a central lumen and a shaped blade with a blade cutting edge. The blade cutting edge is oriented at a substantially right angle to the longitudinal axis of the sheath when the sheath is oriented substantially perpendicular to the inter atrial septum. The shaped blade is adapted to cut a 3 mm or larger durable aperture in the inter atrial septum, and the catheter further includes a tissue articulator adapted to hold the inter atrial septum.
In the described embodiments, the tissue articulator includes first and second positions/settings and an actuator connected to the tissue articulator. The actuator is configured so that in a second position or second setting the tissue articulator holds the inter atrial septum against the shaped blade for cutting. The overall system is configured for inserting into the right atrium, steering so the shaped blade is oriented relative to the septum, cutting the aperture between the right atrium and the left atrium, and removing cut tissue from the right atrium.
Claims Coverage
The provided material includes three independent claims centered on forming a 3 mm or larger durable aperture in the inter atrial septum using a right-angle blade orientation enforced by a substantially perpendicular sheath, together with a tissue articulator controlled to hold septal tissue against the blade during cutting. Across the independent claims, the inventive features emphasize steerable orthogonal orientation, right-angle cutting edge geometry, durable aperture formation, tissue holding via a movable articulator, and removal of cut tissue from the right atrium.
Substantially perpendicular sheath with steerable distal end
A sheath comprising an elongated sheath shaft having a first bend region, a central lumen and a distal end, and a first steering wire having a first position and a second position, wherein at the first position the first bend region is substantially linear, and wherein at the second position the distal end of the sheath is substantially perpendicular to a longitudinal axis of the sheath.
Right-angle blade cutting edge adapted to cut a durable septal aperture
A shaped blade comprising a blade cutting edge that is oriented at a substantially right angle to the longitudinal axis of the sheath when the sheath is oriented substantially perpendicular to the inter atrial septum, and is adapted to cut a 3 mm or larger durable aperture in the inter atrial septum.
Tissue articulator holding inter atrial septum against blade
A tissue articulator adapted to hold the inter atrial septum.
Actuator-controlled tissue articulator second setting during cutting
A tissue articulator having a first setting and a second setting, the tissue articulator being adapted to hold the interatrial septum against the shaped blade for cutting while in the second setting, and an actuator connected to the tissue articulator having a first position and a second position, wherein when the actuator is in the second position the tissue articulator holds the interatrial septum against the shaped blade.
Method of treating a heart by cutting and removing cut septal tissue
Inserting a catheter into the right atrium of the heart, while the catheter is in the right atrium actuating the actuator to move the tissue articulator into a second position that holds the tissue against the shaped cutting blade, cutting an aperture in the interatrial septum between the right atrium and the left atrium, removing a cut tissue from the right atrium.
Across the independent claims, the core coverage is a steerable sheath that can be oriented substantially perpendicular to the inter atrial septum so that a blade cutting edge is oriented substantially right angle to the sheath axis. A shaped blade adapted to cut a 3 mm or larger durable aperture cooperates with a tissue articulator held against the blade by an actuator in a second position or setting. The method claim further defines treating a heart by performing the cutting in the right atrium and removing cut tissue from the right atrium.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treating a heart by cutting an aperture in the interatrial septum between the right atrium and the left atrium and removing cut tissue from the right atrium.
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