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Publication Number
US-11890019-B2
Publication Date
2024-02-06
Expiration Date
Abstract
System for inserting a self-expandable occluder into a patient and for releasing the occluder in the left atrial appendage of the patient, the system including an insertion unit which has a drive unit and an insertion catheter having an outer tube and an inner tube extending through the outer tube, wherein a proximal end region of the occluder is movement-coupled to the outer tube, and wherein a distal end region of the occluder is movement-coupled to the inner tube.
Core Innovation
The invention describes a system for inserting a self-expandable occluder into a patient and for releasing the occluder in the left atrial appendage. The system includes the occluder and an insertion unit with a drive unit and an insertion catheter. The insertion catheter has an outer tube and an inner tube extending through the outer tube, and a proximal end region of the occluder is movement-coupled to the outer tube while a distal end region of the occluder is movement-coupled to the inner tube.
For release, the drive unit interacts with the inner tube and the outer tube so that, when actuated, the inner tube can be moved in a distal or proximal direction while the outer tube can be moved in the proximal direction or distal direction. This configuration moves the distal end and the proximal end of the occluder away from or toward one another. During insertion, a distal end of the outer tube is disposed inside the occluder.
The outer tube includes at least one latching finger-like end portion at its distal end region, and the latching finger-like end portion cooperates with the proximal end region of the occluder only when the inner tube is disposed inside the outer tube. The disclosed occluder geometry includes a proximal tubular portion and a pot-shaped distal end region, with an example where an inner tube is seated in the pot-shaped distal region.
The document also describes an example occluder structure with a frame and anchoring means, biological tissue covering for fluid-tight closure, and X-ray markers for positioning. The system further includes a drive mechanism with first and second transmission elements and drive threads, plus a mechanism for stable form-fit between the latching finger-like end portion and the occluder proximal tubular region when the inner tube is inside.
Claims Coverage
The provided independent claims cover an insertion unit configured to insert a self-expandable occluder into a patient and release it in the left atrial appendage, with three key inventive features: opposite-direction movement coupling of occluder ends via an inner and outer tube, a latching finger-like distal mechanism that cooperates with the occluder proximal end only under a defined inner-tube-in-outer-tube condition, and a drive unit interacting with the inner tube and outer tube through transmission elements and drive threads.
Opposite-direction movement-coupling of occluder ends via inner and outer tubes
An occluder with a proximal end region movement-coupled to an outer tube and a distal end region movement-coupled to an inner tube, wherein during release the drive unit moves the inner tube in a distal or proximal direction and moves the outer tube in the proximal direction or distal direction such that the distal end and proximal end of the occluder are moved away from or toward one another.
Latching finger-like distal cooperation conditioned on inner tube position
An outer tube comprising at least one latching finger-like end portion at its distal end region, wherein the latching finger-like end portion cooperates with the proximal end region of the occluder only when the inner tube is disposed inside the outer tube, and wherein a distal end of the outer tube is disposed inside the occluder during insertion.
Drive unit interacting with inner tube and outer tube through transmission elements and drive threads
A drive unit that interacts with the inner tube and the outer tube through first and second transmission elements and drive threads, such that, when actuated, the inner tube and outer tube can be moved in distal and proximal directions relative to each other to adjust the distance between the distal and proximal occluder end regions for release.
Across the independent claims, the core claim coverage centers on movement-coupled proximal and distal occluder end regions controlled by a drive unit through opposite-direction movement of an inner and outer tube, together with a latching finger-like distal end portion that engages the occluder proximal end only when the inner tube is disposed inside the outer tube.
Stated Advantages
Fluid-tight closure of the left atrial appendage is provided by a biological tissue membrane covering the occluder frame.
X-ray markers enable positioning of the occluder.
Torque minimization and reduction of displacement risk are described for the detachment/removal sequence.
Documented Applications
Insertion of a self-expandable occluder into a patient with release in the left atrial appendage of the patient.
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