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Publication Number
US-9095374-B2
Publication Date
2015-08-04
Expiration Date
Abstract
A catheter having a distal balloon and a deformable guidewire shaft of the catheter. The deformable guidewire shaft is adjacent to and external to the balloon. Inflation of the balloon bends the deformable guidewire shaft in order to orient or deflect a distal tip of the deformable guidewire shaft in a desired direction to guide and direct a guidewire extending through the deformable guidewire shaft towards a specific endovascular region. For example, it may be desired to orient the distal tip of the guidewire shaft towards a target vessel of a bifurcation or the balloon catheter may be used to bypass a Chronic Total Occlusion (CTO).
Core Innovation
The invention relates to a balloon catheter comprising a main catheter shaft with a guidewire lumen and an inflation lumen, and a balloon extending from the distal end of the main catheter shaft. A deformable guidewire shaft is positioned adjacent and external to the balloon and defines a lumen in fluid communication with the guidewire lumen of the main catheter shaft. A proximal bond fixes the balloon to the main catheter shaft and a distal bond fixes the balloon to the distal end of the deformable guidewire shaft, while an intermediate portion of the deformable guidewire shaft remains unbonded to the balloon.
The catheter incorporates first and second magnetic components coupled to or insertable within the intermediate portions of the balloon and the deformable guidewire shaft respectively. These magnetic components are operable to selectively and temporarily couple the intermediate portions together. This selective coupling determines the bending behavior of the assembly during inflation, allowing for controlled mechanical manipulation of the distal assembly in situ.
Balloon inflation causes the balloon and the deformable guidewire shaft to bend in radially opposing directions when the intermediate portions are not coupled, and causes them to bend in the same direction when coupled. This behavior selectively orients the distal end of the deformable guidewire shaft in a direction different from that of the main catheter shaft. This mechanism addresses the problem of enabling precise endovascular targeting by providing directional control of the guidewire shaft relative to the main catheter shaft.
Claims Coverage
The independent claims cover two aspects: a balloon catheter structure with magnetic selective coupling and inflation-driven bending, and an in situ method that percutaneously advances the balloon catheter to a target location and orients the distal end by inflating the balloon.
Inflation-driven selective bending using magnetic coupling of balloon and deformable guidewire shaft
A balloon catheter having a main catheter shaft with a guidewire lumen and an inflation lumen, a balloon, and a deformable guidewire shaft extending adjacent and external to the balloon. A proximal bond fixes the balloon to the main catheter shaft and a distal bond fixes the balloon to the distal end of the deformable guidewire shaft, with an outer surface between the bonds not bonded to the balloon. Magnetic components associated with intermediate portions of the balloon and the deformable guidewire shaft selectively and temporarily couple the portions together, wherein inflation causes radially opposing bending when uncoupled and same-direction bending when coupled, selectively orienting the distal end in a direction different from the main catheter shaft.
In situ orientation of a deformable guidewire shaft by percutaneously advancing and inflating the balloon catheter
A method of orienting a distal end of a balloon catheter in situ comprising percutaneously advancing the balloon catheter through a vasculature to a target location. The method utilizes a catheter where a balloon and a deformable guidewire shaft are bonded at proximal and distal ends but unbonded at intermediate portions, and includes selectively and temporarily coupling said intermediate portions via magnetic components. Inflating the balloon causes the balloon and the deformable guidewire shaft to bend in radially opposing directions when not coupled and in the same direction when coupled, thereby orienting the distal end of the deformable guidewire shaft relative to the main catheter shaft.
Across the independent claims, the core coverage is for a balloon catheter where balloon inflation produces radially opposing versus same-direction bending of a deformable guidewire shaft depending on selective temporary magnetic coupling between intermediate portions of the balloon and the deformable guidewire shaft.
Stated Advantages
Selectively orienting the distal end of the deformable guidewire shaft in a direction different from that of the main catheter shaft.
Documented Applications
Targeting bifurcations with selective orientation of the deformable guidewire shaft toward a chosen endovascular target.
Bypassing chronic total occlusions (CTO), including subintimal tract creation and re-entry guidance, with optional stent deployment after guidewire/catheter positioning [procedural detail omitted for safety].
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