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Publication Number
US-9398921-B2
Publication Date
2016-07-26
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
A balloon catheter includes a main catheter shaft with a guidewire lumen and an inflation lumen, and a balloon extending from a distal end of the main catheter shaft. The inflation lumen is in fluid communication with an interior of the balloon to enable balloon inflation, and a deformable guidewire shaft extends from the distal end of the main catheter shaft, adjacent and external to the balloon, defining a lumen in fluid communication with the guidewire lumen of the main catheter shaft.
The balloon is fixed to the main catheter shaft and to the deformable guidewire shaft using a proximal bond and a distal bond. The proximal bond fixes a proximal end of the balloon to a distal end of the main catheter shaft, and the distal bond fixes a distal end of the balloon to a distal end of the deformable guidewire shaft, with an outer surface of the deformable guidewire shaft between the proximal and distal bonds not bonded to the balloon.
Upon inflation, balloon inflation causes the balloon and the deformable guidewire shaft to bend in radially opposing directions. This bending orients the distal end of the deformable guidewire shaft in a direction different from that of the main catheter shaft, enabling in situ orientation toward a direction different from the main catheter shaft. Embodiments further include visualization features using a radiopaque marker band and additional configurations that allow bending in the same radial direction or selectively directed output using magnetic coupling components, including an electromagnet variant.
Claims Coverage
The document includes two independent claims: one to a balloon catheter and one to a method of orienting a distal end in situ. The independent claim set is built around a radially opposing bending mechanism that orients a deformable guidewire shaft distal tip in a direction different from the main catheter shaft.
Radially opposing bending to orient a deformable guidewire shaft distal tip
A balloon catheter having a main catheter shaft with a guidewire lumen and an inflation lumen, a balloon extending from the distal end of the main catheter shaft, and a deformable guidewire shaft extending from the distal end of the main catheter shaft adjacent and external to the balloon. The balloon has a proximal bond fixing the proximal end of the balloon to the distal end of the main catheter shaft and a distal bond fixing the distal end of the balloon to the distal end of the deformable guidewire shaft, with an outer surface of the deformable guidewire shaft between the proximal and distal bonds not bonded to the balloon. Balloon inflation causes the balloon and the deformable guidewire shaft to bend in radially opposing directions, thereby orienting the distal end of the deformable guidewire shaft in a direction different from that of the main catheter shaft.
In situ percutaneous advancement and inflation to orient the deformable guidewire shaft distal tip
A method of orienting a distal end of a balloon catheter in situ by percutaneously advancing the balloon catheter through a vasculature to a target location and inflating the balloon. The balloon catheter includes a main catheter shaft with a guidewire lumen and an inflation lumen in fluid communication with an interior of the balloon, and a deformable guidewire shaft adjacent and external to the balloon with a lumen in fluid communication with the guidewire lumen. A proximal bond fixes a proximal end of the balloon to a distal end of the main catheter shaft and a distal bond fixes a distal end of the balloon to a distal end of the deformable guidewire shaft, with an outer surface of the deformable guidewire shaft between the proximal and distal bonds not coupled to the balloon. Inflating the balloon causes the balloon and the deformable guidewire shaft to bend in radially opposing directions, thereby orienting the distal end of the deformable guidewire shaft in a direction different from that of the main catheter shaft.
Across both independent claims, the core inventive coverage is the coupling-free outer intermediate portion of the deformable guidewire shaft to the balloon, combined with balloon inflation that bends the balloon and the deformable guidewire shaft in radially opposing directions to orient the deformable guidewire shaft distal end away from the main catheter shaft direction.
Stated Advantages
Orients the distal end of the deformable guidewire shaft in a direction different from that of the main catheter shaft.
Enables in situ orientation of the deformable guidewire shaft toward a direction different from the main catheter shaft.
Documented Applications
Orienting the deformable guidewire shaft toward specific branches at a bifurcation.
Assisting subintimal crossing and re-entry in chronic total occlusion (CTO) using a selectively directed deformable tip to orient the distal end in a direction different from that of the main catheter shaft.
Optionally followed by stent deployment in the subintimal reentry conduit.
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