Balloon Guiding Sheath Textured Surface Arteriotomy
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Solution Overview
Problem
Current thrombectomy procedures for treating acute ischemic stroke involve large arteriotomies that increase the risk of bleeding, particularly in patients receiving thrombolytics, and require lengthy placement of sheaths and balloon guide catheters.
Innovation Solution
A balloon guiding sheath with a textured surface is introduced, which allows direct insertion into a patient's vasculature through a smaller arteriotomy, providing effective navigation and rapid flow arrest by inflating an inflatable balloon on its outer surface.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a balloon guiding catheter is delivered through a sheath to the ICA, then access to the target vessel is achieved, but the arteriotomy size increases and placement time increases
Solution Approach 1:
The patent combines the functions of the guiding catheter and sheath into a single integrated balloon guiding sheath device. The device includes an elongated body with a balloon mounted on its outer surface, eliminating the need for separate sheath and catheter components. This integration allows direct access to the ICA through a smaller arteriotomy while maintaining the ability to provide proximal occlusion and deliver thrombectomy tools.
Solution Approach 2:
The balloon guiding sheath serves multiple functions simultaneously: it provides vascular access, enables proximal occlusion through balloon inflation, and acts as a delivery system for thrombectomy tools. The device can be used for both diagnostic and therapeutic purposes, replacing the need for separate guiding catheters and sheaths.
2Reliability
If a sheath and balloon guide catheter are placed separately, then access to the ICA is achieved, but the procedure time increases
Solution Approach 1:
The patent combines the functions of the guiding catheter and sheath into a single integrated balloon guiding sheath device. The device includes an elongated body with a balloon mounted on its outer surface, eliminating the need for separate sheath and catheter components. This integration allows direct access to the ICA through a smaller arteriotomy while maintaining the ability to provide proximal occlusion and deliver thrombectomy tools.
3Ease of operation
If a textured surface is added to the outer tube, then balloon inflation is improved, but device complexity increases
Solution Approach 1:
The patent applies a textured surface specifically to the outer tube in the region where the balloon will be inflated. The texture consists of raised patterns that create expansion spaces between the balloon and tube during inflation. This localized modification improves balloon deployment without requiring complex changes to the entire device structure.
Data Source
AI summary
A balloon guiding sheath may include an elongated sheath comprising a proximal end, a distal end, an inner tube, an outer tube surrounding the inner tube, an access port located adjacent the proximal end, a distal port located adjacent the distal end, and a working lumen extending between the access port and the distal port. The balloon guiding sheath may also include an inflatable balloon located on an outer surface of the elongated sheath adjacent the distal end. The balloon guiding sheath may also include a textured surface located along an outer portion of the outer tube and located beneath the inflatable balloon. The elongated sheath may be sized and configured to enable direct insertion into vasculature of a patient through an arteriotomy in at least one of a carotid artery or a vertebral artery to position the inflatable balloon at a target site.