Endovenous Cerebrospinal Fluid Shunt Delivery Without Cranial Surgery
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Solution Overview
Problem
Conventional cerebrospinal fluid (CSF) shunts require invasive cranial surgery, which is risky and has high failure rates, and safer alternatives for implantation are needed to reduce complications and improve shunt longevity.
Innovation Solution
An endovenous approach is used to position a CSF shunt in the spinal canal, with an inlet region in the intradural space and an outlet region in a venous pathway, utilizing a guide catheter, anchor, and sheath to navigate through veins and stabilize the shunt, and incorporating anti-reflux and flow-regulating features.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional cranial surgery is used to implant CSF shunts, then CSF diversion function is achieved, but surgical risk and failure rate increase
Solution Approach 1:
The patent inverts the conventional cranial surgical approach by implementing an endovenous delivery method. Instead of accessing the intradural space through the skull, the shunt is delivered through venous pathways (superior vena cava, brachiocephalic veins) to reach the target location, thereby avoiding cranial surgery risks while achieving the same CSF diversion function
Solution Approach 2:
The patent uses the venous system as an intermediary pathway to deliver the shunt to the intradural space. The shunt is introduced through peripheral veins, navigated through the venous system using guide catheters and stylets, and positioned in the target location without direct cranial access, thus reducing surgical trauma and complications
2Object-affected harmful factors
If endovenous approach is used to position CSF shunt, then surgical risk is reduced, but procedural complexity increases
Solution Approach 1:
The delivery system is segmented into distinct functional components: a guide catheter for venous navigation, a stylet with radiopaque markers for positioning guidance, and the shunt device itself. This segmentation allows each component to perform its specific function while simplifying the overall procedural steps and reducing the learning curve for operators
Solution Approach 2:
The patent incorporates radiopaque markers on the stylet and shunt components that appear as distinct radiopaque signals on fluoroscopic imaging. These visual indicators change the appearance on imaging modalities to provide real-time feedback on device position and orientation, simplifying the navigation process and reducing procedural complexity
3Reliability
If shunt inlet region is positioned in intradural space, then CSF diversion effectiveness is improved, but risk of intradural complications increases
Solution Approach 1:
The shunt design incorporates self-positioning features including a stylet with radiopaque markers that guide the inlet region to the optimal location in the intradural space. The stylet's radiopaque signals provide real-time feedback during fluoroscopic guidance, allowing the device to self-correct its position and reduce the risk of malpositioning-related complications
Solution Approach 2:
The patent replaces traditional mechanical anchoring mechanisms with fluoroscopic guidance and radiopaque marker-based positioning. The stylet's radiopaque signals allow for precise non-contact positioning and verification, reducing mechanical trauma to surrounding tissues and minimizing the risk of intradural complications
Data Source
AI summary
A method including: introducing a shunt into a vascular system, wherein the shunt includes an inlet aperture in an inlet region and an outlet aperture in an outlet region; positioning the inlet region into an epidural or intervertebral vein; with a stylet, puncturing a wall of the epidural or intervertebral vein, traversing an interstitial space, and puncturing a thecal sac, wherein the stylet includes a wire extending through the shunt; moving the shunt to cause the inlet region to extend through a wall of the epidural or intervertebral vein; moving the shunt to cause the inlet region to extend into an interstitial space; and moving the shunt to cause the inlet region to extend through the thecal sac, such that the inlet region is positioned in an intradural space, and such that the outlet region is positioned in a venous pathway.


