Subcutaneous CSF Access Device with Sealing Membrane
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Solution Overview
Problem
Current methods for accessing cerebrospinal fluid (CSF) are outdated and suffer from deficiencies such as patient discomfort and safety risks due to exposed proximal ends of CSF drains.
Innovation Solution
The development of a CSF-access device with a central bore and lateral channels, featuring a delivery assembly for minimally invasive over-the-wire implantation, an epidural-blocking structure, and a tissue anchor for secure placement and repeated access without repeated dura puncture.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current methods of accessing CSF are used, then CSF can be accessed, but patient comfort deteriorates and safety risks increase due to exposed proximal ends of CSF drains
Solution Approach 1:
The proximal end of the CSF drain is extracted from the exposed position and relocated to a subcutaneous pocket, separating the functional distal end from the vulnerable proximal end. This extraction eliminates the harmful exposure while preserving the necessary CSF access function.
Solution Approach 2:
A subcutaneous pocket acts as an intermediary structure between the exposed skin and the CSF drain. This intermediary protects the proximal end from direct exposure to the external environment, reducing infection risk while maintaining access capability.
2Adaptability or versatility
If repeated dura puncture is performed for CSF access, then CSF can be accessed multiple times, but patient comfort deteriorates and safety risks increase
Solution Approach 1:
The device is preliminarily configured with a reusable access mechanism that establishes a permanent pathway. This preliminary setup eliminates the need for repeated puncture actions, providing adaptability for multiple accesses while preventing the discomfort and risks associated with repeated trauma.
3Device complexity
If proximal end of CSF drain is left exposed, then device structure is simple, but patient comfort deteriorates and infection risk increases
Solution Approach 1:
The device is segmented into functional components: the distal end for CSF access, the proximal end for external connection, and an intermediate subcutaneous pocket for protection. This segmentation allows each component to serve its specific function while collectively reducing infection risk without excessive complexity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The CSF-access device provides increased patient comfort and safety by allowing subcutaneous implantation of the proximal end, reducing the risk of infection, and enabling repeated access to the CSF space without repeated dura puncture.
Implementation Method 1
a magnetic collar configured to guide and otherwise facilitate coupling of the proximal end of the device to a distal end of a device-retrieval assembly
Implementation Method 2
a piercing stylet disposed within the delivery needle and configured to pierce a dura of the patient to gain access to a CSF space of the patient
Implementation Method 3
the balloon can be deflated and removed from the CSF-space in a low-profile configuration
Data Source
AI summary
A device for accessing a cerebrospinal fluid of a patient is provided. The device can include a central conduit that defines a central bore, which extends from a proximal end of the device to a distal end of the device. The device can further include a shunting port on the central conduit and within a longitudinal distance of 6 mm from the distal end of the device. The device further include a sealing membrane at the proximal end that forms a fluidic seal at the proximal end of the central bore.