CED Device Tissue-Receiving Space and Bullet Nose for Backflow Prevention
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Solution Overview
Problem
Convection-enhanced delivery systems face challenges with backflow of infused fluid along the insertion pathway due to the poroelastic nature of tissues, particularly in the brain, which affects the distribution and penetration of therapeutic agents.
Innovation Solution
The development of CED devices with a tissue-receiving space that compresses tissue to form a seal, combined with a bullet-shaped nose to reduce backflow, and a micro-tip with a fluid channel system that includes a first outer sheath and a catheter body, allowing for controlled delivery of therapeutic agents with minimal reflux.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If infusion velocity is increased to enhance drug penetration into target tissue, then delivery efficiency is improved, but backflow of infused fluid along the insertion pathway increases
Solution Approach 1:
The tissue-receiving space is formed by compressing tissue with the device structure before infusion begins. This preliminary compression creates a sealed environment that prevents backflow before the infusion process starts, allowing high infusion velocities to be used without fluid loss along the insertion pathway.
Solution Approach 2:
The outer sheath acts as an intermediary structure between the infusion catheter and the surrounding tissue. It creates a controlled interface that directs fluid flow into the target tissue while preventing reflux along the catheter surface, effectively mediating between the high-velocity infusion and the tissue environment.
2Adaptability or versatility
If flexible microcatheter designs are used to reduce backflow, then device adaptability is improved, but backflow prevention effectiveness is insufficient
Solution Approach 1:
The invention combines the flexible microcatheter design with an outer sheath and tissue-receiving space structure. This merging of components creates a hybrid system that maintains the adaptability of flexible catheters while adding the backflow prevention capabilities of a sealed delivery system.
Solution Approach 2:
The device uses composite construction with an inner catheter and outer sheath, creating a multi-layered structure. This composite design allows the inner catheter to remain flexible for navigation while the outer sheath provides structural support and backflow prevention, combining properties of different materials and structures.
3Reliability
If seal formation is improved to prevent backflow, then delivery reliability is improved, but tissue trauma increases
Solution Approach 1:
The tissue-receiving space is created through dynamic compression during device insertion rather than permanent tissue displacement. The compression is applied temporarily to form the seal, then maintained at a level that prevents backflow while minimizing ongoing tissue damage. This dynamic approach allows seal formation with reduced trauma compared to static anchoring methods.
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 solution effectively reduces or prevents backflow, enhancing the penetration and distribution of therapeutic agents into target tissues, enabling higher delivery rates and more uniform distribution with reduced tissue trauma.
Implementation Method 1
Tissue can be compressed into or pinched/pinned by the tissue-receiving space as the device is inserted into a target region of a patient, thereby forming a seal that reduces or prevents proximal backflow of fluid ejected from the outlet beyond the tissue-receiving space.
Implementation Method 2
delivering fluid containing the therapeutic agent under positive pressure through the fluid conduit and into a portion of the tissue adjacent to a distal end of the fluid conduit
Data Source
AI summary
Systems and methods are disclosed herein that generally involve CED devices with various features for reducing or preventing backflow. In some embodiments, CED devices include a tissue-receiving space disposed proximal to a distal fluid outlet. Tissue can be compressed into or pinched/pinned by the tissue-receiving space as the device is inserted into a target region of a patient, thereby forming a seal that reduces or prevents proximal backflow of fluid ejected from the outlet beyond the tissue-receiving space. In some embodiments, CED devices include a bullet-shaped nose proximal to a distal fluid outlet. The bullet-shaped nose forms a good seal with surrounding tissue and helps reduce or prevent backflow of infused fluid.


