Pressure-Controlled Catheter Delivery for Targeted Tissue Infusion
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Solution Overview
Problem
Existing treatments for diseases like pancreatic cancer and diabetes face inefficiencies due to inadequate delivery of therapeutic agents to target tissues, such as the pancreas, leading to reduced drug concentrations and unintended exposure to non-target organs, and current catheter technologies lack precise control over infusion pressure and vessel isolation.
Innovation Solution
A system comprising an outer guide sheath and two catheters with distal occlusion devices, including a dynamic microvalve and static balloon, allows for precise delivery of therapeutic agents under controlled pressure into small feeder vessels, isolating the target area and preventing reflux or leakage into unintended tissues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If sub-selective endovascular injection of cells is used to treat pancreatic disease, then cells can be delivered to the pancreas, but the number of cells reaching the target tissue varies and non-target organs are exposed to inadvertent exposure
Solution Approach 1:
The system divides the vascular supply to the pancreas into separate segments by using multiple catheters positioned in different feeder vessels (splenic artery and superior mesenteric artery). This segmentation allows independent control of cell delivery to specific pancreatic regions, improving precision while avoiding non-target organs.
Solution Approach 2:
The system applies local quality by delivering cells through specific feeder vessels that have preferential flow to particular pancreatic regions. By selecting appropriate feeder vessels and using occlusion devices, the system ensures cells are delivered to the intended target tissue rather than being distributed systemically.
2Quantity of substance
If intra-arterial chemotherapy is administered through small catheters, then higher drug concentration can reach the tumor, but catheter localization is difficult due to redundant blood supply and anatomical variability
Solution Approach 1:
The system performs preliminary action by using pre-formed catheter assemblies with integrated occlusion devices that can be positioned and secured before drug delivery begins. The catheters are designed with specific tip configurations and occlusion mechanisms that facilitate accurate placement in feeder vessels prior to chemotherapy administration.
Solution Approach 2:
The system uses an intermediary approach by employing occlusion devices (such as balloons or filters) as mediators between the catheter and the vascular system. These intermediaries help anchor the catheter in place and control the release of drug-loaded cells, facilitating both accurate localization and controlled delivery.
3Quantity of substance
If treatment is infused under significant pressure to increase delivery, then higher drug concentration reaches the tumor, but treatment can reflux into healthy tissues causing harm
Solution Approach 1:
The system converts the potentially harmful reflux effect into a beneficial feature by using pressure-responsive occlusion devices. The occlusion devices are designed to open under pressure to allow forward flow of treatment to the tumor, but automatically close when pressure reverses or equalizes to prevent reflux into healthy tissues. This transforms a potential harm into a protective mechanism.
Solution Approach 2:
The system applies dynamics by using pressure-responsive occlusion devices that automatically adjust their state based on intravascular pressure changes. The occlusion devices transition between open and closed states in response to pressure gradients, enabling the system to adapt to changing hemodynamic conditions and prevent reflux while maintaining delivery.
4Productivity
If standard catheters are used for intra-arterial delivery, then treatment can be administered, but control of infused treatment is limited and flow is from high pressure to low pressure areas
Solution Approach 1:
The system applies self-service by incorporating pressure-responsive occlusion devices that automatically regulate treatment flow based on intravascular pressure conditions. The occlusion devices self-adjust without external control, using their pressure-sensitive properties to open under forward flow conditions and close under reflux conditions, thereby providing intelligent pressure control while maintaining system simplicity.
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 system ensures targeted delivery of therapeutic agents to deep tissues by maintaining pressure differentials and vessel isolation, enhancing treatment efficacy while minimizing exposure to non-target organs.
Implementation Method 1
When the treatment agent is infused, the pressure in the vessel downstream (distal) of the treatment is always higher than that upstream (proximal) of the treatment, causing the microvalve to open and block reflux of the agent
Implementation Method 2
The microporous polymer allows generation of fluid pressure at one side of the microvalve, while blocking particles on the pressurized side of the microvalve that exceed 5 μm from passing through the microvalve
Implementation Method 3
The pressure-control element may be a dynamic device or a static device... A dynamic pressure-control element may include a microvalve that automatically expands to the diameter of the vessel in which it is deployed when subject to predetermined fluid pressure conditions
Data Source
AI summary
A treatment system includes a guide sheath, and a catheter provided with a pressure-controlled element. The pressure-control element preferably includes an expanded configuration adapted to extend across a small feeder vessel branching from the splenic vein. The pressure-control element is positioned with the feeder vessel, and a therapeutic agent is delivered under pressure directly into the feeder vessel, where it is forced to penetrate deep into tissue. Pressure responsive elements for monitoring intravascular pressure are also provided to time delivery of the therapeutic agent for maximum uptake by the target organ. Methods for treating tissues and organs via vascular pathways are provided.