Catheter Balloon with Protective Element for Drug Delivery
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Solution Overview
Problem
Existing catheter systems for localized drug delivery face challenges in protecting the balloon inflation structure from needle damage during expansion and ensuring separate transit of guidewires, activation fluids, and drugs, while also providing accurate needle placement and indicating the balloon's position and expansion status.
Innovation Solution
A medical instrument featuring a catheter shaft assembly with an inflatable body, a tissue penetrating member, and a protective element, where the inflatable body is inflatable from a contracted configuration to expanded configurations, and includes separate lumens for guidewires, drugs, and inflation fluids, with a torque transmission system for precise needle placement and a radio-opaque protective element for visualization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the inflatable body is expanded to expose the tissue penetrating member for drug delivery, then the drug delivery function is enabled, but the inflatable body may be damaged by the sharp needle tip during expansion
Solution Approach 1:
The catheter is pre-configured with the needle enclosed within the inflatable body in a safe, protected state before use. The operator first inflates the balloon to expand the catheter, which automatically exposes the needle tip in a controlled manner, ensuring the needle is only exposed when needed and not during insertion or storage
Solution Approach 2:
The inflatable body acts as an intermediary mechanism between the needle and the external environment. By controlling the inflation and deflation of this intermediate structure, the needle can be safely enclosed during transit and then exposed for drug delivery when required, protecting the needle from damage while enabling its function
2Reliability
If separate lumens are used for guidewires, drugs, and inflation fluids, then fluid separation is maintained, but the device complexity increases
Solution Approach 1:
The catheter is divided into multiple separate lumens, each dedicated to a specific function: one lumen for the guidewire, another for drug delivery, and a third for inflation fluid. This segmentation ensures that fluids remain separated and do not mix, maintaining reliability while organizing complexity into distinct, manageable channels
Solution Approach 2:
The catheter shaft is designed as a multi-functional structure that simultaneously accommodates multiple lumens for different purposes. This universal design allows a single catheter device to perform multiple functions (guidewire support, drug delivery, balloon inflation) without requiring separate devices, thereby managing complexity through integration rather than multiplication of components
3Length of moving object
If the needle is carried on the exterior of the expansible surface structure, then the needle penetration depth is maximized, but the routing of fluids through catheter tubing and into needles requires design complexity for focally sealing tubings
Solution Approach 1:
The needle is nested within or integrated with the expansible surface structure rather than being completely external. The fluid routing system is similarly nested within the catheter walls, with sealing mechanisms integrated into the structure itself. This nesting approach allows the needle to extend outward for deep penetration while keeping fluid pathways compact and sealed within the catheter body, reducing the complexity of external sealing arrangements
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 ensures the balloon is protected during expansion, maintains fluid separation, and enables accurate and predictable needle placement, enhancing the efficiency and precision of localized drug delivery.
Implementation Method 1
the inflatable body being inflatable from a contracted configuration to one or more expanded configurations
Implementation Method 2
a radio-opaque protective element for visualization
Data Source
Figure 1
Figure 2
Figure 3A~3B
AI summary
Disclosed herein are medical instrument and medical method for localized drug delivery. The medical instrument can comprise a catheter shaft assembly, a hub coupled to the proximal end of the catheter shaft assembly, an inflatable component at the distal end of the catheter shaft assembly, a tissue penetrating member coupled to the inflatable component in an orientation transverse to the longitudinal axis of the catheter shaft assembly, and at least one protective element coupled to the inflatable component in proximity to the tissue penetrating member. The protective element can be configured to prevent any damage of the inflatable body during a placement of the medical instrument and an actuation of the inflatable component.