Closed-System Bladder Catheter for Chemotherapy Containment
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Solution Overview
Problem
Current intravesical chemotherapy treatments for bladder cancer lack a closed-system approach, leading to hazardous drug exposure risks and increased costs due to the need for hospital settings equipped with biological safety cabinets and specialized waste handling facilities, limiting outpatient procedures and increasing patient inconvenience.
Innovation Solution
The GENIUS™ system provides a fully closed-system device for administering and disposing of chemotherapy drugs, featuring a pre-filled syringe with attached administration and drainage components, a three-way stopcock for fluid control, and a self-contained waste reservoir, ensuring the chemotherapy drug remains contained from start to finish without requiring disassembly or exposure to the environment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If current open-system methodologies are used for intravesical chemotherapy administration, then the procedure can be performed with simple catheter and syringe components, but hazardous drug exposure risks increase and require hospital settings with specialized safety infrastructure
Solution Approach 1:
The system is divided into distinct functional modules: a closed-system transfer device for safe drug transfer, a catheter assembly for administration, and a waste collection system. Each segment maintains closure integrity independently, allowing the hazardous chemotherapy drug to be contained throughout the entire procedure without requiring complex integrated systems.
Solution Approach 2:
A closed-system transfer device acts as an intermediary between the chemotherapy vial and the catheter assembly. This intermediate device provides a controlled environment for drug transfer, eliminating direct exposure risks while simplifying the overall system architecture by pre-assembling the connection interface.
2Reliability
If a closed-system approach is implemented for chemotherapy administration, then hazardous drug containment is improved, but device complexity and initial cost increase
Solution Approach 1:
The catheter assembly integrates multiple functions into a single unit: the catheter shaft, balloon for retention, and integrated waste collection chamber are merged into one component. This reduces the number of separate pieces that need to be connected and maintained, simplifying the closed system while improving reliability.
Solution Approach 2:
The catheter assembly is pre-assembled with the waste collection chamber and closure mechanisms in place before use. The balloon is pre-positioned and the waste chamber is pre-sealed, eliminating the need for complex assembly steps during the procedure and reducing operational complexity.
3Object-affected harmful factors
If hospital settings with biological safety cabinets are required for chemotherapy administration, then safe drug handling is ensured, but patient convenience decreases and outpatient procedures are limited
Solution Approach 1:
The catheter assembly includes an integrated waste collection chamber that automatically collects and contains the chemotherapy drug after administration. The system is self-contained with all necessary safety features built-in, eliminating the need for external biological safety cabinets or specialized hospital infrastructure, thereby enabling outpatient procedures.
4Adaptability or versatility
If separate CSTD and catheter components are used as in prior art systems, then flexibility in component selection is maintained, but the system cannot provide a single closed path from beginning to end of procedure
Solution Approach 1:
The catheter assembly serves multiple functions within the closed system: it acts as the delivery conduit for the chemotherapy drug, the retention mechanism through the balloon, and the waste collection chamber. This multi-functional design provides a single closed path for the entire procedure while maintaining the flexibility to adapt to different patient needs through adjustable components.
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
This solution reduces the need for hazardous handling controls, allows urologists to perform procedures in outpatient settings, decreases costs, and enhances patient convenience by maintaining drug containment and safety throughout the treatment process, eliminating the need for hospital-based administration.
Implementation Method 1
the medicament pressure reservoir being configured to store negative pressure that withdraws from the organ used chemotherapy medicament through the drain lumen and the stopcock
Data Source
AI summary
A closed-system, drug administering catheter assembly includes a transfer adapter, a stopcock, a medicament injector containing chemotherapy medicament, a medicament pressure reservoir, and a urethral balloon catheter comprising a drain lumen and a distal tip, all connected together in a closed-system. The medicament injector is configured to inject the chemotherapy medicament through the stopcock, the drain lumen, and into an environment of the distal tip within a patient's organ without leakage of the chemotherapy medicament from the patient into an environment of the patient. The medicament pressure reservoir is configured to store negative pressure that withdraws from the organ used chemotherapy medicament through the drain lumen and the stopcock and holds the used chemotherapy medicament in the medicament pressure reservoir without leakage of the used chemotherapy medicament into the environment of the patient.