Subcutaneous Ureteral Bypass Device with Sampling Port
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Solution Overview
Problem
Existing ureteral obstruction treatments, particularly in small patients like children and animals, face issues such as excessive morbidity, mortality, infection, discomfort, and device complications like encrustation, kinking, and dislodgement, with traditional methods being invasive and ineffective.
Innovation Solution
A ureteral bypass device with catheters secured within the renal pelvis and bladder, a subcutaneous port for sampling and flushing, and a non-dynamic reservoir to prevent encrustation and infection, allowing for long-term, non-invasive management.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional externalized percutaneous nephrostomy tube is used for long-term urinary diversion, then urinary drainage can be provided, but regular catheter exchanges, urinary tract infections, urinary leakage, catheter dislodgement, and impaired quality of life occur
Solution Approach 1:
The device is divided into distinct segments: a nephrostomy catheter portion positioned in the renal pelvis, a cystostomy catheter portion positioned in the urinary bladder, and a subcutaneous port portion. This segmentation allows each component to perform its specific function while reducing complications associated with single long catheters.
Solution Approach 2:
The nephrostomy and cystostomy catheter portions are nested within a single subcutaneous port structure, with both catheter portions fluidly connected to the port. This nested configuration internalizes the drainage system, eliminating external tubes and reducing infection risk while maintaining long-term drainage reliability.
2Object-affected harmful factors
If subcutaneous ureteral bypass devices are used, then infection and leakage risks are reduced, but device complexity and surgical invasiveness increase
Solution Approach 1:
The subcutaneous port serves multiple functions: it acts as a reservoir for both the nephrostomy and cystostomy catheter portions, provides a access point for urine sampling and flushing, and eliminates the need for external tubes. This multi-functionality reduces overall device complexity despite the internalized structure.
Solution Approach 2:
The device enables self-service through the subcutaneous port, which allows for urine sampling, flushing, and potential medication administration without requiring surgical intervention or external tube management. This reduces the need for regular nursing care and hospital visits.
3Measurement precision
If traditional diagnostic methods are used for device testing, then accurate diagnosis can be obtained, but invasive and expensive procedures are required
Solution Approach 1:
The subcutaneous port acts as an intermediary access point that enables non-invasive sampling and flushing of the urinary system. Instead of requiring cystoscopy or other invasive diagnostic procedures, clinicians can obtain urine samples and perform flushing through the port, maintaining diagnostic accuracy while greatly improving ease of operation.
4Reliability
If small patients (pediatric and veterinary) receive traditional surgical procedures for ureteral obstruction, then obstruction can be relieved, but excessive morbidity and mortality occur
Solution Approach 1:
The segmented catheter design with separate nephrostomy and cystostomy portions allows for smaller individual catheter diameters suitable for pediatric and veterinary patients, while still providing effective obstruction relief through the combined system.
Solution Approach 2:
Instead of performing complex open surgical procedures to relieve obstruction, the device inverts the approach by creating a bypass system that diverts urine flow around the obstruction through the subcutaneous port, achieving relief with minimal surgical intervention and reduced morbidity.
Data Source
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AI summary
Ureteral bypass devices and procedures for performing internalized urinary diversions within patients. Such a procedure includes implanting a first catheter and securing a distal end of the first catheter within the renal pelvis or ureter of a patient, implanting a cystostomy catheter through and securing a distal end of the cystostomy catheter within the urinary bladder of the patient, fluidically connecting proximal ends of the first and cystostomy catheters to an adapter, and then subcutaneously implanting a sampling/flushing port and fluidically connecting a proximal end of the sampling/flushing port to the adapter via a third catheter to yield an artificial ureteral bypass device, in which the first and cystostomy catheters are fluidically connected together and fluidically connected to the subcutaneously-placed sampling/flushing port.