Subcutaneous Ureteral Bypass Device with Self-Sealing Septum
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Solution Overview
Problem
Current ureteral bypass devices face issues such as dislodgement, discomfort, invasive placement, large size, and concerns of occlusion or encrustation, particularly in small pediatric and veterinary patients, where traditional surgical or endourological procedures are risky or impractical.
Innovation Solution
A ureteral bypass device comprising nephrostomy and cystostomy catheters with locking mechanisms and a shunting port for secure placement under the skin or within the abdominal cavity, allowing for fluidic connection and enabling diagnostic and therapeutic procedures without invasive methods, with a self-sealing septum for access and a design suitable for various patient sizes and species.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical or endourological procedures are used for ureteral obstructions, then the obstruction can be treated, but the procedures are associated with excessive morbidity or mortality, are impossible due to size or anatomy, or are contraindicated in small pediatric and veterinary patients
Solution Approach 1:
The patent introduces a percutaneous nephrostomy tube as an intermediary device that creates a direct drainage pathway from the renal pelvis to the external environment or urinary bladder, bypassing the obstructed ureter. This intermediary approach avoids the risks of traditional surgical procedures while effectively treating ureteral obstructions in small pediatric and veterinary patients who would otherwise be unsuitable candidates for conventional treatments.
Solution Approach 2:
The patent replaces complex surgical mechanical systems (open surgery, endourological instruments) with a simpler percutaneous insertion system. The nephrostomy tube is inserted through a small puncture in the kidney using minimal instrumentation, substituting the need for complex surgical mechanical systems while achieving the same therapeutic goal of relieving ureteral obstruction.
2Duration of action of stationary object
If an externalized percutaneous nephrostomy tube is used for long-term drainage, then urinary diversion is achieved, but the device requires regular exchanges, carries risk of urinary tract infections, urinary leakage and catheter dislodgement, and impairs quality of life
Solution Approach 1:
The patent extracts the problematic externalized catheter system and replaces it with an internalized subcutaneous tunnel system. The nephrostomy tube is routed through a subcutaneous tunnel to the urinary bladder, removing the external component that causes social embarrassment and quality of life impairment while maintaining long-term drainage capability and reducing infection risk.
Solution Approach 2:
The patent creates a self-retaining system where the nephrostomy tube is secured within the renal pelvis and bladder through internal locking mechanisms and the subcutaneous tunnel provides natural retention. The system serves itself by utilizing the patient's own anatomy (subcutaneous tissue, urinary bladder) to maintain the drainage pathway without requiring external fixation or frequent medical intervention.
3Reliability
If subcutaneous urinary diversion devices are used to internalize the nephrostomy catheter, then infection, leakage and dislodgement are reduced, but the device complexity increases and placement becomes more difficult
Solution Approach 1:
The patent merges multiple functions into a single integrated nephrostomy tube system: the tube provides drainage, the subcutaneous tunnel provides retention and protection, and the internal locking mechanisms provide secure anchoring. This consolidation reduces the need for separate components and simplifies the overall device structure while maintaining high reliability and reducing complications.
Solution Approach 2:
The patent utilizes the flexible subcutaneous tissue as a natural protective shell and retention mechanism for the nephrostomy tube. The subcutaneous tunnel acts as a flexible barrier that protects the tube from dislodgement and infection while allowing natural body movements. This use of the patient's own flexible tissue eliminates the need for complex artificial retention structures.
4Device complexity
If non-locking pigtail catheters or non-fenestrated double-pigtail stents are used, then the device structure is simpler, but dislodgement and occlusion occur frequently
Solution Approach 1:
The patent applies preliminary action by pre-forming the locking loops and fenestrations in the nephrostomy tube before insertion. The locking loops are pre-shaped to engage with the renal pelvis and bladder walls, and fenestrations are pre-positioned to ensure proper drainage. This preliminary preparation ensures reliable retention and patency from the moment of insertion without requiring complex adjustment procedures.
Solution Approach 2:
The patent applies local quality by adding locking loops at specific locations (distal end for renal pelvis engagement, proximal end for subcutaneous retention) and fenestrations at strategic positions along the tube. These localized structural features provide enhanced retention and drainage functionality without significantly increasing overall device complexity, addressing the specific needs of different anatomical regions.
Data Source
AI summary
A ureteral bypass device and procedure suitable for performing internal urinary diversions within patients, including patients such as humans and veterinary animals (cats and dogs). The device includes a nephrostomy catheter having a proximal end, an oppositely-disposed distal end, and means for securing the distal end within the renal pelvis of a kidney of a patient, a cystostomy catheter having a proximal end, an oppositely-disposed distal end, and means for securing the distal end of the cystostomy catheter within the urinary bladder of the patient, and an adaptor fluidically connected to the proximal ends of the nephrostomy and cystostomy catheters so as to fluidically connect the nephrostomy and cystostomy catheters together through the adaptor. If implanted subcutaneously, the adaptor may include an entry site that has a self-sealing septum that can be accessed with a needle while the device remains implanted and secured under the skin to subcutaneous tissue.