Prostatic Urethral Stent Handle for Secure Anchoring and Retrieval
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Solution Overview
Problem
Current treatments for benign prostatic hyperplasia (BPH), such as pharmacologic approaches and surgical therapies, are inadequate in effectiveness and often come with significant side effects or complications, while existing prostatic stents suffer from poor anchoring, migration, and difficult removal, leading to poor outcomes.
Innovation Solution
A minimally invasive urethral stent designed with a proximal region for anchoring, a middle region for maintaining urethral patency, and a distal region with a handle for delivery and retrieval, constructed from materials like shape-memory alloys or flexible polymers, coated with PTFE or hydrophilic materials, and optionally with therapeutic agents, to maintain urethral patency without interfering with natural expansion and collapse.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional prostatic stents are used, then urethral patency can be maintained, but anchoring is poor and migration occurs
Solution Approach 1:
The stent is divided into distinct functional regions: a proximal anchoring region with leaflets for secure attachment, a middle expanding region for maintaining urethral patency, and a distal region with a handle for manipulation. This segmentation allows each region to perform its specific function optimally while preventing migration.
Solution Approach 2:
The proximal leaflets are configured with curved surfaces that conform to the contours of the prostatic urethra, creating a secure anchoring mechanism. The curved geometry of the leaflets allows them to engage with the urethral wall effectively, preventing stent migration while maintaining patency.
2Reliability
If surgical therapies like TURP are used, then symptom relief is achieved, but recovery time is long and complications occur
Solution Approach 1:
The patent replaces complex surgical mechanical systems (electrosurgical resection, laser ablation) with a simpler mechanical stent device that maintains urethral patency through its expanding structure. This substitution eliminates the need for extensive surgical intervention, reducing recovery time and complications while achieving effective symptom relief.
Solution Approach 2:
The stent is designed as a minimally invasive, removable device that can be easily deployed and retrieved through the urethra. This disposable-like approach (though the stent is reusable with removal capability) avoids the permanent, complex changes associated with TURP and other surgical therapies, enabling quick recovery and reduced complications.
3Loss of substance
If laser therapy is used, then blood loss is minimized, but post-operative catheterization time increases and cost increases
Solution Approach 1:
The patent replaces laser therapy with a mechanical stent solution that maintains urethral patency through physical expansion. This substitution eliminates the need for laser fiber and generator equipment, reduces post-operative catheterization time, and lowers costs while maintaining the benefit of minimal blood loss through the minimally invasive insertion approach.
4Ease of operation
If prostatic urethral lift is used, then minimally invasive treatment is achieved, but durability is questionable and painful recovery occurs
Solution Approach 1:
The stent's expanding structure with curved leaflets creates a more durable outcome by providing continuous mechanical support to the prostatic urethra. The curved geometry allows the stent to conform to the urethral contours and maintain patency more effectively over time, improving durability while maintaining the minimally invasive approach and reducing painful recovery.
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 stent effectively maintains urethral patency, reduces symptoms of BPH, minimizes patient discomfort, and avoids complications by anchoring securely within the prostatic urethra, allowing for easy deployment and retrieval, and is customizable to individual anatomical dimensions.
Implementation Method 1
A minimally invasive urethral stent designed with a proximal region for anchoring, a middle region for maintaining urethral patency
Implementation Method 2
the handle is configured to be deflected when pulled in an axial direction from the position outside of the passageway to another position in the passageway
Implementation Method 3
constructed from materials like shape-memory alloys or flexible polymers
Data Source
AI summary
A stent is disclosed that is configured to maintain patency of the prostatic urethra despite an enlarged prostate. The stent can include a handle that, in an undeflected position, is disposed outside of the flow path of the stent. When the handle is pulled, the handle can deflect to generally aligned with a central axis of the stent. A capture device is disclosed that includes a tapered tip to navigate a working channel of a delivery device and a hook that can capture the stent handle and be moved into a tube to retain the stent handle to facilitate maneuvering of the stent in and out of the working channel of the delivery device. A loading adapter with a tapered port is disclosed that can be disposed on the delivery device to distribute compressive forces applied by the port on the stent during loading into the working channel.