Expandable Urethral Scaffolding for BPH Tissue Displacement

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Solution Overview

Problem

Current treatments for benign prostatic hyperplasia (BPH) are invasive, associated with complications, and often require anesthesia, making them unsuitable for long-term management, especially in outpatient settings, and can be challenging to diagnose and manage without elaborate urodynamic evaluation.

Innovation Solution

A scaffolding device with tissue-engaging portions and a bi-directional expansion member that transitions between compressed and deployed configurations to increase the cross-sectional area of a body lumen, such as the prostatic urethra, facilitating tissue displacement and patency restoration without the need for anesthesia or elaborate testing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If transurethral resection of the prostate or targeted tissue removal using directed energy is used, then the obstructing prostate tissues are removed, but complications such as bladder neck contracture, impotence, retrograde ejaculation occur and general or regional anesthesia is required

Engineering Contradiction:
Improveeffectiveness of BPH treatmentVSAvoidcomplications and anesthesia requirements
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces mechanical tissue removal (resection) and thermal ablation with a mechanical expansion system. The expandable implant physically displaces obstructing prostate tissue to enlarge the urethral lumen without removing or destroying tissue, thereby avoiding complications associated with tissue removal and thermal damage while eliminating the need for general or regional anesthesia

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the physical parameters of the urethral lumen by introducing an expandable implant that increases the cross-sectional area and diameter of the urethra. This parameter change (from normal to expanded) provides sufficient luminal patency to relieve obstruction caused by enlarged prostate tissue without requiring tissue removal

Inventive Principle:
Principle #35Parameter changes

2Duration of action of moving object

If long-term urethral stents are used, then management of BPH is attempted, but encrustation occurs and removal becomes difficult

Engineering Contradiction:
Improvelong-term BPH managementVSAvoidencrustation and removal difficulty
Core Design Contradiction:
Duration of action of moving objectVSObject-generated harmful factors

Solution Approach 1:

The patent employs a flexible expandable implant with radial expansion capability that can be easily inserted and removed. The flexible construction allows the device to navigate the urethra during insertion and be collapsed for removal, preventing the encrustation problems associated with rigid stents and enabling simple extraction without surgical intervention

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The patent uses a dynamic expandable implant that can transition between compressed and expanded states. This dynamic特性 allows the device to be easily inserted in a compressed state, expanded to provide long-term BPH management, and readily removed by collapsing it, thereby avoiding the encrustation and removal difficulties of static stents

Inventive Principle:
Principle #15Dynamics

3Ease of operation

If indwelling urinary catheter or intermittent self-catheterization is used, then urinary management is achieved, but patient discomfort and inconvenience increase along with risk of urinary tract infection and hematuria

Engineering Contradiction:
Improveurinary managementVSAvoidpatient discomfort, infection risk, and hematuria
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent provides a self-service solution where the expandable implant automatically maintains urethral patency through its expanded structure, eliminating the need for continuous catheterization or self-catheterization procedures. The device serves itself by maintaining the enlarged luminal diameter that prevents obstruction, thereby eliminating patient discomfort, infection risks, and hematuria associated with long-term catheter use

Inventive Principle:
Principle #25Self-service

Data Source

PatentEP3393372B1System for increasing a cross-sectional area of a body lumen
Publication Date: 2024.06.19 PRODEON MEDICAL CORP
  • EP3393372B1 patent drawingFigure 1~2
  • EP3393372B1 patent drawingFigure 3~4
  • EP3393372B1 patent drawingFigure 5~8

AI summary

Devices and methods are disclosed for managing and/or treating body tissues obstructing a hollow body lumen, such as the prostatic lobe tissues obstructing the urethra. A scaffolding may be provided with opposing tissue-engaging portions and at least one expansion member configured to transition between a compressed configuration having a reduced distance between the tissue-engaging portions and a deployed configuration having an increased distance between the tissue-engaging portions.