Multi-needle injection device for stress urinary incontinence
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Solution Overview
Problem
Current treatments for Stress Urinary Incontinence (SUI) are inadequate in effectively strengthening the pelvic floor muscles, particularly in women post-pregnancy or menopause, as they often involve invasive procedures or limited injection precision.
Innovation Solution
A multi-needle injection device with a flexible cannula and handle mechanism that allows needles to extend through apertures for precise injection of therapeutic agents into the tissue surrounding the urethra, enabling simultaneous injection at multiple locations while avoiding sensitive areas like the anterior urethra.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple separate injection procedures are performed to treat different areas of pelvic floor tissue, then comprehensive treatment coverage is improved, but patient suffering and treatment time increase
Solution Approach 1:
The patent combines multiple injection functions into a single device by incorporating multiple needles (at least two, preferably three or more) within one handle assembly. This allows simultaneous or sequential injection into multiple pelvic floor locations (anterior, lateral, posterior urethral regions) without requiring multiple separate procedures, thereby reducing treatment time while maintaining comprehensive coverage
Solution Approach 2:
The device is designed as a universal injection system that can treat all major pelvic floor regions through a single handle. The multiple needles are configured to reach different anatomical locations (anterior to pubic bone, lateral to urethra, posterior toward rectum), making the device versatile for comprehensive SUI treatment without needing procedure-specific devices
2Ease of operation
If traditional injection methods are used to strengthen pelvic floor tissue, then treatment simplicity is maintained, but injection precision and tissue targeting accuracy deteriorate
Solution Approach 1:
Each needle in the device is specifically configured for targeted injection into distinct pelvic floor regions. The needles have different orientations and projection distances to reach specific anatomical locations (anterior, lateral, posterior), allowing precise local treatment while maintaining overall operational simplicity through a single device insertion
Solution Approach 2:
The device replaces manual, imprecise injection techniques with a mechanically guided system. The handle provides structural support and positioning, while the needles are pre-configured at specific angles and depths to automatically target the correct tissue locations when inserted, reducing reliance on operator skill while improving precision
3Reliability
If invasive surgical procedures are performed to treat SUI, then treatment effectiveness is improved, but patient trauma and recovery time increase
Solution Approach 1:
The device extracts the essential therapeutic function (bulking agent injection) from invasive surgical procedures. By delivering the bulking material directly to the pelvic floor tissue through perineal insertion rather than open surgery, the device maintains treatment effectiveness while eliminating the harmful effects of extensive surgical intervention
Solution Approach 2:
The device changes the parameter of invasiveness by transitioning from surgical-grade intrusion to minimally invasive perineal injection. The needles are designed to penetrate only the necessary depth to reach the pelvic floor muscles, and the procedure can be performed in an office setting rather than operating room, reducing patient trauma while maintaining therapeutic efficacy
Data Source
AI summary
A medical device and a method of treating stress urinary incontinence are provided. The device includes a cannula with a plurality of apertures. A plurality of needles is disposed within a lumen of the cannula. A handle includes a housing and a shifter mechanism to translate the plurality of needles from a first position in which the needles are disposed within the lumen of the cannula, to a second position in which a distal portion of each needle extends out of the lumen through respective apertures. The handle also includes a slot including a transversal track defining a potential range of rotational motion of the shifter mechanism with respect to the housing, and a plurality of longitudinal tracks defining a potential range of translational motion of the shifter mechanism with respect to the housing. The shifter mechanism may also rotate the cannula with respect to the handle.