Vaginal Atrophy Device Using Negative Pressure Microtrauma
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Solution Overview
Problem
Current treatments for vaginal atrophy, particularly in postmenopausal women and breast cancer survivors, lack affordability, safety, and effectiveness, with existing methods failing to address the underlying hormonal changes causing vaginal dryness and inflammation without causing irreversible damage to the vaginal epithelium.
Innovation Solution
A device configured for self-administered use that applies mechanical microtrauma to the vaginal wall through negative pressure therapy, stimulating angiogenesis and collagen production by creating micro-deformations such as micro-tears, punctures, or stretches, to stimulate the production of Hyaluronic Acid and improve tissue health.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If hormonal treatments are used to treat vaginal atrophy, then symptoms are temporarily relieved, but side effects and safety concerns arise
Solution Approach 1:
The patent replaces hormonal (chemical) treatment with a mechanical system that uses a vacuum pump to apply negative pressure through apertures, creating controlled microtrauma to stimulate tissue regeneration. This mechanical approach eliminates the side effects associated with hormonal therapy while maintaining treatment effectiveness.
Solution Approach 2:
The device enables self-administered treatment by the patient without requiring medical intervention or hormonal substances. The mechanical microtrauma therapy stimulates the body's own natural healing processes, allowing the vaginal tissue to regenerate using the patient's inherent biological mechanisms rather than external hormonal agents.
2Reliability
If mechanical microtrauma is applied to stimulate angiogenesis, then tissue regeneration is improved, but excessive tissue damage may occur
Solution Approach 1:
The device applies mechanical microtrauma locally through multiple small apertures distributed across the treatment surface, creating focused micro-deformations in specific areas of the vaginal wall rather than widespread damage. This localized approach stimulates angiogenesis and tissue regeneration in targeted regions while minimizing overall tissue injury.
Solution Approach 2:
The device applies a controlled degree of negative pressure that creates partial microtrauma - sufficient to stimulate the healing response and angiogenesis but not excessive enough to cause severe damage. The vacuum pump parameters are calibrated to achieve the optimal level of mechanical stress for tissue regeneration without crossing into harmful territory.
3Reliability
If multiple treatment parameters are optimized for effectiveness, then treatment results improve, but device complexity increases
Solution Approach 1:
The device is segmented into distinct functional components: a vacuum pump for generating negative pressure, a treatment module with multiple apertures for delivering mechanical microtrauma, and a control system. This segmentation allows each component to be optimized independently for its specific function while maintaining overall treatment effectiveness, and simplifies manufacturing and maintenance.
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 device effectively treats vaginal atrophy by promoting angiogenesis, thickening the vaginal wall, reducing dryness, and improving moisture retention without causing excessive tissue damage, providing a safe and non-hormonal solution for millions of women affected by this condition.
Implementation Method 1
the device being arranged to generate, in use, a negative pressure at the apertures
Implementation Method 2
Mechanical microtrauma refers to small deformations to the vaginal wall due to physical interaction between the device and wall that are sufficient to cause inflammation-induced angiogenesis
Data Source
AI summary
A device (1, 20, 100, 200) to treat vaginal atrophy comprising a treatment module (2, 21, 101, 201) configured for insertion into the vagina and having a microtrauma module. The micro trauma module is configured to deliver negative pressure mechanical microtrauma therapy to a wall of the vagina when inserted. The microtrauma module comprises a plurality of apertures (6, 106, 206) in fluidic connection with a vacuum pump, the device being arranged to generate a negative pressure at the apertures (6, 106).


