Compressible Vaginal Insert for Pelvic Organ Support
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Solution Overview
Problem
Current solutions for pelvic organ prolapse and urinary/fecal incontinence, such as surgical mesh and pessaries, come with complications like mesh erosion, discomfort, and difficulty in self-insertion/removal, necessitating frequent medical interventions and limiting their widespread use.
Innovation Solution
A vaginal insert device with a cone-shaped body and rib structure that applies adjustable pressure to the organ wall, allowing for easy insertion and removal without physician intervention, and can be reusable or disposable, addressing the need for a non-surgical, comfortable, and convenient solution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical mesh is placed through the vagina to treat POP and SUI, then symptoms are ameliorated, but serious complications occur including mesh erosion, pain, infection, and organ perforation
Solution Approach 1:
The patent describes a disposable vaginal insert device that is used for a limited period (e.g., during exercise or specific activities) and then discarded. This eliminates the long-term presence of foreign material in the vagina, avoiding complications like mesh erosion and chronic infection while providing temporary symptom relief when needed.
Solution Approach 2:
The device changes its physical parameters by expanding from a compressed insertion state to a functional expanded state within the vagina. This allows the same device to be easily inserted (small dimensions) and then provide adequate support (larger dimensions) without requiring complex adjustment mechanisms or long-term adaptation.
2Reliability
If traditional pessaries are placed in the vagina for extended periods, then POP and SUI are managed, but the devices are uncomfortable and difficult for patients to insert and remove
Solution Approach 1:
The device incorporates dynamic characteristics by being compressible and expandable. It is inserted in a compressed state that fits easily through the vaginal opening, then expands to its functional shape to provide support. This dynamic transformation eliminates the need for complex insertion tools and makes removal simpler, as the device can be compressed for extraction.
Solution Approach 2:
The device is designed as a unitary compressed structure that segments the insertion process into two simple stages: insertion in compressed form and expansion to functional form. This segmentation avoids the need for multiple components or complex assembly procedures during insertion and removal.
3Reliability
If pessaries require regular office visits with a physician for insertion and removal, then proper placement is ensured, but patient convenience and widespread use are limited
Solution Approach 1:
The device is designed to be self-inserted and self-removed by the patient without requiring physician intervention. The compressed-functional expansion mechanism enables patients to perform the insertion and removal themselves, eliminating the need for repeated office visits while maintaining proper device placement through intuitive design.
4Reliability
If a vaginal insert device applies pressure to the organ wall to treat incontinence and prolapse, then symptoms are improved, but the device must remain in place for extended periods limiting convenience
Solution Approach 1:
The device is designed for periodic use rather than continuous wear - inserted before activities that trigger symptoms (such as exercise) and removed afterward. This periodic application provides treatment when needed while allowing the vagina to remain free of foreign material during other times, improving comfort and convenience.
Data Source
AI summary
The present disclosure, in certain embodiments, relates to a flexible and non-absorbent vaginal insert device that is easier to insert and remove and is for use in improving and preventing symptoms associated with pelvic organ prolapse and urinary and/or fecal incontinence when the device is inserted. In certain embodiments, the device has an optionally cone-shaped upper portion that provides pelvic organ support and a removal portion or stem that facilitates insertion and removal of the device.