Vaginal Remodeling Balloon with Pulsating Thermal Stimulation
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Solution Overview
Problem
Current treatments for vaginal atrophy and vaginal relaxation syndrome (VRS) have limited success, as existing devices using energy sources like heat, light, and mechanical vibration fail to effectively activate collagen and elastin tissues, and promote tissue remodeling and blood flow, leading to inadequate vaginal rejuvenation.
Innovation Solution
A dilatation balloon system that mechanically induces stress and provides pulsating motion to the vaginal wall, adjustable in frequency and degree, combined with heated fluid to stimulate collagen remodeling and blood flow, and optional electrical stimulation for muscle contraction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If heat and mechanical energy are applied to remodel collagen and elastin, then tissue tightening is achieved, but the treatment success has been limited and inadequate vaginal rejuvenation occurs
Solution Approach 1:
The patent combines multiple energy modalities (thermal energy from heated balloon, mechanical energy from pulsating dilation, and electrical energy from stimulation electrodes) into a single integrated treatment system. This multi-modal approach addresses the limitation of single-modality treatments by simultaneously targeting collagen remodeling, tissue expansion, and muscle reactivation, thereby improving overall treatment reliability and rejuvenation effectiveness.
Solution Approach 2:
The treatment employs a composite approach by combining different forms of energy delivery (heat, mechanical pressure, electrical stimulation) through a single device platform. The balloon catheter system integrates thermal heating capability, mechanical pulsation mechanism, and electrical stimulation electrodes, creating a composite treatment modality that overcomes the inadequacies of individual energy types alone.
2Force
If a balloon is introduced into a tight vagina, then mechanical stress can be applied, but insertion discomfort and pain occur
Solution Approach 1:
The balloon is designed to be dynamically adjustable in size and compliance. It can be inserted in a collapsed state to minimize insertion trauma, then gradually inflated to the desired treatment pressure. The balloon material and inflation rate can be adjusted to match patient tolerance, allowing mechanical stress application while minimizing insertion pain through controlled, progressive expansion.
Solution Approach 2:
The system applies preliminary mechanical stress through gradual balloon inflation rather than sudden full expansion. The balloon is inflated incrementally to allow tissue adaptation and reduce shock to the vaginal wall, thereby applying the necessary mechanical stress for collagen remodeling while minimizing insertion discomfort and pain through progressive loading.
3Reliability
If pulsating motion is applied to stretch and relax vaginal wall, then collagen remodeling is enhanced, but device complexity increases
Solution Approach 1:
The pulsating motion is achieved through a pneumatic or hydraulic pump system that periodically inflates and deflates the balloon. This uses fluid pressure dynamics to create the pulsation cycle, which is mechanically simple yet effective at producing the stretching and relaxing motion needed for collagen remodeling. The pump system provides reliable pulsation without requiring complex mechanical actuation mechanisms within the balloon itself.
Solution Approach 2:
The treatment employs periodic pulsation cycles of balloon inflation and deflation rather than continuous pressure. This periodic action creates rhythmic stretching and relaxing of the vaginal wall tissues, enhancing collagen remodeling through cyclic mechanical stress. The timing and duration of pulses can be controlled to optimize tissue response while keeping the control mechanism relatively simple through basic timer or pressure-sensor feedback.
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 balloon system effectively stimulates collagen remodeling, promotes tissue rejuvenation, and improves vaginal muscle function, addressing the limitations of previous treatments by combining mechanical dilatation with heat and optional electrical stimulation for enhanced tissue response.
Implementation Method 1
The balloon can be uniformly heated by adding a heated fluid to the interior of the balloon... The fluid may be heated by low voltage heating element within the balloon, to provide heat energy to stimulate cell function, remodeling of collagen, and facilitate blood flow
Implementation Method 2
a dilatation balloon capable of mechanically inducing stress in the vaginal wall while providing a pulsating motion to stretch and relax the vaginal wall
Implementation Method 3
The fluid may be heated by low voltage heating element within the balloon
Data Source
AI summary
A system and method for vaginal remodeling and treating gynecological disorders. A vaginal remodeling system comprising a flexible, inflatable, vaginal balloon capable of transferring heat and mechanical stress in a controlled manner to restore vaginal function. The proposed method to reactivate the cells in the vaginal tissue using thermal energy and mechanical energy using balloon dilatation and/or pulsing to promote the rejuvenation of the vaginal tissue will be accomplished by the system described in this disclosure.