Fractional RF Grid Array for Tissue Heating and Collagen Stimulation
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Solution Overview
Problem
Existing treatments for urinary and fecal incontinence, pelvic prolapse, and pelvic pain face challenges such as limited durability, compatibility issues, and inconsistent results due to the risk of burns and uneven energy distribution.
Innovation Solution
A medical device utilizing a grid fractional radiofrequency (RF) array with monopolar microelectrodes delivers RF energy to target tissues, heating them to a temperature that stimulates the production of type 1 collagen without burning the tissue, thereby addressing the issues of incontinence and prolapse.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If radiofrequency energy is applied to heat target tissue to stimulate collagen production, then tissue strength is improved, but risk of burns increases
Solution Approach 1:
The patent divides the radiofrequency energy delivery system into multiple microelectrodes arranged in a grid pattern. Each microelectrode delivers a portion of the total RF energy, distributing the thermal load across many small contact points rather than concentrating it at a single point. This segmentation allows the tissue to be heated to collagen-stimulating temperatures without creating localized burn zones.
Solution Approach 2:
The patent creates different thermal zones at different depths of the tissue. The epidermis is protected from excessive heating while the dermis and deeper target tissues are heated to the optimal temperature range for collagen production. This localized temperature control enables selective heating of specific tissue layers with different thermal requirements.
2Productivity
If radiofrequency energy is concentrated to heat target tissue effectively, then treatment efficacy is improved, but uniformity of energy distribution deteriorates
Solution Approach 1:
The grid of microelectrodes segments the RF energy delivery across multiple points, ensuring that energy is distributed uniformly across the entire treatment area. Each microelectrode contributes equally to the overall heating effect, creating consistent thermal zones throughout the target tissue without hot or cold spots.
Solution Approach 2:
The patent combines the effects of multiple microelectrodes into a unified thermal field within the target tissue. While each microelectrode delivers energy locally, the cumulative effect creates a broad, uniform heating pattern in the dermis and deeper tissues, merging individual electrode effects into a cohesive treatment zone.
3Duration of action of moving object
If high radiofrequency power is applied to achieve therapeutic heating, then collagen production is stimulated, but tissue damage increases
Solution Approach 1:
By dividing the total RF power across numerous microelectrodes, each electrode operates at a low power level that is safe for direct tissue contact. The cumulative effect of all microelectrodes achieves the therapeutic power level needed for collagen stimulation, but the segmented delivery prevents localized tissue damage that would occur with a single high-power electrode.
Solution Approach 2:
The microelectrode grid design inherently cushions the tissue from excessive energy concentration at any single point. The distributed electrode arrangement acts as a protective mechanism, ensuring that even if one electrode delivers slightly more energy than intended, the overall energy distribution remains within safe limits due to the buffering effect of surrounding electrodes.
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 achieves consistent and reproducible results by uniformly distributing RF energy, reducing the risk of burns, and promoting the production of type 1 collagen, leading to improved tissue strength and reduced incontinence symptoms.
Implementation Method 1
using radiofrequency (RF) energy to heat target tissue to a temperature that is sufficient to simulate fibroblasts within the body to produce mostly type 1 collagen without burning the tissue
Implementation Method 2
The grid fractional applicator spreads out the RF energy to protect the epidermis and creates a uniform thermal zone in the dermis for safe, reproducible and consistent results
Data Source
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AI summary
A device and method for treating female urinary incontinence and also for treating fecal incontinence are presented. A fractional RF grid array is used to heat target tissue to a temperature of about 40 - 45° C for a specified period of time, thus stimulating fibroblasts to produce type 1 collagen preferably without producing significant amounts of type 3 collagen. The device includes a temperature sensor and a control circuit to maintain the desired temperature of the target tissue and avoid overheating. Target tissue includes tissue in and around the urethra, and in and around the anus including the perineum. The wand to which the RF grid array is mounted has visible gradations on it so that the user can treat one area at a time, then reliably move the grid array to the next adjacent area even though the grid array is hidden from view inside a portion of the body. The device can also be used for vaginoplasty.