Intravaginal Electrical Stimulation Device for Pelvic Pain
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current devices for treating pelvic pain, such as TENS, are ineffective due to their inability to deliver direct and consistent electrical stimulation to the neural pathways responsible for pelvic pain, leading to limited relief for women suffering from dysmenorrhea, dyspareunia, and chronic pelvic pain.
Innovation Solution
An intravaginal electrical stimulation device (IVES) that uses intravaginal components with paracervical electrodes and an external controller to deliver personalized, low-voltage electrical stimulation directly to the pelvic and paracervical nerves, allowing for neuromodulation and reduction or elimination of pelvic pain.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If TENS devices are used to treat pelvic pain, then electrical stimulation is provided to the lower abdomen or back, but the stimulation areas are far removed from the neural pathways, resulting in limited and inconsistent pain relief
Solution Approach 1:
The invention transitions from external abdominal/back stimulation to internal vaginal stimulation, changing the spatial dimension of electrode placement. This allows electrodes to be positioned in direct contact with or close proximity to the pelvic nerves, fundamentally altering the treatment approach from distant indirect stimulation to direct neural pathway stimulation.
Solution Approach 2:
The vaginal cavity serves as an intermediary space that provides direct access to the pelvic nerves. By placing electrodes within the vagina, the device creates a direct transmission path for electrical stimulation to reach the neural structures, eliminating the need for distant external application and improving both reliability and effectiveness.
2Reliability
If electrical stimulation is applied directly to pelvic nerves via intravaginal components, then neuromodulation effectiveness is improved, but device complexity increases
Solution Approach 1:
The device is divided into separate modular components: an intravaginal portion with electrodes that can be inserted into the vagina, and an external controller that remains outside the body. This segmentation allows the complex electrical stimulation functionality to be isolated in the external controller while the intravaginal portion remains relatively simple, improving both effectiveness and ease of use.
Solution Approach 2:
The external controller serves multiple functions: it generates the electrical stimulation signals, controls the timing and parameters of delivery, and interfaces with the user. This multi-functionality consolidates complex operations into a single external device, reducing the complexity burden on the intravaginal components.
3Reliability
If personalized low-voltage electrical stimulation is delivered directly to pelvic nerves, then pain relief reliability is improved, but energy consumption increases
Solution Approach 1:
The electrical stimulation is delivered in periodic pulses rather than continuous current. The external controller can program specific pulse frequencies, durations, and intervals, allowing energy to be delivered only when needed for neuromodulation. This periodic delivery pattern maintains effective pain relief while significantly reducing overall energy consumption compared to continuous stimulation.
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 IVES device provides effective and direct neuromodulation of pelvic and paracervical nerves, reducing or eliminating pelvic pain associated with dysmenorrhea, dyspareunia, and chronic pelvic pain, offering more reliable relief compared to existing treatments.
Implementation Method 1
deliver personalized, low-voltage electrical stimulation directly to the pelvic and paracervical nerves
Implementation Method 2
The IVES device provides effective and direct neuromodulation of pelvic and paracervical nerves
Data Source
Figure 1
Figure 2
Figure 3A
AI summary
An intravaginal electrical stimulation device for treating pelvic pain in a female patient comprises a set of intravaginal components and an external controller. The intravaginal components include a frame, at least one pair of paracervical electrodes embedded in the proximal portion of the frame, an intravaginal capsule, an electrode plug that plugs into a socket in the proximal end of the capsule, and connecting wires that electrically couple the electrode plug to the paracervical electrodes. The intravaginal components are designed to inserted into the patient's vagina so that the paracervical electrodes are in direct contact with the vaginal epithelium in the lateral vaginal fornices. Electronics, including a microprocessor and an electrical stimulation generator, are configured to generate and transmit low-voltage electrical current to the paracervical electrodes to create an electrical field that neuromodulates the pelvic and paracervical nerves, the nerves that innervate the uterus, and other anatomical structures of the lower pelvis, which tends to reduce or eliminate pelvic pain. The set intravaginal components are configured so that a woman can easily insert them into her vagina (with or without a medical practitioner being present). The external controller, which communicates with the intravaginal components over a wireless data communication channel, sends instructions to and receives status updates from the microprocessor inside the intravaginal capsule. The external controller may be operated by the female patient to control the electrical profile (e.g., frequency, amplitude and duration) of the electrical stimulation delivered to her body, and thereby cause the intravaginal components to deliver well-controlled, personalized, electrical stimulation to her pelvic and paracervical nerves when she is experiencing pain, or when she anticipates the onset of pelvic pain due to, for example, menstruation or sexual intercourse.