Electronic Inflatable Penile Implant System (EIPIS) for Erectile Dysfunction and Gender-Affirming Surgeries

Abstract

This invention introduces an advanced Electronic Inflatable Penile Implant System (EIPIS) specifically designed for erectile dysfunction treatment and gender-affirming surgeries. The EIPIS comes in two activation variants: one operated through integrated manual buttons or a dedicated Android mobile app, enabling flexible control, and the other featuring a hands-free activation method utilizing EEG signals from a wearable device, allowing neural signal-based management. Each variant includes an electronically controlled inflatable implant crafted with biocompatible materials, mechanical structures, and embedded circuitry to ensure consistent functionality and reliability. Furthermore, the system integrates a Wireless Power Transfer System (WPTS) that enables non-invasive battery recharging via external skin contact pads. An accompanying mobile app enhances the user experience, offering customizable control options for erectile dysfunction patients and transgender individuals seeking artificial male genitalia. This invention marks a significant advancement in penile implant technology, providing a user-friendly, efficient solution for medical and gender-affirming applications.

Specification

Description:TITLE OF THE INVENTION
Electronic Inflatable Penile Implant System (EIPIS) for Erectile Dysfunction and Gender-Affirming Surgeries

FIELD OF THE INVENTION
This invention relates to medical devices and, more specifically, to an electronically inflatable penile implant system designed for the treatment of erectile dysfunction and as an aid in gender-affirming surgeries. The invention provides a flexible, non-invasive method of activating and controlling the implant, enhancing user convenience, accessibility, and power efficiency.

BACKGROUND OF THE INVENTION
Erectile dysfunction (ED) and the creation of artificial male genitalia for transgender individuals undergoing female-to-male (FTM) transitions are significant medical challenges. Traditional solutions for ED often include mechanical or hydraulic implants requiring manual activation, which may be physically demanding or intrusive. Gender-affirming surgeries face similar challenges in offering practical, user-friendly devices for FTM individuals.
Existing penile prostheses are generally limited by manual or physically restrictive activation methods and invasive battery recharging procedures. Furthermore, the lack of non-invasive control mechanisms limits these devices' accessibility to individuals with restricted mobility. There is, therefore, a need for an advanced penile implant system that offers dual-mode activation, hands-free control, and wireless recharging capabilities.
OBJECTIVES OF THE INVENTION (EIPIS)
The present invention relates to an advanced Electronic Inflatable Penile Implant System (EIPIS) specifically designed to treat erectile dysfunction (ED) and serve as a surgical aid in gender-affirming procedures. The invention comprises two variants, each providing unique activation methods and functionalities. The objectives of the invention are as follows:
1. To Provide a Reliable Solution for Erectile Dysfunction Treatment
• To develop a penile implant system that offers effective, consistent, and reliable artificial erectile support for individuals suffering from erectile dysfunction.
• To improve the quality of life for ED patients by restoring sexual functionality through a dependable implant mechanism.
2. To Facilitate Gender-Affirming Surgical Procedures
• To provide a comprehensive solution in penile implant technology that assists in creating functional artificial male genitalia for female-to-male transgender individuals.
• To support gender-affirming surgery by delivering controlled erectile functionality, allowing for a realistic experience that aligns with the specific requirements of transgender individuals.
3. To Offer Dual Activation Mechanisms for User Flexibility
• Variant 1: To provide a user-friendly control system with manual buttons and a dedicated Android mobile application, granting flexibility and ease of use in controlling the implant's inflation and deflation functions.
• Variant 2: To introduce an innovative control mechanism utilizing EEG signal extraction technology, enabling hands-free activation of the implant by capturing neural signals through a wearable EEG device. This feature is intended for users with limited physical mobility, enhancing accessibility.
4. To Ensure Biocompatibility and Safety of the Implant System
• To design the implant using biocompatible materials that are safe for long-term implantation, ensuring minimal adverse reactions and promoting patient safety.
• To incorporate a Battery Management System (BMS) that monitors battery status and health, thereby reducing risks associated with implanted electronic devices and enhancing the safety of the system.
5. To Integrate Wireless Power Transfer Technology (WPTS) for Non-Invasive Recharging
• To include a Wireless Power Transfer System that enables the implant's battery to be recharged through external skin pads, thereby avoiding the need for invasive procedures to replace or recharge the battery.
• To enhance user convenience and improve implant longevity by providing an efficient, seamless power management solution that supports the system's continuous operation.
6. To Develop a Mobile Application for Personalized Control and Monitoring
• To create a dedicated mobile application that facilitates easy management of the implant's functions, allowing users to customize settings and operate the implant conveniently.
• To provide an intuitive, secure, and user-friendly interface that caters to both ED patients and transgender individuals, thereby offering a solution that meets diverse user requirements.
7. To Ensure Discretion, Privacy, and Security of the Implant System
• To design the implant system in a way that enables users to discreetly activate and control its functions, ensuring privacy and avoiding undue attention.
• To incorporate secure communication protocols, particularly in the mobile application and EEG-controlled variant, to safeguard user data and prevent unauthorized access to the implant's control system.
8. To Promote Accessibility for Individuals with Physical Mobility Limitations
• To make the implant accessible for users with varying levels of mobility by providing both manual and EEG-controlled activation options, thereby enhancing inclusivity.
• To enable operation by individuals who may have physical limitations, allowing them to control the implant without relying on complex or challenging physical actions.
9. To Advance Penile Implant Technology through Innovative Features
• To introduce new features in penile implant systems, such as brain-computer interfacing via EEG signals and wireless power transfer, which represent significant advancements in this field of medical devices.
• To establish a new standard in penile implant technology by integrating state-of-the-art electronics with biocompatible materials, creating a sophisticated solution for ED treatment and gender-affirming surgeries.
The aforementioned objectives aim to provide an innovative, user-centric implant solution that addresses the needs of individuals with erectile dysfunction and transgender individuals seeking gender-affirming surgery. The invention emphasizes ease of control, safety, accessibility, and advanced technological integration, thus establishing a significant advancement in penile implant technology.

SUMMARY OF THE INVENTION
The present invention provides an advanced Electronic Inflatable Penile Implant System (EIPIS) that addresses the limitations of traditional penile implants by offering flexible activation modes, wireless recharging, and compatibility with non-invasive control technologies. The invention comprises two product variants:
Variant 1: Activated by manual buttons integrated within the device or remotely via a dedicated Android mobile application.
Variant 2: Features EEG signal extraction technology that allows hands-free activation through neural signals captured by a portable EEG wearable device.
Both variants feature an inflatable penile implant constructed from biocompatible materials, embedded with an electronic circuit, and powered by a Wireless Power Transfer System (WPTS). This system allows for non-invasive battery recharging through external skin pads, eliminating the need for surgical intervention for battery replacement. A specialized mobile application provides an intuitive interface, enabling users to control the implant's functions, catering to erectile dysfunction patients and transgender individuals seeking artificial male genitalia.

DETAILED DESCRIPTION OF THE INVENTION
Components of the System
Implant Structure:
The penile implant is composed of biocompatible materials suitable for long-term implantation, minimizing risks of rejection or adverse reactions.
The implantable structure is designed to inflate and deflate electronically, mimicking natural erection functionality. The inflatable portion contains chambers that expand upon activation, creating an erection, and deflate upon deactivation.
Dual-Mode Activation:
Manual Activation (Variant 1): The implant includes integrated buttons allowing the user to manually control the inflation and deflation functions.
Remote Control via Mobile Application (Variant 1): A dedicated Android mobile application provides users with a remote-control option, allowing easy activation and deactivation without direct physical contact.
EEG-Based Hands-Free Activation (Variant 2): This variant includes EEG signal extraction technology, which uses a wearable device to capture and interpret neural signals. The system processes EEG data, enabling hands-free control of the implant's inflation and deflation functions. This feature enhances accessibility for users with physical limitations.
Wireless Power Transfer System (WPTS):
The implant includes a wireless charging module designed to recharge the device's battery through external skin pads. This module uses inductive coupling, enabling efficient, non-invasive battery charging and eliminating the need for surgical intervention for battery replacement.
Embedded Electronic Circuit:
The implant houses an embedded electronic circuit responsible for regulating the inflation and deflation processes. The circuit ensures stable and consistent performance, regardless of environmental conditions or user handling.
Mobile Application:
The Android-based mobile application provides users with a simple interface to control the implant. The application allows users to adjust inflation levels, monitor battery status, and access a range of customization options for a personalized user experience.
The app is designed to serve both erectile dysfunction patients and transgender individuals, allowing comprehensive control over the implant's functionality.

DESCRIPTION OF DRAWINGS
Description of Drawing 1
The diagram illustrates the core components and system architecture of the Electronic Inflatable Penile Implant System (EIPIS), segmented into two main subsystems: the Electronic System and the Mechanical System. A Wireless Interface connects the system to a dedicated Android application, providing user control and management.
1. Electronic System
Microcontroller/Processor: Central to the control operations, the microcontroller or processor manages signals, data processing, and device functionality.
Network Connectivity Modules: These modules facilitate wireless communication between the implant and the Android application, enabling remote control and monitoring.
Motor: The motor drives the Pump in the Mechanical System, controlling the inflation and deflation of the implant's inflatable cylinders.
Implant Power Management:
• BMS (Battery Management System): Manages battery health, charging, and discharging cycles to optimize power usage and maintain safety.
• Implantable Battery Pack: Powers the implant, designed for safe, long-term implantation.
• WPTS (Wireless Power Transfer System) Receiver Section: This component receives power from external skin pads for wireless charging, eliminating the need for invasive battery replacement.
2. Mechanical System
Reservoir: Holds fluid that is transferred to the inflatable cylinders upon activation.
Pump: Controlled by the motor, the pump moves fluid from the reservoir into the inflatable cylinders for erection and back into the reservoir for deflation.
Two Inflatable Cylinders: Placed within the penile shaft, these cylinders expand or contract depending on fluid transfer, enabling erection and deflation functions.
3. Wireless Interface
The wireless interface enables communication between the Electronic System and the Android Application, allowing the user to control the inflation and deflation functions remotely. This application provides a user-friendly interface for patients, offering flexible control over the implant's functions.
This structured system design ensures efficient operation and user control, addressing the specific needs of erectile dysfunction treatment and gender-affirming procedures. The integration of power management, wireless charging, and network connectivity enhances the implant's reliability and convenience for users.

Description of Drawing 2
The block diagram illustrates the design and functionality of the Brain-Controlled Electronic Inflatable Penile Implant System (EIPIS). This system introduces an advanced control method that incorporates EEG signal extraction for hands-free operation, in addition to the core Electronic and Mechanical subsystems. The Body Implant System is primarily controlled through a Wearable EEG Signal Extraction Device, interfaced via a Low Power BLE Connectivity Module.
1. Brain Control Implant System
Wearable EEG Signal Extraction Device: This device is designed to detect and process EEG signals from the user's brain, facilitating hands-free control of the implant.
Low Power BLE Connectivity Module for Interfacing: Enables communication between the EEG device and the implant's control circuitry, allowing seamless transmission of brain-derived control signals.
Serial Read EEG Data/Signal: This component receives EEG data from the wearable device, interprets the signals, and converts them into commands to control the inflation and deflation of the implant.
2. Electronic System: (As Describe in Description of Drawing 1) Same Electronic system we are using for EEG brain activated EIPIS variant.
3. Mechanical System: (As Describe in Description of Drawing 1) Same mechanical system we are using for EEG brain activated EIPIS variant.
4. Wireless Implant Control Circuitry
Acts as a bridge between the EEG control signals and the implant's electronic system, ensuring that commands from the brain are accurately interpreted and executed by the implant.
5. Body Implant System
This is the complete assembly of the electronic and mechanical components embedded within the body, enabling controlled erectile function through both manual and EEG-based commands.
This system architecture allows for a sophisticated method of controlling penile inflation, offering options for both manual and brain-controlled activation. The inclusion of EEG-based control enhances accessibility for users with limited mobility, and the wireless power transfer feature provides convenient recharging without invasive procedures. This innovation presents a comprehensive solution for both erectile dysfunction and gender-affirming surgeries, with a strong emphasis on user convenience, flexibility, and advanced functionality.
, C , C , Claims:Claims
1. A penile implant system comprising:

an electronically inflatable implant;

a dual-mode activation mechanism capable of: a) manual activation via integrated physical buttons on the implant, and b) remote activation via a dedicated mobile application on a wireless device;

wherein said dual-mode activation mechanism provides flexible and personalized control over the inflation and deflation functions of the implant based on the user's physical ability and preference.
2. A penile implant system as claimed in Claim 1, wherein the implant further comprises:

an EEG-controlled activation mechanism configured to receive neural signals from a wearable EEG device;

wherein said EEG-controlled activation mechanism enables hands-free inflation and deflation of the implant based on detected EEG signals, enhancing accessibility for users with limited physical mobility.
3. A penile implant system as claimed in Claim 1, wherein the system includes a Wireless Power Transfer System (WPTS), comprising:

an implantable power receiver configured to receive wireless power from an external skin pad;

wherein said WPTS facilitates battery recharging of the implant's power source without invasive procedures, thus reducing the need for surgical intervention for battery maintenance.
4. A penile implant system as claimed in Claim 1, wherein the implant is constructed from biocompatible materials, comprising:

a selection of non-reactive and medically approved materials for safe, prolonged implantation;

wherein the biocompatible construction reduces the risk of rejection and ensures compatibility with surrounding tissue over extended periods.
5. A penile implant system as claimed in Claim 1, further comprising:

 an embedded electronic circuit within the implant, configured to regulate inflation and deflation operations precisely;

 wherein said embedded electronic circuit provides consistent and reliable operational performance under various user conditions.
6. A penile implant system as claimed in Claim 1, wherein the system further comprises a dedicated mobile application, the application comprising:

 a user interface configured to allow users to control and monitor the implant's functions;

 customizable settings for inflation and deflation levels;

 wherein said mobile application provides a user-friendly means for managing the implant, particularly tailored to individuals requiring erectile support or gender-affirming functionality.
7. A penile implant system as claimed in Claim 2, wherein the EEG-controlled activation mechanism is configured to interpret neural signals for controlling inflation and deflation without manual input, comprising:

 a signal processing module that analyzes EEG signals and converts them into control commands;

 wherein said neural activation allows users with limited hand mobility to control the implant effectively.
8. A penile implant system as claimed in Claim 1, designed to support both erectile dysfunction treatment and gender-affirming surgical applications, comprising:

 an inflatable penile implant that serves as artificial male genitalia when fully inflated, tailored for transgender individuals undergoing female-to-male transition;

 wherein said design provides versatility, addressing the needs of both erectile dysfunction patients and transgender individuals.
9. A penile implant system as claimed in Claim 1, further comprising:

 a power management system configured to optimize energy consumption for prolonged battery life;

 wherein said power management system enhances user convenience by minimizing the frequency of battery recharging and maximizing device operational intervals.

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