Reproductive Tract PEF Catheter for Scar-Free Cervical Ablation
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Solution Overview
Problem
Current treatments for conditions like cervical intraepithelial neoplasia (CIN) and cervical cancer in situ (CIS) often result in complications such as infection, bleeding, scarring, and impact on fertility due to the removal of deeper tissues, leading to potential cervical lumen narrowing and premature labor.
Innovation Solution
A catheter system with energy delivery bodies, such as cup-shaped or expandable electrodes, is used to deliver non-thermal pulsed electric fields (PEFs) to target tissues within the reproductive tract, selectively destroying abnormal cells while preserving the collagen structure and avoiding scarring, using bipolar or monopolar configurations with external return electrodes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional treatments remove deeper tissues to treat CIN and CIS, then abnormal cells are effectively eliminated, but scarring and cervical lumen narrowing occur leading to infertility and preterm labor
Solution Approach 1:
The patent applies pulsed electric fields with specific parameters (voltage, pulse duration, frequency) to selectively destroy abnormal cells while preserving healthy tissue architecture. By controlling the electrical parameters, the treatment achieves effective cell elimination without the thermal damage and scarring associated with conventional methods.
Solution Approach 2:
The invention replaces mechanical surgical removal of tissue with non-thermal pulsed electric field application. This substitution eliminates the need for physical tissue excision that causes scarring and structural damage, while still achieving complete elimination of abnormal cells through electroporation.
2Reliability
If conventional surgical methods are used to treat cervical dysplasia, then abnormal tissue is removed, but complications such as infection and bleeding occur
Solution Approach 1:
The patent replaces mechanical surgical procedures with non-invasive pulsed electric field delivery through a catheter system. This eliminates open surgical wounds that predispose patients to infection and bleeding, while maintaining effective treatment of abnormal cervical tissue.
Solution Approach 2:
The invention uses a catheter as an intermediary device to deliver pulsed electric fields internally to the cervical tissue. This allows targeted treatment without external incisions or surgical access, thereby preventing complications associated with surgical entry points.
3Reliability
If deeper tissues are removed to ensure complete treatment of CIN and CIS, then abnormal cell elimination is improved, but cervical structure is damaged leading to premature labor
Solution Approach 1:
The patent utilizes controlled pulsed electric field parameters to achieve selective cell destruction limited to the epithelial layer where CIN and CIS occur. By adjusting voltage and pulse duration, the treatment spares deeper stromal tissues and maintains cervical structural integrity necessary for pregnancy.
Solution Approach 2:
The invention applies treatment with localized effect confined to the abnormal epithelial cells through controlled electric field penetration depth. This localized action eliminates the need to remove deeper healthy tissues, preserving cervical strength and function while treating the pathology.
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 system effectively treats abnormal cells without causing scarring, maintaining tissue patency and reducing complications like infertility and preterm labor, while allowing for the regeneration of healthy tissue.
Implementation Method 1
deliver non-thermal pulsed electric fields (PEFs) to target tissues within the reproductive tract, selectively destroying abnormal cells while preserving the collagen structure
Implementation Method 2
The energy comprises non-thermal energy and treating the area of tissue comprises destroying at least a portion of cells within the area of tissue while maintaining its collagen structure
Data Source
AI summary
Devices, systems and methods are provided for treating conditions of the reproductive tract. A number of conditions can afflict the lining and cell layers deeper within the anatomical structures. For example, cervical intraepithelial neoplasia (CIN), also known as cervical dysplasia, is a condition involving abnormal growth of cells on the surface of the cervix that could potentially lead to cervical cancer in situ (CIS). Other conditions include human papillomavirus (HPV)-related cervical disease, various endometrial diseases, acute and chronic cervicitis, and various infections (e.g. trichomoniasis) to name a few. In some embodiments, treatments eliminate diseased, damaged, abnormal or otherwise undesired cells leaving the tissue framework intact. This allows the tissue to regenerate in a normal fashion, avoiding the formation of scar tissue. When the tissue framework is left intact, the framework structure repopulates with healthy cells, regenerating the normal tissue without altering the structural properties.