Endometrial Ablation Device with Flexible Membrane Electrode
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Solution Overview
Problem
Existing endometrial tissue ablation systems are complex and costly, requiring expensive materials and manufacturing techniques, and lack a simple mechanism for maintaining consistent contact with the uterine fundus during the ablation procedure.
Innovation Solution
An endometrial tissue treatment device featuring an elongate positioning member with an energy applicator and an expandable-collapsible support structure, including a non-compliant balloon that self-expands to conform to the uterine cavity, and a tensioning member to ensure contact with the fundal wall, along with a moisture-permeable electrode array for RF energy delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If complex materials and manufacturing techniques are used in existing endometrial tissue ablation systems, then reliability and ablation effectiveness are improved, but device complexity and manufacturing cost increase
Solution Approach 1:
The patent employs a flexible membrane as the electrode carrying member instead of complex rigid structures. This thin film approach maintains ablation effectiveness while significantly reducing device complexity and manufacturing cost. The membrane can conform to the uterine cavity shape and delivers RF energy effectively through its flexible, conformable structure.
Solution Approach 2:
The patent changes the physical state and properties of the electrode carrying member from rigid to flexible membrane form. This parameter change allows the device to achieve reliable tissue contact and effective ablation through the membrane's ability to conform to tissue surfaces, eliminating the need for complex rigid positioning mechanisms.
2Reliability
If complex materials and manufacturing techniques are used in existing endometrial tissue ablation systems, then ablation effectiveness is improved, but manufacturing cost increases
Solution Approach 1:
The flexible membrane electrode carrying member can be manufactured using simpler, less expensive processes compared to rigid structured systems. The membrane approach reduces material costs and manufacturing complexity while maintaining the ability to deliver effective RF ablation energy to the endometrial tissue.
Solution Approach 2:
The patent employs a disposable flexible membrane that can be manufactured at low cost and discarded after single use. This approach eliminates the need for expensive, complex reusable systems while ensuring consistent performance and eliminating sterilization requirements, thereby reducing overall manufacturing and operational costs.
3Reliability
If existing ablation systems are used, then ablation function is achieved, but consistent contact with the uterine fundus cannot be maintained
Solution Approach 1:
The flexible membrane naturally conforms to the contours of the uterine cavity including the fundus region. This conformability ensures consistent tissue contact across the entire treatment surface without requiring complex mechanical positioning systems, springs, or actuators to maintain contact pressure.
Solution Approach 2:
The flexible membrane is self-adjusting and automatically conforms to the uterine cavity shape upon insertion and inflation. This self-service characteristic eliminates the need for complex external control mechanisms to maintain consistent contact, as the membrane adapts passively to the tissue geometry through its inherent flexibility.
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 provides effective and efficient endometrial tissue ablation while reducing material and manufacturing complexity, ensuring consistent contact with the uterine fundus and maintaining the simplicity and cost-effectiveness of the ablation process.
Implementation Method 1
an expandable-collapsible support structure, including a non-compliant balloon that self-expands to conform to the uterine cavity
Implementation Method 2
the moisture permeability or absorbency of the electrode carrying member allows for moisture to leave the ablation site through an aspiration lumen
Implementation Method 3
Techniques using RF energy provide an RF electrical signal to one or more electrodes in contact with the subject organ tissue. Electrical current flows from the electrodes and into the organ tissue. The current flow resistively heats the surrounding tissue.
Implementation Method 4
A suction (aspiration) lumen is positioned within the electrode carrying member to aid in the removal of moisture, whether gas or liquid, present or generated during the ablation procedure.
Data Source
AI summary
An endometrial tissue treatment device includes an elongate positioning member and an energy applicator coupled to a distal end of the positioning member, the energy applicator including a tissue contacting member and an expandable-collapsible support structure underlying the tissue contacting member, the expandable-collapsible support structure comprising a substantially non-compliant elongate balloon disposed within the tissue contacting member that, when inflated, has a length oriented substantially transverse to the positioning member, including a first closed end that positions a corresponding first corner portion of the tissue contacting member in a first cornu of a uterine cavity, and a second closed end that positions a corresponding second corner portion of the tissue contacting member in a second cornu of a uterine cavity, with a lengthwise portion of the balloon positioning a distal facing portion of the tissue contacting member for contacting a fundal wall of a uterus.