Tissue Resecting Device With Adaptive Insulation for Fibrous Tissue
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Solution Overview
Problem
Existing methods for treating uterine polyps, such as hysteroscopic resection and mechanical cutting, face challenges in efficiently and effectively resecting fibrous uterine tissue without causing damage or device failure.
Innovation Solution
A tissue resecting device with an elongated structure featuring an outer and inner sleeve, an electrode element, and an insulative layer that delaminates when encountering fibrous tissue, altering the electrical pathway to prevent device failure and ensure safe operation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If an insulative layer covers the inner sleeve and electrode element, then electrical insulation is improved, but device reliability deteriorates when used on fibrous tissue due to potential electrical shorts
Solution Approach 1:
The insulative layer is designed to dynamically change its state based on tissue type encountered. When RF energy is applied to fibrous tissue, the insulative layer transitions from a continuous insulating state to a disrupted state where it delaminates or peels back, allowing electrical contact between the inner sleeve and outer sleeve to serve as a return electrode. This dynamic adaptation resolves the contradiction by maintaining insulation for polyps while enabling reliable operation on fibrous tissue.
Solution Approach 2:
The electrical properties of the device are changed based on the tissue type being treated. The insulative layer's degree of contact between itself and the inner sleeve is reduced when used on fibrous tissue, altering the electrical pathway. This parameter change allows the device to switch between insulated mode (for polyps) and conductive mode (for fibrous tissue), resolving the contradiction between insulation and reliability.
2Object-affected harmful factors
If the insulative layer remains intact during resection, then electrical insulation is maintained, but device functionality deteriorates when treating fibrous tissue due to inability to establish return electrical pathway
Solution Approach 1:
The insulative layer is designed to dynamically change its state based on tissue type encountered. When RF energy is applied to fibrous tissue, the insulative layer transitions from a continuous insulating state to a disrupted state where it delaminates or peels back, allowing electrical contact between the inner sleeve and outer sleeve to serve as a return electrode. This dynamic adaptation resolves the contradiction by maintaining insulation for polyps while enabling reliable operation on fibrous tissue.
Solution Approach 2:
The potential harmful effect of the insulative layer preventing electrical contact is converted into a beneficial feature. The insulative layer's failure mode (delamination or peeling back) on fibrous tissue is designed to create the necessary electrical pathway for RF current to flow through the tissue and return via the inner sleeve and outer sleeve contact, enabling effective treatment of fibrous tissue that would otherwise be impossible.
3Adaptability or versatility
If the device is designed for universal use on all tissue types, then versatility is improved, but device complexity increases due to need for multiple insulative layer configurations
Solution Approach 1:
The device uses the tissue itself to control the state of the insulative layer. The RF energy applied to different tissue types automatically causes the insulative layer to either remain intact (for polyps) or delaminate/peel back (for fibrous tissue). This self-service mechanism eliminates the need for complex control systems or multiple configurations, achieving versatility through a simple, elegant design that responds automatically to tissue properties.
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 effectively resects uterine polyps and other abnormal uterine tissue by preventing electrical shorts and device failure, ensuring consistent performance and safety during procedures.
Implementation Method 1
An electrode element having a first polarity is coupled to the inner sleeve and movable across the window between the proximal position and the distal position
Implementation Method 2
the insulative layer is configured such that a degree of contact between the insulative layer and the inner sleeve is reduced when used to resect tissue more fibrous than uterine polyp tissue to expose a portion of the inner sleeve
Data Source
AI summary
Devices, systems, and methods for resecting tissue are disclosed. In some embodiments, a tissue resecting device may comprise an elongated structure having a longitudinal axis, the elongated structure comprising an outer sleeve with a distal window configured to receive uterine polyp tissue and an inner sleeve configured to move between a proximal position and a distal position relative to the window. In some further embodiments, the device may also comprise an electrode element coupled to the inner sleeve. In some even further embodiments, the device may include an insulative layer covering at least a portion of the inner sleeve, wherein the tissue resecting device is configured to fail when used to resect tissue more fibrous than uterine polyp tissue.