Radiofrequency Probe for Marginal Tissue Ablation
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Solution Overview
Problem
Current medical devices for delivering radiofrequency energy to ablate tissue surrounding a surgically removed tumor, particularly in breast tissue, are inadequate in providing precise and uniform energy delivery, leading to potential recurrence of tumors and complications such as skin, lung, and heart issues, prompting a need for improved methods and devices.
Innovation Solution
A probe with a radiofrequency applicator head designed for hollow body cavities, featuring a shaft with a distal applicator head and multiple electrodes that can be advanced radially to deliver controlled doses of energy uniformly around the cavity, allowing for precise ablation of marginal tissue, optionally using a surgical robot for stability and enhanced energy distribution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If needle arrays are used to deliver radiofrequency energy to marginal tissue, then tumor recurrence risk is reduced, but energy delivery precision and uniformity are insufficient
Solution Approach 1:
The applicator head is divided into multiple electrode segments arranged radially around the cavity. Each electrode can be independently controlled to deliver radiofrequency energy, allowing precise targeting of specific tissue regions while maintaining uniform overall energy distribution across the marginal tissue.
Solution Approach 2:
Different electrodes within the array can deliver different energy levels based on local tissue characteristics and treatment requirements. The system allows customized energy delivery patterns to address varying tissue densities and tumor margins in different locations around the cavity.
2Reliability
If ionizing radiation is used for whole breast irradiation, then tumor control is achieved, but skin, lung, and heart complications occur
Solution Approach 1:
The invention replaces harmful ionizing radiation with non-ionizing radiofrequency energy to achieve the same therapeutic goal of tumor control. Radiofrequency ablation delivers thermal energy that destroys cancer cells through localized heating, eliminating the systemic side effects of radiation while maintaining effective tumor control.
3Device complexity
If mastectomy is performed instead of lumpectomy with radiation, then treatment complexity is reduced, but cosmetic outcomes and patient morbidity worsen
Solution Approach 1:
The invention combines lumpectomy with immediate radiofrequency ablation of the tumor bed in a single surgical procedure. The applicator is inserted into the lumpectomy cavity and delivers energy to the marginal tissue, eliminating the need for separate radiation therapy sessions and achieving both tumor removal and margin sterilization simultaneously.
4Manufacturing precision
If electrodes are advanced radially from applicator head, then energy coverage around cavity is improved, but device complexity increases
Solution Approach 1:
The electrode array transitions from a retracted configuration during insertion to an advanced radial configuration during treatment. The electrodes can be dynamically deployed and retracted to adapt to different cavity sizes and shapes, providing flexible energy delivery patterns without requiring multiple fixed applicator designs.
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
Enables precise and uniform ablation of marginal tissue, reducing the risk of cancerous cell recurrence and minimizing complications by ensuring complete energy coverage around the cavity, adaptable for various body cavities including breast tissue, ureter, uterus, and other natural passages.
Implementation Method 1
A plurality of electrodes is disposed within the applicator head and may be reciprocated between a retracted configuration within the applicator head and an advanced configuration where a distal portion of each electrode extends beyond the outer surface of the applicator head. Energy, typically radiofrequency energy but optionally microwave or other energy that may be delivered by electrodes or electrode-like antennas, is then delivered into the tissue
Implementation Method 2
The present invention provides a probe having a radiofrequency applicator head specifically designed to treat hollow body cavities... to deliver precise, measured doses of radiofrequency energy at controlled depths to the tissue margin surrounding the cavity... complete and uniform ablation of the marginal tissue can be achieved
Data Source
AI summary
A probe includes a shaft and an applicator head designed to treat irregularly-shaped hollow cavities, such as a cavity in breast tissue created by a lumpectomy procedure. The applicator head has a fixed geometry, and a plurality of electrodes can be advanced from an exterior surface of the applicator head in an omnidirectional pattern. The electrodes are used to deliver radiofrequency current or other energy to ablate the marginal tissue.