Deflectable Stylets for Radiofrequency Ablation
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Solution Overview
Problem
Current radiofrequency ablation systems for treating uterine fibroids are time-consuming and expensive due to difficulties in piercing fibroid tissue, requiring iterative advancement of antennae and prolonged radiation application, which limits accessibility and availability for patients.
Innovation Solution
A radiofrequency ablation device with an elongated cannula and deflectable stylets that can be laterally deflected to penetrate fibroid tissue more effectively, allowing for rapid and extensive tissue ablation with minimal invasiveness, using a combination of conductors and stylets with a deflection surface to maximize penetration and minimize friction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If iterative advancement of antennae is used to pierce fibroid tissue, then penetration capability is improved, but procedure time increases significantly
Solution Approach 1:
The ablation element is segmented into multiple stylets that can be deployed simultaneously or sequentially. Each stylet is independently controllable, allowing the system to achieve comprehensive tissue penetration without requiring repeated iterative advancement of a single antenna. The stylets are contained within a cannula and can be advanced together in one action.
Solution Approach 2:
The stylets are pre-positioned within the cannula in a ready-to-deploy configuration. Before the procedure begins, the ablation element is prepared with all stylets contained and positioned for simultaneous deployment. This preliminary arrangement eliminates the need for iterative advancement during the actual procedure, as all penetrating elements are ready to be inserted in a single action.
2Reliability
If prolonged radiation application is used for tissue ablation, then ablation effectiveness is improved, but procedure time and cost increase
Solution Approach 1:
The ablation process is segmented across multiple stylets that can deliver RF energy simultaneously to different locations within the fibroid tissue. This parallel ablation approach achieves comprehensive tissue destruction in a single procedure session rather than requiring prolonged sequential treatment with a single antenna.
Solution Approach 2:
Multiple ablation stylets are combined into a single deployable unit within the cannula. When deployed, these stylets work together to ablate different portions of the fibroid simultaneously, merging their ablation zones to achieve complete tissue destruction in one procedure rather than requiring extended treatment time with a single element.
3Volume of stationary object
If multiple stylets are deployed simultaneously, then ablation volume is increased, but device complexity increases
Solution Approach 1:
Multiple stylets are nested within the cannula in a compact configuration before deployment. The stylets are contained one within another or arranged in a space-efficient manner inside the cannula, allowing multiple ablation elements to be housed in a single delivery device without excessive complexity. The nested arrangement simplifies the overall device structure compared to having separate delivery mechanisms for each stylet.
4Strength
If deflectable stylets are used to penetrate fibroid tissue, then penetration effectiveness is improved, but friction during advancement increases
Solution Approach 1:
The stylets are designed with deflectable characteristics that allow them to dynamically adjust their configuration during advancement. The stylets can bend or change angle in response to tissue resistance, allowing them to navigate through fibroid tissue more effectively while minimizing friction. This dynamic flexibility enables the stylets to follow the path of least resistance rather than forcing a rigid path.
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 significantly reduces procedure time from weeks to days, making it more accessible and affordable, while minimizing the risk of uterine damage and complications, thus offering a safer and more efficient treatment for uterine fibroids.
Implementation Method 1
delivering electromagnetic energy or other energy through the ablation apparatus to the tumor to induce hyperthermia and tumor ablation
Implementation Method 2
using a radiofrequency ablation probe... to treat tumors in the human liver by hyperthermia
Data Source
AI summary
The inventive ablation element comprises an elongated cannula having a proximal end and a distal end. The cannula defines an internal lumen within the cannula and a cannula axis. A plurality of conductors contained within the lumen, each of the conductors has a proximal end proximate the proximal end of the cannula, and a distal end proximate the distal end of the cannula. A plurality of ablation stylets each has a proximal end and a distal end, and each coupled at the respective proximal end of the stylet to the distal end of a respective conductor, the stylets comprise a deflectable material, the conductors together with their respective stylets being mounted for axial movement. A trocar point defined proximate the distal end of the cannula.