Tissue Marker with Shape Memory Fixation for Tumor Marking
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Solution Overview
Problem
Current tissue marking methods for lumpectomy procedures, such as using guide wires, can be inaccurate and invasive, leading to potential tumor dissemination and complex logistical challenges.
Innovation Solution
A method employing an ultrasonic probe to generate an image of the tumor, align a needle with the tumor, and deploy an elongated tissue marker with shape memory fixation elements that expand to anchor within the tumor, allowing precise marking and planning for surgical excision.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a guide wire is used for tissue marking, then the procedure is less invasive, but the placement accuracy is poor and migration can occur
Solution Approach 1:
The patent combines the imaging function (ultrasonic probe) with the marking function (needle and tissue marker deployment) into a single integrated surgical instrument. This allows real-time visualization and precise placement of the tissue marker in one coordinated action, eliminating the separate steps required for guide wire placement and improving both accuracy and reliability.
Solution Approach 2:
The ultrasonic probe provides real-time imaging feedback that allows the surgeon to visualize the needle and tissue marker placement as it occurs. This immediate feedback enables precise positioning of the tissue marker within the tumor, ensuring accurate marking without migration, while maintaining the minimally invasive nature of the procedure.
2Device complexity
If a guide wire is used for tissue marking, then the procedure is simpler, but tumor dissemination can occur due to inaccurate placement
Solution Approach 1:
Real-time ultrasonic imaging provides continuous feedback during the marking procedure, allowing the surgeon to precisely track needle advancement and tissue marker placement. This ensures the tissue marker is accurately positioned within the tumor boundaries, preventing cut-through of the tumor and eliminating the risk of carcinogenic cell dissemination while maintaining procedural simplicity.
Solution Approach 2:
The patent replaces the blind mechanical insertion of guide wires with an image-guided system. The ultrasonic imaging substitutes for manual positioning techniques, providing visual confirmation of needle and tissue marker placement to ensure accurate positioning within the tumor and prevent harmful dissemination of cancer cells.
3Measurement precision
If an ultrasonic probe with needle and tissue marker is used, then placement accuracy is improved, but the device complexity increases
Solution Approach 1:
The patent merges multiple functions (ultrasonic imaging, needle deployment, and tissue marker release) into a single integrated surgical instrument. This consolidation improves placement accuracy by coordinating all functions through one system while managing complexity through functional integration rather than separate devices requiring multiple setup steps.
Solution Approach 2:
The surgical instrument is designed as a multi-functional device that performs ultrasonic imaging, needle advancement, and tissue marker deployment within a single unified system. This universal design achieves high placement accuracy through coordinated function while the modular integration keeps the overall device complexity manageable compared to using multiple separate instruments.
4Stability of the object's composition
If fixation elements are deployed from the tissue marker, then the marker stability is improved, but the device complexity increases
Solution Approach 1:
The fixation elements are designed to transition from a collapsed, low-profile state during insertion to an expanded, anchored state after deployment. This dynamic transformation provides stable fixation of the tissue marker within the tumor while maintaining a simple, compact structure during the insertion phase, effectively managing the complexity-stability trade-off through state change rather than permanent complex structure.
Solution Approach 2:
The fixation elements are nested within the tissue marker body during insertion, allowing the marker to pass through the needle in a compact configuration. After deployment, the fixation elements expand outward from the nested position to anchor the marker in the tumor tissue. This nesting approach provides stable fixation while keeping the device structure simple and compact during the critical insertion phase.
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
This approach enhances the accuracy and safety of tumor marking, reducing the risk of tumor dissemination and improving the precision of surgical excision by providing a stable and visible marker for surgeons.
Implementation Method 1
generating an image of a tumor in the breast tissue on a display using an ultrasonic probe of the surgical instrument
Implementation Method 2
The fixation elements may be fabricated from shape memory material, such that the fixation elements transition toward the expanded configuration in response to heat from the breast tissue
Data Source
AI summary
A method of marking a tumor includes positioning a surgical instrument adjacent breast tissue, generating an image of a tumor in the breast tissue on a display using an ultrasonic probe of the surgical instrument, aligning a needle of the surgical instrument with the tumor using the image of the tumor generated on the display, deploying the needle from the ultrasound probe into the breast tissue, and deploying an elongated tissue marker from the needle into the tumor, thereby fixing a distal portion of the tissue marker in the tumor.