Color-Coded Marking Clips for In Vivo and Ex Vivo Orientation
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Solution Overview
Problem
Current methods for surgical specimen margin orientation marking, such as ink marking and reference sutures, are inaccurate and prone to errors due to specimen manipulation or miscommunication, making it difficult to maintain tissue sample orientation and ensure proper excision.
Innovation Solution
The use of color-coded marking clips and sutures that selectively engage tissue, maintaining in vivo and ex vivo orientation by creating a mirror image marking system, with optional features like microchip technology, RFID, and drug delivery capabilities.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If ink marking is used to mark specimen margins, then marking can be applied, but accuracy is poor and errors occur due to specimen manipulation
Solution Approach 1:
A reference suture is introduced as an intermediary element between the specimen margin and the marking system. The suture is securely attached to the specimen at the margin and extends outward, serving as a stable reference that remains attached even when the specimen is manipulated or repositioned, thereby maintaining orientation accuracy throughout the workflow
Solution Approach 2:
The reference suture is attached to the specimen margin before the actual marking process. This preliminary attachment ensures that the orientation reference is established and secured in advance, preventing any loss of orientation information during subsequent specimen handling, manipulation, or repositioning events
2Reliability
If reference suture is placed in the specimen, then orientation can be maintained, but errors still occur due to manipulation or miscommunication
Solution Approach 1:
The marking indicator is merged with the reference suture by attaching it directly to the suture. This combination ensures that the visual marking and the orientation reference are always together and cannot be separated, eliminating errors where the suture might be lost or the marking might become detached during specimen manipulation
Solution Approach 2:
The marking indicator attached to the reference suture provides continuous visual feedback about the specimen's orientation. As the specimen is manipulated, the indicator moves with the suture, providing real-time information about the current orientation state, which helps prevent miscommunication between surgical team members
3Device complexity
If conventional marking methods are used, then simple marking is achieved, but communication efficiency between surgeons and pathologists is poor
Solution Approach 1:
Different colored marking indicators are used to represent different orientation references (e.g., different margins or anatomical landmarks). This color-coding system provides immediate visual communication about specimen orientation, allowing surgeons and pathologists to quickly understand the specimen's configuration without lengthy verbal explanations, thereby reducing communication time while maintaining system simplicity
Data Source
AI summary
According to one embodiment, an apparatus is disclosed. The apparatus includes an endoscopic clip placement tool and one or more marking clips attached to a specimen mass by the clip placement tool to mark a margin and orientation of the specimen mass. A specimen marking clip is also provided that is adapted to selectively attach to tissue inside of a patient and corresponding tissue that has been excised from the patient for analysis. Sutures may be associated with the clips to help ensure correct in vivo and ex vivo sample orientation. In vivo clips may remain in the patient's body if necessary.