Raised-Rim Extraction Tray for Encapsulated S-IMD Removal
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Solution Overview
Problem
Existing methods for removing subcutaneous implantable medical devices (S-IMDs) face challenges such as difficulty in grasping and pulling due to smooth surfaces and tissue encapsulation, leading to increased manual effort and risk of damage or trauma.
Innovation Solution
An extraction tool with a handle and tray featuring a platform and raised rim to securely capture the S-IMD, allowing for easy withdrawal with minimal force, and optionally including tapered tips for blunt dissection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional forceps are used to grasp and pull the S-IMD, then the extraction procedure can be performed with simple tools, but the forceps may slip along the smooth outer surface of the S-IMD and require increased manual effort
Solution Approach 1:
The extraction tool is divided into distinct functional segments: a tray with platform and raised rim for secure containment, a handle for manipulation, and optional tapered tips for tissue dissection. This segmentation allows each component to perform its specific function optimally, with the tray providing secure grasping without requiring excessive force.
Solution Approach 2:
The tray acts as an intermediary between the physician's hand and the S-IMD. Instead of directly grasping the smooth S-IMD surface with forceps, the physician manipulates the tray which securely contains the S-IMD through its platform and raised rim configuration, thereby preventing slippage without requiring excessive grasping force.
2Reliability
If more force is applied to avoid slippage of forceps, then the S-IMD can be extracted more reliably, but there is increased risk of damaging the S-IMD and inflicting trauma on patient tissue
Solution Approach 1:
The tray with its platform and raised rim provides a pre-configured secure containment structure that prevents the need for excessive force during extraction. The design inherently cushions and distributes the extraction forces, protecting both the S-IMD and surrounding tissue from trauma while maintaining reliable extraction capability.
Solution Approach 2:
The tray serves as a protective intermediary that secures the S-IMD gently yet firmly through its geometric containment structure rather than through aggressive grasping. This intermediary mechanism reduces the risk of damage to both the device and patient tissue while ensuring reliable extraction.
3Device complexity
If conventional forceps are used to access the S-IMD, then the procedure requires minimal specialized equipment, but tissue encapsulation around the S-IMD increases the force necessary to extricate it
Solution Approach 1:
The tool is segmented into functional components including a tray for secure containment, a handle for manipulation, and tapered tips for tissue dissection. This segmentation allows the tool to effectively address tissue encapsulation through the tapered tips while the tray maintains secure, low-force containment of the S-IMD.
Solution Approach 2:
The tray acts as an intermediary containment structure that secures the S-IMD through its platform and raised rim geometry rather than through forceful grasping. This allows the physician to overcome tissue encapsulation forces while the tray maintains gentle yet secure hold on the device, reducing the force needed for extraction.
4Ease of operation
If the extraction tool includes a tray with platform and raised rim to securely contain the S-IMD, then manual effort is reduced, but the device complexity increases
Solution Approach 1:
The tray with platform and raised rim serves multiple functions: secure containment of the S-IMD, distribution of extraction forces, and potential integration with tapered tips for tissue dissection. This multi-functionality justifies the increased structural complexity by eliminating the need for multiple separate tools or excessive manual effort.
Data Source
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AI summary
An extraction tool (100) includes a handle (102) and a tray (104) that extends from the handle (102). The tray (104) is configured to be advanced into a subcutaneous region of a patient. The tray (104) includes a platform (110) and a raised rim (112) that projects above a top surface (114) of the platform (110). The top surface (114) of the platform (110) and the raised rim (112) define a cavity (116) configured to receive and contain a subcutaneous implantable medical device (S-IMD) (200, 250) therein. The handle (102) is configured to be manipulated by an operator to withdraw the extraction tool (100) from the patient with the S-IMD (200, 250) on the tray (104).