Subcutaneous Device Placement Guide Strap for Safe Tunneling
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Solution Overview
Problem
The challenge in implanting subcutaneous devices, such as coil electrodes for ICDs, lies in maneuvering tunneling tools around the curvature of the posterior axilla without turning inward to create pneumothorax or outward to puncture the skin, necessitating either non-sterile assistance or imaging guidance.
Innovation Solution
An apparatus comprising a strap with an indentation to guide the tunneling tool, providing mechanical support and precision, and optionally incorporating an electrical impedance measurement system for real-time guidance, eliminating the need for external assistance or imaging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a tunneling tool is used to create a space between subcutaneous and muscular plane, then the subcutaneous device can be implanted, but the tool may turn inward between ribs and create pneumothorax or turn outward and puncture the skin
Solution Approach 1:
A guide strap is introduced as an intermediary device between the physician's hand and the patient's skin. The strap includes an indentation that receives a fold of skin and fat layer, creating a controlled interface that guides the tunneling tool along a safe path while preventing inward turning between ribs or outward turning that would puncture the skin.
Solution Approach 2:
The guide strap is positioned and secured to the patient's skin before the tunneling procedure begins. By pre-establishing the skin fold within the indentation and securing the strap, the safe pathway is prepared in advance, allowing the physician to simply follow the predetermined safe path during tunneling without real-time complex maneuvers.
2Ease of operation
If a non-sterile scrub nurse hand is used to guide the tunneling tool, then the tool can be maneuvered around curvature, but the assistance is non-sterile and introduces contamination risk
Solution Approach 1:
The guide strap is designed to be self-guiding through its indentation structure. The skin fold within the indentation automatically guides the tunneling tool along the correct path around the posterior axilla curvature, eliminating the need for a scrub nurse's hand to physically guide the tool. The system serves itself by using the patient's own skin anatomy as the guiding mechanism.
Solution Approach 2:
The manual mechanical guidance system (scrub nurse's hand) is replaced with a passive mechanical guide structure (the strap with indentation). This substitution maintains the maneuverability benefits of hands-on guidance while eliminating the sterility issues associated with non-sterile manual assistance.
3Measurement precision
If x-ray or imaging systems are used to guide the tunneling tool, then precise positioning can be achieved, but the device complexity and cost increase
Solution Approach 1:
The guide strap is a simple, inexpensive, disposable device that provides sufficient guidance for the tunneling procedure. Unlike expensive, complex, and reusable imaging systems, the strap can be discarded after a single use, eliminating the need for costly equipment while providing adequate positioning accuracy for the specific anatomical path it is designed to guide.
Solution Approach 2:
The guide strap acts as a simple intermediary that directly interfaces with the tunneling tool and patient anatomy, providing tactile and structural guidance without requiring complex imaging infrastructure. This intermediary approach achieves positioning accuracy through mechanical guidance rather than through complex detection and feedback systems.
Data Source
AI summary
An apparatus for guiding the placement of a subcutaneous device that includes a strap having an indentation configured for a fold of skin and fat layer to be positioned within the indentation as the subcutaneous device is advanced to a desired implantation site.