Tunneling Tool and Anchor for Minimally Invasive Subcutaneous Implantation
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Solution Overview
Problem
Current methods for implanting subcutaneous devices often require invasive procedures, leading to longer recovery times, more pain, and scarring, while anchoring techniques for devices like medical leads can be inconsistent and cause damage due to varying suture tensions.
Innovation Solution
A tunneling tool with a guide for creating precise tissue channels and anchors with mechanisms for secure attachment to elongate devices, minimizing tissue disruption and preventing movement, using features like locking members, tissue engagement elements, and adjustable components to ensure secure fixation without direct suturing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open surgical procedures are used to implant subcutaneous devices, then the implant can be securely placed, but the procedure time, pain, and scarring increase
Solution Approach 1:
The implant system is divided into separate components: an anchor component that remains in the tissue and a device component that can be removed or adjusted. This segmentation allows for minimally invasive insertion while maintaining secure placement through the anchor's engagement with surrounding tissue structures.
Solution Approach 2:
A tunneling tool with a guide acts as an intermediary to create a precise tissue channel and pocket beneath the skin. The guide component of the tunneling tool provides real-time visualization and control during insertion, enabling minimally invasive placement while ensuring accurate positioning of the implant.
2Reliability
If varying suture techniques are used to anchor leads, then anchoring can be achieved, but anchoring success varies and device damage may occur
Solution Approach 1:
The anchor component is designed with self-anchoring capabilities through its engagement with surrounding tissue structures. The geometry and material properties of the anchor allow it to automatically secure itself without requiring external sutures or fixation mechanisms that could damage the device.
Solution Approach 2:
The traditional suture-based mechanical anchoring system is replaced with a dedicated anchor component that uses controlled engagement with tissue structures. This substitution eliminates the variability and damage risk associated with manual suturing techniques while providing consistent anchoring force.
3Reliability
If direct suturing is used to attach anchors to tissue, then secure attachment can be achieved, but tissue disruption and recovery time increase
Solution Approach 1:
The anchor component is designed with specific local geometric features and material properties that enable secure attachment to surrounding tissue structures without requiring extensive suturing. The local engagement mechanisms provide sufficient anchoring force while minimizing the overall tissue disruption required for implantation.
Data Source
Figure 1A~1B
Figure 2A~2C
Figure 3
AI summary
A tunneling tool for forming a tissue channel and/or pocket beneath a portion of skin along a body comprises a distal end having a tunneling member and a guide. The tunneling member is configured for forming the tissue channel and/or pocket beneath the portion of skin while the guide remains above the skin and indicates the location of at least a portion of the tunneling member. An anchor for securing an elongate device to body tissue comprises an anchor body configured to receive the elongate device; a mechanism configured to removably attach the anchor body to the elongate device so as to resist movement of the elongate device in relation to the anchor body; and at least one tissue engagement element configured to assist in attaching the anchor body to the body tissue.