Implantable Helix Electrode With Tissue-Cutting Blade
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Solution Overview
Problem
Existing implantable medical devices face challenges in penetrating the endocardium during implantation, particularly when targeting deep cardiac structures like the left bundle branch, leading to potential tissue damage and detachment issues.
Innovation Solution
Incorporating a blade section configured to cut into tissue as the helix element is screwed in, allowing the device to penetrate deeper by forming an opening for the body to engage with the tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the body is made larger to facilitate implantation and engagement with tissue, then ease of operation is improved, but the body cannot follow the helix element into tissue due to the endocardium wrapping around it
Solution Approach 1:
The device is segmented into two functional parts: the helix element for anchoring and the body for housing components. The helix element can penetrate tissue independently while the body remains external, resolving the contradiction between body size and tissue penetration capability.
Solution Approach 2:
The helix element acts as an intermediary between the body and the tissue. It facilitates engagement with the tissue by screwing into the septum while the body follows along the helical channel, preventing endocardium wrapping and ensuring reliable deep tissue engagement.
2Measurement precision
If the helix element is made longer to reach deeper cardiac structures, then measurement precision is improved, but stability of the device is worsened
Solution Approach 1:
The device separates the depth-reaching function (helix element) from the stability-providing function (body). The helix element can be sufficiently long to reach deep cardiac structures like the left bundle branch, while the body remains compact and stable outside the tissue.
Solution Approach 2:
The solution moves the problem to another dimension by allowing the helix element to extend axially into the tissue while the body remains in the external dimension. This dimensional separation allows deep penetration without compromising external stability.
3Reliability
If the body penetrates through the endocardium to engage with tissue, then reliability of anchoring is improved, but tissue damage increases
Solution Approach 1:
The device separates the tissue-penetrating function (helix element) from the tissue-contacting function (body). Only the thin helix element penetrates the endocardium through the helical channel, minimizing tissue damage, while the body remains external and does not cause additional damage.
Solution Approach 2:
The helix element has localized penetrating quality with its sharp geometry and helical shape designed for minimal-invasive insertion. The body has localized housing quality for protecting components. This local differentiation allows reliable anchoring through the helix while preventing widespread tissue damage.
Data Source
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AI summary
An implantable medical device (1) for implantation into a patient comprises a body (100, 150) having a distal end (101, 151) and an electrode device (14) for at least one of emitting an electrical stimulation signal and sensing an electrical sense signal, said electrode device (14) being arranged at said distal end (101, 151) of the body (100, 150) and comprising a helix element (142) to be screwed into tissue. A blade section (16) is configured to cut into tissue when said helix element (142) is screwed into tissue.