Leadless Pacemaker Detachable Housing for Tissue-Safe Component Replacement
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Solution Overview
Problem
Existing leadless pacemakers face challenges with battery depletion and the need for updated control circuitry, requiring removal from the heart, which can be difficult and may damage cardiac tissue, and re-implantation is complicated by fibrosis and unstable tissue conditions.
Innovation Solution
A leadless implantable medical device with a detachable housing design, allowing the removable component with power supply and control circuitry to be replaced without disturbing the fixed component's attachment to the heart tissue, using a detachable interface for energy transfer and a fixation mechanism that minimizes tissue disruption.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of repair
If the entire leadless pacemaker device is removed from the heart when battery depletion or circuit updates are needed, then the device can be replaced, but the removal process may damage surrounding cardiac and vascular tissue and is difficult to perform
Solution Approach 1:
The pacemaker device is divided into two separable components: a first body portion containing the battery and control circuitry that can be removed, and a second body portion with the electrode array that remains fixed in the heart. This segmentation allows replacement of only the removable portion without disturbing the implanted electrode array and surrounding tissue, eliminating the need to remove the entire device and thus preventing tissue damage.
2Reliability
If the leadless pacemaker is fixed to the tissue wall, then stable pacing and sensing are achieved, but fibrosis develops around the fixation mechanism making future removal difficult
Solution Approach 1:
The design extracts the removable battery and control circuitry from the fixed electrode portion, allowing the electrode array to remain permanently implanted while the consumable components are periodically replaced. This separates the permanent fixation function from the replaceable components, eliminating the need to disrupt fibrotic tissue during removal operations.
3Reliability
If a new pacemaker is implanted at the same location as the previous one, then stable sensing and pacing values are maintained, but identifying the previous location is difficult and fibrosis limits accessibility
Solution Approach 1:
The removable body portion serves as a reusable platform that can be removed and replaced at the same cardiac location multiple times. The fixed electrode array remains in place, providing stable pacing and sensing values, while the removable portion can be exchanged without requiring re-implantation at a different location, thus maintaining consistency despite fibrosis and tissue changes.
Data Source
AI summary
A leadless implantable medical device (IMD) may include an electrode, a housing, and an energy transfer component. The housing retains a pulse generator configured to provide stimulation energy for delivery to a tissue of interest, a power supply, a memory storing programmable instructions, and a processor communicatively coupled to the memory. The processor is responsive to the programmable instructions to control operation of the leadless IMD. The electrode is securely affixed to the tissue of interest. The housing includes first and second body portions mated to one another at a detachable interface. The electrode is coupled to the second body portion. The energy transfer component is distributed between the first and second body portions and is configured to convey at least one of stimulation energy or sensed signals across the detachable interface when the first and second body portions are mated to one another.