IMD Fixation Tines for Tissue Penetration and Engagement Confirmation
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Solution Overview
Problem
Existing implantable medical devices (IMDs) face challenges with mechanical and MRI compatibility issues due to elongate lead wires, and there is a need for improved fixation components that can securely anchor these devices within the body while ensuring easy confirmation of tissue engagement.
Innovation Solution
The development of fixation components with a plurality of tines, each having controlled deployment and deflection stiffness, allowing for secure penetration and engagement of tissue, and enabling visualization of adequate fixation through fluoroscopy, utilizing a base with pre-formed curvatures and straight sections to facilitate secure anchoring and easy confirmation of tissue engagement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If elongate lead wires are used to connect pulse generator to electrodes, then the device can be implanted remote from the heart, but mechanical and MRI compatibility issues arise
Solution Approach 1:
The patent removes the elongate lead wire from the system entirely. The pulse generator device is reconfigured as a compact implantable medical device with electrodes integrated directly into the housing, eliminating the need for separate lead wires and their associated mechanical and MRI compatibility problems.
Solution Approach 2:
The patent combines the pulse generator, electrodes, and fixation components into a single integrated compact implantable medical device. The electrodes are mounted directly on the housing, and fixation tines are integrated into the device structure, merging previously separate components into one unified system.
2Force
If fixation tines are made stiff to penetrate tissue, then penetration force is sufficient, but flexibility to confirm engagement is reduced
Solution Approach 1:
The patent applies different mechanical properties to different sections of the fixation tines. The proximal portion has higher stiffness to provide sufficient penetration force, while the distal portion has lower stiffness to provide flexibility for confirming engagement. This local differentiation of mechanical properties resolves the contradiction between penetration capability and engagement verification.
Solution Approach 2:
The fixation tine is divided into multiple sections with different mechanical characteristics. The proximal portion is designed with greater stiffness for penetration, while the distal portion is designed with lesser stiffness for flexibility. This segmentation allows each section to perform its specific function optimally without compromising the other.
3Ease of operation
If fixation tines are made flexible to confirm engagement, then ease of operation improves, but penetration capability is reduced
Solution Approach 1:
The patent applies different mechanical properties to different sections of the fixation tines. The proximal portion has higher stiffness to provide sufficient penetration force, while the distal portion has lower stiffness to provide flexibility for confirming engagement. This local differentiation of mechanical properties resolves the contradiction between penetration capability and engagement verification.
4Reliability
If compact IMD design is implemented to eliminate lead wires, then MRI compatibility and mechanical issues are reduced, but fixation requirements become more critical
Solution Approach 1:
The fixation component is segmented into multiple tines with specific geometric configurations. Each tine includes curved sections and straight sections arranged to provide both penetration capability and engagement confirmation. This segmentation allows the fixation system to be optimized independently from the main device body.
Solution Approach 2:
The patent optimizes geometric parameters of the fixation tines, including curvature radii, section lengths, and tine spacing, to achieve the desired balance between penetration force and engagement flexibility. By carefully controlling these parameters, the fixation component provides reliable anchoring without excessive complexity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The fixation components provide improved tissue fixation and flexibility, allowing for secure anchoring of IMDs and easy confirmation of tissue engagement, enhancing the implantation process while avoiding tissue damage and ensuring compatibility with MRI.
Implementation Method 1
Each respective tine of the plurality of tines has a deployment stiffness that enables the respective tine to penetrate the tissue at a target implant site
Implementation Method 2
Each respective tine of the plurality of tines also has a deflection stiffness that may enable a clinician to confirm adequate fixation of the tines into the tissue of the patient
Data Source
AI summary
An example fixation component for an implantable medical device (IMD) includes a base and a plurality of tines configured be deployed with a target deployment stiffness to engage tissue a target implant site while maintaining a target deflection stiffness after deployment. The base defines a longitudinal axis of the fixation component and is fixedly attached near the distal end of the IMD. Each tine is spaced apart from one another around a perimeter of the distal end of the IMD and extend from the base. A shape of each tine is selected to control each of the target deployment stiffness and target deflection stiffness.