Fixation Component Tines for Implantable Medical Device
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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 provide better tissue penetration, contact, and disengagement for compact IMDs.
Innovation Solution
The development of fixation components with a plurality of tines, including a penetrator tine and a protector tine, which are designed to provide improved tissue fixation, penetration, and disengagement by controlling deployment and deflection stiffness, allowing for secure implantation and easy retrieval of IMDs.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If elongate lead wires are used to connect pulse generator to electrodes, then the device can be implanted remotely from the heart, but mechanical and MRI compatibility issues arise
Solution Approach 1:
The patent removes the elongate lead wires from the system entirely, extracting the problematic component that caused mechanical and MRI compatibility issues. The pulse generator is repositioned to be implanted directly in the heart chamber, eliminating the need for lead wires while maintaining electrode connectivity through integrated fixation components.
Solution Approach 2:
The invention transitions from a distributed architecture (pulse generator remote from heart) to a compact integrated architecture (pulse generator within heart chamber). This dimensional repositioning allows the device to function without lead wires, resolving the compatibility issues while achieving the desired electrode placement.
2Reliability
If fixation components are designed for secure tissue penetration, then tissue fixation is improved, but device retrieval becomes difficult
Solution Approach 1:
The fixation component incorporates tines with deformable preset curvatures that allow dynamic behavior: during implantation, the tines are compressed into a low-profile configuration for easy delivery; upon deployment, they expand to engage tissue securely; during retrieval, the entire assembly can be withdrawn with the tines returning to their compressed state, enabling both secure fixation and easy retrieval.
Solution Approach 2:
The tines are pre-configured with deformable curvatures that enable them to automatically assume their tissue-engaging configuration upon deployment without requiring additional activation steps. This preliminary configuration ensures reliable fixation is achieved immediately upon release from the delivery catheter.
3Length of stationary object
If the penetrator tine has high deployment stiffness for deep tissue penetration, then penetration depth is improved, but the risk of tissue damage increases
Solution Approach 1:
The penetrator tine features a localized incisive distal end with high stiffness concentrated at the tip for effective tissue penetration, while the proximal section has lower stiffness to flex and absorb excess forces. This gradient in local properties allows deep penetration without transmitting damaging forces to surrounding tissues or the device structure.
Solution Approach 2:
The tine structure utilizes varying material or geometric parameters along its length, with the distal section having higher deployment stiffness for penetration and the proximal section having lower stiffness for force absorption. This parameter gradient enables controlled penetration depth while minimizing tissue damage risk.
4Reliability
If the fixation component includes multiple tines for improved tissue contact, then fixation reliability is improved, but device complexity increases
Solution Approach 1:
The fixation component is segmented into multiple identical or similar tine structures that can be manufactured using the same process and attached in a standardized manner. This modular segmentation improves fixation reliability through multiple contact points while managing complexity through repetition of proven design elements.
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 described fixation components enhance tissue fixation and electrode contact while facilitating easy implantation and retrieval of IMDs, addressing the mechanical and MRI compatibility issues associated with elongate lead wires.
Implementation Method 1
the incisive distal end is configured to pierce a tissue
Implementation Method 2
a curved section of the penetrator tine defining a deformable preset curvature of the penetrator tine
Data Source
Figure 1
Figure 2A
Figure 2B~2C
AI summary
An example fixation component for an implantable medical device (IMD) includes a base and tines extending from the base and being spaced apart from one another. The tines include a penetrator tine and a protector tine. The penetrator tine includes a curved section defining a deformable preset curvature that extends laterally from a proximal section that is fixed to the base, traversing a longitudinal axis of the fixation component, to a distal section that terminates in an incisive distal end that is configured to penetrate a tissue to form a puncture. The protector tine includes a curved section defining a deformable preset curvature that extends from a proximal section that is fixed to the base, outward from the longitudinal axis, to a distal section that terminates in a non-incisive distal end that is configured to pass through the puncture.