Tethering Assembly for Compact Pacemaker Deployment
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Solution Overview
Problem
Traditional implantable cardiac pacemakers face mechanical complications and MRI compatibility issues due to elongate lead wires, prompting the need for compact devices that can be implanted closer to the pacing site, with effective tethering solutions for deployment and positioning.
Innovation Solution
A tethering assembly within a delivery catheter system, comprising a tether line, grip member, and release member, allows for secure attachment and controlled deployment of medical devices, utilizing a tubular member for backup force and a handle assembly with a locking mechanism to manage tension, enabling precise positioning and repositioning of the device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If traditional elongate lead wires are used in implantable cardiac pacemakers, then the device can be implanted remote from the heart, but mechanical complications and MRI compatibility issues occur
Solution Approach 1:
The patent extracts and eliminates the elongate lead wire component from the traditional pacemaker system. Instead of using long lead wires to connect the pulse generator to the heart, the invention employs a compact pulse generator that can be implanted close to the pacing site, thereby removing the source of mechanical complications and MRI compatibility issues while maintaining the essential electrical connection function through a much shorter tethering assembly
Solution Approach 2:
The patent applies parameter changes by dramatically reducing the length parameter of the connecting element between the pulse generator and the heart. The lead wire length is changed from traditional elongate dimensions to a compact tethering assembly with minimal length, which fundamentally alters the mechanical properties and eliminates the associated complications while preserving the electrical function
2Reliability
If the device is implanted in close proximity to the pacing site, then mechanical complications and MRI compatibility issues are reduced, but effective tethering solutions for deployment and positioning are needed
Solution Approach 1:
The tethering assembly is segmented into distinct functional components: a grip member for securing the device, a release member for controlled deployment, and a tether line for force transmission. This segmentation allows each component to be optimized for its specific function while collectively providing a complete tethering solution that manages deployment complexity effectively
Solution Approach 2:
The tethering assembly acts as an intermediary mechanism between the delivery catheter and the implantable device. It provides a controlled interface for transferring the device from the catheter to the implant site, managing the forces and movements involved in deployment while protecting both the device and the catheter from damage
3Ease of operation
If the tether line is tensioned to push the device out from the grip member cavity, then deployment is achieved, but control and backup force management are required
Solution Approach 1:
The distal end of the tubular member is pre-positioned to abut the release member before deployment occurs. This preliminary positioning ensures that when tension is applied to the tether line, the force is immediately transmitted to push the device out of the grip member cavity, providing built-in backup force management without requiring complex active control systems
Solution Approach 2:
The deployment mechanism is designed to be self-regulating through the interaction between the tether line tension, the release member legs, and the tubular member abutment. The system automatically manages the force distribution and deployment timing without requiring external control systems, as the mechanical arrangement itself provides the necessary tension control and backup force
Data Source
Figure 1
Figure 2A~2C
Figure 3A~3B
AI summary
In an interventional medical system, a delivery catheter for deploying a medical device of the system has a tethering assembly that includes a tether line, a grip member, and a release member, wherein the tether line extends through a longitudinal lumen of a base of the release member and is coupled to a base of the grip member, and the release member has legs extending though apertures formed through the base of the grip member. The device may be tethered to the catheter such that a proximal end of the device is held within a cavity defined by a plurality of elastic fingers of the grip member that extend distally from the base thereof; and the device may be deployed from the catheter by moving the legs of the release member within the grip member cavity to push the proximal end of the device out from the cavity.