Catheter Tether Retainer for Compact Implantable Device
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Solution Overview
Problem
Existing implantable cardiac medical devices face mechanical complications and MRI compatibility issues due to elongate lead wires, prompting the need for compact devices that can be securely attached to delivery catheters without the tedious process of looping and threading tethers through catheter lumens.
Innovation Solution
A delivery catheter system with an elongate inner shaft and a receptacle in sliding engagement, along with a tether and snare mandrel, allows for easy engagement and locking of a compact implantable device, enabling secure attachment and containment within the catheter, independent of the device's packaging from the catheter.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the traditional process of looping and threading tethers through catheter lumens is used to secure the device to the catheter, then the device can be securely attached, but the process becomes tedious and complex
Solution Approach 1:
A tether retainer is introduced as an intermediary component that simplifies the tether attachment process. The retainer is received within the catheter lumen and provides a simplified mechanism for securing the tether, eliminating the need for complex looping and threading operations while maintaining secure device attachment
Solution Approach 2:
The tether attachment system is segmented into distinct functional components: the tether itself, the tether retainer, and the catheter lumen interface. This segmentation allows each component to be optimized independently and simplifies the overall attachment process by dividing it into manageable steps
2Duration of action of stationary object
If the device is packaged separately from the catheter to extend shelf life, then storage and sterilization are improved, but the ease of securing the device to the catheter is reduced
Solution Approach 1:
The tether retainer is pre-installed within the catheter lumen during catheter manufacturing, before the device is attached. This preliminary preparation ensures that when the device and catheter are brought together during the procedure, the tether can be quickly and easily secured without requiring complex assembly steps
3Object-affected harmful factors
If a compact implantable device is used to eliminate lead wires, then mechanical complications and MRI compatibility issues are reduced, but the method of securing the device to the catheter becomes more critical
Solution Approach 1:
The tether retainer acts as a reliable intermediary that ensures secure attachment between the compact device and the catheter. By providing a dedicated retention mechanism within the lumen, it enhances the reliability of the attachment without requiring complex external fixation systems
Data Source
Figure 1
Figure 2A~2B
Figure 3A
AI summary
A system includes a delivery catheter and a separately-packaged implantable medical device assembly. The assembly includes a relatively compact implantable medical device, a support shaft, a tether, and a snare mandrel. The tether, which extends in the support shaft, has a distal portion coupled to the device, at a distal end of the support shaft, and a proximal portion protruding from a proximal end of the support shaft, for engagement by a hook of the snare mandrel. An operator may use the engaged snare mandrel to pull the support shaft into a lumen of an inner shaft of the catheter so that the coupled device comes into engagement with a flared end of the catheter inner shaft. Then, after locking the proximal portion of the tether within the catheter, the operator may advance a receptacle of the catheter over the device.