VAD Percutaneous Cable Replacement via Disconnect Coupler
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Solution Overview
Problem
Long-term ventricular assist device (VAD) patients face issues with percutaneous cable wear and tear, leading to potential device failure and skin/tissue trauma at the cable exit site, necessitating frequent replacements to prevent infection and ensure continuous device functionality.
Innovation Solution
The development of an apparatus and method for replacing the percutaneous cable of VADs, featuring a distal or proximal disconnect coupler and connector system that allows for removable connection and repositioning of the cable, enabling partial or full replacement without disturbing internal implantable components, and includes design features for secure skin tunneling and sealing to minimize bulk and prevent fluid ingress.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the percutaneous cable is made replaceable with disconnect couplers, then the reliability of the VAD system is improved by allowing cable replacement without surgical intervention, but the device complexity increases due to the addition of disconnect couplers and connector portions
Solution Approach 1:
The percutaneous cable is divided into replaceable segments with disconnect couplers at strategic locations. The cable includes a first portion with a first disconnect coupler and a second portion with a second disconnect coupler, allowing the cable to be segmented into multiple replaceable sections. This segmentation enables users to replace only the worn portion rather than the entire cable, improving reliability while managing complexity through modular design.
Solution Approach 2:
The cable connection system transitions from a static permanent connection to a dynamic replaceable connection. The disconnect couplers enable the cable to be disconnected and reconnected, providing flexibility and adaptability. This dynamic capability allows the system to respond to wear and damage by enabling cable replacement without requiring surgical intervention, thereby improving reliability.
2Object-affected harmful factors
If the percutaneous cable exit site is repositioned through skin and tissue, then the harmful effects of skin/tissue trauma and infection are reduced, but the loss of time increases due to the tunneling process and repositioning requirement
Solution Approach 1:
The cable is segmented with disconnect couplers that enable replacement of the external portion without requiring surgical repositioning of the entire cable. Users can disconnect the external portion at the coupler and replace it through the existing exit site, eliminating the need for time-consuming surgical tunneling while still allowing periodic cable replacement to prevent infection and trauma.
Solution Approach 2:
The disconnect couplers are designed to be user-accessible, allowing patients to perform cable replacement themselves without requiring surgical intervention. This self-service capability enables routine maintenance of the cable by replacing worn portions through the existing exit site, avoiding the time loss associated with surgical repositioning while maintaining hygiene and preventing infection.
3Reliability
If the percutaneous cable is replaced frequently to prevent device failure, then the reliability is improved, but the loss of time increases due to frequent replacement procedures
Solution Approach 1:
The cable is divided into replaceable segments with disconnect couplers positioned at strategic locations. This segmentation allows users to replace only the worn external portion rather than the entire cable, reducing the time required for replacement. The modular design enables quick disconnect and reconnect operations, minimizing downtime while maintaining reliable device functionality.
Solution Approach 2:
The disconnect couplers are pre-positioned at strategic locations along the cable during manufacturing. This preliminary positioning enables rapid replacement operations by allowing users to disconnect and replace the cable portion between the couplers without needing to locate connection points during the replacement process, thereby reducing the time required for maintenance while ensuring reliable device operation.
Data Source
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AI summary
There are disclosed apparatus and methods for replacing a percutaneous cable in connection with a vascular device. In an embodiment, the apparatus includes a distal disconnect coupler, a distal connector portion of the cable configured for removable connection with the distal disconnect coupler, and a connector cap configured for removable connection with the distal disconnect coupler and for tunneling through skin and tissue. In one embodiment, a method of repositioning a percutaneous cable in connection with a vascular device includes providing the cable with a distal disconnect coupler, disconnecting the cable at the distal disconnect coupler, attaching a connector cap to the distal disconnect coupler, removing the percutaneous cable from a first exit site, tunneling the connector cap together with the distal disconnect coupler through skin and tissue to form a new exit site, disconnecting the connector cap, and connecting the cable to the distal disconnect coupler.