Delivery Catheter with Locking Mandrel for Kink Resistance
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing implantable medical device delivery systems face challenges with kink resistance and accurate deployment, particularly in tortuous vascular pathways, often resulting in unpredictable kinking and potential migration of the sensor device during or after deployment.
Innovation Solution
The development of a delivery catheter system with an elongated shaft and locking mandrel, featuring a reduced profile portion and circumferentially spaced ports, which allows for improved maneuverability and secure fixation of the implantable medical device within the vasculature, eliminating the need for an outer sheath and balloon, thereby reducing kinking and migration risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an outer sheath and balloon are used for retaining and deploying the sensor, then the device can be delivered through vasculature, but the catheter experiences increased kinking and unpredictable behavior in tortuous vascular pathways
Solution Approach 1:
The patent removes the outer sheath and balloon components from the delivery system, retaining only the essential elements for device delivery and deployment. This extraction eliminates the sources of kinking and unpredictable behavior while preserving the core functionality of delivering and deploying the sensor device through vasculature.
Solution Approach 2:
The delivery catheter is divided into distinct functional segments: a flexible shaft for navigation, a locking mandrel for device retention, and a deployment mechanism. This segmentation allows each component to be optimized independently - the shaft for flexibility and maneuverability, while the locking mandrel provides secure device retention without requiring an outer sheath.
2Reliability
If a traditional delivery system with outer sheath is used, then device retention is achieved, but device migration occurs during or after deployment
Solution Approach 1:
The locking mandrel is pre-configured with features that engage the sensor device before deployment. The mandrel maintains precise device positioning throughout the delivery process, and the device is released only when deliberately activated at the target location, preventing unintended migration.
Solution Approach 2:
The locking mandrel serves as an intermediary component between the delivery catheter and the sensor device. It provides secure retention during delivery while enabling controlled release at the destination, acting as a mediator that ensures both device retention and positioning accuracy without requiring an outer sheath.
3Reliability
If an outer sheath is used to retain the sensor, then the sensor is secured during delivery, but the overall catheter profile increases causing more kinking
Solution Approach 1:
The outer sheath is completely removed from the delivery system. Instead, the sensor device is retained by the locking mandrel within the flexible shaft, achieving secure sensor retention with a significantly reduced catheter profile that resists kinking in tortuous vasculature.
Solution Approach 2:
The delivery catheter employs a flexible shaft without a rigid outer sheath. This flexible construction allows the catheter to conform to tortuous vascular pathways without kinking, while the locking mandrel provides the necessary sensor retention through mechanical engagement features.
Data Source
AI summary
A kit for intravascular implantation of an implantable medical device (IMD) within a patient includes the IMD, an elongated shaft, and a locking mandrel. The IMD comprises a fixation assembly comprising a loop and defines at least one longitudinal lumen and a port in fluid communication with the lumen. The shaft is sized to traverse a vasculature of the patient. The port is sized to receive at least a portion of the loop. The locking mandrel is configured to be positioned within the at least one lumen of the shaft and to pass through the loop within the lumen at the port. A reduced profile portion of the shaft defines a reduced profile with respect to at least one other portion of the shaft. At least a portion of the reduced profile portion is configured to be adjacent to the IMD when the IMD is positioned on the shaft.