Leadless Pacemaker Loading Device Funneling Structure
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Solution Overview
Problem
Conventional leadless cardiac pacemakers are preloaded onto catheter-based delivery systems at manufacturing, leading to inefficiencies such as the need for separate systems for multiple pacemakers, increased waste and cost, and complex sterilization and inventory management.
Innovation Solution
A device and method for loading a leadless pacemaker onto a catheter-based delivery system, featuring a distal portion with a volume to receive the pacemaker and a proximal portion with a funneling structure that guides tethers through the pacemaker's attachment feature, allowing for efficient reuse of the delivery system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If leadless pacemakers are preloaded onto catheter-based delivery systems at manufacturing, then the pacemaker is ready for immediate implantation, but separate delivery systems are required for multiple pacemakers, increasing waste and cost
Solution Approach 1:
The system is divided into two independent components: a reusable catheter-based delivery system and disposable leadless pacemakers. The delivery system can be separated from the pacemaker after implantation, allowing the delivery system to be sterilized and reused while the pacemaker is disposed of after use. This segmentation eliminates the need to discard entire preloaded delivery systems after a single use.
Solution Approach 2:
The catheter-based delivery system is designed with universal compatibility to accommodate multiple different leadless pacemaker models and configurations. The delivery system can be used repeatedly for implanting different pacemakers after sterilization, making it a multi-functional tool that serves multiple implantation procedures rather than being dedicated to a single pacemaker.
2Ease of operation
If leadless pacemakers are preloaded onto catheter-based delivery systems at manufacturing, then the pacemaker is ready for immediate implantation, but complex sterilization and inventory management are required
Solution Approach 1:
By separating the delivery system from the pacemaker, the sterilization process only needs to be applied to the delivery system, not to each individually packaged preloaded unit. The pacemakers can be sterilized independently using standard medical device sterilization processes, simplifying the overall sterilization workflow and inventory management.
Solution Approach 2:
The system enables recovery and reuse of the expensive catheter-based delivery system while allowing disposable pacemakers to be discarded after use. This recovery approach eliminates the need for complex re-sterilization of entire preloaded systems and simplifies inventory management by allowing the delivery system to serve multiple pacemakers across different procedures.
3Reliability
If separate delivery systems are used for multiple pacemakers, then each pacemaker can be delivered reliably, but the cost and waste increase significantly
Solution Approach 1:
The catheter-based delivery system is designed as a universal platform that can accommodate multiple different leadless pacemaker models, sizes, and configurations through standardized interface mechanisms. This universality allows a single delivery system to be reused across multiple implantation procedures for different pacemakers, reducing the total quantity of delivery systems needed while maintaining reliable delivery performance.
Solution Approach 2:
The system enables recovery of the delivery system after pacemaker implantation through detachment mechanisms that allow the delivery system to be separated from the implanted pacemaker. The recovered delivery system can then be sterilized and reused for subsequent pacemaker implantations, significantly reducing the number of delivery systems that would otherwise be required if each pacemaker received a dedicated preloaded system.
Data Source
AI summary
A device for loading a leadless pacemaker onto a catheter-based delivery system includes a distal portion and a proximal portion. The distal portion includes a retention feature configured to receive the leadless pacemaker. The proximal portion is proximal the distal portion and includes a funneling structure opening toward the retention feature. The distal and proximal portions of the device are configured such that, when a distal end of the catheter-based delivery system is brought towards the proximal portion of the loading device and the leadless pacemaker is retained by the retention feature, the funneling structure guides features of the distal end of the catheter-based delivery system through an opening in an attachment feature located at a proximal end of the leadless pacemaker.