Disposable Pacemaker Segmentation and Stylet Port Design
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Solution Overview
Problem
Current temporary pacing systems are bulky, expensive, and limit patient mobility due to entanglement risks with wires, and may not be accessible to all medical facilities, requiring longer maintenance times and impractical turn-around times.
Innovation Solution
A disposable temporary pacemaker system with a compact, low-cost design featuring a housing with a stylet port and a pacing lead secured to it, using a pulse generator printed circuit board assembly and a battery, allowing for easy mobility and reduced maintenance, with a power pull-tab for activation and an expandable pad for protection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a capital equipment box with wires and connectors is used for temporary pacing, then the patient can receive stable cardiac pacing therapy, but the patient's mobility is limited and the patient is at risk of becoming entangled in the wires
Solution Approach 1:
The pacemaker system is divided into separate modular components: a compact pulse generator unit and separate pacing leads. This segmentation allows the leads to be positioned and secured independently while keeping the pulse generator accessible and manageable, reducing wire entanglement risks while maintaining pacing stability.
Solution Approach 2:
The pacing leads are routed through a subcutaneous tunnel from the insertion site to the pulse generator location, creating a three-dimensional spatial arrangement that prevents wire entanglement and improves patient mobility while maintaining electrical connection stability.
2Reliability
If a capital equipment box is used for temporary pacing, then the patient can receive pacing therapy, but the equipment is expensive and requires longer maintenance turn-around time
Solution Approach 1:
The pacemaker system is designed as a disposable temporary device that can be quickly deployed and discarded after use. This eliminates the need for expensive capital equipment and lengthy maintenance cycles, as each unit is pre-packaged, sterile, and ready for immediate use without requiring complex maintenance procedures.
3Reliability
If a capital equipment box is used for temporary pacing, then the patient can receive pacing therapy, but the equipment is bulky and limits patient mobility
Solution Approach 1:
The pacemaker system is divided into separate modular components: a compact pulse generator unit and separate pacing leads. This segmentation allows the leads to be positioned and secured independently while keeping the pulse generator accessible and manageable, reducing wire entanglement risks while maintaining pacing stability.
Solution Approach 2:
The pacemaker system is designed as a disposable temporary device that can be quickly deployed and discarded after use. This eliminates the need for expensive capital equipment and lengthy maintenance cycles, as each unit is pre-packaged, sterile, and ready for immediate use without requiring complex maintenance procedures.
4Ease of manufacture
If a disposable pacemaker design is used, then the cost is reduced and maintenance needs are minimized, but the device must be compact and portable
Solution Approach 1:
The pulse generator, battery, pacing leads, and stylet port are combined into a single integrated disposable unit. This merging of components achieves cost-effectiveness by eliminating the need for expensive capital equipment while maintaining a compact form factor that does not significantly limit patient mobility.
Data Source
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AI summary
A disposable pacemaker comprises a housing including a stylet port, a pulse generator printed circuit board assembly situated in the housing, and a pacing lead secured to the housing. The pacing lead includes a lumen aligned with the stylet port, such that the stylet port and the lumen of the pacing lead are configured to receive a stylet.