Introducer Sheath Electrodes for Bleed Detection
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Solution Overview
Problem
Current medical procedures lack effective methods for early detection of pericardial or retroperitoneal bleeding, arteriovenous fistulae, or hematomas, which can lead to delayed recognition and potentially life-threatening complications, as these conditions often present with no initial signs until hemodynamic derangements occur.
Innovation Solution
An introducer sheath with multiple electrodes and an impedance assessment unit that injects a current or voltage across the electrodes to measure impedance changes, allowing for real-time detection of fluid accumulation or bleeding by computing and transmitting impedance values wirelessly to an external apparatus for timely intervention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional catheter access procedures are used without impedance monitoring, then the procedure is simpler and less complex, but early detection of bleeding or fluid accumulation is delayed until hemodynamic derangements occur
Solution Approach 1:
The introducer sheath is designed to perform multiple functions: it serves as both the access device for catheter insertion and as an impedance monitoring system. The electrodes integrated into the sheath allow it to detect bleeding and fluid accumulation while maintaining its primary function of providing vascular access, thereby combining diagnostic and therapeutic roles in a single device.
Solution Approach 2:
The impedance monitoring system is nested within the introducer sheath structure. The electrodes are embedded in the sheath wall, and the impedance assessment unit is integrated into the hub assembly. This nested configuration allows the monitoring system to be contained within the existing sheath dimensions without significantly increasing overall device complexity or size.
2Loss of time
If impedance monitoring is continuously performed, then bleeding detection is more rapid and timely, but energy consumption and device complexity increase
Solution Approach 1:
The impedance monitoring system performs measurements at periodic intervals rather than continuously. The controller is configured to take impedance measurements at predetermined time intervals, which reduces power consumption while still providing timely detection of bleeding or fluid accumulation. This periodic sampling approach balances the need for rapid detection with energy conservation.
Solution Approach 2:
The impedance assessment unit includes a power source that is self-contained within the hub assembly, allowing the device to operate independently without requiring external power during the procedure. The system manages its own power requirements through the periodic measurement strategy and can alert operators when bleeding is detected, enabling timely intervention without continuous energy expenditure.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables rapid detection of bleeding or fluid accumulation, allowing for prompt management and potentially lifesaving interventions by alerting operators before symptoms appear, thereby reducing the risk of complications such as cardiac tamponade or thrombosis.
Implementation Method 1
The impedance assessment unit (248) includes a power source (259) and a wireless transceiver (252) and is configured to inject one of a predetermined current or voltage across a first pair of electrodes (20a, 20d) and to measure the other of the current or voltage across a second pair of electrodes (20b, 20c)
Data Source
AI summary
An introducer includes a sheath for introducing a catheter into a blood vessel at an insertion site and a plurality of electrodes on the sheath. The introducer also includes an impedance assessment unit connected to the electrodes. The impedance assessment unit includes a power source and a wireless transceiver and is configured to inject one of a predetermined current or voltage across a first pair of electrodes and to measure the other of the current or voltage across a second pair of electrodes. The impedance assessment unit also is configured to perform at least one: wirelessly transmit current and voltage values to an external apparatus for detection of a bleed, and compute an impedance based on the current and voltage and wirelessly transmit the computed impedance to the external apparatus for detection of the bleed.