Multi-lumen Cardiac Introducer for Simultaneous Instrument Access
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Solution Overview
Problem
Current medical procedures face challenges in accessing cardiac anatomy efficiently, particularly in procedures like cardiac valve repair and atrial fibrillation treatment, due to limitations in simultaneous access and imaging within the heart, leading to increased complexity and risk.
Innovation Solution
A multi-lumen introducer device with fluidly isolated lumens allows concurrent access for multiple medical instruments and imaging devices, facilitating minimally invasive procedures by providing a single access point for instruments like ablation catheters and intracardiac echocardiography catheters, enhancing precision and safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple separate access paths are used for simultaneous instrument insertion and imaging, then access capability is improved, but procedure complexity and risk increase
Solution Approach 1:
The patent combines multiple access functions (instrument insertion, imaging, irrigation, suction) into a single multi-lumen introducer device. The device integrates multiple lumens within one introducer sheath, allowing simultaneous passage of different medical instruments and imaging devices through a single access site, thereby reducing procedure complexity while maintaining versatile access capability.
Solution Approach 2:
The introducer device is designed with multi-functionality to perform multiple roles simultaneously. Different lumens serve different purposes: one for instrument passage, another for imaging devices, and additional lumens for irrigation and suction. This universal design allows a single device to replace multiple separate access paths.
2Adaptability or versatility
If multiple separate access paths are used for concurrent procedures, then simultaneous access is improved, but surgical time increases
Solution Approach 1:
By merging multiple access functions into a single introducer device with multiple lumens, the patent enables concurrent procedures to be performed through one access site. This eliminates the need to sequentially establish multiple separate access paths, thereby reducing surgical time while maintaining the ability to perform simultaneous instrument insertion and imaging.
Solution Approach 2:
The introducer device is prepared in advance with all necessary lumens configured for different functions. This preliminary setup allows multiple instruments and imaging devices to be rapidly deployed simultaneously through the pre-configured lumens, avoiding the time-consuming process of establishing multiple separate access paths during the procedure.
3Measurement precision
If separate access sites are used for imaging and treatment, then imaging accuracy is improved, but patient risk and complications increase
Solution Approach 1:
The patent merges imaging and treatment functions into a single introducer device. The imaging lumen allows imaging devices to be positioned accurately for real-time guidance, while treatment instruments pass through separate lumens of the same introducer. This integration maintains imaging accuracy while reducing patient risk by minimizing the number of access sites and associated complications.
Solution Approach 2:
The multi-lumen introducer acts as an intermediary structure that facilitates both imaging and treatment through a single access site. The imaging devices pass through dedicated lumens to provide real-time visualization, while treatment instruments are guided by this imaging through separate lumens, ensuring precise delivery with minimal patient exposure to procedural risks.
Data Source
AI summary
An introducer device includes a proximal hub including a first port and a second port, first and second fluid valves associated with the first port and the second port, respectively, a first elongate lumen projecting distally from the proximal hub, the first elongate lumen being in fluid communication with the first port, and a second elongate lumen projecting distally from the proximal hub, the second elongate lumen being in fluid communication with the second port and fluidly isolated from the first elongate lumen.