Multi-lumen Catheter with Deflectable Member for Septal Crossing
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Solution Overview
Problem
Current medical devices for septal crossing and vascular access often require multiple steps, such as wire/needle exchanges, which can be cumbersome and inefficient.
Innovation Solution
A medical device with an elongate shaft featuring multiple lumens and a deflectable member that shifts between configurations to direct a guidewire or needle, reducing the need for exchanges by allowing seamless transition between lumens, and optionally incorporating a trapper balloon or compliant distal balloon for enhanced navigation and anchoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple separate devices are used for wire/needle exchanges in septal crossing procedures, then functional versatility is improved, but device complexity and procedural steps increase
Solution Approach 1:
The patent combines multiple separate medical devices (guidewire delivery catheter, needle delivery catheter, trapper balloon catheter) into a single integrated multi-lumen catheter system. The first lumen accommodates the guidewire delivery catheter, the second lumen accommodates the needle delivery catheter, and the third lumen accommodates the trapper balloon catheter, allowing all functions to be performed through one device rather than requiring multiple separate device insertions and exchanges.
Solution Approach 2:
The external catheter shaft is designed as a universal platform that can simultaneously perform multiple functions: guiding the guidewire through the septum, delivering the needle for puncture, and deploying the trapper balloon for anchoring. This multi-functional design eliminates the need for sequential device exchanges while maintaining all necessary capabilities for the procedure.
2Reliability
If wire/needle exchanges are performed using conventional methods, then procedural completeness is improved, but time consumption and efficiency worsen
Solution Approach 1:
All necessary components (guidewire delivery catheter, needle delivery catheter, trapper balloon catheter) are pre-positioned within the external catheter shaft before the procedure begins. The guidewire delivery catheter is advanced through the first lumen, the needle delivery catheter through the second lumen, and the trapper balloon catheter through the third lumen, so that when the procedure starts, all components are ready for immediate deployment without requiring time-consuming exchanges.
Solution Approach 2:
The procedure maintains continuous useful action by eliminating interruptions for device exchanges. The deflectable member continuously directs components through the septum without requiring withdrawal or replacement of the external catheter, allowing the procedural steps to flow continuously from guidewire advancement to needle puncture to balloon deployment.
3Adaptability or versatility
If multiple device insertions are required for septal crossing, then functional capability is improved, but risk of complications increases
Solution Approach 1:
By merging multiple device functions into a single external catheter shaft with multiple lumens, the patent reduces the number of times the catheter must be inserted and removed. The deflectable member enables all necessary components to be advanced through the septum in a single continuous action, minimizing the risk of complications associated with repeated insertions and exchanges.
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
Simplifies medical interventions by reducing the number of steps required for septal crossing and vascular access, improving efficiency and reducing the risk of complications by maintaining device positioning and facilitating smooth navigation through anatomical structures.
Implementation Method 1
a deflectable member disposed within the shaft, the deflectable member being designed to shift between a first configuration and a second configuration
Data Source
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AI summary
Medical devices and methods for making and using medical devices are disclosed. An example medical device may include an elongate shaft having a proximal end region and a distal end region. A first lumen may be defined in the shaft. A second lumen may be defined in the shaft. The distal end region may include a common lumen region in fluid communication with the first lumen and the second lumen. A deflectable member may be disposed within the shaft. The deflectable member may be designed to shift between a first configuration where the deflectable member directs a first medical device disposed within the common lumen region into the first lumen and a second configuration where the deflectable member allows a second medical device to move between the common lumen region and the second lumen.