Multi-lumen Catheter with Shapeable Guide-wire for Cardiac Device Alignment
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Solution Overview
Problem
Conventional catheter technology lacks the precision and control needed for safe and effective deployment of cardiac devices, such as the WATCHMAN device, within the left atrial appendage, risking ineffective treatment and complications like device embolism or thrombus formation due to improper positioning.
Innovation Solution
A multi-lumen catheter system with a dual-lumen sheath and a shapeable guide-wire made of shape-memory material, allowing for precise manipulation and alignment of the cardiac device relative to the target anatomy, and optionally using a balloon for protection against anatomical damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional catheter technology is used, then the catheter structure is simple, but the ability to manipulate and align the cardiac device precisely is insufficient
Solution Approach 1:
The catheter is divided into multiple lumens (first lumen for guide-wire, second lumen for cardiac device, third lumen for balloon) within a single sheath, allowing independent manipulation of each component to achieve precise device placement while maintaining overall structural integration
Solution Approach 2:
The guide-wire and balloon are nested within the catheter sheath lumens, with the guide-wire passable through the third lumen and the balloon expandable within the target anatomy, enabling compact storage and controlled deployment of multiple functional elements
2Ease of operation
If the guide-wire is made rigid for manipulation control, then the ability to manipulate the device improves, but the risk of damaging proximal anatomy increases
Solution Approach 1:
The guide-wire transitions from a flexible state during navigation through the catheter to a rigid state when deployed in the target anatomy, providing manipulation control only when needed while minimizing damage risk during navigation through proximal vessels
Solution Approach 2:
The balloon acts as an intermediary protective element between the guide-wire and proximal anatomy, absorbing potential mechanical interactions and preventing direct contact between the rigid guide-wire and vulnerable anatomical structures
3Adaptability or versatility
If a single lumen catheter is used, then the device complexity is low, but the ability to deploy multiple components simultaneously is limited
Solution Approach 1:
The catheter sheath is segmented into multiple independent lumens, each capable of carrying different components (guide-wire, cardiac device, balloon) simultaneously, enabling versatile multi-component deployment while maintaining independent control of each component
Solution Approach 2:
The multi-lumen catheter structure serves multiple functions: guiding the wire, delivering the device, and providing balloon protection, all through a single integrated catheter system that can be deployed through standard vascular access
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 precise deployment of cardiac devices, reducing the risk of damage to proximal anatomy and improving treatment efficacy by allowing coordinated manipulation and alignment of the device within the left atrial appendage.
Implementation Method 1
The shapeable guide-wire may comprise a shape-memory material, such that the guide-wire may be manipulated into a pre-determined shape configuration before being advanced within the first lumen. The distal end of the guide-wire may be articulated into a first shape prior to insertion into the second lumen, may bend into a second shape during deployment through the second lumen, and may reflex in to a third shape that is substantially similar to the first shape after the distal end of the guide-wire extends beyond the distal end of the sheath.
Data Source
AI summary
Deploying a cardiac device using a multi-lumen catheter includes advancing a multi-lumen sheath through vasculature towards a target anatomy, advancing a shapeable guide-wire through a first lumen disposed within the multi-lumen sheath, advancing a cardiac device through a second lumen disposed within the multi-lumen sheath using a device delivery catheter, such that the cardiac device advances toward the target anatomy, advancing the shapeable guide-wire, such that a distal end of the shapeable guide-wire extends past the distal end of the sheath and abuts against the cardiac device, and simultaneously manipulating, with each of the shapeable guide-wire and the cardiac device delivery system, the orientation of the cardiac device within the target anatomy until a target plane is achieved.