Stent Delivery Sheath Alignment for Sequential Tack Deployment
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Solution Overview
Problem
Current stent and stent delivery systems have limitations and drawbacks, particularly in the treatment of atherosclerotic occlusive disease, which affects blood supply and can lead to severe health issues.
Innovation Solution
A delivery device with unique shapes and configurations for holding multiple intraluminal devices, such as tacks, in a compressed state, allowing for precise alignment and sequential deployment using radiopaque markers and adjustable sheaths for controlled release into the treatment area.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If multiple intraluminal devices are delivered sequentially from a single delivery device, then treatment efficiency and productivity are improved, but device complexity increases due to multiple delivery platforms and alignment mechanisms
Solution Approach 1:
The delivery device is segmented into multiple delivery platforms (first, second, third platforms) arranged in series along the inner shaft, each capable of holding and deploying an intraluminal device independently. This segmentation allows sequential delivery of multiple devices through a single catheter, improving productivity while managing complexity through modular design
Solution Approach 2:
Each delivery platform is designed with universal features including radiopaque markers for alignment, compressed state holding capability, and deployment mechanisms. The platforms can all hold intraluminal devices in a compressed state and release them sequentially, providing multi-functionality that improves treatment efficiency without requiring entirely separate delivery systems
2Measurement precision
If radiopaque markers are used for alignment of delivery platforms, then measurement precision and positioning accuracy are improved, but device complexity increases due to additional markers and alignment mechanisms
Solution Approach 1:
Radiopaque markers are incorporated into the delivery platforms and intraluminal devices, which appear as distinct radiopaque structures on fluoroscopic imaging. These markers enable precise visual alignment and positioning during the procedure without adding mechanical complexity, as the alignment is achieved through imaging guidance rather than mechanical alignment mechanisms
Solution Approach 2:
The radiopaque markers serve as intermediary reference points that facilitate alignment between the delivery device and the intraluminal devices. By providing visible reference points on both the delivery platform and the device to be deployed, the markers act as mediators that enable precise positioning without requiring direct mechanical coupling or complex alignment mechanisms
3Volume of moving object
If intraluminal devices are held in compressed state on the delivery device, then device miniaturization and ease of insertion are improved, but manufacturing precision requirements increase to maintain device integrity during compression
Solution Approach 1:
The intraluminal devices are pre-compressed to a compressed state before being loaded onto the delivery platforms. This preliminary compression action allows the devices to be delivered through a smaller catheter diameter, improving miniaturization and ease of insertion. The compression is performed beforehand, allowing manufacturing of the devices in their final configuration and then mechanically compressed for delivery, rather than requiring manufacturing precision at the compressed dimensions
Solution Approach 2:
The intraluminal devices are nested within the delivery device in a compressed state, with each device positioned on a separate delivery platform along the inner shaft. This nesting arrangement allows multiple compressed devices to be contained within the delivery catheter, achieving miniaturization for vascular access while the devices maintain their structural integrity through the nested configuration
4Reliability
If sequential deployment of multiple intraluminal devices is performed, then treatment effectiveness is improved for atherosclerotic occlusive disease, but procedure time and loss of time increase due to step-by-step deployment
Solution Approach 1:
The sequential deployment mechanism allows continuous useful action during the procedure. After each intraluminal device is deployed from its platform, the delivery device remains in position and can immediately proceed to deploy the next device without requiring withdrawal or repositioning. This continuity maintains treatment effectiveness while minimizing idle time between deployments
Solution Approach 2:
The deployment of intraluminal devices occurs in periodic sequential steps, with each device deployed at a controlled interval from the previous one. The periodic action allows the operator to deploy devices one at a time in a systematic manner (first platform, then second, then third), ensuring proper positioning and expansion of each device while maintaining an efficient overall procedure flow
Data Source
AI summary
A delivery device can include several different features including, at least: a shuttle and trigger retraction of an outer sheath; an interlock device to prevent actuation of the trigger; a retraction override switch and lock; and an inner shaft adjuster to ensure correct alignment of the inner shaft and the outer sheath prior to device deployment. The inner shaft adjuster may include, at least: a proximal portion of the handle housing having slots therethrough: pins operatively fixed to the inner shaft and extending through and slidable within the slots: and a cap having an inner helical groove that mates with the pins. Rotation of the cap may push the pins and the inner shaft in a proximal-distal direction. The cap may have a distal lip configured to accept a proximal extension of the interlock and retain it in a locked position until the inner shaft has been adjusted or moved.