Shape Memory Endoscopic Closure Device for Luminal Perforations
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Solution Overview
Problem
Natural orifice transluminal endoscopic surgery (NOTES) procedures face challenges in safely closing luminal perforations during endoscopic procedures, particularly due to difficulties in effectively approximating and securing tissue closures using existing flexible instruments.
Innovation Solution
The development of medical devices featuring flexible legs made of shape memory materials, equipped with resilient members and a cinch mechanism, which deploy from an endoscope to engage and pull tissue closer together, facilitating safe closure of luminal perforations by transitioning from a linear to a curvilinear shape upon deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If flexible instruments are used for NOTES procedures, then ease of operation through natural orifices is improved, but the ability to effectively approximate and secure tissue closures deteriorates
Solution Approach 1:
The closure device is divided into multiple flexible legs (at least two) that can independently engage with tissue at different locations. Each leg acts as a separate approximation element, allowing the device to securely close luminal perforations while maintaining flexibility for natural orifice delivery.
Solution Approach 2:
The device incorporates dynamic elements including a resilient member that can be stretched during delivery and then releases to pull legs together, and a cinch mechanism that can be advanced to force legs closer together. These dynamic components enable the device to transition from a deliverable configuration to an effective tissue approximation configuration.
2Reliability
If the device includes a resilient member and cinch mechanism, then tissue closure reliability is improved, but device complexity increases
Solution Approach 1:
The resilient member and cinch mechanism are integrated into a single closure device structure, combining multiple functions (tensioning, approximation, and securing) into one unified instrument. This merging approach achieves reliable tissue closure while limiting the increase in overall device complexity.
Solution Approach 2:
The closure device performs multiple functions: the resilient member provides tensioning and elastic recovery, the cinch mechanism provides adjustable approximation force, and the flexible legs provide tissue engagement. This multi-functionality consolidates several closure operations into a single device, improving reliability without proportionally increasing complexity.
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 secure and efficient closure of luminal perforations during NOTES procedures, reducing the frequency of colon resections and treating gastrointestinal bleeding by effectively approximating large defects and maintaining tissue closure.
Implementation Method 1
at least two flexible elongate legs formed of a shape memory material and having free end portions configured to attach to target tissue. The legs are configured to have a substantially straight configuration in the endoscope lumen and a pre-formed curvilinear shape after deployment.
Implementation Method 2
at least one resilient member having opposing end portions, a respective end portion being attached to each leg at a location away from the free end. The resilient member is configured to take on a stretched configuration inside an endoscope during delivery.
Data Source
AI summary
Devices include at least two spaced apart flexible legs formed of a shape memory material, each leg having a respective free end configured to engage local tissue. The devices can also include at least one resilient member having opposing end portions, a respective end portion being attached to each leg at a location away from the free end. The resilient member is configured to take on a stretched configuration inside an endoscope during delivery. Alternatively or additionally, the devices include a cinch that is configured to snugly hold portions of both legs to force the legs closer together.