Shape-Memory Wound Closure Element for Endoscopic Tissue Defects
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Solution Overview
Problem
Endoscopic procedures such as EMR and ESD often result in tissue defects or wounds that are difficult to close due to their size or location, leading to prolonged healing times and increased risk of infection.
Innovation Solution
A medical device comprising a closure element with a shape-memory configuration, which can be deployed through an endoscope to approximate tissue edges and close wounds. The closure element is configured to transition from a delivery configuration to a deployed configuration, constricting around the wound to facilitate healing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Area of stationary object
If traditional closure devices are used, then small wounds can be closed, but large wounds cannot be closed effectively
Solution Approach 1:
The closure element is divided into multiple segments or sections that can independently engage with tissue. This segmentation allows the closure element to conform to and close larger wound areas by distributing the closure force across multiple engagement points, making it effective for wounds exceeding the working area of standard endoscopes
Solution Approach 2:
The closure element transitions from a compressed one-dimensional configuration during delivery through the endoscope to a three-dimensional expanded configuration at the wound site. This dimensional transformation enables the closure element to achieve sufficient size and complexity to close large wounds while maintaining deliverability through narrow endoscope channels
2Reliability
If the wound remains open, then no closure intervention is needed, but infection risk increases and healing time is prolonged
Solution Approach 1:
The closure element is designed to immediately approximate tissue edges upon deployment, creating a sealed environment before healing begins. This preliminary closure action prevents contamination and establishes optimal healing conditions from the start, reducing both infection risk and overall healing time
Solution Approach 2:
The closure element incorporates self-adjusting features that allow it to automatically conform to the wound geometry and maintain appropriate closure force throughout the healing process. This self-service capability ensures consistent wound closure without requiring additional intervention, promoting reliable and timely healing
3Area of stationary object
If the closure element is made larger to close bigger wounds, then closure effectiveness improves, but deliverability through endoscope working channel deteriorates
Solution Approach 1:
The closure element is designed to nest within itself or within the delivery device in a compressed state. This nested configuration allows the large-area closure element to be delivered through the narrow working channel of the endoscope, then deployed to achieve full wound coverage at the target site
Solution Approach 2:
The closure element exhibits dynamic properties, transitioning from a flexible, compressed state during delivery to a rigid, expanded state during closure. This dynamic transformation allows the element to adapt its size and shape, fitting through narrow delivery channels while achieving large wound coverage when deployed
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
The device effectively closes wounds by approximating tissue edges, reducing the risk of infection, and promoting faster healing, even for wounds larger than the working area of an endoscope.
Implementation Method 1
The closure element may include a plurality of biodegradable portions interspersed between a plurality of adjacent light-activated shape-memory portions along a length of the closure element. The activated configuration of the closure element may be a light-activated shape-memory configuration.
Implementation Method 2
The deployed configuration of the closure element may be a shape-memory configuration. The shape-memory configuration of the closure element may be a coil, a knot, or a torus, or a combination thereof.
Implementation Method 3
The closure element may extend along a length between terminal ends. The closure element may further include tissue-puncturing protrusions at each terminal end of the closure element. The tissue-puncturing protrusions may be hooks, tines, or barbs, or a combination thereof.
Data Source
AI summary
The present disclosure pertains to medical devices. More particularly, the present disclosure pertains to devices, systems, and methods for closing a wound, such as a tissue defect resulting from an endoscopic mucosal resection or endoscopic submucosal dissection procedure. In one example, a device for closing a wound may include a closure element having a delivery configuration and a deployed configuration, the closure element configured to be disposed about an endcap of an endoscope in a delivery configuration. A release filament may have a distal end releasably coupled to the closure element and a proximal end extendable within the endcap. The closure element may be configured to substantially close about the wound in the deployed configuration.