Deformable Prong Closure Device for Gastrocutaneous Fistula
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Solution Overview
Problem
Gastrostomy tube removal often requires surgical closure of gastrocutaneous fistulas, which is costly and invasive, as natural closure occurs in only half the cases, and endoscopic treatments face challenges due to visibility and tissue unevenness.
Innovation Solution
A gastrocutaneous closure device with deformable prongs that radially compress for insertion through a sleeve and expand for secure closure against the stomach wall, allowing for external abdominal access and potential cauterization to promote healing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If endoscopic treatment is used to access the interior stomach wall through the esophagus, then the fistula site can be reached, but visibility and uneven tissue surface cause misalignment of the closure device with the fistula opening
Solution Approach 1:
Instead of accessing the stomach interior through the esophagus (conventional endoscopic approach), the invention inverts the approach by accessing the fistula site from the external abdominal surface through the gastrocutaneous fistula tract. This external-to-internal approach eliminates visibility problems and allows direct alignment with the fistula opening, as the closure device is delivered through the existing tract rather than attempting to visualize and target the site from within the stomach lumen
2Reliability
If a surgical closure is performed to close the gastrocutaneous fistula, then the fistula can be effectively closed, but medical costs increase and surgical intervention is required
Solution Approach 1:
The invention replaces complex surgical mechanical closure procedures with a simpler self-expanding mechanical closure device. The closure device is delivered through a minimally invasive percutaneous approach and uses spring-loaded or shape-memory alloy mechanisms to automatically expand and secure the fistula closure, eliminating the need for complex surgical manipulation and reducing both procedural complexity and cost
Solution Approach 2:
The closure device incorporates self-expanding mechanisms that automatically deploy and secure the fistula closure without requiring continuous surgical manipulation. The device performs its own deployment and positioning functions, reducing the need for complex surgical intervention and making the procedure more cost-effective while maintaining reliable closure
3Strength
If the closure device prongs are expanded to engage the stomach wall, then secure closure is achieved, but the device cannot pass through the narrow fistula tract
Solution Approach 1:
The closure device employs dynamic, state-changeable structures that allow it to transition between compressed and expanded states. During delivery, the device is compressed to a small diameter to pass through the narrow fistula tract. Once deployed at the fistula site, the device expands to a larger diameter to engage the stomach wall and achieve secure closure. This dynamic transformation resolves the contradiction between needing small delivery dimensions and large engagement dimensions
4Ease of operation
If a deformable clip with arcuate prongs is used, then the device can compress and expand for insertion and closure, but the device complexity increases
Solution Approach 1:
The closure device is segmented into multiple functional components: a central hub, multiple arcuate prongs, and a delivery mechanism. Each segment has a specific function - the hub provides structural support, the prongs provide engagement and compression, and the delivery mechanism enables controlled deployment. This segmentation allows the complex functionality to be achieved through modular, independently optimized components rather than a monolithic complex structure
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 accurate and minimally invasive closure of gastrocutaneous fistulas without anesthesia, reducing medical costs and complications by ensuring precise placement and promoting healing through radial expansion and cauterization.
Implementation Method 1
A closure or clip has a plurality of prongs defined by a deformable material, such that the prongs extend radially from a central hub... The deformable prongs may therefore radially compress or retract to define a larger or smaller diameter
Implementation Method 2
The sleeve walls compress and draw the distal ends, or tips, of the prongs towards the central axis now defined by the shaft
Implementation Method 3
Upon insertion through the gastrocutaneous fistula into the stomach interior, the clip is pushed out the end of the shaft to return to a rest or undeformed position inside the stomach lumen
Implementation Method 4
The shaft then partially retracts to force the clip against the sleeve, which in turn radially expands the prongs in response to partial retraction of the shaft through the sleeve
Implementation Method 5
The undeformed clip has a diameter larger than the sleeve, such that once pushed through the sleeve, it expands to a radial diameter greater than the sleeve... drawing the stomach wall inward toward the hub for closing the fistula
Data Source
AI summary
A gastrocutaneous closure device allows gastrocutaneous fistula closure from external abdominal access through the fistula site. Access through the fistula ensures accurate closure placement on the interior lumen wall of the stomach. A closure or clip has a plurality of prongs defined by a deformable material, such that the prongs extend radially from a central hub in an arcuate or curved, semicircular shape. The arcuate shape converges towards a central point or axis at a distal end, and the proximate end of the prongs attaches to the central hub such that the prongs radiate from the hub and the distal end curves back toward the axis through the hub. The deformable prongs may therefore radially compress or retract to define a larger or smaller diameter. The fistula lies on the axis such that the biased, inserted prongs pull the inner stomach wall closed around the healing fistula.