Extragastic Stomach Plication Instrument for Minimally Invasive Volume Reduction
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Solution Overview
Problem
Current obesity treatment methods, such as gastric bypass surgery and gastric banding, are invasive, carry significant morbidity risks, and are often ineffective or have adverse side effects, limiting their applicability to only severely obese patients with BMI ≥ 40 or ≥ 35 and co-morbidities, while less invasive options like gastric pacing and drugs have shown unsatisfactory weight loss results.
Innovation Solution
A method and instrument for extragastric stomach volume reduction involving end effectors that contact external stomach surfaces, create plications, and attach folded tissue surfaces serosa-to-serosa, assisted by suction and suturing, with an optional expandable implant to further reduce stomach volume.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If gastric bypass surgery is performed to reduce stomach volume, then weight loss effectiveness is improved, but morbidity and surgical risk increase significantly
Solution Approach 1:
Instead of performing surgery from the inside of the stomach (traditional gastric bypass), the invention performs plication from the outside of the stomach. The end effectors approach the stomach from the external surface, creating plications by folding and securing the stomach wall externally, thereby avoiding internal stapling and malabsorption while achieving volume reduction
Solution Approach 2:
The invention extracts the plication procedure from the internal gastric environment and relocates it to the external gastric surface. By removing the need for internal staplers and intestinal rerouting, the procedure achieves stomach volume reduction without the severe side effects of traditional bypass surgery
2Ease of operation
If gastric banding is performed to restrict food passage, then invasiveness is reduced, but weight loss effectiveness decreases
Solution Approach 1:
The invention introduces plication as an intermediary mechanism between gastric banding and gastric bypass. Rather than simply restricting food passage with a band or performing extensive bypass surgery, the plication creates permanent folds in the stomach wall that physically reduce volume while maintaining a minimally invasive approach
Solution Approach 2:
The plication procedure allows for dynamic adjustment of stomach volume reduction. The end effectors can be positioned at different locations and depths to create customized plications, and the degree of volume reduction can be modified by adjusting the number and spacing of plications, providing flexibility between banding and bypass extremes
3Volume of stationary object
If stapling is used to create a small stomach pouch, then stomach volume reduction is achieved, but tissue damage and erosion occur
Solution Approach 1:
Instead of stapling from the inside of the stomach pouch (which causes mucosal erosion), the invention performs plication from the outside of the stomach. The end effectors approach and secure the stomach wall externally, avoiding direct contact with and damage to the sensitive mucosal lining while still achieving volume reduction through folding
Solution Approach 2:
The invention converts the potential harm of external manipulation into benefit by using external plication to avoid internal damage. The external approach, which might seem to risk external tissue damage, actually protects the internal mucosa from stapler-induced erosion and inflammation
4Ease of operation
If LAPBAND is placed to constrict the fundus-cardia junction, then food passage restriction is achieved, but band displacement and slippage occur
Solution Approach 1:
The plication creates self-supporting folds in the stomach wall that maintain their position through the natural tension and structure of the folded tissue itself. The plicated stomach wall is self-reinforcing, with the folded layers supporting each other, eliminating the need for external bands that can slip or displace
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
This approach allows for a less invasive, effective reduction in stomach volume, potentially applicable to a broader range of obese patients, including those with BMI 30-35, by creating plications that can be adjusted and reducing the risk of complications associated with traditional surgical methods.
Implementation Method 1
a first plurality of suction ports extending along a length of the first elongate end effector and configured to deliver suction to the external surface of the stomach to engage the first elongate end effector therewith
Data Source
AI summary
Methods, instruments and systems are provided for separating opposite walls of the stomach by extragastric application of suction. Plication of the stomach can be performed between the separated walls after which the separate walls are brought back toward one another. In another aspect, methods, instruments, devices and systems are provided for reducing the effective volume of a stomach by performing one or more extragastric plications of the stomach.