Inflatable Balloon Pouch Forming Catheter
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Solution Overview
Problem
There is a need for alternative medical devices and methods for forming a pouch between layers of tissue, particularly in the abdominal wall, to facilitate the insertion and implantation of medical devices such as diabetes-reversing implants in a minimally invasive manner.
Innovation Solution
A dissection device comprising an inflatable balloon attached to a catheter, which is inserted between tissue layers, inflated to separate them, and then deflated for withdrawal, creating a pouch that can accommodate medical implants, with the balloon's design featuring a series of interconnected chambers for controlled expansion and a tapered portion for easy insertion and removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a traditional surgical method is used to form a pouch between tissue layers, then the pouch can be created, but the procedure causes significant tissue damage, inflammation, and risk of re-adhesion
Solution Approach 1:
The patent replaces traditional mechanical surgical dissection with a controlled inflation mechanism. An inflatable balloon is inserted between tissue layers and inflated to separate them, creating a pouch without direct mechanical cutting or dissection. This substitution of mechanical surgical tools with an inflation-based system reduces tissue trauma while maintaining pouch formation capability.
Solution Approach 2:
The patent employs pneumatic principles by using an inflatable balloon that can be expanded with fluid or gas. The balloon is inserted in a collapsed state, positioned between tissue layers, and then inflated to create separation and form the pouch. The pneumatic expansion allows for controlled tissue separation with minimal mechanical contact and damage.
2Object-affected harmful factors
If a minimally invasive approach is used to reduce tissue damage, then tissue trauma is reduced, but the ability to effectively separate and form a pouch may be compromised
Solution Approach 1:
The inflatable balloon is divided into multiple interconnected chambers that can be inflated sequentially or simultaneously. This segmentation allows for controlled expansion forces distributed across different regions, ensuring effective tissue separation while minimizing localized trauma. The multi-chamber design provides progressive pouch formation with reduced risk of tissue damage.
Solution Approach 2:
The balloon system transitions from a collapsed delivery configuration to an expanded operational configuration through controlled inflation. This dynamic transformation allows the device to adapt to the tissue anatomy, ensuring effective pouch formation while minimizing trauma. The balloon can be inflated to the precise degree needed for each patient's tissue characteristics.
3Manufacturing precision
If the balloon is designed with a complex multi-chamber structure for controlled expansion, then the pouch formation precision is improved, but the device complexity increases
Solution Approach 1:
The balloon is segmented into multiple chambers that can be inflated in a controlled sequence or simultaneously. Each chamber contributes to a specific region of pouch formation, allowing for precise control over the expansion pattern. This segmentation provides manufacturing precision through distributed control while the modular chamber design manages overall device complexity.
Solution Approach 2:
The multi-chamber balloon structure employs a nested configuration where chambers are arranged concentrically or in nested patterns. This nesting allows for compact packaging in a collapsed state for minimally invasive delivery, while enabling complex expansion patterns when inflated. The nested structure achieves precise pouch formation without requiring excessive device complexity.
4Object-affected harmful factors
If the balloon is made highly compliant to conform to tissue, then tissue damage is minimized, but the ability to effectively separate tissue layers may be reduced
Solution Approach 1:
The balloon transitions from a compliant collapsed state during insertion to a more rigid expanded state during pouch formation. In the collapsed configuration, the balloon is highly compliant to navigate tissue pathways with minimal damage. Upon inflation, the balloon develops sufficient rigidity and expansion force to effectively separate tissue layers and form the pouch, then can be deflated and removed with minimal trauma.
Solution Approach 2:
The physical parameters of the balloon, particularly its compliance and rigidity, change dynamically with inflation pressure. At low pressure during insertion, the balloon is compliant and flexible. As inflation pressure increases, the balloon becomes more rigid and exerts greater separating force on tissue layers. This parameter change allows the same device to minimize tissue damage during insertion while providing sufficient force for effective pouch formation.
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 forms a pouch within the abdominal wall, minimizing tissue damage and allowing for the vascularization of the implant site, facilitating the implantation of medical devices while reducing re-adhesion and inflammation.
Implementation Method 1
an inflatable balloon being expandable from a collapsed delivery configuration to an expanded configuration
Data Source
AI summary
A dissection device may include an inflatable balloon disposed at a distal end of a catheter, the catheter having an inflation lumen extending through the catheter to an interior space defined within the inflatable balloon. The inflatable balloon may include a top wall, a bottom wall spaced apart from the top wall, an outer perimeter wall extending between the top wall and the bottom wall, and a plurality of inner walls each extending between the top wall and the bottom wall and in sealing contact with the outer perimeter wall at a first end of the inner wall. The inflatable balloon may include a series of interconnected chambers including a central chamber in direct fluid communication with the inflation lumen, and laterally disposed chambers each having an opening fluidly connecting to each adjacent chamber.


