Coring Tip Balloon Deflation Device
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Solution Overview
Problem
Conventional methods for deflating and removing implantable gastric balloons often result in tears or ruptures due to beveled or conical piercing tips, leading to fluid leakage, increased procedure complexity, and risk of aspiration, as well as compromised maneuverability and stretch resistance.
Innovation Solution
A deflation device with a sharpened, hollow coring tip that creates a smooth, circular hole in the balloon wall, allowing for controlled deflation and removal without tearing, using a catheter with low surface friction and resistance to stretching, and optional RF energy for enhanced coring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If beveled or conical piercing tips are used to puncture the balloon wall, then the piercing action is simple and direct, but the balloon wall tears or ruptures causing fluid leakage
Solution Approach 1:
The piercing tip is designed with a curved, rounded leading edge instead of a sharp bevel or cone. This curvature allows the tip to gradually separate balloon wall fibers rather than forcing them apart, creating a clean circular incision that prevents tearing while maintaining manufacturing simplicity
Solution Approach 2:
The piercing tip geometry is optimized with specific dimensional parameters including a curved leading edge radius of 0.5-2.0mm and a length-to-diameter ratio of 2:1 to 4:1. These parameter changes transform the piercing mechanism from a tearing action to a controlled cutting action that preserves balloon wall integrity
2Loss of time
If conventional piercing methods are used, then the procedure is quick, but fluid leakage and aspiration risk increase
Solution Approach 1:
The catheter is pre-positioned against the balloon wall at the desired puncture site before activation. The piercing tip is contained within the catheter during approach, allowing precise positioning without premature puncture. This preliminary positioning ensures the first puncture is exactly where needed, preventing uncontrolled leakage and aspiration
Solution Approach 2:
The catheter acts as an intermediary that controls the piercing tip's exposure and movement. The tip remains protected within the catheter during navigation, then emerges controlled to create the puncture. This intermediary structure prevents uncontrolled fluid leakage by managing the puncture creation process
3Ease of operation
If the catheter has larger diameter for easier manipulation, then maneuverability improves, but stretch resistance decreases
Solution Approach 1:
The catheter is constructed from composite materials including a fluoropolymer jacket (such as PTFE or FEP) over a reinforcing braid of stainless steel or nitinol wires. This composite structure provides both the flexibility needed for maneuverability through tortuous pathways and the tensile strength to resist stretching forces during balloon removal
4Ease of operation
If the coring tip creates a larger hole for easier catheter insertion, then insertion ease improves, but balloon wall tearing increases
Solution Approach 1:
The coring tip creates a clean circular hole through its curved cutting edge that severs balloon wall fibers cleanly. The hole diameter is precisely controlled at 1.2-1.5 times the catheter outer diameter, providing sufficient clearance for smooth catheter passage while maintaining circular geometry that prevents irregular tearing of the balloon wall
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
Significantly reduces the risk of balloon rupture and leakage, enabling complete evacuation and easier removal with reduced risk of fluid aspiration and esophageal drag, facilitating a safer and more efficient procedure.
Implementation Method 1
The catheter may have an inner diameter of between about 0.060 inches and about 0.085 inches, and an outer diameter of between about 0.080 inches and about 0.125 inches. The coring tip may have an inner diameter of between about 0.030 inches and about 0.045 inches and an outer diameter of between about 0.040 inches and about 0.065 inches.
Implementation Method 2
The coring tip may also be advanced into the balloon while applying an energy, such as RF hi-frequency electrical energy to the coring tip.
Data Source
AI summary
Deflation devices including a catheter having a proximal opening at a proximal end and a distal opening at a distal end, and a coring member disposed within the catheter are disclosed herein. In one embodiment, the coring member comprises a handle disposed near the proximal end of the catheter, a cable, and a coring tip disposed near the distal end of the catheter. The distal end of the catheter can be configured to press against a wall of a balloon to create a substantially normalized surface of the balloon relative to a coring tip. A method for deflating and removing an implanted device, in accordance with another embodiment, can include pressing a distal end of a catheter against the wall of an inflated balloon of the device, and advancing the coring tip within the catheter beyond the distal end of the catheter and into the balloon.