Balloon Protrusions for Surgical Access Device Fixation
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Solution Overview
Problem
Existing surgical access devices lack effective mechanisms to enhance the fixation and stability of the balloon within tissue, which can lead to instability and reduced performance during minimally invasive surgical procedures.
Innovation Solution
The method involves forming a balloon with a plurality of protrusions extending radially outwardly from an inflatable anchor, which is manufactured using a mold with specific geometry and vent holes to shape the molding material into the desired form.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If a smooth balloon surface is used, then the manufacturing process is simple, but the fixation force within tissue is insufficient
Solution Approach 1:
The balloon surface is modified with localized protrusions at specific regions (distal and proximal portions) rather than uniformly across the entire surface. This local quality change enhances fixation force at critical interfaces with tissue while maintaining manufacturing feasibility through targeted mold design.
Solution Approach 2:
The protrusions on the balloon surface are formed with curved, spherical, or dome-like geometries rather than sharp angular shapes. This curvature allows the protrusions to better conform to and engage with tissue surfaces, enhancing fixation while being easily formed through standard blow-molding processes with appropriately designed mold cavities.
2Reliability
If protrusions are added to enhance fixation, then the anchoring performance improves, but the manufacturing complexity increases
Solution Approach 1:
The protrusions are integrated directly into the balloon structure during the blow-molding process itself, rather than being added as separate components through secondary operations. The mold cavity includes protrusion-forming features that are formed simultaneously with the balloon body, merging the anchoring features with the main structural formation step.
Solution Approach 2:
The balloon structure itself serves to create the protrusions through the blow-molding process. The molding material, when inflated within the mold, naturally forms the protrusions by engaging with the vent holes and cavity geometry, eliminating the need for separate machining or attachment steps.
3Force
If a simple mold design is used, then the manufacturing process is easier, but the balloon cannot form protrusions for enhanced fixation
Solution Approach 1:
The mold is divided into two separate halves (first mold half and second mold half) that can be independently manufactured and assembled. Each mold half contains specific cavity features and vent holes that collectively form the protrusions when closed together, allowing for easier manufacturing of individual mold components while achieving complex balloon geometry.
Solution Approach 2:
The vent holes in the mold serve as intermediary features that mediate between the simple cylindrical mold structure and the complex protrusion geometry on the balloon. These vent holes act as negative forms that shape the protrusions during inflation, providing a straightforward mechanism to generate complex surface features.
4Strength
If the balloon is made with uniform thickness, then manufacturing is simpler, but the structural strength and fixation are reduced
Solution Approach 1:
The balloon is designed with non-uniform wall thickness, featuring thicker regions at the distal and proximal portions where protrusions are located to provide enhanced strength and fixation, while the intermediate portion maintains appropriate thickness for flexibility and sealing. This local quality variation optimizes structural performance where needed without unnecessarily complicating the overall manufacturing process.
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 balloon with protrusions provides enhanced fixation force within tissue, improving the stability and performance of the surgical access device, thereby supporting more effective minimally invasive surgical procedures.
Implementation Method 1
expanding the molding material may include subjecting the molding material to gas, pressure, or increased temperature
Implementation Method 2
expanding the molding material may include subjecting the molding material to gas, pressure, or increased temperature
Implementation Method 3
The first and second mold halves each includes vent holes extending therethrough that are in fluid communication with the cavity
Data Source
AI summary
A method of forming a balloon for a surgical access device includes positioning a molding material into a channel defined in a first mold half of a mold and mounting a second mold half onto the first mold half to cover the channel and form a cavity within the mold. The first and second mold halves each includes vent holes extending therethrough that are in fluid communication with the cavity. The method also includes expanding the molding material to conform to the shape of the cavity to form a balloon including protrusions extending radially outwardly therefrom. The protrusions are formed by engagement of the molding material with the vent holes.