Balloon-Based Medical Delivery Device for Consistent Agent Dosing
Solution Overview
Problem
Current endoscopic medical devices face challenges in consistently delivering hemostatic or regenerative agents to remote sites within the body, such as the gastrointestinal tract, due to inconsistent dosing and difficulty in reaching deep tissues.
Innovation Solution
A medical device featuring a balloon at its distal end that transitions from a deflated to an inflated configuration, using lumens and channels to deliver materials from internal pockets to the target site, ensuring consistent and effective delivery of agents to the treatment area.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If mechanical systems are used for agent delivery, then the device structure is simple, but the dosing consistency and delivery reliability are poor
Solution Approach 1:
The patent employs a balloon-based pneumatic system where inflation of the balloon delivers the hemostatic agent through pressure-driven expansion. The balloon transitions from a deflated state (where the agent is contained in pockets) to an inflated state (where the agent is expelled onto the tissue), providing consistent and controllable dosing through fluid pressure rather than complex mechanical mechanisms.
Solution Approach 2:
The delivery mechanism relies on changing the physical state of the balloon from deflated to inflated by controlling inflation parameters (fluid pressure, volume, and timing). This parameter change enables precise control over agent delivery timing and dosage, ensuring consistent dosing without complex mechanical dosing systems.
2Ease of operation
If mechanical delivery systems are used, then the device is easy to manufacture, but the agent cannot reach deep tissues effectively
Solution Approach 1:
The patent utilizes the radial dimension by inflating the balloon outward from the sheath to contact and treat deep tissue surfaces. The balloon expands in the radial direction, allowing the agent to be delivered onto tissue that is deep within the body lumen, overcoming the limitation of linear delivery through the working channel.
3Manufacturing precision
If the balloon is inflated to deliver material, then the delivery precision is improved, but the device complexity increases
Solution Approach 1:
The balloon structure is segmented into multiple functional lumens: a sheath lumen for inflation fluid delivery, a balloon lumen for agent containment and delivery, and channels connecting the agent pockets to the balloon interior. This segmentation allows each lumen to perform a specific function, achieving precise delivery control while maintaining manufacturing simplicity through modular design.
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-based delivery system ensures precise and consistent delivery of materials to the target site, overcoming previous issues of inconsistent dosing and deep tissue access, facilitating effective hemostasis and tissue healing.
Implementation Method 1
a fluid from the fluid containment device may be configured to be supplied to the sheath lumen to transition the balloon from the deflated configuration to the inflated configuration
Data Source
AI summary
A medical device includes a sheath having a proximal end, a distal end, and at least one lumen extending from the proximal end to the distal end, and a balloon at the distal end of the sheath and having an inflated configuration and a deflated configuration. The balloon defines at least one space radially inward of an exterior surface of the balloon, the at least one space configured to retain a material, and the transition of the balloon from the deflated configuration to the inflated configuration delivers the material from the at least one space to a target site in a body.