Retractable Balloon Wound Drainage Device
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Solution Overview
Problem
Current medical devices and procedures are not adequately suited for treating post-operative surgical confined wounds, as they often require re-opening the wound for device removal, which can lead to complications such as infection and tissue damage, and lack flexibility and cost-effectiveness.
Innovation Solution
A medical device with a retractable inflatable balloon and sheath system that promotes hemostasis by applying controlled pressure outside the wound cavity, allowing for percutaneous removal without re-opening the wound, featuring a non-adhesive, hydrophobic, and flexible design with optional pharmaceutical coatings and pressure sensors for precise control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional wound device is used for post-operative confined wounds, then the wound can be treated, but the wound must be re-opened for device removal which causes infection risk and tissue damage
Solution Approach 1:
The balloon is nested within the catheter in a collapsed state during insertion, then expanded outside the catheter at the wound site, and finally collapsed again within the catheter for removal. This nested configuration allows the device to be inserted through a small puncture, perform its function externally, and be removed without reopening the wound.
Solution Approach 2:
The balloon transitions between collapsed and expanded states dynamically. It is collapsed during insertion through the catheter, expanded to contact and apply pressure to the wound tissue, then collapsed again for retraction into the catheter and removal. This dynamic state change enables the device to fulfill its hemostasis function while allowing minimally invasive removal.
2Reliability
If an inflatable balloon is used for hemostasis, then bleeding control is improved, but the device becomes complex and difficult to remove from enclosed wounds
Solution Approach 1:
The balloon is designed to nest within the catheter when collapsed and expand outside the catheter when inflated. This nesting capability allows the balloon to be easily inserted through the catheter, deployed at the wound site for effective hemostasis, and then retracted back into the catheter for simple removal without reopening the wound.
Solution Approach 2:
The balloon is inflated through fluid communication with the catheter using hydraulic pressure. This pneumatic/hydraulic mechanism allows for controlled inflation and deflation, enabling the balloon to expand to the necessary size for hemostasis and then collapse for easy retraction and removal through the same catheter access.
3Reliability
If the balloon is made adhesive to tissue for better contact, then hemostasis promotion is improved, but the device becomes difficult to remove without tissue damage
Solution Approach 1:
The balloon's contact with tissue is dynamic rather than permanent. It is inflated to achieve adequate contact and pressure for hemostasis, maintains this state for the required treatment duration, then is deflated and retracted. This dynamic approach ensures effective hemostasis while preventing tissue damage during removal, as the balloon does not permanently adhere to the tissue.
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 controls bleeding and promotes wound healing without re-opening the wound, reducing the risk of infection and tissue damage, while being easily removable and adaptable to various wound shapes, thus enhancing patient safety and cost-effectiveness.
Implementation Method 1
The balloon is temporary inflated and arranged outside the sheath, in contact with tissue surrounding a wound cavity for hemostasis promotion
Implementation Method 2
the balloon and/or the sheath have an outer surface that is at least partly non-absorbent for liquid and/or non-adhesive to the tissue
Data Source
Figure 1
Figure 2
Figure 3A~3C
AI summary
A wound drainage and hemostasis promoting medical device (1) is disclosed. A balloon (15) is temporary inflated and arranged outside a sheath (10), in contact with tissue surrounding a wound cavity for hemostasis promotion. The drainage device comprises a fluid communication channel for wound exudate from a wound. The balloon is deflated and retracted into said sheath for removal from said wound cavity. Thus the medical device is percutaneously retractable from said confined wound.