Adhesive Patch with Compression Bladder for Sheath Stabilization
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Solution Overview
Problem
Current methods for securing secondary devices, such as sheaths, during minimally invasive surgical procedures are inadequate, leading to potential movement, displacement, and complications like hematoma formation or trauma at the puncture site.
Innovation Solution
A medical device comprising a patch with a compression bladder and adhesive materials, configured to support secondary devices like sheaths during procedures and provide hemostasis by inflating to a predetermined pressure after device removal, ensuring the secondary device remains in place and controlling bleeding.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If no securing mechanism is used for secondary devices, then the device complexity is reduced, but the secondary device may move or displace during procedure causing harm
Solution Approach 1:
The patent combines the securing function and compression function into a single integrated patch device. The patch includes both an anchor mechanism with adhesive backing for securing the secondary device and a compression bladder for applying pressure, merging multiple functions into one device to reduce overall system complexity while preventing device displacement and trauma.
Solution Approach 2:
The patch is applied to the patient's skin before the secondary device is inserted. The anchor mechanism is prepared in advance with adhesive activated, and the compression bladder is positioned ready for inflation. This preliminary preparation ensures the securing mechanism is in place before device insertion, preventing displacement without requiring complex additional securing steps during the procedure.
2Stability of the object's composition
If a secure anchor mechanism is used, then the secondary device stability is improved, but the device complexity increases
Solution Approach 1:
The patent extracts the securing function into a separate modular patch component that can be independently applied to the skin. The patch with its anchor mechanism and adhesive backing is prepared and applied separately from the secondary device itself, simplifying the overall system by dividing functions into independent modules rather than integrating complexity into the device.
Solution Approach 2:
The patch acts as an intermediary between the patient's skin and the secondary device. Instead of directly attaching the device to the skin or using complex mechanical anchors, the adhesive-backed patch serves as a mediating layer that secures the device through its anchor mechanism while maintaining simplicity in the overall attachment system.
3Loss of time
If compression is applied immediately after device removal, then hemostasis is achieved faster, but the timing control becomes more critical
Solution Approach 1:
The compression bladder is positioned and prepared in advance on the patch, ready for immediate inflation upon device removal. The pathway for inflation is pre-established, allowing rapid application of compression without requiring complex timing coordination or additional setup steps, thus achieving fast hemostasis while maintaining ease of operation.
4Object-affected harmful factors
If the patch covers the entire puncture site, then the sterile field protection is improved, but the access to puncture site is reduced
Solution Approach 1:
The patch is designed with a cutout region that provides localized coverage - the adhesive material and compression bladder cover the necessary areas for securing and compressing the puncture site, while the cutout maintains access to the puncture site itself. This selective coverage protects the sterile field where needed while preserving accessibility where required.
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 secures secondary devices during procedures and achieves rapid hemostasis, reducing the risk of complications like hematoma formation and maintaining a sterile field, thereby enhancing surgical efficiency and patient safety.
Implementation Method 1
The compression bladder is configured to be inflated to a predetermined pressure to provide a desired degree of hemostasis to a patient's radial artery
Implementation Method 2
a first adhesive material arranged on a first surface of the first patch portion... a second adhesive material arranged on a first surface of the second patch portion
Data Source
AI summary
A device that holds a radial sheath, catheter or similar structure in place during surgical procedures. The device has a strap configured to fit around a patient's wrist and a two-part section that includes a sheath holder or clamp. The clamp is configured to accept a free end of the sheath or other device and to allow the physician access to the open end of that sheath so that they can insert instruments through it. The second section contains a compression device that, when positioned over the puncture site, can be expanded such that it provides pressure and patent hemostasis to the site to stop bleeding. Adhesive surfaces with peel away releasable liners on one or more surfaces of the device allow the flap featuring the compression balloon to be folded over onto the flap containing the sheath clamp and hold it in place.