Detachable RF Occlusive Device Release Mechanism
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Solution Overview
Problem
There is a need for alternative medical devices and methods for manufacturing and using intracorporeal medical devices, such as occlusive devices, that can efficiently promote embolization and size reduction of body lumens while minimizing coagulation on release mechanisms.
Innovation Solution
An occlusive medical device system comprising a microcatheter with an elongate shaft and a releasable occlusive medical device, where an RF generator is connected to the device through a release mechanism, allowing for controlled electrical states to facilitate the deployment and detachment of the occlusive device within the body lumen, utilizing a nitinol composite wire for attachment and release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the occlusive medical device is delivered through a microcatheter using a release mechanism, then the device can be precisely positioned and deployed within the body lumen, but coagulation may form on the release mechanism preventing successful detachment
Solution Approach 1:
The system applies RF energy to the occlusive medical device before detachment is attempted, pre-heating the device and surrounding tissue to prevent coagulation formation on the release mechanism. This preliminary thermal action ensures the release mechanism remains free of coagulation during the critical detachment phase.
Solution Approach 2:
The patent replaces purely mechanical release mechanisms with an RF-energy-assisted release system. Instead of relying solely on mechanical forces to detach the device, RF energy is used to thermally manage the interface between the occlusive device and release mechanism, preventing coagulation that would otherwise block mechanical detachment.
2Reliability
If RF energy is applied to the occlusive medical device to prevent coagulation, then detachment reliability improves, but uncontrolled RF energy delivery could cause harmful heating or tissue damage
Solution Approach 1:
The system incorporates feedback control through the electrical connection between the RF generator and the occlusive medical device via the release mechanism. The system monitors electrical state changes to detect when the device is properly positioned and when detachment is appropriate, automatically controlling RF energy delivery to prevent overheating or tissue damage.
Solution Approach 2:
The patent utilizes changes in electrical parameters (electrical state, conductivity) of the release mechanism and occlusive device to control RF energy delivery. By monitoring these parameter changes, the system ensures RF energy is applied at appropriate times and intensities, preventing harmful heating while maintaining detachment reliability.
3Object-affected harmful factors
If the release mechanism remains inside the microcatheter during RF energy delivery, then the system maintains electrical isolation and safety, but the occlusive device cannot be deployed outside the microcatheter to perform its function
Solution Approach 1:
The system transitions from a static configuration (release mechanism inside microcatheter) to a dynamic configuration (release mechanism and occlusive device outside microcatheter). The elongate shaft moves relative to the microcatheter, enabling the release mechanism to exit the microcatheter while maintaining electrical connection through the conductive release wire, thus allowing both safety and functionality.
Solution Approach 2:
The conductive release wire acts as an intermediary element that maintains electrical connection between the RF generator and the occlusive device after the release mechanism exits the microcatheter. This intermediary ensures continuous electrical isolation and safety while enabling the occlusive device to be deployed outside the microcatheter for its intended function.
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
Enables precise embolization and size reduction of body lumens by controlled RF energy delivery, minimizing coagulation on release mechanisms and ensuring effective detachment of the occlusive device, thus addressing the limitations of existing technologies.
Implementation Method 1
In a second electrical state electrical current is flowing to the occlusive medical device... sending RF energy to the occlusive medical device while the release mechanism is disposed within the distal end of the microcatheter to heat the treatment site
Data Source
AI summary
An occlusive medical device system may include a microcatheter, an elongate shaft, an occlusive medical device, wherein a release wire is configured to releasably attach the medical device to the distal end of the shaft at a release mechanism, and an RF generator. In a first electrical state current is not flowing and in a second electrical state current is flowing to the medical device. The shaft is slidable between a first position wherein the medical device is disposed within the microcatheter, a second position wherein at least a portion of the medical device is disposed outside of the microcatheter and the release mechanism is disposed within the microcatheter, and a third position wherein the release mechanism is disposed outside of the microcatheter. The medical device system is configured to be in the second electrical state when the elongate shaft is in the second position.