Expandable Member Bursting for Puncture Sealing
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Solution Overview
Problem
Current methods for sealing punctures in blood vessels during medical procedures are often cumbersome, painful, and inefficient, particularly due to issues with manual pressure, absorbable intra-vessel anchors, and plug placement, which can lead to complications like hematoma and inadequate sealing.
Innovation Solution
A medical material delivery device featuring a shaft with a lumen and an expandable member that can burst or leak when disrupted, allowing for the delivery of therapeutic agents directly to the puncture site, using mechanisms like longitudinal breakage lines, chemical solvents, or needles to ensure effective sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual pressure is applied to seal a puncture, then the puncture can be sealed, but it is uncomfortable for the patient and time consuming
Solution Approach 1:
The device performs preliminary action by pre-positioning the sealing plug and delivery mechanism at the puncture site before sealing is needed. The catheter is inserted through the puncture tract during the procedure, and the plug is ready for immediate deployment, eliminating the need for prolonged manual compression and reducing patient discomfort and procedure time.
2Reliability
If absorbable intra-vessel anchors with collagen sponges are used, then puncture sealing can be achieved, but they may not work in certain situations such as femoral artery punctures or when peripheral vascular disease is present
Solution Approach 1:
The invention extracts the sealing component (plug) from the blood vessel lumen and places it extraluminally at the puncture site. This eliminates the need for anchors that must be deployed inside the vessel, making the device applicable to all puncture locations including femoral artery and patients with peripheral vascular disease, thereby significantly improving adaptability.
Solution Approach 2:
The catheter serves as an intermediary delivery mechanism that navigates through the puncture tract to deliver the sealing plug precisely to the puncture site. This intermediary approach allows the plug to be positioned accurately without requiring complex anchor deployment mechanisms inside the vessel, enhancing versatility across different clinical scenarios.
3Device complexity
If a plug is deposited outside the blood vessel at the puncture site, then no component needs to be inside the blood vessel, but blood pressure can cause the plug to move away from the puncture site resulting in hematoma or inadequate sealing
Solution Approach 1:
The device performs preliminary action by pre-positioning the sealing plug directly at the puncture site using the catheter delivery system before blood pressure can displace it. The plug is deployed in situ rather than being thrown extraluminally, ensuring immediate stabilization against blood pressure forces and preventing hematoma formation while maintaining structural simplicity.
4Productivity
If the expandable member is disrupted to deliver the therapeutic agent, then the agent can be delivered effectively, but the disruptor must be carefully controlled to avoid complications
Solution Approach 1:
The expandable member is designed with self-service disruption mechanisms where the therapeutic agent itself or the expansion process triggers the disruption. For example, the agent may contain embedded disruptors that activate upon contact with blood or tissue fluids, or the expansion force itself causes predetermined fracture points to fail, delivering the agent efficiently while minimizing external intervention and potential complications.
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 provides a quick, less painful, and secure method for sealing punctures, reducing the risk of complications and ensuring effective closure of blood vessel openings.
Implementation Method 1
An expandable member is positioned in conjunction with the guide and communicates with the lumen of the shaft for expansion by the therapeutic agent
Data Source
AI summary
A medical material delivery device includes a shaft having a lumen that receives a therapeutic agent, and can include a guide having a channel for receiving a medical instrument adapted for positioning in conjunction with a bodily part. An expandable member positioned in conjunction with the guide is adapted for communication with the bodily part and is arranged to burst open when the expandable member is disrupted by a disrupting mechanism to deliver the therapeutic agent to the bodily part. Further embodiments include a medical instrument and an expandable member in conjunction with the medical instrument to burst or leak to deliver a therapeutic agent. The medical material delivery device can include a bodily fluid locator attached with the device, as well as can include a second expandable member to inflate and deflate to localize a bodily part, with a first expandable member bursting to deliver a therapeutic agent.