Removable Loading Tool for Drug-Coated Balloon Protection
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Solution Overview
Problem
Current medical device delivery systems face challenges in minimizing damage to drug-coated balloons and coatings during procedures, particularly when passing through hemostatic valves, and in maximizing the working length of balloon catheters for effective local drug delivery in treating conditions like restenosis.
Innovation Solution
A removable dual function loading tool and balloon protector with a tubular configuration, featuring a proximal region with a slit and a tapered section, allows for the protection and safe passage of drug-coated medical devices through hemostatic valves while enabling maximum working length of the balloon catheter by minimizing shear effects on the coating and allowing for easier loading and deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a drug-coated balloon catheter is passed through a hemostatic valve during delivery, then the device can be delivered to the target site, but the coating on the balloon may be damaged due to shear forces
Solution Approach 1:
A loading tool is introduced as an intermediary device between the operator and the drug-coated balloon catheter. The loading tool features a tapered proximal region that guides the balloon catheter through the hemostatic valve, reducing direct contact and shear forces on the coating. The loading tool acts as a protective mediator that enables safe passage while preserving coating integrity.
Solution Approach 2:
The loading tool is designed with a tubular structure that can be collapsed or compressed to reduce its profile during passage through the hemostatic valve. This flexible design allows the loading tool to navigate through tight spaces without exerting excessive force on the drug-coated balloon, thereby protecting the coating from damage.
2Length of moving object
If the balloon catheter is made longer to improve working length, then more extensive treatment areas can be reached, but the device becomes more difficult to deliver and manipulate
Solution Approach 1:
The delivery system is segmented into distinct components: a separate loading tool and the balloon catheter. This segmentation allows the long balloon catheter to be loaded into and supported by the loading tool during delivery, making manipulation easier. The loading tool can be removed at the target site, leaving the full-length balloon catheter for treatment.
Solution Approach 2:
The balloon catheter is nested within the loading tool during the delivery phase. This nesting configuration allows the long balloon catheter to be contained within a smaller delivery profile, facilitating easier passage through the hemostatic valve and vascular system. Once at the target site, the loading tool is removed, and the balloon catheter is deployed for full-length treatment.
Data Source
AI summary
A medical device assembly including a catheter having a proximal end, a distal end, and a lumen therethrough. A medical device is disposed about a distal portion of the catheter. A removable loading tool and protector is disposed about the catheter and the medical device, and includes a body having a generally tubular configuration and having a proximal end, a distal end, an intermediate region disposed between the proximal end and the distal end, and a lumen disposed therethrough; and a proximal region having a length and extending from the proximal end of the body, the proximal region having at least one slit positioned adjacent to the proximal end of the body. The proximal region has a first inner diameter and the intermediate region has a second inner diameter, the first inner diameter of the proximal region being greater than the second inner diameter of the intermediate region.