Active Agent Coated Balloon Delivery System with Tunneling Sheath
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Solution Overview
Problem
Existing methods for delivering active agents via expandable balloons face challenges in maximizing agent transfer to target sites due to agent loss during procedure and damage to the active agent coating, particularly when interacting with medical components and blood.
Innovation Solution
A delivery system featuring a tunneling sheath that protects the active agent coated balloon, maintaining the coating integrity and preventing agent loss, while allowing the balloon to remain stationary relative to the sheath during insertion and inflation, ensuring effective delivery to the treatment site.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If the balloon catheter is advanced through the blood vessel with the active agent coating exposed, then the balloon can be positioned at the target site, but the active agent coating is damaged and agent is lost during the procedure
Solution Approach 1:
The balloon catheter is nested within the tunneling sheath during advancement through the blood vessel. The sheath acts as a protective outer layer that encloses the vulnerable active agent coating on the balloon, preventing damage and loss during the procedure while allowing the balloon to be positioned at the target site.
Solution Approach 2:
The tunneling sheath serves as an intermediary protective layer between the active agent coating on the balloon and the external environment (blood, medical components). This intermediary structure prevents direct contact and damage to the coating during vessel navigation and positioning.
2Adaptability or versatility
If the active agent coating is applied to the balloon surface, then therapeutic delivery to the target site is enabled, but the coating is vulnerable to damage from blood and medical components
Solution Approach 1:
The balloon with the active agent coating is nested within the protective tunneling sheath during insertion and advancement. This nesting arrangement protects the coating from harmful factors in the blood and from contact with medical components while maintaining the therapeutic delivery capability of the coated balloon at the target site.
Solution Approach 2:
The tunneling sheath acts as an intermediary protective barrier that shields the active agent coating from harmful factors including blood exposure and contact with medical components during the procedure, while allowing the coated balloon to perform its therapeutic function when deployed.
3Productivity
If the balloon is made expandable for delivery, then the balloon can deliver therapeutic agents effectively, but the balloon is vulnerable to damage during insertion and inflation
Solution Approach 1:
The expandable balloon with active agent coating is nested within the tunneling sheath during insertion through the blood vessel. This protective nesting maintains the durability of the coating during the vulnerable insertion phase while preserving the balloon's expandability and therapeutic delivery efficiency when deployed at the target site.
Solution Approach 2:
The tunneling sheath serves as an intermediary protective structure that safeguards the expandable balloon's active agent coating during insertion and positioning, preventing damage that would reduce therapeutic delivery efficiency, while allowing the balloon to expand and function effectively at the target site.
Data Source
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AI summary
Delivery systems (100) for active agent coated balloons and related methods. A delivery system can include a tunneling sheath (104) and a balloon catheter (106). The tunneling sheath can include a tubular shaft (602) having an outer diameter and defining a lumen. The tunneling sheath can include a proximal collar (105) defining a lumen. The balloon catheter can include a balloon catheter shaft disposed within the tubular shaft. The balloon catheter shaft can include a lumen for the passage of a fluid therein. The balloon catheter can include an expandable balloon (108) disposed on the balloon catheter shaft. The balloon catheter shaft can include an active agent layer disposed on the expandable balloon. The position of the expandable balloon can be configured to be stationary relative to the tubular shaft as the delivery system is passed through a blood vessel of a patient.