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

VSEngineering 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

Engineering Contradiction:
Improveactive agent transfer amountVSAvoidcoating integrity
Core Design Contradiction:
Quantity of substanceVSReliability

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.

Inventive Principle:
Principle #7Nested doll (Nesting)

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.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

Engineering Contradiction:
Improvetherapeutic delivery capabilityVSAvoidcoating damage from blood and components
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

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.

Inventive Principle:
Principle #7Nested doll (Nesting)

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.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

Engineering Contradiction:
Improvetherapeutic agent delivery efficiencyVSAvoidballoon coating durability
Core Design Contradiction:
ProductivityVSStrength

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.

Inventive Principle:
Principle #7Nested doll (Nesting)

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.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP3436095B1Delivery system for active agent coated balloon
Publication Date: 2024.07.24 SURMODICS INC
  • EP3436095B1 patent drawingFigure 1
  • EP3436095B1 patent drawingFigure 2
  • EP3436095B1 patent drawingFigure 3

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.