Occlusion Balloon for Vascular Perforation Management

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Solution Overview

Problem

Current lead extraction procedures face challenges in managing vascular perforations during cardiac lead removal, as existing tools may accidentally pierce or perforate veins, leading to uncontrolled blood flow, which can be difficult to mitigate quickly and safely.

Innovation Solution

A temporary occlusion balloon device with a catheter shaft and inflatable balloon, coated with a hemostatic composition, is used to occlude perforations in blood vessels. The balloon, which can be inflated with a saline and contrast solution, is designed to reduce blood flow and allow time for surgical repair, featuring a crescent-shaped cross-sectional area and radiopaque markers for precise placement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If lead extraction procedures are performed, then cardiac pacing system functionality is maintained or improved, but vascular perforation risk increases leading to uncontrolled blood flow

Engineering Contradiction:

Improvesafety of lead extractionVSAvoidvascular perforation and uncontrolled blood flow

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The occlusion balloon is positioned and inflated before significant blood loss occurs from the perforation. The device is advanced through the vasculature to the perforation site and inflated to occlude the vessel, preventing further blood flow and buying time for surgical intervention.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The occlusion balloon acts as an intermediary device between the perforation site and the bloodstream. It temporarily blocks the vessel lumen, mediating the conflict between maintaining blood flow and stopping hemorrhage during lead extraction procedures.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Productivity

If existing extraction tools are used, then lead removal is achieved, but accidental piercing or perforation of veins may occur

Engineering Contradiction:

Improvelead removal efficiencyVSAvoidaccidental vein piercing

Core Design Contradiction:

ProductivityVSObject-affected harmful factors

Solution Approach 1:

The occlusion balloon serves as a protective measure prepared in advance for potential perforations. The device is kept ready and can be rapidly deployed to cushion against the harmful effects of accidental vein piercing by immediately occluding the vessel when perforation is detected or anticipated.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

3Ease of operation

If vascular perforation occurs, then lead extraction may be completed, but blood flow control becomes difficult and time-consuming

Engineering Contradiction:

Improveblood flow controlVSAvoidtime for mitigation

Core Design Contradiction:

Ease of operationVSLoss of time

Solution Approach 1:

The occlusion balloon is positioned and inflated immediately upon detection of perforation, before significant blood loss occurs. This preliminary action of occluding the vessel simplifies blood flow control and reduces the time needed for mitigation compared to attempting to control bleeding after it has already occurred.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The device replaces complex manual attempts to control vascular bleeding with a simple mechanical inflation system. The balloon occludes the vessel through pneumatic pressure, substituting for difficult manual compression or surgical clamping procedures that would be required without the device.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

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 effectively reduces blood flow through vascular perforations, providing time for surgical intervention by inflating to occlude the perforation and deploying a hemostatic composition to promote clotting and healing, enhancing the safety and precision of lead extraction procedures.

Implementation Method 1

The device effectively reduces blood flow through vascular perforations, providing time for surgical intervention by inflating to occlude the perforation

Methodology Applied

Scientific EffectOcclusion:

Implementation Method 2

deploying a hemostatic composition to promote clotting and healing

Methodology Applied

Scientific EffectHemostasis: Coagulation

Implementation Method 3

featuring a crescent-shaped cross-sectional area and radiopaque markers for precise placement

Methodology Applied

Scientific EffectRadiopacity: X-Ray

Data Source

PatentUS20230241360A1Temporary occlusion balloon devices and methods for preventing blood flow through a vascular perforation

Publication Date: 2023.08.03 SPECTRANETICS CORP

AI summary

A device for occluding a perforation in a blood vessel includes a catheter shaft that has a first lumen and a second lumen. The first lumen is adapted to receive at least one of a guidewire and an implanted cardiac lead, and the second lumen is adapted to receive an inflation fluid. The device further includes an inflatable balloon that is carried by the catheter shaft. The inflatable balloon is adapted to receive the inflation fluid from the second lumen, wherein the second lumen includes a cross-sectional area at a location within the catheter shaft between 0.65 mm2 and 1.90 mm2 and the inflatable balloon comprises polyurethane having a Shore A durometer of about 85 A.