Inflatable Balloon Access Wire for Vascular Occlusion

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Solution Overview

Problem

Current methods for managing vascular injuries during large bore intravascular procedures are cumbersome and often fail to provide immediate stabilization, leading to significant blood loss and complications, as they require multiple steps and exchanges of guidewires and catheters, and may not ensure immediate access for treatment devices like balloons and stents.

Innovation Solution

A method and device that allow for simultaneous blood flow occlusion and device exchanges using an access wire with an inflatable balloon, which can be advanced through a vascular access sheath without additional guidewires, enabling treatment of vascular injuries while maintaining access for additional therapeutic devices, and is compatible with existing vascular closure systems.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If multiple guidewires and catheters are exchanged to treat vascular injuries, then treatment capability is improved, but procedure complexity and time are increased

Engineering Contradiction:
Improvetreatment capabilityVSAvoidprocedure complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent combines the functions of multiple guidewires and catheters into a single integrated access wire assembly. The access wire includes an inflatable balloon, a sheath, and a treatment device delivery mechanism all integrated into one structure, eliminating the need for multiple separate wire and catheter exchanges while maintaining full treatment capability.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The access wire is designed as a multi-functional device that can perform multiple tasks: it provides vascular access, delivers treatment devices (stents, balloons), and enables flow occlusion through its integrated balloon. This universal design replaces the need for multiple specialized wires and catheters, reducing procedural complexity while maintaining adaptability.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Adaptability or versatility

If multiple guidewires and catheters are exchanged to treat vascular injuries, then treatment capability is improved, but blood loss increases

Engineering Contradiction:
Improvetreatment capabilityVSAvoidblood loss
Core Design Contradiction:
Adaptability or versatilityVSLoss of substance

Solution Approach 1:

The access wire with integrated balloon is positioned and the balloon is inflated to occlude flow before treatment device deployment. This preliminary flow occlusion prevents blood loss during the entire treatment process, eliminating the need for repeated wire and catheter exchanges that would cause additional bleeding.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

By combining flow occlusion capability and treatment device delivery into a single access wire assembly, the system maintains continuous flow control throughout the procedure, preventing blood loss that would occur during multiple separate wire and catheter exchanges.

Inventive Principle:
Principle #5Merging (Combining)

3Ease of operation

If vascular access sheath is removed to treat injury, then access to injury site is improved, but immediate stabilization is lost

Engineering Contradiction:
Improveaccess to injury siteVSAvoidimmediate stabilization
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The access wire integrates both the stabilization balloon and treatment device delivery functions within the vascular access sheath. This allows the sheath to be removed for injury access while the balloon remains inflated to maintain stabilization, and treatment devices can be delivered through the same access pathway.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The access wire acts as an intermediary device that maintains the therapeutic relationship between the operator and the injury site. Even after sheath removal, the access wire with its integrated balloon and treatment device delivery capability maintains both stabilization and access, serving as a continuous mediator throughout the procedure.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

This approach minimizes blood loss, facilitates immediate stabilization of vascular injuries, and allows for efficient delivery of treatment devices, such as stents, during and after intravascular procedures, thereby reducing morbidity and mortality associated with vascular complications.

Implementation Method 1

position an inflatable balloon on the access wire in a vascular access sheath

Methodology Applied
Scientific EffectInflation:

Implementation Method 2

inflating the balloon to occlude the blood vessel

Methodology Applied
Scientific EffectOcclusion:

Data Source

PatentUS9532785B2Method and devices for flow occlusion during device exchanges
Publication Date: 2017.01.03 ACCESS CLOSURE INC
  • US9532785B2 patent drawing
  • US9532785B2 patent drawing
  • US9532785B2 patent drawing

AI summary

Methods and devices for maintaining vascular access and/or minimizing bleeding during percutaneous interventions. The method can include advancing an access wire through a previously placed access catheter in a contralateral femoral artery to position an inflatable balloon on the access wire in a vascular access sheath located in an ipsilateral femoral artery, without using any additional guidewires to advance the access wire. After withdrawing the vascular access sheath at least partway out of the ipsilateral femoral artery to expose the vascular injury, the balloon can be inflated to occlude the ipsilateral femoral artery or an ipsilateral iliofemoral artery at or near the vascular injury.