Dual-Balloon Wrist Hemostasis Device Preventing Radial Artery Occlusion

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Solution Overview

Problem

Radial artery occlusion frequently occurs after endovascular procedures, leading to permanent loss of patency and reduced access for future procedures, due to inadequate hemostasis and pressure application in existing devices.

Innovation Solution

A hemostatic device with two balloons is used to compress the radial artery and occlude the ipsilateral ulnar artery, maintaining blood flow in the radial artery during compression, thereby reducing the risk of occlusion. The device includes a flexible band with a curved frame and balloons positioned to apply pressure effectively around the wrist and ulnar artery, ensuring patency of the radial artery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If pressure is applied to the puncture site to achieve hemostasis, then bleeding is stopped, but radial artery occlusion occurs making the artery unavailable for future access

Engineering Contradiction:

Improvehemostasis effectivenessVSAvoidradial artery occlusion

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The compression device is divided into two separate compression regions: one for the radial artery and one for the ulnar artery. This segmentation allows independent control of compression on each artery, enabling hemostasis on the radial artery while maintaining patency through collateral flow via the ulnar artery compression

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The ulnar artery compression acts as an intermediary mechanism to prevent radial artery occlusion. By compressing the ulnar artery, the device creates a pressure gradient that maintains radial artery patency while still achieving hemostasis at the puncture site

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If compression duration is extended to ensure hemostasis, then bleeding control is improved, but risk of radial artery occlusion increases

Engineering Contradiction:

Improvehemostasis controlVSAvoidcompression duration

Core Design Contradiction:

ReliabilityVSDuration of action of moving object

Solution Approach 1:

The device incorporates pressure sensors that provide real-time feedback on compression pressure and arterial flow status. This feedback mechanism allows the system to monitor radial artery patency during compression and adjust compression duration and intensity dynamically, preventing occlusion while ensuring adequate hemostasis

Inventive Principle:

Principle #23Feedback

3Device complexity

If single-point compression is used to stop bleeding, then device simplicity is maintained, but radial artery occlusion frequently occurs

Engineering Contradiction:

Improvecompression structureVSAvoidartery patency maintenance

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The compression device performs multiple functions simultaneously: it provides hemostasis at the radial artery puncture site while also preventing radial artery occlusion through ulnar artery compression. This multi-functionality is achieved within a single integrated device structure

Inventive Principle:

Principle #6Universality (Multi-functionality)

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 achieves hemostasis while maintaining radial artery flow, reducing the risk of occlusion and preserving the artery's patency for future access, as demonstrated by successful recanalization and reduced occurrence of radial artery occlusion in clinical trials.

Implementation Method 1

the bleeding from the radial artery is stopped by compressing the radial artery at the puncture site using inflation of a first balloon

Methodology Applied

Scientific EffectCompression: Compression

Implementation Method 2

the radial artery flow is increased by occlusive compression of ipsilateral ulnar artery using inflation of a second balloon

Methodology Applied

Scientific EffectCompression: Compression

Data Source

PatentEP3372175B1Apparatus to stop bleeding

Publication Date: 2022.06.15 VASOINNOVATIONS INC

Figure 1A~1B
Figure 2A~2C
Figure 3A~3B

AI summary

A hemostatic device is provided to stop bleeding at a puncture site on the wrist of a patient, the device comprising a transparent flexible band to be wrapped at the site where the bleeding is to be stopped, a curved frame having an inner peripheral side and possessing a first curved portion in its first half and a second curved portion in its second half, a first balloon provided on the inner peripheral side in the first half of the curved frame and a second balloon provided on the inner peripheral side in the second half of the curved frame, the first balloon being larger than the second balloon. The bleeding from radial artery is stopped by compressing the radial artery at the puncture site using inflation of the first balloon and radial artery flow is increased by compression of ipsilateral ulnar artery using inflation of the second balloon.