HIFU Varicose Vein Treatment Bubble Cloud Prevention

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Solution Overview

Problem

Existing HIFU treatments for varicose veins face challenges in avoiding the creation of lesions outside the target area and ensuring proper lesion formation, particularly due to the formation of bubble clouds during ultrasound energy delivery, which can interfere with subsequent pulses and affect treatment efficacy.

Innovation Solution

The method involves positioning the focal spot of the HIFU beam deeper than the target, with specific distance ranges and safety margins to minimize bubble formation in tissue between the treatment head and the target, and adjusting the beam position if bubble clouds are detected to avoid interference, using a device with integrated imaging and control systems for precise targeting and compression.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If the HIFU beam is focused at the target depth to maximize treatment efficiency, then the treatment efficacy is improved, but bubble clouds form in the tissue between the transducer and target, causing pre-focal heat deposition and interfering with subsequent pulses

Engineering Contradiction:
Improvetreatment efficiencyVSAvoidbubble cloud formation
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent inverts the conventional focusing approach by positioning the focal spot deeper than the target rather than at the target. This reversal prevents bubble cloud formation in the tissue between transducer and target, as bubbles form only beyond the target where they cannot interfere with the treatment. The focal spot is placed at a depth exceeding the target depth, fundamentally changing the focal positioning strategy to eliminate pre-focal cavitation.

Inventive Principle:
Principle #13The other way round (Inversion)

Solution Approach 2:

The patent applies preliminary anti-action by proactively positioning the focal spot beyond the target to prevent bubble cloud formation that would otherwise occur at the target location. This preventive positioning stops the harmful effect before it can develop, ensuring that no bubble clouds form in the treatment path that could reflect subsequent pulses or cause pre-focal heating.

Inventive Principle:
Principle #9Preliminary anti-action

2Reliability

If the focal spot is positioned deeper than the target to avoid bubble cloud formation, then pre-focal heat deposition is minimized, but the distance between focal spot and target increases requiring larger safety margins

Engineering Contradiction:
Improvelesion formation accuracyVSAvoidfocal spot to target distance
Core Design Contradiction:
ReliabilityVSLength of stationary object

Solution Approach 1:

The patent changes the depth parameter of the focal spot from being equal to target depth to being greater than target depth. This parameter modification fundamentally alters the treatment geometry, positioning the focal spot beyond the target to prevent bubble formation in the pre-focal zone. The method establishes a new parameter relationship where focal depth exceeds target depth, ensuring reliable lesion formation without pre-focal interference.

Inventive Principle:
Principle #35Parameter changes

3Productivity

If multiple pulses are delivered to treat the entire vein segment, then complete vein occlusion is achieved, but bubble clouds from earlier pulses interfere with subsequent pulses reducing treatment efficacy

Engineering Contradiction:
Improvevein occlusion completenessVSAvoidpulse effectiveness
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent inverts the focal positioning to resolve the interference problem during multi-pulse treatment. By placing the focal spot beyond the target rather than at the target, the method ensures that bubble clouds form only in the post-focal region where they cannot reflect or absorb energy from subsequent pulses. This allows multiple pulses to be delivered effectively across the entire vein segment without degradation in pulse effectiveness.

Inventive Principle:
Principle #13The other way round (Inversion)

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 effectively limits bubble cloud formation, ensuring accurate and efficient lesion creation within the targeted area, improving treatment outcomes by minimizing pre-focal heat deposition and avoiding undesired cavitation or boiling, thus enhancing the effectiveness of HIFU treatments for varicose veins.

Implementation Method 1

Thermal effects can also damage the endothelium but are more efficient since the damages may extend to the other layers of the vein wall (media, adventitia) and thermal denaturation of the collagen results in a beneficial lumen shrinkage.

Methodology Applied
Scientific EffectThermal effects: Heating

Implementation Method 2

HIFU devices allow the non-invasive treatment of targets within a patient's body. For focusing the HIFU device within the target zone, imaging of the area surrounding the target zone is performed

Methodology Applied
Scientific EffectHigh-Intensity Focused Ultrasound (HIFU): Ultrasound

Implementation Method 3

If the pulses induce cavitation or boiling in the tissue located between the transducer and the vein, the bubble cloud will play the role of a strong reflector for subsequent pulses delivered at or close to the current site

Methodology Applied
Scientific EffectCavitation: Cavitation

Implementation Method 4

If the pulses induce cavitation or boiling in the tissue located between the transducer and the vein, the bubble cloud will play the role of a strong reflector for subsequent pulses

Methodology Applied
Scientific EffectBoiling: Boiling

Implementation Method 5

A compression unit is provided for applying a compression force to the object

Methodology Applied
Scientific EffectMechanical compression: Compression

Data Source

PatentUS20220305297A1Method, device, and method for using of a device to coagulate varicose veins with high-intensity focused ultrasound
Publication Date: 2022.09.29 THERACLION
  • US20220305297A1 patent drawing
  • US20220305297A1 patent drawing
  • US20220305297A1 patent drawing

AI summary

The invention discloses a method and a device to treat vessels. In particular, the invention is directed at a method to occlude varicose veins while avoiding the formation of bubble clouds in the tissue surrounding the vessel and/or their interaction with the ultrasound beam. The invention is further directed at a device adapted to perform the method.