Cryoablation Probe Segmentation for Procedure Time Reduction

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Solution Overview

Problem

Current cryoablation devices are inefficient, costly, and prone to tissue damage due to heat loss and radiation exposure, with single-use needles leading to contamination and prolonged procedure times, and lack precise control over necrosis and tissue destruction.

Innovation Solution

A cryoablation device with a probe and multiple sleeves allows for quick, precise, and minimally invasive tissue ablation, using a pressurized material to cool the probe tip, forming an ice ball for targeted tissue destruction, and includes features like air gaps for insulation and antimicrobial coatings to prevent contamination and infection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If traditional single-needle cryoablation is used, then tissue ablation can be achieved, but the procedure time is prolonged due to waiting for ice ball melting before needle removal

Engineering Contradiction:
Improveprocedure timeVSAvoidwaiting time for ice ball melting
Core Design Contradiction:
ProductivityVSLoss of time

Solution Approach 1:

The device divides the cryoablation system into separate components: a reusable probe and disposable needles. The needle can be removed independently from the ice ball formation site, eliminating the need to wait for complete melting before needle removal. This segmentation allows the needle to be extracted while the ice ball remains in place, significantly reducing procedure time.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces an intermediary mechanism where the needle serves as a delivery vehicle for the cryoablation probe but can be separated from the treatment site. The probe remains in place to maintain the ice ball while the needle is removed, allowing continuous treatment without waiting for ice ball dissolution.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of manufacture

If non-insulated cryoablation probes are used, then simple construction is achieved, but heat loss to adjacent tissues increases causing unwanted freezing and necrosis

Engineering Contradiction:
Improveprobe construction simplicityVSAvoidheat loss to adjacent tissues
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The patent applies an insulating coating or shell around the probe body to reduce heat loss to adjacent tissues. This thin film insulation layer prevents unwanted freezing and necrosis of healthy tissues while maintaining the probe's flexibility and ease of insertion. The insulation is applied as a coating rather than a thick layer, preserving probe maneuverability.

Inventive Principle:
Principle #30Flexible shells and thin films

3Reliability

If single-use needles are used for cryoablation, then contamination risk is reduced, but device cost increases and procedural efficiency decreases

Engineering Contradiction:
Improvecontamination preventionVSAvoidprocedural efficiency
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The system is segmented into disposable needles and reusable probes. The needle, which enters the patient's body, is disposable to prevent contamination, while the expensive probe component remains outside the sterile field and can be reused. This segmentation maintains infection control while improving cost-effectiveness and procedural efficiency.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent implements a strategy where only the needle portion is discarded after single use, while the probe is recovered and reused for subsequent procedures. This selective discarding approach maintains sterility where needed while recovering expensive components, improving both safety and economic efficiency.

Inventive Principle:
Principle #34Discarding and recovering

4Stability of the object's composition

If ice ball formation grows in all directions equally, then uniform freezing is achieved, but control over necrosis boundaries becomes difficult risking damage to healthy tissue

Engineering Contradiction:
Improveuniform freezingVSAvoidnecrosis boundary control
Core Design Contradiction:
Stability of the object's compositionVSManufacturing precision

Solution Approach 1:

The patent employs multiple needles positioned at different locations and angles to create localized ice balls that can be controlled to affect specific tissue regions. By adjusting needle positions, depths, and activation timing, the ice ball formation can be tailored to achieve uniform freezing within the target area while preventing spread to healthy tissues, thus improving boundary control precision.

Inventive Principle:
Principle #3Local quality

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 reduces procedure time, minimizes tissue damage, and allows for reusable, cost-effective, and precise ablation of nerves and soft tissues, enhancing pain relief while preventing infection and tissue regrowth.

Implementation Method 1

release a pressurized material into the interior surface of the probe so as to cool the exterior surface of the probe to a selected temperature

Methodology Applied
Scientific EffectPhase change: Phase Change

Implementation Method 2

cool the exterior surface of the probe to a selected temperature

Methodology Applied
Scientific EffectHeat transfer: Conduction (thermal)

Implementation Method 3

engagement produces an air gap that surrounds the exterior surface of the probe to form a seal

Methodology Applied
Scientific EffectThermal insulation: Thermal Insulation

Implementation Method 4

formation of, what is known in the art as, an ice ball around the tip

Methodology Applied
Scientific EffectFreezing: Freezing

Implementation Method 5

ice formation within the extracellular space creates an osmotic gradient, resulting in cellular dehydration

Methodology Applied
Scientific EffectOsmosis: Osmosis

Implementation Method 6

Ice crystals then form within the cells causing cell membranes to rupture resulting in cell death

Methodology Applied
Scientific EffectCryolysis: Cryolysis

Data Source

PatentUS9033966B2Nerve and soft tissue ablation device
Publication Date: 2015.05.19 WARSAW ORTHOPEDIC INC
  • US9033966B2 patent drawing
  • US9033966B2 patent drawing
  • US9033966B2 patent drawing

AI summary

Ablation devices useful for destroying nerve and/or soft tissue via a minimally invasive procedure to alleviate pain are provided. The device comprises a probe having an interior surface that defines an internal passage and an exterior surface comprising a tip. The internal passage has a filament comprising an opening configured to release a pressurized material into the interior surface of the probe so as to cool the exterior surface of the probe to a selected temperature. An introducer is provided having an interior surface configured for engagement with the exterior surface of the probe. This engagement produces an air gap that surrounds the exterior surface of the probe to form a seal, and an exterior surface comprising an opening configured for engagement with the exterior surface of the probe is configured for ablating nerve and/or soft tissue. Methods for ablating nerve and/or soft tissue utilizing the ablation devices are also provided.