PCNL Needle Guide With Radiopaque Markers for Precise Alignment

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Solution Overview

Problem

Maintaining proper orientation and direction of an access needle during a percutaneous nephrolithotomy (PCNL) procedure is challenging due to needle flexing and patient movement, while minimizing medical professional exposure to harmful fluoroscopic radiation is difficult.

Innovation Solution

A medical device with a radiopaque ring and a radiolucent core, combined with a flexible and angled design, allows precise alignment and advancement of the access needle under fluoroscopic guidance, reducing radiation exposure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If medical professionals use tongs or forceps to grip the access needle during advancement, then radiation exposure is minimized, but needle orientation and direction become difficult to maintain

Engineering Contradiction:
Improveradiation exposureVSAvoidneedle orientation control
Core Design Contradiction:
Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The patent introduces a needle guide device as an intermediary between the medical professional and the access needle. This guide provides a stable platform with radiopaque markers that enable precise orientation control without requiring the professional to directly manipulate the needle under radiation exposure. The guide acts as a mediator that transfers and maintains the required angular orientation from the proximal to distal end.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the manual mechanical control method (using tongs or forceps to grip and orient the needle) with a radiopaque guide structure that provides mechanical orientation constraints. The guide's rigid structure with integrated radiopaque markers substitutes the need for manual orientation adjustments, allowing the professional to maintain proper needle direction from a radiation-shielded position.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Productivity

If the access needle is advanced directly into the kidney target, then procedural efficiency is improved, but accurate orientation and depth control become difficult due to needle flexing and patient movement

Engineering Contradiction:
Improveprocedural efficiencyVSAvoidneedle placement precision
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The patent implements preliminary action by providing a needle guide that is positioned and oriented on the patient's skin surface before needle insertion. The guide pre-establishes the correct trajectory and angular orientation, allowing the access needle to be advanced along a predetermined safe path. This preliminary positioning prevents needle flexing and ensures accurate depth control, maintaining both procedural efficiency and placement precision.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent utilizes parameter changes by incorporating radiopaque markers at specific positions and angles on the needle guide. These markers change the visual parameters under fluoroscopic imaging, allowing the medical professional to verify and maintain precise orientation and depth parameters during needle advancement without compromising procedural efficiency.

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If radiopaque markers are added to enhance visibility under fluoroscopy, then needle alignment accuracy is improved, but device complexity increases

Engineering Contradiction:
Improvealignment accuracyVSAvoiddevice structure
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent applies merging by integrating radiopaque markers directly into the needle guide structure itself, rather than using separate components. The markers are incorporated as part of the guide's body or attached to its surface, combining the orientation reference function with the mechanical guide structure. This reduces overall device complexity while maintaining high alignment accuracy under fluoroscopic guidance.

Inventive Principle:
Principle #5Merging (Combining)

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

Enables accurate and efficient access to the renal capsule with reduced radiation exposure for medical professionals by stabilizing the needle and enhancing visibility through radiopaque markers.

Implementation Method 1

a radiopaque ring may be disposed about a portion of an outer surface of the distal end of the elongate shaft... A radiopaque coil may be disposed within the radiolucent silicone core

Methodology Applied
Scientific EffectRadiation absorption: Absorption (EM radiation)

Implementation Method 2

The base and a portion of the distal end of the elongate shaft may comprise a radiolucent material. The lumen may comprise a radiolucent silicone core

Methodology Applied
Scientific EffectRadiation transmission: X-Ray

Data Source

PatentUS12594139B2Devices and methods to access a target within the body
Publication Date: 2026.04.07 BOSTON SCI MEDICAL DEVICE LTD
  • US12594139B2 patent drawing
  • US12594139B2 patent drawing
  • US12594139B2 patent drawing

AI summary

The present disclosure relates generally to the field of medical devices and establishing access to a target within the body, such as placing an access needle into a renal capsule into the human body. In particular, the present disclosure relates to devices and methods for performing a percutaneous nephrolithotomy (PCNL) procedure accurately and efficiently while minimizing exposure of the medical professional to harmful radiation.