Surgical Instrument Guide Assembly for Precise PCNL Needle Access
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Solution Overview
Problem
Existing medical procedures for percutaneous access, such as PCNL, are time-consuming and require multiple adjustments to accurately insert instruments due to the depth and variability of anatomical structures, leading to potential inaccuracies and significant radiation exposure for both patients and medical professionals.
Innovation Solution
A device comprising a base component and guide assembly that stabilizes the instrument at a targeted point of entry and insertion angle, using elements like end effectors, handles, and adjustable legs to maintain alignment, reducing the need for manual adjustments and radiation exposure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If manual needle insertion with repeated angle adjustments is used, then flexibility in adapting to anatomical variability is improved, but procedure time increases and insertion accuracy decreases
Solution Approach 1:
The guide assembly pre-establishes the correct insertion angle and direction before needle insertion begins. The guide needle is positioned and secured at the optimal angle targeting the renal calyx, eliminating the need for repeated manual angle adjustments during the procedure. This preliminary positioning ensures that subsequent needle insertions follow the pre-determined accurate path.
Solution Approach 2:
The guide assembly acts as an intermediary device between the operator and the needle insertion process. It provides a stable reference structure with pre-calculated angles that mediates the complex task of navigating anatomical variability, allowing the operator to simply follow the guide's predetermined path rather than continuously calculating and adjusting angles.
2Measurement precision
If repeated needle repositioning attempts are made to achieve accurate access, then insertion accuracy may improve, but tissue trauma increases
Solution Approach 1:
The guide assembly performs preliminary positioning and angle determination before the actual needle insertion. By pre-establishing the correct trajectory and securing the guide needle in place, it eliminates the need for repeated repositioning attempts, thereby preventing additional tissue trauma from multiple needle insertions and withdrawals.
Solution Approach 2:
The guide assembly serves as a protective intermediary that preserves tissue integrity. It provides a stable, pre-calibrated pathway that guides the needle in a single accurate attempt, preventing the harmful effects of repeated punctures and tissue manipulation associated with manual repositioning techniques.
3Measurement precision
If fluoroscopy is used continuously to guide needle insertion, then real-time imaging accuracy is improved, but radiation exposure increases
Solution Approach 1:
The guide assembly performs preliminary angle calculation and positioning using pre-procedural imaging (CT or MRI scans) to determine the optimal insertion path. Once the guide needle is positioned according to these pre-calculated parameters, continuous fluoroscopy is no longer needed for angle adjustments, significantly reducing radiation exposure while maintaining accurate guidance.
Solution Approach 2:
The invention replaces the radiation-based fluoroscopic guidance system with a mechanical guide assembly that provides physical guidance through pre-determined geometric angles. This mechanical substitution eliminates the need for continuous fluoroscopy during needle insertion, reducing radiation exposure while maintaining precise positioning through the guide's physical structure.
4Adaptability or versatility
If multiple angle adjustments are made during needle insertion, then adaptability to anatomical variations is improved, but insertion precision decreases
Solution Approach 1:
The guide assembly incorporates pre-calculated insertion angles based on pre-procedural imaging that accounts for individual patient anatomy. These preliminary calculations embed the necessary adaptability to anatomical variations directly into the guide's geometry, allowing precise needle insertion without requiring additional angle adjustments that would compromise precision.
Solution Approach 2:
The guide assembly creates a simplified geometric copy or model of the optimal insertion path derived from complex pre-procedural imaging data. By translating the three-dimensional anatomical relationships into a two-dimensional guide plane with fixed angles, it preserves the essential adaptive information while providing a stable, precise framework for needle insertion without requiring further adjustments.
Data Source
AI summary
Devices for guiding an instrument into a body of a patient, at a targeted point of entry and along an insertion path at a targeted insertion angle, are described herein, such as a guide for an access needle in a PCNL procedure for accessing the kidney to remove kidney stones. The devices include base component aligned with a point of entry, and a guide assembly which cooperates with the base component to allow an instrument to be aligned and fixed at various circumferential and vertical angles. The devices and methods allow a medical professional to accurately and stably guide an instrument at a targeted point and angle and to a desired depth, while minimizing the exposure to radiation used to image the insertion path.