Radiodense Marker System for Lumbar Spine Hardware Placement

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Solution Overview

Problem

Current surgical hardware placement techniques in lumbar spine surgery require multiple radiographic images, leading to increased radiation exposure for patients and medical staff, which poses health risks and inefficiencies in minimally invasive procedures.

Innovation Solution

A system and apparatus utilizing radiodense metal strips and transparency sheets to minimize radiation exposure by allowing precise placement of surgical hardware using fewer x-rays, with the device having rails and bubble levels for accurate positioning and transparency sheets for alignment with x-ray images.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If multiple radiographic images are taken during lumbar spine surgery, then accurate localization of anatomical landmarks and hardware placement is improved, but radiation exposure to patient and medical staff increases

Engineering Contradiction:
Improvelocalization accuracyVSAvoidradiation exposure
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent applies preliminary action by placing radiodense markers and transparency sheets with anatomical landmarks on the patient's back before surgery begins. These markers remain in place throughout the procedure, allowing the surgical team to reference them on minimal radiographic images without needing to take multiple images for localization. The pre-positioned markers eliminate the need for repeated radiographic imaging to identify anatomical structures.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent uses transparency sheets that contain printed radiographic images and anatomical landmarks as a copy or representation of the actual anatomy. These transparency sheets are placed on the patient's back and can be visually referenced during surgery without requiring additional radiographic imaging. The transparency sheets serve as a visual copy that guides hardware placement while minimizing radiation exposure.

Inventive Principle:
Principle #26Copying

2Ease of operation

If fluoroscopy is used to obtain frequent radiographic images during surgery, then real-time guidance for hardware placement is improved, but cumulative radiation exposure to medical staff increases significantly

Engineering Contradiction:
Improvereal-time guidanceVSAvoidcumulative radiation exposure
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The radiodense markers are attached to the patient's back before surgery, and transparency sheets with anatomical references are prepared in advance. This preliminary setup allows the surgical team to perform most of the localization and planning work before the patient is exposed to radiation, reducing the need for frequent fluoroscopic images during the procedure.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The transparency sheets act as an intermediary between the radiographic images and the surgical field. Instead of relying directly on frequent fluoroscopic imaging to guide each step, the transparency sheets provide a stable visual reference that mediates the guidance process, allowing surgeons to proceed with fewer direct radiographic exposures.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Object-affected harmful factors

If stereotactic guidance techniques are used for hardware placement, then radiation exposure during positioning is reduced, but the complexity of the surgical procedure increases

Engineering Contradiction:
Improveintraoperative radiationVSAvoidsurgical procedure complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent divides the guidance system into separate, simple components: radiodense markers attached to the patient's back, transparency sheets with printed anatomical landmarks, and standard surgical instruments. Each component is simple and independent, avoiding the need for complex stereotactic equipment while achieving accurate guidance through their coordinated use.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Instead of using complex stereotactic registration systems that require matching 3D coordinates, the patent uses simple 2D transparency sheets with printed radiographic images that directly overlay the patient's anatomy. This copying approach simplifies the guidance process by eliminating the need for complex coordinate registration and 3D reconstruction algorithms.

Inventive Principle:
Principle #26Copying

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 the accurate placement of surgical hardware with reduced radiation exposure, improving safety and efficiency by allowing surgeons to perform procedures with fewer x-rays and minimizing cumulative radiation risks for both patients and medical staff.

Implementation Method 1

The first rail sometimes has a plurality of lower slide slots configured to couple with at least one stacking support to orient the device with the respect to the ground. In some embodiments, the device has a first bubble level attached to the first rail, the first bubble level displaying indicia of whether the longitudinal axis is level to the ground.

Methodology Applied
Scientific EffectRadiodensity: Absorption (EM radiation)

Implementation Method 2

A first bubble level attached to the first rail, the first bubble level displaying indicia of whether the longitudinal axis is level to the ground. A second bubble level can be attached to the second rail which displays indicia of whether the transverse axis is level to the ground.

Methodology Applied
Scientific EffectBubble level: Spirit Level

Data Source

PatentUS10743824B2System and apparatus for surgical hardware placement
Publication Date: 2020.08.18 MASSENGALE JUSTIN
  • US10743824B2 patent drawing
  • US10743824B2 patent drawing
  • US10743824B2 patent drawing

AI summary

A system assists a physician in placing surgical hardware within a patient. The system includes a device having first and second radiodense strips which is placed over a patient. X-rays are taken of the device and patient and x-ray sheets are created. The system also includes a batch of transparency sheets. The transparency sheets can be aligned with the radiodense strips on the x-ray sheets to provide the physician with locations and positions for the placement of surgical hardware.