Trackable Tool Packaging for Surgical Installation Calibration

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Solution Overview

Problem

Current surgical tools face challenges in accurate installation verification due to the interference of markers or trackers with sterilization processes and the need for additional instruments, leading to increased operating time and costs, as well as reduced accuracy in manual digitization techniques.

Innovation Solution

A protective packaging system with trackable features that retains the tool and determines the actual state of the tool center point, allowing for precise verification of proper installation by comparing it to an expected state, using a localizer and controllers to evaluate alignment and seating accuracy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If markers or trackers are attached to the tool for navigation tracking, then the tool can be tracked by the navigation system, but the markers interfere with sterilization processes and may be destroyed during sterilization

Engineering Contradiction:

Improvetracking accuracyVSAvoidsterilization process

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The tracking function is extracted from the tool itself and placed on the protective packaging. The packaging includes trackable features that can be detected by the navigation system, while the tool remains free of markers for sterilization. This separates the tracking requirement from the sterilization requirement, allowing each to be satisfied independently.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The protective packaging serves as an intermediary between the tool and the navigation system. Instead of tracking the tool directly, the system tracks the packaging that contains the tool, using the trackable features on the packaging to determine tool position and orientation indirectly.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Measurement precision

If additional instruments such as tracked digitization devices are used to verify tool installation, then installation accuracy can be confirmed, but operating time and costs increase

Engineering Contradiction:

Improveinstallation verification accuracyVSAvoidoperating time

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The verification function is merged with the protective packaging itself. The packaging includes trackable features that enable the navigation system to verify tool installation directly, eliminating the need for separate digitization devices. This integration reduces the number of steps and instruments required while maintaining verification accuracy.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The protective packaging provides its own verification capability through the integrated trackable features. The system can self-verify installation accuracy by comparing the detected position of the trackable features with the expected position, without requiring external verification instruments or manual digitization by the operator.

Inventive Principle:

Principle #25Self-service

3Reliability

If manual digitization techniques are used to calibrate tool installation, then installation can be verified, but measurement accuracy decreases due to manual operator involvement

Engineering Contradiction:

Improveinstallation verification capabilityVSAvoiddigitization accuracy

Core Design Contradiction:

ReliabilityVSMeasurement precision

Solution Approach 1:

The manual mechanical digitization process is replaced with an automated optical/electromagnetic tracking system. The trackable features on the packaging are detected by the navigation system's localizer, providing automated, high-precision measurement without manual operator involvement. This substitution eliminates human error in digitization while maintaining verification capability.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

4Measurement precision

If a custom end effector with markers is used for calibration, then tool installation can be assessed, but the end effector must be customized for each tool increasing costs and complexity

Engineering Contradiction:

Improveinstallation assessment accuracyVSAvoidend effector customization

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The protective packaging serves multiple functions: it protects the tool during handling and storage, and it provides tracking and verification capabilities. The trackable features on the packaging are universal and can be used with any tool type, eliminating the need for custom-modified end effectors for different tools. The packaging itself becomes the universal interface for tracking and verification.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Data Source

PatentUS11690680B2Trackable protective packaging for tools and methods for calibrating tool installation using the same

Publication Date: 2023.07.04 MAKO SURGICAL CORP

AI summary

Protective packaging, surgical kits, systems, and methods are described herein for assisting in determining whether a tool is properly installed on a surgical device. The protective packaging retains the tool and has trackable features defined relative to a tool center point of the tool. The trackable features have a predetermined state defined relative to the tool center point and the trackable features are configured to be detectable by a localizer to locate the tool center point. One or more controllers can compare the actual state of the tool center point with an expected state of the tool center point, which is based on an expected condition in which the tool is properly mounted to the surgical device. Based on the comparison, the one or more controllers can determine whether the tool is properly mounted to the surgical device.