Biomimetic Platform for Quantifying Injection-Induced Tissue Swelling

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Solution Overview

Problem

Current methods for quantifying injection-induced pain and discomfort (IPD) caused by biologics are subjective and inadequate, posing challenges in the administration and development of injection devices and affecting patient quality of life.

Innovation Solution

A biomimetic platform is developed to quantify spatiotemporal tissue swelling during biologic injections, using engineered tissue constructs and digital image correlation to measure mechanical stress and interstitial fluid pressure, which stimulates nociceptors and correlates with IPD.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If subjective assessment methods are used to evaluate injection-induced pain and discomfort, then the assessment process is simple, but the measurement precision and reliability are insufficient

Engineering Contradiction:
Improvequantification accuracy of tissue swellingVSAvoidcomplexity of measurement platform
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent creates a biomimetic tissue construct that copies the mechanical and structural properties of native subcutaneous tissue. This engineered tissue model allows objective measurement of injection-induced swelling without requiring complex in vivo monitoring systems, thereby improving measurement precision while maintaining manageable device complexity

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent replaces subjective human assessment with an engineered tissue system that translates mechanical swelling into measurable physical changes. The tissue construct acts as a mechanical transducer, converting the complex physiological response into observable deformation that can be quantified objectively

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

2Measurement precision

If comprehensive spatiotemporal measurement of tissue swelling is implemented, then the measurement precision improves, but the device complexity and measurement difficulty increase

Engineering Contradiction:
Improvespatiotemporal resolution of swelling measurementVSAvoiddifficulty of measuring tissue deformation
Core Design Contradiction:
Measurement precisionVSDifficulty of detecting and measuring

Solution Approach 1:

The patent incorporates fluorescently labeled fibroblasts within the tissue construct, which emit light signals that change in response to mechanical deformation. This optical signaling mechanism enables high-resolution spatiotemporal tracking of swelling dynamics without requiring complex mechanical sensors or imaging systems

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The fluorescently labeled cells serve as intermediary elements that mediate between the mechanical swelling process and the measurement system. These labeled cells translate mechanical deformation into optical signals that are easier to detect and measure, reducing the difficulty of spatiotemporal measurement

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If engineered tissue constructs with labeled cells are used, then the measurement precision and predictive capability improve, but the manufacturing complexity increases

Engineering Contradiction:
Improvepredictive accuracy of IPD assessmentVSAvoidease of constructing engineered tissue
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent performs preliminary labeling of fibroblasts with fluorescent markers before embedding them in the tissue construct. This advance preparation allows the cells to be readily identifiable during measurement without adding complexity to the final assembly process, improving reliability while maintaining ease of manufacture

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent combines multiple functions into the engineered tissue construct: the labeled fibroblasts simultaneously serve as structural components, mechanical sensors, and optical reporters. This merging of functions reduces the need for separate measurement systems, thereby improving predictive accuracy without proportionally increasing manufacturing complexity

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentUS12016690B2Characterization of injection-induced tissue swelling during subcutaneous injection of biologics
Publication Date: 2024.06.25 PURDUE RES FOUND
  • US12016690B2 patent drawing
  • US12016690B2 patent drawing
  • US12016690B2 patent drawing

AI summary

Disclosed herein is a platform and method to quantify spatiotemporal tissue swelling during biologics injection, and to predict associated increase in the mechanical stress and interstitial fluid pressure (IFP) of tissues. Accurate measure and estimation of tissue swelling, thus, can be quantitative and predictive indicator of the IPD.