Method for measurement and model-free evaluation of injectable biomaterials properties

Inventors

Gasik, Michael

Assignees

Seqvera Ltd Oy

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Publication Number

US-10809171-B2

Patent

Publication Date

2020-10-20

Expiration Date


Abstract

The invention discloses a method for testing of injectable biomaterials and their performance in the treated materials, to obtain functional properties of the biomaterials and of the specimen injected with that biomaterial. The purpose of the method is to measure these properties during injection of a biomaterial into a target object, then measure the properties of a target object specimen after the injection, and then combine these results using material model-free data processing with possible prediction.

Core Innovation

The invention describes a method of measurement of properties and performance of injectable biomaterials using an in-vitro, non-destructive testing framework. An injectable biomaterial is placed into an injection device comprising a plunger and a needle, and the needle is immersed into a target object at a desired depth and inclination. Contact of the plunger with a first sensor probe is established to apply a mechanical stimulus to the plunger, inducing movement of the biomaterial from the injection device into the target object while simultaneously measuring displacement of the plunger and a force applied to the plunger as a function of time.

After injecting a desired amount, the needle is retracted and the target object is repositioned into a second sample holder absent of explicit mechanical fixation. A mechanical contact of the object with a second sensor probe is established, and a non-destructive mechanical stimulus is applied to the object via the second sensor probe while simultaneously measuring displacement of the object and a force applied to the object as a function of time. The method includes subtracting from the measurements contributions from background sources, inclusive the injection device holder, the sensor and measurement device parts themselves.

Measured data obtained during injection are processed together with the non-destructive measurements using time convolution. The method then calculates at least one of viscostiffness, alpha value, and flow compliance for the injectable biomaterial and calculates at least one of dynamic modulus, alpha value, and viscostiffness of the target object. The processing is described as model-free for calculating properties from the measured displacement and force over time, enabling calculation of time-invariant properties for the biomaterial and dynamic modulus-related parameters for the target.

Claims Coverage

The independent claim is directed to a two-stage, non-destructive measurement workflow that includes time-resolved displacement/force sensing during injection, background subtraction, time convolution processing, and calculation of viscostiffness, alpha value, and flow compliance for the injectable biomaterial and dynamic modulus, alpha value, and viscostiffness for the target object. The inventive content centers on the dual-probe measurements, non-destructive stimulation of the target, background-source subtraction, and time-convolution-based calculation of viscoelastic and compliance-like parameters in a model-free manner.

Two-stage measurement with plunger-contact sensing and object-contact sensing

Placing an injectable biomaterial into an injection device comprising a plunger and a needle; positioning the injection device onto a first sample holder; immersing the needle into a target object at a desired depth and inclination; establishing contact of the plunger with a first sensor probe; applying a mechanical stimulus to the plunger via the first sensor probe inducing movement of the biomaterial into the target object; measuring displacement of the plunger and force applied to the plunger simultaneously as a function of time; retracting the needle and repositioning the target object into a second sample holder absent of explicit mechanical fixation; establishing a mechanical contact of the object with a second sensor probe; applying a non-destructive mechanical stimulus to the object via the second sensor probe; and measuring via the second probe a displacement of the object and a force applied to the object simultaneously as a function of time.

Background-source subtraction of time-resolved displacement and force

Subtracting from the measurements taken of displacement and force contributions from background sources, inclusive the injection device holder, the sensor and measurement device parts themselves.

Time convolution processing to calculate viscostiffness, alpha value, flow compliance, and dynamic modulus parameters

Processing measured data obtained during injection and non-destructive probing by time convolution; calculating at least one of viscostiffness, alpha value, and flow compliance for the injectable biomaterial; and calculating at least one of dynamic modulus, alpha value, and viscostiffness of the target object.

Across the inventive features, the claim scope covers a method that measures plunger displacement and force during injection, then measures object displacement and force during a non-destructive stimulus on the target object, performs background subtraction, and uses time convolution to calculate viscoelastic and compliance-like parameters for the injectable biomaterial and dynamic modulus-related parameters for the target object.

Stated Advantages

Enables non-destructive mechanical testing of the target object using the second sensor probe absent explicit mechanical fixation.

Enables determination of time-invariant properties such as alpha value and viscostiffness for the injectable biomaterial and dynamic modulus-related parameters for the target object using time convolution processing.

Improves measurement fidelity by subtracting contributions from background sources including the injection device holder and measurement device parts.

Documented Applications

In-vitro non-destructive evaluation/testing of injectable biomaterials, including evaluation of injectable biomaterials and measurement of dynamic mechanical behavior of a target object after injection.

Injectability testing of injectable biomaterials by measuring properties and performance during injection using time-resolved displacement and force.

Prediction of longer-time behavior of the injected target based on time-convolution, model-free processing of measured signals.

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