DEVICE AND METHOD FOR THE OPTICAL ASSESSMENT OF THE LEVEL OF HEMOLYSIS IN A BLOOD SAMPLE

Abstract

A method for the optical evaluation of the level of hemolysis in a blood sample, said method comprising the steps of prearranging a device 100 comprising a light emitter, at least two photodetectors and a control unit arranged to operate the light emitter and to receive data by the photodetectors. The method then comprises a step of emitting, by the light emitter, of an inspection electromagnetic radiation towards the blood sample, said inspection electromagnetic radiation comprising a plurality of inspection electromagnetic waves having respective wavelengths .sub.E. A step follows of receiving, by the photodetectors, a return electromagnetic radiation coming from the blood sample, said return electromagnetic radiation comprising a plurality of return electromagnetic waves having respective wavelengths .sub.R.

Claims

1. A method for the optical evaluation of the level of hemolysis in a blood sample, said method comprising the steps of: prearranging a device (100) for the optical evaluation of the level of hemolysis comprising: a light emitter; at least two photodetectors; a control unit arranged to operate said light emitter and to receive data from said photodetectors; prearranging a blood sample to be analysed; emitting, by said light emitter, an inspection electromagnetic radiation towards said blood sample, said inspection electromagnetic radiation comprising a plurality of inspection electromagnetic waves having respective wavelengths .sub.E; receiving, by said photodetectors, a return electromagnetic radiation coming from said blood sample, said return electromagnetic radiation comprising a plurality of return electromagnetic waves having respective wavelengths .sub.R; generating, by said photodetectors, two respective electric signals associated with return electromagnetic waves having wavelengths of interest .sub.R1* and .sub.R2*, said electric signals generated having an intensity of current or a voltage proportional to said return electromagnetic waves having said wavelengths of interest .sub.R1* and .sub.R2*; calculating, by said control unit, a value of the level of hemolysis in said blood sample on the basis of said electric signals generated.

2. The method for the optical evaluation of the level of hemolysis in a blood sample, according to claim 1, wherein a step is also provided, by said control unit, of modulating the intensity of said inspection electromagnetic radiation as function of said level of hemolysis calculated, said modulating step ending when the intensity of said inspection electromagnetic radiation has a predetermined value associated with the value of the level of hemolysis calculated.

3. The method for the optical evaluation of the level of hemolysis in a blood sample, according to claim 1, wherein said wavelengths of interest .sub.R1* and .sub.R2* are comprised between 400 and 600 nm.

4. The method for the optical evaluation of the level of hemolysis in a blood sample, according to claim 1, wherein said wavelength of interest .sub.R1* is comprised between 520 and 550 nm and wherein said wavelength of interest .sub.R2* is comprised between 550 and 590 nm.

5. The method for the optical evaluation of the level of hemolysis in a blood sample, according to claim 4, wherein, in said step of calculating, said value of the level of hemolysis is a value inversely proportional to said intensity of current or to said voltage of said electric signals generated.

6. The method for the optical evaluation of the level of hemolysis in a blood sample, according to claim 1, wherein said wavelength of interest .sub.R1* is about 415 nm and wherein said wavelength of interest .sub.R2* is comprised between 520 and 550 nm.

7. The method for the optical evaluation of the level of hemolysis in a blood sample, according to claim 6, wherein, in said step of calculating, said value of the level of hemolysis is a value directly proportional to said intensity of current or to said voltage of said electric signals generated.

8. The method for the optical evaluation of the level of hemolysis in a blood sample, according to claim 1, wherein said device for the optical evaluation comprises a wireless antenna and wherein a step is provided of emitting, by said wireless antenna, data concerning said evaluation of the value of the level of hemolysis in said blood sample.

9. A device (100) for the optical evaluation of the level of hemolysis comprising: a light emitter arranged to emit an inspection electromagnetic radiation towards said blood sample, said inspection electromagnetic radiation comprising a plurality of inspection electromagnetic waves having respective wavelengths .sub.E; at least two photodetectors arranged to: receive a return electromagnetic radiation coming from said blood sample, said return electromagnetic radiation comprising a plurality of return electromagnetic waves having respective wavelengths .sub.R; generate two electric signals associated with return electromagnetic waves having wavelengths of interest .sub.R1* and .sub.R2*, said electric signals generated having an intensity of current or a voltage proportional to said return electromagnetic waves having said wavelengths of interest .sub.R1* and .sub.R2*; a control unit arranged to: operate said light emitter and receive data from said photodetectors; calculate a value of the level of hemolysis in said blood sample on the basis of said electric signals generated.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0059] The invention will be now shown with the following description of some exemplary embodiments, exemplifying but not limitative, with reference to the attached drawings in which:

[0060] FIG. 1 shows a possible embodiment of the device for the optical evaluation of the level of hemolysis in a blood sample, according to the present invention, during the reading of a blood sample inside a bag;

[0061] FIG. 2 schematically shows the following steps of the method for the optical evaluation of the level of hemolysis in a blood sample, according to the present invention;

[0062] FIG. 3 shows a possible embodiment of the device applied in three different points of a blood bag.

DESCRIPTION OF SOME PREFERRED EXEMPLARY EMBODIMENTS

[0063] With reference to FIGS. 1 and 2, the method for the optical evaluation of the level of hemolysis in a blood sample, according to the present invention, comprises a first step of prearranging a device 100 arranged to evaluate the level of hemolysis of a blood sample, for example located in a bag 200 [301].

[0064] In particular, the device 100 comprises a light emitter, two photodetectors and a control unit.

[0065] In FIG. 1 a possible embodiment is shown of the device 100 during the reading of a blood sample in a bag 200. In particular, in this figure, the device 100 is arranged near the tube 210, where the blood was drawn by gravity, by a preliminary step of the method. Advantageously, between the main body of the bag 200 and the tube 210, a filtering membrane can be placed which is able to let only the liquid component of the blood flow into the tube 210, separating it from the corpuscular component, so as to allow a more accurate assessment of the level of hemolysis.

[0066] FIGS. 3A, 3B and 3C show another possible embodiment of the device 100 positioned close to a blood bag 200 in three different possible application points. In particular, in FIG. 3B the device 100 is arranged in the lower part of the bag 200, near the tube 210, like in FIG. 1, whereas in FIGS. 3A and 3C the device 100 is arranged, respectively, in the upper part and in the central part of the bag 200.

[0067] Advantageously, the control unit is suitable for activating the device 100 when the device is positioned in the vicinity of a blood bag 200. This activation can take place by means of an activation sensor, such as for example an accelerometer, a hall effect sensor, a weight sensor, or other type of sensor. In particular, this activation sensor determines the activation of the device 100 when the latter is moved and subsequently hooked to the bag 200.

[0068] This activation sensor can also be integrated with an artificial intelligence or a microprocessor which manages, by means of wireless signals or recognitions (images, QR code, RFID), the procedure for hooking the device 100 to the bag 200, simplifying the quality control of the medical material to be monitored.

[0069] Once the device 100 is placed in proximity to the blood sample, the method provides for a step of emission, by means of the light emitter, of an electromagnetic radiation comprising a plurality of inspection electromagnetic waves having respective wavelengths .sub.E [302].

[0070] Thus follows a step of receiving a return electromagnetic radiation comprising a plurality of return electromagnetic waves having respective wavelengths .sub.R [303].

[0071] There is therefore a step of generation, by means of the photodetectors, of two electrical signals associated with return electromagnetic waves having wavelengths of interest .sub.R1* and .sub.R2* [304].

[0072] In particular, the electrical signals generated have a current intensity or a voltage proportional to the return electromagnetic waves having said wavelengths of interest .sub.R1* and .sub.R2*.

[0073] The method then comprises a step of calculation, by means of the control unit, of a value of the hemolysis level in the blood sample on the basis of the generated electrical signals [306].

[0074] Furthermore, according to an embodiment of the invention, the method also comprises a step of modulating the intensity of the inspection electromagnetic radiation as a function of the calculated hemolysis level.

[0075] In particular, this modulation step is obtained through an iterative process which ends when the intensity of the electromagnetic radiation has a predetermined value associated with the value of the calculated hemolysis level.

[0076] In a further embodiment of the invention, not shown in the figures, the device 100 can be completely integrated into the bag 200 making this bag 200 become a device of the Internet of Things (IoT) type.

[0077] The foregoing description exemplary embodiments of the invention will so fully reveal the invention according to the conceptual point of view, so that others, by applying current knowledge, will be able to modify and/or adapt for various applications such embodiment without further research and without parting from the invention, and, accordingly, it is therefore to be understood that such adaptations and modifications will have to be considered as equivalent to the specific embodiments. The means and the materials to realise the different functions described herein could have a different nature without, for this reason, departing from the field of the invention. It is to be understood that the phraseology or terminology that is employed herein is for the purpose of description and not of limitation.