WO2022146165A1

WO2022146165A1 - Method of labelling and identification of goods

Info

Publication number: WO2022146165A1
Application number: PCT/RU2020/000784
Authority: WO
Inventors: Gleb Borisovich SUKHORUKOV; Olga Aleksandrovna SINDEEVA; Arkady Sergeevich ABDURASHITOV; Alexander Valentinovich CHEKANOV
Original assignee: Skolkovo Institute of Science and Technology
Current assignee: Skolkovo Institute of Science and Technology
Priority date: 2020-12-30
Filing date: 2020-12-30
Publication date: 2022-07-07
Anticipated expiration: 2023-06-30

Abstract

The invention we propose is a polymer -based data storage solution for the identification (marking), tracing, and logistics following of delivery and use of goods where the physical implementation of such solution would be technically possible. Our solution is technically articulated through a thin sheet or film of stable to an environment of use or bio-degradable polymer (including the possibility of being an edible polymer) with periodic or non-periodic indentations or surface-reliefs, which alter its optical thickness, to use it to encode and store the data. The information can be retrieved by analysis of the diffraction pattern formed on a light detector due to laser beam passes through the polymer film or is reflected on it. A polymer thin film is directly embedded (or firmly associated) into the good, in which the technical design of the physical product would allow a laser beam passage.

Description

METHOD OF LABELLING AND IDENTIFICATION OF GOODS

FIELD

The presented embodiments are generally related to data storage devices, more specifically to optical storage devices in the form of stable or biodegradable polymer film that can store encoded information about a physical good, such as but not only: medical drugs, cosmetics, medical and food products, or other engineered materials and physical goods.

BACKGROUND

Consumer and industrial goods (e.g., medical drugs, devices and tools, cosmetics, food products, and other categories of physical goods) include various data storage and protection devices such as barcodes, holographic stickers, and similar. These are generally belonging to the packaging of the good and could be optically decoded if needed but most often can be easily falsified or removed from the packaging and replaced.

Certain types of raw materials and manufactured goods (e.g., tablets or pills) may differ in shape or color; thus identification can be performed visually, wherever possible, by a specialist (e.g., pharmacist) or automatically via a computer vision system. While the form most often remains unchanged, the color of goods (e.g., tablets and other medications) can vary within wide limits (prescribed in the standard instructions for medicines), which undoubtedly complicates the installation of authenticity during a routine visual examination. The same goes for the size and shape of the package.

Apart from tablets, other goods (e.g., medical tools and devices as well as non-medical goods) lack properly hidden but readable identification. Food and cosmetics products are also often exposed to falsification risk.

SUMMARY

A data storage device for a medical drug (in tablet), cosmetics, or other medical and food products include a thin polymer film with indentations and/or surface-reliefs which encodes general and/or security information about the specific drug, its contents, date of manufacturing and best before date. The decoding process may be done as follows: due to local optical thickness differences along the plane of a film, a laser beam that passes through the film or is reflected will undergo a define modulation of its phase which will result in production of a certain complex diffraction pattern on a screen or any matrix-type light detector.

The initial complex amplitude distribution along the laser beam and/or its state of polarization and/or its wavelength may also be varied to add another layer of protection for such data storage devices thus, a valid diffraction pattern can be achieved only with a defined ‘decoding’ configuration of the laser beam, otherwise, the resulting diffraction pattern will be meaningless. The main advantage of optical encoding is a higher number of degrees of freedom, which could be used to extend the level of protection for an arbitrary substance compare to other methods such as radio- and water- marks or other type of protection solutions. The decoding process can also be performed through analysis of photographic images of the encoded patterns.

Required information about the tablet may be encoded in various ways, for example:

1. By a standard bar- or matrix- graphical codes. In this regime, local optical thickness differences are distributed along the polymer film in a such way that laser light passes though the film or reflected on the film will obtain a certain phase modulation which by a lens could be converted into the image of bar- or matrix- code. Lastly, this image could be digitized by an image sensor and, when fed into the specialized decoding software, allow data recovery.

2. By a one-to-one mapping between unique diffraction patterns and a specific class of pills. In this case, the identification is performed by a matching of the digitized diffraction pattern with the existing database. No further information is transferred in this method.

3. By a custom coding algorithm which may use spatial locations of diffraction orders with a combination of different grids to encode production and/or security information.

4. By introducing a multilayered film or a combination of differently patterned polymer films that could extend the storage capacitance of the device or increase the number of producible unique diffraction patterns.

Another use of polymer encoding is based on using sensitive polymers. Polymer film with patterns, while made, for instance, form polymers or their components sensitive to temperature (temperature dependent polymers such as PNIMAN) could undergo phase transition and elimination of diffraction pattern while heat over phase transition, or humidity (for hydrophilic polymers) or other sensitivity. Subjecting these films (as well as the good they are embedded in) to critical condition where the pattern has changed lead to non-reversible loss of encoding and hence may tell of spoilt properties of goods. The information encoded by patterned polymer films incorporated into the medical tablets, cosmetics, food products, and other goods can be used for tracing these items during their manufacturing, transportation, selling, and consumption. Regulations (governmental, industrial, standards) of the use of these goods can be implemented using this laser readout technology to follow and trace single goods.

BRIEF DESCRIPTION OF THE DRAWINGS

The embodiments will be clearly characterized by the following detailed description section wherein a like numerals used as a reference designator to a like structural elements.

Fig. 1 shows the fabrication process of the medical drug in the form of a tablet with an embedded polymer data storage device.

Fig. 2 pointed out the basic optical schematic for the decoding process needed to recover stored information.

Fig. 3. Different kinds of grids like square or hexagonal in nodes of which an indentation and/or surface-reliefs are made.

Fig. 4 describes possible cross-section views of the polymer-based data storage device.

Fig. 5 and fig. 6 reflects a few of possible designs for cosmetic packaging with embedded polymer tag.

Fig. 7 shows a possible flow chart for the polymer tag production chain.

DETAILED DESCRIPTION

The numeral references are made to the specific parts of the embodiments illustrated in the appending drawings. It should be pointed out that the following descriptions and drawings are not limiting the described device to one preferred type as well as one physical implementation.

Fig. 1. Two halves of a pill 1, 3 with a hole 5 in the middle are pressed against each over to fix the polymer data storage device 2. 4 is the completed tablet drug with embedded polymer data storage device. The process of tablet formation with a polymer film consists of three stages. 1 stage - independent synthesis of 2 parts of a tablet from the medicinal substance in a press-mold using a hydraulic or some other press. The configuration of the press-mold can be different and allows for the manufacture of tablets of different sizes; forms; thickness; diameter, shape, and position of the hole for reading information from a polymer film. 2 stage - placing a polymer data storage device between two independent parts of a tablet. 3 stage - pressing of two parts of the tablet among themselves. The general principle is indicated here. However, the polymer data storage device position in the tablet and the number of formation steps can vary.

Fig. 2. The possible optical scheme for the readout process of the tablet drug 7. A coherent laser beam 6 with the identified complex amplitude distribution, polarization and wavelength is passing through the polymer data storage device via a specific hole. Lens 9 is placed in such a configuration that polymer data storage device and an array of photosensitive elements 11 are located in front and back focal planes of the lens, respectively (Fraunhofer diffraction case). A resulted diffraction pattern 10 is then digitized and fed into the specialized software that performed a decoding process. Low focal length lenses could be used to minimize the size of the optical decoding unit so it could be incorporated in a specific field environment with ease.

Fig. 3. A few of many possible arrangements of the local indentations and/or surface-reliefs along the plane of the polymer data storage device. The grid could be square 13 or, for instance, 14 - hexagonal. Such grid difference will result in unique diffraction patterns which could be used for one-to-one mapping of the specific pills’ classes. In general, the grid could preserve periodicity along the whole plane of the polymer data storage device or be partially periodically within a local vicinity and such periodical clusters could be spread along the plane of the polymer.

The polymer film with structured microrelief (micro-terrain) and/or patterned structure are produced using conventional lithography approaches. It could be done through the fabrication of photolithography mask in silica (or other ceramic) and later transform to replica of PDMS stamp (as example of widely used in microtechnology. Then the polymeric microrelief/pattemed structure is produced by dip-coating and printing or imprinting of stamp (PDMS or other solid support) into a polymer. The key factor is the formation of encoding film out of edible polymers or biodegradable, which has no harm while consumed by a patient with the tablet. The thickness of the polymer film could be down to a few micron, and polymer may represent FDA approved list of polymers (e.g., polylactic acid, poly (lactic-co-glycolic acid), polycaprolactone, gelatin, pectin, and others (including copolymers)). Patterned structure and the transfer of structure should be done sufficiently accurately to ensure the diffraction from the final film of edible polymer.

The described method for creating a patterned film is one of several possible methods. Other methods for applying relief with sufficient quality to implement reliable coding can be used to apply microrelief.

Fig. 4. The cross-section view of the polymer data storage device indicates the possible forms of indentations and/or surface-reliefs. 14 are the spherical indentations periodically distributed along the plane of the polymer. In such configuration, the diffraction pattern observed on the photosensitive elements 11 will be presented in the form of bright spots with a period that is a reciprocal of the indentation’s period.

15 is another possible way of shaping the polymer film. In this case, a surface-reliefs of different height are distributed in a certain way on the polymer so that a coherent light beam that passes through the film or is reflected on the film, will acquire different phase-shifts along its profile proportional to the height of reliefs. In such scenario an image in which information is encoded, of arbitrary complexity by means of a lens placed could be projected onto the array of photosensitive elements by the lens, placed in a particular fashion. This method is known as computer-generated holography (CGH). The major possible restriction on such technique besides production accuracy is the fact that such diffraction films affecting only the phase of a laser beam, but to produce an accurate projection of the desired code a complex amplitude (amplitude and phase) of a laser beam has to be modified. Thus an iterative algorithm like iterative Fourier transform algorithm (IFTA) is generally used to approximate the quality of projected images to a certain level of accuracy by only changing the phaseshifts distribution along the plane of a film and set its amplitude transmission to unity.

Figures 5 and 6 represent one of many possible solutions for tagging a packaging of the cosmetic entities such as creams and mascara, respectively. 16 is a full assembly of the flask for the viscous cosmetics fluids. Clear window 17 inside a threaded cap in a combination with empty pillar 20 allowing a free laser beam passage though a polymer film 18 mounted on top of the pillar 20 or embedded into the metallic foil seal usually used to prevent air flow inside the flask for better storage. Mascara tubes could also be tagged by our polymer films. For instance, a clear window could be made inside the handle, thus allowing the placing of the film. Such tags placing allows product verification without damaging any of the manufacturing packagings.

Fig. 7 shows a possible flowchart of polymer tag fabrication process. First, an appropriate encoding algorithm is chosen (for instance, it could be a bar or QR code). On the second stage, data from the encryption algorithm is transformed into the discrete and quantized phase shifts along the polymer film using an iterative Fourier transform algorithm (IFTA [US9766456B2]). From this point, a few of many fabrication processes are discussed. The right branch on fig. 7 describes an optical approach: a high-power laser source 23 with the help of steering optics and objective lens 24 vaporize excessive polymer material, thus adjusting the physical thickness of the film to meet the desired phase shifts distribution [US8670151 B2] . The left branch of fig. 7 reflects the more standard embossing approach. A high precision master negative mold 25 is fabricated through a lithographic process. After the molding process 26, the polymer film 27 obtains a thickness distribution along its plane, thus leads to the same result as in the right branch. In one embodiment, the invention represents a medical tablet encoding that is made on an edible thin polymer film integrated or firmly tied to the tablet, wherein the polymer film produces a readable optical image (diffraction pattern). Such encoding can also be embedded in hermetically sealed packaging for cosmetics, food, other medical tools, devices, and other goods.

The main component of the soft gel pills is gelation. This type of pills always contains liquid medicine. Softgel material is antioxidant, which means that the contents have a long shelflife and are well protected against UV rays and oxidation. The custom pattern could be produced directly on the smooth gelatin surfaces via the hot embossing process. Preheated silicon stamp is pressed against the surface of the soft gel pill with a light force, thus producing indentations and reliefs.

Pre-filled syringes are usually used to store expensive liquid medicine like vaccines, insulin etc. Besides protective labels on the body of the syringe, there are no strong protection levels against the liquid interchanging. We proposed a method of using thin patterned polymer film as a disposable seal to protect against this type of counterfeit. Polymer film with a distinct pattern is glued on the tip of the syringe after a particular medicine in the form of a liquid has been filled inside the syringe during the manufacturing process. To ensure a reliable readout process of the polymer film a support, made of the same polymer, is placed underneath the film to provide a flat reference surface. Before the injection, the polymer seal is punctured allowing liquid to flow through.

Some liquid medicines come in the form of glass bottles for multi-dose usage. These bottles are usually sealed with a hermetic rubbery stopper and metal tear-off cap. Our label could be placed on top of the rubber seal; thus after a metal cap is removed to obtain the contained liquid, a syringe needle must puncture both the rubber seal and the label damaging them and making the label unreadable.

The laser beam is guided via the beam splitting plate to the glass window. Medicine in the form of the soft gel pills or pre-filled syringes is gently pressed against the glass window with enough mechanical force, thus flattening the pill’s surface with the embedded pattern or the film’s surface on the tip of the syringe, allowing a stable readout process. The light’s intensity distribution in the complex diffraction pattern produced by the lens is captured by the photosensitive element.

In some embodiments, the polymer film is integrated into the structure of the tablet, and removal of the polymer film will destroy the integrity of the tablet.

In some embodiments, the polymer film has a micro-pattern and thickness from 0.1 to 50 micron.

In some other embodiments, the polymer film is made of a material that is editable (if needed to be consumed) and consists of pure or blended polymers (for example, polylactic acid, polysaccharides, gelatin, pectin, PLGA or a combination of thereof). In some embodiments, the overall dimension of the integrated polymer film as small enough as to provide space for laser light to produce a measurable diffraction pattern.

In some other embodiments, the polymer film is made of a material or a combination of materials that are non-degradable (for other applications, cosmetics, coding of other goods).

In some embodiments, the polymer film is integrated into the tablet either by placing it in the center of the tablet (for example, by pressing two parts of tablets having a hole in between) or by placing it aside or in other part or associated by other means.

In some embodiments, the polymer film is to be associated with a good by any means implemented in such a way that their separation (the good and the film) will indicate that a marking of good is damaged and not valid anymore. Such good should not be used since the integrity was compromised. In some embodiments, encoded information in the polymer film is recorded in imprinted or by another way via impacted periodic or non-periodic structure with micro-relief or pattern

In some embodiments, the polymer film integrated into medicine may contain information about the composition of the medicine, characteristics, manufacturer, production date, expiration date, or any other information important for the patient, doctor, pharmacist, or regulating authorities. In other embodiments, the polymer film integrated into a non-medical good may contain similar information. In some embodiments, the volume of information encoded in the film may be increased by either using computer-generated holography algorithm to produce a 2d matrix-type image (like QR-code) or using multilayered films to produce complex patterns.

Relevant data, i.e., serial number or picture, is encoded onto the surface of the film or a physical surface of an item via strictly placed indentation or reliefs. The reliefs can vary in their shape, size, and depth. Such configuration and encoding of indentations or reliefs are targeted to increase the difficulty of observing and/or modifying an embedded pattern. This aims to provide increased security of the stored data against unauthorized access, requiring the appropriate technological means (e.g., laser beam and decoding algorithms) to retrieve the stored data.

To obtain, for example, a serial number or any arbitrary data, a predefined coherent light source (e.g. a laser beam) should pass through the film or be reflected on the item’s surface. The diffracted light, with the help of a lens, will form an image. In this image, relevant data could appear directly (decoded) or being graphically represented. Different kinds of data storage algorithms could be used to achieve the desired robustness level against stretching/scratching and local irregularities of the pattern. Thus, even if third-party members somehow are able to readout the data from the film, it will be meaningless without the knowledge of the data conversion algorithm.

In some embodiments, the reading of information encoded in the film is made by an image reading algorithm (laser, holder for tablet and camera) and processing the data into unique code for the tablet. In yet another embodiment, the invention represents a method for marking an object using a film made of a biodegradable polymer, the method comprising the following stages: receiving unique information characterizing the object; embedding this information to the film by forming a unique relief on a surface of the film or inside the film; integrating the film within the object.

In yet another embodiment, the invention represents a method for identifying an object using a film made of a biodegradable polymer, the method comprising the following stages: integrating the film within the object, wherein the film contains a unique relief on a surface of the film or inside the film that encodes unique information characterizing the object; scanning the relief on the film integrated within the object with a device configured to emit a coherent light beam; matching a diffraction pattern captured after scanning with a stored set of patterns and identifying the object when matching is detected.

Claims

CLAIMS The method for identifying objects, comprising at least the following steps: obtaining identifying information, converting the identifying information into a microrelief structure or structured pattern, applying said microrelief structure or pattern to an information carrier, placing said information carrier on an identifiable object. The method according to claim 1, characterized in that said microrelief structure or structured pattern can be applied using a laser with a wavelength in the range between 13nm and 1 micron. The method according to claim 1, characterized in that said microrelief structure or structured pattern can be red-out using a laser with a wavelength in the range between 500nm and 1 micron. The method according to claim 1, characterized in that said microrelief structure or structured pattern is preliminarily can be applied to a stamp by means of which it is transferred to the identifiable object. The method according to claim 1, characterized in that said microreliefstructure or structured pattern comprises a plurality of elements with different depths within the range according to laser specification and polymer properties. The method according to claim 1 , characterized in that the elements of said microrelief structure or structured pattern are geometrically shaped.

The method according to claim 1, characterized in that said microstructure or structured pattern is readable with any readable angle between 0° -360° depending on pattern configuration and placement. The method according to claim 1, characterized in that a biodegradable film can be used as the information carrier. The method according to claim 1 , characterized in that an edible or not edible film can be used as the information carrier. The method according to claim 1, characterized in that a medical tablet or capsule is used as the identifiable object. The method according to claim 1 , characterized in that a sealing element of a pre-filled syringe is used as the identifiable object. The method according to claim 1 , characterized in that a sealing element of a glass medical bottle is used as the identifiable object. The method according to claim 1, characterized in that the information carrier can be a material that can support laser tagging.

9 The method according to claim 1, characterized in that polymer films has micropatterned and thickness from 0.1 to 50 micron. The method according to claim 1, characterized in that polymer material is editable and consist of pure or blended polymers The method according to claim 1, characterized in that polymer film is tied to tablet either in the center or aside or in other part The method according to claim 1, characterized in that encoded information in the polymer film is recorded in imprinted or by other way impacted periodic or nonperiodic structure with micro-relief or pattern The method according to claim 1, characterized in that volume of information for encoded information can be increased by either using computer-generated holography algorithm to produce a 2d matrix-type image or using multilayered films to produce complex patterns The method according to claim 1, characterized in that overall dimension of tied polymer film could be as small as just enough to allow a laser light to cause the diffraction. The method according to claim 1, characterized in that overall dimension of tied polymer film or physical surface could be as small as just enough to fulfill data encoding process. The method according to claim 1, characterized in that polymer film contain information about medicine contents and characteristics, manufacturer, date of production and best before and other information important for the patient, doctor, pharmacist and regulating authorities. The method according to claim 1, characterized in that reading of information is made by image reading algorithm and processing the data into a unique code of tablet. The method according to claim 1, characterized in that tablet encoding is made by edible thin polymer films firmly tied to medical tablet and also can be embedded in hermetically sealed packaging for cosmetic, food, other medical tools and devices, and other good while needed Polymer film produces readable optical image (diffraction pattern)