WO2019108080A1

WO2019108080A1 - Multilayered protective strip for laser perforator

Info

Publication number: WO2019108080A1
Application number: PCT/RU2017/000888
Authority: WO
Inventors: Екатерина Валерьевна САВЧУК; Валерий Геннадиевич ПОЛУШКИН
Original assignee: Общество с ограниченной ответственностью "НСЛ"
Priority date: 2017-12-01
Filing date: 2017-12-01
Publication date: 2019-06-06
Also published as: WO2019108087A1

Abstract

The invention relates to medical technology, in particular to equipment for devices for non-contact perforation by means of focused laser irradiation of the skin of a human finger for collecting capillary blood, namely to a single-use protective disposable material for a laser perforator. A strip includes a first layer having a through-hole for the passage of a laser beam, and a second layer made of fluorinated ethylene propylene (FEP). In addition, one of the surfaces of the first layer contacts with the skin of a human finger, and a second surface contacts with the second layer such that the second layer covers at least the through-hole of the first layer. Using the invention makes it possible to provide protection against the spread of products evaporating from the skin and odor, to provide disposability of the zone of contact of the human finger immediately near the puncture zone with the instrument housing, to reduce the dimensions of the article, and to lower the production cost thereof.

Description

MULTILAYER PROTECTIVE STRIP FOR LASER PUNCH

The technical field to which the invention relates.

The invention relates to medical equipment, in particular, to equipment for devices for contactless perforation by focused laser radiation on the skin of a person’s finger for taking a sample of capillary blood, namely, a disposable protective consumable for a laser perforator. The invention may also find use when used with express blood analyzers, in particular with blood glucose meters.

Background of the invention

Laser skin perforators are being actively developed and applied at the present time. The use of a laser contactless skin perforator eliminates the infection of the patient's body with viruses and various infectious diseases. When a laser perforator is triggered, ablation of the skin occurs at the point of contact of a focused laser beam on a human finger pad, resulting in a microchannel sufficient to collect a blood sample for analysis.

However, there are some negative aspects of the microchannel formation procedure using a laser perforator, which can degrade the operation of the device and reduce the commercial attractiveness of the technology.

One such aspect is the displacement of tissue debris, which can settle on the surface of the focusing lens, reducing its light transmission and, therefore, requiring frequent cleaning or replacement of the lens. In addition, the deposition of such detritus on the surface of the device can lead to the growth of various microorganisms, contributing to the possible transmission of infectious diseases, if the device is subsequently used by another person.

Another negative aspect of laser perforation of the skin is the release of evaporation products, accompanied by the spread of the characteristic smell and sound of cotton as a result of ablation of the skin. These effects can cause a negative perception among consumers when performing this procedure.

Another negative aspect of some prior art procedures is the possibility of splashing blood from a microchannel onto a focusing lens or onto the surface of a laser punch body, which could potentially increase the likelihood of transmitting infectious diseases if the device is subsequently used by another patient. Thus, there is a need to create safe, easily replaceable consumables that will help minimize these drawbacks of the laser skin perforation procedure.

Traditionally, a laser punch uses disposable protective caps designed to ensure hygiene in the area of human contact with the body of the device and protect the device’s focus lens installed in the lens holder from skin evaporation at the time of perforation (EP 2692291 A1, US2014296743 A1, CN201127609 Y and so Further).

The disadvantages of the above-mentioned disposable caps are quite cumbersome dimensions and significant losses of laser radiation.

The closest analogue is a multi-layer flat strip used for both perforation of the patient’s skin and for measuring glucose level (test strip) (US2014221802 A1), which includes a substrate with a hole for transmitting a laser beam onto which a polypropylene film is applied. At one end of the strip, configured to be installed in a specific connector, the electrode layer and the reagent tank are integrated.

However, the properties of polypropylene, including a sufficiently high absorption at the wavelength of generation of a laser perforator based on YAG: Er (yttrium-aluminum garnet doped with erbium ions) and an insufficiently high melting point, do not allow the strip to be positioned in close proximity to the puncture zone, where high energy density, sufficient for the formation of a microchannel. When using the specified strip in order to avoid burning through the polypropylene film, it is located far from the puncture zone in such a way that evaporation products and blood splashes can fall and be localized in the volume of the instrument case. Over time, this can lead to the formation of microbial growth inside the device, an unpleasant odor and potentially the likelihood of transmission of infectious diseases when used by several people. Using the strip inside the case does not provide hygiene in a multi-user mode of operation.

Disclosure of the invention

The technical task to be solved by the invention is the creation of a disposable protective consumable material, made as a flat strip, for a laser punch with low losses of laser radiation (less than 12%) when passing through the window of such a strip, providing protection against the spread of skin evaporation and odor products and the disposability of the zone of contact of a person’s finger in close proximity to the puncture zone with the body of the device.

Another technical problem, the solution of which the invention is directed, is to reduce the overall dimensions and reduce the cost of production of disposable protective consumables for a laser punch.

An additional technical task, the solution of which the invention is directed, is the possibility of ensuring the symmetry of the strip on the position of the window relative to the sides of the strip, which increases the usability for the end user.

The tasks are solved by creating a multi-layer protective strip for a laser perforator, which includes a first layer with a through hole for the passage of a laser beam and a second layer made of fluorinated ethylene propylene (FEP), while one of the surfaces of the first layer contacts the skin of a person’s finger, and the second - with the second layer in such a way that the second layer covers at least the through hole of the first layer.

In some embodiments of the invention, the first layer is contacted with the second layer by means of an adhesive layer located between said layers.

In some embodiments of the invention, the strip further includes a third layer with a through hole for the passage of the laser beam in contact with the surface of the second layer.

In some embodiments of the invention, the through holes of the first layer and the third layer are coaxial.

In some embodiments of the invention, the third layer is in contact with the second layer, and the second layer is in contact with the first layer by means of adhesive layers located between said layers.

In some embodiments of the invention, the material of the first layer is a material from the following row: PET (polyethylene terephthalate or polyester), polystyrene, vinyl (polyvinyl chloride, PVC) or other polymeric materials, paper.

In some embodiments of the invention, the material of the third layer is a material from the following row: PET (polyethylene terephthalate or polyester), polystyrene, vinyl (polyvinyl chloride, PVC) or other polymeric materials, paper.

In some embodiments of the invention, the surface of the second layer of fluorinated ethylene-propylene (FEP) is modified and characterized by increased adhesion. In some embodiments of the invention, the thickness of the first layer and the third layer is selected independently and is in the range from 50 μm to 1000 μm. In particular, the thickness of the first layer and / or the third layer may be 500 μm.

In some embodiments of the invention, the thickness of the second layer is in the range from 10 μm to 250 μm. In particular, the thickness of the second layer is 50 μm.

In this case, depending on the circumstances, any of these technical tasks can be considered as the main one, and the rest - as auxiliary ones. However, in more preferred embodiments of the invention, all these tasks are solved together in connection with each other.

As it is known, FEP (Fluorinated ethylene-propylene) is the most transparent polymer material in the field of generation of a laser perforator on the basis of YAG: Еg with a high melting point, and also has the lowest refractive index among all thermoplastic materials, which reduces the loss of laser radiation when passing through film of the specified material and provide a high value of the energy density, sufficient for the formation of a microchannel, and also place the protective film in the immediate bl Soest to the region puncture.

The advantage of contacting the claimed invention directly with the skin of a person’s finger during laser perforation is the localization of all evaporation products that are formed as a result of this procedure, including blood splashing (in case of increased pressure in a person or formation of a microchannel in the area of the vessel) between the finger, FEP film in the area of the window and the walls of the first layer (base, substrate). In this case, a positive effect is also manifested in the fact that evaporation products are largely deposited on the walls of the substrate and the FEP film and do not spread beyond the strip, even when the finger is removed from the strip.

Terms and Definitions

In the present description and in the claims, the terms "includes", "including" and "includes", "having", "supplied", "comprising" are interpreted to mean "includes, among other things". These terms are not intended to be interpreted as “consists only of”.

In addition, the terms "first", "second" and "third", etc. they are used simply as conditional markers, without imposing any numerical or other restrictions on the enumerated objects. The term "connected" means functionally connected, and any number or combination of intermediate elements between the components to be connected (including the absence of intermediate elements) can be used.

In the context of this application, the term "disposable strip" means that the specified strip is individual, and, if used, can be used by one person 1-3 times.

In the materials of this application, the term "contacts" in relation to the layers of the strip means the contact of the two surfaces of the layers in whole or at least partially. It is implied that if the surfaces of the layers are in full contact, then the geometrical forms of these layers practically correspond to each other.

If the strip is in contact with human skin, it is assumed that the finger of a person touches the surface of the first layer or the third layer of the strip (if the strip is made symmetrical) in the area of the through hole for transmitting laser radiation (window) to position the finger in the working plane.

The term "geometric shape" strips in this document should be understood as a rectangular strip with a corresponding length and width.

The term FEP film in this document means a film made of fluorinated propylene and ethylene (FEP), which is a fully fluorinated fluoroplast, which is a copolymer of tetrafluoroethylene and hexafluoropropylene. The specified material has the lowest index of refraction among all thermoplastic materials, and the transmission properties in the infrared region of the spectrum are superior to glass.

Brief Description of the Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the above general description of the invention and the detailed description below, serve to explain the principles of the present invention. In the drawings, the same position is used to refer to the same parts.

FIG. 1 shows a general view of a multilayer strip according to the present invention.

FIG. 2 shows the contact of a person’s finger with a multi-layered strip for perforating the skin. FIG. 3 shows a simplified view of a disassembled state of a multi-layer strip, dotted lines indicate the position of the various layers of the multi-layer strip.

FIG. 4 shows a view of a universal multilayer strip disassembled.

FIG. 5 shows a multi-layer strip with an adhesive layer.

FIG. 6 shows a universal multi-layer strip with adhesive layers.

Detailed description of embodiments of the invention.

The present invention provides a consumable material for a laser perforator, which is a multi-layer protective strip used to perforate a patient's skin.

In the proposed solution, a protective consumable for a laser perforator is made in the form of a disposable flat strip 100, as shown in FIG. made of fluorinated ethylene propylene).

The first layer 110 (substrate) of the strip 100 is in direct contact with the skin of a person’s finger in the area of the opening 1 11, as shown in FIG. 2. The through hole 1 1 1 of the first layer 110 is substantially circular, however, it can have any geometric shape. The through hole 11 1 of the first layer 110 is located predominantly in the center of the strip 100 in the case of a symmetrical version or at a small distance from the edges of said layer 110 in such a way as to ensure reliable fixing of the strip 100 in the instrument case on one side and sufficient space for the strip to be taken when installing and removing the strip 100 from the case. The hole 111 should be coaxial with the axis of the laser beam in the device.

The strip 100 preferably has a rectangular shape. To provide more accurate mounting in the laser punch strip may have technological holes, protrusions, slots and any other additional structural elements. The geometric shapes of the substrate 1 10 and FEP films 120 can almost coincide with each other, and at the same time the contact of these two layers is carried out over the entire surface. However, the present invention provides options (FIG. 3) for making a flat strip 200 when the geometric dimensions and shapes of the FEP film 220 differ from the size and shape of the substrate 210, in which case the film 220 contacts the substrate 210 only in the area of the through-hole 211 its complete overlap.

Non-limiting examples of materials from which the substrate 1 10 (base) can be made are: PET (polyethylene terephthalate or polyester), polystyrene, vinyl (polyvinyl chloride, PVC) or any other possible examples of polymeric materials, paper (paper base).

The thickness of the first layer 110 is in the range from 50 μm to 1000 μm. In particular, the thickness of the first layer may be 500 microns.

The second layer of the strip 120 is a layer of FEP film with a thickness of 10 to 250 microns without a hole. The thickness of the second layer 120 is selected from the necessity and sufficiency of ensuring the minimum absorption during the passage of the laser beam through the film and the preservation of the specified layer under the influence of the specific energy density of the laser radiation. Damage to the FEP film layer 120 (for example, burning it) can lead to a distortion of the shape of the laser beam, as well as the evaporation products of the film on the open wound of the finger.

The preferred thickness of the second layer 120 is 50 μm. However, the claimed invention is not limited to the specified value, and the thickness can be selected any within the specified range.

The thickness of the first layer 110 (substrate) and the diameter of the through hole 1 11 are selected based on ensuring that the skin of the finger does not touch the FEP film 120. The absence of mechanical contact of the skin of the finger with the strip does not require sterilization of the strips and, accordingly, reduces the cost of production and makes the puncture procedure hygienic.

For example, with the diameter of the through hole 1 1 1 for the passage of laser radiation up to 2.5 mm, the thickness of the first layer 1 10 (substrate), to which the finger is pressed, must be at least 0.5 mm.

Turning now to specific and preferred embodiments of the invention, the multi-layer protective strip can be made as follows, as shown in FIG. 4-6.

One of the embodiments of the invention, as shown in figure 4, is the implementation of disposable strips 300 symmetrical and versatile. By these features it is meant that the strip 300 can be installed into the device by either side of its relative long side. The strip 300 in this embodiment further includes a third layer 330, which is a base with a through hole 331 coaxial with the hole 31 1 of the first layer 310.

The material, shape, thickness, and diameter of the hole 331 of the third layer 330 can be selected similarly to the material, shape, and other parameters of the second layer described above. To prevent the skin of the finger from contacting with a layer of FEP film in one of the embodiments of the invention, the thickness of the substrates (first layer 310 and third layer 330) must be the same. Due to the low absorption coefficient of the FEP film 320, even when the window of the strip is located close to the perforation plane, the film is not damaged. The layers of the strip can be contacted by means of adhesive bonding, however, thermal welding of the surface or any other known from the prior art is possible.

Figure 5 shows the invention in one embodiment, in the case where the strip 400 has 3 layers, which are: a base 410 (substrate) with a hole 411, an adhesive layer 440 (with a hole 441), a working layer 420 of FEP film thickness 10 - 250 microns (without opening).

Figure 6 shows the invention in one embodiment, in the case where the symmetric strip 500 has 5 layers: the first layer 510 with the hole 51 1, the adhesive layer 540 (with the hole 541), the working layer 520 of FEP film thickness 10 - 250 μm (without hole), glue layer 550 (with hole 551), base 530 (substrate) with a hole.

Moreover, in all embodiments of the invention, the adhesive layer binds the surfaces of the layers in such a way that it is absent in the area of the through-hole of the substrate layers.

From a technological point of view, the production of such disposable protective strips according to embodiments of the present invention with a FEP film as a window is complicated by the very weak adhesion of the FEP film due to the very low surface energy. To solve this problem, it is necessary to use a FEP film with a specially treated surface, which increases the adhesion properties. One of the most promising and modern methods for modifying the surface of polymers is the effect of low-temperature plasma, which allows you to change the properties of the surfaces of these materials within wide limits and significantly expand their areas of use. Environmentally friendly modern plasma-chemical methods greatly benefit compared to chemical modification, which uses such aggressive reagents as acids, hydroxides, alkaline earth metals and their compounds, etc. The most important feature of the process of plasma-chemical modification of polymeric materials that determines particular interest in this method , is that only the processed surface of the material and a very thin surface layer, the thickness of which, according to different estimates, undergoes changes am ranges from 100 angstroms to several microns. The bulk polymer does not change, preserving the mechanical, physico-chemical and electrophysical properties of the modified material.

Additionally, such a consumable material can be integrated with a test strip for various rapid test systems for determining blood parameters, for example, with test stripes for rapid blood analyzers, in particular blood glucose meters. Layers with electrodes and a capillary are added, and the electrodes should bend around the window zone in which the transparent FEP film is located.

The advantage of this solution will be - the use of one consumables when conducting a rapid blood test, in particular for measuring blood sugar levels using a laser punch combined with a blood glucose meter.

The disposable strip can be used as follows: at one end, the strip is clamped with fingers and installed in a laser punch, in the case of which there can be special guides and fixing elements that facilitate installation and positioning of the strip. The strip is inserted all the way. When this is achieved, the alignment of the working aperture of the laser punch and the working window of the strip.

The above description of an exemplary embodiment provides an overview of the principles for the design, operation, manufacture and use of the device proposed by the present invention. At least one example of these embodiments is illustrated in the accompanying drawings. It will be apparent to those skilled in the art that the specific devices described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment can be combined with features of other embodiments. It is assumed that such modifications and changes are within the scope of the present invention.

Claims

CLAIM

1. Multi-layer protective strip for a laser punch, comprising at least:

the first layer with a through hole for the passage of the laser beam, the second layer made of fluorinated ethylene-propylene (FEP), with one of the surfaces of the first layer in contact with the skin of a person's finger, and the second with the second layer so that the second layer overlaps on At least through hole of the first layer.

2. The strip under item 1, characterized in that the first layer is in contact with the second layer by means of an adhesive layer located between the specified layers.

3. The strip according to claim 1, characterized in that the through hole in the first layer is made symmetrically with respect to the long side of the strip.

4. The strip according to claim 1, characterized in that the through hole in the first layer is made in the center of the first layer of the strip.

5. The strip according to claim 1, characterized in that it further includes a third layer with a through hole for the passage of the laser beam in contact with the surface of the second layer.

6. The strip under item 5, characterized in that the through holes of the first layer and the third layer are coaxial.

7. The strip according to claim 5, characterized in that the third layer is in contact with the second layer, and the second layer is in contact with the first layer by means of adhesive layers located between these layers.

8. The strip according to claim 1, characterized in that the material of the first layer is a material from the following row: PET (polyethylene terephthalate or polyester), polystyrene, vinyl (polyvinyl chloride, PVC) or other polymeric materials, paper.

9. The strip according to claim 5, characterized in that the material of the third layer is a material from the following row: PET (polyethylene terephthalate or polyester), polystyrene, vinyl (polyvinyl chloride, PVC) or other polymeric materials, paper.

10. The strip according to any one of paragraphs 1-9, characterized in that the surface of the second layer of fluorinated ethylene-propylene (FEP) is modified and characterized by increased adhesion. Yu

11. The strip on any item 1-9, characterized in that the thickness of the second layer is 10-250 microns.

12. The strip according to claim 1, characterized in that the thickness of the second layer is 50 μm.

13. The strip on any item 1-9, characterized in that the thickness of the first layer is 50-1000 microns.

14. The strip on p. 14, characterized in that the thickness of the first layer is 500 μm.

15. The strip on any item 5-9, characterized in that the thickness of the third layer is 50-1000 microns.

16. The strip indicated in paragraph 15, characterized in that the thickness of the third layer is 500 μm.