WO2019108080A1 - Bande de protection multicouches pour perforateur laser - Google Patents

Bande de protection multicouches pour perforateur laser Download PDF

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Publication number
WO2019108080A1
WO2019108080A1 PCT/RU2017/000888 RU2017000888W WO2019108080A1 WO 2019108080 A1 WO2019108080 A1 WO 2019108080A1 RU 2017000888 W RU2017000888 W RU 2017000888W WO 2019108080 A1 WO2019108080 A1 WO 2019108080A1
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WO
WIPO (PCT)
Prior art keywords
layer
strip
hole
thickness
contact
Prior art date
Application number
PCT/RU2017/000888
Other languages
English (en)
Russian (ru)
Inventor
Екатерина Валерьевна САВЧУК
Валерий Геннадиевич ПОЛУШКИН
Original Assignee
Общество с ограниченной ответственностью "НСЛ"
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Общество с ограниченной ответственностью "НСЛ" filed Critical Общество с ограниченной ответственностью "НСЛ"
Priority to PCT/RU2017/000888 priority Critical patent/WO2019108080A1/fr
Priority to PCT/RU2018/000196 priority patent/WO2019108087A1/fr
Publication of WO2019108080A1 publication Critical patent/WO2019108080A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose

Definitions

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 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.
  • 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.
  • Er yttrium-aluminum garnet doped with erbium ions
  • 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 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.
  • FEP fluorinated ethylene propylene
  • the first layer is contacted with the second layer by means of an adhesive layer located between said layers.
  • 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.
  • the through holes of the first layer and the third layer are coaxial.
  • 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.
  • 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.
  • 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.
  • the surface of the second layer of fluorinated ethylene-propylene (FEP) is modified and characterized by increased adhesion.
  • the thickness of the first layer and the third layer is selected independently and is in the range from 50 ⁇ m to 1000 ⁇ m. In particular, the thickness of the first layer and / or the third layer may be 500 ⁇ m.
  • the thickness of the second layer is in the range from 10 ⁇ m to 250 ⁇ m. In particular, the thickness of the second layer is 50 ⁇ m.
  • any of these technical tasks can be considered as the main one, and the rest - as auxiliary ones.
  • all these tasks are solved together in connection with each other.
  • FEP Fluorinated ethylene-propylene
  • YAG ⁇ g with a high melting point
  • 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).
  • blood splashing in case of increased pressure in a person or formation of a microchannel in the area of the vessel
  • FEP film in the area of the window and the walls of the first layer (base, substrate).
  • 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.
  • connection 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.
  • the term "disposable strip” means that the specified strip is individual, and, if used, can be used by one person 1-3 times.
  • 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.
  • 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.
  • geometric shape strips in this document should be understood as a rectangular strip with a corresponding length and width.
  • 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.
  • FEP fluorinated propylene and ethylene
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 ⁇ m to 1000 ⁇ m. 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 ⁇ m.
  • 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.
  • the thickness of the first layer 1 10 (substrate), to which the finger is pressed must be at least 0.5 mm.
  • the multi-layer protective strip can be made as follows, as shown in FIG. 4-6.
  • 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.
  • the thickness of the substrates 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 ⁇ m (without hole), glue layer 550 (with hole 551), base 530 (substrate) with a hole.
  • 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.
  • 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.
  • 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 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.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Pathology (AREA)
  • Immunology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Urology & Nephrology (AREA)
  • Chemical & Material Sciences (AREA)
  • Surgery (AREA)
  • Medical Informatics (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Veterinary Medicine (AREA)
  • Cell Biology (AREA)
  • General Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Diabetes (AREA)
  • Optics & Photonics (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention se rapporte au domaine des techniques médicales, notamment à un équipement pour des dispositifs de perforation sans contact par rayonnement laser focalisé de la peau du doigt d'une personne afin de prélever un spécimen de sang capillaire, et concerne notamment un matériau de protection jetable à usage unique pour un perforateur laser. Cette bande comprend une première couche avec des ouvertures traversantes pour le passage du faisceau laser, et une seconde couche faite d'éthylène-propylène fluoré (FEP). Une des surfaces de la première couche entre en contact avec la peau du doigt du patient, et la seconde avec la seconde couche de sorte que la seconde couche recouvre au moins une ouverture traversante de la première couche. Cette invention permet d'assurer une protection contre la propagation de produits d'évaporation de la peau et contre l'odeur, et l'usage unique de la zone de contact du doigt de la personne à proximité immédiate de la zone de perforation avec le corps de l'instrument, de réduire les dimensions hors tout de l'article et d'abaisser les coûts intrinsèques de fabrication.
PCT/RU2017/000888 2017-12-01 2017-12-01 Bande de protection multicouches pour perforateur laser WO2019108080A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/RU2017/000888 WO2019108080A1 (fr) 2017-12-01 2017-12-01 Bande de protection multicouches pour perforateur laser
PCT/RU2018/000196 WO2019108087A1 (fr) 2017-12-01 2018-03-27 Bande intégrée à usage unique utilisée dans un perforateur laser cutané combiné à un analyseur sanguin

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/RU2017/000888 WO2019108080A1 (fr) 2017-12-01 2017-12-01 Bande de protection multicouches pour perforateur laser

Publications (1)

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WO2019108080A1 true WO2019108080A1 (fr) 2019-06-06

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PCT/RU2017/000888 WO2019108080A1 (fr) 2017-12-01 2017-12-01 Bande de protection multicouches pour perforateur laser
PCT/RU2018/000196 WO2019108087A1 (fr) 2017-12-01 2018-03-27 Bande intégrée à usage unique utilisée dans un perforateur laser cutané combiné à un analyseur sanguin

Family Applications After (1)

Application Number Title Priority Date Filing Date
PCT/RU2018/000196 WO2019108087A1 (fr) 2017-12-01 2018-03-27 Bande intégrée à usage unique utilisée dans un perforateur laser cutané combiné à un analyseur sanguin

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5426032A (en) * 1986-08-13 1995-06-20 Lifescan, Inc. No-wipe whole blood glucose test strip
US6284550B1 (en) * 1997-06-10 2001-09-04 Home Diagnostics, Inc. Diagnostic sanitary test strip
RU2002120940A (ru) * 2001-08-01 2004-02-20 Лайфскен, Инк. (Us) Устройство для определения концентрации анализируемого вещества и способы их применения
US20050234437A1 (en) * 1999-07-14 2005-10-20 Cardiofocus, Inc. Deflectable sheath catheters with out-of-plane bent tip

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8409424B2 (en) * 2006-12-19 2013-04-02 Apex Biotechnology Corp. Electrochemical test strip, electrochemical test system, and measurement method using the same

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5426032A (en) * 1986-08-13 1995-06-20 Lifescan, Inc. No-wipe whole blood glucose test strip
US6284550B1 (en) * 1997-06-10 2001-09-04 Home Diagnostics, Inc. Diagnostic sanitary test strip
US20050234437A1 (en) * 1999-07-14 2005-10-20 Cardiofocus, Inc. Deflectable sheath catheters with out-of-plane bent tip
RU2002120940A (ru) * 2001-08-01 2004-02-20 Лайфскен, Инк. (Us) Устройство для определения концентрации анализируемого вещества и способы их применения

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