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SE2051096A1 - An optical sensor plate for measuring blood flow of a patient - Google Patents

An optical sensor plate for measuring blood flow of a patient

Info

Publication number
SE2051096A1
SE2051096A1 SE2051096A SE2051096A SE2051096A1 SE 2051096 A1 SE2051096 A1 SE 2051096A1 SE 2051096 A SE2051096 A SE 2051096A SE 2051096 A SE2051096 A SE 2051096A SE 2051096 A1 SE2051096 A1 SE 2051096A1
Authority
SE
Sweden
Prior art keywords
optical
flexible support
major surface
optical source
cover
Prior art date
Application number
SE2051096A
Other languages
Swedish (sv)
Other versions
SE545864C2 (en
Inventor
Martin Jepsson
Stefan Grönqvist
Tova Persson
Original Assignee
Pusensor Ab
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 Pusensor Ab filed Critical Pusensor Ab
Priority to SE2051096A priority Critical patent/SE545864C2/en
Priority to PCT/SE2021/050884 priority patent/WO2022060280A1/en
Priority to EP21773904.4A priority patent/EP4213706A1/en
Publication of SE2051096A1 publication Critical patent/SE2051096A1/en
Publication of SE545864C2 publication Critical patent/SE545864C2/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/44Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
    • A61B5/441Skin evaluation, e.g. for skin disorder diagnosis
    • A61B5/447Skin evaluation, e.g. for skin disorder diagnosis specially adapted for aiding the prevention of ulcer or pressure sore development, i.e. before the ulcer or sore has developed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/026Measuring blood flow
    • A61B5/0261Measuring blood flow using optical means, e.g. infrared light
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/026Measuring blood flow
    • A61B5/0295Measuring blood flow using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
    • A61B5/1455Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/72Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271Specific aspects of physiological measurement analysis
    • A61B5/7275Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0233Special features of optical sensors or probes classified in A61B5/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04Arrangements of multiple sensors of the same type
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/12Manufacturing methods specially adapted for producing sensors for in-vivo measurements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/164Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted in or on a conformable substrate or carrier
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0062Arrangements for scanning
    • A61B5/0064Body surface scanning
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/44Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
    • A61B5/441Skin evaluation, e.g. for skin disorder diagnosis
    • A61B5/445Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Pathology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Physiology (AREA)
  • Hematology (AREA)
  • Cardiology (AREA)
  • Dermatology (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Optics & Photonics (AREA)
  • Artificial Intelligence (AREA)
  • Computer Vision & Pattern Recognition (AREA)
  • Psychiatry (AREA)
  • Signal Processing (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)

Abstract

An optical sensor plate (1) for measuring blood flow, comprising: a flexible support (2) having a first (2a) and a second major surface (2b), an optical source (3) and an optical detector (4) arranged on the first major surface (2a). The optical source (3) emitting light into the skin of a subject and the detector (4) detecting light after reflection in the skin and underlying tissue. The optical source (3) and the optical detector (4) being separated on the first major surface (2a) by an optically opaque wall (5), such that the amount of light reaching the optical detector (4) directly from the optical source (3) is limited. A cover (6) is arranged on the first major surface (2a) of the flexible support (2), covering and embedding the optical detector (4), the optical source (3) and the opaque wall (5).

Description

1AN OPTICAL SENSOR PLATE FOR l\/IEASURING BLOOD FLOW OF A PATIENT TECHNICAL FIELD[001] The present document relates to an optical sensor plate and to a method of producing such an optical sensor plate.
BACKGROUND ART[002] Pressure ulcers afflict people of all ages across the globe and are one of the mostcommon injuries suffered by patients in the course of care. A pressure ulcer is an injury to theskin and/or underlying tissue caused by insufficient blood flow as a result of pressure on theskin, for example, due to extended periods of laying or sitting. The pressure deprives the cellsof the oxygen and nutrients they need. Pressure ulcers are the cause of tremendous suffering,high healthcare costs and can occasionally lead to death. 3. 3. id="p-3" id="p-3" id="p-3" id="p-3" id="p-3" id="p-3" id="p-3" id="p-3" id="p-3" id="p-3" id="p-3" id="p-3" id="p-3" id="p-3" id="p-3" id="p-3" id="p-3"
[003] Patients undergo a pressure ulcer risk assessment when admitted to hospitalsand care homes according to established methods; usually through the application ofassessment scales. Those patients who are assessed to have the greatest risk of developingpressure ulcers are the most likely to be treated using preventative measures. Assessmentscales are widely used, but these are not very precise since they rely on an assessment of thepatient's condition and are rather subjective. ln WO2019/190378 is described a method andtechnique based on an assessment of the individual's physiological status, through anexamination of the patient's superficial blood flow in places where pressure ulcers tend tooccur, and the skin is bearing the patient's body weight. Blood flow data related to theassessed area while subjecting the assessed area to the at least two different pressure statesis obtained by means of photoplethysmography and the risk of pressure ulcers on the patientis based on assessment ofthe blood flow data obtained for the at least two different pressurestates.[004] ln photoplethysmography (PPG) the skin is illuminated and the reflected light is measured by applying a sensor unit to a skin surface. This is an established technology that is used in for example heart rate monitors and other devices. 2[005] A PPG sensor for use in pressure ulcer risk assessment, as well as other opticalsensors used for measuring blood flow in superficial tissue, need to be flexible such as tofollow the shape ofthe body of the patient and also be biocompatible as it is applied incontact with the skin surface of the patient.[006] ln for example WO2014/165022, is shown a flexible optical sensor comprising aflexible support pad onto which optical light sources and light detectors are mounted. Thesupport pad being arranged to be in contact with a skin surface of a patient allowing light fromthe light source to be reflected in the superficial tissue and thereafter detected by the detector.
SUMMARY OF THE INVENTION[007] lt is an object of the present disclosure to provide an improved or at least analternative flexible optical sensor plate to what is known in prior art and a method ofproducing such a optical sensor plate. 8. 8. id="p-8" id="p-8" id="p-8" id="p-8" id="p-8" id="p-8" id="p-8" id="p-8" id="p-8" id="p-8" id="p-8" id="p-8" id="p-8" id="p-8" id="p-8" id="p-8" id="p-8"
[008] The invention is defined by the appended independent patent claims. Non-limiting embodiments emerge from the dependent patent claims, the appended drawings andthe following description. 9. 9. id="p-9" id="p-9" id="p-9" id="p-9" id="p-9" id="p-9" id="p-9" id="p-9" id="p-9" id="p-9" id="p-9" id="p-9" id="p-9" id="p-9" id="p-9" id="p-9" id="p-9"
[009] According to a first aspect there is provided an optical sensor plate for measuringblood flow of a subject. The optical sensor plate comprises a flexible support having a firstmajor surface and an opposing second major surface, at least one optical source arranged onthe first major surface ofthe flexible support, and arranged to emit light, and at least oneoptical detector arranged on the first major surface of the flexible support, and arranged todetect light from said optical source. The flexible support is configured to conform to a skinsurface of a subject such that the at least one optical source emits light into the skin andunderlying tissue and the at least one optical detector detects light from the at least oneoptical source after reflection in the skin and underlying tissue. The at least one optical sourceand the at least one optical detector are separated on the first major surface of the flexiblesupport by (a) wall(s) being optically opaque to wavelengths implemented by the at least oneoptical source and the at least one optical detector, such that the amount of light reaching the optical detector directly from the optical source is limited. A biocompatible, transparent and elastic cover is arranged on the first major surface of the flexible support, covering and 3 embedding the at least one optical detector, the at least one optical source and the opaquewall(s) arranged on the flexible support. . . id="p-10" id="p-10" id="p-10" id="p-10" id="p-10" id="p-10" id="p-10" id="p-10" id="p-10" id="p-10" id="p-10" id="p-10" id="p-10" id="p-10" id="p-10" id="p-10" id="p-10"
[0010] The optical sensor plate may for example be used in photoplethysmography or inother optical sensors used for measuring blood flow in the skin and underlying tissue of apatient.[0011] As the at least one optical source and the at least one optical detector areseparated on the first major surface ofthe flexible substrate by optically opaque walls, no orvery little light reaches the optical detector directly from the at least one optical sourcethrough cross-talk, and light detected by the detector is mainly light reflected in the skin andunderlying tissue. 12. 12. id="p-12" id="p-12" id="p-12" id="p-12" id="p-12" id="p-12" id="p-12" id="p-12" id="p-12" id="p-12" id="p-12" id="p-12" id="p-12" id="p-12" id="p-12" id="p-12" id="p-12"
[0012] The cover is arranged on the first major surface of the support, covering andembedding the at least one optical detector, the at least one optical source and the opaquewall(s) arranged on the support. When measuring a blood flow of a patient, the cover isarranged in contact with the skin of the patient. The cover, hence, protects the opticalelements on the major surface of the support during measurements. 13. 13. id="p-13" id="p-13" id="p-13" id="p-13" id="p-13" id="p-13" id="p-13" id="p-13" id="p-13" id="p-13" id="p-13" id="p-13" id="p-13" id="p-13" id="p-13" id="p-13" id="p-13"
[0013] By embedding is here meant that not only does the cover lie on top ofthe opticalelements and opaque wall(s) arranged on the support. The cover is also arranged to fill in allcavities between optical elements and opaque walls arranged on the first major surface oftheflexible support. 14. 14. id="p-14" id="p-14" id="p-14" id="p-14" id="p-14" id="p-14" id="p-14" id="p-14" id="p-14" id="p-14" id="p-14" id="p-14" id="p-14" id="p-14" id="p-14" id="p-14" id="p-14"
[0014] With such an optical sensor plate, the first major surface thereof, provided withthe cover and arranged to be in contact with the skin of a patient during measurements,exhibits a smooth, biocompatible surface, without cavities, cracks orjoints, therebypreventing bacterial accumulation at the first major surface. Further, the cover also makes theoptical sensor plate possible to clean. . . id="p-15" id="p-15" id="p-15" id="p-15" id="p-15" id="p-15" id="p-15" id="p-15" id="p-15" id="p-15" id="p-15" id="p-15" id="p-15" id="p-15" id="p-15" id="p-15" id="p-15"
[0015] As the optical components and wall(s) are embedded in the cover, there are noor at least very small air pockets created in the vicinity of the optical components. Thereby,light emitted from the optical source, reflected in the skin or underlying tissue and detectedby the optical detector travels through the transparent cover without phase transitionscreated by air pockets in the vicinity of the optical components. 16. 16. id="p-16" id="p-16" id="p-16" id="p-16" id="p-16" id="p-16" id="p-16" id="p-16" id="p-16" id="p-16" id="p-16" id="p-16" id="p-16" id="p-16" id="p-16" id="p-16" id="p-16"
[0016] The opaque wall(s) may be made of a plastic material, silicone or rubber. 17. 17. id="p-17" id="p-17" id="p-17" id="p-17" id="p-17" id="p-17" id="p-17" id="p-17" id="p-17" id="p-17" id="p-17" id="p-17" id="p-17" id="p-17" id="p-17" id="p-17" id="p-17"
[0017] The plastic material may for example be polyurethane or epoxy. 4[0018] The biocompatible, transparent and elastic cover may be made of a plastic material or silicone. 19. 19. id="p-19" id="p-19" id="p-19" id="p-19" id="p-19" id="p-19" id="p-19" id="p-19" id="p-19" id="p-19" id="p-19" id="p-19" id="p-19" id="p-19" id="p-19" id="p-19" id="p-19"
[0019] The plastic material may for example be polyurethane or epoxy.[0020] The cover may have a level of transmission of at least 85%.[0021] With a lower level of transmission, the quality of the blood flow measurements may deteriorate. Using a cover with a lower transmission level is possible, such as a transmission level of 70% or more, if the brightness of the optical source is adjusted. 22. 22. id="p-22" id="p-22" id="p-22" id="p-22" id="p-22" id="p-22" id="p-22" id="p-22" id="p-22" id="p-22" id="p-22" id="p-22" id="p-22" id="p-22" id="p-22" id="p-22" id="p-22"
[0022] A thickness of the cover covering the optically opaque wall(s) may be less than0.6 mm.[0023] The thickness of the cover covering the wall(s) may be less than about 0.6 mm but preferably not less than about 0.1 mm. The thinner the thickness of the cover covering thewall(s), the less problems with light reaching the optical detector directly from the at least oneoptical source through cross-talk over the wall(s), and light detected by the detector is mainlylight reflected in the skin and underlying tissue. 24. 24. id="p-24" id="p-24" id="p-24" id="p-24" id="p-24" id="p-24" id="p-24" id="p-24" id="p-24" id="p-24" id="p-24" id="p-24" id="p-24" id="p-24" id="p-24" id="p-24" id="p-24"
[0024] The thickness of the cover covering the optical elements may be similar to thethickness of the cover covering the wall(s) or be slightly thicker as the walls may protrude from the major surface a bit longer than the optical elements protrude from the major surface. The thickness of the cover covering the optical elements may be about 0.1 mm to about 1 mm. . . id="p-25" id="p-25" id="p-25" id="p-25" id="p-25" id="p-25" id="p-25" id="p-25" id="p-25" id="p-25" id="p-25" id="p-25" id="p-25" id="p-25" id="p-25" id="p-25" id="p-25"
[0025] A coating layer may be arranged on the cover having a thickness of 0.5 mm orless.[0026] According to a second aspect there is provided a method of producing an optical sensor plate for measuring blood flow of a subject. The method comprises to provide a flexiblesupport having a first major surface and an opposing second major surface, arrange at leastone optical source on the first major surface ofthe flexible support, the optical source beingarranged to emit light, and arrange at least one optical detector on the first major surface ofthe flexible support, wherein the at least one optical detector is arranged to detect light fromsaid optical source. The flexible support is configured to conform to a skin surface of a subjectsuch that the at least one optical source emits light into the skin and underlying tissue and theat least one optical detector detects light from the at least one optical source after reflectionin the skin and underlying tissue. The at least one optical source and the at least one opticaldetector are separated on the first major surface ofthe flexible support by walls being optically opaque to wavelengths implemented by the at least one optical source and the at 5least one optical detector such that the amount of light reaching the optical detector directlyfrom the optical source is limited, and a biocompatible, transparent and elastic cover castedon the first major surface ofthe flexible support, covering and embedding the optical detector, optical source and opaque wall(s) arranged on the flexible support. 27. 27. id="p-27" id="p-27" id="p-27" id="p-27" id="p-27" id="p-27" id="p-27" id="p-27" id="p-27" id="p-27" id="p-27" id="p-27" id="p-27" id="p-27" id="p-27" id="p-27" id="p-27"
[0027] The optically opaque wall(s) may be arranged on the first major surface bygluing. 28. 28. id="p-28" id="p-28" id="p-28" id="p-28" id="p-28" id="p-28" id="p-28" id="p-28" id="p-28" id="p-28" id="p-28" id="p-28" id="p-28" id="p-28" id="p-28" id="p-28" id="p-28"
[0028] Prior to casting, the optically opaque wall(s) may be treated with plasma and/orprimer. 29. 29. id="p-29" id="p-29" id="p-29" id="p-29" id="p-29" id="p-29" id="p-29" id="p-29" id="p-29" id="p-29" id="p-29" id="p-29" id="p-29" id="p-29" id="p-29" id="p-29" id="p-29"
[0029] The casting step may comprise to provide a casting tool comprising a first part arranged to receive the first major surface of the flexible support and a second part arrangedto form a lid over the first part, cover the insides of at least the first part of the casting toolwith a layer of liquid covering material, heating the casting tool with covering material untilthe covering material is partially cured, arranging the flexible support with the at least oneoptical source, the at least one optical detector and the optically opaque wall(s) arrangedthereon on the partially cured covering material in the first part of the casting tool, arrangingthe second part ofthe casting tool on the first part covering the flexible support, adding liquidcovering material to the casting tool, heating the casting tool until the covering material isfully cured, and removing the thus formed covered optical sensor plate from the casting tool. . . id="p-30" id="p-30" id="p-30" id="p-30" id="p-30" id="p-30" id="p-30" id="p-30" id="p-30" id="p-30" id="p-30" id="p-30" id="p-30" id="p-30" id="p-30" id="p-30" id="p-30"
[0030] The method may further comprise applying a coating layer on the cover.
BRIEF DESCRIPTION OF THE DRAWINGS 31. 31. id="p-31" id="p-31" id="p-31" id="p-31" id="p-31" id="p-31" id="p-31" id="p-31" id="p-31" id="p-31" id="p-31" id="p-31" id="p-31" id="p-31" id="p-31" id="p-31" id="p-31"
[0031] Fig. 1 is a cross sectional side view of an optical sensor plate comprising a flexiblesupport with an optical source and an optical detector arranged on a major surface thereof.The optical elements being separated by an optically opaque wall. A cover is arranged on thefirst major surface ofthe flexible support, covering and embedding the optical detector, theoptical source and the opaque wall. 32. 32. id="p-32" id="p-32" id="p-32" id="p-32" id="p-32" id="p-32" id="p-32" id="p-32" id="p-32" id="p-32" id="p-32" id="p-32" id="p-32" id="p-32" id="p-32" id="p-32" id="p-32"
[0032] Fig. 2 shows a top view of a flexible support with an optical source and an opticaldetector arranged on a major surface thereof. 33. 33. id="p-33" id="p-33" id="p-33" id="p-33" id="p-33" id="p-33" id="p-33" id="p-33" id="p-33" id="p-33" id="p-33" id="p-33" id="p-33" id="p-33" id="p-33" id="p-33" id="p-33"
[0033] Fig. 3 is a side view of the flexible support shown in Fig. 2.[0034] Fig. 4 shows a sheet of optically opaque material with cut-outs for optical elements. 6[0035] Figs 5a and 5b show a casting tool for producing a cover on a flexible supportwith optical elements as shown in Figs 2 and 3. ln Fig. 5a a first part ofthe casting tool isshown arranged to receive the first major surface of the flexible support with the opticalelements and opaque walls arranged thereon. ln Fig. 5b a second part ofthe casting tool isshown which is arranged to form a lid over the first part of the casting tool.[0036] Fig. 6 is a top view of the optical sensor plate shown in Fig. 1.[0037] Fig. 7 schematically illustrates a method of producing the optical sensor plate shown in Figs 1 and 6.
DETAILED DESCRIPTION[0038] A photoplethysmography sensor plate for use in pressure ulcer risk assessment,as well as other optical sensors plates used for measuring blood flow in superficial tissue, needto be flexible such as to follow the shape of the body of the patient allowing light from lightsources to be reflected in the superficial tissue and thereafter detected by detectors. Such asensor plate also needs to be biocompatible as it is applied in contact with the skin surface ofthe patient.[0039] ln Fig. 1 is shown a cross sectional side view of an optical sensor plate 1 for use in measuring blood flow of a subject for example in photoplethysmography. The optical sensorplate 1 comprises a flexible support 2 having a first major surface 2a and an opposing secondmajor surface 2b. The flexible support 2 may be a substantially flat shaped, flexible support. lnone alternative embodiment, at least the first major surface 2a inay have a cohcave curvatißrein an unbiased state. in some esnbodintents, the flexâbie support 2 is configureci to flex in atEeast one orthogonai direction. Aiteritativeiy, the fiexibie support :nav be configureci to flex inat Eeast tvvo orthogonal directions, such as the x and y-directions. 40. 40. id="p-40" id="p-40" id="p-40" id="p-40" id="p-40" id="p-40" id="p-40" id="p-40" id="p-40" id="p-40" id="p-40" id="p-40" id="p-40" id="p-40" id="p-40" id="p-40" id="p-40"
[0040] At least one optical source 3 is arranged on the first major surface 2a of theflexible support 2, and is arranged to emit light. The optical source may be a LED. At least oneoptical detector 4 is arranged on the first major surface 2a of the flexible support 2, and isarranged to detect light from the optical source 3. The optical detector may be aphotodetector. ln some embodiments, the optical sensor plate 1 comprises at least two optical sources 3, each optical source 3 emitting light of different wavelengths, such as red and green light. 7[0041] The optical source 3 and optical detector 4 are arranged on the first majorsurface 2a of the flexible support 2, protruding in a direction normal to the first major surface2a. The flexible support 2 may he a prlhtefl Circuit board (PCB), see Figs 1-3, having a firstrrlajor' surface Ba with cohcluctive traces thereon and the optical elements, i.e. opticalsource(s) and optical detectorlsl, arranged thereon and electrically couplecl to the eonductlvetraces of the FEB, The flexible support 2 ihay be comprised of rlgld parts onto vvhlch theoptical elements 3, 4 [and cohcluctlve tracesj are arranged tft/lth flexible parts cohnectlng therlgid parts of the PCB. The rigid parts could for example he ofglass~reinforced epoxy lamlhatematerial such as FR-Ål. The flexible parts may for example be rnacle of polyamide,[0042] The flexible support 2 is configured to conform to a skin surface of a subject,such as an area of the back of a patient, such that the optical source(s) 3 emit(s) light into theskin and underlying tissue and the at least one optical detector 4 detects light from the at leastone optical source 3 after reflection in the skin and underlying tissue.[0043] The at least one optical source 3 and optical detector 4 are separated on the firstmajor surface 2a of the flexible substrate 2 by an optically opaque wall or walls 5. The wall 5being optically opaque to wavelengths implemented by the at least one optical source 3 andthe at least one optical detector 4, such that the amount of light reaching the optical detector4 directly from the optical source 3 is limited, i.e no or little cross-talk, and light detected bythe detector 4 is mainly light reflected in the skin and underlying tissue. The material of theoptically opaque wall(s) 5 may be a plastic material, silicone, or rubber. The plastic materialmay for example be polyurethane or epoxy.[0044] The optically opaque wall(s) 5 arranged on the first major surface 2a oftheflexible support, protrudes in a direction normal to the first major surface 2a. The opticallyopaque walls 5 may have the form of a sheet or liner with cut-outs, see Fig. 4, for opticalelements and other components arranged on the first major surface of the flexible support 2.Alternatively, the walls 5 may be comprised of strips, squares or similar arranged on the firstmajor surface. The optically opaque walls (5) may be glued on the first major surface 2a oftheflexible support (2).[0045] ln Fig. 7 is schematically illustrated a method for producing the optical sensorplate 1 described above. Having provided 100 the flexible support 2, arranged thereon 101, 102 at least one optical source 3 and at least one optical detector 4, and separated 103 the at least one optical source 3 and the at least one optical detector 4 with optically opaque walls 5, 8 a biocompatible, transparent and elastic cover 6 is casted 104 on the first major surface 2a ofthe flexible support 2, covering and embedding the optical detector 4, optical source 3 andopaque wa||(s) 5 arranged on the flexible support 2. Prior to casting 104, the optically opaquewa||(s) 5 may be treated with plasma and/or primer 105. 46. 46. id="p-46" id="p-46" id="p-46" id="p-46" id="p-46" id="p-46" id="p-46" id="p-46" id="p-46" id="p-46" id="p-46" id="p-46" id="p-46" id="p-46" id="p-46" id="p-46" id="p-46"
[0046] ln Fig. 6 is shown an optical sensor plate with such a cover 6.[0047] When measuring a blood flow of a patient using the optical sensor plate 1, thecover 6 is arranged in contact with the skin ofthe patient. The other parts arranged on themajor surface are, hence, protected from direct contact with the skin surface. 48. 48. id="p-48" id="p-48" id="p-48" id="p-48" id="p-48" id="p-48" id="p-48" id="p-48" id="p-48" id="p-48" id="p-48" id="p-48" id="p-48" id="p-48" id="p-48" id="p-48" id="p-48"
[0048] A thickness of the cover 6 covering the optically opaque wa||(s) 5 may be lessthan 0.6 mm. The thinner the thickness of the cover 6 covering the wa||(s) 5, the less problemswith light reaching the optical detector 4 directly from the at least one optical source 3through cross-talk over the wa||(s) 5, and light detected by the detector 4 is mainly lightreflected in the skin and underlying tissue. The thickness of the cover 6 covering the opticalelements 3, 4 may be similar to the thickness of the cover covering the wa||(s) or be slightlythicker as the walls may protrude from the major surface a bit longer than the opticalelements 3, 4. 49. 49. id="p-49" id="p-49" id="p-49" id="p-49" id="p-49" id="p-49" id="p-49" id="p-49" id="p-49" id="p-49" id="p-49" id="p-49" id="p-49" id="p-49" id="p-49" id="p-49" id="p-49"
[0049] That the cover 6 is biocompatible is here meant that a two-way response, i.e.,the body's response to the cover and the cover's response to the body. The biocompatibilityrefers to the ability of the cover to perform its intended function, without eliciting anysignificant or long-term undesirable local or systemic effects in the patient. The biocompatiblecover should preferably be compatible in accordance with the ISO 10993 standard. 50. 50. id="p-50" id="p-50" id="p-50" id="p-50" id="p-50" id="p-50" id="p-50" id="p-50" id="p-50" id="p-50" id="p-50" id="p-50" id="p-50" id="p-50" id="p-50" id="p-50" id="p-50"
[0050] That the cover 6 is transparent is here meant that objects covered can bedistinctly seen and that the cover is being transparent to wavelengths emitted by or detectedby the optical elements, and may have a level of transmission of at least 85%. 51. 51. id="p-51" id="p-51" id="p-51" id="p-51" id="p-51" id="p-51" id="p-51" id="p-51" id="p-51" id="p-51" id="p-51" id="p-51" id="p-51" id="p-51" id="p-51" id="p-51" id="p-51"
[0051] The cover 6 may be made of a plastic material or silicone. The plastic materialmay for example be polyurethane or epoxy. The material may for example be a two-component silicone. 52. 52. id="p-52" id="p-52" id="p-52" id="p-52" id="p-52" id="p-52" id="p-52" id="p-52" id="p-52" id="p-52" id="p-52" id="p-52" id="p-52" id="p-52" id="p-52" id="p-52" id="p-52"
[0052] That the cover 6 is elastic is here meant that the cover conforms to the flexibilityof the flexible support 2 without rupturing. The elastic cover should have an elastic elongation,i.e. the maximum length the cover can be stretched without breaking as a percentage of the material's original length, such as at least 50%, or at least 75% or at least 100%. 9[0053] The cover 6 is arranged on the first major surface 2a of the support 2, coveringand embedding the at least one optical detector 3, the at least one optical source 4 and theopaque wa||(s) 5 arranged on the support 2. The cover 6, hence, protects the optical elementson the major surface of the support. The cover is arranged to cover at least a portion of thefirst major surface. The cover can also be arranged to cover the whole first major surface 2aand possibly also edges thereof. The cover 6 may also be arranged to cover the second majorsurface 2b of the flexible support 2. The optical sensor plate 1 may also comprise otherelectronic components, protected by the cover 6, such as a micro controller, lCs, AD converter,etc.[0054] By embedding is here meant that not only does the cover 6 lie on top oftheoptical elements 3, 4 and opaque wa||(s) 5 arranged on the support. The cover 6 is alsoarranged to fill in all cavities between optical elements 3, 4 and opaque walls 5 arranged onthe first major surface 2a of the flexible support 2.[0055] With such an optical sensor plate 1, the first major surface 2a thereof, providedwith the cover and arranged to be in contact with the skin of a patient during measurements,exhibits a smooth, biocompatible surface, without cavities, cracks orjoints, therebypreventing bacterial accumulation at the first major surface. Further, the cover 6 also makesthe optical sensor plate 1 possible to clean. An outer surface of the cover may have a surfacefinish of at least Ra 3.2 pm. (Ra being the arithmetic average of a set of individualmeasurements of surface peaks and valleys.)[0056] As the optical components 3, 4 and wa||(s) 5 are embedded in the cover 6, thereare no or at least very small air pockets created in the vicinity of the optical components.Thereby, light emitted from the optical source 3, reflected in the skin or underlying tissue anddetected by the optical detector 4 travels through the transparent cover 6 without phasetransitions created by air pockets in the vicinity of the optical components.[0057] ln Fig. 7 is further illustrated an embodiment ofthe casting step 104. A castingtool 10, see Figs 5a and 5b, is provided 104a and comprises a first part 10a arranged to receivethe first major surface 2a of the flexible support 2 with optical elements 4, 5 and opaquewa||(s) 5 arranged thereon, and a second casting tool part 10b is arranged to form a lid overthe first part 10a. The insides of the first part 10a of the casting tool 10 are covered 104b with a layer of liquid covering material. Optionally also the insides of the second part 10b ofthe casting tool 10 are covered 104b with a layer ofthe liquid covering material. The casting tool with covering material is heated 104c until the covering material is partially cured.Thereafter, the flexible support 2 with the at least one optical source 3, the at least one opticaldetector 4 and the optically opaque wall(s) 5 arranged thereon is arranged 104d on thepartially cured covering material in the first part 10a of the casting tool 10. The second part10b of the casting tool 10 is arranged 104e on the first part 10a covering the second majorsurface 2b ofthe flexible support 2. Thereafter liquid covering material is added 104f to thecasting tool 10, and the casting tool 10 heated 104g until the covering material is fully cured.Finally, the thus formed covered optical sensor plate 1 is removed 104h from the casting tool10. lf also the second part 10b ofthe casting tool is 10 is covered with covering material thesecond major surface 2b of the support 2 will also be covered with cover 6. The casting toolmay be made ofaluminium. 58. 58. id="p-58" id="p-58" id="p-58" id="p-58" id="p-58" id="p-58" id="p-58" id="p-58" id="p-58" id="p-58" id="p-58" id="p-58" id="p-58" id="p-58" id="p-58" id="p-58" id="p-58"
[0058] The curing may be done in an oven at temperatures up to 150°C. The curingtemperature depends on the material used for the cover 6. With partially cured is here meantthat the material is cured during only a part of its curing time, such that the material becomeshard but still sticky so it will adhere well to material that is added and such that when placingthe flexible support 2 with the elements arranged thereon on the partially cured covermaterial, the flexible support will not sink to the bottom ofthe first part 10a of the casting tool10 but stay on top of the half-cured material. 59. 59. id="p-59" id="p-59" id="p-59" id="p-59" id="p-59" id="p-59" id="p-59" id="p-59" id="p-59" id="p-59" id="p-59" id="p-59" id="p-59" id="p-59" id="p-59" id="p-59" id="p-59"
[0059] The thickness of the layer of casting material in the second part 2b of the castingtool may be in the order of 0.05-1.5 mm. Thereby, a thickness of the cover 6 on the secondmajor surface 2b of the support 2 may be 0.05-1.5 mm. 60. 60. id="p-60" id="p-60" id="p-60" id="p-60" id="p-60" id="p-60" id="p-60" id="p-60" id="p-60" id="p-60" id="p-60" id="p-60" id="p-60" id="p-60" id="p-60" id="p-60" id="p-60"
[0060] Through the casting procedure, also edges of the support 2 connecting the firstand second major surfaces 2a, 2b, may be covered with the cover 6 (see Fig. 1). 61. 61. id="p-61" id="p-61" id="p-61" id="p-61" id="p-61" id="p-61" id="p-61" id="p-61" id="p-61" id="p-61" id="p-61" id="p-61" id="p-61" id="p-61" id="p-61" id="p-61" id="p-61"
[0061] Prior to casting, the optically opaque walls may be treated with plasma and/orprimer for activation of the material and better wettability. The plasma treatment could be forexample low-pressure plasma or atmospheric pressure plasma. The primer could for examplebe applied by brush or spray. 62. 62. id="p-62" id="p-62" id="p-62" id="p-62" id="p-62" id="p-62" id="p-62" id="p-62" id="p-62" id="p-62" id="p-62" id="p-62" id="p-62" id="p-62" id="p-62" id="p-62" id="p-62"
[0062] A coating layer 7 may be applied 106 on the cover 6 (see Fig. 1) through forexample flow coating, spray coating or dip coating. The coating layer may for example be ofsilicone, polyurethane or epoxy. The coating layer 7 may increase the strength and durability of the cover layer 6 and, hence, ofthe optical sensor plate 1. The thickness ofthe coating layer may be less than 0.5 mm and preferably less than 0.1 mm, such that the coating layer 7 does 11 not affect the properties of the cover 6 and the optical sensor plate 1. The coating layer 7 maybe arranged on the cover 6 on the first major surface 2a, and/or on the second major surface2b and/or on edges of the support 2 connecting the first and second major surfaces 2a, 2b.[0063] The transmission requirements on the coating layer 7 are similar to thetransmission requirements on the cover 6. The coating layer 7 could be a layer, which issomewhat harder than the cover 6. As the coating layer 7 is arranged to be in contact with theskin of a patient during measurements, it should exhibit a smooth, biocompatible surface,without cavities, cracks orjoints, thereby preventing bacterial accumulation. lt should further be possible to clean. An outer surface of the coating layer 7 may have a surface finish of at least Ra 3.2 pm.

Claims (11)

1. An optical sensor plate (1) for measuring blood flow of a subject, comprising: a flexible support (2) having a first major surface (2a) and an opposing secondmajor surface (2b), at least one optical source (3) arranged on the first major surface (2a) of theflexible support (2), and arranged to emit light, at least one optical detector (4) arranged on the first major surface (2a) of theflexible support (2), and arranged to detect light from said optical source (3), the flexible support (2) being configured to conform to a skin surface of a subjectsuch that the at least one optical source (3) emits light into the skin and underlying tissue andthe at least one optical detector (4) detects light from the at least one optical source (3) afterreflection in the skin and underlying tissue, the at least one optical source (3) and the at least one optical detector (4) beingseparated on the first major surface (2a) of the flexible support (2) by (a) wall(s) (5) beingoptically opaque to wavelengths implemented by the at least one optical source (3) and the atleast one optical detector (4), such that the amount of light reaching the optical detector (4)directly from the optical source (3) is limited, a biocompatible, transparent and elastic cover (6) arranged on the first majorsurface (2a) of the flexible support (2), covering and embedding the at least one opticaldetector (4), the at least one optical source (3) and the opaque wall(s) (5) arranged on the flexible support (2).
2. The optical sensor plate (1) of claim 1, wherein the optically opaque wall(s) (5) is/are made of a plastic material, silicone or rubber.
3. The optical sensor plate (1) of claim 1 or 2, wherein the biocompatible, transparent and elastic cover (6) is made of a plastic material or silicone.
4. The optical sensor plate (1) of any of claims 1-3, wherein the cover (6) has a level of transmission of at least 85%.
5. 135. The optical sensor plate (1) of any of claims 1-4, wherein a thickness of the cover (6) covering the optically opaque wa||(s) (5) is less than 0.6 mm.
6. The optical sensor plate (1) of any of claims 1-5, wherein a coating layer (7) is arranged on the cover (6) having a thickness of 0.5 mm or less.
7. A method of producing an optical sensor plate (1) for measuring blood flow of asubject, comprising: providing (100) a flexible support (2) having a first major surface (2a) and anopposing second major surface (2b), arranging (101) at least one optical source (3) on the first major surface (2a) ofthe flexible support (2), the optical source (3) being arranged to emit light, arranging (102) at least one optical detector (4) on the first major surface (2a) ofthe flexible support (2), wherein the at least one optical detector (4) is arranged to detect lightfrom said optical source (3), the flexible support (2) being configured to conform to a skin surface of a subjectsuch that the at least one optical source (3) emits light into the skin and underlying tissue andthe at least one optical detector (4) detects light from the at least one optical source (3) afterreflection in the skin and underlying tissue, separating (103) the at least one optical source (3) and the at least one opticaldetector (4) on the first major surface (2a) of the flexible support (2) by (a) wa||(s) (5) beingoptically opaque to wavelengths implemented by the at least one optical source (3) and the atleast one optical detector (4) such that the amount of light reaching the optical detector (4)directly from the optical source (3) is limited, casting (104) a biocompatible, transparent and elastic cover (6) on the first majorsurface (2a) of the flexible support (2), covering and embedding the optical detector (4), optical source (3) and opaque wa||(s) (5) arranged on the flexible support (2).
8. The method of claim 7, wherein the optically opaque wa||(s) (5) are arranged on the first major surface (2a) by gluing.
9. 149. The method of any of claims 7 and 8, wherein prior to Casting, the optically opaque wall(s) (5) is/are treated with plasma and/or primer (105).
10. The method of any of claims 7-9, wherein the casting step (104) comprises: - providing (104a) a casting tool (10) comprising a first part (10a) arranged to receive the firstmajor surface (2a) of the flexible support (2) and a second part (10b) arranged to form a |idover the first part (10a), - covering (104b) the insides of at least the first part (10a) of the casting tool (10) with a layerof liquid covering material, - heating (104c) the casting tool (10) with covering material until the covering material ispartially cured, - arranging (104d) the flexible support (2) with the at least one optical source (3), the at leastone optical detector (4) and the optically opaque wall(s) (5) arranged thereon on the partiallycured covering material in the first part (10a) of the casting tool (10), - arranging (104e) the second part (10b) of the casting tool (10) on the first part (10a) coveringthe flexible support (2), - adding (104f) liquid covering material to the casting tool (10), - heating (104g) the casting tool (10) until the covering material is fully cured, - removing (104h) the thus formed covered optical sensor plate (1) from the casting tool (10).
11. The method of any of claims 7-10, further comprising applying (106) a coating layer (7) on the cover (6).
SE2051096A 2020-09-21 2020-09-21 An optical sensor plate for measuring blood flow via the skin of a patient SE545864C2 (en)

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