Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
  • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
  • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
  • A61B5/683—Means for maintaining contact with the body
  • A61B5/6832—Means for maintaining contact with the body using adhesives
  • A61B5/6833—Adhesive patches
• • 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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
  • A61B5/14546—Measuring 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 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• • 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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
  • A61B5/1455—Measuring 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
  • A61B5/14551—Measuring 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 for measuring blood gases
  • A61B5/14552—Details of sensors specially adapted therefor
• • 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 or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
  • A61B5/1455—Measuring 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
  • A61B5/14551—Measuring 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 for measuring blood gases
  • A61B5/14556—Measuring 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 for measuring blood gases by fluorescence
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/48—Other medical applications
  • A61B5/4869—Determining body composition
  • A61B5/4875—Hydration status, fluid retention of the body
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
  • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
  • A61B5/683—Means for maintaining contact with the body
  • A61B5/6838—Clamps or clips
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
  • A61B2560/02—Operational features
  • A61B2560/0266—Operational features for monitoring or limiting apparatus function
  • A61B2560/028—Arrangements to prevent overuse, e.g. by counting the number of uses
  • A61B2560/0285—Apparatus for single use
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
  • A61B2560/04—Constructional details of apparatus
  • A61B2560/0443—Modular apparatus
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
  • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
  • A61B5/6813—Specially adapted to be attached to a specific body part
  • A61B5/6814—Head
  • A61B5/6815—Ear
  • A61B5/6816—Ear lobe

Definitions

• a device for application of a sensor to a measurement site a sensor head, a kit of an application device and sensor and use of an application device for optical measurements of physiological parameters
• the invention is directed to a device for application of a sensor to a measurement site, a sensor head, a kit of application device and sensor and use of an application device for optical measurements of physiological parameters on or through the skin according to the independent claims.
• reusable sensor heads for transcutaneous CO 2 /O 2 meas ⁇ urements are affixed to the measuring site by adhesive adaptors after applying a contact fluid on either sensor head or patient's skin.
• Those adaptors have the only purpose to fix the sensor to the measuring site directly on the patient's skin.
• Af ⁇ ter use of such adaptors a sensor head has to be elaborately cleaned, which leads to high service needs of the sensor, re ⁇ quires training and consequently leads to high costs.
• Such adap ⁇ tors are for example known for electrochemical sensors in medi ⁇ cal applications from WO 2008/132205.
• the object is accomplished by a device for application of a sen ⁇ sor to a measurement site according to the independent claims.
• the device has at least one application area enabling the appli ⁇ cation of the device to a patient skin.
• the device comprises an interface for connecting the device to a sensor head, wherein the device comprises at least a wall arrangement providing an applicator volume above the patient's skin.
• the wall arrangement comprises a patient's side and a sensor side.
• At least one gas permeable membrane separates the applicator volume into a first volume being directed to the measuring site at the patient's side of the wall arrangement and a second vol ⁇ ume being separated from the patient's skin and directed to the sensor side of the wall arrangement.
• a device for application of a sensor to a measurement site com ⁇ prising at least one gas permeable membrane enables measurements of gases diffusing from the measurement site and still separates the sensor head from a direct contact to the measurement site. This leads to a lower contamination of the sensor head used.
• the volume of the first and the second volume each does not ex ⁇ ceed 10 mm 3 and is preferably smaller than 4 mm 3 for sensor appli ⁇ cation areas of approx. 80 mm 2 .
• the application area comprises an adhesive, which is compatible with the human skin.
• the wall arrangement preferably comprises walls that are sub ⁇ stantially perpendicular to the measurement site. This way, a volume above the measurement site is created.
• the wall arrange ⁇ ment can be polyangular, circular or elliptical.
• the largest ex ⁇ tension of the wall arrangement does not exceed 5 cm preferably does not exceed 1.5 cm.
• a sensor head being inserted into the device is still rotatable while being inserted or thereafter.
• the wall arrangement comprises a patient's side, which is the area of the wall arrangement directly adjacent to the measurement site and a sensor side being the portion of the wall arrangement directed to the sensor.
• the gas-permeable mem ⁇ brane is arranged substantially in parallel to the measurement site.
• the gas permeable membrane can fur ⁇ ther have other functions or can be combined with additional functional layers. Other functions can for example be electrical insulation and/or partial optical transparency.
• At least the wall arrangement and the membrane can ⁇ not be disassembled without being destroyed.
• the interface enables the connection of a sensor head to the de ⁇ vice.
• the interface can comprise a sealing function to prevent significant gas leakage and/or to prevent disturbances of opti ⁇ cal measurements by ambient light.
• the device does not comprise any electrical or electronical com ⁇ ponents; as understood herein identification means such as RFID- chips, RFID-antennas , or identification resistors and printable electronical or optical components such as, but not limited to, OFETs, OLEDs (organic light emitting diodes) , or OPDs (organic photo diodes) are not electronic or electrical components.
• identification means such as RFID- chips, RFID-antennas , or identification resistors and printable electronical or optical components such as, but not limited to, OFETs, OLEDs (organic light emitting diodes) , or OPDs (organic photo diodes) are not electronic or electrical components.
• the membrane can consist of a polymer, like fluoropolymers , such as PTFE, or Polyester, Polyethylenterephtalat (PET) , Polymeth- ylpentene or Parylene or Polyethersulfone (PES) , acrylic copoly ⁇ mers, cellophane, rubber or silicon elastomer (silastic) films, or of ceramic or semiconductor or metallic films or thin sheets such as alumina, silica, silicon, silicon nitride, titanium nitride, steels, titanium, aluminium, etc.
• the membrane can be po ⁇ rous or free of pores or contain deliberately introduced pore ⁇ like structures, e.g. structured or etched silicon, in particu- lar the membrane can comprise a combination of different poros ⁇ ities such as fine pored and coarse-pored or porous and free of pores .
• the gas-permeable membrane can further be fluid-impermeable.
• the device can also comprise a second fluid-impermeable membrane, additionally to the first, gas-permeable membrane.
• a further fluid-impermeable functionality of the membrane or a second fluid impermeable membrane prevents fluids from getting into the second volume. Hence, no fluid originating from the measurement site can get into direct contact with sensor head, which is important in particular for optical measurements.
• a water trap e.g. a hydrophilic material within the first volume, to intentionally collect the diffusing water from the measurement site.
• the gas-permeable membrane can further be electrically insulat ⁇ ing. This leads to a suppression of electrostatic discharge events .
• the application area and/or the wall arrangement on the pa ⁇ tient's site can be provided with a contact medium (e.g. fluid, gel or paste) as common in sensor application on skin.
• a contact medium e.g. fluid, gel or paste
• the contact medium seals the first volume from ambient air and/or from ambient radiation.
• the contact medium and/or the application layer can be covered by a detachable cover layer before use.
• the contact medium and the adhesive layer on the application area can further be the same layer comprising a medium fulfilling both functions.
• a detachable cover layer on the one hand keeps the application layer clean and functional and on the other hand protects the membrane inside the device from external influences during transport or storage.
• Such external influences could be mechanical impacts, fluids, gases, or radiation such as ambient light that influence the membrane or other additional layers being arranged within the device, such that the membrane or the additional layers are de ⁇ stroyed or become non-functional.
• the second volume or the gas-permeable membrane can comprise one or several gas sensitive dyes, wherein preferably the sensitive dyes are arranged in a layer, which preferably is protected by a protection layer against environmental gases before use.
• the sensitive dyes are sensitive to CO 2 (e.g. Calmagite, Naphtol Blue Black, Naphtolphtalein or HPTS ( 1-hydroxypyren- 3, 6, 8-trisulfonate) ) , 0 2 (e.g. Ruthenium or Pt and Pd octaethyl- porphyrins based fluorescent dyes), and/or water vapour (e.g. cobalt (II) chloride, copper (II) chloride, calmagite, etc.).
• the sensitive dyes can further comprise a pH-indicating dye or a fluorescent dye.
• a sensitive layer comprising a sensitive dye can be disposed to ⁇ gether with the device.
• sensitive dyes only remain stable during a limited time frame. This time frame is signifi ⁇ cantly shorter than the product life time of a sensor head, es ⁇ pecially in case of an optical sensor head.
• the sensitive dye may also be sensitive to atmospheric gases and ambient light
• the sensitive layer is preferably protected by a protec ⁇ tion layer before use.
• the sensi ⁇ tive elements of the device may also be protected by gas and light tight packaging of the whole device.
• the interface can comprise a sealing element for sealing the se ⁇ cond volume from ambient gases and/or ambient radiation in use.
• a further sealing element suppresses the intrusion of ambient air into the second volume. This leads to more accurate measuring results .
• the sealing element can be an elastomer part or some other gas- tight material.
• the gas-permeable membrane can be an at least partly reflecting layer, having reflecting properties at least in a wavelength range from 400 nm to 1 ⁇ , a white layer, or a metallic layer.
• an additional at least partly reflecting layer, having reflecting properties at least in a wavelength range from 400 nm to 1 ⁇ , a white layer, or a metallic layer can be pro ⁇ vided .
• the light emitted from the sensor head can be reflected back to a detector within the sensor head and increase the propagation length within the light-affecting element, which can be a gaseous medium or for example some sensitive dye.
• the light-affecting element can be a gaseous medium or for example some sensitive dye.
• ambi- ent light can be reflected away from the optically sensitive components of device and/or sensor head, which reduces the amount of created but unwanted parasitic signal.
• the device may be stuck onto the measurement site by means of an adhesive layer. Additionally or alternatively, the device can be clamped onto the measurement site.
• the clamping solution is especially advantageous for measuring sites on ears, earlobes, fingers, toes or nose.
• the device can comprise means for identification and/or calibra ⁇ tion data.
• a sensor head can identify what kind of device is being connected to the sensor head. Hence, the handling is simplified and safety is increased.
• the kind of measurement, the sensitive element used, the wavelength required for measurement, and/or the kind of membranes comprised in the device can be coded within the device.
• calibration data can be encoded within the device.
• identification and/or calibration data are encoded in a RFID-chip or a resistor arrangement or mechanical identification means .
• the aforementioned device is for measurement of the concentrations of transcutaneous CO 2 and/or transcutaneous O 2 and/or water vapour and/or of spectral properties of haemoglobin and/or myoglobin and/or bilirubin and/or water and/or acetone, ethanol or other alcohols, and/or of pulse oximetric 0 2 . All aforementioned physiological parameters can be determined optically and need a defined measuring site. Some further need a defined measuring volume.
• a sensor head comprising detection optics for detection of human status variables, preferably for detection of transcutaneous CO 2 tension and/or transcutaneous O 2 tension and/or water vapour and/or spectral properties of haemoglobin and/or myoglobin and/or bilirubin and/or water and/or acetone, ethanol or other alcohols, and/or for pulse oximetric measurements of 0 2 .
• detection optics for detection of human status variables, preferably for detection of transcutaneous CO 2 tension and/or transcutaneous O 2 tension and/or water vapour and/or spectral properties of haemoglobin and/or myoglobin and/or bilirubin and/or water and/or acetone, ethanol or other alcohols, and/or for pulse oximetric measurements of 0 2 .
• a layer according to the invention comprises complete layers and partial layers.
• the layer or layers not being provided can be easily disposed instead of being cleaned and by this facilitates the use of the sensor head.
• the layer not being provided can be a colorimetric or fluorescent indication layer.
• the indication layer can be a colorimetric, such as CO 2 - or pH- sensitive, layer or a fluorescent layer or a combination there ⁇ of. Based on a chemical reaction the change of colorimetric or fluorescent indication layer can be detected by the optics and/or electro-optics of the sensor head and the amount of the gaseous medium to be determined can be calculated based on the measuring results.
• a colorimetric such as CO 2 - or pH- sensitive, layer or a fluorescent layer or a combination there ⁇ of.
• the sensor head can comprise all necessary optical and electro- optical parts. Alternatively, some of the necessary parts such as the electro-optical parts can be arranged externally. In this case for example the light for the measurement can be conducted to the sensor head by optical fibres.
• the layer not being provided, in particular in case of an opti ⁇ cal measurement sensor head can be a gas-permeable protection layer, which in addition may also be fluid impermeable.
• the layer not being provided in particular in case of optical colorimetric, fluorescence and/or absorption measurements, can be a light reflecting layer, having reflecting properties within a wavelength range from 400 nm to 1 ⁇ .
• the layers not being provided can be any combination of a gas-permeable and possibly fluid impermeable protection layer, a fluid impermeable protection layer, an at least partially light reflecting layer, and a colorimetric or fluorescent indication layer.
• a light reflecting layer increases the absorption path length in case of absorption measurements.
• the re ⁇ flecting layer does not necessarily have reflecting properties over the complete layer surface. Even a combination of reflect ⁇ ing and non-reflecting areas of the reflecting layer can be useful, for example in case of combined measurements.
• kits of a sensor head and a de ⁇ vice for application of a sensor to a measurement site according to the above mentioned features, where only the combination of the sensor head and the device for application results in a ful ⁇ ly functional measurement sensor.
• Figure 1 schematic view of a device for application of sensor to a measurement site
• Figure 2 schematic view of a device for application of sensor to a measurement site comprising a membrane with sensitive dye
• Figure 3 schematic view of a device for application of sensor to a measurement site by a clamping ar ⁇ rangement ;
• Figure 4 a schematic view of a device for application of a sensor to a measurement site by an adhesive ar- rangement .
• Figure 1 shows a device 1 for application of a sensor to a meas ⁇ uring site.
• the device 1 comprises an application area 2 being covered with an adhesive layer.
• the adhesive layer fixes the de ⁇ vice 1 to the skin 3.
• the device 1 further comprises a wall ar ⁇ rangement 5 which is oriented substantially perpendicular to the application area 2.
• the wall arrangement 5 can further exhibit different geometrical shapes such as conical elements or
• the wall arrangement 5 provides an applicator volume 7 above the skin 3.
• the wall arrangement can limit the applicator volume in a circular, elliptical or polyangular shape.
• the wall arrangement 5 is made from plastic material such as ABS or POM or other bio-compatible plastic materials in injection moulding.
• the wall arrangement could further be stamped or blanked.
• Fur ⁇ thermore the wall arrangement 5 comprises an interface 4 which enables the connection with the sensor head.
• the interface 4 is adapted to fit into a groove being arranged on a sensor head.
• the interface 4 leads to a Poka Yoke connection of the sensor head and the device 1. Hence, the sensor head either fits into the device 1 in a correct manner so that measurements are possible or it does not fit at all.
• the sensor head preferably is rotatable in the device 1 during and/or after fitting them together.
• a gas permeable membrane 6 separates the applicator volume within the wall arrange ⁇ ment 5 into the first volume 7 being directed to the measuring site at a patients' site of the wall arrangement and a second volume 8 being separate from the patients' skin and directed to the sensor site of the wall arrangement 5.
• the mem ⁇ brane 6 further comprises water-impermeable properties. Of course even further layers are possible.
• the membrane 6 consists of a fluoropolymer such as PTFE.
• the membrane 6 is covered with a contact medium 11.
• Figure 2 shows a device 1 as described in figure 1 comprising an application area 2 being stuck onto the skin 3.
• the device 1 comprises a wall arrangement 5 and a gas permeable membrane 6.
• the wall arrangement further comprises an interface 4 adapted to connect the device 1 to the sensor head.
• the device 1 comprises a sensitive layer 9 being able to react to a gaseous medium diffusing from the skin 3.
• the sensitive layer 9 comprises a pH-indicator which indi ⁇ cates a change in the pH value based on changing partial pres ⁇ sures of CO 2 by a colour change.
• a sensitive layer can be a layer as disclosed in EP 1 889 050.
• Figure 3 shows a device 1 in a clamping arrangement.
• a clamping arrangement is preferably clipped to an ear, ear lobe or ala of the nose.
• a clamping area 10 resiliently presses against the ap ⁇ plication area 2, wherein the earlobe is positioned in between the clamping area 10 and the application area 2.
• the application area 2 may be covered with an adhesive layer as well as the clamping area 10.
• the device 1 further comprises a wall arrangement 5, which is arranged substantially perpendicu ⁇ lar to the application area 2 in use.
• a membrane 6 is arranged substantially perpendicular to the wall arrangement 5 and in parallel to the application area 2 in use.
• the wall arrangement 5 comprises an interface 4 which enables an optical sensor head to be attached to the device 1.
• a contact medium lay ⁇ er 11 can be added to the application area.
• the de ⁇ vice 1 is made from POM (polyoxymethylene) or ABS (acrylonitrile butadiene styrene) in injection moulding.
• FIG 4 shows a device 1 in an adhesive arrangement.
• An adhe ⁇ sive arrangement can basically be stuck to a measuring site any ⁇ where.
• the adhesive arrangement comprises an application area 2 providing an adhesive layer.
• the device 1 further comprises a wall arrangement 5 which is arranged substantially perpendicular to the application area 2.
• a membrane 6 is provided substan ⁇ tially in parallel to the application area 2 in use.
• the wall arrangement 5 further comprises an interface 4 which enables an optical sensor head to be attached to the device 1.
• the device is made from plastic material and cannot be dismounted without destroying the device 1.
• the membrane 6 further comprises a sen ⁇ sitive layer 9 which does not cover the complete membrane 6.
• the sensitive layer 9 further comprises a reflective layer.
• This em ⁇ bodiment is preferably used for combined measurements of colori- metric and pulse oximetric measurements or measurements of spec ⁇ tral properties of haemoglobin and/or myoglobin and/or bilirubin and/or water and/or acetone, ethanol or other alcohols.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Physics & Mathematics (AREA)
• Surgery (AREA)
• General Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Biophysics (AREA)
• Animal Behavior & Ethology (AREA)
• Pathology (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Optics & Photonics (AREA)
• Spectroscopy & Molecular Physics (AREA)
• Cardiology (AREA)
• Physiology (AREA)
• Pulmonology (AREA)
• Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
• Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
• Measuring And Recording Apparatus For Diagnosis (AREA)

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• 2012
  • 2012-09-25 IN IN3255DEN2014 patent/IN2014DN03255A/en unknown
  • 2012-09-25 EP EP12762011.0A patent/EP2773266B1/en active Active
  • 2012-09-25 CN CN201280053285.4A patent/CN104023636B/zh active Active
  • 2012-09-25 US US14/351,276 patent/US10105065B2/en active Active
  • 2012-09-25 WO PCT/EP2012/068851 patent/WO2013064313A1/en active Application Filing
  • 2012-09-25 JP JP2014537540A patent/JP2014534019A/ja active Pending
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