WO2009141755A1 - Dispositif destiné à adapter la pression exercée par une sonde à un site de mesure et / ou de traitement - Google Patents

Dispositif destiné à adapter la pression exercée par une sonde à un site de mesure et / ou de traitement Download PDF

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Publication number
WO2009141755A1
WO2009141755A1 PCT/IB2009/051942 IB2009051942W WO2009141755A1 WO 2009141755 A1 WO2009141755 A1 WO 2009141755A1 IB 2009051942 W IB2009051942 W IB 2009051942W WO 2009141755 A1 WO2009141755 A1 WO 2009141755A1
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WO
WIPO (PCT)
Prior art keywords
pressure
probe
skin
measurement
force
Prior art date
Application number
PCT/IB2009/051942
Other languages
English (en)
Inventor
Yan Liu
Bastiaan W. M. Moeskops
Kiran K. Thumma
Golo Von Basum
Original Assignee
Koninklijke Philips Electronics N.V.
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 Koninklijke Philips Electronics N.V. filed Critical Koninklijke Philips Electronics N.V.
Publication of WO2009141755A1 publication Critical patent/WO2009141755A1/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
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • 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
    • A61B5/6834—Means for maintaining contact with the body using vacuum
    • 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
    • A61B5/6843—Monitoring or controlling sensor contact pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • 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
    • A61B5/14532—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 for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42—Details of probe positioning or probe attachment to the patient
    • A61B8/4272—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue
    • A61B8/4281—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue characterised by sound-transmitting media or devices for coupling the transducer to the tissue

Definitions

  • the present invention relates to measurement and/or treatment probes. More particularly the present invention relates to a device for adapting pressure exerted by a probe at a measurement and/or treatment site on a human or animal body, to a method for making such a device and to a method for adapting pressure exerted by a probe at a measurement and/or treatment site on a human or animal body using such a device.
  • Non-invasive measurement is the most desirable method for consumers. But the uncertainty and inaccuracy hampered the acceptance of non- invasive tests. There is a strong need in the non-invasive glucose-monitoring market to solve the inaccuracy or unreliability problems. It has been found that various interfering elements, such as e.g. humidity, temperature, perfusion rate etc., affect the results of such non- invasive measurements. Additionally, the skin- interface plays a big role during performance of the non- invasive measurements. Therefore, in known techniques the shape of probe may be adapted so as to ensure contact of the probe with the skin. For example, US 5,906,580 relates to a probe having a shape suitable for fitting different application sites.
  • a probe of an ultrasound system may depend on its intended application.
  • the probe when the probe is intended for use in non- invasive scanning of a surface of a body, the probe may have a flexible face that conforms to specific parts of the body as it is moved across such specific parts.
  • the sweat glands 2 and hair follicles 3 are defined as unwanted spots when measuring analyte(s) in capillaries, blood and/or interstitial fluid as they negatively affect the results during non-invasive measurements.
  • the probe 4 When applying a probe 4 onto the skin 1 (see Fig. 2), the probe 4 will exert a pressure onto the measuring site, which results in a contact of the skin 1 with at least an edge 5 of the probe 4. However, the probe 4 may lose contact in the middle of a measuring area because of skin mechanical behaviors. This is illustrated in Fig. 2.
  • the device and method may be used, for example, with noninvasive or minimally invasive biosensing, e.g. also with a microsensor located subcutaneously.
  • the present invention provides a device for adapting pressure exerted by a probe at a measurement and/or treatment site on a human or animal body.
  • the device comprises: a probe comprising at least one pressure sensor for measuring pressure at an interface between the probe and skin of the human or animal body and a pressure and/or suction system comprising at least one force element, and a controller for controlling the at least one force element of the pressure and/or suction system so as to activate it and allow it to adapt the pressure at the measurement and/or treatment site to a desired value when the measured pressure is different from the desired pressure value by at least a pre-determined offset value.
  • the measured pressure being different from the desired pressure value is meant that the measured pressure deviates from the desired pressure value with at least a pre-determined offset value, for example, more than 0.01 g/cm 2 , more than 0.1 g/cm 2 , more than 1 g/cm 2 , more than 3 g/cm 2 or more than 5 g/cm 2 .
  • a pre-determined offset value for example, more than 0.01 g/cm 2 , more than 0.1 g/cm 2 , more than 1 g/cm 2 , more than 3 g/cm 2 or more than 5 g/cm 2 .
  • that contains a microsensor may be adapted to the shape of the probe such that always an optimal contact may be achieved between the probe and the measurement and/or treatment site or an optimal contact may be achieved with a region of the skin above a volume containing a microsensor. This increases accuracy of the measurement and/or treatment performed.
  • the probe may have a contact surface for contacting the skin when the probe is provided onto the skin.
  • the contact surface may be substantially flat and rigid. According to other embodiments, the contact surface may be flexible.
  • the probe may furthermore comprise a force application system for driving the at least one force element of the pressure and/or suction system.
  • a force application system for driving the at least one force element of the pressure and/or suction system. Applying a positive force to the force elements results in a pressure force being exerted to the skin. Applying a negative force to the force elements results in a suction pressure being exerted to the skin.
  • the suction pressure can be used to move a subcutaneous microsensor to a good location.
  • the probe may furthermore comprise at least one measurement and/or treatment element for performing measurement of the physiological parameter and/or performing treatment of the human or animal body.
  • the measurement and/or treatment element may, for example, be an optical fibre.
  • the device according to embodiments of the invention may be incorporated in a skin sensing device or as a minimally invasive microsensor sensing device and/or treatment device.
  • the present invention also provides the use of a device according to embodiments of the present invention in a skin sensing or in a minimally invasive microsensor sensing device and/or treatment device.
  • the present invention provides a skin sensing or a minimally invasive microsensor sensing device and/or treatment device comprising: an imaging modality for detecting interfering features and/or target sites on skin of a human or animal body or a subcutaneous microsensor, and a device according to embodiments of the present invention for applying an amount of suction pressure and/or pressure force upon detection of such interfering features and/or target sites on skin of a human or animal body or a subcutaneous microsensor and optionally for measuring a physiological parameter in and/or performing treatment on a human or animal body.
  • the skin sensing device or minimally invasive microsensor sensing device and/or treatment device may furthermore comprise a size-changeable aperture plate for determining the size of a measurement and/or treatment site on the skin.
  • the present invention provides a method for forming a device for adapting pressure exerted by a probe at a measurement and/or treatment site on or in a human or animal body.
  • the method comprises: providing a probe comprising at least one pressure sensor for measuring pressure at an interface between the probe and skin of the human or animal body and a pressure and/or suction system comprising at least one force element, and providing a controller for controlling the at least one force element of the pressure and/or suction system so as to activate it and allow it to, when the measured pressure is different from a desired pressure value by at least a pre-determined offset value, adapt the pressure at the measurement and/or treatment site to the desired value.
  • the method may furthermore comprise providing a force application system for driving the at least force element of the pressure and/or suction system.
  • the method may furthermore comprise providing at least one measurement and/or treatment element to the probe for performing measurement of the physiological parameter and/or performing treatment of the human body.
  • the present invention provides a method for adapting pressure exerted by a probe at a measurement and/or treatment site on a human or animal body.
  • the method comprises: a) measuring pressure exerted at an interface between the probe and skin at different positions of a measurement and/or treatment site, b) determining a deviation of the measured pressure of the different positions of the measurement and/or treatment site from a desired pressure value, and c) if the deviation is higher than a pre-determined offset value, adjusting the pressure at the different positions of the measurement and/or treatment site to the desired value by means of force elements. Determining a desired pressure value may be performed by measuring pressure as a function of time and mutually comparing the measured pressures.
  • steps a) to c) may be repeated at least once.
  • the method may furthermore comprise, before applying pressure force and/or suction pressure, determining the presence of interfering features at the measurement and/or treatment site. From the presence of interfering features and/or target sites on skin of a human or animal body or a subcutaneous microsensor the method may comprise determining the size of a measurement and/or treatment site.
  • the present invention provides a controller for controlled driving of a pressure and/or suction system of a device for adapting pressure exerted by a probe at a measurement and/or treatment site on a human or animal body, the controller comprising a control unit for controlling at least one force element of the pressure and/or suction system.
  • the present invention also provides a computer program product for performing, when executed on a computing means, a method according to embodiments of the invention.
  • the present invention also provides a machine readable data storage device storing the computer program product according to embodiments of the invention.
  • the present invention also provides transmission of the computer program product according to embodiments of the invention over a local or wide area telecommunications network.
  • An advantage of a device is that by providing a pressure and/or suction system, the shape of the measurement and/or treatment site or the volume of the measurement and/or treatment site may be adapted e.g. optimized to the shape of the probe such that always an optimal contact may be achieved between the probe and the measurement and/or treatment site or an optimal contact may be obtained with a region of the skin above a volume containing a microsensor. This increases accuracy of the measurement and/or treatment performed afterwards.
  • the probe and methods according to embodiments of the invention may be used with any technique for sensing analytes within the skin or within a body fluid of a human being or an animal.
  • the probe and methods according to embodiments of the invention may be used for, for example, non- invasive or minimally invasive glucose detection by means of e.g. optical spectroscopy.
  • Further applications may include measurements of skin properties such as e.g. skin cancer, skin aging by any means of radiation, e.g. light.
  • Fig. 1 and Fig. 2 show a schematic view of respectively the skin of a human being and pressure exerted on that skin when scanning it with a probe according to the prior art.
  • Fig. 3 schematically illustrates a device according to embodiments of the present invention.
  • Fig. 4 shows a cross-section (left hand side) and a top view (right hand side) of a probe that can be used with a device according to embodiments of the invention.
  • Fig. 5 shows an example of an algorithm to be used with a method according to embodiments of the present invention.
  • Fig. 6 to Fig. 8 illustrate probes that can be used with a device according to different embodiments of the present invention.
  • Fig. 9 shows a top view of a probe as shown in Fig. 8.
  • Fig. 10 illustrates a skin sensing and/or treatment device according to embodiments of the present invention.
  • Fig. 11 shows an example of an algorithm to be used with a method according to embodiments of the present invention.
  • Fig. 12 schematically illustrates a system controller for use with a device according to embodiments of the present invention.
  • Fig. 13 is a schematic representation of a processing system as can be used for performing a method according to embodiments of the present invention.
  • an element described herein of an apparatus embodiment is an example of a means for carrying out the function performed by the element for the purpose of carrying out the invention.
  • minimally invasive as used for example in the phrase minimally invasive measurement of physiological parameters in a human or animal body, includes those methods where there is a minor level of invasion.
  • An example is where the measurement itself is non- invasive but the determination of the analyte is done with the help of an implanted microsensor, e.g. a subcutaneous microsensor.
  • the sensor is implanted beneath the skin which is in contact with subcutaneous fluids.
  • the sensor may include gels, particles, liquids which are biodegradable.
  • the biosensor that has to be implanted is small in size, and does not require a complicated or painful insertion below the skin.
  • the micro sensor comprises an assay such as for example for the determination of glucose, e.g. based on optical methods.
  • the measurement of glucose through spectroscopy can be made by a change in the absorption of light according to the absorption and scattering properties of minimally invasive microsensors, or to the change in light emitted or reflected from such microsensors located below the skin.
  • Such methods using microsensors may include, for example, observing fluorescence (e.g.
  • the microcapsules can be polyelectrolyte microcapsules, - detecting glucose using boronic acid-substituted violegens in fluorescent hydrogels in which a fluorescent anionic dye and a viologen are appended to boronic acid, which serve as glucose receptors, and are immobilized into a hydrogel, the fluorescence of the dye being modulated by the quenching efficiency of the viologen based receptor which is dependent upon the glucose concentration, - other methods, e.g. to monitor oxygen or pH or other "smart tattoo" methods.
  • the present invention provides a device for adapting pressure exerted by a probe at a measurement and/or treatment site on a human or animal body, a method for forming such a device and a method for adapting pressure exerted by a probe at a measurement and/or treatment site on a human or animal body by using such a device.
  • the physiological parameter may, for example, be any physiological parameter with respect to analytes present in a body fluid such as blood or an interstitial fluid (also referred to as tissue fluid or intercellular fluid), of which analytes it is desired to detect their presence and/or to determine their concentration or may relate to a subcutaneous microsensor, e.g. one comprising beads, particles, gels, liquids that are preferably biodegradable.
  • An example hereof is the concentration of glucose in the blood of a human being.
  • the analyte can be any organic molecule which is present in a human or animal body such as, for example, cholesterol, haemoglobin, acetone, water, lactic acid or melanin, or can be any inorganic molecule in a human or animal body such as, for example, iron or calcium, or can be another feature such as, for example the presence and/or concentration of gases or pH.
  • Embodiments of the present invention can be generally applied to any sensing method or treatment method, or a combination of both, which benefit from a good contact between a contact surface of the probe and skin of the human or animal body.
  • sensing methods may, for example, be ultrasound, temperature sensing, pressure sensing, measurements using parts of the electromagnetic spectrum (such as optical, microwave or radiowave methods), skin impedance and capacitance measurements, and measurements of flux of compounds (such as TransEpidermal Water Loss) as well as minimally invasive sensing.
  • the physiological parameter may also be a parameter suitable for determining skin properties such as e.g. skin cancer or skin aging.
  • the parameter may, for example, be reflectivity, evenness, temperature, temperature difference, color, color differences, stains.
  • parameters for determining skin properties such as skin cancer and skin aging could be optical properties of the skin. These may, among others, comprise performing measurements of absorption, scattering, reflection or birefringence at one or more wavelengths.
  • the device and methods according to embodiments of the invention show a good efficiency and accuracy.
  • the device and methods according to embodiments of the invention may be may be used with any technique for sensing analytes within the skin or within a body fluid of a human being or an animal, e.g. minimally invasive sensing using subcutaneous microsensors.
  • the device and methods according to embodiments of the invention may be used for, for example, non-invasive or minimally invasive glucose detection by means of optical spectroscopy. Further applications may include measurements of skin properties such as e.g. skin cancer, skin aging by any means of radiation, e.g. light.
  • the present invention provides a device for adapting pressure exerted by a probe at a measurement and/or treatment site on a human or animal body.
  • the device comprises: a probe comprising at least one pressure sensor for measuring pressure at an interface between the probe and skin of the human or animal body and a pressure and/or suction system comprising at least one force element, and a controller for controlling the at least one force element of the pressure and/or suction system so as to activate it and allow it to adjust the pressure at the measurement and/or treatment site to the desired value when the measured pressure is different from a desired pressure value by at least a predetermined offset value.
  • the measured pressure being different from the desired pressure value by at least a predetermined offset value is meant that the measured pressure deviates from the desired pressure value by more than 0.01 g/cm 2 , e.g. more than 0.1 g/cm 2 , more than 1 g/cm 2 , more than 3 g/cm 2 or more than 5 g/cm 2 , depending on the measurement and/or treatment that has to be performed subsequently.
  • the value of the predetermined offset value may be determined by two main factors. The first one is the resolution of the force sensors of the pressure and/or suction system which depends on the material and/or working mechanism of the force sensor. The second is sensitivity of the measurement and/or treatment to force variations, depending on which sensing and/or treatment method is to be applied.
  • the pressure at the interface between the probe and the skin to be measured by the at least one pressure sensor can be pressure resulting from the probe being pushed against the skin, but can also be air pressure in a vacuum chamber that pulls the skin towards and/or into the probe.
  • Pressure and suction also referred to as vacuum
  • pressure elements can be applied by means of the same force elements of the pressure and/or suction system.
  • the force elements When a positive force is applied to the force elements, the force elements will exert a pressure force to the skin. In that case, the force elements may be referred to as pressure elements.
  • the force elements When a negative force is applied to the force elements, the force elements will exert a suction pressure to the skin. In that case, the force elements may be referred to as suction elements.
  • An advantage of a device is that by providing a pressure and/or suction system, the shape of the measurement and/or treatment site may be adapted to the shape of the probe such that always an optimal contact may be achieved between the probe and the measurement and/or treatment site or an optimal contact can be obtained with a region of the skin above a volume containing a microsensor. This increases accuracy of the measurement and/or treatment subsequently performed.
  • FIG. 3 A schematic illustration of a device 35 according to embodiments of the present invention is illustrated in Fig. 3.
  • the device 35 comprises a probe 10.
  • Fig. 4 illustrates a cross-section (left hand side) and a top view (right hand side) of a probe 10 that can be used with a device 35 according to embodiments of the invention.
  • the probe 10 comprises at least one pressure sensor 11.
  • the at least one pressure sensor 11 which may also be referred to as force sensor, may be located at a contact surface of the probe 10.
  • the contact surface of the probe 10 is meant the surface which, when used for measuring a physiological parameter in and/or treatment of a human or animal body, makes contact to skin of the human being or animal.
  • Any suitable number of pressure sensors 11 may be provided at the contact surface of the probe 10.
  • the probe 10 may comprise between 1 and 100 for example between 1 and 50, between 1 and 20 or between 2 and 5 pressure sensors 11, depending on the application the probe 10 is intended for.
  • the number of pressure or force sensors 11 present at the contact surface of the probe 10 may not be determined by the intended application only. It may also depend on, for example, the size of the force sensors and the size of the measurement and/or treatment site. As an example, in transdermal drug delivery or in any other application using a microneedle array, a lower amount and/or smaller size of force sensors may be desired, resulting in a sufficient space for efficient medication injection. A proper contact of skin with the medication injection channel is preferred in order to enhance the efficiency of the drug delivery.
  • the at least one pressure sensor 11 is for measuring the pressure at different points of a measurement and/or treatment site.
  • the pressure is measured at an interface between the probe 10 and skin of the human being or animal.
  • the pressure to be measured may, according to embodiments of the invention, be pressure resulting from the probe 10 being pushed against the skin, but can, according to other embodiments, also be air pressure in a vacuum chamber that pulls the skin into the probe.
  • the pressure sensors 11 when the probe 10 comprises a plurality of pressure sensors 11, the pressure sensors 11 may be randomly distributed over the contact surface.
  • the pressure sensors 11 may be organized in a geometrical pattern, for example in an array, e.g. they may be logically organized in columns and rows.
  • the probe 10 furthermore comprises a pressure and/or suction system 12.
  • the pressure and/or suction system 12 comprises at least one force element 17. Any suitable number of force elements 17 may be provided in the pressure and/or suction system 12.
  • the pressure and/or suction system 12 may comprise between 1 and 100 for example between 1 and 50, between 1 and 20 or between 2 and 5 force elements 17, depending on the application the probe 10 is intended for.
  • the at least one force element 17 is for providing a particular pressure, i.e. suction pressure and/or pressure force to the surface to the measurement and/or treatment site on the skin of a human being or an animal. When a positive force is applied to the at least one force element 17, the at least one force element 17 may exert a pressure force to the skin and may be referred to as pressure element.
  • the at least one force element 17 may exert a suction pressure to the skin and may be referred to as suction element.
  • the suction pressure may be used to move a subcutaneous microsensor to a better location.
  • the skin When using suction elements, i.e. when applying a negative force to the at least one pressure element 17, according to embodiments of the present invention, the skin may be lifted by suction pressure towards the suction elements 17 by which the unwanted spots or spots with less desirable morphological features such as the presence of hairs, can be avoided such that wanted spots or spots with desirable morphological features, e.g. capillary bed(s), may be easy to reach.
  • pressure elements i.e. when applying a positive force to the at least one force element 17, according to alternative embodiments of the present invention
  • skin may be pressed down, away from the pressure element 17, so as to avoid irregularities in the skin and in that way increase the contact between the probe 10 and the skin.
  • the force elements 17 of the pressure and/or suction system 12 may be controlled by a controller 13 which uses the results obtained by the at least one pressure sensor 11 as feedback.
  • the controller 13 uses this feedback to activate force elements and allow them to, when the measured pressure is different from a desired pressure value by at least a predetermined offset value, adjust the pressure at the measurement site to the desired value (see further).
  • the controller 13 may control the pressure and/or suction system 12 according to an algorithm which may be stored in the controller 13. An example of such an algorithm is illustrated in Fig. 5.
  • the pressure exerted by the probe 10 to the skin at that measurement and/or treatment site may be measured (step 20).
  • the probe 10 may be provided to skin by a means of a device or may be provided manually. After the probe 10 is placed on the skin, the probe 10 may further be used hands-free in order to minimize force variation induced by a user. With “being used hands-free” is meant that the probe 10 is not held by a user during performance of the measurement and/or treatment. According to embodiments of the invention, it may not be really necessary to measure the pressure at the interface between the probe 10 and the skin at the moment the probe 10 is provided to the skin. Measurement of the pressure at the interface between the probe 10 and the skin may also be performed later on, for example just before measurement of a physiological parameter and/or performance of treatment is to be performed.
  • a desired value of the pressure exerted by the probe 10 to the measurement and/or treatment site has to be determined, also referred to as desired pressure value.
  • the desired pressure value may be a predetermined pressure value which is determined before use of the probe 10. This predetermined pressure value may also be referred to as target pressure value. Determining the predetermined pressure value may be done by measuring force as a function of time and mutually comparing the obtained values.
  • the determined target pressure value may then be stored in memory.
  • the target pressure value can be a scalar (just one numeric value) that specifies the average force to be measured, when averaging over all pressure sensors 11.
  • the target pressure value can be a function/equation that specifies the relation between force levels recorded by different pressure sensors 11 on the probe 10.
  • the target pressure value can differ from site to site, and thus from pressure sensor 11 to pressure sensor 11.
  • the target pressure value may be higher at a center of the probe 10 than at edges of the probe 10.
  • the target pressure value at the centre of the probe 10 may, for example, be 50 g/cm 2 , while the target pressure value at the edges of the probe 10 may be half of that value.
  • the desired pressure value may depend on measurements and/or treatments performed after the probe 10 has been provided to the skin. This may, for example, be the case when a probe 10 according to embodiments of the invention is incorporated in e.g. a sensing and/or treatment device. In that case, first e.g. optical information may be obtained w.r.t. the measurement and/or treatment site and that optical information may then be used to determine a desired pressure value (see further).
  • the desired pressure value may depend on moving a subcutaneous sensor to a better location.
  • step 30 is to determine whether an average measure pressure values is substantially equal to a target value which also is an average value. If this is not the case, i.e.
  • the force elements 17 may be driven by e.g. a pressure actuator to adapt the pressure (step 40).
  • the process will step-out the control loop and a feedback signal is sent to users (step 80).
  • a threshold variation value for example between 0 to 5 g/cm 2 , for example, 0.01 g/cm 2
  • the process will step-out the control loop and a feedback signal is sent to users (step 80).
  • a feedback signal is sent to users. This may indicate that there is something wrong, for example there does not exist a good contact between the probe 10 and the skin, or there is something wrong with power application, e.g.
  • pressure may be determined at different points. If the measured pressure values are not substantially equal to the target pressure plus/minus an offset value, for example between 0 to 5 g/cm 2 , for example, 0.01 g/cm 2 , 0.1 g/cm 2 , 1 g/cm 2 , 3 g/cm 2 or 5 g/cm 2 , it is determined if and how much the measured pressure at each different position of the measurement and/or treatment site deviates from the predetermined pressure value (step 50).
  • an offset value for example between 0 to 5 g/cm 2 , for example, 0.01 g/cm 2 , 0.1 g/cm 2 , 1 g/cm 2 , 3 g/cm 2 or 5 g/cm 2 .
  • the pressure and/or suction system 12 is then activated and is used to adjust the pressure at these positions (step 70).
  • the threshold variation level for example between 0 to 5 g/cm2, for example, 0.01 g/cm2, 0.1 g/cm 2 , 1 g/cm 2 , 3 g/cm 2 or 5 g/cm 2
  • the non- invasive or minimally invasive measurement of the physiological parameter e.g. non-invasive or minimally invasive glucose monitoring, or treatment of the human or animal body may be performed (step 60).
  • probes 10 that can be used with a device 35 according to embodiments of the present invention will be described by means of different embodiments. It has to be understood that these embodiments are for the ease of explanation and are not intended to limit the invention in any way.
  • the contact surface 14 of the probe 10 may be substantially flat and substantially rigid.
  • substantially rigid is meant that the contact surface 14 of the probe 10 is not prone to deformation under the influence of pressure exerted to it, e.g. when the probe 10 is applied to the measurement and/or treatment site 15 on the skin 16 of the human being or animal.
  • the probe 10 may comprise five force elements 17.
  • the force elements 17 may be driven so as to exert a suction pressure to the skin 16.
  • a mutual distance between neighboring force elements 17 may be in a predetermined range to minimize the effect of the applied suction pressure on the non-invasive or minimally invasive measurement and/or treatment performed afterwards.
  • the mutual distance between neighboring force elements 17 may be between 50 ⁇ m and 20 mm, for example between 5 mm and 20 mm, and may for example be 10 mm.
  • Fibres, e.g. optical fibres, which may be used as sensing elements (see further) may have diameters of between 50 ⁇ m and 1000 ⁇ m. Therefore, the distance between neighboring force elements 17 may be such that such optical fibres may still be provided in between the force elements 17.
  • a minimum separation distance between neighboring force elements 17 may be 50 ⁇ m. During practical mechanical design, this would mean that the force elements 17 can be packed together with a thin wall separating them.
  • a negative pressure may be applied to the force elements 17 in order to exert a suction pressure to the skin 16 at the spots where the pressure exerted by the probe 10 differs from the predetermined value with a deviation of a pre-determined offset value, for example, 0.01 g/cm 2 , 0.1 g/cm 2 , 1 g/cm 2 , 3 g/cm 2 , 5 g/cm 2 or more.
  • the negative pressure applied through the force elements 17 may be different for different force elements 17, depending on the difference in pressure applied by the probe 10 to the skin 16 at different spots or locations of the measurement and/or treatment site 15. According to other embodiments of the invention, however, the negative force applied through the force elements 17 may be the same for the different force elements 17. This may be the case when the probe 10 exerts a same pressure at each spot of the measurement and/or treatment site 15, or in other words, when the deviation from the desired pressure value is the same for each spot of the measurement and/or treatment site 15. By applying a negative force through the force elements 17, a suction pressure is exerted to the skin 16 at the measurement and/or treatment site 15.
  • the skin 16 adapts to the shape of the probe 10, or more specifically, the skin 16 adapts to the shape of the contact surface 14 of the probe 10. This increases the usability of the probe 10 as it can be used with any kind of skin surface and does not have to be adapted for different applications.
  • the probe 10 may furthermore comprise at least one measurement element 18, in the embodiment illustrated in Fig. 6 two measurement elements 18, to perform the required non-invasive or minimally invasive measurement, e.g. non-invasive or minimally invasive glucose monitoring, and/or treatment.
  • the measurement elements 18 may be optical fibres for performing optical measurements. According to a second embodiment of the first aspect which is illustrated in
  • the contact surface 14 of the probe 10 may be flexible, i.e. may be deformable under the influence of pressure exerted to it.
  • the probe 10 may comprise five force elements 17.
  • the force elements 17 may be linked to a force application system.
  • a mutual distance between neighboring force elements 17 may be in a predetermined range to minimize the effect of the applied pressure force on the non- invasive or minimally invasive measurement and/or treatment performed.
  • the mutual distance between neighboring pressure elements 19 may be between 50 ⁇ m and 200 ⁇ m, for example between 5 mm and 20 mm, and may for example be 10 mm. Fibres, e.g.
  • optical fibres which may be used as sensing elements 18, may have diameters of between 50 ⁇ m and 1000 ⁇ m. Therefore, the distance between neighboring force elements 17 may be such that such fibres may still be provided in between the force elements 17. Hence, a minimum separation distance between neighboring force elements 17 may be 50 ⁇ m. During practical mechanical design, this would mean that the force elements 17 can be packed together with a thin wall separating them.
  • a positive force may be applied to the force elements 17 such that they exert a pressure force to the skin 16 at those spots where the pressure exerted by the probe 10 differs from the predetermined value with a deviation of more than a pre-determined offset value, for example, more than 0.01 g/cm 2 , more than 0.1 g/cm 2 , more than 1 g/cm 2 , more than 3 g/cm 2 or more than 5 g/cm 2 .
  • the positive force exerted through the force elements 17 may be different for different force elements 17, depending on the difference in pressure applied by the probe 10 to the skin 16 at different spots of the measurement and/or treatment site 15. According to other embodiments of the invention, however, the positive force applied through the force elements 17 may be the same for the different force elements 17. This may be the case when the probe 10 exerts a same pressure at each spot of the measurement and/or treatment site 15, or in other words, when the deviation from the desired pressure value is the same for each spot of the measurement and/or treatment site 15.
  • a pressure force is exerted onto the skin 16 at different spots of the measurement and/or treatment site 15.
  • a different degree of pressure force may be applied to different spots on the skin 16 at the measuring and/or treatment site 15.
  • the shape of the probe 10 is adapted to the shape of the skin 16.
  • exerting a pressure on the skin 16 may deform it slightly.
  • this effect may be optimized, e.g. minimized.
  • the probe 10 may have a flexible surface, hardly no pressure/suction will be applied to the skin 16 in order to reduce the skin deformation.
  • the probe 10 may furthermore comprise at least one measurement element 18 to perform the required non-invasive or minimally invasive measurement, e.g. non-invasive or minimally invasive glucose monitoring and/or treatment of the human or animal body.
  • the measurement elements 18 may be optical fibres.
  • the probe 10 may have properties which are a combination of the properties of a probe 10 according to the first embodiment and a probe 10 according to the second embodiment.
  • the probe 10 may have a flexible contact surface 14, i.e. the contact surface 14 of the probe 10 may be deformable under the influence of pressure exerted to it.
  • the probe 10 may comprise at least two force elements 17 which may be driven differently. A positive force may be applied to part of the force elements 17 which then may exert a pressure to the skin 16 while a negative force may be applied to the other force elements 17 thereby exerting a suction pressure to the skin 16.
  • the force elements 17 to which a positive force is applied and those to which a negative force is applied may be placed alternately.
  • the force elements 17 to which a negative force is applied are filled with points while the force elements 17 to which a positive force is applied are filled with stripes.
  • a mutual distance between neighboring force elements 17 may be in a certain range to optimize, e.g. minimize, the effect of applied suction pressure and/or applied pressure force on the minimally invasive or non-invasive measurement performed.
  • the mutual distance between neighboring vacuum elements 17 and pressure elements 19 may be between 50 ⁇ m and 20 mm, for example between 5 mm and 20 mm, and may for example be 10 mm.
  • Fibres e.g. optical fibres, which may be used as sensing elements 18, may have diameters of between 50 ⁇ m and 1000 ⁇ m. Therefore, the distance between neighboring force elements 17 may be such that such optical fibres may still be provided in between the force elements 17. Hence, a minimum separation distance between neighboring force elements 17 may be 50 ⁇ m. During practical mechanical design, this would mean that the force elements 17 can be packed together with a thin wall separating them.
  • the skin 16 adapts to the shape of the probe 10, or more specifically, the skin 16 adapts to the shape of the contact surface 14 of the probe 10. This increases the usability of the probe 10 as it can be used with any kind of skin surface and does not have to be adapted for different applications.
  • the probe 10 may furthermore comprise at least one measurement element 18 to perform the required non-invasive or minimally invasive measurement, e.g. non-invasive or minimally invasive glucose monitoring, and/or treatment of the human or animal body.
  • the measurement elements 18 may be optical fibres.
  • Fig. 9 shows a cross-section of a probe 10 to be used with a device 35 according to the third embodiment, i.e. comprising vacuum elements 17, pressure elements 19 and measurement elements 18. Similar as in Fig. 8, the force elements 17 to which a negative force is applied are filled with points while the force elements 17 to which a positive force is applied are filled with stripes.
  • a probe 10 according to embodiments of the present invention may be used with any technique for sensing analytes within or underneath the skin 16, e.g. for sensing analytes in blood or interstitial fluid or for sensing these analytes indirectly by monitoring a subcutaneous microsensor comprising an assay for such analytes.
  • the probe 10 may be used for, for example, non- invasive or minimally invasive glucose detection by means of optical spectroscopy. Further applications of a probe 10 according to embodiments of the invention may include measurements of skin properties such as e.g. skin cancer, skin aging by any means of radiation, e.g. light.
  • a probe 10 according to embodiments of the invention may also be used with any treatment technique as was described above.
  • a device 35 according to embodiments of the invention may be used with a skin sensing and/or treatment device. Therefore, according to a second aspect, the present invention provides a sensing and/or treatment device 100.
  • a sensing and/or treatment device 100 may comprise an imaging modality for detecting interfering features on the skin and/or target sites within the skin 16 or a subcutaneous microsenor, and at least one device 35 according to embodiments of the present invention for applying an amount of suction pressure and/or pressure force upon detection of such interfering features and/or target sites and/or a subcutaneous microsensor and for performing the required measurement and/or treatment.
  • Fig. 10 schematically illustrates an example of a sensing and/or treatment device 100 according to an embodiment of the present invention.
  • the sensing and/or treatment device 100 comprises an imaging modality 22, also referred to as imaging recognition device, a size-changeable aperture plate 24 and a device 35 with a controller 13 and a probe 10 comprising a pressure and/or suction system 12, measurement elements 18 and at least one pressure sensor 23.
  • the measurement elements 18 may be optical fibres.
  • the imaging modality 22 is thus used to detect the location of interfering features 25 on the skin 16 and/or target sites within the skin 16 and/or a subcutaneous microsensor. Examples of interfering features on the skin may be hairs (see reference number 25 in Fig. 10) or sweat glands.
  • interfering features 25 may also be referred to as unwanted spots or spots with undesirable features.
  • target sites within the skin 16 may be capillary beds or blood vessels.
  • the imaging modality 22 may furthermore be used to determine the thickness of epidermis and dermis of the skin 16 at the measurement and/or treatment site 15.
  • the information on location obtained on interfering elements 25 and/or target sites and/or subcutaneous microsensor may then be used to set the operational parameters of the force elements 17 of the pressure and/or suction system 12 of the probe 10.
  • the operational parameters may, for example, comprise the diameter of the aperture plate 24 and the amount of suction pressure and/or pressure force that is to be applied.
  • the diameter of the aperture plate 24 determines the size over which a pressure force or suction pressure is applied to the skin 16.
  • the size of the sensing and/or treatment measurement volume is mainly determined by the spatial layout of the (e.g. optical) components performing the sensing and/or treatment functions.
  • the epidermis and dermis of the skin 16 are contacted with the probe 10, e.g. lifted up, to an appropriate level, according to one embodiment depending on the thickness of the epidermis and dermis such that either interfering features are avoided or the beneficial location, i.e. target site, is targeted.
  • the 'appropriate level' only depends on thickness of the skin layers when a certain skin layer is to be targeted.
  • the 'appropriate level' could also be determined by the location of an interfering feature 25, such as a hair.
  • the suction may also be used to move a microsensor into a better position.
  • a certain amount of suction pressure and/or pressure force may be applied when unwanted spots are detected while loading the device 100 to the skin 16 of a human being or an animal.
  • the skin 16 may be uplifted towards an appropriate level and stabilized by suction pressure and/or pressure force before performing the required measurement and/ or treatment such that unwanted spots may be avoided during the measurement and/or treatment.
  • the sensing and/or treatment device 100 may operate according to an algorithm.
  • An example of such an algorithm is schematically illustrated in Fig. 11. It has to be understood that this is just an example and is not intended to limit the invention in any way.
  • the sensing and/or treatment device 100 is loaded onto the skin 16 of a human being or an animal (step 110). Unwanted spots such as e.g. hairs or sweat glands may then be detected (step 120). If no such unwanted spots are detected, the measurement and/or treatment may immediately be performed. If unwanted spots are detected, skin composition and/or position of the unwanted spots may be determined (respectively step 140 and 150). Optionally wanted items such as e.g. a subcutaneous microsensor may be detected (step 120). If wanted items are detected, skin composition and/or position of the wanted items may be determined (respectively step 140 and 150).
  • unwanted spots such as e.g. hairs or sweat glands may then be detected (step 120). If no such unwanted spots are detected, the measurement and/or treatment may immediately be performed. If unwanted spots are detected, skin composition and/or position of the unwanted spots may be determined (respectively step 140 and 150).
  • wanted items such as e.g. a subcutaneous microsensor may be detected (step 120). If wanted items are detected, skin
  • parameters such as diameter of aperture and/or the suction pressure and/or pressure force to be applied (respectively step 160 and 170) may be determined. These parameters may then be applied to deform the skin 16 (step 180) or to move a subcutaneous microsensor to a better location. After deformation of the skin 16 or movement of microsensor, step 120 may be repeated. If no unwanted spots and/or if wanted elements are detected in the measuring volume, an analyte measurement and/ or treatment may be performed (step 130).
  • the sensing and/or treatment device 100 may be used with any technique for sensing analytes within the skin 16 and/or with any treatment method as described earlier.
  • the sensing and/or treatment device 100 according to embodiments of the present invention may be used for, for example, noninvasive or minimally invasive glucose detection by means of optical spectroscopy.
  • Further applications may include measurements of skin properties such as e.g. skin cancer or skin aging, for example by any means of radiation, e.g. light.
  • a target pressure value is dynamically determined as part of a control loop which may comprise an imaging modality 22, such as e.g. Optical Coherence Tomography, Ultrasound, Orthogonal Polarized Spectral Imaging, Fluorescent Imaging such as fluorescence resonance energy transfer among others.
  • the data provided by the imaging modality 22 may, according to embodiments of the invention, be an image, or a depth scan. This image may be analyzed by an imaging process algorithm that determines the desired measurement location within this image or depth scan or determines if a wanted item iw within the scan, e.g. a subcutaneous microsensor. This selection can be based on image processing technologies, such as, for example, edge detection, feature extraction, object recognition, or mathematical models.
  • This selection also takes into account the known physical features of skin 16, e.g. layer structure, optical properties of different layers, shape of certain features such as hairs or blood vessels.
  • This selection can take into account the known or unknown physical features of a subcutaneous microsensor such as optical properties, e.g. fluorescence, shape of certain features, size, etc.
  • this selection takes into account known limitations of the device 100, such as minimum achievable pressure or maximum achievable skin displacement.
  • a method for adapting pressure exerted by a probe 10 at a measurement and/or treatment site 15 on a human or animal body.
  • the method comprises: a) measuring pressure exerted at an interface between the probe 10 and skin 16 at different positions of a measurement and/or treatment site 15, b) determining a deviation of the measured pressure of the different positions of the measurement and/or treatment site 15 from a desired pressure value, and c) if the deviation is higher than a predetermined offset value, e.g.
  • the deviation is higher than 0.01 g/cm 2 , 0.1 g/cm 2 , 1 g/cm 2 , 3 g/cm 2 or 5 g/cm 2 , adjusting the pressure at the different positions of the measurement and/or treatment site 15 by means of feree elements 17.
  • a physiological parameter may be measured and/or a treatment may be performed.
  • the desired pressure value may be a predetermined pressure value which is determined before use starting the measurement and/or treatment.
  • the determined target pressure value may then be stored in memory.
  • the target pressure value can be a scalar (just one numeric value) that specifies the average force to be measured, when averaging over all pressure sensors 11.
  • the target pressure value can, be a function/equation that specifies the relation between force levels recorded by different pressure sensors 11 on the probe 10.
  • the target pressure value can differ from site to site, and thus from pressure sensor 11 to pressure sensor 11.
  • the target pressure value may be higher at a center of the probe 10 than at edges of the probe 10.
  • the target pressure value at the centre of the probe 10 may, for example, be 50 g/cm 2 , while the target pressure value at the edges of the probe 10 may be half of that value.
  • steps a) to c) of the method as described above may be repeated at least once.
  • the method may furthermore comprise determining the presence of an interfering feature 25 at the measurement and/or treatment site 15.
  • the method may furthermore comprise determining the presence of a wanted feature at the measurement and/or treatment site 15 such as a subcutaneous microsensor. Either of these may be done by means of an imaging modality 22 of a sensing and/or treatment device 100 according to embodiments of the invention as described above.
  • Operational parameters of the force elements 17 of the pressure and/or suction system 12 of the probe 10 may be obtained.
  • Operational parameters may, for example, comprise the diameter of an aperture plate 24 and the amount of suction pressure and/or pressure force that is to be applied.
  • the diameter of the aperture plate 24 determines the size of the measurement and/or treatment site 15.
  • the aperture plate 24 may have a variable diameter, e.g. such as a diaphragm.
  • the epidermis and dermis of the skin 16 may be lifted up to an appropriate level, depending on the thickness of the epidermis and dermis such that either interfering features 25 are avoided or the beneficial location, i.e. target site, is targeted or a subcutaneous microsensor may be moved into a better location or orientation. This may lead to an improved accuracy of the results obtained during minimally invasive or non-invasive measurement, e.g. detecting analytes in blood or interstitial fluid, and/or treatment of the human or animal body.
  • the present invention also provides a system controller 13 for use in a device 35 according to embodiments of the present invention for controlled driving of at least one force element 17 of a pressure and/or suction system 12 of the device 35.
  • the system controller 13 which is schematically illustrated in Fig. 12, may comprise a control unit 26 for controlling the at least one force element 17 of the pressure and/or suction system 12.
  • the controller 13 may control the at least one force element 17 of the pressure and/or suction system 12 according to an algorithm as was illustrated in Fig. 5, which algorithm may be stored in the controller 13. Therefore, the control unit 13 may comprise a memory e.g. electronic memory to store the algorithm.
  • the system controller 13 may include a computing device, e.g. microprocessor, for instance it may be a micro-controller.
  • a programmable controller for instance a programmable digital logic device such as a
  • the use of an FPGA allows subsequent programming of the device 35, e.g. by downloading the required settings of the FPGA.
  • the system controller 13 may be operated in accordance with settable parameters, such as driving parameters, for example temperature and timing parameters.
  • Fig. 13 shows one configuration of processing system 200 that includes at least one customizable or programmable processor 41 coupled to a memory subsystem 42 that includes at least one form of memory, e.g., RAM, ROM, and so forth.
  • the processor 41 or processors may be a general purpose, or a special purpose processor, and may be for inclusion in a device, e.g., a chip that has other components that perform other functions.
  • one or more aspects of the method according to embodiments of the present invention can be implemented in digital electronic circuitry, or in computer hardware, firmware, software, or in combinations of them.
  • the processing system may include a storage subsystem 43 that has at least one disk drive and/or CD-ROM drive and/or DVD drive.
  • a display system, a keyboard, and a pointing device may be included as part of a user interface subsystem 44 to provide for a user to manually input information, such as parameter values. More elements such as network connections, interfaces to various devices, and so forth, may be included, but are not illustrated in Fig. 13.
  • the various elements of the processing system 40 may be coupled in various ways, including via a bus subsystem 45 shown in Fig. 13 for simplicity as a single bus, but will be understood to those in the art to include a system of at least one bus.
  • the memory of the memory subsystem 42 may at some time hold part or all (in either case shown as 46) of a set of instructions that when executed on the processing system 40 implement the steps of the method embodiments described herein.
  • the present invention also includes a computer program product which provides the functionality of any of the methods according to embodiments of the present invention when executed on a computing device.
  • Such computer program product can be tangibly embodied in a carrier medium carrying machine-readable code for execution by a programmable processor.
  • the present invention thus relates to a carrier medium carrying a computer program product that, when executed on computing means, provides instructions for executing any of the methods as described above.
  • carrier medium refers to any medium that participates in providing instructions to a processor for execution. Such a medium may take many forms, including but not limited to, non-volatile media, and transmission media.
  • Non- volatile media includes, for example, optical or magnetic disks, such as a storage device which is part of mass storage.
  • Computer readable media include, a CD-ROM, a DVD, a flexible disk or floppy disk, a tape, a memory chip or cartridge or any other medium from which a computer can read.
  • Various forms of computer readable media may be involved in carrying one or more sequences of one or more instructions to a processor for execution.
  • the computer program product can also be transmitted via a carrier wave in a network, such as a LAN, a WAN or the Internet.
  • Transmission media can take the form of acoustic or light waves, such as those generated during radio wave and infrared data communications. Transmission media include coaxial cables, copper wire and fibre optics, including the wires that comprise a bus within a computer.

Abstract

La présente invention concerne un dispositif (35) destiné à adapter la  pression exercée par une sonde (10) au niveau d’un site (15) de mesure et / ou de traitement sur le corps d’un humain ou d’un animal. Le dispositif comporte une sonde (10) comprenant au moins un capteur (11) de pression destiné à mesurer la pression au niveau d’une interface entre la sonde (10) et la peau (16) du corps de l’humain ou de l’animal et un système (12) de pression et / ou d’aspiration comportant au moins un élément (17) de force. Le dispositif (35) comporte en outre une unité (13) de commande destinée à commander le ou les éléments (17) de force du système (12) de pression et / ou d’aspiration de façon à les activer et à leur permettre de régler la pression au niveau du site (15) de mesure et / ou de traitement à une valeur souhaitée de pression lorsque la pression mesurée diffère de la valeur souhaitée de la pression d’au moins une valeur prédéterminée de décalage. La présente invention concerne également un procédé de fabrication d’un tel dispositif (35) et un procédé adaptant la pression exercée par une sonde (10) au niveau d’un site (15) de mesure et / ou de traitement sur le corps d’un humain ou d’un animal à l’aide d’un tel dispositif (35).
PCT/IB2009/051942 2008-05-19 2009-05-12 Dispositif destiné à adapter la pression exercée par une sonde à un site de mesure et / ou de traitement WO2009141755A1 (fr)

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EP3127480A4 (fr) * 2014-04-04 2017-12-13 Seiko Epson Corporation Appareil de mesure biologique et procédé de mesure biologique
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