WO1999044495A1 - A device for the determination of blood sugar - Google Patents

A device for the determination of blood sugar Download PDF

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Publication number
WO1999044495A1
WO1999044495A1 PCT/SE1999/000294 SE9900294W WO9944495A1 WO 1999044495 A1 WO1999044495 A1 WO 1999044495A1 SE 9900294 W SE9900294 W SE 9900294W WO 9944495 A1 WO9944495 A1 WO 9944495A1
Authority
WO
WIPO (PCT)
Prior art keywords
blood sugar
contact surfaces
electric contact
sugar content
determination
Prior art date
Application number
PCT/SE1999/000294
Other languages
French (fr)
Inventor
John-Jacob Engellau
Original Assignee
Conarma 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 Conarma Ab filed Critical Conarma Ab
Priority to AU27558/99A priority Critical patent/AU2755899A/en
Publication of WO1999044495A1 publication Critical patent/WO1999044495A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • 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
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 

Definitions

  • the present invention relates to a device and a method for the determination of blood sugar content.
  • Diabetes is a chronic metabolic disorder characterised by insufficient production of the hormone insulin. Diabetes causes fluctuations in the patient's blood sugar content. Serious complications, such as vascular changes which can lead to amputation, blindness and heart and kidney disease, may arise as a consequence of diabetes. The diabetic's loss of or reduced insulin production can be compensated for by means of existing insulin preparations. However, the patient's ability to "feel" his current blood sugar content is also reduced.
  • diabetics are obliged to use measuring methods which are carried out by means of a blood test and the addition of chemical reagents.
  • a biophysical parameter can be determined using either an invasive ("bloody”) or a non-invasive ("blood- less”) technique.
  • a measuring device especially for the determination of blood sugar content, is previously known from US-A-5 , 502 , 396. This known measuring device is based on the step of arranging a sample on the sensor forming part of the measuring device. This patent specification thus describes a device for invasive determination of the blood sugar content .
  • a device for non-invasive determination of the constituents of blood is known from WO 97/15227. According to that specification, data representative of the patient's ECG are used for determining the blood sugar content .
  • US-A-5, 119, 819 shows a device for non-invasive determination of changes in blood sugar content. With the aid of the device, acoustic speeds are measured in the tissue, which are then related to values of blood sugar content .
  • GB-2,033,575 describes a device for non-invasive determination of the capillary blood flow rate, in which is provided a means, which is adapted to be held against the patient's body surface, for applying alternating current.
  • Current is carried, at the depth of the capillary bed, along a path between two spaced-apart points.
  • the resulting voltage drop which is measured along at least part of the length of the current path, is said to pro- vide an indication of the capillary blood flow rate.
  • a further object of the invention is to provide a method of non- invasive blood sugar content determination.
  • the absorption capacity and electrical conductivity of blood in a certain tissue portion varies depending on the concentration of glucose in the blood flowing through the tissue portion.
  • This variation can be recorded, amplified, and read non-invasively, without direct access to the blood, in a device compris- ing a measuring part and a sensor part electrically connected thereto.
  • the user places, for example, his finger in the sensor part, whereby an open electric circuit is closed.
  • the reading is carried out spontaneously by means of the sensor part and can take place in most everyday situations.
  • This enables the diabetic to continuously record his current blood sugar conten . Having this knowledge enables the diabetic to adjust his diabetes therapy to minimise blood sugar content fluctuations.
  • IDDM patients Insulin-Dependent-Diabetes-Mellitus
  • ions e.g. sodium ions
  • the invention is based on the insight that blood sugar molecules have a dielectric effect on, inter alia, sodium ions.
  • the electrical impedance of a tissue with a high capillary blood flow rate varies with blood sugar content within certain frequency ranges .
  • closing an open electric circuit by placing a body part with a high capillary blood flow rate between two poles is the equi- valent of placing an impedance between the poles.
  • the magnitude of this impedance varies with the blood sugar content in the body part within certain frequency ranges for an applied electric field. Examples of body parts with a high capillary blood flow rate include the fingertips, toes, and earlobes .
  • this impedance variation can be integrated with a calibration process based on two or more programmable blood sugar values, determined by means of conventional measuring methods.
  • the impedance is determined at only one or a few frequencies, which enables very fast and simple measuring.
  • the molecular composition of the capillary blood is constant in all respects other than the blood sugar concentration. If the number of electrolytes in the blood varies between measurements, it may thus affect the measuring result. Consequently, according to a second method, the impedance is instead determined at a plurality of frequencies in a broad frequency spectrum. This determination is somewhat more time-consuming, but affords the possibility of compensating for changes in the composition of the blood between measurements.
  • Sodium chloride (NaCl) is a particularly important component in the electrolytic balance of blood.
  • Fig. 1 is a schematic view of a measuring device according to the invention, showing a measuring part and a sensor part connected thereto
  • Fig. 2 is a schematic view of the measuring part included in the device according to Fig. 1.
  • the measuring part 1 shown in Fig. 1 comprises a current supply means 11, an electric circuit 12, a memory medium 13, a microcomputer 14, and means 15 for inputting information to and reading information from the memory medium 13 as well as for reading measurement data.
  • the measuring part 1 is electrically connected to the sensor part 2, which comprises two opposing and spaced-apart electric contact surfaces 21, 22 with a first and a second electric potential.
  • an electric current e.g. of a magnitude of 10 mA
  • the impedance between the poles is proportional to the blood sugar content in the blood flowing through the human tissue.
  • the relationship between the impedance and the blood sugar content can be described by the formula:
  • Vg Ki x Z
  • Vg the blood sugar concentration
  • the calibration coefficient of the individual is obtained by means of the measuring device through at least two consecutive measurements at known blood sugar contents of the individual. These values, from a blood sugar determination of the capillary blood in a chemical blood sugar meter, are input as reference values to the memory medium 13 in connection with the respective cali- bration measurements. In connection with the calibration, the blood sugar values should have a minimum difference of 10mmol/1.
  • the voltage drop across the mass of tissue (the fingertip) placed between the poles is proportional to the blood sugar content of the blood flowing through the capillaries within a specific measurement range, e.g. 2-17 mmol/1.
  • the current measurement value is stated with, for example, one decimal and is expressed in, for example, mmol/1.
  • the electric contact surfaces 21, 22 are located at a fixed distance from each other, which is determined by the individual who is going to use the measuring device.
  • Measurement range blood sugar 2-17 mmol/1.
  • Accuracy 0.1 ⁇ 0.05 mmol/1
  • Measurement time 1-2 seconds
  • Calibration difference minimum 10 mmol/1
  • Calibration values two or more.
  • Measuring part microcomputer, electric circuit, display, keypad for calibration, batteries and fault indicator. Dimensions: height 20 x width 8 x depth 4 (cm) Display: LCD
  • Connecting cord with measuring part (for fingertip)
  • Sensor part diameter 10-25 mm (20 different dimensions)
  • Depth 20 mm, conical with a flat bottom.
  • the current supply means 11 comprises a multi-frequency generator, which generates a broad frequency spectrum within the frequency range of 0.1-2000 MHz.
  • An electric field is generated between the contact surfaces 21, 22 (the poles) .
  • electrical impedance is determined with the aid of the means 15 for at least a part of the frequency components generated by the multi-frequency generator.
  • This impedance spectrum is compared in the microcomputer 14 with spectra included in a spectrum library stored in the memory medium 13.
  • This spectrum library has been created by determining impedance spectra for known blood sugar concentrations of the patient, the loads being obtained by means of conventional methods.
  • the part of the spectrum which contains the "blood sugar signal” is identified and other parts of the spectrum are utilised to compensate for changes in the composition of the blood between measurements. Subsequently, a value for the blood sugar content of the blood is calculated.
  • the measuring instrument generates a warning signal if the microcomputer 14 detects signals for which it cannot compensate. These signals may represent external interference sources such as the patient ' s medicine intake.

Abstract

A device and methods are described for the determination of blood sugar content comprising a measuring part (1) and a sensor part (2). The electric contact surfaces (21, 22) of the sensor part are contactable with either side of a piece of living human tissue having a high capillary blood flow rate for non-invasive determination of the blood sugar content.

Description

A DEVICE FOR THE DETERMINATION OF BLOOD SUGAR
Field of the Invention
The present invention relates to a device and a method for the determination of blood sugar content. Background of the Invention Diabetes is a chronic metabolic disorder characterised by insufficient production of the hormone insulin. Diabetes causes fluctuations in the patient's blood sugar content. Serious complications, such as vascular changes which can lead to amputation, blindness and heart and kidney disease, may arise as a consequence of diabetes. The diabetic's loss of or reduced insulin production can be compensated for by means of existing insulin preparations. However, the patient's ability to "feel" his current blood sugar content is also reduced. Today, regardless of the stage of development of the disease, in order to check their blood sugar content diabetics are obliged to use measuring methods which are carried out by means of a blood test and the addition of chemical reagents. Such measuring methods are not available to diabe- tics for regular checks in everyday conditions. Furthermore, this blood test method provides insufficient therapeutic data for measures adapted to the disease, comprising diet, tablets and insulin. The lack of knowledge about the current blood sugar content means that the fluctuations in the diabetic's blood sugar contents can be considerable, leading to faster destruction of peripheral vessels, etc. In the long term, this leads to extensive medical intervention.
Up-to-the minute knowledge, in various life situa- tions, of the current blood sugar content would substantially improve the diabetic's own therapy with respect to diet, tablet intake, and insulin dosage. A simple, inexpensive and easy-to-use measuring device for the determination of blood sugar, usable in everyday living, would afford the diabetic an entirely new therapeutic situation.
A biophysical parameter can be determined using either an invasive ("bloody") or a non-invasive ("blood- less") technique. A measuring device, especially for the determination of blood sugar content, is previously known from US-A-5 , 502 , 396. This known measuring device is based on the step of arranging a sample on the sensor forming part of the measuring device. This patent specification thus describes a device for invasive determination of the blood sugar content .
A device for non-invasive determination of the constituents of blood is known from WO 97/15227. According to that specification, data representative of the patient's ECG are used for determining the blood sugar content .
US-A-5, 119, 819 shows a device for non-invasive determination of changes in blood sugar content. With the aid of the device, acoustic speeds are measured in the tissue, which are then related to values of blood sugar content .
GB-2,033,575 describes a device for non-invasive determination of the capillary blood flow rate, in which is provided a means, which is adapted to be held against the patient's body surface, for applying alternating current. Current is carried, at the depth of the capillary bed, along a path between two spaced-apart points. The resulting voltage drop, which is measured along at least part of the length of the current path, is said to pro- vide an indication of the capillary blood flow rate. Summary of the Invention
It is an object of the invention to provide a measuring device for the determination of blood sugar content, which is simple, inexpensive, and easy to use, and by means of which diabetics can check their blood sugar content whenever they wish and act accordingly. A further object of the invention is to provide a method of non- invasive blood sugar content determination.
These objects have been achieved by means of a device of the type stated in the preamble to claim 1, and exhibiting the characteristics stated in the characterising portion of claim 1, as well as by methods of non- invasive determination of blood sugar content according to claims 3, 4, and 5.
The absorption capacity and electrical conductivity of blood in a certain tissue portion, e.g. the fingertip, varies depending on the concentration of glucose in the blood flowing through the tissue portion. This variation can be recorded, amplified, and read non-invasively, without direct access to the blood, in a device compris- ing a measuring part and a sensor part electrically connected thereto. In connection with measuring, the user places, for example, his finger in the sensor part, whereby an open electric circuit is closed. The reading is carried out spontaneously by means of the sensor part and can take place in most everyday situations. This enables the diabetic to continuously record his current blood sugar conten . Having this knowledge enables the diabetic to adjust his diabetes therapy to minimise blood sugar content fluctuations. Especially in the case of IDDM patients (Insulin-Dependent-Diabetes-Mellitus) , this is of major importance for the interplay between diet and insulin administration.
It is known that ions, e.g. sodium ions, which are dissolved in the blood are affected by electric fields. The invention is based on the insight that blood sugar molecules have a dielectric effect on, inter alia, sodium ions. As a result, the electrical impedance of a tissue with a high capillary blood flow rate varies with blood sugar content within certain frequency ranges . From an electrical point of view, closing an open electric circuit by placing a body part with a high capillary blood flow rate between two poles is the equi- valent of placing an impedance between the poles. As described above, the magnitude of this impedance varies with the blood sugar content in the body part within certain frequency ranges for an applied electric field. Examples of body parts with a high capillary blood flow rate include the fingertips, toes, and earlobes .
Furthermore, the determination of this impedance variation can be integrated with a calibration process based on two or more programmable blood sugar values, determined by means of conventional measuring methods.
According to a first method, the impedance is determined at only one or a few frequencies, which enables very fast and simple measuring. However, it has a limitation in that it is necessary to assume that the molecular composition of the capillary blood is constant in all respects other than the blood sugar concentration. If the number of electrolytes in the blood varies between measurements, it may thus affect the measuring result. Consequently, according to a second method, the impedance is instead determined at a plurality of frequencies in a broad frequency spectrum. This determination is somewhat more time-consuming, but affords the possibility of compensating for changes in the composition of the blood between measurements. Sodium chloride (NaCl) is a particularly important component in the electrolytic balance of blood. Even small variations in this concentration can result in major changes in the electrical impedance. The results of initial trials show that the impedance in the frequen- cy range 1-100 MHz is significantly blood sugar dependent, while at around 1500 MHz impedance data is obtained which is linearly dependent on the NaCl concentration, but independent of the sugar content in the blood. Brief Description of the Drawings The invention will be described in more detail below with reference to the accompanying drawings, in which Fig. 1 is a schematic view of a measuring device according to the invention, showing a measuring part and a sensor part connected thereto, and Fig. 2 is a schematic view of the measuring part included in the device according to Fig. 1.
Description of Preferred Embodiments
As seen in Fig. 2, according to a preferred embodiment, the measuring part 1 shown in Fig. 1 comprises a current supply means 11, an electric circuit 12, a memory medium 13, a microcomputer 14, and means 15 for inputting information to and reading information from the memory medium 13 as well as for reading measurement data. The measuring part 1 is electrically connected to the sensor part 2, which comprises two opposing and spaced-apart electric contact surfaces 21, 22 with a first and a second electric potential. When the user places, for example, his finger between the contact surfaces (poles) in such a way that the contact surfaces abut against it on either side, an electric current, e.g. of a magnitude of 10 mA, flows through it. The impedance between the poles is proportional to the blood sugar content in the blood flowing through the human tissue. In other words, the relationship between the impedance and the blood sugar content can be described by the formula:
Vg = Ki x Z, where
Vg = the blood sugar concentration
Ki = the calibration coefficient of the individual Z = the impedance in the tissue
The calibration coefficient of the individual is obtained by means of the measuring device through at least two consecutive measurements at known blood sugar contents of the individual. These values, from a blood sugar determination of the capillary blood in a chemical blood sugar meter, are input as reference values to the memory medium 13 in connection with the respective cali- bration measurements. In connection with the calibration, the blood sugar values should have a minimum difference of 10mmol/1.
The voltage drop across the mass of tissue (the fingertip) placed between the poles is proportional to the blood sugar content of the blood flowing through the capillaries within a specific measurement range, e.g. 2-17 mmol/1. The current measurement value is stated with, for example, one decimal and is expressed in, for example, mmol/1. The electric contact surfaces 21, 22 are located at a fixed distance from each other, which is determined by the individual who is going to use the measuring device. A technical specification is given below as a non-limiting example of a preferred embodiment of a measuring device according to the invention: Measurement range: blood sugar 2-17 mmol/1. Accuracy: 0.1 ± 0.05 mmol/1 Measurement time: 1-2 seconds Calibration difference: minimum 10 mmol/1 Calibration values: two or more. Components
Measuring part: microcomputer, electric circuit, display, keypad for calibration, batteries and fault indicator. Dimensions: height 20 x width 8 x depth 4 (cm) Display: LCD
Operating temperature: -5 - 40 °C
Connecting cord with measuring part: (for fingertip)
Cable length: 40 cm
Sensor part: diameter 10-25 mm (20 different dimensions) Depth: 20 mm, conical with a flat bottom.
According to another embodiment of the invention, the current supply means 11 comprises a multi-frequency generator, which generates a broad frequency spectrum within the frequency range of 0.1-2000 MHz. An electric field is generated between the contact surfaces 21, 22 (the poles) . For the tissue placed between the poles, electrical impedance is determined with the aid of the means 15 for at least a part of the frequency components generated by the multi-frequency generator. This impedance spectrum is compared in the microcomputer 14 with spectra included in a spectrum library stored in the memory medium 13. This spectrum library has been created by determining impedance spectra for known blood sugar concentrations of the patient, the loads being obtained by means of conventional methods. With the aid of the microcomputer 14 the part of the spectrum which contains the "blood sugar signal" is identified and other parts of the spectrum are utilised to compensate for changes in the composition of the blood between measurements. Subsequently, a value for the blood sugar content of the blood is calculated. The measuring instrument generates a warning signal if the microcomputer 14 detects signals for which it cannot compensate. These signals may represent external interference sources such as the patient ' s medicine intake.
The above description relates to the determination of the blood sugar content of human blood, but it will be appreciated that the invention is also applicable to the determination of the blood sugar content of blood from other mammals.

Claims

1. A device for the determination of blood sugar content, comprising a measuring part (1) , which comprises a current supply means (11) , an electric circuit (12) , a memory medium (13), a microcomputer (14), and means (15) for inputting information to and reading information from the memory medium (13), as well as for reading measurement data; a sensor part (2) , which is electrically connected to the measuring part and comprises at least two opposing, spaced-apart electric contact surfaces (21, 22) c h a r a c t e r i s e d in that the electric contact surfaces (21, 22) of the sensor part are contactable with either side of a piece of living human tissue with a high capillary blood flow rate for non- invasive measuring of the blood sugar content.
2. A device according to claim 1, wherein the cur- rent supply means (11) comprises a multi-frequency generator.
3. A method of non-invasive determination of blood sugar content, comprising the steps of calibrating a measuring device by inputting at least two reference values; arranging at least two electric contact surfaces on opposite sides of a body part having a high capillary blood flow rate; applying a predetermined voltage between the two electric contact surfaces; reading the current between the two electric contact surfaces; and, by utilising the reference values, converting the read current value to a value of the blood sugar content .
4. A method of non-invasive determination of blood sugar content, comprising the steps of calibrating a measuring device by inputting at least two reference values; arranging at least two electric contact surfaces on opposite sides of a body part having a high capillary blood flow rate; applying a predetermined current between the two electric contact surfaces; reading the voltage between the two electric contact surfaces; and, by utilising the reference values, converting the read voltage value to a value of the blood sugar content.
5. A method of non-invasive determination of blood sugar content, comprising the steps of calibrating a measuring device by inputting at least two reference values; arranging at least two electric contact surfaces on opposite sides of a body part having a high capillary blood flow rate; applying an electric field between the two electric contact surfaces; determining the electrical impedance between the two electric contact surfaces at several frequencies; and, by utilising the reference values, converting the determined impedance to a value of the blood sugar con- tent.
PCT/SE1999/000294 1998-03-02 1999-03-02 A device for the determination of blood sugar WO1999044495A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU27558/99A AU2755899A (en) 1998-03-02 1999-03-02 A device for the determination of blood sugar

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE9800629A SE512047C2 (en) 1998-03-02 1998-03-02 Measuring device, especially for blood sugar determination
SE9800629-9 1998-03-02

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Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1656065A2 (en) * 2003-08-19 2006-05-17 A.D. Integrity Applications Ltd. A method of monitoring glucose level
US7184810B2 (en) 2002-09-04 2007-02-27 Solianis Holding Ag Method and a device for measuring glucose
US7315767B2 (en) 2001-03-06 2008-01-01 Solianis Holding Ag Impedance spectroscopy based systems and methods
CN100427025C (en) * 2003-04-10 2008-10-22 宇东科技股份有限公司 Method for judging concentration of lood sugar
US7534208B2 (en) 2002-09-24 2009-05-19 Max Link Device for the measurement of glucose concentrations
US7693561B2 (en) 2001-03-06 2010-04-06 Solianis Holding Ag Method and device for determining the concentration of a substance in body liquid
US8197406B2 (en) 2003-12-02 2012-06-12 Biovotion Ag Device and method for measuring a property of living tissue
US9247905B2 (en) 2009-04-17 2016-02-02 Biovotion Ag Wide band field response measurement for glucose determination
US9713447B2 (en) 2005-11-10 2017-07-25 Biovotion Ag Device for determining the glucose level in body tissue

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2033575A (en) * 1978-05-24 1980-05-21 Rolfe P Investigating substances in a patient's bloodstream
US5119819A (en) * 1990-05-02 1992-06-09 Miles Inc. Method and apparatus for non-invasive monitoring of blood glucose
WO1997015227A1 (en) * 1995-10-26 1997-05-01 Medtronic, Inc. Continuous monitoring of diabetes-related blood constituents
WO1997023159A1 (en) * 1995-12-22 1997-07-03 Cme Telemetrix Inc. Integrating cavity for spectroscopic measurement in light scattering samples

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2033575A (en) * 1978-05-24 1980-05-21 Rolfe P Investigating substances in a patient's bloodstream
US5119819A (en) * 1990-05-02 1992-06-09 Miles Inc. Method and apparatus for non-invasive monitoring of blood glucose
WO1997015227A1 (en) * 1995-10-26 1997-05-01 Medtronic, Inc. Continuous monitoring of diabetes-related blood constituents
WO1997023159A1 (en) * 1995-12-22 1997-07-03 Cme Telemetrix Inc. Integrating cavity for spectroscopic measurement in light scattering samples

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7315767B2 (en) 2001-03-06 2008-01-01 Solianis Holding Ag Impedance spectroscopy based systems and methods
US7693561B2 (en) 2001-03-06 2010-04-06 Solianis Holding Ag Method and device for determining the concentration of a substance in body liquid
US7184810B2 (en) 2002-09-04 2007-02-27 Solianis Holding Ag Method and a device for measuring glucose
US7534208B2 (en) 2002-09-24 2009-05-19 Max Link Device for the measurement of glucose concentrations
CN100427025C (en) * 2003-04-10 2008-10-22 宇东科技股份有限公司 Method for judging concentration of lood sugar
EP1656065A2 (en) * 2003-08-19 2006-05-17 A.D. Integrity Applications Ltd. A method of monitoring glucose level
EP1656065A4 (en) * 2003-08-19 2010-03-03 Ad Integrity Applications Ltd A method of monitoring glucose level
US8197406B2 (en) 2003-12-02 2012-06-12 Biovotion Ag Device and method for measuring a property of living tissue
US9713447B2 (en) 2005-11-10 2017-07-25 Biovotion Ag Device for determining the glucose level in body tissue
US9247905B2 (en) 2009-04-17 2016-02-02 Biovotion Ag Wide band field response measurement for glucose determination

Also Published As

Publication number Publication date
AU2755899A (en) 1999-09-20
SE9800629L (en) 1999-09-03
SE9800629D0 (en) 1998-03-02
SE512047C2 (en) 2000-01-17

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