US6657717B2 - Device for verifying the accuracy of a spectral analyzer - Google Patents
Device for verifying the accuracy of a spectral analyzer Download PDFInfo
- Publication number
- US6657717B2 US6657717B2 US10/085,983 US8598302A US6657717B2 US 6657717 B2 US6657717 B2 US 6657717B2 US 8598302 A US8598302 A US 8598302A US 6657717 B2 US6657717 B2 US 6657717B2
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Classifications
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- 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
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- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
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- A61B2560/0223—Operational features of calibration, e.g. protocols for calibrating sensors
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- 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
- A61B5/14532—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 glucose, e.g. by tissue impedance measurement
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y10S977/926—Topical chemical, e.g. cosmetic or sunscreen
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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Definitions
- This invention is in the field of non-invasive spectral analysis of analytes in tissues and relates more particularly to a device which may be used with a non-invasive monitoring system used for determining concentrations of various blood components.
- Non-invasive devices exist which are used externally to measure either the concentration of the constituent in gases admitted by the body or the concentrations contained in a patient's body part, typically a finger.
- U.S. Pat. No. 5,429,128 describes a finger receptor which receives a finger of a user and is for use with a non-invasive monitoring device.
- U.S. Pat. No. 5,361,758 describes such a monitoring device.
- the present inventors have developed a device shaped to fit a receptor which is operatively connected to a non-invasive monitoring device, which device is useful in monitoring the precision and accuracy of the non-invasive monitoring device and which permits photometric correction of the instrument.
- the invention provides a method and a device made of materials for carrying out the method which reproduce absorption spectra associated with various body parts when such parts are subjected to spectral determination.
- a device according to the present invention is made of a material that exhibits the same light scattering and absorbance characteristics as a body part, preferably of an earlobe, lip, fold of skin or finger, most preferably, a finger.
- an artificial member which mimics the absorbance spectrum of a body part and includes the spectral components of blood analytes comprising a light scattering and reflecting material, which member has a chamber portion comprising one or more chambers, said member configured to be reproducibly received in a measuring receptor which receptor is operatively connected to a non-invasive monitoring device, preferably the body part which is mimicked is a finger.
- a measuring receptor which receptor is operatively connected to a non-invasive monitoring device, preferably the body part which is mimicked is a finger.
- there is one chamber while in another there are two chambers.
- each chamber is filled with an O-cellulose material which mimics light scattering properties of tissue, preferably each chamber is filled with a gel material containing Amaranth and sodium benzoate and holding light scattering and reflective particles which mimic the light scattering properties of tissue.
- the material which fills each chamber is fluid free.
- the reflective particles comprise Teflon-PTFE, Titanium Dioxide (TiO 2 ) or are Polystyrene nanospheres.
- the light scattering and reflecting material of the member is Teflon-PTFE, preferably the configuration of the member where in the configuration of the member to be reproducibly received, comprises a stabilizing member extending from the chamber portion to reversibly urge other surfaces of the member into contact with the measuring receptor, preferably the stabilizing member is as depicted in FIG. 9 .
- the member of the method mimics the absorbance spectrum of a body part and includes the spectral components of blood analytes comprising a light scattering and reflecting material, which member has a chamber portion comprising one or more chambers, said member configured to be reproducibly received in a measuring receptor, which receptor is operatively connected to a non-invasive monitoring device, preferably the body part which is mimicked is a finger.
- a measuring receptor which receptor is operatively connected to a non-invasive monitoring device, preferably the body part which is mimicked is a finger.
- there is one chamber while in another there are two chambers.
- each chamber is filled with an O-cellulose material which mimics slight scattering properties of tissue, preferably each chamber is filled with a gel material containing Amaranth and sodium benzoate and holding light scattering and reflective particles which mimic the light scattering properties of tissue.
- the material which fills each chamber is fluid free.
- the reflective particles comprise Teflon-PTFE, Titanium Dioxide (TiO 2 ) or are Polystyrene nanospheres.
- the light scattering and reflecting material of the member is Teflon-PTFE, preferably the configuration of the member wherein the configuration of the member to be reproducibly received, comprises a stabilizing member extending from the chamber portion to reversibly urge other surfaces of the member into contact with the measuring receptor, preferably the stabilizing member is as depicted in FIG. 9 .
- the invention in another embodiment provides a method for mimicking the absorbance spectrum of a body part which includes the spectral components of blood analytes.
- the method comprises inserting a member in a measuring device which is operatively connected to a non-invasive monitoring device; taking measurements with the device and comparing the results with those obtained from a body part of subject which the member is intended to mimic, wherein the member is comprised of a light scattering and reflecting material, which member has a chamber portion comprising one or more chambers, and the member is configured to be reproducibly received in the measuring receptor.
- the member of the method mimics the absorbance spectrum of a body part and includes the spectral components of blood analytes comprising a light scattering and reflecting material, which member has a chamber portion comprising one or more chambers, said member configured to be reproducibly received in a measuring receptor which receptor is operatively connected to a non-invasive monitoring device, preferably the body part which is mimicked is a finger.
- a measuring receptor which receptor is operatively connected to a non-invasive monitoring device, preferably the body part which is mimicked is a finger.
- there is one chamber while in another there are two chambers.
- each chamber is filled with an O-cellulose material which mimics light scattering properties of tissue, preferably each chamber is filled with a gel material containing Amaranth and sodium benzoate and holding light scattering and reflective particles which mimic the light scattering properties of tissue.
- the material which fills each chamber is fluid free.
- the reflective particles comprise Teflon-PTFE, Titanium Dioxide (TiO 2 ) or are Polystyrene nanospheres.
- the light scattering and reflecting material of the member is Teflon-PTFE, preferably the configuration of the member wherein the configuration of the member to be reproducibly received, comprises a stabilizing member extending from the chamber portion to reversibly urge other surfaces of the member into contact with the measuring receptor, preferably the stabilizing member is as depicted in FIG. 9 .
- FIG. 1 shows absorbance spectra from 500-1380 nm for globulins, glucose, urea, creatinine, cholesterol and human serum albumin with water displacement compensation.
- FIG. 2 shows 2013 absorbance spectra from 585-1100 nm for the finger from 32 subjects.
- FIG. 3 shows absorbance spectra (580-1100 nm) for water in a subject's finger and an artificial member of the present invention.
- FIG. 4 shows absorbance spectra from 580-1100 nm for a subject's finger and an artificial member as shown in FIG. 3, as well as the curve representing difference of the first two spectra.
- FIG. 5 is absorbance spectra from 580-1100 nm for water in a finger and in an artificial member of the invention where the member contains pink sponge (SCOTCH BRIGHTTM) and water.
- FIG. 6 is absorbance spectra from 580-1100 nm for water in a finger and in an artificial member of the invention where the member contains Polystyrene nanospheres in water and gelatin plus Amaranth and sodium benzoate as a preservative.
- FIG. 7 is an isometric exploded view of an artificial member according to the present invention in a configuration for use with a finger receptor.
- FIG. 8 is a side view of the member of FIG. 7 .
- FIG. 9 is an isometric exploded view of a further embodiment of an artificial member according to the present invention in a configuration for use with a finger receptor.
- FIG. 10 is a side view of the member of FIG. 9 .
- FIG. 11 is a side view of an assembled member of FIGS. 9 and 10.
- FIG. 12 shows an artificial finger according to the present invention used in association with a finger receptor, which is operatively connected to a non-invasive monitoring device.
- concentration or “concentration level” means the amount or quantity of a constituent in a solution whether the solution is in vitro or in vivo.
- carbohydrates means a substance, or analyte found in a tissue and includes carbohydrates such as, for example, glucose, bilirubin, a protein, for example, albumin or hemoglobin.
- fluid free means having no appreciable amount of liquid present.
- tissue means any tissue of the body of a subject including, for example, blood, extracellular spaces, and can mean the entire composition of a body part such as a finger or ear lobe.
- subject means any member of the animal kingdom including, preferably, humans.
- the present inventors have prepared a device which is capable of insertion in a receptor which is used with a non-invasive monitoring device.
- the use of such a device or artificial member is to enable the user of such a non-invasive monitoring device to quickly and easily check the precision and accuracy of the non-invasive monitoring device.
- Spectral data obtained using a standard spectrophotometer and compensated for water displacement, were collected from in vitro measurement of a cuvette containing samples of various blood constituents and are illustrated in FIG. 1 .
- the spectra associated with the various constituents are complex.
- the spectra for a living finger is relatively simple, particularly in the 500-1100 nm region. This may be seen in FIG. 2 . Measurements taken in this region are relatively consistent regardless of individual measurements or the individual being scanned.
- the data presented in FIG. 2 represent the combined spectra of 33 people for whom a total of 2,013 measurements were taken and are collectively presented. Accordingly, an artificial member must be able to provide a spectrum which is comparable to those presented in FIG.
- an artificial member of the present invention is made of a highly reflective material such as, for example, teflon, in particular, teflon-PTFE virgin material (where PTFE means polytetrafluoroethylene).
- PTFE means polytetrafluoroethylene
- the artificial member must show sufficient internal reflectance to achieve a comparable result.
- a chamber, or container space exists in the member, although, depending on the body part being mimicked, reflective material may comprise part of the internal structure of the chamber of the member.
- An artificial member must be capable of being easily inserted into and removed from a receptor which is used to measure spectral characteristics of constituents in a body part.
- the shape of the artificial member will be determined by the shape of the receptor.
- the artificial member In the case of a finger receptor, the artificial member must have corresponding shapes to ensure that there is a constant path length from the point at which light is delivered to the finger or artificial finger and the point at which light exits the finger or artificial body part.
- an artificial member of the present invention is for use in association with any measuring receptor which is combined with any non-invasive monitoring device which is based on the principle of measuring the absorbance (or reflectance) of radiation passing through (or reflecting from) a body part.
- such devices operate according to the Beer-Lambert Law, namely, that the concentration of constituents is proportional to a constant of proportionality (the extinction coefficient), the path length, and the absorbance (LOG 10[1/T], where T is the transmittance, i.e., the proportion of light of a given wavelength that is transmitted through the matrix).
- the concentration of a given constituent By measuring the absorbance at a number of predetermined wavelengths, some of which will control for path length, it is possible to calculate the concentration of a given constituent.
- the same principles of measurement which are applied to determining concentration of constituents in body parts with a non-invasive device are equally applicable to an artificial member of the present invention. Consequently, while water is a preferred constituent for measurement and accuracy testing with an artificial member, any other constituent, or constituents may be used.
- the constituents will be preferably held in the member, preferably in the chamber or chambers of the member. In some applications, it may be necessary to introduce other absorbing or reflecting material in the chamber or intermixed with the composition of the reflective material.
- absorbance measurements may be taken, and without limiting the scope of the applicability of the present invention, the two methods are: (1) use light from a scanning monochromator and pass it through a selected part of the body and collect the light transmitted through onto a silicon detector. A second measurement involves a measurement of the light transmitted in the absence of the body part. From these two measurements the transmittance, and hence the absorbance, may be calculated; (2) use a polychromatic light source, pass it through the body part to be measured, collect the light, collimate it onto a diffraction grating and focus the different wavelengths of light on a linear array detector. Each element of the array will then measure the intensity of light for a narrow band of wavelengths.
- the present invention includes artificial members replicating each of these.
- One of the problems encountered in measuring absorbance in tissue is the spectral variability from one instrument to another due to physical differences in light transmission and collection. Because the phantom finger is designed to minimize variability of spectral response and physical placement in the finger receptor, it can be used to quantify the spectral differences between instruments. With careful wavelength calibration, the difference in spectral response of the phantom finger between one instrument and another may be used to correct the spectrum of the second instrument to that of the first by adding the spectral difference to the second instrument. This is termed photometric correction and coupled with suitable wavelength accuracy, is the basis on which algorithms can be transferred from one instrument to another.
- an artificial member according to the present invention is illustrated.
- the artificial member is intended to represent an artificial finger 200 for use in association with a finger receptor 310 , which is operatively connected (via 330 ) to a non-invasive monitoring device 320 such as a spectrophotometer, as shown in FIG. 12 .
- the artificial finger 10 is comprised of a handle which may be prepared from aluminum or any other material which is rigid and has strength characteristics.
- the handle at 20 has a tip 30 which is used to connect the handle with a holding collar 40 .
- the holding collar is used to provide a large grasping means as well as sealing cover for the highly reflective and light scattering portion of the artificial finger 80 .
- the holding collar 40 is made of black plastic (DELRIN); however, any other minimally reflective or nonreflective plastic material is acceptable.
- the holding collar fits by means of an interference fit over the artificial member 80 .
- the artificial member 80 is comprised of a material which provides a scattering effect similar to tissue such as the skin or a digit, namely Teflon-PTFE; however, any other material such as FluorosintTM (DSM Engineering Plastic Products, Inc.) or Teflon-PTFE with 25% glass fibers which is capable of providing such scattering effect is suitable.
- This member has a hollow or chamber-like portion which determines the amount of internal scattering based on the material filling the cavity. The exact dimensions of this chamber are selected to achieve a spectrum of absorption similar to that observed of a natural finger. More than one chamber may be used. According to a preferred embodiment to the chamber as shown in FIG. 7 is divided into two portions, 90 and 100 , although similar results may be achieved with more chambers.
- the chambers 90 and 100 act as containers to hold water or any other solutions which are being used as part of the artificial member. Also placed in the artificial member for the purposes of replicating absorbance of a finger are O-cello materials commonly available as sponge 60 , 70 (SCOTCH BRIGHTTM) and which are shaped to fit into the containers 90 or 100 .
- the chamber may also be filled with gel materials which hold light scattering materials such as Titanium Dioxide (Ti0 2 ) or Polystyrene nanospheres.
- a stopper 50 made of rubber or other suitable material is fashioned to fit in to seal the top open end of containers 90 and 100 over which holder collar 40 is placed.
- FIG. 8 provides a side view of the artificial finger and illustrates the components in place.
- the shaping of the artificial finger in order to provide an interface between the artificial member and the receptor thereby achieving a minimum of variability and maximum of repeatability whilst allowing for the passage of light through the artificial member thereby optimizing pathlength and its variability between measurements with the artificial member is seen in the isometric exploded view in FIG. 7 as item 110 .
- This shaping will vary from one artificial member to the other depending upon the receptor for which the artificial members created and depending upon the device in which the artificial member is being used to verify the accuracy of the spectral analyzer.
- this artificial member is also intended to represent an artificial finger for use in association with a finger receptor which is operatively connected to a non-invasive monitoring device such as a spectrophotometer.
- the artificial finger 200 of FIGS. 9, 10 , and 11 is comprised of a handle, which may be prepared from aluminum or any other material, which is rigid and has strength characteristics.
- the handle at 290 has a tip 300 , which is used to connect the handle to the artificial member 210 at 230 .
- the artificial member is comprised of a material which provides a scattering effect similar to tissue such as the skin or a digit, namely, Teflon-PTFE; however, any other material such as FluorosintTM or Teflon-PTFE with 25% glass fibers which is capable of providing such a scattering effect is suitable.
- This member has a hollow or chamber-like portion 220 , which determines the amount of internal scattering based on the material filling the cavity.
- the exact dimensions of this chamber are selected to achieve a spectrum of absorption similar to that observed of a natural finger. More than one chamber may be used.
- the chamber 220 acts as a container to hold water or any other solutions which are being used as part of the artificial member 210 . Also placed in the artificial member for the purposes of replicating absorbance of a finger are O-cello materials commonly available as sponge 260 (SCOTCH BRIGHTTM) and which is shaped to fit into the container 220 .
- the chamber 220 may also be filled with gel materials, which hold light scattering materials such a Titanium Dioxide (TiO 2 ) or Polystyrene nanospheres.
- a stopper 270 made of rubber or other suitable material is fashioned to fit in to seal the top open end of the chamber 220 .
- the stopper 270 may be inserted or removed by gripping the stub 280 provided for this purpose.
- a plunger, or “stabilizing member” 240 made of 303 Stainless Steel or other material which is rigid and has strength characteristics is press fit into the top of the artificial member into mating cavity 250 and is held in place by an interference fit between the two parts.
- the purpose of the interlocking plunger 240 is to provide exact placement and holding of the artificial member when inserted into a finger receptor which is operatively connected to a non-invasive monitoring device.
- the stabilizing member 240 when the artificial member is inserted into the finger receptor mates, with a corresponding hole precisely placed in the finger receptor for this purpose, resulting in accurate placement of the artificial member 210 each time it is inserted into the finger receptor.
- An artificial finger made of Teflon-PTFE was prepared, although as just stated, any other highly reflective and light scattering material can be used.
- the artificial finger has a hollow portion containing within a further reflective surface, also made of Teflon-PTFE.
- the artificial finger When filled with water, the artificial finger provides a spectrum somewhat similar to that observed in a normal finger (see FIG. 3 ). However, the peak of high absorbance found in the 580 nm region for a normal finger is noticeably missing. Indeed, the different aspects of the artificial finger and a normal finger are illustrated in FIG. 4 . As may be seen, the only significant difference resides in the portion of the spectrum peak in the 580 nm region.
- sponge pads e.g., SCOTCH BRIGHTTM
- This artificial finger can be used to check the performance of any non-invasive monitoring device which is used to monitor the concentrations of various components of a subject's body parts.
- An artificial finger made of Teflon-PTFE was prepared, although as just stated, any other highly reflective and light scattering material can be used.
- the artificial finger has a hollow portion containing within a further reflective surface, also made of Teflon-PTFE.
- the artificial finger When filled with water, the artificial finger provides a spectrum somewhat similar to that observed in a normal finger (see FIG. 3 ). However, the peak of high absorbance found in the 580 nm region for a normal finger is noticeably missing. Indeed, the different aspects of the artificial finger and a normal finger are illustrated in FIG. 4 . As may be seen, the only significant difference resides in the portion of the spectrum peak in the 580 nm region.
- sponge pads e.g., SCOTCH BRIGHTTM
- SCOTCH BRIGHTTM SCOTCH BRIGHTTM
- An artificial finger made of Teflon-PTFE was prepared and, as just stated, any other highly reflective and light scattering material can be used.
- the artificial finger has a hollow portion containing within a further reflective surface, also made of Teflon-PTFE.
- the artificial finger when filled with water, the artificial finger provides a spectrum somewhat similar to that observed in a normal finger, and the only significant difference resides in the portion of the spectrum peak in the 580 nm region.
- nanospheres of polystyrene in water and gelatin plus Amaranth and sodium benzoate as a preservative were used. The results are illustrated in FIG. 6 .
- this artificial finger can be used to check the performance of any non-invasive monitoring device which is used to monitor the concentrations of various components of a subject's body parts.
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- Immunology (AREA)
- Crystallography & Structural Chemistry (AREA)
- Spectroscopy & Molecular Physics (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
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Abstract
Description
Claims (28)
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
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US10/085,983 US6657717B2 (en) | 1999-08-31 | 2002-02-28 | Device for verifying the accuracy of a spectral analyzer |
US10/186,274 US6614521B2 (en) | 1999-08-31 | 2002-06-28 | Device for verifying the accuracy of a spectral analyzer |
US10/208,292 US20020186369A1 (en) | 1999-08-31 | 2002-07-30 | Device for verifying the accuracy of a spectral analyzer |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US15168199P | 1999-08-31 | 1999-08-31 | |
PCT/CA2000/001006 WO2001015596A1 (en) | 1999-08-31 | 2000-08-31 | Device for verifying the accuracy of a spectral analyzer |
US10/085,983 US6657717B2 (en) | 1999-08-31 | 2002-02-28 | Device for verifying the accuracy of a spectral analyzer |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/CA2000/001006 Continuation WO2001015596A1 (en) | 1999-08-31 | 2000-08-31 | Device for verifying the accuracy of a spectral analyzer |
Related Child Applications (3)
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US10/186,274 Continuation-In-Part US6614521B2 (en) | 1999-08-31 | 2002-06-28 | Device for verifying the accuracy of a spectral analyzer |
US10/186,274 Continuation US6614521B2 (en) | 1999-08-31 | 2002-06-28 | Device for verifying the accuracy of a spectral analyzer |
US10/208,292 Division US20020186369A1 (en) | 1999-08-31 | 2002-07-30 | Device for verifying the accuracy of a spectral analyzer |
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US20020118361A1 US20020118361A1 (en) | 2002-08-29 |
US6657717B2 true US6657717B2 (en) | 2003-12-02 |
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US10/186,274 Expired - Lifetime US6614521B2 (en) | 1999-08-31 | 2002-06-28 | Device for verifying the accuracy of a spectral analyzer |
US10/208,292 Abandoned US20020186369A1 (en) | 1999-08-31 | 2002-07-30 | Device for verifying the accuracy of a spectral analyzer |
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US10/208,292 Abandoned US20020186369A1 (en) | 1999-08-31 | 2002-07-30 | Device for verifying the accuracy of a spectral analyzer |
Country Status (7)
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US (3) | US6657717B2 (en) |
EP (1) | EP1207780B1 (en) |
JP (1) | JP2003508734A (en) |
AT (1) | ATE343346T1 (en) |
CA (1) | CA2382531C (en) |
DE (1) | DE60031551T2 (en) |
WO (1) | WO2001015596A1 (en) |
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US20020118361A1 (en) | 2002-08-29 |
US20020186369A1 (en) | 2002-12-12 |
EP1207780A1 (en) | 2002-05-29 |
DE60031551D1 (en) | 2006-12-07 |
ATE343346T1 (en) | 2006-11-15 |
JP2003508734A (en) | 2003-03-04 |
EP1207780B1 (en) | 2006-10-25 |
US6614521B2 (en) | 2003-09-02 |
CA2382531C (en) | 2009-09-29 |
DE60031551T2 (en) | 2007-08-23 |
WO2001015596A1 (en) | 2001-03-08 |
US20030030798A1 (en) | 2003-02-13 |
CA2382531A1 (en) | 2001-03-08 |
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