CA2450104A1 - Bodily fluid sampling device and test media cassette to be used with such a device - Google Patents

Bodily fluid sampling device and test media cassette to be used with such a device Download PDF

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Publication number
CA2450104A1
CA2450104A1 CA002450104A CA2450104A CA2450104A1 CA 2450104 A1 CA2450104 A1 CA 2450104A1 CA 002450104 A CA002450104 A CA 002450104A CA 2450104 A CA2450104 A CA 2450104A CA 2450104 A1 CA2450104 A1 CA 2450104A1
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CA
Canada
Prior art keywords
test media
bodily fluid
test
media tape
tape
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
CA002450104A
Other languages
French (fr)
Other versions
CA2450104C (en
Inventor
Jeffrey N. Roe
Steven N. Roe
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to CA2694412A priority Critical patent/CA2694412C/en
Publication of CA2450104A1 publication Critical patent/CA2450104A1/en
Application granted granted Critical
Publication of CA2450104C publication Critical patent/CA2450104C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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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
    • A61B5/14546—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 analytes not otherwise provided for, e.g. ions, cytochromes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
    • A61B5/1405—Devices for taking blood samples
    • A61B5/1411—Devices for taking blood samples by percutaneous method, e.g. by lancet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061—Means for enhancing collection
    • A61B5/150099—Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150358—Strips for collecting blood, e.g. absorbent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A61B5/150419—Pointed piercing elements, e.g. needles, lancets for piercing the skin comprising means for capillary action
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150473—Double-ended needles, e.g. used with pre-evacuated sampling tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150503—Single-ended needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150633—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150694—Procedure for removing protection means at the time of piercing
    • A61B5/150702—Procedure for removing protection means at the time of piercing fully automatically removed, i.e. the removing does not require any action by the user
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150694—Procedure for removing protection means at the time of piercing
    • A61B5/150717—Procedure for removing protection means at the time of piercing manually removed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15103—Piercing procedure
    • A61B5/15107—Piercing being assisted by a triggering mechanism
    • A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
    • A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A61B5/15188—Constructional features of reusable driving devices
    • A61B5/1519—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for propelling the piercing unit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/4875—Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
    • G01N33/48764—Test tape taken off a spool
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N2001/028—Sampling from a surface, swabbing, vaporising
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00009—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with a sample supporting tape, e.g. with absorbent zones
    • G01N2035/00019—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with a sample supporting tape, e.g. with absorbent zones cassette structures
    • 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
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/25—Chemistry: analytical and immunological testing including sample preparation

Abstract

A bodily fluid sampling device (30) includes a piercing device (42) and a sensor (56) enclosed in a housing (32). A cassette (54), which contains test media (64), is positioned proximal to the sensor (56) so that the sensor (56 ) is able to analyze a bodily fluid sample collected on the test media (64). T he cassette (54) includes a supply portion (66) from which unused test media (6 4) is supplied and a storage portion (68) in which contaminated test media (64) is stored after exposure to the bodily fluid. The cassette (54) is adapted t o collect a series of bodily fluid samples without requiring disposal of the test media (64).

Claims (29)

1. A bodily fluid sampling device, comprising:
a test media cassette that includes a test media tape on which bodily fluid from an incision is collected, a supply portion from which the test media tape is supplied and a storage portion in which the test media tape is stored; and means for expressing the bodily fluid from the incision.
2. The sampling device of claim 1, wherein said means for expressing the bodily fluid includes a vacuum assembly operable to draw the bodily fluid from the incision via suction.
3. The sampling device of claim 2, further comprising:
a piercing device to pierce the skin, said piercing device defining a cavity that is operatively coupled to said vacuum assembly to draw the bodily fluid from the incision to said test media tape.
4. The sampling device of claim 3, wherein said test media tape includes separate test sections, each of said test sections including a vacuum passageway defined in said test media tape and a seal membrane, said seal membrane being adapted to be pierced and seal around said piercing device when the bodily fluid is collected, each of said test sections further including a test pad positioned between said vacuum passageway and said seal membrane, said test pad being adapted to collect the bodily fluid.
5. The sampling device of claim 4, further comprising:
a sensor positioned proximal to said test media tape to analyze the bodily fluid.
6. The sampling device of claim 1, further comprising:
a piercing device to pierce the skin.
7. ~The sampling device of claim 6, further comprising:
a sensor positioned proximal to said test media tape to analyze the bodily fluid.
8. ~The sampling device of claim 1, further comprising:
a sensor positioned proximal to said test media tape to analyze the bodily fluid.
9. ~The sampling device of claim 8, wherein said sensor includes an optical sensor.
10. ~The bodily fluid sampling device of claim 1, wherein:
said supply portion includes a supply reel around which an uncontaminated section of said test media tape is wound; and said storage portion includes a storage reel around which a contaminated section of said test media tape is wound.
11. ~A bodily fluid sampling device, comprising:
a test media cassette including a test media tape configured to collect the bodily fluid, a supply portion configured.to store. an uncontaminated section of the test media tape that is uncontaminated with the bodily fluid, and a storage portion configured to store a contaminated section of the test media tape that is contaminated with the bodily fluid; and a vacuum assembly positioned proximal the test media cassette to draw the bodily fluid from the incision via suction for collection by the test media tape.
12. The sampling device of claim 11, further comprising:
a piercing device to pierce the skin, the piercing device defining a cavity that is operatively coupled to the vacuum assembly to draw the bodily fluid from the incision to the test media tape.
13. The sampling device of claim 12, wherein the test media tape includes separate test sections, each of the test sections including a vacuum passageway defined in the test media tape and a seal membrane, the seal membrane being adapted to be pierced and seal around the piercing device when the bodily fluid is collected, each of the test sections further including a test pad positioned between the vacuum passageway and the seal membrane, the test pad being adapted to collect the bodily fluid.
14. The sampling device of claim 13, further comprising:
a sensor positioned proximal to the test media tape to analyse the bodily fluid.
15. A test media cassette, comprising:
a test media tape on which bodily fluid from an incision is collected;
a cover tape covering the test media tape to preserve the test media tape;
a supply reel from which the test media tape is supplied; and a storage reel around which the test media tape is stored.
16. The test media cassette of claim 15, further comprising:
a cover reel attached to the cover tape, the cover reel being adapted to peel the cover tape from the test media tape before exposure to the bodily fluid.
17. The test media cassette of claim 15, further comprising:
a cover including a supply portion in which the supply reel is rotatably mounted, a storage portion in which the storage reel is rotatably mounted, the cover defining an exposure opening along the test media tape at which the test media tape is exposed to the bodily fluid.
18. A bodily fluid sampling device, comprising:
a test media tape on which bodily fluid from an incision is collected, wherein the test media tape includes a test pad containing a reagent for testing the bodily fluid, and a blister pack positioned proximal to the test pad, the blister pack having a raised surface adapted to draw the bodily fluid to the test pad through capillary action;
a supply portion from which the test media tape is supplied; and a storage portion in which the test media tape is stored.
19. The sampling device of claim 18, further comprising:
a piercing device adapted to pierce skin; and the test media tape defining a throughway to allow passage of the piercing device through the test media tape during piercing of the skin.
20. A method, comprising:
expressing bodily fluid from an incision in skin with a sampling device that includes a test media cassette, wherein the test media cassette includes a test media tape, a supply portion from which the test media tape is supplied and a storage portion in which the test media tape is stored; and collecting the bodily fluid from the incision with the test media tape of the test media cassette.
21. The method of claim 20, wherein said expressing includes drawing the bodily fluid from the incision via suction.
22. The method of claim 21, further comprising:
wherein the sampling device includes a piercing device that has a cavity and a vacuum assembly to create suction in the cavity;
forming the incision in the skin with the piercing device;
wherein said drawing the bodily fluid from the incision includes creating suction in the cavity of the piercing device with the vacuum assembly; and wherein said collecting includes transporting the bodily fluid through the cavity from the incision to the test strip.
23. The method of claim 22, further comprising:

wherein the test media tape defines a passageway, includes a seal membrane adapted to seal around a piercing device and includes a test pad positioned between the passageway and the seal membrane; and puncturing the seal membrane of the test media tape with the piercing device.
24. The method of claim 20, further comprising:
advancing the test media tape to store a portion of the test media contaminated with the bodily fluid in the storage portion.
25. The method of claim 20, further comprising:
wherein the sampling device includes a piercing device; and forming the incision in the skin with the piercing device.
26. The method of claim 20, further comprising analyzing the fluid collected on the test media strip with a sensor in the sampling device.
27. The method of claim 26, wherein the sensor includes an optical sensor and said analyzing includes optically testing the fluid.
28. A method, comprising:
contacting a sampling device against skin, wherein the sampling device includes a piercing device and a test media cassette moveably coupled to the sampling device, wherein the test media cassette includes a test media tape, a supply portion from which the test media tape is supplied and a storage portion in which the test media tape is stored;
piercing the skin with the piercing device to form an incision in the skin while the sampling device remain in contact with the skin; and moving the test media cassette towards the incision to collect bodily fluid from the incision with the test media tape while the sampling device remain in contact with the skin.
29. The method of claim 28, wherein:
the test media cassette is pivotally mounted in the sampling device; and said moving includes pivoting the test media cassette towards the incision to collect the bodily fluid from the incision.
CA2450104A 2001-06-08 2002-06-07 Bodily fluid sampling device and test media cassette to be used with such a device Expired - Lifetime CA2450104C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2694412A CA2694412C (en) 2001-06-08 2002-06-07 Bodily fluid sampling device and test media cassette to be used with such a device

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US29698901P 2001-06-08 2001-06-08
US60/296,989 2001-06-08
PCT/US2002/018159 WO2002100274A1 (en) 2001-06-08 2002-06-07 Bodily fluid sampling device and test media cassette to be used with such a device

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2694412A Division CA2694412C (en) 2001-06-08 2002-06-07 Bodily fluid sampling device and test media cassette to be used with such a device

Publications (2)

Publication Number Publication Date
CA2450104A1 true CA2450104A1 (en) 2002-12-19
CA2450104C CA2450104C (en) 2010-05-11

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Family Applications (2)

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CA2450104A Expired - Lifetime CA2450104C (en) 2001-06-08 2002-06-07 Bodily fluid sampling device and test media cassette to be used with such a device
CA2694412A Expired - Lifetime CA2694412C (en) 2001-06-08 2002-06-07 Bodily fluid sampling device and test media cassette to be used with such a device

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA2694412A Expired - Lifetime CA2694412C (en) 2001-06-08 2002-06-07 Bodily fluid sampling device and test media cassette to be used with such a device

Country Status (8)

Country Link
US (5) US6988996B2 (en)
EP (1) EP1416851B1 (en)
JP (3) JP3845413B2 (en)
AT (2) ATE335435T1 (en)
CA (2) CA2450104C (en)
DE (2) DE60213822T2 (en)
ES (2) ES2315961T3 (en)
WO (1) WO2002100274A1 (en)

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