GB2323792B - Body fluid sampling device and methods of use - Google Patents

Body fluid sampling device and methods of use

Info

Publication number
GB2323792B
GB2323792B GB9810082A GB9810082A GB2323792B GB 2323792 B GB2323792 B GB 2323792B GB 9810082 A GB9810082 A GB 9810082A GB 9810082 A GB9810082 A GB 9810082A GB 2323792 B GB2323792 B GB 2323792B
Authority
GB
United Kingdom
Prior art keywords
needle
skin
plunger
sample
fluid sampling
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.)
Expired - Lifetime
Application number
GB9810082A
Other languages
English (en)
Other versions
GB9810082D0 (en
GB2323792A (en
Inventor
Brent G Duchen
Joel S Douglas
Jeffrey N Roe
Ryszard Radwanski
Andrew M Drexler
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.)
Mercury Diagnostics Inc
Original Assignee
Mercury Diagnostics Inc
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 Mercury Diagnostics Inc filed Critical Mercury Diagnostics Inc
Publication of GB9810082D0 publication Critical patent/GB9810082D0/en
Publication of GB2323792A publication Critical patent/GB2323792A/en
Application granted granted Critical
Publication of GB2323792B publication Critical patent/GB2323792B/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186Devices 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045Devices for taking samples of body liquids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring 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
    • A61B5/14532Measuring 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
    • AHUMAN NECESSITIES
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    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/150022Source of blood for capillary blood or interstitial fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150053Details 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
    • A61B5/150061Means for enhancing collection
    • A61B5/150068Means for enhancing collection by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
    • AHUMAN NECESSITIES
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    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150053Details 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
    • A61B5/150061Means for enhancing collection
    • A61B5/150083Means for enhancing collection by vibration, e.g. ultrasound
    • AHUMAN NECESSITIES
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    • A61B5/150007Details
    • A61B5/150053Details 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
    • A61B5/150061Means for enhancing collection
    • A61B5/150099Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
    • AHUMAN NECESSITIES
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    • A61B5/150007Details
    • A61B5/150053Details 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
    • A61B5/150106Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced
    • A61B5/150137Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced by vibration
    • AHUMAN NECESSITIES
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    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150053Details 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
    • A61B5/150106Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced
    • A61B5/15016Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced by accessories for bringing the piercing element into the body, e.g. through rotation of the piercing element
    • AHUMAN NECESSITIES
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    • A61B5/150007Details
    • A61B5/150175Adjustment of penetration depth
    • A61B5/15019Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism
    • AHUMAN NECESSITIES
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    • A61B5/150007Details
    • A61B5/150175Adjustment of penetration depth
    • A61B5/150198Depth adjustment mechanism at the proximal end of the carrier of the piercing element
    • AHUMAN NECESSITIES
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    • A61B5/150007Details
    • A61B5/150343Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes
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    • A61B5/150007Details
    • A61B5/150358Strips for collecting blood, e.g. absorbent
    • AHUMAN NECESSITIES
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    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150389Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • A61B5/150396Specific tip design, e.g. for improved penetration characteristics
    • AHUMAN NECESSITIES
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    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150412Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A61B5/150419Pointed piercing elements, e.g. needles, lancets for piercing the skin comprising means for capillary action
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150412Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A61B5/150427Specific tip design, e.g. for improved penetration characteristics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150473Double-ended needles, e.g. used with pre-evacuated sampling tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150503Single-ended needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150503Single-ended needles
    • A61B5/150519Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150801Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
    • A61B5/150824Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming by visual feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150977Arrays of piercing elements for simultaneous piercing
    • AHUMAN NECESSITIES
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    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150977Arrays of piercing elements for simultaneous piercing
    • A61B5/150984Microneedles or microblades
    • AHUMAN NECESSITIES
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    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15103Piercing procedure
    • A61B5/15107Piercing being assisted by a triggering mechanism
    • A61B5/15111Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
    • AHUMAN NECESSITIES
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    • A61B5/15101Details
    • A61B5/15103Piercing procedure
    • A61B5/15107Piercing being assisted by a triggering mechanism
    • A61B5/15113Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
    • AHUMAN NECESSITIES
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    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15115Driving 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
    • A61B5/15117Driving 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
    • AHUMAN NECESSITIES
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    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15134Bladeless capillary blood sampling devices, i.e. devices for perforating the skin in order to obtain a blood sample but not using a blade, needle, canula, or lancet, e.g. by laser perforation, suction or pressurized fluids
    • A61B5/15136Bladeless capillary blood sampling devices, i.e. devices for perforating the skin in order to obtain a blood sample but not using a blade, needle, canula, or lancet, e.g. by laser perforation, suction or pressurized fluids by use of radiation, e.g. laser
    • AHUMAN NECESSITIES
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    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186Devices 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
    • A61B5/15188Constructional features of reusable driving devices
    • A61B5/1519Constructional features of reusable driving devices comprising driving means, e.g. a spring, for propelling the piercing unit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186Devices 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
    • A61B5/15188Constructional features of reusable driving devices
    • A61B5/15192Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
    • A61B5/15194Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
    • AHUMAN NECESSITIES
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    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/157Devices characterised by integrated means for measuring characteristics of blood
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B82NANOTECHNOLOGY
    • B82YSPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
    • B82Y30/00Nanotechnology for materials or surface science, e.g. nanocomposites
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045Devices for taking samples of body liquids
    • A61B2010/008Interstitial fluid
    • AHUMAN NECESSITIES
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    • A61B17/00Surgical instruments, devices or methods
    • A61B2017/00743Type of operation; Specification of treatment sites
    • A61B2017/00747Dermatology
    • A61B2017/00765Decreasing the barrier function of skin tissue by radiated energy, e.g. using ultrasound, using laser for skin perforation
    • AHUMAN NECESSITIES
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    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0295Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pathology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Optics & Photonics (AREA)
  • Chemical & Material Sciences (AREA)
  • Emergency Medicine (AREA)
  • Nanotechnology (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Materials Engineering (AREA)
  • Condensed Matter Physics & Semiconductors (AREA)
  • Composite Materials (AREA)
  • General Physics & Mathematics (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • External Artificial Organs (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
  • Optical Measuring Cells (AREA)
  • Surgical Instruments (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Processing And Handling Of Plastics And Other Materials For Molding In General (AREA)
GB9810082A 1996-05-17 1997-05-16 Body fluid sampling device and methods of use Expired - Lifetime GB2323792B (en)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US1713396P 1996-05-17 1996-05-17
US1991896P 1996-06-14 1996-06-14
US2365896P 1996-08-01 1996-08-01
US2534096P 1996-09-03 1996-09-03
US71454896A 1996-09-16 1996-09-16
US71045696A 1996-09-17 1996-09-17
US72707496A 1996-10-08 1996-10-08
PCT/US1997/008402 WO1997042886A1 (en) 1996-05-17 1997-05-16 Body fluid sampling device and methods of use

Publications (3)

Publication Number Publication Date
GB9810082D0 GB9810082D0 (en) 1998-07-08
GB2323792A GB2323792A (en) 1998-10-07
GB2323792B true GB2323792B (en) 2000-05-10

Family

ID=27567563

Family Applications (4)

Application Number Title Priority Date Filing Date
GB9810082A Expired - Lifetime GB2323792B (en) 1996-05-17 1997-05-16 Body fluid sampling device and methods of use
GB9810081A Expired - Fee Related GB2322561B (en) 1996-05-17 1997-05-16 Methods and apparatus for expressing body fluid from an incision
GB9811003A Expired - Lifetime GB2322562B (en) 1996-05-17 1997-05-16 Disposable element for use in a body fluid sampling device
GB9811004A Expired - Lifetime GB2325167B (en) 1996-05-17 1997-05-16 Blood and interstitial fluid sampling device

Family Applications After (3)

Application Number Title Priority Date Filing Date
GB9810081A Expired - Fee Related GB2322561B (en) 1996-05-17 1997-05-16 Methods and apparatus for expressing body fluid from an incision
GB9811003A Expired - Lifetime GB2322562B (en) 1996-05-17 1997-05-16 Disposable element for use in a body fluid sampling device
GB9811004A Expired - Lifetime GB2325167B (en) 1996-05-17 1997-05-16 Blood and interstitial fluid sampling device

Country Status (11)

Country Link
EP (2) EP0955909B1 (enExample)
JP (2) JP3356782B2 (enExample)
AT (2) ATE381904T1 (enExample)
AU (6) AU3206797A (enExample)
DE (11) DE69733836T2 (enExample)
DK (3) DK64798A (enExample)
ES (2) ES2284185T3 (enExample)
GB (4) GB2323792B (enExample)
IL (3) IL124425A0 (enExample)
MX (2) MX9804093A (enExample)
WO (4) WO1997042888A1 (enExample)

Families Citing this family (226)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5593852A (en) 1993-12-02 1997-01-14 Heller; Adam Subcutaneous glucose electrode
EP1579814A3 (en) 1996-05-17 2006-06-14 Roche Diagnostics Operations, Inc. Methods and apparatus for sampling and analyzing body fluid
US7828749B2 (en) 1996-05-17 2010-11-09 Roche Diagnostics Operations, Inc. Blood and interstitial fluid sampling device
US7666150B2 (en) * 1996-05-17 2010-02-23 Roche Diagnostics Operations, Inc. Blood and interstitial fluid sampling device
US20020010406A1 (en) 1996-05-17 2002-01-24 Douglas Joel S. Methods and apparatus for expressing body fluid from an incision
US5951493A (en) 1997-05-16 1999-09-14 Mercury Diagnostics, Inc. Methods and apparatus for expressing body fluid from an incision
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