WO2003039369A1 - Method and apparatus for sampling bodily fluid - Google Patents

Method and apparatus for sampling bodily fluid Download PDF

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Publication number
WO2003039369A1
WO2003039369A1 PCT/US2002/030531 US0230531W WO03039369A1 WO 2003039369 A1 WO2003039369 A1 WO 2003039369A1 US 0230531 W US0230531 W US 0230531W WO 03039369 A1 WO03039369 A1 WO 03039369A1
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WO
WIPO (PCT)
Prior art keywords
incision
skin
suction
syringe
bodily fluid
Prior art date
Application number
PCT/US2002/030531
Other languages
French (fr)
Inventor
Edward P. Perez
Original Assignee
Roche Diagnostics Gmbh
F. Hoffmann-La Roche Ag
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 Roche Diagnostics Gmbh, F. Hoffmann-La Roche Ag filed Critical Roche Diagnostics Gmbh
Priority to CA002461370A priority Critical patent/CA2461370A1/en
Priority to JP2003541466A priority patent/JP4320255B2/en
Priority to EP02775995A priority patent/EP1432353A1/en
Publication of WO2003039369A1 publication Critical patent/WO2003039369A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other 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
    • A61B10/0045Devices for taking samples of body liquids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices 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
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • 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
    • A61B5/150053Details 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
    • 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
    • A61B5/150053Details 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
    • 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
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150236Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
    • 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
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150244Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
    • 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
    • A61B5/150374Details 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
    • 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
    • A61B5/150374Details 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
    • 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
    • A61B5/15101Details
    • 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
    • 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
    • A61B5/15101Details
    • 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
    • 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
    • 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
    • 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
    • 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
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other 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
    • A61B10/0045Devices for taking samples of body liquids
    • A61B2010/008Interstitial fluid

Definitions

  • the present invention relates to lancing devices and methods for obtaining samples of blood and other fluids from a body for analysis or processing.
  • Lancets in conventional use generally have a rigid body and a sterile needle which protrudes from one end.
  • the lancet may be used to pierce the skin, thereby enabling the collection of a blood sample from the opening created.
  • the blood is transferred to a test device or collection device.
  • Blood is most commonly taken from the fingertips, where the supply is generally excellent.
  • the fingertips become sensitive or calloused thereby making it difficult to obtain a sample.
  • the nerve density in this region causes significant pain in many patients. Therefore alternate sampling sites, such as earlobes and limbs, is sometimes practiced to access a bodily fluid sample.
  • U.S. Pat. No. 4,503,856, Cornell et al. describes a spring loaded lancet injector.
  • the reusable device interfaces with a disposable lancet.
  • the lancet holder may be latched in a retracted position.
  • a spring causes the lancet to pierce the skin at high speed and then retract. The speed is important to reduce the pain associated with the puncture.
  • Some blood glucose monitoring systems require that the blood sample be applied to a test device which is in contact with a test instrument. In such situations, bringing the finger of a patient directly to the test device poses some risk of contamination from blood of a previous patient.
  • it is common to lance a patient collect a sample in a micropipette via capillary action and then deliver the sample from the pipette to the test device.
  • Haynes U.S. Pat. No. 4,920,977 describes a blood collection assembly with lancet and microcollection tube. This device incorporates a lancet and collection container in a single device. The lancing and collection are two separate activities, but the device is a convenient single disposable unit for situations when sample collection prior to use is desirable. Similar devices are disclosed in Sarrine U.S. Pat. No. 4,360,016, and OBrien U.S. Pat. No. 4,924,879.
  • Single use devices have also been developed for single use tests, i.e. home cholesterol testing, and for institutional use to eliminate cross-patient contamination multi-patient use.
  • Grossman et al. U.S. Pat. No.4,869,249, and Swierczek U.S. Pat. No. 5,402,798, also disclose disposable, single use lancing devices.
  • U.S. Pat. No. 5,421,816; 5,445,611; and 5,458,140 disclose, as a replacement for invasive sampling, the use of ultrasound to act as a pump for expressing interstitial fluid directly through intact (non-lanced) skin. The amount of fluid which can be obtained in that way is very limited, however.
  • An object of the present invention therefore, is to provide a device and a method for obtaining a sample of bodily fluid through the skin which is virtually pain free and minimally invasive.
  • Another object of this invention is to provide a method which can result in a sample of either blood or interstitial fluid, depending on the sample site and the penetration depth utilized. While there are no commercially available devices utilizing interstitial fluid (ISF) at this time, there are active efforts to establish the correlation of analytes, such as glucose, in ISF compared to whole blood. If ISF could be readily obtained and correlation is established, ISF may be preferable as a sample since there is no interference of red blood cells or hematocrit adjustment required.
  • ISF interstitial fluid
  • Another object of this invention is to provide a method which can draw a small but adjustable sample, i.e. 3 microliters for one test device and 8 microliters for another test device, as appropriate.
  • Another object of this invention is to provide a method by which the drawn sample is collected and may be easily presented to a testing device, regardless of the location of the sample site on the body.
  • This approach helps with infection control in that multiple patients are not brought in contact with a single test instrument; only the sampling device with a disposable patient-contact portion is brought to the test instrument.
  • the disposable portion of a test device may be physically coupled with the sampler so the sample can be brought directly into the test device during sampling.
  • the test device may then be read in a test instrument if appropriate or the testing system can be integrated into the sampler and the test device can provide direct results displayed for the patient.
  • It is a further object of the invention is to provide a device for minimally invasive sampling comprising a reusable sampler and disposable sample collection.
  • Yet another object of the present invention is to provide a method of increasing the amount of bodily fluid available for sampling.
  • a method for sampling blood comprising the steps of placing a forward end of a housing against a skin surface, advancing a hollow piercing element forwardly to cut an incision through the skin surface, and depressing a ring of body tissue in surrounding relationship to the incision to spread apart sides of the incision while urging bodily fluid toward and into the incision. Simultaneously, the piercing element is moved within the incision to keep the incision open. A suction may be applied to the skin to aid the pooling of bodily fluid in the area of the incision. Additionally, a suction may be applied to the piercing element to draw in bodily fluid from the incision and into a tube communicating with the piercing element.
  • the sampling device comprises a housing, a piercing element carrier mounted in the housing and carrying a hollow piercing element.
  • a tube communicates with the piercing element.
  • a driver mechanism mounted in the housing drives the syringe carrier forwardly to cut an incision in the skin and maintain and end of the piercing element in the incision.
  • a stimulator mechanism disposed on the housing depresses a ring of body tissue in surrounding relationship to the incision to spread apart sides of the incision while urging bodily fluid toward the incision.
  • a syringe-moving mechanism disposed on the housing moves the end of the piercing element relative to the incision to maintain the incision open while the stimulator mechanism urges bodily fluid thereto.
  • a suction mechanism disposed on the housing creates a suction to cause bodily fluid to pool in the area to be incised, as will be described in greater detail below. Additionally, the suction element may be applied to the tube and utilized for drawing in bodily fluid through the piercing element and into the tube.
  • Still another aspect of the invention relates to a device for obtaining a sampling of a bodily fluid through the skin
  • a housing member containing a hollow piercing element for piercing the skin.
  • a first spring member disposed in the housing urges the piercing element to protrude from a forward end of the housing sufficient to cut an incision through the skin.
  • a stop member defines a maximum penetration depth of the piercing element.
  • a second spring disposed in the housing partially retracts the piercing element while maintaining a front end of the piercing element in the incision.
  • a tube communicates with a rear end of the piercing element.
  • a suction mechanism creates a suction in the tube for drawing in bodily fluid through the piercing element.
  • FIG. 1 is a longitudinal sectional view taken through a sampling device according to the present invention, with a syringe thereof in an armed state;
  • FIG. 2 is a view similar to FIG. 1 after the syringe has been triggered and forms an incision in a skin surface;
  • FIGS. 3 is a view similar to FIG. 2 after a suction mechanism has been actuated to draw in bodily fluid through the syringe;
  • FIG. 3 A is a sectional view taken along the line 3 A— 3 A in FIG. 3;
  • FIG. 4 is a schematic view of a syringe being reciprocated longitudinally within an incision according to the present invention
  • FIG. 5 is a schematic view of a syringe being reciprocated laterally within an incision according to the present invention
  • FIG. 6 is a schematic view of a syringe being oscillated in an elliptical direction according to the present invention
  • FIG. 7 is a schematic view of a syringe being rotated within an incision according to the present invention.
  • FIG. 8 is a longitudinal sectional view of a lower portion of a modified sampling device according to the present invention, with a syringe disposed in a retracted state;
  • FIG. 9 is a view similar to FIG. 8 after the syringe has been urged forwardly;
  • FIG. 10 is a side elevational view of a lower end of a syringe having a stop member fixed thereto according to the present invention.
  • FIG. 11 is a sectional view taken along the line 11-11 in FIG. 10;
  • FIG. 12 is a top view of a integrated testing/lancing apparatus according to one embodiment of the present invention.
  • FIG. 13 is a cross-sectional side view illustrating an integrated lancet and test strip holder according to the present invention.
  • FIG. 14 is a side view illustrating the anti-coring needle in accordance with a lancing device of the present invention.
  • FIGS. 1-3 Depicted in FIGS. 1-3 is a bodily fluid sampling device 10 comprising an outer cylindrical housing 12. Screwed into an upper end of the housing 12 is a fixing sleeve 14 in which are formed upper and lower recesses 16, 18. The upper recess 16 has an internal screw thread connected to an externally threaded stop ring 20 which can be adjusted to a selected vertical position relative to the housing.
  • a hollow drive rod 22 Screwed onto a lower end of the drive rod 22 is a syringe carrier 24.
  • a syringe carrier 24 Mounted in a lower end of the carrier 24 is a syringe 26 of the type which includes a longitudinal capillary passage 28 (see FIG. 4). That passage is preferably offset laterally with respect to a center axis of the syringe.
  • any suitable type of hollow piercing element can be employed, such as a needle or sharp cannula, for example.
  • An upper end of the syringe communicates with a sampling tube 30, an upper end of the tube fitting into a lower recess 32 formed in the drive rod 22.
  • the drive rod 22 includes a radial enlargement 33 in which an outwardly open, annular groove 34 is formed that is sized to receive a pin 36 of a first trigger 38.
  • a plunger 40 Slidably mounted within the sampling tube 30 is a plunger 40 having a soft tip 42 that snugly (sealingly) engages an inner surface of the tube 30.
  • An upper end of the plunger 40 is fixed to the lower end of a drawbar 46 which slides within a center bore of the drive rod 22.
  • a mounting sleeve 48 Screwed to an upper end of the drive rod 22 is a mounting sleeve 48 in which a second trigger 50 is mounted for lateral sliding movement.
  • a center hole 52 Formed in the second trigger 50 is a center hole 52 that is larger than the outer diameter of the drawbar 46.
  • the drawbar 46 has a recess 54 sized to receive respective sides of the hole 52.
  • a drive spring 56 in the form of a coil compression spring acts between the enlargement 33 and the fixing sleeve 14. Resting on the fixing sleeve 14 is a retraction spring 58 in the form of a coil compression spring. Acting between the enlargement 33 and the top of the plunger 40 is a suction spring 60 in the form of a coil compression spring.
  • piezoelectric transducer 66 Mounted on the syringe carrier 24 is a piezoelectric transducer 66 which is electrically connected to a battery 68. Piezoelectric transducers are conventional types of vibrators which can be oriented to produce vibrations in any desired direction. A lower end of the piezoelectric transducer 66 is in contact with the syringe for vibrating the syringe, i.e., either vertically (longitudinally), laterally, or elliptically (a combination of vertical and lateral vibrations).
  • a stimulator sleeve 70 Disposed at a lower end of the housing 12 is a stimulator sleeve 70. That sleeve has an annular lower face 72 of frusto-conical shape, and is screwed into a sleeve carrier 74. Projecting from diametrically opposite positions of the sleeve carrier 74 are pins 76 which are slidably disposed in respective vertical slots 78 formed in the housing 12.
  • each drive gear 80 Rotatably mounted on diametrically opposite sides of the housing 12 are a pair of identical drive gears 80 (see also FIG. 3A). Formed in an inner surface of each drive gear 80 is a cam groove 82 in which a respective pin 76 projects. Mounted above the drive gear for rotation about a central longitudinal axis of the housing is a ring gear 84 which is rotated by an output pinion 86 of an electric motor 88. The underside of the ring gear 84 is formed with teeth that mesh with teeth formed around the outer peripheries of the drive gears 80. Therefore, rotation of the pinion gear 86 is transmitted to the drive gears 80 to rotate the drive gears. The accompanying rotation of the eccentric grooves 82 of the drive gears causes the pins 76, and thus the sleeve carrier 74, to reciprocate vertically, along with the stimulator sleeve.
  • the mounting sleeve 48 is pulled upwardly by a user until a beveled face 90 of the enlargement 33 of the drive rod 22 cams the first trigger 38 laterally outwardly.
  • the first trigger is urged inwardly by a spring (not shown) to insert the pin 36 into the groove 34 for retaining the drive rod 22 in the armed state (FIG. 1).
  • the drive spring 56 is compressed from a relaxed state, and the syringe carrier 24, together with the syringe 26, is raised.
  • the drawbar 46 is retained by the second trigger 50, with the suction spring 60 disposed in a compressed state.
  • the lower end 72 of the housing 12 is placed against the skin surface S, preferably at a portion of the body having fewer nerve endings than, say the fingertip.
  • a forearm would be a suitable location.
  • Suction may be applied to the skin surface S at this time.
  • the suction may be applied and held, or applied and released prior to the syringe cutting the skin.
  • the trigger 38 is then pulled out against a spring bias to release the drive rod 22 and the compressed drive spring 56.
  • the drive rod 22, the syringe carrier 24, and syringe 26 are driven downwardly, so that the syringe cuts an incision I through the skin surface S, as shown in FIG. 2.
  • the mounting sleeve 48 engages an upper end of the retraction spring 58 and then abuts the stop ring 20, thereby limiting the incision depth and slightly compressing the retraction spring 58.
  • the retraction spring 58 then moves the drive rod 22 slightly upwardly, but not enough to completely remove the syringe 26 from the incision I.
  • the motor 88 is actuated, either manually, or automatically in response to the firing of the syringe, to vertically reciprocate the stimulator sleeve 70. Consequently, the lower face 72 repeatedly depresses a ring of skin and body tissue which surrounds the incision.
  • Each depression of that ring causes the incision to bulge and the sides of the incision to be spread apart, and urges bodily fluid such as blood or interstitial fluid toward and outwardly through the incision I, as explained also in commonly assigned U.S Patents No. 5,879,311, and 5,591,493.
  • the syringe 26 is vibrated relatively slowly by the piezoelectric transducer 66 to keep the incision open.
  • the direction of vibration can be determined by the particular orientation of the transducer 66.
  • the direction of vibration is longitudinal or vertical (FIG. 4); in another embodiment the vibration is lateral (FIG. 5); in another embodiment the vibration is a combination of lateral and vertical, i.e., generally elliptical oscillation (-FIG. 6).
  • the second trigger 50 is manually actuated to release the drawbar 46, causing the spring 60 to raise the plunger 40 within the tube 30. That produces a suction in the tube 30 below the plunger 40, which draws in a sample 91 of bodily fluid through the syringe 26 (FIG. 3).
  • the device can be removed from the skin, and the sample delivered to a suitable test site.
  • the device may contain a test device in conjunction with the sampling device described above. Suitable test devices which may be incorporated with the sampler described above are shown and described in co-pending U.S. Patent Application No. (Insert)
  • the syringe can be rotated about its own center axis while disposed in the incision I.
  • a rotatable syringe 92 as shown in FIG. 7 can be utilized in a device 10' shown in FIGS. 8 and 9. That device 10' is similar to that depicted in FIGS. 1-3 with the addition of a rotary gear 94 that is driven by a pinion 95 of a second motor 96.
  • the gear 94 includes an upwardly open recess 98 sized to receive, with a snug fit, a lower end 100 of the tube 30 in which the syringe 92 is disposed.
  • the lower portion 100 of the tube 30 enters the recess 98 to create a frictional engagement between the tube 30 and the gear 94 (see FIG. 9).
  • the syringe 92 includes a pointed end 102 in the form of one-half of a cone. As the syringe rotates about its own axis, the semi-conical segment 102 cuts a conical recess 104 in the incision and keeps the incision open as the stimulator sleeve 70 reciprocates.
  • any of the syringes described thus far can be provided with a stop which would replace the stop ring 20.
  • a stop 110 is shown in FIGS. 10 and 11 in connection with the syringe 92.
  • the stop 110 comprises a disc fixed to the syringe. When the disc contacts the skin surface, no further entry of the syringe into the skin can occur.
  • the stop ring 20 could also be used to open and close the incision to promote bodily fluid pooling.
  • the present invention minimizes the pain experienced by a user, because it can be used to provide a sample of bodily fluid at an area of the body which contains fewer nerve endings than in an area such as the finger tips.
  • bodily fluid is caused to pool in the incision, thereby providing an ample sample to be sucked through the syringe and into a collection tube.
  • an area of the body less sensitive to pain can be used as a source of bodily fluid.
  • the stimulator member 70 is disclosed as having a generally annular skin contacting surface, i.e., a surface which is symmetric about the center axis thereof, the member 70 could instead have an elliptical or polygonal end face whereby the ring of body tissue depressed thereby would have a corresponding shape.
  • An alternative method according to the present invention includes the use of a suction device prior to use of the lancing device.
  • the lower end of the housing 12 is placed against the skin surface S, preferably at a portion of the body where the sample is to be taken from. For example, a forearm would be a suitable location.
  • a vacuum source is activated whereupon the skin S adjacent the lower end of the housing 12 is drawn into the frusto-conical shaped distal tip.
  • the suction causes bodily fluid beneath the skin to pool in the area of skin S in contact with the testing device 10.
  • the vacuum is released thereby releasing the skin.
  • the trigger 38 is then pulled out against a spring bias to release the drive rod 22 and the compressed drive spring 56.
  • the drive rod 22, the syringe carrier 24, and syringe 26 are driven downwardly, so that he syringe cuts an incision I through the skin surface S.
  • the mounting sleeve 48 engages an upper end of the retraction spring 58 and then abuts the stop ring 20, thereby limiting the incision depth and slightly compressing the retraction spring 58.
  • the retraction spring 58 then moves the drive rod 22 slightly upwardly, but not enough to completely remove the syringe 26 from the incision I.
  • the motor 88 is actuated, either manually, or automatically in response to the firing of the syringe, to vertically reciprocate the stimulator sleeve 70.
  • the lower face 72 repeatably depresses a ring of skin and body tissue which surrounds the incision.
  • the depression of the ring causes the skin adjacent the incision to bulge and the sides of the incision spread apart, such that bodily fluid is urged from the incision in response to the applied force.
  • the second trigger 50 is manually actuate to release the drawbar 46, causing the spring 60 to raise the plunger 40 within the tube 30. This produces suction in the tube 30 below the plunger 40, which draws in a sample 91 of bodily fluid through the syringe.
  • the sample may then be delivered to an appropriate test media or testing device as described above.
  • the vacuum may be repeatedly applied to the skin prior to deployment of the needle to form the incision I.
  • a vacuum source to the skin S this encourages bodily fluid to pool in the location adjacent to where the incision is to be made. Because bodily fluid is pooled in this area prior to formation of the incision I, once the incision I is formed the a sample is bodily fluid is easily collected because of the large volume of fluid available within the area.
  • the vacuum mechanism may be activated after the incision is formed to further express fluid from the incision.
  • a vibratory force, a heat force, and/or an ultrasonic force may be applied to the area to be lanced to further the expression of bodily fluid.
  • the vacuum may be repeatedly applied to the skin after the formation of incision I. Repeated application of a vacuum after the incision is formed encourages bodily fluid to continue to pool in the area adjacent to the incision, thereby aiding collection of the bodily fluid.
  • the test device 100 comprises a main body 120, a test strip holder/tip assembly 130, and a lancing device 150.
  • the functions of the testing device 100 are similar to that as described above with reference to testing device 10.
  • the testing device 100 is prepared for use by first inserting a disposable lancet/test strip holder and test strip into the lancing device 150.
  • the lancing device 150 is then prepared for use by pulling up on a driving mechanism (not shown) thereby compressing a driving spring (not shown).
  • the device 100 is placed over an area to be lanced, wherein a vacuum mechanism disposed within the main body 120 and in communication with the tip assembly 130 is then activated. Skin S is drawn into the distal end of the device 100.
  • the vacuum mechanism may then be deactivated thereby releasing the vacuum force on the skin, or repeatedly activated and deactivated.
  • device 100 releases the driving spring, wherein a lancet is advanced through the patient's skin to form an incision I therein.
  • the lancet may then be retracted from the incision I.
  • the vacuum device may be activated, activated and deactivated, or repeatedly activated and deactivated after forming the incision.
  • a vibratory force may be applied to the lancet, the vibratory force may be applied vertically, horizontally, or any combination thereof.
  • a sample of bodily fluid may then be withdrawn from the incision and transported to a test area.
  • the sample may be withdrawn from the incision through a capillary tube having one end disposed within the end of the test device 100 and the other end in communication with a chemical pad of a test strip and or electrochemical measuring device.
  • the test strip may include capillary means such as a capillary tube or a cascading capillary.
  • the test strip may be disposed adjacent to the distal end of the testing device wherein the lancet passes through an aperture in the test strip.
  • the test strip may further include a gasket and/or a deep dermal constriction device.
  • the test device 200 may include a test strip (not pictured) and lancet 220 which may be formed as an integrated unit.
  • the lancet 220 may be embodied in the form of an anti-coring needle having a pre-bent radius of curvature R and a fluid inlet 223 such as that described in co-pending provisional patent application no. 60/297,098 filed on June 8, 2001, the entirety of which is herein incorporated by reference.
  • the test device is placed over the area to be lanced, a vacuum is drawn on the skin thereby increasing the amount of bodily fluid adjacent the test device. The vacuum is release and the lancet is advanced thereby forming an incision within the patient's skin.
  • Bodily fluid may then be withdrawn from the incision.
  • the bodily fluid is then collected using one of the devices described above.
  • the test device may be removed from the patient's skin, this may be prompted by a audible and/or visual marker.
  • the test device will then deliver to the patient a visual indication of the test results.

Abstract

Bodily fluid is sampled by causing a syringe mounted in a housing to be displaced toward a skin surface. A suction element disposed on the housing is utilized to create a suction in the area to be incised causing bodily fluid to pool. Additionally, the suction mechanism may be utilized to create a suction in the tube for drawing in bodily fluid through the piercing element and into the tube. The syringe remains in the resulting incision while the surrounding body tissue is stimulated by a stimulator ring to urge bodily fluid toward the incision. Simultaneously, the syringe may be moved relative to the incision to keep the incision open. Such movement of the syringe may comprise reciprocation in the longitudinal or lateral directions, or both. Alternatively, the movement of the syringe may comprise rotation about a longitudinal center line of the syringe, with the pointed end of the syringe being in the shape of one-half of a cone segment. The suction may then be applied to the area being incised to promote further pooling of bodily fluid. After the bodily fluid has been pooled, suction may be created in a collection tube disposed in communication with the syringe, to draw bodily fluid inwardly through the syringe.

Description

METHOD AND APPARATUS FOR SAMPLING BODILY FLUID
PRIOR APPLICATIONS
This application claims benefit to U.S. Provisional Applications: Ser. No.
60/296,950, 60/297,045, and 60/297,098 each filed June 8, 2001; 60/263,533 filed January 22, 2001; and U.S. Patent Applications Ser. No. 09/528,097 filed March 17, 2000; US97/08401 file May 16, 1997; US97/08400 filed May 16, 1997; 09/887,574 filed June 21, 2001; 09/586,969 filed June 5, 2000; 09/180,839 filed November 16, 1998; 09/542,040 filed March 31, 2000; 09/567,054 filed May 8, 2000; The entireties of each of which are herein incorporated by reference.
HELD OF THE INVENTION
The present invention relates to lancing devices and methods for obtaining samples of blood and other fluids from a body for analysis or processing.
BACKGROUND OF THE INVENTION
Many medical procedures in use today require a relatively small sample of blood, in the range of 3-50 milliliters. It is more cost effective and less traumatic to the patient to obtain such a sample by lancing or piercing the skin at a selected location, such as the finger, to enable the collection of 1 or 2 drops of blood, than by using a phlebotomist to draw a tube of venous blood. With the advent of home use tests such as self monitoring of blood glucose, there is a requirement for a simple procedure which can be performed in any setting by a person needing to test.
Lancets in conventional use generally have a rigid body and a sterile needle which protrudes from one end. The lancet may be used to pierce the skin, thereby enabling the collection of a blood sample from the opening created. The blood is transferred to a test device or collection device. Blood is most commonly taken from the fingertips, where the supply is generally excellent. However, because the patient must perform multiple tests daily, the fingertips become sensitive or calloused thereby making it difficult to obtain a sample. Additionally, the nerve density in this region causes significant pain in many patients. Therefore alternate sampling sites, such as earlobes and limbs, is sometimes practiced to access a bodily fluid sample.
To reduce the anxiety of piercing the skin and the associated pain, many spring loaded devices have been developed. The following two patents are representative of the devices which were developed in the 1980's for use with home diagnostic test products.
U.S. Pat. No. 4,503,856, Cornell et al., describes a spring loaded lancet injector. The reusable device interfaces with a disposable lancet. The lancet holder may be latched in a retracted position. When the user contacts a release, a spring causes the lancet to pierce the skin at high speed and then retract. The speed is important to reduce the pain associated with the puncture.
Levin et al. U.S. Pat. No. 4,517,978 describes a blood sampling instrument. This device, which is also spring loaded, uses a standard disposable lancet. The design enables easy and accurate positioning against a fingertip so the impact site can be readily determined. After the lancet pierces the skin, a bounce back spring retracts the lancet to a safe position within the device.
In institutional settings, it is often desirable to collect the sample from the patient and then introduce the sample to a test device in a controlled fashion. Some blood glucose monitoring systems, for example, require that the blood sample be applied to a test device which is in contact with a test instrument. In such situations, bringing the finger of a patient directly to the test device poses some risk of contamination from blood of a previous patient. With such systems, particularly in hospital settings, it is common to lance a patient, collect a sample in a micropipette via capillary action and then deliver the sample from the pipette to the test device.
Haynes U.S. Pat. No. 4,920,977 describes a blood collection assembly with lancet and microcollection tube. This device incorporates a lancet and collection container in a single device. The lancing and collection are two separate activities, but the device is a convenient single disposable unit for situations when sample collection prior to use is desirable. Similar devices are disclosed in Sarrine U.S. Pat. No. 4,360,016, and OBrien U.S. Pat. No. 4,924,879.
Jordan et al. U.S. Pat. No. 4,850,973 and No. 4,858,607, disclose a combination device which may be alternatively used as a syringe-type injection device and a lancing device with disposable solid needle lancet, depending on configuration.
Lange et al. U.S. Pat. No. 5,318,584 describes a blood lancet device for withdrawing blood for diagnostic purposes. This invention uses a rotary/sliding transmission system to reduce the pain of lancing. The puncture depth is easily and precisely adjustable by the user.
Suzuki et al. U.S. Pat. No. 5,368,047, Dombrowski U.S. Pat. No.4,654,513 and Ishibashi et al. U.S. Pat. No. 5,320,607 each describe suction-type blood samplers. These devices develop suction between the lancing site and the end of the device when the lancet holding mechanism withdraws after piercing the skin. A flexible gasket around the end of the device helps seal the end around the puncture site until adequate sample is drawn from the puncture site or the user pulls back on the device. Garcia et al. U.S. Pat. No. 4,637,403 and Haber et al. U.S. Pat. No. 5,217,480, disclose combination lancing and blood collection devices which use a diaphragm to create a vacuum over the wound site.
Erickson et al. U.S. Pat. No. 5,582,184 describes a means of collecting and measuring bodily fluids. This system uses a coaxial syringe and capillary tube disposed within a spacer member. The spacer member limits the depth of syringe penetration, and compresses body tissue around the syringe while the syringe is in the skin, for improving the flow of interstitial fluid to the syringe. A suction device draws bodily fluid through the syringe and into the capillary tube.
Single use devices have also been developed for single use tests, i.e. home cholesterol testing, and for institutional use to eliminate cross-patient contamination multi-patient use. Grossman et al. U.S. Pat. No.4,869,249, and Swierczek U.S. Pat. No. 5,402,798, also disclose disposable, single use lancing devices. U.S. Pat. No. 5,421,816; 5,445,611; and 5,458,140 disclose, as a replacement for invasive sampling, the use of ultrasound to act as a pump for expressing interstitial fluid directly through intact (non-lanced) skin. The amount of fluid which can be obtained in that way is very limited, however.
The disclosures of the above patents are incorporated herein by reference.
Even with the many improvements which have been made, the pain associated with lancing remains a significant issue for many patients. The need for blood sampling and the fear of the associated pain is also a major obstacle for the millions of diagnosed diabetics, who do not adequately monitor their blood glucose due to the pain involved. Moreover, lancing to obtain a blood sample for other diagnostic applications is becoming more commonplace, and a less painful, minimally invasive device is needed to enhance those appUcations and make those technologies more acceptable. An object of the present invention therefore, is to provide a device and a method for obtaining a sample of bodily fluid through the skin which is virtually pain free and minimally invasive.
Therefore, it is another object of the invention to provide a lancet carrier which eliminates the above-mentioned shortcomings.
Another object of this invention is to provide a method which can result in a sample of either blood or interstitial fluid, depending on the sample site and the penetration depth utilized. While there are no commercially available devices utilizing interstitial fluid (ISF) at this time, there are active efforts to establish the correlation of analytes, such as glucose, in ISF compared to whole blood. If ISF could be readily obtained and correlation is established, ISF may be preferable as a sample since there is no interference of red blood cells or hematocrit adjustment required.
Another object of this invention is to provide a method which can draw a small but adjustable sample, i.e. 3 microliters for one test device and 8 microliters for another test device, as appropriate.
Another object of this invention is to provide a method by which the drawn sample is collected and may be easily presented to a testing device, regardless of the location of the sample site on the body. This approach helps with infection control in that multiple patients are not brought in contact with a single test instrument; only the sampling device with a disposable patient-contact portion is brought to the test instrument. Alternatively, the disposable portion of a test device may be physically coupled with the sampler so the sample can be brought directly into the test device during sampling. The test device may then be read in a test instrument if appropriate or the testing system can be integrated into the sampler and the test device can provide direct results displayed for the patient. It is a further object of the invention is to provide a device for minimally invasive sampling comprising a reusable sampler and disposable sample collection.
Yet another object of the present invention is to provide a method of increasing the amount of bodily fluid available for sampling.
SUMMARY OF THE INVENTION
These and other objects are achieved by the present invention, one aspect of which relates to a method for sampling blood comprising the steps of placing a forward end of a housing against a skin surface, advancing a hollow piercing element forwardly to cut an incision through the skin surface, and depressing a ring of body tissue in surrounding relationship to the incision to spread apart sides of the incision while urging bodily fluid toward and into the incision. Simultaneously, the piercing element is moved within the incision to keep the incision open. A suction may be applied to the skin to aid the pooling of bodily fluid in the area of the incision. Additionally, a suction may be applied to the piercing element to draw in bodily fluid from the incision and into a tube communicating with the piercing element.
Another aspect of the present invention relates to a sampling device for sampling bodily fluid. The sampling device comprises a housing, a piercing element carrier mounted in the housing and carrying a hollow piercing element. A tube communicates with the piercing element. A driver mechanism mounted in the housing drives the syringe carrier forwardly to cut an incision in the skin and maintain and end of the piercing element in the incision. A stimulator mechanism disposed on the housing depresses a ring of body tissue in surrounding relationship to the incision to spread apart sides of the incision while urging bodily fluid toward the incision. A syringe-moving mechanism disposed on the housing moves the end of the piercing element relative to the incision to maintain the incision open while the stimulator mechanism urges bodily fluid thereto. A suction mechanism disposed on the housing creates a suction to cause bodily fluid to pool in the area to be incised, as will be described in greater detail below. Additionally, the suction element may be applied to the tube and utilized for drawing in bodily fluid through the piercing element and into the tube.
Still another aspect of the invention relates to a device for obtaining a sampling of a bodily fluid through the skin comprising a housing member containing a hollow piercing element for piercing the skin. A first spring member disposed in the housing urges the piercing element to protrude from a forward end of the housing sufficient to cut an incision through the skin. A stop member defines a maximum penetration depth of the piercing element. A second spring disposed in the housing partially retracts the piercing element while maintaining a front end of the piercing element in the incision. A tube communicates with a rear end of the piercing element. A suction mechanism creates a suction in the tube for drawing in bodily fluid through the piercing element.
BRIEF DESCRIPTION OF THE DRAWINGS
The objects and advantages of the invention will become apparent from the following detailed description of preferred embodiments thereof in connection with the accompanying drawings in which like numerals designate like elements and in which:
FIG. 1 is a longitudinal sectional view taken through a sampling device according to the present invention, with a syringe thereof in an armed state;
FIG. 2 is a view similar to FIG. 1 after the syringe has been triggered and forms an incision in a skin surface;
FIGS. 3 is a view similar to FIG. 2 after a suction mechanism has been actuated to draw in bodily fluid through the syringe;
FIG. 3 A is a sectional view taken along the line 3 A— 3 A in FIG. 3;
FIG. 4 is a schematic view of a syringe being reciprocated longitudinally within an incision according to the present invention;
FIG. 5 is a schematic view of a syringe being reciprocated laterally within an incision according to the present invention;
FIG. 6 is a schematic view of a syringe being oscillated in an elliptical direction according to the present invention;
FIG. 7 is a schematic view of a syringe being rotated within an incision according to the present invention;
FIG. 8 is a longitudinal sectional view of a lower portion of a modified sampling device according to the present invention, with a syringe disposed in a retracted state;
FIG. 9 is a view similar to FIG. 8 after the syringe has been urged forwardly;
FIG. 10 is a side elevational view of a lower end of a syringe having a stop member fixed thereto according to the present invention; and
FIG. 11 is a sectional view taken along the line 11-11 in FIG. 10;
FIG. 12 is a top view of a integrated testing/lancing apparatus according to one embodiment of the present invention;
FIG. 13 is a cross-sectional side view illustrating an integrated lancet and test strip holder according to the present invention; and
FIG. 14 is a side view illustrating the anti-coring needle in accordance with a lancing device of the present invention.
DESCRIPTION OF PREFERRED EMBODIMENTS
For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations, modifications, and further applications of the principles of the invention being contemplated as would normally occur to one skilled in the art to which the invention relates.
Depicted in FIGS. 1-3 is a bodily fluid sampling device 10 comprising an outer cylindrical housing 12. Screwed into an upper end of the housing 12 is a fixing sleeve 14 in which are formed upper and lower recesses 16, 18. The upper recess 16 has an internal screw thread connected to an externally threaded stop ring 20 which can be adjusted to a selected vertical position relative to the housing.
Slidably disposed for longitudinal movement within the fixing sleeve 14 is a hollow drive rod 22. Screwed onto a lower end of the drive rod 22 is a syringe carrier 24. Mounted in a lower end of the carrier 24 is a syringe 26 of the type which includes a longitudinal capillary passage 28 (see FIG. 4). That passage is preferably offset laterally with respect to a center axis of the syringe. In lieu of a syringe, any suitable type of hollow piercing element can be employed, such as a needle or sharp cannula, for example. An upper end of the syringe communicates with a sampling tube 30, an upper end of the tube fitting into a lower recess 32 formed in the drive rod 22.
Intermediate its upper and lower ends, the drive rod 22 includes a radial enlargement 33 in which an outwardly open, annular groove 34 is formed that is sized to receive a pin 36 of a first trigger 38.
Slidably mounted within the sampling tube 30 is a plunger 40 having a soft tip 42 that snugly (sealingly) engages an inner surface of the tube 30. An upper end of the plunger 40 is fixed to the lower end of a drawbar 46 which slides within a center bore of the drive rod 22.
Screwed to an upper end of the drive rod 22 is a mounting sleeve 48 in which a second trigger 50 is mounted for lateral sliding movement. Formed in the second trigger 50 is a center hole 52 that is larger than the outer diameter of the drawbar 46. The drawbar 46 has a recess 54 sized to receive respective sides of the hole 52.
A drive spring 56 in the form of a coil compression spring acts between the enlargement 33 and the fixing sleeve 14. Resting on the fixing sleeve 14 is a retraction spring 58 in the form of a coil compression spring. Acting between the enlargement 33 and the top of the plunger 40 is a suction spring 60 in the form of a coil compression spring.
Mounted on the syringe carrier 24 is a piezoelectric transducer 66 which is electrically connected to a battery 68. Piezoelectric transducers are conventional types of vibrators which can be oriented to produce vibrations in any desired direction. A lower end of the piezoelectric transducer 66 is in contact with the syringe for vibrating the syringe, i.e., either vertically (longitudinally), laterally, or elliptically (a combination of vertical and lateral vibrations).
Disposed at a lower end of the housing 12 is a stimulator sleeve 70. That sleeve has an annular lower face 72 of frusto-conical shape, and is screwed into a sleeve carrier 74. Projecting from diametrically opposite positions of the sleeve carrier 74 are pins 76 which are slidably disposed in respective vertical slots 78 formed in the housing 12.
Rotatably mounted on diametrically opposite sides of the housing 12 are a pair of identical drive gears 80 (see also FIG. 3A). Formed in an inner surface of each drive gear 80 is a cam groove 82 in which a respective pin 76 projects. Mounted above the drive gear for rotation about a central longitudinal axis of the housing is a ring gear 84 which is rotated by an output pinion 86 of an electric motor 88. The underside of the ring gear 84 is formed with teeth that mesh with teeth formed around the outer peripheries of the drive gears 80. Therefore, rotation of the pinion gear 86 is transmitted to the drive gears 80 to rotate the drive gears. The accompanying rotation of the eccentric grooves 82 of the drive gears causes the pins 76, and thus the sleeve carrier 74, to reciprocate vertically, along with the stimulator sleeve.
The operation of the sampling device 10 will now be explained. To arm the device, the mounting sleeve 48 is pulled upwardly by a user until a beveled face 90 of the enlargement 33 of the drive rod 22 cams the first trigger 38 laterally outwardly. When the groove 34 of the enlargement becomes aligned with the cammed-out first trigger 38, the first trigger is urged inwardly by a spring (not shown) to insert the pin 36 into the groove 34 for retaining the drive rod 22 in the armed state (FIG. 1). Simultaneously, the drive spring 56 is compressed from a relaxed state, and the syringe carrier 24, together with the syringe 26, is raised. The drawbar 46 is retained by the second trigger 50, with the suction spring 60 disposed in a compressed state.
The lower end 72 of the housing 12 is placed against the skin surface S, preferably at a portion of the body having fewer nerve endings than, say the fingertip. A forearm would be a suitable location. Suction may be applied to the skin surface S at this time. The suction may be applied and held, or applied and released prior to the syringe cutting the skin. The trigger 38 is then pulled out against a spring bias to release the drive rod 22 and the compressed drive spring 56. As a result, the drive rod 22, the syringe carrier 24, and syringe 26 are driven downwardly, so that the syringe cuts an incision I through the skin surface S, as shown in FIG. 2.
During downward movement of the drive rod 22, the mounting sleeve 48 engages an upper end of the retraction spring 58 and then abuts the stop ring 20, thereby limiting the incision depth and slightly compressing the retraction spring 58. The retraction spring 58 then moves the drive rod 22 slightly upwardly, but not enough to completely remove the syringe 26 from the incision I. Then, the motor 88 is actuated, either manually, or automatically in response to the firing of the syringe, to vertically reciprocate the stimulator sleeve 70. Consequently, the lower face 72 repeatedly depresses a ring of skin and body tissue which surrounds the incision. Each depression of that ring causes the incision to bulge and the sides of the incision to be spread apart, and urges bodily fluid such as blood or interstitial fluid toward and outwardly through the incision I, as explained also in commonly assigned U.S Patents No. 5,879,311, and 5,591,493.
In order to enable the inwardly urged bodily fluid to pool at the incision (for subsequent sampling), the syringe 26 is vibrated relatively slowly by the piezoelectric transducer 66 to keep the incision open. As noted earlier, the direction of vibration can be determined by the particular orientation of the transducer 66. In one embodiment, the direction of vibration is longitudinal or vertical (FIG. 4); in another embodiment the vibration is lateral (FIG. 5); in another embodiment the vibration is a combination of lateral and vertical, i.e., generally elliptical oscillation (-FIG. 6).
It will be appreciated that if the syringe were not moved within the incision, the presence of a stationary syringe within the incision could result in a closing of the incision by collagen in the skin, whereby bodily fluid could not pool at the incision.
After a short period, sufficient to allow an ample amount of bodily fluid to pool at the incision, the second trigger 50 is manually actuated to release the drawbar 46, causing the spring 60 to raise the plunger 40 within the tube 30. That produces a suction in the tube 30 below the plunger 40, which draws in a sample 91 of bodily fluid through the syringe 26 (FIG. 3). Then, the device can be removed from the skin, and the sample delivered to a suitable test site. Alternatively, the device may contain a test device in conjunction with the sampling device described above. Suitable test devices which may be incorporated with the sampler described above are shown and described in co-pending U.S. Patent Application No. (Insert)
As an alternative to the reciprocation of the syringe, the syringe can be rotated about its own center axis while disposed in the incision I. In that regard, a rotatable syringe 92 as shown in FIG. 7 can be utilized in a device 10' shown in FIGS. 8 and 9. That device 10' is similar to that depicted in FIGS. 1-3 with the addition of a rotary gear 94 that is driven by a pinion 95 of a second motor 96. The gear 94 includes an upwardly open recess 98 sized to receive, with a snug fit, a lower end 100 of the tube 30 in which the syringe 92 is disposed. Thus, when the syringe carrier 24' is driven toward the skin, the lower portion 100 of the tube 30 enters the recess 98 to create a frictional engagement between the tube 30 and the gear 94 (see FIG. 9). By then rotating the pinion 95, the gear 94, the tube 30, and the syringe 92 are rotated relative to the carrier 24' about an axis coinciding with a center axis of the syringe 92. The syringe 92 includes a pointed end 102 in the form of one-half of a cone. As the syringe rotates about its own axis, the semi-conical segment 102 cuts a conical recess 104 in the incision and keeps the incision open as the stimulator sleeve 70 reciprocates.
Any of the syringes described thus far can be provided with a stop which would replace the stop ring 20. Such a stop 110 is shown in FIGS. 10 and 11 in connection with the syringe 92. The stop 110 comprises a disc fixed to the syringe. When the disc contacts the skin surface, no further entry of the syringe into the skin can occur. The stop ring 20 could also be used to open and close the incision to promote bodily fluid pooling.
It will be appreciated that the present invention minimizes the pain experienced by a user, because it can be used to provide a sample of bodily fluid at an area of the body which contains fewer nerve endings than in an area such as the finger tips. By stimulating the body tissue surrounding the incision, while moving the syringe relative to the incision, bodily fluid is caused to pool in the incision, thereby providing an ample sample to be sucked through the syringe and into a collection tube. Thus, an area of the body less sensitive to pain can be used as a source of bodily fluid.
Although the stimulator member 70 is disclosed as having a generally annular skin contacting surface, i.e., a surface which is symmetric about the center axis thereof, the member 70 could instead have an elliptical or polygonal end face whereby the ring of body tissue depressed thereby would have a corresponding shape.
An alternative method according to the present invention includes the use of a suction device prior to use of the lancing device. The lower end of the housing 12 is placed against the skin surface S, preferably at a portion of the body where the sample is to be taken from. For example, a forearm would be a suitable location. A vacuum source is activated whereupon the skin S adjacent the lower end of the housing 12 is drawn into the frusto-conical shaped distal tip. The suction causes bodily fluid beneath the skin to pool in the area of skin S in contact with the testing device 10. The vacuum is released thereby releasing the skin. The trigger 38 is then pulled out against a spring bias to release the drive rod 22 and the compressed drive spring 56. As a result, the drive rod 22, the syringe carrier 24, and syringe 26 are driven downwardly, so that he syringe cuts an incision I through the skin surface S. During the downward movement of the drive rod 22, the mounting sleeve 48 engages an upper end of the retraction spring 58 and then abuts the stop ring 20, thereby limiting the incision depth and slightly compressing the retraction spring 58. The retraction spring 58 then moves the drive rod 22 slightly upwardly, but not enough to completely remove the syringe 26 from the incision I. Then, the motor 88 is actuated, either manually, or automatically in response to the firing of the syringe, to vertically reciprocate the stimulator sleeve 70. Consequently, the lower face 72 repeatably depresses a ring of skin and body tissue which surrounds the incision. The depression of the ring causes the skin adjacent the incision to bulge and the sides of the incision spread apart, such that bodily fluid is urged from the incision in response to the applied force.
After a short period, sufficient to allow an ample amount of bodily fluid to pool at the incision, the second trigger 50 is manually actuate to release the drawbar 46, causing the spring 60 to raise the plunger 40 within the tube 30. This produces suction in the tube 30 below the plunger 40, which draws in a sample 91 of bodily fluid through the syringe. The sample may then be delivered to an appropriate test media or testing device as described above.
Additionally, as described above, the vacuum may be repeatedly applied to the skin prior to deployment of the needle to form the incision I. By repeatably applying a vacuum source to the skin S this encourages bodily fluid to pool in the location adjacent to where the incision is to be made. Because bodily fluid is pooled in this area prior to formation of the incision I, once the incision I is formed the a sample is bodily fluid is easily collected because of the large volume of fluid available within the area.
It is further contemplated that the vacuum mechanism may be activated after the incision is formed to further express fluid from the incision. In addition to the vacuum source, it is also contemplated that a vibratory force, a heat force, and/or an ultrasonic force may be applied to the area to be lanced to further the expression of bodily fluid. Additionally, the vacuum may be repeatedly applied to the skin after the formation of incision I. Repeated application of a vacuum after the incision is formed encourages bodily fluid to continue to pool in the area adjacent to the incision, thereby aiding collection of the bodily fluid.
Referring now to Figure 12 there is shown yet another alternative embodiment of the present invention. As shown in Figure 12 the test device 100 comprises a main body 120, a test strip holder/tip assembly 130, and a lancing device 150. The functions of the testing device 100 are similar to that as described above with reference to testing device 10. The testing device 100 is prepared for use by first inserting a disposable lancet/test strip holder and test strip into the lancing device 150. The lancing device 150 is then prepared for use by pulling up on a driving mechanism (not shown) thereby compressing a driving spring (not shown). The device 100 is placed over an area to be lanced, wherein a vacuum mechanism disposed within the main body 120 and in communication with the tip assembly 130 is then activated. Skin S is drawn into the distal end of the device 100. The vacuum mechanism may then be deactivated thereby releasing the vacuum force on the skin, or repeatedly activated and deactivated.
After the vacuum device has been utilized, device 100 releases the driving spring, wherein a lancet is advanced through the patient's skin to form an incision I therein. The lancet may then be retracted from the incision I. Alternatively, it may be desirable to leave the lancet within or directly adjacent the incision for the reasons described above. Additionally, the vacuum device may be activated, activated and deactivated, or repeatedly activated and deactivated after forming the incision. Furthermore, a vibratory force may be applied to the lancet, the vibratory force may be applied vertically, horizontally, or any combination thereof.
A sample of bodily fluid may then be withdrawn from the incision and transported to a test area. The sample may be withdrawn from the incision through a capillary tube having one end disposed within the end of the test device 100 and the other end in communication with a chemical pad of a test strip and or electrochemical measuring device. Alternatively, the test strip may include capillary means such as a capillary tube or a cascading capillary. In yet another alternative embodiment, the test strip may be disposed adjacent to the distal end of the testing device wherein the lancet passes through an aperture in the test strip. The test strip may further include a gasket and/or a deep dermal constriction device. Furthermore, by placing the strip against the patient's skin and lancing there through this eliminates the need for a capillary to transport the bodily fluid from the incision to the test strip. This may lead to shorter sample times and/or lessen the likelihood of a failed test due to inadequate sample delivery.
In yet an additional alternative embodiment as shown in Figures 13 and 14, the test device 200 may include a test strip (not pictured) and lancet 220 which may be formed as an integrated unit. The lancet 220 may be embodied in the form of an anti-coring needle having a pre-bent radius of curvature R and a fluid inlet 223 such as that described in co-pending provisional patent application no. 60/297,098 filed on June 8, 2001, the entirety of which is herein incorporated by reference. In this embodiment, the test device is placed over the area to be lanced, a vacuum is drawn on the skin thereby increasing the amount of bodily fluid adjacent the test device. The vacuum is release and the lancet is advanced thereby forming an incision within the patient's skin. Bodily fluid may then be withdrawn from the incision. The bodily fluid is then collected using one of the devices described above. After a sufficiently sized sample has been collected, the test device may be removed from the patient's skin, this may be prompted by a audible and/or visual marker. The test device will then deliver to the patient a visual indication of the test results.
While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that only the preferred embodiment has been shown and described and that all changes and modifications that come within the spirit of the invention are desired to be protected.

Claims

What is claimed is:
1. A method of expressing bodily fluid from an incision in the skin, the method comprising: disposing a testing device against the skin at a location from which the bodily fluid sample is to be taken, the testing device including a distal end portion forming a seal with the skin; activating a vacuum source communicating with the distal end portion of the testing device and drawing the skin in the area into the distal end portion of the testing device; deactivating the vacuum source; forming an incision in the skin with a hollow piercing element; and collecting the bodily fluid for testing using the hollow piercing element.
2. The method according to claim 1, wherein the testing device includes the vacuum source.
3. The method according to claim 1, wherein the vacuum source is applied before forming the incision.
4. The method according to claim 1, wherein the vacuum source is applied after the forming the incision.
5. The method according to claim 1, wherein the vacuum source is applied before and after the forming the incision.
6. The method according to claim 1, wherein the step of deactivating the vacuum source further includes releasing the vacuum between the testing device and the area of the skin to be lanced.
7. The method according to claim 1, wherein the testing device further includes a hollow fluid transport member having one end in fluid communication with the hollow piercing element and a second end in fluid communication with a test strip.
8. The method according to claim 7, wherein the vacuum source creates a vacuum in the hollow fluid transport member.
9. The method according to claim 7, wherein the test strip is chemical based.
10. The method according to claim 7, wherein the test strip is electrochemical.
11. The method according to claim 1 , wherein the method further includes drawing the sample of bodily fluid from the incision to a test strip, determining the level of glucose in the bodily fluid, and displaying the level on a display included on the testing device.
12. The method according to claim 1, wherein the testing device further includes a stimulating device disposed about the distal end of the testing device, the method further including stimulating the area of the skin to be lanced with the stimulating device to pucker the skin.
13. The method according to claim 1, wherein the method further includes vibrating the hollow piercing element after forming the incision.
14. The method according to claim 1, wherein the method further includes rotating the hollow piercing element after forming the incision.
15. The method according to claim 5, wherein the testing device further includes a stimulating device disposed about the distal end of the testing device, wherein the method further includes oscillating the stimulating to cause the area of the skin to be lanced to pucker, said method further including oscillating the hollow piercing element after forming the incision.
16. A hand-held apparatus for extracting bodily fluid from an incision in the skin, comprising: a body having a distal end, the distal end being positionable against the skin surrounding an incision location; a suction means coupled with said body for applying a suction to the distal end of said body; a cutting member connected with said body and movable between a first position displaced from the skin and a second position extending into the skin at an incision location; and a fluid extraction member positioned to receive bodily fluid from the incision location.
17. The invention of claim 16 wherein said suction means is for applying the suction prior to said cutting member contacting the skin.
18. The invention of claim 17 wherein said suction means is further for releasing the suction prior to said cutting member contacting the skin.
19. The invention of claim 16 wherein said suction means is for applying the suction after said cutting member contacts the skin.
20. The invention of claim 19 wherein said suction member is for first applying the suction and then subsequently releasing the suction.
21. The invention of claim 16 wherein said body further includes means for vibrating said cutting member after contacting the skin.
22. The invention of claim 16 wherein said body includes means for rotating said cutting member after contacting the skin.
23. The invention of claim 16 wherein said suction means is for applying the suction to said fluid extraction member.
24. The invention of claim 16 in which said body further includes a testing member wherein said fluid extraction member is configured to deposit extracted fluid onto said testing member.
25. The invention of claim 16 wherein said cutting member is hollow.
26. The invention of claim 16 wherein said body further includes means for oscillating the distal end.
27. The invention of claim 21 in which said body further includes a testing member, said fluid extraction member being configured to deposit extracted fluid onto said testing member, said body further including means for oscillating the distal end.
28. The invention of claim 21 wherein said cutting member is hollow and is in fluid communication with said fluid extraction member, said suction means being for applying suction to said fluid extraction member, said body further including means for oscillating the distal end.
PCT/US2002/030531 2001-09-26 2002-09-25 Method and apparatus for sampling bodily fluid WO2003039369A1 (en)

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Cited By (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1611848A1 (en) * 2004-06-30 2006-01-04 Lifescan Scotland Ltd Devices, systems and methods for extracting bodily fluid and monitoring an analyte therein
EP1628567A2 (en) * 2003-05-30 2006-03-01 Pelikan Technologies Inc. Method and apparatus for fluid injection
EP1752097A1 (en) * 2005-08-11 2007-02-14 Lifescan, Inc. Method for extracting interstitial fluid
US9072842B2 (en) 2002-04-19 2015-07-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9089294B2 (en) 2002-04-19 2015-07-28 Sanofi-Aventis Deutschland Gmbh Analyte measurement device with a single shot actuator
US9248267B2 (en) 2002-04-19 2016-02-02 Sanofi-Aventis Deustchland Gmbh Tissue penetration device
US9261476B2 (en) 2004-05-20 2016-02-16 Sanofi Sa Printable hydrogel for biosensors
US9427532B2 (en) 2001-06-12 2016-08-30 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9561000B2 (en) 2003-12-31 2017-02-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for improving fluidic flow and sample capture
US9560993B2 (en) 2001-11-21 2017-02-07 Sanofi-Aventis Deutschland Gmbh Blood testing apparatus having a rotatable cartridge with multiple lancing elements and testing means
US9694144B2 (en) 2001-06-12 2017-07-04 Sanofi-Aventis Deutschland Gmbh Sampling module device and method
US9724021B2 (en) 2002-04-19 2017-08-08 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9795747B2 (en) 2010-06-02 2017-10-24 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
US9820684B2 (en) 2004-06-03 2017-11-21 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a fluid sampling device
US9839386B2 (en) 2002-04-19 2017-12-12 Sanofi-Aventis Deustschland Gmbh Body fluid sampling device with capacitive sensor
US10034628B2 (en) 2003-06-11 2018-07-31 Sanofi-Aventis Deutschland Gmbh Low pain penetrating member
WO2019020327A1 (en) * 2017-07-25 2019-01-31 Ascilion Ab A suction applying device, an apparatus for sampling a bodily fluid and a method for detecting a component in a bodily fluid
EP3380174A4 (en) * 2015-11-28 2019-04-24 Biopreme Medical Technologies, Inc. Negative pressure injection device
CN109872314A (en) * 2019-02-20 2019-06-11 数坤(北京)网络科技有限公司 A kind of Optimized Segmentation method and apparatus based on center line

Families Citing this family (92)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6036924A (en) 1997-12-04 2000-03-14 Hewlett-Packard Company Cassette of lancet cartridges for sampling blood
US6391005B1 (en) 1998-03-30 2002-05-21 Agilent Technologies, Inc. Apparatus and method for penetration with shaft having a sensor for sensing penetration depth
ES2357887T3 (en) 2001-06-12 2011-05-03 Pelikan Technologies Inc. APPARATUS FOR IMPROVING THE BLOOD OBTAINING SUCCESS RATE FROM A CAPILLARY PUNCTURE.
US7682318B2 (en) 2001-06-12 2010-03-23 Pelikan Technologies, Inc. Blood sampling apparatus and method
EP1395185B1 (en) 2001-06-12 2010-10-27 Pelikan Technologies Inc. Electric lancet actuator
US9226699B2 (en) 2002-04-19 2016-01-05 Sanofi-Aventis Deutschland Gmbh Body fluid sampling module with a continuous compression tissue interface surface
US7981056B2 (en) 2002-04-19 2011-07-19 Pelikan Technologies, Inc. Methods and apparatus for lancet actuation
US8337419B2 (en) 2002-04-19 2012-12-25 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
WO2002100254A2 (en) 2001-06-12 2002-12-19 Pelikan Technologies, Inc. Method and apparatus for lancet launching device integrated onto a blood-sampling cartridge
US7344507B2 (en) 2002-04-19 2008-03-18 Pelikan Technologies, Inc. Method and apparatus for lancet actuation
CA2448902C (en) 2001-06-12 2010-09-07 Pelikan Technologies, Inc. Self optimizing lancing device with adaptation means to temporal variations in cutaneous properties
US7004928B2 (en) 2002-02-08 2006-02-28 Rosedale Medical, Inc. Autonomous, ambulatory analyte monitor or drug delivery device
US7901362B2 (en) 2002-04-19 2011-03-08 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7491178B2 (en) 2002-04-19 2009-02-17 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8267870B2 (en) 2002-04-19 2012-09-18 Sanofi-Aventis Deutschland Gmbh Method and apparatus for body fluid sampling with hybrid actuation
US7892183B2 (en) 2002-04-19 2011-02-22 Pelikan Technologies, Inc. Method and apparatus for body fluid sampling and analyte sensing
US7976476B2 (en) 2002-04-19 2011-07-12 Pelikan Technologies, Inc. Device and method for variable speed lancet
US8360992B2 (en) 2002-04-19 2013-01-29 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7331931B2 (en) 2002-04-19 2008-02-19 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7547287B2 (en) 2002-04-19 2009-06-16 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7371247B2 (en) 2002-04-19 2008-05-13 Pelikan Technologies, Inc Method and apparatus for penetrating tissue
US8372016B2 (en) 2002-04-19 2013-02-12 Sanofi-Aventis Deutschland Gmbh Method and apparatus for body fluid sampling and analyte sensing
US7909778B2 (en) 2002-04-19 2011-03-22 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7198606B2 (en) 2002-04-19 2007-04-03 Pelikan Technologies, Inc. Method and apparatus for a multi-use body fluid sampling device with analyte sensing
US7291117B2 (en) 2002-04-19 2007-11-06 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7674232B2 (en) 2002-04-19 2010-03-09 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US9314194B2 (en) 2002-04-19 2016-04-19 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US7229458B2 (en) 2002-04-19 2007-06-12 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7717863B2 (en) 2002-04-19 2010-05-18 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7297122B2 (en) 2002-04-19 2007-11-20 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7232451B2 (en) 2002-04-19 2007-06-19 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7648468B2 (en) 2002-04-19 2010-01-19 Pelikon Technologies, Inc. Method and apparatus for penetrating tissue
US8221334B2 (en) 2002-04-19 2012-07-17 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US20040127818A1 (en) * 2002-12-27 2004-07-01 Roe Steven N. Precision depth control lancing tip
US8574895B2 (en) 2002-12-30 2013-11-05 Sanofi-Aventis Deutschland Gmbh Method and apparatus using optical techniques to measure analyte levels
US7052652B2 (en) 2003-03-24 2006-05-30 Rosedale Medical, Inc. Analyte concentration detection devices and methods
US20050070819A1 (en) * 2003-03-31 2005-03-31 Rosedale Medical, Inc. Body fluid sampling constructions and techniques
ES2490740T3 (en) 2003-06-06 2014-09-04 Sanofi-Aventis Deutschland Gmbh Apparatus for blood fluid sampling and analyte detection
EP1671096A4 (en) 2003-09-29 2009-09-16 Pelikan Technologies Inc Method and apparatus for an improved sample capture device
EP1680014A4 (en) 2003-10-14 2009-01-21 Pelikan Technologies Inc Method and apparatus for a variable user interface
US7822454B1 (en) 2005-01-03 2010-10-26 Pelikan Technologies, Inc. Fluid sampling device with improved analyte detecting member configuration
DE602005011251D1 (en) * 2004-02-06 2009-01-08 Bayer Healthcare Llc ZETTENVORRICHTUNG
US9775553B2 (en) 2004-06-03 2017-10-03 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a fluid sampling device
US20050277849A1 (en) * 2004-06-10 2005-12-15 Daniel Wong Vacuum sample expression device
EP1841359A1 (en) * 2004-09-09 2007-10-10 Bayer Healthcare, LLC Damping system for a lancet using compressed air
US8652831B2 (en) 2004-12-30 2014-02-18 Sanofi-Aventis Deutschland Gmbh Method and apparatus for analyte measurement test time
US9055898B2 (en) 2005-03-04 2015-06-16 Bayer Healthcare Llc Lancet release mechanism
US8784444B2 (en) * 2005-03-04 2014-07-22 Bayer Healthcare Llc Lancet release mechanism
US20060281187A1 (en) 2005-06-13 2006-12-14 Rosedale Medical, Inc. Analyte detection devices and methods with hematocrit/volume correction and feedback control
US8460329B2 (en) * 2005-06-30 2013-06-11 Bayer Healthcare Llc Single-puncture lancing system
EP1903927A2 (en) * 2005-06-30 2008-04-02 Bayer Healthcare, LLC Single-puncture lancing system
WO2007011645A1 (en) * 2005-07-14 2007-01-25 Bayer Healthcare Llc Lancing device for one skin puncture
US8617195B2 (en) 2005-08-04 2013-12-31 Bayer Healthcare Llc Lancing device
EP2989981B8 (en) 2005-09-30 2018-09-05 Intuity Medical, Inc. Multi-site body fluid sampling and analysis cartridge
US8801631B2 (en) * 2005-09-30 2014-08-12 Intuity Medical, Inc. Devices and methods for facilitating fluid transport
US8057404B2 (en) * 2005-10-12 2011-11-15 Panasonic Corporation Blood sensor, blood testing apparatus, and method for controlling blood testing apparatus
EP1797822A1 (en) * 2005-12-15 2007-06-20 Roche Diagnostics GmbH Lancing system for sampling of bodily fluid
US20090215159A1 (en) * 2006-01-23 2009-08-27 Quidel Corporation Device for handling and analysis of a biological sample
US7794656B2 (en) * 2006-01-23 2010-09-14 Quidel Corporation Device for handling and analysis of a biological sample
US7871568B2 (en) * 2006-01-23 2011-01-18 Quidel Corporation Rapid test apparatus
US20070202186A1 (en) 2006-02-22 2007-08-30 Iscience Interventional Corporation Apparatus and formulations for suprachoroidal drug delivery
US7618396B2 (en) * 2006-08-09 2009-11-17 Avant Medical Corp. Injection system with hidden needles
PL2314206T3 (en) * 2006-09-04 2013-11-29 Hoffmann La Roche Piercing system for removal of a bodily fluid
US8303615B2 (en) * 2007-03-12 2012-11-06 Bayer Healthcare Llc Lancet-eject mechanism
WO2009126900A1 (en) 2008-04-11 2009-10-15 Pelikan Technologies, Inc. Method and apparatus for analyte detecting device
JP4388597B1 (en) * 2008-05-09 2009-12-24 パナソニック株式会社 Skin incision instrument
CN101938941B (en) 2008-05-13 2012-07-25 松下电器产业株式会社 Skin incision instrument
EP2293719B1 (en) 2008-05-30 2015-09-09 Intuity Medical, Inc. Body fluid sampling device -- sampling site interface
WO2009148624A1 (en) 2008-06-06 2009-12-10 Intuity Medical, Inc. Detection meter and mode of operation
EP2299904B1 (en) 2008-06-06 2019-09-11 Intuity Medical, Inc. Medical measurement method
US9375169B2 (en) 2009-01-30 2016-06-28 Sanofi-Aventis Deutschland Gmbh Cam drive for managing disposable penetrating member actions with a single motor and motor and control system
GB0919568D0 (en) * 2009-11-09 2009-12-23 Owen Mumford Ltd Skin stimulus
US8919605B2 (en) 2009-11-30 2014-12-30 Intuity Medical, Inc. Calibration material delivery devices and methods
US8965476B2 (en) 2010-04-16 2015-02-24 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
CA2803797A1 (en) 2010-06-25 2011-12-29 Intuity Medical, Inc. Analyte monitoring methods and systems
EP2460553A1 (en) * 2010-12-02 2012-06-06 Debiotech S.A. Device for inserting needles
CA3154143A1 (en) 2011-08-03 2013-02-07 Intuity Medical, Inc. Devices and methods for body fluid sampling and analysis
EP2887982B1 (en) * 2012-08-27 2022-11-23 Clearside Biomedical, Inc. Apparatus for drug delivery using microneedles
CN103654872B (en) * 2012-09-20 2015-08-05 苏州生物医学工程技术研究所 Reusable automatic synchronous negative-pressure formula sampling device for biopsy
CA2884845C (en) * 2012-09-27 2020-12-29 Facet Technologies, Llc Depth-adjust mechanism for lancing device
CN116327482A (en) 2013-05-03 2023-06-27 科尼尔赛德生物医学公司 Apparatus and method for ocular injection
WO2014205412A1 (en) 2013-06-21 2014-12-24 Intuity Medical, Inc. Analyte monitoring system with audible feedback
FI4035762T3 (en) 2015-09-09 2023-12-04 Drawbridge Health Inc Devices for sample collection, stabilization and preservation
CA3062845A1 (en) 2016-05-02 2017-11-09 Clearside Biomedical, Inc. Systems and methods for ocular drug delivery
IL264764B2 (en) 2016-08-12 2024-02-01 Clearside Biomedical Inc Devices and methods for adjusting the insertion depth of a needle for medicament delivery
KR102458200B1 (en) 2016-08-24 2022-10-25 벡톤 디킨슨 앤드 컴퍼니 A device for the attached flow of blood
DE212018000019U1 (en) 2017-01-10 2018-11-08 Drawbridge Health, Inc. Devices and systems for sampling
US10830760B2 (en) 2017-12-20 2020-11-10 General Electric Company Device for rapid detection of tuberculosis-lipoarabinomannan (TB-LAM) with enhanced sensitivity
CA3208266A1 (en) 2019-02-22 2020-08-27 Deka Products Limited Partnership Infusion set and inserter assembly systems and methods
KR20230076130A (en) * 2020-08-18 2023-05-31 프로버스 메디컬 테크놀로지스 아이앤씨 Lancing device and how to use it
US11877848B2 (en) * 2021-11-08 2024-01-23 Satio, Inc. Dermal patch for collecting a physiological sample
US11510602B1 (en) * 2021-11-08 2022-11-29 Satio, Inc. Dermal patch for collecting a physiological sample

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4895147A (en) * 1988-10-28 1990-01-23 Sherwood Medical Company Lancet injector
US6015392A (en) * 1996-05-17 2000-01-18 Mercury Diagnostics, Inc. Apparatus for sampling body fluid
US6086545A (en) * 1998-04-28 2000-07-11 Amira Medical Methods and apparatus for suctioning and pumping body fluid from an incision
EP1112717A1 (en) * 1996-12-06 2001-07-04 Abbott Laboratories Apparatus suitable for obtaining blood samples in a diagnostic test

Family Cites Families (229)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US528097A (en) * 1894-10-23 Powder or shot feeding mechanism
US6285A (en) * 1849-04-10 Beehive
US263533A (en) * 1882-08-29 kinder
US296950A (en) * 1884-04-15 John s
US297045A (en) * 1884-04-15 Seth wheelee
US2646799A (en) 1951-02-14 1953-07-28 Jr George W Jacoby Blood lancet
US2714890A (en) * 1953-08-06 1955-08-09 Vang Alfred Vibratory surgical instruments
US3086288A (en) * 1955-04-20 1963-04-23 Cavitron Ultrasonics Inc Ultrasonically vibrated cutting knives
US3030959A (en) 1959-09-04 1962-04-24 Praemeta Surgical lancet for blood sampling
US3208452A (en) * 1960-09-08 1965-09-28 Panray Parlam Corp Surface treating device
US3235337A (en) 1962-10-22 1966-02-15 Miles Lab Diagnostic compositions and test indicators
CH522395A (en) 1968-07-26 1972-05-15 Micromedic Systems Inc Test tube intended for percutaneous and digital blood sampling
CH500707A (en) 1968-07-26 1970-12-31 Micromedic Systems Inc Device for performing percutaneous and digital blood sampling
GB1323675A (en) 1969-07-09 1973-07-18 Nat Res Dev Endoscopes
CH538277A (en) 1970-09-04 1973-06-30 Micromedic Systems Inc Percutaneous blood test device
US3673475A (en) * 1970-09-15 1972-06-27 Fred M Hufnagel Pulse drive circuit for coils of dental impact tools and the like
US3734085A (en) 1971-07-30 1973-05-22 T Russell Stimulator
US3832776A (en) * 1972-11-24 1974-09-03 H Sawyer Electronically powered knife
DE2611721B2 (en) 1976-03-19 1978-10-26 R. Geerd Dr.Med. 6108 Weiterstadt Hamer Vacuum suction device for aspirating tissue serum
US4077406A (en) * 1976-06-24 1978-03-07 American Cyanamid Company Pellet implanter for animal treatment
US4154228A (en) * 1976-08-06 1979-05-15 California Institute Of Technology Apparatus and method of inserting a microelectrode in body tissue or the like using vibration means
DE2642896C3 (en) * 1976-09-24 1980-08-21 7800 Freiburg Precision snapper for setting standard stab wounds in the skin for diagnostic purposes
USD254444S (en) 1977-09-01 1980-03-11 Levine Robert A Blood sampling needle
US4222380A (en) 1977-12-02 1980-09-16 Olympus Optical Co., Ltd. Celiac injector
US4223674A (en) * 1978-06-29 1980-09-23 Arthur J. McIntosh Implant gun
US4356826A (en) * 1979-05-09 1982-11-02 Olympus Optical Co., Ltd. Stabbing apparatus for diagnosis of living body
DE3013384A1 (en) 1980-04-05 1981-10-15 Günter van Dr.med. 4000 Düsseldorf Endert CANNULA
US4360016A (en) 1980-07-01 1982-11-23 Transidyne General Corp. Blood collecting device
US4441510A (en) 1980-07-25 1984-04-10 Worley Michael W Method and apparatus for fetal pH scalp studies
US4553541A (en) 1981-03-23 1985-11-19 Becton, Dickinson And Co. Automatic retractable lancet assembly
US4383530A (en) 1981-06-05 1983-05-17 John Bruno Hypodermic needle and method of making needles
US4503856A (en) 1981-06-29 1985-03-12 Sherwood Medical Company Lancet injector
US4449529A (en) * 1981-11-18 1984-05-22 Becton Dickinson And Company Automatic retractable lancet assembly
US4535773A (en) * 1982-03-26 1985-08-20 Inbae Yoon Safety puncturing instrument and method
US4462405A (en) * 1982-09-27 1984-07-31 Ehrlich Joseph C Blood letting apparatus
US4517978A (en) 1983-01-13 1985-05-21 Levin Paul D Blood sampling instrument
US4580564A (en) 1983-06-07 1986-04-08 Andersen Michael A Finger pricking device
US4518384A (en) * 1983-06-17 1985-05-21 Survival Technology, Inc. Multiple medicament cartridge clip and medicament discharging device therefor
DE3426090A1 (en) 1983-10-06 1985-04-18 Karl Storz GmbH & Co, 7200 Tuttlingen Obstetric apparatus
US4637978A (en) 1983-10-28 1987-01-20 Eastman Kodak Company Assay for analysis of whole blood
US4577630A (en) 1984-02-14 1986-03-25 Becton, Dickinson And Co. Reusable breach loading target pressure activated lancet firing device
US4622974A (en) 1984-03-07 1986-11-18 University Of Tennessee Research Corporation Apparatus and method for in-vivo measurements of chemical concentrations
GB8406154D0 (en) 1984-03-09 1984-04-11 Palmer G C Sampling fluid
NL8401536A (en) 1984-05-11 1985-12-02 Medscan B V I O BLOOD SAMPLING UNIT.
DE3508365A1 (en) 1984-06-14 1985-12-19 Weise, Gustav, 8000 München Watch with a bracelet consisting of a plurality of links
EP0166574A3 (en) 1984-06-28 1987-06-16 Mitchell P. Dombrowski, M.D. Fetal blood sampling instrument
US4653511A (en) 1984-10-05 1987-03-31 Goch Thomas A Microsample blood collecting device
US5279294A (en) 1985-04-08 1994-01-18 Cascade Medical, Inc. Medical diagnostic system
US4627445A (en) 1985-04-08 1986-12-09 Garid, Inc. Glucose medical monitoring system
US4787398A (en) 1985-04-08 1988-11-29 Garid, Inc. Glucose medical monitoring system
US4653513A (en) 1985-08-09 1987-03-31 Dombrowski Mitchell P Blood sampler
US4750489A (en) * 1985-08-29 1988-06-14 Coopervision, Inc. Radial keratotomy knife and system using same
IL80628A0 (en) * 1985-11-18 1987-02-27 Bajada Serge Apparatus for testing the sensory system in humans or animals
US4658821A (en) 1986-01-08 1987-04-21 Packaging Corporation International A/K/A/ Medicore Ejector for an automatic lancet arm
DE3708031A1 (en) 1986-03-20 1987-11-12 Wolfgang Dr Med Wagner Measurement device or induction device with measurement device, or device for material recovery for a measurement device for metabolic states in the blood by puncturing under reduced pressure in a suction cup with displacement of the measurement zone outside the tip region of the puncturing device
US4685463A (en) 1986-04-03 1987-08-11 Williams R Bruce Device for continuous in vivo measurement of blood glucose concentrations
US4873993A (en) 1986-07-22 1989-10-17 Personal Diagnostics, Inc. Cuvette
US5029583A (en) 1986-07-22 1991-07-09 Personal Diagnostics, Inc. Optical analyzer
US4790979A (en) 1986-08-29 1988-12-13 Technimed Corporation Test strip and fixture
US4794926A (en) * 1986-11-24 1989-01-03 Invictus, Inc. Lancet cartridge
US5002054A (en) 1987-02-25 1991-03-26 Ash Medical Systems, Inc. Interstitial filtration and collection device and method for long-term monitoring of physiological constituents of the body
GB8710470D0 (en) 1987-05-01 1987-06-03 Mumford Ltd Owen Blood sampling devices
US4805623A (en) 1987-09-04 1989-02-21 Vander Corporation Spectrophotometric method for quantitatively determining the concentration of a dilute component in a light- or other radiation-scattering environment
GB2222251A (en) 1987-09-08 1990-02-28 Wolfgang Wagner Device for metabolism control
US4850973A (en) 1987-10-16 1989-07-25 Pavel Jordon & Associates Plastic device for injection and obtaining blood samples
US4844095A (en) 1987-12-14 1989-07-04 Medicore, Inc. Automatic lancet device
US5070886A (en) 1988-01-22 1991-12-10 Safety Diagnostice, Inc. Blood collection and testing means
US5014718A (en) 1988-01-22 1991-05-14 Safety Diagnostics, Inc. Blood collection and testing method
US4883068A (en) 1988-03-14 1989-11-28 Dec In Tech, Inc. Blood sampling device and method
US5320808A (en) * 1988-08-02 1994-06-14 Abbott Laboratories Reaction cartridge and carousel for biological sample analyzer
US4924879A (en) 1988-10-07 1990-05-15 Brien Walter J O Blood lancet device
US5108889A (en) * 1988-10-12 1992-04-28 Thorne, Smith, Astill Technologies, Inc. Assay for determining analyte using mercury release followed by detection via interaction with aluminum
US4920977A (en) 1988-10-25 1990-05-01 Becton, Dickinson And Company Blood collection assembly with lancet and microcollection tube
US4994073A (en) 1989-02-22 1991-02-19 United States Surgical Corp. Skin fastener
US5035704A (en) 1989-03-07 1991-07-30 Lambert Robert D Blood sampling mechanism
CA1337167C (en) 1989-03-14 1995-10-03 Eastman Kodak Company Needle housing with retractable needle
US5054499A (en) 1989-03-27 1991-10-08 Swierczek Remi D Disposable skin perforator and blood testing device
US4953552A (en) 1989-04-21 1990-09-04 Demarzo Arthur P Blood glucose monitoring system
US5145565A (en) * 1989-05-01 1992-09-08 Spacelabs, Inc. Contamination-free method and apparatus for measuring body fluid chemical parameters
US5100620A (en) 1989-05-15 1992-03-31 Miles, Inc. Capillary tube/gap reagent format
US4994079A (en) 1989-07-28 1991-02-19 C. R. Bard, Inc. Grasping forceps
US4976724A (en) 1989-08-25 1990-12-11 Lifescan, Inc. Lancet ejector mechanism
US5415169A (en) * 1989-11-21 1995-05-16 Fischer Imaging Corporation Motorized mammographic biopsy apparatus
US4994068A (en) 1989-11-24 1991-02-19 Unidex, Inc. Combination sterile pad support and lancet containing lancet disposal element
US5052403A (en) 1989-12-29 1991-10-01 Habley Medical Technology Corporation Self-contained, safety blood collection system
US5250066A (en) 1990-03-19 1993-10-05 Becton Dickinson And Company Plastic pointed articles and method for their preparation
US5271385A (en) 1990-03-29 1993-12-21 United States Surgical Corporation Abdominal cavity organ retractor
US5097810A (en) * 1990-04-06 1992-03-24 Henry Fishman Allergy testing apparatus and method
US5161532A (en) 1990-04-19 1992-11-10 Teknekron Sensor Development Corporation Integral interstitial fluid sensor
US5066859A (en) 1990-05-18 1991-11-19 Karkar Maurice N Hematocrit and oxygen saturation blood analyzer
US5152775A (en) * 1990-10-04 1992-10-06 Norbert Ruppert Automatic lancet device and method of using the same
US5188118A (en) * 1990-11-07 1993-02-23 Terwilliger Richard A Automatic biopsy instrument with independently actuated stylet and cannula
US5189751A (en) * 1991-03-21 1993-03-02 Gemtech, Inc. Vibrating toothbrush using a magnetic driver
US5402798A (en) 1991-07-18 1995-04-04 Swierczek; Remi Disposable skin perforator and blood testing device
US5163442A (en) 1991-07-30 1992-11-17 Harry Ono Finger tip blood collector
DE69229180T2 (en) 1991-11-12 1999-10-14 Urs A Ramel LANCETTE DEVICE
US5231993A (en) 1991-11-20 1993-08-03 Habley Medical Technology Corporation Blood sampler and component tester with guide member
US5222504A (en) * 1992-02-11 1993-06-29 Solomon Charles L Disposable neurological pinwheel
JP2572823Y2 (en) 1992-02-13 1998-05-25 株式会社アドバンス Simple blood sampler
US5165418B1 (en) 1992-03-02 1999-12-14 Nikola I Tankovich Blood sampling device and method using a laser
GB9207120D0 (en) 1992-04-01 1992-05-13 Owen Mumford Ltd Improvements relating to blood sampling devices
DE4212315A1 (en) 1992-04-13 1993-10-14 Boehringer Mannheim Gmbh Blood lancet device for drawing blood for diagnostic purposes
JPH0610900A (en) 1992-04-27 1994-01-21 Canon Inc Method and device for moving liquid and measuring device utilizing these method and device
US5318583A (en) 1992-05-05 1994-06-07 Ryder International Corporation Lancet actuator mechanism
US5217480A (en) 1992-06-09 1993-06-08 Habley Medical Technology Corporation Capillary blood drawing device
US5277198A (en) 1992-07-27 1994-01-11 Ryder International Corporation Blood sampling syringe
US5421816A (en) 1992-10-14 1995-06-06 Endodermic Medical Technologies Company Ultrasonic transdermal drug delivery system
US5569212A (en) 1994-07-22 1996-10-29 Raya Systems, Inc. Apparatus for electrically determining injection doses in syringes
US5282822A (en) 1993-01-19 1994-02-01 Sherwood Medical Company Lancet ejector for lancet injector
US5529074A (en) * 1993-02-26 1996-06-25 Greenfield; Jon B. Uniform pressure diagnostic pinwheel
US5395387A (en) 1993-02-26 1995-03-07 Becton Dickinson And Company Lancet blade designed for reduced pain
US5353806A (en) 1993-03-04 1994-10-11 The Venture Fund Of Washington Liquid collection device
US5902279A (en) 1993-04-20 1999-05-11 Advanced Cytometrix, Inc. Aspiration needle and method
EP0622626B1 (en) * 1993-04-23 2002-03-06 Roche Diagnostics GmbH System for analysing the components of fluid samples
JP2630197B2 (en) 1993-04-28 1997-07-16 株式会社ニッショー Blood suction device
DE4320463A1 (en) 1993-06-21 1994-12-22 Boehringer Mannheim Gmbh Blood lancet device for drawing blood for diagnostic purposes
US5387203A (en) 1993-06-28 1995-02-07 Goodrich; Hubert J. Subcutaneous extractor
JP3494183B2 (en) 1993-08-10 2004-02-03 株式会社アドバンス Simple blood collection device
US5582184A (en) 1993-10-13 1996-12-10 Integ Incorporated Interstitial fluid collection and constituent measurement
US5472427A (en) 1993-10-22 1995-12-05 Rammler; David H. Trocar device
EP0725593B1 (en) 1993-10-28 2004-04-07 I-Stat Corporation Fluid sample collection and introduction device
US5458140A (en) 1993-11-15 1995-10-17 Non-Invasive Monitoring Company (Nimco) Enhancement of transdermal monitoring applications with ultrasound and chemical enhancers
US5885211A (en) * 1993-11-15 1999-03-23 Spectrix, Inc. Microporation of human skin for monitoring the concentration of an analyte
US5445611A (en) 1993-12-08 1995-08-29 Non-Invasive Monitoring Company (Nimco) Enhancement of transdermal delivery with ultrasound and chemical enhancers
US5397334A (en) 1994-01-11 1995-03-14 Sherwood Medical Company Distal movement limiting assembly for finger stick device
US5474084A (en) 1994-03-15 1995-12-12 Cunniff; Joseph G. Algesimeter with detachable pin wheel
JP3368985B2 (en) 1994-05-10 2003-01-20 バイエルコーポレーション Automatic feeding device
US5591139A (en) * 1994-06-06 1997-01-07 The Regents Of The University Of California IC-processed microneedles
JP2723048B2 (en) 1994-06-24 1998-03-09 株式会社ニッショー Blood suction device
US5700695A (en) 1994-06-30 1997-12-23 Zia Yassinzadeh Sample collection and manipulation method
US5518006A (en) 1994-08-09 1996-05-21 International Technidyne Corp. Blood sampling device
US5514152A (en) * 1994-08-16 1996-05-07 Specialized Health Products, Inc. Multiple segment encapsulated medical lancing device
US5504011A (en) 1994-10-21 1996-04-02 International Technidyne Corporation Portable test apparatus and associated method of performing a blood coagulation test
GB9422260D0 (en) 1994-11-04 1994-12-21 Owen Mumford Ltd Improvements relating to skin prickers
US5947957A (en) 1994-12-23 1999-09-07 Jmar Technology Co. Portable laser for blood sampling
US5575403A (en) * 1995-01-13 1996-11-19 Bayer Corporation Dispensing instrument for fluid monitoring sensors
US5630986A (en) 1995-01-13 1997-05-20 Bayer Corporation Dispensing instrument for fluid monitoring sensors
US5655542A (en) * 1995-01-26 1997-08-12 Weilandt; Anders Instrument and apparatus for biopsy and a method thereof
US5628764A (en) 1995-03-21 1997-05-13 Schraga; Steven Collar lancet device
CA2170560C (en) * 1995-04-17 2005-10-25 Joseph L. Moulton Means of handling multiple sensors in a glucose monitoring instrument system
WO1996037256A1 (en) 1995-05-22 1996-11-28 Silicon Microdevices, Inc. Micromechanical patch for enhancing the delivery of compounds through the skin
JPH08317917A (en) 1995-05-25 1996-12-03 Advance Co Ltd Blood drawing device
KR0135178Y1 (en) 1995-06-26 1999-03-20 김인환 Lancet device for obtaining blood samples
US5671753A (en) 1995-06-27 1997-09-30 Pitesky; Isadore Disposable multiple allergen testing apparatus
JP3638958B2 (en) 1995-07-28 2005-04-13 アプルス株式会社 Assembly for adjusting the penetration depth of the lancet
DE29514084U1 (en) 1995-09-01 1995-11-02 Biosafe Diagnostics Corp Blood collection and test device
US5682233A (en) 1995-09-08 1997-10-28 Integ, Inc. Interstitial fluid sampler
US5879367A (en) * 1995-09-08 1999-03-09 Integ, Inc. Enhanced interstitial fluid collection
US5779642A (en) 1996-01-16 1998-07-14 Nightengale; Christopher Interrogation device and method
US5662127A (en) 1996-01-17 1997-09-02 Bio-Plas, Inc. Self-contained blood withdrawal apparatus and method
US5628309A (en) 1996-01-25 1997-05-13 Raya Systems, Inc. Meter for electrically measuring and recording injection syringe doses
DE19604156A1 (en) 1996-02-06 1997-08-07 Boehringer Mannheim Gmbh Skin cutting device for taking pain-free small amounts of blood
US5916229A (en) * 1996-02-07 1999-06-29 Evans; Donald Rotating needle biopsy device and method
WO1997029465A1 (en) * 1996-02-08 1997-08-14 Philips Electronics N.V. Initialisation of a wireless security system
US5801057A (en) * 1996-03-22 1998-09-01 Smart; Wilson H. Microsampling device and method of construction
JP3098971B2 (en) 1996-05-15 2000-10-16 松下電工株式会社 Hair removal device
US5857983A (en) * 1996-05-17 1999-01-12 Mercury Diagnostics, Inc. Methods and apparatus for sampling body fluid
EP1579814A3 (en) * 1996-05-17 2006-06-14 Roche Diagnostics Operations, Inc. Methods and apparatus for sampling and analyzing body fluid
US5951492A (en) 1996-05-17 1999-09-14 Mercury Diagnostics, Inc. Methods and apparatus for sampling and analyzing body fluid
DE69733836T2 (en) 1996-05-17 2006-04-27 Roche Diagnostics Operations, Inc., Indianapolis BODY FLUID DETECTION AND ANALYSIS DEVICE
US5951493A (en) 1997-05-16 1999-09-14 Mercury Diagnostics, Inc. Methods and apparatus for expressing body fluid from an incision
US6332871B1 (en) 1996-05-17 2001-12-25 Amira Medical Blood and interstitial fluid sampling device
US5879311A (en) 1996-05-17 1999-03-09 Mercury Diagnostics, Inc. Body fluid sampling device and methods of use
EP0906062B1 (en) * 1996-05-17 2007-12-26 Roche Diagnostics Operations, Inc. Body fluid sampling device
EP2160981B1 (en) 1996-05-17 2013-04-10 Roche Diagnostics Operations, Inc. Apparatus for expressing body fluid from an incision
US5810199A (en) * 1996-06-10 1998-09-22 Bayer Corporation Dispensing instrument for fluid monitoring sensor
US5758643A (en) * 1996-07-29 1998-06-02 Via Medical Corporation Method and apparatus for monitoring blood chemistry
FI112029B (en) * 1996-09-02 2003-10-31 Nokia Corp Device for taking and analyzing samples in liquid form, such as blood samples
GB9619462D0 (en) * 1996-09-18 1996-10-30 Owen Mumford Ltd Improvements relating to lancet devices
US6146361A (en) 1996-09-26 2000-11-14 Becton Dickinson And Company Medication delivery pen having a 31 gauge needle
US5776157A (en) * 1996-10-02 1998-07-07 Specialized Health Products, Inc. Lancet apparatus and methods
US5935864A (en) 1996-10-07 1999-08-10 Saliva Diagnostic Systems Inc. Method and kit for collecting samples of liquid specimens for analytical testing
US5714390A (en) * 1996-10-15 1998-02-03 Bio-Tech Imaging, Inc. Cartridge test system for the collection and testing of blood in a single step
US6063039A (en) * 1996-12-06 2000-05-16 Abbott Laboratories Method and apparatus for obtaining blood for diagnostic tests
ATE227844T1 (en) 1997-02-06 2002-11-15 Therasense Inc SMALL VOLUME SENSOR FOR IN-VITRO DETERMINATION
US5830219A (en) * 1997-02-24 1998-11-03 Trex Medical Corporation Apparatus for holding and driving a surgical cutting device using stereotactic mammography guidance
US5968063A (en) * 1997-05-14 1999-10-19 Jennifer Chu Intramuscular stimulation therapy facilitating device and method
US5948695A (en) 1997-06-17 1999-09-07 Mercury Diagnostics, Inc. Device for determination of an analyte in a body fluid
FI111217B (en) 1997-06-19 2003-06-30 Nokia Corp Apparatus for sampling
US5938679A (en) * 1997-10-14 1999-08-17 Hewlett-Packard Company Apparatus and method for minimally invasive blood sampling
US6013513A (en) * 1997-10-30 2000-01-11 Motorola, Inc. Molecular detection apparatus
US5964718A (en) 1997-11-21 1999-10-12 Mercury Diagnostics, Inc. Body fluid sampling device
DE19824036A1 (en) * 1997-11-28 1999-06-02 Roche Diagnostics Gmbh Analytical measuring device with lancing device
US6155992A (en) 1997-12-02 2000-12-05 Abbott Laboratories Method and apparatus for obtaining interstitial fluid for diagnostic tests
US5971941A (en) * 1997-12-04 1999-10-26 Hewlett-Packard Company Integrated system and method for sampling blood and analysis
US5871494A (en) 1997-12-04 1999-02-16 Hewlett-Packard Company Reproducible lancing for sampling blood
US6036924A (en) * 1997-12-04 2000-03-14 Hewlett-Packard Company Cassette of lancet cartridges for sampling blood
US6071294A (en) * 1997-12-04 2000-06-06 Agilent Technologies, Inc. Lancet cartridge for sampling blood
US6162639A (en) 1997-12-19 2000-12-19 Amira Medical Embossed test strip system
US6306347B1 (en) 1998-01-21 2001-10-23 Bayer Corporation Optical sensor and method of operation
JP2000014662A (en) * 1998-01-22 2000-01-18 Terumo Corp Humor examination device
US6193673B1 (en) * 1998-02-20 2001-02-27 United States Surgical Corporation Biopsy instrument driver apparatus
US6261241B1 (en) 1998-03-03 2001-07-17 Senorx, Inc. Electrosurgical biopsy device and method
US6139562A (en) * 1998-03-30 2000-10-31 Agilent Technologies, Inc. Apparatus and method for incising
US6391005B1 (en) * 1998-03-30 2002-05-21 Agilent Technologies, Inc. Apparatus and method for penetration with shaft having a sensor for sensing penetration depth
SG102538A1 (en) 1998-04-24 2004-03-26 Roche Diagnostics Gmbh Storage container for analytical devices
US5951582A (en) * 1998-05-22 1999-09-14 Specialized Health Products, Inc. Lancet apparatus and methods
US6022366A (en) 1998-06-11 2000-02-08 Stat Medical Devices Inc. Lancet having adjustable penetration depth
US6338790B1 (en) * 1998-10-08 2002-01-15 Therasense, Inc. Small volume in vitro analyte sensor with diffusible or non-leachable redox mediator
US6285454B1 (en) * 1998-12-07 2001-09-04 Mercury Diagnostics, Inc. Optics alignment and calibration system
DE69939598D1 (en) 1999-01-04 2008-10-30 Terumo Corp LANDZETTENANORDNUNG FOR REMOVAL AND FOR DETECTION OF BODY FLUIDS
US6210420B1 (en) * 1999-01-19 2001-04-03 Agilent Technologies, Inc. Apparatus and method for efficient blood sampling with lancet
DE60045351D1 (en) 1999-02-04 2011-01-20 Integ Inc Needle for body fluid tester
US6132449A (en) * 1999-03-08 2000-10-17 Agilent Technologies, Inc. Extraction and transportation of blood for analysis
US6306152B1 (en) * 1999-03-08 2001-10-23 Agilent Technologies, Inc. Lancet device with skin movement control and ballistic preload
US6402701B1 (en) * 1999-03-23 2002-06-11 Fna Concepts, Llc Biopsy needle instrument
US6120462A (en) * 1999-03-31 2000-09-19 Ethicon Endo-Surgery, Inc. Control method for an automated surgical biopsy device
US6231531B1 (en) * 1999-04-09 2001-05-15 Agilent Technologies, Inc. Apparatus and method for minimizing pain perception
US6152942A (en) 1999-06-14 2000-11-28 Bayer Corporation Vacuum assisted lancing device
WO2001000090A1 (en) 1999-06-30 2001-01-04 Nederlandse Organisatie Voor Toegepast- Natuurwetenschappelijk Onderzoek Tno Pricking device, carrier and cassette comprising a plurality of lancets
DE19945828B4 (en) * 1999-09-24 2011-06-01 Roche Diagnostics Gmbh Analysis element and method for the determination of an analyte in liquid
JP4359671B2 (en) 1999-09-29 2009-11-04 アークレイ株式会社 Body fluid collection tool
DE19948759A1 (en) * 1999-10-09 2001-04-12 Roche Diagnostics Gmbh Blood lancet device for drawing blood for diagnostic purposes
JP4210782B2 (en) * 1999-10-13 2009-01-21 アークレイ株式会社 Blood sampling position indicator
US6228100B1 (en) * 1999-10-25 2001-05-08 Steven Schraga Multi-use lancet device
US6364889B1 (en) * 1999-11-17 2002-04-02 Bayer Corporation Electronic lancing device
US6375627B1 (en) * 2000-03-02 2002-04-23 Agilent Technologies, Inc. Physiological fluid extraction with rapid analysis
US6379969B1 (en) * 2000-03-02 2002-04-30 Agilent Technologies, Inc. Optical sensor for sensing multiple analytes
DE10010694A1 (en) 2000-03-04 2001-09-06 Roche Diagnostics Gmbh Lancet including tipped needle with body surrounding tip
US6402704B1 (en) * 2000-04-18 2002-06-11 Sonexxus Incorporated Prothrombin test apparatus for home use
DE10029453C2 (en) 2000-06-21 2002-06-13 Roche Diagnostics Gmbh Pump for very low flow rates
US6561989B2 (en) * 2000-07-10 2003-05-13 Bayer Healthcare, Llc Thin lance and test sensor having same
EP1203563A3 (en) * 2000-10-31 2004-01-02 Boehringer Mannheim Gmbh Analyzing mean with integrated lancet
WO2002064193A2 (en) * 2000-12-14 2002-08-22 Georgia Tech Research Corporation Microneedle devices and production thereof
US6491709B2 (en) 2000-12-22 2002-12-10 Becton, Dickinson And Company Alternate-site lancer
CN101966085B (en) 2001-01-19 2013-01-16 松下电器产业株式会社 Lancet-integrated sensor, measurer, and catridge for biosensor
MXPA03006421A (en) * 2001-01-22 2004-12-02 Hoffmann La Roche Lancet device having capillary action.
US7041068B2 (en) 2001-06-12 2006-05-09 Pelikan Technologies, Inc. Sampling module device and method
US7547287B2 (en) * 2002-04-19 2009-06-16 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4895147A (en) * 1988-10-28 1990-01-23 Sherwood Medical Company Lancet injector
US6015392A (en) * 1996-05-17 2000-01-18 Mercury Diagnostics, Inc. Apparatus for sampling body fluid
EP1112717A1 (en) * 1996-12-06 2001-07-04 Abbott Laboratories Apparatus suitable for obtaining blood samples in a diagnostic test
US6086545A (en) * 1998-04-28 2000-07-11 Amira Medical Methods and apparatus for suctioning and pumping body fluid from an incision

Cited By (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9427532B2 (en) 2001-06-12 2016-08-30 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9937298B2 (en) 2001-06-12 2018-04-10 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9802007B2 (en) 2001-06-12 2017-10-31 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
US9694144B2 (en) 2001-06-12 2017-07-04 Sanofi-Aventis Deutschland Gmbh Sampling module device and method
US9560993B2 (en) 2001-11-21 2017-02-07 Sanofi-Aventis Deutschland Gmbh Blood testing apparatus having a rotatable cartridge with multiple lancing elements and testing means
US9089294B2 (en) 2002-04-19 2015-07-28 Sanofi-Aventis Deutschland Gmbh Analyte measurement device with a single shot actuator
US9795334B2 (en) 2002-04-19 2017-10-24 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9907502B2 (en) 2002-04-19 2018-03-06 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9186468B2 (en) 2002-04-19 2015-11-17 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9248267B2 (en) 2002-04-19 2016-02-02 Sanofi-Aventis Deustchland Gmbh Tissue penetration device
US9839386B2 (en) 2002-04-19 2017-12-12 Sanofi-Aventis Deustschland Gmbh Body fluid sampling device with capacitive sensor
US9072842B2 (en) 2002-04-19 2015-07-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US9498160B2 (en) 2002-04-19 2016-11-22 Sanofi-Aventis Deutschland Gmbh Method for penetrating tissue
US9724021B2 (en) 2002-04-19 2017-08-08 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
EP1628567A2 (en) * 2003-05-30 2006-03-01 Pelikan Technologies Inc. Method and apparatus for fluid injection
EP2238892A3 (en) * 2003-05-30 2011-02-09 Pelikan Technologies Inc. Apparatus for body fluid sampling
EP1628567A4 (en) * 2003-05-30 2007-09-19 Pelikan Technologies Inc Method and apparatus for fluid injection
US10034628B2 (en) 2003-06-11 2018-07-31 Sanofi-Aventis Deutschland Gmbh Low pain penetrating member
US9561000B2 (en) 2003-12-31 2017-02-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for improving fluidic flow and sample capture
US9261476B2 (en) 2004-05-20 2016-02-16 Sanofi Sa Printable hydrogel for biosensors
US9820684B2 (en) 2004-06-03 2017-11-21 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a fluid sampling device
EP1611848A1 (en) * 2004-06-30 2006-01-04 Lifescan Scotland Ltd Devices, systems and methods for extracting bodily fluid and monitoring an analyte therein
EP1752097A1 (en) * 2005-08-11 2007-02-14 Lifescan, Inc. Method for extracting interstitial fluid
EP1752096A3 (en) * 2005-08-11 2007-03-21 LifeScan, Inc. Sampling module for extracting interstitial fluid
US9795747B2 (en) 2010-06-02 2017-10-24 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
EP3380174A4 (en) * 2015-11-28 2019-04-24 Biopreme Medical Technologies, Inc. Negative pressure injection device
US10695509B2 (en) 2015-11-28 2020-06-30 Biopreme Medical Technologies Inc. Negative pressure injection device
WO2019020327A1 (en) * 2017-07-25 2019-01-31 Ascilion Ab A suction applying device, an apparatus for sampling a bodily fluid and a method for detecting a component in a bodily fluid
US11363977B2 (en) 2017-07-25 2022-06-21 Ascilion Ab Suction applying device, an apparatus for sampling a bodily fluid and a method for detecting a component in a bodily fluid
CN109872314A (en) * 2019-02-20 2019-06-11 数坤(北京)网络科技有限公司 A kind of Optimized Segmentation method and apparatus based on center line

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