US20040204662A1 - Methods and apparatus for expressing body fluid from an incision - Google Patents

Methods and apparatus for expressing body fluid from an incision Download PDF

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Publication number
US20040204662A1
US20040204662A1 US10/764,261 US76426104A US2004204662A1 US 20040204662 A1 US20040204662 A1 US 20040204662A1 US 76426104 A US76426104 A US 76426104A US 2004204662 A1 US2004204662 A1 US 2004204662A1
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United States
Prior art keywords
skin
incision
stimulator
housing
lancing
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
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US10/764,261
Inventor
Edward Perez
Jeffrey Roe
Charles Raney
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Roche Diabetes Care Inc
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Roche Diagnostics Operations Inc
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Filing date
Publication date
Priority claimed from US08/975,978 external-priority patent/US5964718A/en
Application filed by Roche Diagnostics Operations Inc filed Critical Roche Diagnostics Operations Inc
Priority to US10/764,261 priority Critical patent/US20040204662A1/en
Assigned to ROCHE DIAGNOSTICS OPERATIONS, INC. reassignment ROCHE DIAGNOSTICS OPERATIONS, INC. CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: AMIRA MEDICAL
Assigned to AMIRA MEDICAL reassignment AMIRA MEDICAL ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ROE, JEFFREY N., PEREZ, EDWARD
Assigned to ROCHE DIAGNOSTICS OPERATIONS, INC. reassignment ROCHE DIAGNOSTICS OPERATIONS, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: RANEY, CHARLES C.
Publication of US20040204662A1 publication Critical patent/US20040204662A1/en
Priority to US11/276,237 priority patent/US20060155316A1/en
Assigned to ROCHE DIABETES CARE, INC. reassignment ROCHE DIABETES CARE, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ROCHE DIAGNOSTICS OPERATIONS, INC.
Abandoned legal-status Critical Current

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    • 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
    • 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
    • A61B5/150076Means for enhancing collection by heating
    • 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
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150412Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • 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
    • A61B5/15111Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
    • AHUMAN NECESSITIES
    • 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
    • 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
    • A61B5/157Devices 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

  • This invention relates to a body fluid testing device and methods for obtaining samples of blood fluid for analysis.
  • Lancets generally have a rigid body and a sterile lance which protrudes from one end. The lancet may be used to pierce the skin, thereby enabling the collection of a body fluid sample from the opening created.
  • the body fluid sample is transferred to a test device or collection device.
  • Body fluid is most commonly taken from the fingertips, where the supply is generally excellent.
  • the nerve density in this region causes significant pain in many patient's. Sampling of alternative sites, such as earlobes and limbs is sometimes practiced to lessen the pain. These sites are also less likely to provide excellent body fluid samples and make body fluid transfer directly to test devices difficult. Examples of body fluids which may be utilized to test for glucose are blood and interstitial fluid.
  • 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 the retract. The speed is important to reduce the pain associated with the puncture.
  • Glucose monitoring devices may utilize a blood sample in many ways, though the two most common methods for collection are a paper strip and a capillary tube.
  • Monitors that utilize a paper strip require the patient to pierce a finger or appropriate location, withdraw a small sample of blood from the pierced area, such as by squeezing, and then placing the paper strip in physical contact with the blood sample and waiting until the paper strip absorbs the blood.
  • Monitors that utilize a capillary tube for fluid collection require the patient to follow the process described above, except that a paper strip is not utilized, instead a small capillary tube is placed over the sample until a sufficient amount of blood is withdrawn into the capillary tube and to the glucose testing area of the testing device.
  • Amira Medical Inc. introduced a new method for home glucose testing.
  • Amira's device AtLast 7 tests blood glucose levels by taking blood from the skin of the forearm, which is a much less sensitive than the fingertips. This device has been very well received by both the diabetic community as well as the blood glucose measurement industry.
  • Haynes U.S. Pat. No. 4,920,977 describes a blood collection assembly with a lancet and micro-collection 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 O'Brian U.S. Pat. No. 4,924,879. Jordan et al., U.S. Pat. No. 4,850,973 and U.S. Pat. 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.
  • Single use devices have also been developed for single use tests, i.e. home cholesterol testing, and for institutional use to eliminate the cross-patient contamination multi-patient use. Crosman et al., U.S. Pat. No. 4,869,249, and Swierczek U.S. Pat. No. 5,402,798, also describe disposable, single use lancing devices.
  • An object of the present invention is to provide a one-step procedure and device for testing glucose levels in body fluids.
  • Another object of the present invention is to provide an apparatus that withdraws a body fluid sample and provides an individual with a body fluid glucose level reading.
  • 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, particularly by penetrating less sensitive areas of the skin.
  • known lancing devices include manually actuable buttons for triggering the lance-driving mechanism once the user has placed the device against his/her skin. Because the user knows the precise instant when the lancet will be triggered and pain will be felt, there is a tendency for the user to jerk or raise the device at the instant of triggering, which can lead to inconsistent skin penetration, or possibly no penetration. Therefore, a further object of the invention is to provide a lancing device which eliminates such a tendency on the part of the user.
  • 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 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 lancet and collection device.
  • the present invention involves a method of obtaining a sample of fluid from a body.
  • the method comprises applying a skin-lancing medium against a skin surface to form an incision therein, removing the skin-lancing medium from the incision; and thereafter applying a force to depress the skin in a manner forming a ring of depressed body tissue in surrounding relationship to the incision, causing the incision to bulge and the sides of the incision to open, whereby body fluid is forced out through the opening of the incision.
  • the invention also relates to a device for sampling body fluid which comprises a housing having an open end, and a skin lancing mechanism for applying a skin-lancing medium against a skin surface to form an incision therein and then remove the skin-lancing medium from the incision.
  • a stimulator member is mounted to the housing at the open end thereof for movement relative to the housing. The stimulator member extends about a longitudinal axis of the housing and is adapted to engage the skin surface to bulge and open the incision in response to a pressing of the end face against the skin surface.
  • the invention also relates to a device for expressing body fluid from a lanced skin surface, which comprises a housing, and a stimulator mechanism mounted to the housing at an end thereof.
  • the stimulator mechanism includes a generally circular array of stimulator elements each mounted to the housing for movement toward and away from a longitudinal axis of the housing.
  • An actuator is mounted to the housing for displacing the stimulator elements toward the axis.
  • the invention also relates to a device for expressing body fluid from a lanced skin surface, which comprises a housing and a stimulator member mounted on the housing at an end thereof.
  • the stimulator member comprises a coil spring which is compressible toward the housing in response to being pushed against a user's skin in surrounding relationship to a lanced portion thereof.
  • Another aspect of the invention relates to a device for expressing body fluid from a lanced skin surface which comprises a housing and a hollow stimulator member mounted at an end of the housing and adapted to engage a user's skin surface in surrounding relationship to a lanced portion thereof.
  • the stimulator member can be heated, or vibrated. If vibrated, the stimulator member applies an ultrasonic frequency to the skin surface.
  • the invention also relates to a device for expressing body fluid from a lanced skin surface which comprises a housing and a hollow stimulator member mounted at an end of the housing for longitudinal movement relative to the housing and adapted to contact a user's skin surface in surrounding relationship to a lanced portion thereof.
  • a motor is mounted in the housing and a reciprocatory mechanism is connected to the motor to be driven thereby, and is operably connected to the stimulator member for reciprocating the stimulator member along a longitudinal axis of the stimulator member.
  • FIG. 1 is a longitudinal sectional view through a blood sampling device according to a first embodiment of the invention, with the lancet carrier in an unarmed condition;
  • FIG. 2 is a view similar to FIG. 1, with the lancet carrier in an armed condition;
  • FIG. 3 is a view similar to FIG. 2 after the lancet carrier has been triggered and a lancet is penetrating the skin;
  • FIG. 4 is a fragmentary view similar to FIG. 1 after an incision has been formed
  • FIG. 5 is a view similar to FIG. 4 showing a stimulator member of the device being depressed to cause the incision to bulge and open;
  • FIG. 6 is a view similar to FIG. 5 after a stimulating action has been performed to form a drop of blood at the open end of the incision;
  • FIG. 7 is a fragmentary longitudinal sectional view through a second embodiment of the invention.
  • FIG. 8 is a fragmentary longitudinal sectional view taken through a third embodiment of the invention.
  • FIG. 9 is a side elevational view of a fourth embodiment of the invention pressed against a skin surface
  • FIG. 10 is an end view of the device depicted in FIG. 9;
  • FIG. 11 is a view similar to FIG. 9 after the device has been compressed against the skin surface to bulge and open an incision;
  • FIG. 12 is an end view of the device in the condition depicted in FIG. 11;
  • FIG. 13 is a fragmentary longitudinal sectional view taken through a fifth embodiment of the invention while in a first state of operation;
  • FIG. 14 is a view similar to FIG. 13 with the device in a second condition of operation
  • FIG. 15 is a fragmentary longitudinal sectional view taken through a sixth embodiment of the invention in a first condition of operation thereof;
  • FIG. 16 is a view similar to FIG. 15 with the device in another condition of operation;
  • FIG. 17 is a view similar to FIG. 16 of yet a further condition of operation of the device.
  • FIG. 18 is a side elevational view, partly in longitudinal section of yet another embodiment of the invention.
  • FIG. 19 is a longitudinal sectional view taken through still a further embodiment of the invention.
  • FIG. 20 is a longitudinal sectional view of a blood lancing device according to a seventh embodiment of the invention while in a first condition or operation thereof;
  • FIG. 21 is an end view of the device in the condition depicted in FIG. 20;
  • FIG. 22A is a view similar to FIG. 20, with the lancet carrier in an armed condition
  • FIG. 22B is a partial cross-sectional side view of the lancing device wherein the lancet has penetrated the patient's skin;
  • FIG. 22C is a view similar to FIG. 22A, illustrating the bulge which forms in the patient's tissue, wherein the stimulating member stretches the skin open for expressing a body fluid sample;
  • FIG. 23 is an end view of an alternative embodiment of the stimulating member of the present invention.
  • FIG. 24 is a cross-sectional side view of the alternative embodiment of the stimulating member illustrated in FIG. 23;
  • FIG. 25 is an end view of another alternative embodiment of the stimulating member of the present invention.
  • FIG. 26 is a partial cross-sectional side view of a lancing device including a stimulating member and a constricting member;
  • FIG. 27 is a partial cross-sectional side view of the lancing device of FIG. 26 in use
  • FIG. 28 is a partial cross-sectional side view of the lancing device of FIG. 26 in use illustrating a bulge of tissue formed by the constricting member;
  • FIG. 29 is a partial cross-sectional side view illustrating the lancing action and spreading of the formed incision by the stimulating member
  • FIG. 30 is a partial cross-sectional side view of an alternative embodiment of a lancing device including a stimulating member and a constricting member;
  • FIG. 31 is a partial cross-sectional side view of the lancing device of FIG. 30 illustrating the formation of an incision within a bulge of tissue;
  • FIG. 32 is a partial cross-sectional side view of the lancing device of FIG. 31 illustrating the spreading of the incision by the stimulating member.
  • FIG. 33 is a side view illustrating a glucose monitoring device in accordance with the present invention.
  • a lancing device 10 (see FIG. 1) according to one preferred embodiment of the invention comprises an outer housing 12 having upper and lower portions 14 , 16 connected together, and an inner housing 18 fixed to the outer housing.
  • a cocking mechanism 20 comprising a pull handle 22 to which is fixedly secured a hollow draw tube 24 .
  • a draw ring 26 Fixed to an inner wall of the draw tube 24 is a draw ring 26 .
  • a draw bar 30 Situated within the draw tube 24 is a draw bar 30 having a pair of flexible hooks 32 at its upper end.
  • the hooks are releasably latched to a sleeve 34 which is movably disposed within the draw ring 26 .
  • a coil compression spring 36 acts between a flange 33 of the sleeve 34 and an inner flange 38 of the draw ring 26 .
  • a trigger sleeve 35 is mounted within the lower portion 16 of the outer housing 12 .
  • a lower end of the trigger sleeve rests upon a first outer flange 37 A of the inner housing, and a second outer flange 37 B of the inner housing rests upon an inner projection 39 of the trigger sleeve.
  • the draw bar 30 frictionally holds a skin-lancing medium in the form of a disposable lancet 40 in which a needle 42 is disposed.
  • the draw bar 30 includes a flexible latch finger 44 that has a projection 45 adapted to be received in a hole 46 of the inner housing 18 (see FIG. 2) when the device is armed.
  • a trigger member 49 is mounted in a hole 47 of the trigger sleeve 35 and includes an arm 48 extending partially into the hole 46 .
  • the trigger member 49 includes an inclined cam follower surface 50 .
  • a coil compression spring 52 acts between a top wall 54 of the inner housing 18 and a shoulder 56 of the draw bar.
  • a firing tube 60 Slidably disposed within a lower end of the lower portion of the outer housing is a firing tube 60 which includes an upper cam surface 62 .
  • an outer hollow stimulator member Fixed to a lower end of the firing tube 60 is an outer hollow stimulator member in the form of a cylindrical ring 64 , having an end surface 65 of generally frusto-conical shape so as to be oriented at a downward and inward inclination to generally face a longitudinal axis A of the device.
  • an inner hollow stimulator member Disposed coaxially within the firing tube 60 and outer stimulator ring 64 is an inner hollow stimulator member also in the form of a cylindrical ring 66 having a frusto-conical end surface 67 also oriented at a downward and inward inclination.
  • the end surfaces 65 and 67 are of circular configuration when viewed along the axis A, other configurations, such as polygonal, oval, etc., are possible.
  • a coil compression spring 68 acts between an upper end of the outer stimulator ring 64 and a downwardly facing shoulder 70 of the inner stimulator ring 66 .
  • the inner stimulator ring 66 includes a lance stop flange 72 adapted to be engaged by a lance ring 74 of the lancet 40 as will be explained.
  • the first flange 37 A of the inner housing rests upon a support sleeve 80 which, in turn, rests upon an upper end of the inner stimulator ring 66 .
  • a lancing device in practice, when a fluid sample, such as blood or interstitial fluid, is to be taken from a user's body, a lancing device according to the present invention can be used to minimize pain. To do so, a region of the user's body having less sensitivity than, for example, a fingertip, is selected. Such a low-sensitivity region could be the user's forearm for example. Initially, the handle 22 is pulled up to raise the drawbar 30 until the projection 45 of the latch finger 44 snaps into the hole 44 of the inner housing 18 , as shown in FIG. 2. Simultaneously, the spring 52 is compressed.
  • the outer stimulator ring 64 is pressed against the user's skin S, e.g., on the selected forearm region FA, the ring 64 and its cam surface 62 are moved upwardly to displace the trigger radially inwardly, whereupon the projection 45 of the latch finger 44 is disengaged from the hole 46 . Accordingly, the spring 52 expands to displace the drawbar 30 downwardly so that the needle 42 punctures the skin sufficiently deep to cut capillaries in the superficial vascular plexus, as shown in FIG. 3. Simultaneously, the spring 68 is compressed. The extent of displacement of the drawbar 30 is limited by engagement between the lance ring 74 with the lance stop 72 .
  • the compressed spring 68 expands to raise the drawbar, as well as the needle 42 and inner stimulator ring 66 from the skin (see FIG. 4).
  • the end face 65 of the outer stimulator ring 64 exerts a downward force F which depresses a ring-shaped portion of the skin and body tissue which is disposed in surrounding relationship to the wound or incision I, causing the wounded area to bulge while pulling apart the sides of the wound (see FIG. 5).
  • fluid such as blood or interstitial fluid is trapped and pressurized so that it travels upwardly through the pulled-open end of the wound since the surrounding ring of depressed skin and body tissue restricts the outward flow of fluid. That action is enhanced by the fact that the force F is inclined inwardly toward the axis A to force the fluid toward the bulged area.
  • the present invention enables an ample supply of blood, interstitial fluid or other body fluid to be obtained relatively painlessly from areas of the body which typically possess lesser amounts of such fluid as compared with the highly sensitive fingertip region.
  • the outer stimulator ring 64 moves upwardly relative to the inner stimulator ring 66 so that the end surface 67 of the inner ring 66 also contacts the skin surface S at a location inwardly of the outer face 65 , thereby promoting the displacement of fluid inwardly toward the wound.
  • the present invention can be practiced by a single stimulator ring arrangement 64 A as shown in FIG. 8.
  • the surfaces 65 , 67 are continuous, i.e., non-interrupted, it may be desirable to provide either or both of those surfaces with circumferentially spaced recesses 80 as shown in FIG. 7.
  • the surface(s) 65 A, 67 A will still depress a ring of body tissue surrounding the wound, but the areas of the ring corresponding to the location of the recesses will be depressed to a lesser extent than the other areas. Those lesser depressed areas will provide less resistance to fluid flow and will thus enable some fluid to leak past the ring, which would be beneficial in the event that the user neglects to release the downward pressure on the device.
  • the stimulator member need not be in the form of a ring.
  • the stimulator member can be in the form of a helical spring 90 formed by a flat strip 92 .
  • Such a spring would function in somewhat similar fashion to the double-ring arrangement of FIGS. 1-7 in that a stimulator surface gradually comes into contact with the skin in a radially inward direction to aid in propelling blood or interstitial fluid toward the center axis.
  • FIGS. 9 and 10 depict a condition when the spring 90 is uncompressed.
  • FIGS. 11 and 12 depict a condition wherein the spring is fully compressed. Shaded regions in FIGS. 10 and 12 represent contact between the spring and the skin. It will be appreciated that during compression of the spring, the contact region of the spring progresses gradually radially inwardly, causing blood or interstitial fluid to be pushed toward the axis A and thus toward the bulged area of the skin.
  • FIGS. 13 and 14 Depicted in FIGS. 13 and 14 is yet another alternative embodiment wherein the outer stimulator ring 64 B is interconnected to the inner stimulator ring 66 B by levers 100 which are pivoted to the firing tube 60 B.
  • the outer stimulator ring 64 B is interconnected to the inner stimulator ring 66 B by levers 100 which are pivoted to the firing tube 60 B.
  • upward sliding movement of the outer ring 64 B is transmitted as a downward force to the inner ring 66 B to slide the latter downwardly and intensify the pumping action.
  • FIGS. 15-17 A further embodiment is depicted in FIGS. 15-17 wherein the firing tube 60 C has a carrier tube 102 affixed at a lower end thereof. Pivotably mounted on the carrier tube 102 is a circular array of levers 104 each having an upper and lower end, each lower end carrying a stimulator element in the form of a roller 106 . Each lever 104 is rotatable about an axis extending orthogonally relative to the axis of the housing.
  • An inner ring 110 is slidable up and down, either by manual force, or by a motor-driven cam (e.g., of the type disclosed later in connection with FIG. 19). That ring 110 has a beveled cam face 112 formed on its lower end.
  • the levers 104 are rotated such that the lower rollers 106 are displaced inwardly and upwardly at a location disposed below the open end of the bulged wound to open the wound and force blood or interstitial fluid toward the wound to form a drop D.
  • the rollers 106 gravitate to a rest position shown in FIG. 15. Repeated applications of the downward force cause the drop to become gradually enlarged as explained earlier.
  • FIG. 18 Depicted in FIG. 18 is an alternative embodiment similar to that depicted in FIGS. 1-6, except that the lower end surface of the outer stimulator ring 64 D is provided with a hollow stimulator element 114 which is electrically connected to a battery 116 mounted in an upper end of the device.
  • the element can be either an electrical resistance element (i.e., a heater) or a vibrator such as a piezoelectric transducer, intended to stimulate fluid flow.
  • a heater will expand the capillaries and make the blood or interstitial fluid less viscous and thus more flowable, in order to increase the amount of the body fluid sample.
  • the element 114 is a vibrator, such as a piezoelectric transducer
  • vibrations can be created which stimulate the flow of body fluid. This could be achieved by operating the transducer to produce frequencies below 28,000 cycles per second.
  • ultrasonic frequencies i.e., frequencies above 20,000 cycles per second
  • the frusto-conical shape 114 A of the end face of the element will optimize the creation of such wave patterns.
  • a heater such as an infrared emitter, mounted in the housing which vasodilates the capillaries to increase blood flow. Another advantage of the use of such frequencies is that only minimal downward force to the device may be necessary since the wave patterns may produce an ample pumping action.
  • FIG. 19 depicts a device which is not automatically fired, but rather requires manual actuation of lever 130 against a bias of a spring 132 to force a trigger 134 to push a projection 136 out of a hole 138 (when the projection extends into that hole).
  • a battery 142 and electric motor 144 mounted to the battery to be actuated thereby.
  • the motor 144 rotates a sleeve 146 about the axis A.
  • the sleeve includes a cam surface 148 which engages a follower roller 150 mounted on a tube 152 .
  • the cam mechanism 146 can be used in an automatically firing device, such as that disclosed in connection with FIG. 1.
  • FIG. 20 there is shown a seventh embodiment of the blood lancing device 10 of the present invention, wherein like reference numerals have been utilized to denote the same or similar elements of the previous embodiments described above and shown in FIGS. 1-19.
  • the lancing device 10 according to a seventh embodiment includes an outer housing 12 having upper and lower portions 14 , 16 connected together, and an inner housing 18 fixed to the outer hosing.
  • a cocking mechanism 20 comprising a pull handle 22 to which is fixedly secured a hollow draw tube 24 .
  • a draw ring 26 Fixed to an inner wall of the draw tube 24 is a draw ring 26 .
  • a draw bar 30 Situated with the draw tube 24 is a draw bar 30 having a pair of flexible hooks 32 at its upper end.
  • the hooks are releasably latched to a sleeve 34 which is movably disposed with the draw ring 26 .
  • a coil compression spring 36 act between a flange 33 of the sleeve 34 and an inner flange 38 of the draw ring 26 .
  • a trigger sleeve 35 is mounted within the lower portion 16 of the outer housing 12 .
  • a lower end of the trigger sleeve rests upon a first outer flange 37 A of the inner housing, and a second outer flange 37 B of the inner housing rests upon an inner projection 39 of the trigger sleeve.
  • the draw bar 30 frictionally holds a skin-lancing medium in the form of a disposable lancet 40 in which a needle or lancet 42 is disposed.
  • the draw bar 30 includes a flexible latch finger 44 that has a projection 45 adapted to be received in a hole 46 of the inner housing 18 when the device is armed.
  • a trigger member 49 is mounted in a hole 47 of the trigger sleeve 35 and includes an arm 48 extending partially into the hole 46 .
  • the trigger 46 includes an inclined cam follower surface 50 .
  • a coil compression spring 52 acts between a top wall 54 of the inner housing 18 and a shoulder 56 of the draw bar.
  • a firing tube 60 which includes an upper cam surface 62 .
  • a stimulator member 160 Fixed to a lower end of the firing tube 60 is a stimulator member 160 in the form of a flexible membrane, having a tissue contacting surface 161 .
  • FIG. 21 there is shown an end view of the lancing device 10 of the present invention illustrating the stimulator member 160 .
  • the stimulator member 160 includes circumferentially spaced interruptions 163 .
  • FIGS. 22A through 22C there are shown partial longitudinal cross-sectional side views of the present invention.
  • FIG. 22A there is shown the distal end of the lancing device 10 as disposed over a potion of skin S to be lanced in preparation for a body fluid sample to be obtained.
  • the tissue contacting surface 161 of the stimulator member 160 contacts the patient's skin.
  • the tissue contacting surface 161 of the stimulator member 160 may be formed having a raised area as shown in FIGS. 23-25, wherein the raised surface contact the skin S thereby providing a friction force f between the distal surface 161 and the skin S.
  • FIG. 22C there is shown the lancet 42 in a retracted position after the lancet 42 has penetrated the skin S to a sufficient depth to cut capillaries in the superficial vascular plexis to form an incision I as shown.
  • the tissue contacting surface 161 of the stimulator member 160 remains in contact with the skin as after the lancet has formed an incision within the patient's skin and is thereby withdrawn from the incision I.
  • the force F applied to the proximal end of the lancing device 10 causes the sleeve 280 to contact the skin, wherein the skin yields to the applied force as shown in FIG. 22C.
  • the skin S forms a bulge about the incision I formed by the lancet.
  • the friction force f between the distal surface 161 and the skin S retains the stimulator member upon the skin S.
  • the incision I is stretched open, thereby allowing more body fluid to be expressed from the incision.
  • the sleeve 180 causes fluid such as blood or interstitial fluid to become trapped and pressurized within the bulged area, so that the body fluid will travel upwardly through the pulled-open incision I.
  • the lancing device 10 is removed from the patient's skin wherein the sample may then be utilized in any manner desirable.
  • the stimulator member 160 and the lancing device 10 produce a sufficiently sized sample between about 0.05 micro liters and 10 micro liters without the need for repetitive motion as described above with regard to the other embodiments of the present invention.
  • the alternative embodiment of the lancing device illustrated in FIGS. 20-22C may be utilized with other methods and devices for producing a sufficiently sized sample.
  • the lancing device 10 may include vibration means (not shown), heating means (not shown), vacuum means (not shown), each of which may be utilized to encourage blood flow within the area to be sampled.
  • the area to be sampled may be stimulated using one of the methods described above prior to using the lancing device 10 .
  • the stimulator member 160 may be constructed of bio-compatible materials such as polyvinyl chloride, silicon, urethane, or similar flexible materials which are adapted to grip and translate a frictional force between the tissue contacting surface 161 and the patient's skin S thereby causing a wound to be stretched open thereby allowing a greater amount of body fluid to flow therefrom.
  • the stimulator member 160 may be formed of materials which are flexible such that a portion of the stimulator member 160 will deform in use, though it shall be understood in a preferred embodiment, the tissue contacting surface 161 remains substantially parallel with the skin surface as shown in FIGS. 22A-22C.
  • the stimulating member 160 may be formed of a rigid material wherein the skin contacting surface of the rigid stimulating member is adapted to provide a friction force between the skin and the tissue contacting surface such that the skin will be retained upon the tissue contacting surface as described above. Additionally, the stimulating member may be pivotally affixed to the sleeve 280 thereby allowing a rigid stimulator member to be utilized in the same manner as a flexible member.
  • the stimulator member 260 illustrated therein may be formed in generally the same manner as that shown and described above, though the stimulator member 260 is formed having a plurality of rings 261 disposed radially about an aperture 266 .
  • the plurality of rings 261 act on the skin S with a frictional force such as that described and shown above.
  • the frictional force f retains the tissue contacting surface 261 of the stimulator member 260 upon the skin surface S, whereby causing the incision I to stretch open as described above.
  • the stimulator member 460 further includes a raised member 462 extending from the tissue contacting surface 461 .
  • the raised member 462 is disposed upon the tissue contacting surface 461 in a spiraling manner, such as that shown in FIGS. 9-11, and 25 .
  • the leading edge 463 of the spiraling raised member 462 will contact the patient's skin first, thereafter as a greater downward force is applied the remaining portion of the spiraling raised member 462 will contact the patient's tissue.
  • the forced imparted by the spiraling raised member 462 will cause the skin to bulge, in addition the constant spiraling motion will cause the fluid under the skin to become concentrated within the center of the bulge.
  • the lancing device 10 may further include a stimulating member 160 as described in detail above with regard to FIGS. 21 through 25.
  • a constricting member 500 may be fixedly attached to the distal end 181 of the sleeve 180 .
  • the constricting member 500 may be constructed of a pliable material, wherein the constricting member 500 will flex as shown in FIG. 28. Examples of materials which the constricting member 500 may be constructed of plastics such as polyethylene, polysilicone, polyvinyl chloride, or alternatively of materials such as titanium, aluminum, steel, stainless steel.
  • the constricting member 500 may be constructed as a separate body which is then fixedly attached to the distal end 181 of the sleeve 180 with an adhesive or mechanical fastener or other process such as melting or fusion welding. Alternatively, the constricting member 500 may be pivotally attached to the distal end 181 of the sleeve 180 (not shown).
  • FIG. 27 there is shown the lancing device 10 as disposed over an area in which it is desired to express a sample of body fluid.
  • the force F is applied to the lancing device 10 the force F is translated through the constricting member 500 into component forces F′ and F′′.
  • the component forces F′ and F′′ cause the patient's skin in contact with the distal end 501 of the constricting member 500 to gather and form a pucker as shown in FIG. 28, wherein the tissue contacting surface 161 of the stimulating member 160 contacts the skin S.
  • the pucker of skin is drawn into the distal end of the lancing device 10 .
  • the pucker of skin is received by the tissue contacting surface 161 of the stimulating member 160 , wherein the stimulating member may include a plurality of ridges to increase frictional contact between the skin and the tissue contacting surface 161 of the stimulating member 160 .
  • a second force F′′′ is applied to the lance 42 , thereby driving the distal tip of a lance or needle into the pucker of skin to form an incision therein as shown in FIG. 28.
  • FIG. 29 there is shown the lancing device 10 wherein the lance or needle 42 has been retracted by spring force K after an incision I has been formed in the patient's skin.
  • a greater force F 2 is applied to the lancing device 10 , this causes the constricting member 500 to further pinch the skin in addition to causing the incision to be spread by the stimulating member 160 due to a friction force f between the skin S and the tissue contacting surface 161 of the stimulating member 160 .
  • the lancet device may not require a repeated motion as described above in order to express a sufficiently sized sample of body fluid.
  • the lancing device 10 may include additional stimulating means such as heat, vibration, ultrasound or other similar known methods or devices which are utilized to increase body fluid flow within a localized area.
  • FIGS. 30-32 there is shown an alternative embodiment of a constricting member 600 .
  • the constricting device 600 may be disposed about the sleeve 180 of the lancing device 10 and adjacent the distal end 181 to the sleeve 180 .
  • the constricting device 600 includes a plurality of arms 610 having a distal end 611 and a proximal end 612 , a biasing member 650 and a pivot 660 .
  • the proximal end 612 of the arm 610 may be pivotally attached to the sleeve 180 .
  • the arm 610 may be pivotally attached to the sleeve through a pin and block configuration as shown in FIGS. 30-32 or alternatively the proximal end 612 may be integrally formed with the sleeve 180 and pivot through the use of a live hinge or similar arrangement.
  • the constricting device member 600 includes a biasing member 650 .
  • the biasing member 650 acts on the arms 610 thereby directing the distal tips 611 of the arms 610 to contact the skin S as shown and to provide forces F′ and F′′.
  • the constricting member 600 acts upon the patient's skin to form a pucker of skin which is received within the distal end of the lancing device 10 . It shall be noted that the constricting member 600 acts upon the patient's skin in the same manner as the constricting device 500 as described above with reference to FIGS. 26 through 29. Wherein the constricting device 600 and stimulating member 160 act in conjunction with one another to express a greater amount of body fluid from an incision formed in the patient's skin.
  • the lancing device in accordance with the present invention may be best utilized in areas where it is difficult to obtain a sufficient sample size, such as a forearm, though it is desirable to lance within this area because of the reduction in pain associated with the lancing.
  • a lancing device 700 in accordance with the present invention, wherein the lancing device 700 further includes a body fluid sampling and testing device.
  • the lancing device 700 may be utilized upon a patient's forearm or similar area, wherein the stimulating member and constricting member in conjunction with a needle or lancet produce a sample size of sufficient volume wherein a test may be performed thereon.
  • the lancing device 700 may be that which is shown and described in co-pending U.S. Provisional Patent Application No. 60/296,950 filed Jun. 8, 2001, now abandoned, Attorney Dkt. No. 018176-385 and to co-pending U.S. Provisional Patent Application No. 60/297,098 filed Jun. 8, 2001, now abandoned, Attorney Dkt. No. 018176-382, the entirety of which are hereby incorporated by reference.
  • the present invention enables a sampling of blood or interstitial fluid to be taken from areas of the body, such as a forearm, that are less insensitive to pain, despite the fact that those areas typically have relatively less fluid as compared, for example, to fingertips (which are highly sensitive to pain).
  • a lancet as a skin-lancing medium
  • other skin-lancing media can be used, such as a laser, or known pneumatic or hydraulic injectors of the type which inject pressurized gas or liquid against the skin.
  • auto injectors are sold by Becton-Dickinson, for example, to inject insulin.
  • the gas e.g., air or nitrogen
  • liquid e.g., water
  • an incision could be formed in the skin for taking samples of body fluid.
  • small particles could be mixed with the gas to promote the tissue-cutting action.
  • the particles could comprise carbon particles of from 1 micron to 0.010 inches in diameter.
  • the lance or needle may remain within the incision during the collection of the sample. Additionally a force may be applied to the lance or needle to stimulate fluid flow from the incision, for example the lance or needle may be vibrated to express fluid from the incision. It shall be understood that the terms “remain within the incision” shall mean to include the instances where the lance or needle remains in contact with the patient's tissue inside of the incision, or where the lance or needle is withdrawn just distal the incision though remains in fluid contact with the body fluid expressed from the incision.

Abstract

A sample of a body fluid such as blood or interstitial fluid is obtained from a body by lancing a portion of a user's skin, preferably in an area other than a finger tip, to form an incision. After the needle has been removed from the incision, a force is applied to depress the skin in a manner forming a ring of depressed body tissue in surrounding relationship to the incision, causing the incision to bulge and the sides of the incision to open, whereby body fluid is forced out through the opening of the incision. A stimulator member is mounted to an end of a lancet-carrying housing for applying the force. The stimulator member can be movable relative to the housing, and can be either heated or vibrated to promote movement of the body fluid.

Description

    PRIOR APPLICATIONS
  • The present application is a continuation of U.S. patent application Ser. No. 09/879,991 filed Jun. 14, 2001, which is a continuation-in-part of U.S. patent application Ser. No. 09/542,040 filed Mar. 31, 2000, now U.S. Pat. No. 6,464,649, which is a continuation of U.S. patent application Ser. No. 09/285,021 filed Apr. 1, 1999, now U.S. Pat. No. 6,066,103, which is a continuation of U.S. patent application Ser. No. 08/975,978 filed Nov. 21, 1997, now U.S. Pat. No. 5,964,718. The above-identified patent applications and patents are hereby incorporated by reference in their entirety.[0001]
  • FIELD OF THE INVENTION
  • This invention relates to a body fluid testing device and methods for obtaining samples of blood fluid for analysis. [0002]
  • BACKGROUND OF THE INVENTION
  • Many medical procedures in use today require a relatively small sample of body fluid, for example in the range of 0.1-50 micro liters. 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 or forearm, to enable the collection body fluid. With the advent of home use tests for the self monitoring of blood glucose, there is a requirement for a simple procedure which can be performed in any setting without a person needing the assistance of a professional. [0003]
  • One device which is commonly utilized to form an opening in the patient's skin is a lancets. Lancets generally have a rigid body and a sterile lance which protrudes from one end. The lancet may be used to pierce the skin, thereby enabling the collection of a body fluid sample from the opening created. The body fluid sample is transferred to a test device or collection device. Body fluid is most commonly taken from the fingertips, where the supply is generally excellent. However, the nerve density in this region causes significant pain in many patient's. Sampling of alternative sites, such as earlobes and limbs is sometimes practiced to lessen the pain. These sites are also less likely to provide excellent body fluid samples and make body fluid transfer directly to test devices difficult. Examples of body fluids which may be utilized to test for glucose are blood and interstitial fluid. [0004]
  • Repeated lancing in limited surface areas, such as fingertips, results in callous formation. This leads to increased difficulty in drawing body fluid and increased pain. [0005]
  • To reduce the anxiety of piercing the skin and the associated pain, many spring loaded devices have been developed wherein the device automatically triggers in response to an applied force. Thus the user cannot anticipate the exact timing of the piercing, thus they are less likely to pull the device away during use. The following two patents are representative of the devices which were developed in the 1980's for use with home diagnostic test products. [0006]
  • 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 the retract. The speed is important to reduce the pain associated with the puncture. [0007]
  • 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. [0008]
  • In home settings it is often desirable to collect a body fluid sample in order to enable a user to perform a test at home, such as glucose monitoring. Some blood glucose monitoring systems, require that the blood sample be applied to a test device wich is in contact with the test instrument. In such situations, bringing the finger to the test device poses some risk of contamination of the sample with a previous sample that may not have been properly cleaned from the device. Glucose monitoring devices may utilize a blood sample in many ways, though the two most common methods for collection are a paper strip and a capillary tube. Monitors that utilize a paper strip, require the patient to pierce a finger or appropriate location, withdraw a small sample of blood from the pierced area, such as by squeezing, and then placing the paper strip in physical contact with the blood sample and waiting until the paper strip absorbs the blood. Monitors that utilize a capillary tube for fluid collection, require the patient to follow the process described above, except that a paper strip is not utilized, instead a small capillary tube is placed over the sample until a sufficient amount of blood is withdrawn into the capillary tube and to the glucose testing area of the testing device. [0009]
  • Many times due to dexterity problems or poor eye site it can be difficult for the patient to either bring the body fluid sample to the testing area or to bring a capillary tube to the fluid sample. Additionally, some patient's have a fear of bodily fluids, such as blood, and would prefer not to see this type of body fluid. [0010]
  • Amira Medical Inc. introduced a new method for home glucose testing. Amira's device AtLast [0011] 7, tests blood glucose levels by taking blood from the skin of the forearm, which is a much less sensitive than the fingertips. This device has been very well received by both the diabetic community as well as the blood glucose measurement industry.
  • Haynes U.S. Pat. No. 4,920,977 describes a blood collection assembly with a lancet and micro-collection 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 O'Brian U.S. Pat. No. 4,924,879. Jordan et al., U.S. Pat. No. 4,850,973 and U.S. Pat. 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. [0012]
  • 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. [0013]
  • 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 with 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 withdrawn from the puncture sire or the user pulls the device back. [0014]
  • Garcia et al., U.S. Pat. No. 4,637,403 discloses a combination lancing and blood collection device which uses a capillary action passage to conduct body fluid to a separate test strip in the form of a micro porous membrane. It is necessary to achieve a precise positioning of the upper end of the capillary passage with respect o the membrane in order to ensure that the body fluid from the passage is transferred to the membrane. If an appreciable gap exits therebetween, no transfer may occur. [0015]
  • It is difficult for a user to determine whether a sufficiently large drop of body fluid has been developed at the incision for providing a large enough sample. [0016]
  • Single use devices have also been developed for single use tests, i.e. home cholesterol testing, and for institutional use to eliminate the cross-patient contamination multi-patient use. Crosman et al., U.S. Pat. No. 4,869,249, and Swierczek U.S. Pat. No. 5,402,798, also describe disposable, single use lancing devices. [0017]
  • The disclosures of the above patents are incorporated herein by reference. [0018]
  • An object of the present invention is to provide a one-step procedure and device for testing glucose levels in body fluids. [0019]
  • Another object of the present invention is to provide an apparatus that withdraws a body fluid sample and provides an individual with a body fluid glucose level reading. [0020]
  • 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 applications and make those technologies more acceptable. [0021]
  • 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, particularly by penetrating less sensitive areas of the skin. [0022]
  • Furthermore, known lancing devices include manually actuable buttons for triggering the lance-driving mechanism once the user has placed the device against his/her skin. Because the user knows the precise instant when the lancet will be triggered and pain will be felt, there is a tendency for the user to jerk or raise the device at the instant of triggering, which can lead to inconsistent skin penetration, or possibly no penetration. Therefore, a further object of the invention is to provide a lancing device which eliminates such a tendency on the part of the user. [0023]
  • Therefore, it is another object of the invention to provide a lancet carrier which eliminates the above-mentioned shortcomings. [0024]
  • 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. [0025]
  • 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. [0026]
  • It is a further object of the invention is to provide a device for minimally invasive sampling comprising a reusable sampler and disposable sample lancet and collection device. [0027]
  • SUMMARY OF THE INVENTION
  • The present invention involves a method of obtaining a sample of fluid from a body. The method comprises applying a skin-lancing medium against a skin surface to form an incision therein, removing the skin-lancing medium from the incision; and thereafter applying a force to depress the skin in a manner forming a ring of depressed body tissue in surrounding relationship to the incision, causing the incision to bulge and the sides of the incision to open, whereby body fluid is forced out through the opening of the incision. [0028]
  • The invention also relates to a device for sampling body fluid which comprises a housing having an open end, and a skin lancing mechanism for applying a skin-lancing medium against a skin surface to form an incision therein and then remove the skin-lancing medium from the incision. A stimulator member is mounted to the housing at the open end thereof for movement relative to the housing. The stimulator member extends about a longitudinal axis of the housing and is adapted to engage the skin surface to bulge and open the incision in response to a pressing of the end face against the skin surface. [0029]
  • The invention also relates to a device for expressing body fluid from a lanced skin surface, which comprises a housing, and a stimulator mechanism mounted to the housing at an end thereof. The stimulator mechanism includes a generally circular array of stimulator elements each mounted to the housing for movement toward and away from a longitudinal axis of the housing. An actuator is mounted to the housing for displacing the stimulator elements toward the axis. [0030]
  • The invention also relates to a device for expressing body fluid from a lanced skin surface, which comprises a housing and a stimulator member mounted on the housing at an end thereof. The stimulator member comprises a coil spring which is compressible toward the housing in response to being pushed against a user's skin in surrounding relationship to a lanced portion thereof. [0031]
  • Another aspect of the invention relates to a device for expressing body fluid from a lanced skin surface which comprises a housing and a hollow stimulator member mounted at an end of the housing and adapted to engage a user's skin surface in surrounding relationship to a lanced portion thereof. In order to promote the flow of body fluid, the stimulator member can be heated, or vibrated. If vibrated, the stimulator member applies an ultrasonic frequency to the skin surface. [0032]
  • The invention also relates to a device for expressing body fluid from a lanced skin surface which comprises a housing and a hollow stimulator member mounted at an end of the housing for longitudinal movement relative to the housing and adapted to contact a user's skin surface in surrounding relationship to a lanced portion thereof. A motor is mounted in the housing and a reciprocatory mechanism is connected to the motor to be driven thereby, and is operably connected to the stimulator member for reciprocating the stimulator member along a longitudinal axis of the stimulator member. [0033]
  • 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 drawing in which like numerals designate like elements and in which: [0034]
  • FIG. 1 is a longitudinal sectional view through a blood sampling device according to a first embodiment of the invention, with the lancet carrier in an unarmed condition; [0035]
  • FIG. 2 is a view similar to FIG. 1, with the lancet carrier in an armed condition; [0036]
  • FIG. 3 is a view similar to FIG. 2 after the lancet carrier has been triggered and a lancet is penetrating the skin; [0037]
  • FIG. 4 is a fragmentary view similar to FIG. 1 after an incision has been formed; [0038]
  • FIG. 5 is a view similar to FIG. 4 showing a stimulator member of the device being depressed to cause the incision to bulge and open; [0039]
  • FIG. 6 is a view similar to FIG. 5 after a stimulating action has been performed to form a drop of blood at the open end of the incision; [0040]
  • FIG. 7 is a fragmentary longitudinal sectional view through a second embodiment of the invention; [0041]
  • FIG. 8 is a fragmentary longitudinal sectional view taken through a third embodiment of the invention; [0042]
  • FIG. 9 is a side elevational view of a fourth embodiment of the invention pressed against a skin surface; [0043]
  • FIG. 10 is an end view of the device depicted in FIG. 9; [0044]
  • FIG. 11 is a view similar to FIG. 9 after the device has been compressed against the skin surface to bulge and open an incision; [0045]
  • FIG. 12 is an end view of the device in the condition depicted in FIG. 11; [0046]
  • FIG. 13 is a fragmentary longitudinal sectional view taken through a fifth embodiment of the invention while in a first state of operation; [0047]
  • FIG. 14 is a view similar to FIG. 13 with the device in a second condition of operation; [0048]
  • FIG. 15 is a fragmentary longitudinal sectional view taken through a sixth embodiment of the invention in a first condition of operation thereof; [0049]
  • FIG. 16 is a view similar to FIG. 15 with the device in another condition of operation; [0050]
  • FIG. 17 is a view similar to FIG. 16 of yet a further condition of operation of the device; [0051]
  • FIG. 18 is a side elevational view, partly in longitudinal section of yet another embodiment of the invention; [0052]
  • FIG. 19 is a longitudinal sectional view taken through still a further embodiment of the invention; [0053]
  • FIG. 20 is a longitudinal sectional view of a blood lancing device according to a seventh embodiment of the invention while in a first condition or operation thereof; [0054]
  • FIG. 21 is an end view of the device in the condition depicted in FIG. 20; [0055]
  • FIG. 22A is a view similar to FIG. 20, with the lancet carrier in an armed condition; [0056]
  • FIG. 22B is a partial cross-sectional side view of the lancing device wherein the lancet has penetrated the patient's skin; [0057]
  • FIG. 22C is a view similar to FIG. 22A, illustrating the bulge which forms in the patient's tissue, wherein the stimulating member stretches the skin open for expressing a body fluid sample; [0058]
  • FIG. 23 is an end view of an alternative embodiment of the stimulating member of the present invention; [0059]
  • FIG. 24 is a cross-sectional side view of the alternative embodiment of the stimulating member illustrated in FIG. 23; [0060]
  • FIG. 25 is an end view of another alternative embodiment of the stimulating member of the present invention; [0061]
  • FIG. 26 is a partial cross-sectional side view of a lancing device including a stimulating member and a constricting member; [0062]
  • FIG. 27 is a partial cross-sectional side view of the lancing device of FIG. 26 in use; [0063]
  • FIG. 28 is a partial cross-sectional side view of the lancing device of FIG. 26 in use illustrating a bulge of tissue formed by the constricting member; [0064]
  • FIG. 29 is a partial cross-sectional side view illustrating the lancing action and spreading of the formed incision by the stimulating member; [0065]
  • FIG. 30 is a partial cross-sectional side view of an alternative embodiment of a lancing device including a stimulating member and a constricting member; [0066]
  • FIG. 31 is a partial cross-sectional side view of the lancing device of FIG. 30 illustrating the formation of an incision within a bulge of tissue; [0067]
  • FIG. 32 is a partial cross-sectional side view of the lancing device of FIG. 31 illustrating the spreading of the incision by the stimulating member; and [0068]
  • FIG. 33 is a side view illustrating a glucose monitoring device in accordance with the present invention. [0069]
  • DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT
  • A lancing device [0070] 10 (see FIG. 1) according to one preferred embodiment of the invention comprises an outer housing 12 having upper and lower portions 14, 16 connected together, and an inner housing 18 fixed to the outer housing.
  • Mounted for vertical reciprocation in the [0071] upper portion 14 of the outer housing 12 is a cocking mechanism 20 comprising a pull handle 22 to which is fixedly secured a hollow draw tube 24. Fixed to an inner wall of the draw tube 24 is a draw ring 26.
  • Situated within the [0072] draw tube 24 is a draw bar 30 having a pair of flexible hooks 32 at its upper end. The hooks are releasably latched to a sleeve 34 which is movably disposed within the draw ring 26. A coil compression spring 36 acts between a flange 33 of the sleeve 34 and an inner flange 38 of the draw ring 26.
  • A [0073] trigger sleeve 35 is mounted within the lower portion 16 of the outer housing 12. A lower end of the trigger sleeve rests upon a first outer flange 37A of the inner housing, and a second outer flange 37B of the inner housing rests upon an inner projection 39 of the trigger sleeve.
  • At its lower end the [0074] draw bar 30 frictionally holds a skin-lancing medium in the form of a disposable lancet 40 in which a needle 42 is disposed. The draw bar 30 includes a flexible latch finger 44 that has a projection 45 adapted to be received in a hole 46 of the inner housing 18 (see FIG. 2) when the device is armed. A trigger member 49 is mounted in a hole 47 of the trigger sleeve 35 and includes an arm 48 extending partially into the hole 46. The trigger member 49 includes an inclined cam follower surface 50.
  • A [0075] coil compression spring 52 acts between a top wall 54 of the inner housing 18 and a shoulder 56 of the draw bar.
  • Slidably disposed within a lower end of the lower portion of the outer housing is a firing [0076] tube 60 which includes an upper cam surface 62. Fixed to a lower end of the firing tube 60 is an outer hollow stimulator member in the form of a cylindrical ring 64, having an end surface 65 of generally frusto-conical shape so as to be oriented at a downward and inward inclination to generally face a longitudinal axis A of the device.
  • Disposed coaxially within the firing [0077] tube 60 and outer stimulator ring 64 is an inner hollow stimulator member also in the form of a cylindrical ring 66 having a frusto-conical end surface 67 also oriented at a downward and inward inclination.
  • The end surfaces [0078] 65 and 67 are of circular configuration when viewed along the axis A, other configurations, such as polygonal, oval, etc., are possible.
  • A [0079] coil compression spring 68 acts between an upper end of the outer stimulator ring 64 and a downwardly facing shoulder 70 of the inner stimulator ring 66.
  • The [0080] inner stimulator ring 66 includes a lance stop flange 72 adapted to be engaged by a lance ring 74 of the lancet 40 as will be explained.
  • The [0081] first flange 37A of the inner housing rests upon a support sleeve 80 which, in turn, rests upon an upper end of the inner stimulator ring 66.
  • In practice, when a fluid sample, such as blood or interstitial fluid, is to be taken from a user's body, a lancing device according to the present invention can be used to minimize pain. To do so, a region of the user's body having less sensitivity than, for example, a fingertip, is selected. Such a low-sensitivity region could be the user's forearm for example. Initially, the [0082] handle 22 is pulled up to raise the drawbar 30 until the projection 45 of the latch finger 44 snaps into the hole 44 of the inner housing 18, as shown in FIG. 2. Simultaneously, the spring 52 is compressed.
  • If the [0083] outer stimulator ring 64 is pressed against the user's skin S, e.g., on the selected forearm region FA, the ring 64 and its cam surface 62 are moved upwardly to displace the trigger radially inwardly, whereupon the projection 45 of the latch finger 44 is disengaged from the hole 46. Accordingly, the spring 52 expands to displace the drawbar 30 downwardly so that the needle 42 punctures the skin sufficiently deep to cut capillaries in the superficial vascular plexus, as shown in FIG. 3. Simultaneously, the spring 68 is compressed. The extent of displacement of the drawbar 30 is limited by engagement between the lance ring 74 with the lance stop 72.
  • Once lancing has occurred, the [0084] compressed spring 68 expands to raise the drawbar, as well as the needle 42 and inner stimulator ring 66 from the skin (see FIG. 4).
  • The user then alternately applies and releases a downward force on the [0085] outer housing 12. Each time that a downward force is applied, the end face 65 of the outer stimulator ring 64 exerts a downward force F which depresses a ring-shaped portion of the skin and body tissue which is disposed in surrounding relationship to the wound or incision I, causing the wounded area to bulge while pulling apart the sides of the wound (see FIG. 5). Hence, fluid such as blood or interstitial fluid is trapped and pressurized so that it travels upwardly through the pulled-open end of the wound since the surrounding ring of depressed skin and body tissue restricts the outward flow of fluid. That action is enhanced by the fact that the force F is inclined inwardly toward the axis A to force the fluid toward the bulged area.
  • When the downward force is released, the sides of the wound close, and fresh fluid flows toward the area of the wound to replace fluid which had been forced upwardly through the wound. As the downward force is reapplied, the above-described action is repeated and additional fluid is forced through the wound. Eventually, this “pumping” action results in the formation of a suitably large drop D of fluid (FIG. 6). [0086]
  • It will thus be appreciated that the present invention enables an ample supply of blood, interstitial fluid or other body fluid to be obtained relatively painlessly from areas of the body which typically possess lesser amounts of such fluid as compared with the highly sensitive fingertip region. [0087]
  • Note that each time that the downward force is applied to the outer housing, the [0088] outer stimulator ring 64 moves upwardly relative to the inner stimulator ring 66 so that the end surface 67 of the inner ring 66 also contacts the skin surface S at a location inwardly of the outer face 65, thereby promoting the displacement of fluid inwardly toward the wound. However, the present invention can be practiced by a single stimulator ring arrangement 64A as shown in FIG. 8.
  • While the [0089] surfaces 65, 67 are continuous, i.e., non-interrupted, it may be desirable to provide either or both of those surfaces with circumferentially spaced recesses 80 as shown in FIG. 7. The surface(s) 65A, 67A will still depress a ring of body tissue surrounding the wound, but the areas of the ring corresponding to the location of the recesses will be depressed to a lesser extent than the other areas. Those lesser depressed areas will provide less resistance to fluid flow and will thus enable some fluid to leak past the ring, which would be beneficial in the event that the user neglects to release the downward pressure on the device.
  • The stimulator member need not be in the form of a ring. As depicted in FIGS. 9-12, the stimulator member can be in the form of a [0090] helical spring 90 formed by a flat strip 92. Such a spring would function in somewhat similar fashion to the double-ring arrangement of FIGS. 1-7 in that a stimulator surface gradually comes into contact with the skin in a radially inward direction to aid in propelling blood or interstitial fluid toward the center axis. In that regard, FIGS. 9 and 10 depict a condition when the spring 90 is uncompressed. In contrast, FIGS. 11 and 12 depict a condition wherein the spring is fully compressed. Shaded regions in FIGS. 10 and 12 represent contact between the spring and the skin. It will be appreciated that during compression of the spring, the contact region of the spring progresses gradually radially inwardly, causing blood or interstitial fluid to be pushed toward the axis A and thus toward the bulged area of the skin.
  • Depicted in FIGS. 13 and 14 is yet another alternative embodiment wherein the [0091] outer stimulator ring 64B is interconnected to the inner stimulator ring 66B by levers 100 which are pivoted to the firing tube 60B. Thus, upward sliding movement of the outer ring 64B is transmitted as a downward force to the inner ring 66B to slide the latter downwardly and intensify the pumping action.
  • A further embodiment is depicted in FIGS. 15-17 wherein the firing [0092] tube 60C has a carrier tube 102 affixed at a lower end thereof. Pivotably mounted on the carrier tube 102 is a circular array of levers 104 each having an upper and lower end, each lower end carrying a stimulator element in the form of a roller 106. Each lever 104 is rotatable about an axis extending orthogonally relative to the axis of the housing.
  • An [0093] inner ring 110 is slidable up and down, either by manual force, or by a motor-driven cam (e.g., of the type disclosed later in connection with FIG. 19). That ring 110 has a beveled cam face 112 formed on its lower end. When the device is pressed against the skin, following a lancing procedure, the ring 110 is moved downwardly so that the cam face 112 engages rollers 108 mounted on upper ends of the levers. Hence, the levers 104 are rotated such that the lower rollers 106 are displaced inwardly and upwardly at a location disposed below the open end of the bulged wound to open the wound and force blood or interstitial fluid toward the wound to form a drop D. When the levers are not contacted by the cam face 112, the rollers 106 gravitate to a rest position shown in FIG. 15. Repeated applications of the downward force cause the drop to become gradually enlarged as explained earlier.
  • Depicted in FIG. 18 is an alternative embodiment similar to that depicted in FIGS. 1-6, except that the lower end surface of the [0094] outer stimulator ring 64D is provided with a hollow stimulator element 114 which is electrically connected to a battery 116 mounted in an upper end of the device. The element can be either an electrical resistance element (i.e., a heater) or a vibrator such as a piezoelectric transducer, intended to stimulate fluid flow. A heater will expand the capillaries and make the blood or interstitial fluid less viscous and thus more flowable, in order to increase the amount of the body fluid sample.
  • On the other hand, if the [0095] element 114 is a vibrator, such as a piezoelectric transducer, vibrations can be created which stimulate the flow of body fluid. This could be achieved by operating the transducer to produce frequencies below 28,000 cycles per second. Alternatively, ultrasonic frequencies, i.e., frequencies above 20,000 cycles per second, will create interferometric wave patterns inside the skin that cause contractions forcing fluid upwardly from the wound. The frusto-conical shape 114A of the end face of the element will optimize the creation of such wave patterns. It may be further beneficial to employ a heater, such as an infrared emitter, mounted in the housing which vasodilates the capillaries to increase blood flow. Another advantage of the use of such frequencies is that only minimal downward force to the device may be necessary since the wave patterns may produce an ample pumping action.
  • FIG. 19 depicts a device which is not automatically fired, but rather requires manual actuation of [0096] lever 130 against a bias of a spring 132 to force a trigger 134 to push a projection 136 out of a hole 138 (when the projection extends into that hole).
  • Mounted in a [0097] housing 140 of the device are a battery 142 and electric motor 144 connected to the battery to be actuated thereby. The motor 144 rotates a sleeve 146 about the axis A. The sleeve includes a cam surface 148 which engages a follower roller 150 mounted on a tube 152.
  • As the [0098] sleeve 146 rotates, the cam surface pushes the tube 152 downwardly against the bias of a coil compression spring 154, to push an inner stimulator ring 156 repeatedly against a skin surface, thereby pumping blood to the top of an incision in the same manner described earlier herein. The inner stimulator ring 156 reciprocates along the axis A within an outer stimulator ring 155. This embodiment eliminates the need for the user to pulsate the device up and down; the pumping operation is achieved automatically in response to actuation of the lever 130.
  • The [0099] cam mechanism 146 can be used in an automatically firing device, such as that disclosed in connection with FIG. 1.
  • Referring now to FIG. 20, there is shown a seventh embodiment of the [0100] blood lancing device 10 of the present invention, wherein like reference numerals have been utilized to denote the same or similar elements of the previous embodiments described above and shown in FIGS. 1-19. The lancing device 10 according to a seventh embodiment includes an outer housing 12 having upper and lower portions 14, 16 connected together, and an inner housing 18 fixed to the outer hosing.
  • Mounted for vertical reciprocation in the [0101] upper portion 14 of the outer housing 12 is a cocking mechanism 20 comprising a pull handle 22 to which is fixedly secured a hollow draw tube 24. Fixed to an inner wall of the draw tube 24 is a draw ring 26.
  • Situated with the [0102] draw tube 24 is a draw bar 30 having a pair of flexible hooks 32 at its upper end. The hooks are releasably latched to a sleeve 34 which is movably disposed with the draw ring 26. A coil compression spring 36 act between a flange 33 of the sleeve 34 and an inner flange 38 of the draw ring 26.
  • A [0103] trigger sleeve 35 is mounted within the lower portion 16 of the outer housing 12. A lower end of the trigger sleeve rests upon a first outer flange 37A of the inner housing, and a second outer flange 37B of the inner housing rests upon an inner projection 39 of the trigger sleeve.
  • At its lower end, the [0104] draw bar 30 frictionally holds a skin-lancing medium in the form of a disposable lancet 40 in which a needle or lancet 42 is disposed. The draw bar 30 includes a flexible latch finger 44 that has a projection 45 adapted to be received in a hole 46 of the inner housing 18 when the device is armed. A trigger member 49 is mounted in a hole 47 of the trigger sleeve 35 and includes an arm 48 extending partially into the hole 46. The trigger 46 includes an inclined cam follower surface 50.
  • A [0105] coil compression spring 52 acts between a top wall 54 of the inner housing 18 and a shoulder 56 of the draw bar.
  • Slidably disposed within the lower end of the lower portion of the outer hosing is a firing [0106] tube 60 which includes an upper cam surface 62. Fixed to a lower end of the firing tube 60 is a stimulator member 160 in the form of a flexible membrane, having a tissue contacting surface 161. Referring now to FIG. 21 there is shown an end view of the lancing device 10 of the present invention illustrating the stimulator member 160. As shown, the stimulator member 160 includes circumferentially spaced interruptions 163.
  • Referring now to FIGS. 22A through 22C, there are shown partial longitudinal cross-sectional side views of the present invention. Referring now to FIG. 22A there is shown the distal end of the lancing [0107] device 10 as disposed over a potion of skin S to be lanced in preparation for a body fluid sample to be obtained. As shown in FIG. 22A, the tissue contacting surface 161 of the stimulator member 160 contacts the patient's skin. The tissue contacting surface 161 of the stimulator member 160 may be formed having a raised area as shown in FIGS. 23-25, wherein the raised surface contact the skin S thereby providing a friction force f between the distal surface 161 and the skin S.
  • Referring now to FIG. 22B, wherein a force F has been applied to the proximal end of the lancing [0108] device 10, wherein the force F is translated to the lancet 42 and lancet holder 240, thereby advancing the lancet into the patient's skin.
  • Referring now to FIG. 22C there is shown the [0109] lancet 42 in a retracted position after the lancet 42 has penetrated the skin S to a sufficient depth to cut capillaries in the superficial vascular plexis to form an incision I as shown.
  • The [0110] tissue contacting surface 161 of the stimulator member 160 remains in contact with the skin as after the lancet has formed an incision within the patient's skin and is thereby withdrawn from the incision I. The force F applied to the proximal end of the lancing device 10 causes the sleeve 280 to contact the skin, wherein the skin yields to the applied force as shown in FIG. 22C. The skin S forms a bulge about the incision I formed by the lancet. The friction force f between the distal surface 161 and the skin S retains the stimulator member upon the skin S. By retaining the contacting surface 161 upon the skin S, the incision I is stretched open, thereby allowing more body fluid to be expressed from the incision. In one embodiment, the sleeve 180 causes fluid such as blood or interstitial fluid to become trapped and pressurized within the bulged area, so that the body fluid will travel upwardly through the pulled-open incision I.
  • After a sufficient sample size has developed, the lancing [0111] device 10 is removed from the patient's skin wherein the sample may then be utilized in any manner desirable.
  • It shall be understood that the [0112] stimulator member 160 and the lancing device 10 produce a sufficiently sized sample between about 0.05 micro liters and 10 micro liters without the need for repetitive motion as described above with regard to the other embodiments of the present invention. In addition, the alternative embodiment of the lancing device illustrated in FIGS. 20-22C may be utilized with other methods and devices for producing a sufficiently sized sample. For example, the lancing device 10 may include vibration means (not shown), heating means (not shown), vacuum means (not shown), each of which may be utilized to encourage blood flow within the area to be sampled. Alternatively, the area to be sampled may be stimulated using one of the methods described above prior to using the lancing device 10.
  • The [0113] stimulator member 160 may be constructed of bio-compatible materials such as polyvinyl chloride, silicon, urethane, or similar flexible materials which are adapted to grip and translate a frictional force between the tissue contacting surface 161 and the patient's skin S thereby causing a wound to be stretched open thereby allowing a greater amount of body fluid to flow therefrom. In addition, the stimulator member 160 may be formed of materials which are flexible such that a portion of the stimulator member 160 will deform in use, though it shall be understood in a preferred embodiment, the tissue contacting surface 161 remains substantially parallel with the skin surface as shown in FIGS. 22A-22C.
  • Alternatively, it is contemplated that the stimulating [0114] member 160 may be formed of a rigid material wherein the skin contacting surface of the rigid stimulating member is adapted to provide a friction force between the skin and the tissue contacting surface such that the skin will be retained upon the tissue contacting surface as described above. Additionally, the stimulating member may be pivotally affixed to the sleeve 280 thereby allowing a rigid stimulator member to be utilized in the same manner as a flexible member.
  • Referring now to FIGS. 23 and 24 the [0115] stimulator member 260 illustrated therein may be formed in generally the same manner as that shown and described above, though the stimulator member 260 is formed having a plurality of rings 261 disposed radially about an aperture 266. In use, the plurality of rings 261 act on the skin S with a frictional force such as that described and shown above. The frictional force f retains the tissue contacting surface 261 of the stimulator member 260 upon the skin surface S, whereby causing the incision I to stretch open as described above.
  • Referring now to FIG. 25 there is shown yet another alternative embodiment of the [0116] stimulator member 460 of the present invention. The stimulator member 460 further includes a raised member 462 extending from the tissue contacting surface 461. The raised member 462 is disposed upon the tissue contacting surface 461 in a spiraling manner, such as that shown in FIGS. 9-11, and 25. In practice, the leading edge 463 of the spiraling raised member 462 will contact the patient's skin first, thereafter as a greater downward force is applied the remaining portion of the spiraling raised member 462 will contact the patient's tissue. The forced imparted by the spiraling raised member 462 will cause the skin to bulge, in addition the constant spiraling motion will cause the fluid under the skin to become concentrated within the center of the bulge.
  • Referring now to FIG. 26 there is shown yet another alternative embodiment in accordance with the present invention. The lancing [0117] device 10 may further include a stimulating member 160 as described in detail above with regard to FIGS. 21 through 25. In addition to the stimulating member 160, a constricting member 500 may be fixedly attached to the distal end 181 of the sleeve 180. The constricting member 500 may be constructed of a pliable material, wherein the constricting member 500 will flex as shown in FIG. 28. Examples of materials which the constricting member 500 may be constructed of plastics such as polyethylene, polysilicone, polyvinyl chloride, or alternatively of materials such as titanium, aluminum, steel, stainless steel.
  • The constricting [0118] member 500 may be constructed as a separate body which is then fixedly attached to the distal end 181 of the sleeve 180 with an adhesive or mechanical fastener or other process such as melting or fusion welding. Alternatively, the constricting member 500 may be pivotally attached to the distal end 181 of the sleeve 180 (not shown).
  • Methods of use relating to the lancing [0119] device 10 will be described in relation to FIGS. 27-29. Referring now to FIG. 27 there is shown the lancing device 10 as disposed over an area in which it is desired to express a sample of body fluid. As the force F is applied to the lancing device 10 the force F is translated through the constricting member 500 into component forces F′ and F″. As the force F increases, the component forces F′ and F″ cause the patient's skin in contact with the distal end 501 of the constricting member 500 to gather and form a pucker as shown in FIG. 28, wherein the tissue contacting surface 161 of the stimulating member 160 contacts the skin S.
  • In addition to forming the puckered area of skin as shown in FIG. 28, when the force F is increased on the lancing [0120] device 10, the pucker of skin is drawn into the distal end of the lancing device 10. The pucker of skin is received by the tissue contacting surface 161 of the stimulating member 160, wherein the stimulating member may include a plurality of ridges to increase frictional contact between the skin and the tissue contacting surface 161 of the stimulating member 160. In addition to forming the pucker of skin, a second force F′″ is applied to the lance 42, thereby driving the distal tip of a lance or needle into the pucker of skin to form an incision therein as shown in FIG. 28.
  • The forces F′ and F″ which the constricting [0121] member 500 applies to the skin cause the skin to form the pucker as described above. Additionally, the forces F′ and F″ cause body fluid to pool within the pucker because the forces constrict or tourniquet vessels under the surface of the skin thereby restricting the flow of body fluid from these areas. Thus, by constricting the flow of body fluid within the pucker a larger body fluid sample may be obtained from the incision formed by the lance or needle.
  • Referring now to FIG. 29 there is shown the lancing [0122] device 10 wherein the lance or needle 42 has been retracted by spring force K after an incision I has been formed in the patient's skin. As shown in FIG. 29 as a greater force F2 is applied to the lancing device 10, this causes the constricting member 500 to further pinch the skin in addition to causing the incision to be spread by the stimulating member 160 due to a friction force f between the skin S and the tissue contacting surface 161 of the stimulating member 160.
  • As a result of the stretching of the incision I, a greater amount of bodily fluid may be expressed from the incision I. Because a greater amount of body fluid may be expressed from the incision I, the lancet device may not require a repeated motion as described above in order to express a sufficiently sized sample of body fluid. Though not shown in FIGS. 27-29, the lancing [0123] device 10 may include additional stimulating means such as heat, vibration, ultrasound or other similar known methods or devices which are utilized to increase body fluid flow within a localized area.
  • Referring now to FIGS. 30-32 there is shown an alternative embodiment of a constricting [0124] member 600. Wherein the constricting device 600 may be disposed about the sleeve 180 of the lancing device 10 and adjacent the distal end 181 to the sleeve 180. The constricting device 600 includes a plurality of arms 610 having a distal end 611 and a proximal end 612, a biasing member 650 and a pivot 660.
  • In accordance with the present invention, the [0125] proximal end 612 of the arm 610 may be pivotally attached to the sleeve 180. The arm 610 may be pivotally attached to the sleeve through a pin and block configuration as shown in FIGS. 30-32 or alternatively the proximal end 612 may be integrally formed with the sleeve 180 and pivot through the use of a live hinge or similar arrangement.
  • As described above the constricting [0126] device member 600 includes a biasing member 650. The biasing member 650 acts on the arms 610 thereby directing the distal tips 611 of the arms 610 to contact the skin S as shown and to provide forces F′ and F″.
  • Referring now to FIGS. 31 and 32 there is shown the lancing [0127] device 10 in use. The constricting member 600 acts upon the patient's skin to form a pucker of skin which is received within the distal end of the lancing device 10. It shall be noted that the constricting member 600 acts upon the patient's skin in the same manner as the constricting device 500 as described above with reference to FIGS. 26 through 29. Wherein the constricting device 600 and stimulating member 160 act in conjunction with one another to express a greater amount of body fluid from an incision formed in the patient's skin.
  • The lancing device in accordance with the present invention may be best utilized in areas where it is difficult to obtain a sufficient sample size, such as a forearm, though it is desirable to lance within this area because of the reduction in pain associated with the lancing. [0128]
  • Referring now to FIG. 33, there is shown a further alternative embodiment of a lancing [0129] device 700 in accordance with the present invention, wherein the lancing device 700 further includes a body fluid sampling and testing device. The lancing device 700 may be utilized upon a patient's forearm or similar area, wherein the stimulating member and constricting member in conjunction with a needle or lancet produce a sample size of sufficient volume wherein a test may be performed thereon. For example, the lancing device 700 may be that which is shown and described in co-pending U.S. Provisional Patent Application No. 60/296,950 filed Jun. 8, 2001, now abandoned, Attorney Dkt. No. 018176-385 and to co-pending U.S. Provisional Patent Application No. 60/297,098 filed Jun. 8, 2001, now abandoned, Attorney Dkt. No. 018176-382, the entirety of which are hereby incorporated by reference.
  • It will be appreciated that the present invention enables a sampling of blood or interstitial fluid to be taken from areas of the body, such as a forearm, that are less insensitive to pain, despite the fact that those areas typically have relatively less fluid as compared, for example, to fingertips (which are highly sensitive to pain). [0130]
  • Therefore, there will be less reluctance on the part of users to have a sampling procedure performed. For example, diabetics who experience a relatively high fear of pain will be less likely to neglect monitoring their blood glucose levels. [0131]
  • In lieu of using a lancet as a skin-lancing medium, other skin-lancing media can be used, such as a laser, or known pneumatic or hydraulic injectors of the type which inject pressurized gas or liquid against the skin. Such auto injectors are sold by Becton-Dickinson, for example, to inject insulin. By eliminating the insulin and merely injecting the gas (e.g., air or nitrogen) or liquid (e.g., water) at pressures above 30 psi. an incision could be formed in the skin for taking samples of body fluid. Advantageously, small particles could be mixed with the gas to promote the tissue-cutting action. The particles could comprise carbon particles of from 1 micron to 0.010 inches in diameter. [0132]
  • In addition to that which is described above, it is contemplated that the lance or needle may remain within the incision during the collection of the sample. Additionally a force may be applied to the lance or needle to stimulate fluid flow from the incision, for example the lance or needle may be vibrated to express fluid from the incision. It shall be understood that the terms “remain within the incision” shall mean to include the instances where the lance or needle remains in contact with the patient's tissue inside of the incision, or where the lance or needle is withdrawn just distal the incision though remains in fluid contact with the body fluid expressed from the incision. [0133]
  • Although the present invention has been described in connection with preferred embodiments thereof, it will be appreciated by those skilled in the art that additions, deletions, modifications, and substitutions not specifically described may be made without departing from the spirit and scope of the invention as defined in the appended claims. In addition, each of the methods and apparatuses described herein may be utilized with testing systems and devices such as those which are contained within the co-filed U.S. Patent Application having Serial No. 60/297,187 filed Jun. 8, 2001, now abandoned, entitled “Control Solution Packet and Methods of Use for Bodily Fluid Sampling Devices;” U.S. Patent Application having Serial No. 60/296,950 filed Jun. 8, 2001, now abandoned, entitled “Lancet Device Having Capillary Action;” U.S. Patent Application having Serial No. 60/297,045 filed Jun. 8, 2001, now abandoned, entitled “Method of Sampling Interstitial Fluid for Glucose Monitoring;” U.S. Patent Application having Serial No. 60/296,989 filed Jun. 8, 2001, now abandoned, entitled “Cassette for a Glucose Monitoring System;” and U.S. Patent Application having Serial No. 60/296,949 filed Jun. 8, 2001, now abandoned, entitled “Test Media for Glucose Monitoring Systems;” the entirety of which are herein incorporated by reference. [0134]

Claims (20)

What is claimed:
1. A method of obtaining a sample of body fluid from a body, comprising the steps of:
A) applying a skin-lancing deice against the skin of a user to form an incision in the skin;
B) removing the skin-lancing device from the incision; and thereafter
C) applying a force to depress the skin in a manner forming a ring of depressed body tissue in surrounding relationship to the incision wherein a stimulating member stretches the incision open, whereby body fluid is expressed from the opening of the incision.
2. The method according to claim 1, wherein a force between the stimulating member and the skin causes the stimulating member to retain the skin in an stretched position.
3. The method according to claim 1 wherein step C includes applying the force in a direction inclined generally toward the bulged incision.
4. The method according to claim 1 wherein step C comprises applying the force progressively closer to the incision.
5. The method according to claim 1 wherein step C includes applying heat in the region of the incision.
6. The method according to claim 1 wherein step C includes applying ultrasonic frequency to the region of the incision.
7. The method according to claim 1 wherein step A comprises lancing a region of the user's body other than a finger tip.
8. The method according to claim 1 wherein step A comprises applying a lancet against the skin.
9. A device for sampling body fluid comprising:
a housing having an open end;
a skin-lancing mechanism mounted in the housing for applying a skin-lancing medium against a skin surface to form an incision therein, and then remove the skin-lancing medium from the incision;
a constricting member mounted to the housing at the open end thereof for movement relative to the housing, the constricting member radially disposed about a longitudinal housing and pivotally attached thereto, wherein the constricting member causes the skin surface to form a bulge in response to a pressing on the housing; and
a stimulator member mounted to the housing at the open end thereof for movement relative to the housing, the stimulator member extending about a longitudinal axis of the housing the axis and adapted to engage the skin surface of the bulge and to stretch open the incision in response to a pressing of the end face against the skin surface.
10. The device according to claim 9 wherein the end face is inclined to generally face the axis.
11. The device according to claim 9 wherein the stimulator member extends continuously about the axis.
12. The device according to claim 9 wherein the stimulator member includes circumferentially spaced interruptions.
13. The device according to claim 9 wherein the stimulator member is movable relative to the housing along the axis.
14. The device according to claim 9 wherein the stimulator member comprises a first stimulator member, and further including at least one additional stimulator member arranged in telescoping relationship to the first stimulator member, the stimulator members being relatively movable along the axis.
15. The device according to claim 14 wherein the stimulator members include first and second stimulator members which are movable relative to the housing and are interconnected to move axially in mutually opposite directions.
16. The device according to claim 15 wherein the first and second stimulator members are interconnected by levers, each lever being pivoted intermediate its ends for rotation about an axis extending orthogonally relative to the longitudinal axis of the housing.
17. The device according to claim 13, wherein the stimulator member and the constricting member are movable relative to the housing and a interconnected to move axially in mutually opposite directions.
18. The device according to claim 9 wherein the stimulator member comprises a helical spring.
19. The device according to claim 9 further including a second stimulator chosen from the group consisting of, a heating mechanism for heating the stimulator member or constricting member, a vibrator mechanism for vibrating the stimulator member or constricting member.
20. The device according to claim 9, wherein the constricting member comprises at least one leg pivotally mounted to the housing, and a biasing member for biasing the leg in response to a force applied to the housing.
US10/764,261 1997-11-21 2004-01-23 Methods and apparatus for expressing body fluid from an incision Abandoned US20040204662A1 (en)

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US11/276,237 US20060155316A1 (en) 1997-11-21 2006-02-20 Methods and apparatus for expressing body fluid from an incision

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US08/975,978 US5964718A (en) 1997-11-21 1997-11-21 Body fluid sampling device
US09/285,021 US6066103A (en) 1997-11-21 1999-04-01 Body fluid sampling device
US09/542,040 US6464649B1 (en) 1997-11-21 2000-03-31 Body fluid sampling device
US09/879,991 US6706000B2 (en) 1997-11-21 2001-06-14 Methods and apparatus for expressing body fluid from an incision
US10/764,261 US20040204662A1 (en) 1997-11-21 2004-01-23 Methods and apparatus for expressing body fluid from an incision
US11/276,237 US20060155316A1 (en) 1997-11-21 2006-02-20 Methods and apparatus for expressing body fluid from an incision

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Cited By (67)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007131567A1 (en) 2006-05-15 2007-11-22 F. Hoffmann-La Roche Ag Method and device for stimulating a tissue for the subcutaneous administration of active substances
US20080027474A1 (en) * 2006-06-15 2008-01-31 Abbott Diabetes Care Inc. Adjustable Lancing Devices and Methods
WO2009047512A1 (en) * 2007-10-12 2009-04-16 Kin Fai Kam Intravenous injection aid
US20090112122A1 (en) * 2007-10-26 2009-04-30 Min-Chieh Chuang Bleeding apparatus
US7648468B2 (en) 2002-04-19 2010-01-19 Pelikon Technologies, Inc. Method and apparatus for penetrating tissue
US7666149B2 (en) 1997-12-04 2010-02-23 Peliken Technologies, Inc. Cassette of lancet cartridges for sampling blood
US7674232B2 (en) 2002-04-19 2010-03-09 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7682318B2 (en) 2001-06-12 2010-03-23 Pelikan Technologies, Inc. Blood sampling apparatus and method
US7699791B2 (en) 2001-06-12 2010-04-20 Pelikan Technologies, Inc. Method and apparatus for improving success rate of blood yield from a fingerstick
US7708701B2 (en) 2002-04-19 2010-05-04 Pelikan Technologies, Inc. Method and apparatus for a multi-use body fluid sampling device
US7717863B2 (en) 2002-04-19 2010-05-18 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7731729B2 (en) 2002-04-19 2010-06-08 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7749174B2 (en) 2001-06-12 2010-07-06 Pelikan Technologies, Inc. Method and apparatus for lancet launching device intergrated onto a blood-sampling cartridge
US7780631B2 (en) 1998-03-30 2010-08-24 Pelikan Technologies, Inc. Apparatus and method for penetration with shaft having a sensor for sensing penetration depth
US7822454B1 (en) 2005-01-03 2010-10-26 Pelikan Technologies, Inc. Fluid sampling device with improved analyte detecting member configuration
US7833171B2 (en) 2002-04-19 2010-11-16 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7850621B2 (en) 2003-06-06 2010-12-14 Pelikan Technologies, Inc. Method and apparatus for body fluid sampling and analyte sensing
US7850622B2 (en) 2001-06-12 2010-12-14 Pelikan Technologies, Inc. Tissue penetration device
US7862520B2 (en) 2002-04-19 2011-01-04 Pelikan Technologies, Inc. Body fluid sampling module with a continuous compression tissue interface surface
US7874994B2 (en) 2002-04-19 2011-01-25 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7892185B2 (en) 2002-04-19 2011-02-22 Pelikan Technologies, Inc. Method and apparatus for body fluid sampling and analyte sensing
US7892183B2 (en) 2002-04-19 2011-02-22 Pelikan Technologies, Inc. Method and apparatus for body fluid sampling and analyte sensing
US7901365B2 (en) 2002-04-19 2011-03-08 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7901362B2 (en) 2002-04-19 2011-03-08 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7909777B2 (en) 2002-04-19 2011-03-22 Pelikan Technologies, Inc Method and apparatus for penetrating tissue
US7909778B2 (en) 2002-04-19 2011-03-22 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7914465B2 (en) 2002-04-19 2011-03-29 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7976476B2 (en) 2002-04-19 2011-07-12 Pelikan Technologies, Inc. Device and method for variable speed lancet
US7988645B2 (en) 2001-06-12 2011-08-02 Pelikan Technologies, Inc. Self optimizing lancing device with adaptation means to temporal variations in cutaneous properties
US8007446B2 (en) 2002-04-19 2011-08-30 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US20110288471A1 (en) * 2010-05-24 2011-11-24 Fallek Steve Method and apparatus for performing injections while vibrating the skin
US8079960B2 (en) 2002-04-19 2011-12-20 Pelikan Technologies, Inc. Methods and apparatus for lancet actuation
US20120065487A1 (en) * 2010-09-07 2012-03-15 Innova Medical Design LLC Systems, methods, and devices for reducing the pain of glucose monitoring and insulin adminstration in diabetic patients
US8197421B2 (en) 2002-04-19 2012-06-12 Pelikan 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
US8262614B2 (en) 2003-05-30 2012-09-11 Pelikan Technologies, Inc. Method and apparatus for fluid injection
US8267870B2 (en) 2002-04-19 2012-09-18 Sanofi-Aventis Deutschland Gmbh Method and apparatus for body fluid sampling with hybrid actuation
US8282576B2 (en) 2003-09-29 2012-10-09 Sanofi-Aventis Deutschland Gmbh Method and apparatus for an improved sample capture device
US20120323142A1 (en) * 2011-05-31 2012-12-20 Sta-Med Llc Blood collection safety devices and methods of use and manufacture
US8337421B2 (en) 2001-06-12 2012-12-25 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8343074B2 (en) * 2004-06-30 2013-01-01 Lifescan Scotland Limited Fluid handling devices
US8360992B2 (en) 2002-04-19 2013-01-29 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8435190B2 (en) 2002-04-19 2013-05-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8556829B2 (en) 2002-04-19 2013-10-15 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8574895B2 (en) 2002-12-30 2013-11-05 Sanofi-Aventis Deutschland Gmbh Method and apparatus using optical techniques to measure analyte levels
US8641644B2 (en) 2000-11-21 2014-02-04 Sanofi-Aventis Deutschland Gmbh Blood testing apparatus having a rotatable cartridge with multiple lancing elements and testing means
US8652831B2 (en) 2004-12-30 2014-02-18 Sanofi-Aventis Deutschland Gmbh Method and apparatus for analyte measurement test time
US8668656B2 (en) 2003-12-31 2014-03-11 Sanofi-Aventis Deutschland Gmbh Method and apparatus for improving fluidic flow and sample capture
US8702624B2 (en) 2006-09-29 2014-04-22 Sanofi-Aventis Deutschland Gmbh Analyte measurement device with a single shot actuator
US8721671B2 (en) 2001-06-12 2014-05-13 Sanofi-Aventis Deutschland Gmbh Electric lancet actuator
US8747355B2 (en) 2010-06-23 2014-06-10 Sta-Med, Llc Automatic-locking safety needle covers and methods of use and manufacture
US8784335B2 (en) 2002-04-19 2014-07-22 Sanofi-Aventis Deutschland Gmbh Body fluid sampling device with a capacitive sensor
US8828203B2 (en) 2004-05-20 2014-09-09 Sanofi-Aventis Deutschland Gmbh Printable hydrogels for biosensors
US8926644B2 (en) 2009-07-30 2015-01-06 Becton, Dickinson And Company Lancing device having saddle-shaped tip
US8965476B2 (en) 2010-04-16 2015-02-24 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9144401B2 (en) 2003-06-11 2015-09-29 Sanofi-Aventis Deutschland Gmbh Low pain penetrating member
US9226699B2 (en) 2002-04-19 2016-01-05 Sanofi-Aventis Deutschland Gmbh Body fluid sampling module with a continuous compression tissue interface surface
US9248267B2 (en) 2002-04-19 2016-02-02 Sanofi-Aventis Deustchland Gmbh Tissue penetration device
US9314194B2 (en) 2002-04-19 2016-04-19 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9351680B2 (en) 2003-10-14 2016-05-31 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a variable user interface
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
US9386944B2 (en) 2008-04-11 2016-07-12 Sanofi-Aventis Deutschland Gmbh Method and apparatus for analyte detecting device
US9427532B2 (en) 2001-06-12 2016-08-30 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9775553B2 (en) 2004-06-03 2017-10-03 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a fluid sampling device
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
US10335554B2 (en) 2008-06-02 2019-07-02 Sta-Med, Llc Needle cover

Families Citing this family (95)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1579814A3 (en) 1996-05-17 2006-06-14 Roche Diagnostics Operations, Inc. Methods and apparatus for sampling and analyzing body fluid
US7235056B2 (en) * 1996-05-17 2007-06-26 Amira Medical Body fluid sampling device and methods of use
US7828749B2 (en) 1996-05-17 2010-11-09 Roche Diagnostics Operations, Inc. Blood and interstitial fluid sampling device
US20020010406A1 (en) 1996-05-17 2002-01-24 Douglas Joel S. Methods and apparatus for expressing body fluid from an incision
US6706000B2 (en) 1997-11-21 2004-03-16 Amira Medical Methods and apparatus for expressing body fluid from an incision
US6591125B1 (en) 2000-06-27 2003-07-08 Therasense, Inc. Small volume in vitro analyte sensor with diffusible or non-leachable redox mediator
CA2449925C (en) 2001-06-08 2010-03-09 F. Hoffmann-La Roche Ag Control solution packets and methods for calibrating bodily fluid sampling devices
US20020188223A1 (en) 2001-06-08 2002-12-12 Edward Perez Devices and methods for the expression of bodily fluids from an incision
US7004928B2 (en) 2002-02-08 2006-02-28 Rosedale Medical, Inc. Autonomous, ambulatory analyte monitor or drug delivery device
ATE409057T1 (en) * 2002-02-11 2008-10-15 Antares Pharma Inc INTRADERMAL INJECTION DEVICE
US7563232B2 (en) * 2002-04-19 2009-07-21 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US20050177071A1 (en) * 2002-09-05 2005-08-11 Hiroshi Nakayama Invasive appliance
US7052652B2 (en) 2003-03-24 2006-05-30 Rosedale Medical, Inc. Analyte concentration detection devices and methods
US20080149524A1 (en) * 2003-03-27 2008-06-26 Rademaker William B Food containers including dental cleaning devices and other personal care items
JP4761701B2 (en) * 2003-05-21 2011-08-31 アークレイ株式会社 Puncture device with adjustable puncture depth
US20040253736A1 (en) * 2003-06-06 2004-12-16 Phil Stout Analytical device with prediction module and related methods
US7258673B2 (en) * 2003-06-06 2007-08-21 Lifescan, Inc Devices, systems and methods for extracting bodily fluid and monitoring an analyte therein
US20040249254A1 (en) * 2003-06-06 2004-12-09 Joel Racchini Devices, systems and methods for extracting bodily fluid and monitoring an analyte therein
JPWO2004112613A1 (en) * 2003-06-23 2006-07-27 テルモ株式会社 Body fluid collecting device and body fluid collecting method
US7481818B2 (en) * 2003-10-20 2009-01-27 Lifescan Lancing device with a floating probe for control of penetration depth
US20050096686A1 (en) * 2003-10-31 2005-05-05 Allen John J. Lancing device with trigger mechanism for penetration depth control
EP1706016A4 (en) * 2003-12-31 2017-07-05 Sanofi-Aventis Deutschland GmbH Improved penetrating member control using auto-pre-tent
EP2011439A1 (en) * 2004-02-06 2009-01-07 Bayer Healthcare, LLC Dampening and retraction mechanism for a lancing device
US20050209625A1 (en) * 2004-03-02 2005-09-22 Chan Frank A Method and apparatus for electrical stimulation to enhance lancing device performance
US7377903B2 (en) * 2004-03-05 2008-05-27 Roche Diagnostics Operations, Inc. Split tip expression device
US20050234492A1 (en) * 2004-03-15 2005-10-20 Tsai Fu H Lancet device and method of use
CN101014285A (en) * 2004-09-09 2007-08-08 拜尔健康护理有限责任公司 Damping system for a lancet using compressed air
US7727163B2 (en) * 2004-09-27 2010-06-01 Percutaneous Systems, Inc. Methods and apparatus for hollow body structure resection
US7775990B2 (en) * 2004-10-27 2010-08-17 Abbott Laboratories Blood expression device
DE102004059491B4 (en) * 2004-12-10 2008-11-06 Roche Diagnostics Gmbh Lancet device for creating a puncture wound and lancet drive assembly
ES2908027T3 (en) 2005-01-24 2022-04-27 Antares Pharma Inc An injector with a pre-filled syringe
TW200640419A (en) 2005-03-04 2006-12-01 Bayer Healthcare Llc Lancet-release mechanism
CN101163445A (en) 2005-03-04 2008-04-16 拜尔保健有限公司 Lancet-release mechanism
US20060217636A1 (en) * 2005-03-28 2006-09-28 Braig James R Dermal lance with nerve stimulus
US20060281187A1 (en) 2005-06-13 2006-12-14 Rosedale Medical, Inc. Analyte detection devices and methods with hematocrit/volume correction and feedback control
EP1903927A2 (en) * 2005-06-30 2008-04-02 Bayer Healthcare, LLC Single-puncture lancing system
EP1919363B1 (en) 2005-07-14 2010-10-20 Bayer HealthCare, LLC Lancing device for one skin puncture
WO2007019202A2 (en) 2005-08-04 2007-02-15 Bayer Healthcare Llc Small lancing device
US8801631B2 (en) 2005-09-30 2014-08-12 Intuity Medical, Inc. Devices and methods for facilitating fluid transport
CA2623589C (en) 2005-09-30 2014-07-22 Intuity Medical, Inc. Catalysts for body fluid sample extraction
US8057404B2 (en) * 2005-10-12 2011-11-15 Panasonic Corporation Blood sensor, blood testing apparatus, and method for controlling blood testing apparatus
US20070112281A1 (en) * 2005-11-17 2007-05-17 Olson Lorin P Cap with revolving body for a dermal tissue lancing device
US20070213682A1 (en) * 2006-03-13 2007-09-13 Hans-Peter Haar Penetration device, kit, and method
WO2007131013A1 (en) 2006-05-03 2007-11-15 Antares Pharma, Inc. Two-stage reconstituting injector
US20080065130A1 (en) * 2006-08-22 2008-03-13 Paul Patel Elastomeric toroidal ring for blood expression
US8372015B2 (en) * 2006-08-28 2013-02-12 Intuity Medical, Inc. Body fluid sampling device with pivotable catalyst member
ES2587021T3 (en) * 2007-03-12 2016-10-20 Ascensia Diabetes Care Holdings Ag Lancet Ejection Mechanism
US7988667B2 (en) * 2007-04-27 2011-08-02 Terumo Kabushiki Kaisha Piercing tool
US20080287978A1 (en) * 2007-05-19 2008-11-20 Hickman Iii Charles B Medical mapping device
WO2009145920A1 (en) 2008-05-30 2009-12-03 Intuity Medical, Inc. Body fluid sampling device -- sampling site interface
WO2009149308A2 (en) * 2008-06-04 2009-12-10 Seventh Sense Biosystems, Inc. Compositions and methods for rapid one-step diagnosis
JP5642066B2 (en) 2008-06-06 2014-12-17 インテュイティ メディカル インコーポレイテッド Method and apparatus for performing an assay to determine the presence or concentration of an analyte contained in a sample of body fluid
ES2907152T3 (en) 2008-06-06 2022-04-22 Intuity Medical Inc Blood glucose meter and method of operation
ES2738539T3 (en) 2008-08-05 2020-01-23 Antares Pharma Inc Multi dose injector
US8123772B2 (en) * 2008-08-14 2012-02-28 Abbott Diabetes Care Inc. Cap for lancing device with adjustable mode of operation
US8092476B2 (en) * 2008-08-14 2012-01-10 Abbott Diabetes Care Inc. Adjustable cap and lancing device and method of use
JP4642934B2 (en) * 2008-11-13 2011-03-02 オリンパスメディカルシステムズ株式会社 Capsule medical device
WO2012018486A2 (en) 2010-07-26 2012-02-09 Seventh Sense Biosystems, Inc. Rapid delivery and/or receiving of fluids
US20110172510A1 (en) * 2010-01-13 2011-07-14 Seventh Sense Biosystems, Inc. Rapid delivery and/or withdrawal of fluids
US20110172508A1 (en) * 2010-01-13 2011-07-14 Seventh Sense Biosystems, Inc. Sampling device interfaces
CN102405015B (en) * 2009-03-02 2017-01-18 第七感生物系统有限公司 Devices and methods for the analysis of an extractable medium
US9033898B2 (en) 2010-06-23 2015-05-19 Seventh Sense Biosystems, Inc. Sampling devices and methods involving relatively little pain
US9295417B2 (en) * 2011-04-29 2016-03-29 Seventh Sense Biosystems, Inc. Systems and methods for collecting fluid from a subject
US9041541B2 (en) * 2010-01-28 2015-05-26 Seventh Sense Biosystems, Inc. Monitoring or feedback systems and methods
US8579865B2 (en) 2009-03-20 2013-11-12 Antares Pharma, Inc. Hazardous agent injection system
WO2011053787A2 (en) * 2009-10-30 2011-05-05 Seventh Sense Biosystems, Inc. Systems and methods for application to skin and control of actuation, delivery and/or perception thereof
US10226586B2 (en) 2011-05-26 2019-03-12 Pourang Bral Means and method to painlessly puncture skin
US9770560B2 (en) 2009-11-12 2017-09-26 Pourang Bral Means and method to administer injections with little or no pain
US10973994B2 (en) 2013-09-16 2021-04-13 Pourang Bral Means and method to invade skin, mucosa, and underlying tissues with little or no pain
WO2011065972A2 (en) * 2009-11-24 2011-06-03 Seventh Sense Biosystems, Inc. Patient-enacted sampling technique
EP2506768B1 (en) 2009-11-30 2016-07-06 Intuity Medical, Inc. Calibration material delivery devices and methods
EP2584964B1 (en) 2010-06-25 2021-08-04 Intuity Medical, Inc. Analyte monitoring devices
CN103068308B (en) 2010-07-16 2016-03-16 第七感生物系统有限公司 For the lower pressure environment of fluid conveying device
US20120039809A1 (en) 2010-08-13 2012-02-16 Seventh Sense Biosystems, Inc. Systems and techniques for monitoring subjects
US8808202B2 (en) 2010-11-09 2014-08-19 Seventh Sense Biosystems, Inc. Systems and interfaces for blood sampling
CN103874461B (en) 2011-04-29 2017-05-10 第七感生物系统有限公司 Devices for collection and/or manipulation of blood spots or other bodily fluids
AU2012249692A1 (en) 2011-04-29 2013-11-14 Seventh Sense Biosystems, Inc. Delivering and/or receiving fluids
US20130158468A1 (en) 2011-12-19 2013-06-20 Seventh Sense Biosystems, Inc. Delivering and/or receiving material with respect to a subject surface
US9220660B2 (en) 2011-07-15 2015-12-29 Antares Pharma, Inc. Liquid-transfer adapter beveled spike
US8496619B2 (en) 2011-07-15 2013-07-30 Antares Pharma, Inc. Injection device with cammed ram assembly
EP4339613A2 (en) 2011-08-03 2024-03-20 Intuity Medical, Inc. Body fluid sampling arrangement
US10209241B2 (en) 2011-08-12 2019-02-19 Rutgers, The State University Of New Jersey High throughput sensitization detection devices and methods
WO2013112877A1 (en) 2012-01-25 2013-08-01 Tasso, Inc. Handheld device for drawing, collecting, and analyzing bodily fluid
EP2833944A4 (en) 2012-04-06 2016-05-25 Antares Pharma Inc Needle assisted jet injection administration of testosterone compositions
US9364610B2 (en) 2012-05-07 2016-06-14 Antares Pharma, Inc. Injection device with cammed ram assembly
DK2953667T3 (en) 2013-02-11 2020-01-27 Antares Pharma Inc Needle-assisted jet injection device with reduced triggering power
ES2742046T3 (en) 2013-03-11 2020-02-12 Antares Pharma Inc Dose injector with pinion system
JP2016522070A (en) 2013-06-21 2016-07-28 インテュイティ メディカル インコーポレイテッド Analyte monitoring system using audible feedback
US20150141871A1 (en) * 2013-09-24 2015-05-21 Kaveh Khast Pain minimizing injection system
EP3769682B1 (en) 2014-08-01 2024-01-03 Tasso, Inc. Systems for gravity-enhanced microfluidic collection, handling and transferring of fluids
AU2016377659B9 (en) 2015-12-21 2021-11-11 Tasso, Inc. Devices, systems and methods for actuation and retraction in fluid collection
WO2018039305A1 (en) 2016-08-24 2018-03-01 Becton, Dickinson And Company A device for obtaining a blood sample
US11291389B2 (en) 2018-03-13 2022-04-05 Phc Holdings Corporation Sensor insertion device
US20210196164A1 (en) * 2018-05-25 2021-07-01 Becton, Dickinson And Company Blood Collection Assembly with Vibration Module
EP3820368B1 (en) 2018-09-14 2023-08-09 Tasso, Inc. Bodily fluid collection device

Citations (93)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1960889A (en) * 1932-08-13 1934-05-29 Samuel R Benedict Snake bite outfit
US2594621A (en) * 1950-08-03 1952-04-29 George W Derrick Blood obtaining instrument
US3030959A (en) * 1959-09-04 1962-04-24 Praemeta Surgical lancet for blood sampling
US3040744A (en) * 1960-06-17 1962-06-26 Kenneth A Hoggard Syringe plunger ejector
US3235337A (en) * 1962-10-22 1966-02-15 Miles Lab Diagnostic compositions and test indicators
US3734085A (en) * 1971-07-30 1973-05-22 T Russell Stimulator
US3741197A (en) * 1970-09-04 1973-06-26 Micromedia Syst Inc Percussion apparatus for blood sampling
US3933439A (en) * 1974-04-29 1976-01-20 Mcdonald Bernard Blood collection device
US3964482A (en) * 1971-05-17 1976-06-22 Alza Corporation Drug delivery device
US4151832A (en) * 1976-03-19 1979-05-01 Geerd Hamer Serum abstraction device
USD254444S (en) * 1977-09-01 1980-03-11 Levine Robert A Blood sampling needle
US4203446A (en) * 1976-09-24 1980-05-20 Hellige Gmbh Precision spring lancet
US4368738A (en) * 1980-04-05 1983-01-18 Bernd Tersteegen Cannula
US4375815A (en) * 1981-03-23 1983-03-08 Becton Dickinson And Company 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
US4517978A (en) * 1983-01-13 1985-05-21 Levin Paul D Blood sampling instrument
US4564513A (en) * 1983-11-11 1986-01-14 Bayer Aktiengesellschaft Process for the production of carbon monoxide
US4580564A (en) * 1983-06-07 1986-04-08 Andersen Michael A Finger pricking device
US4637978A (en) * 1983-10-28 1987-01-20 Eastman Kodak Company Assay for analysis of whole blood
US4637403A (en) * 1985-04-08 1987-01-20 Garid, Inc. Glucose medical monitoring system
US4648408A (en) * 1984-05-11 1987-03-10 Medscan B.V. Blood sampling unit
US4653511A (en) * 1984-10-05 1987-03-31 Goch Thomas A Microsample blood collecting device
US4653513A (en) * 1985-08-09 1987-03-31 Dombrowski Mitchell P Blood sampler
US4658821A (en) * 1986-01-08 1987-04-21 Packaging Corporation International A/K/A/ Medicore Ejector for an automatic lancet arm
US4660570A (en) * 1984-06-28 1987-04-28 Dombrowski Mitchell P Fetal blood sampling instrument
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
US4895147A (en) * 1988-10-28 1990-01-23 Sherwood Medical Company Lancet injector
US4920977A (en) * 1988-10-25 1990-05-01 Becton, Dickinson And Company Blood collection assembly with lancet and microcollection tube
US4924879A (en) * 1988-10-07 1990-05-15 Brien Walter J O Blood lancet device
US4925447A (en) * 1988-06-22 1990-05-15 Rosenblatt/Ima Invention Enterprises Aspirator without partition wall for collection of bodily fluids including improved safety and efficiency elements
US4981473A (en) * 1988-06-22 1991-01-01 Rosenblatt/Ima Invention Enterprises Aspirator without partition wall for collection of bodily fluids including improved safety and efficiency elements
US4990154A (en) * 1989-06-19 1991-02-05 Miles Inc. Lancet assembly
US4994068A (en) * 1989-11-24 1991-02-19 Unidex, Inc. Combination sterile pad support and lancet containing lancet disposal element
US4994073A (en) * 1989-02-22 1991-02-19 United States Surgical Corp. Skin fastener
US4995402A (en) * 1988-10-12 1991-02-26 Thorne, Smith, Astill Technologies, Inc. Medical droplet whole blood and like monitoring
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
US5014718A (en) * 1988-01-22 1991-05-14 Safety Diagnostics, Inc. Blood collection and testing method
US5019059A (en) * 1986-12-15 1991-05-28 Uresil Corporation Apparatus and method for collecting body fluids
USD324423S (en) * 1988-12-24 1992-03-03 Kabivitrum Ab Combined medical syringe and vial for administering subcutaneous injections
US5102404A (en) * 1986-12-15 1992-04-07 Uresil Corporation Apparatus and method for collecting body fluids
USD332306S (en) * 1990-03-12 1993-01-05 Garth Geoffrey C Manually operated aspirator for emergency medical use
US5193552A (en) * 1989-03-14 1993-03-16 Eastman Kodak Company Needle device for safely collecting blood or injecting drugs
US5195534A (en) * 1991-08-16 1993-03-23 Helena Laboratories Corporation Biological fluid collection and dispensing apparatus and method
US5201324A (en) * 1989-03-27 1993-04-13 Remi Swierczek Disposable skin perforator and blood testing device
US5277198A (en) * 1992-07-27 1994-01-11 Ryder International Corporation Blood sampling syringe
US5279586A (en) * 1992-02-04 1994-01-18 Becton, Dickinson And Company Reusable medication delivery pen
US5279294A (en) * 1985-04-08 1994-01-18 Cascade Medical, Inc. Medical diagnostic system
US5282822A (en) * 1993-01-19 1994-02-01 Sherwood Medical Company Lancet ejector for lancet injector
US5304193A (en) * 1993-08-12 1994-04-19 Sam Zhadanov Blood lancing device
US5309924A (en) * 1992-04-29 1994-05-10 Peabody Alan M Spill-proof blood collection device
US5387203A (en) * 1993-06-28 1995-02-07 Goodrich; Hubert J. Subcutaneous extractor
US5395387A (en) * 1993-02-26 1995-03-07 Becton Dickinson And Company Lancet blade designed for reduced pain
US5402798A (en) * 1991-07-18 1995-04-04 Swierczek; Remi Disposable skin perforator and blood testing device
US5487748A (en) * 1992-04-01 1996-01-30 Owen Mumford Limited Blood sampling device
US5512158A (en) * 1995-02-28 1996-04-30 Hewlett-Packard Company Capillary electrophoresis method and apparatus for electric field uniformity and minimal dispersion of sample fractions
US5518006A (en) * 1994-08-09 1996-05-21 International Technidyne Corp. Blood sampling device
US5607401A (en) * 1991-09-03 1997-03-04 Humphrey; Bruce H. Augmented polymeric hypodermic devices
US5611809A (en) * 1994-11-04 1997-03-18 Owen Mumford Limited Needle devices for medical use
US5613978A (en) * 1996-06-04 1997-03-25 Palco Laboratories Adjustable tip for lancet device
US5624458A (en) * 1993-10-20 1997-04-29 Anne Marie Varro Lancet device
US5628765A (en) * 1994-11-29 1997-05-13 Apls Co., Ltd. Lancet assembly
US5628309A (en) * 1996-01-25 1997-05-13 Raya Systems, Inc. Meter for electrically measuring and recording injection syringe doses
US5628764A (en) * 1995-03-21 1997-05-13 Schraga; Steven Collar lancet device
US5707384A (en) * 1995-06-26 1998-01-13 Teramecs Co., Ltd. Lancet device for obtaining blood samples
US5709699A (en) * 1995-09-01 1998-01-20 Biosafe Diagnostics Corporation Blood collection and testing device
US5730753A (en) * 1995-07-28 1998-03-24 Apls Co., Ltd. Assembly for adjusting pricking depth of lancet
US5741291A (en) * 1996-02-23 1998-04-21 Yoo; Tae Woo Acupuncture of the bleeding
US5746217A (en) * 1993-10-13 1998-05-05 Integ Incorporated Interstitial fluid collection and constituent measurement
USRE35803E (en) * 1992-04-13 1998-05-19 Boehringer Mannheim Gmbh Blood lancet device for and method withdrawing blood for diagnostic purposes
US5857983A (en) * 1996-05-17 1999-01-12 Mercury Diagnostics, Inc. Methods and apparatus for sampling body fluid
US5871494A (en) * 1997-12-04 1999-02-16 Hewlett-Packard Company Reproducible lancing for sampling blood
US5873887A (en) * 1996-10-25 1999-02-23 Bayer Corporation Blood sampling device
US5879311A (en) * 1996-05-17 1999-03-09 Mercury Diagnostics, Inc. Body fluid sampling device and methods of use
US5885219A (en) * 1996-01-16 1999-03-23 Nightengale; Christopher Interrogation device and method
US5891053A (en) * 1995-05-25 1999-04-06 Kabushiki Kaisya Advance Blood-collecting device
US6015392A (en) * 1996-05-17 2000-01-18 Mercury Diagnostics, Inc. Apparatus for sampling body fluid
US6022366A (en) * 1998-06-11 2000-02-08 Stat Medical Devices Inc. Lancet having adjustable penetration depth
US6027459A (en) * 1996-12-06 2000-02-22 Abbott Laboratories Method and apparatus for obtaining blood for diagnostic tests
US6036924A (en) * 1997-12-04 2000-03-14 Hewlett-Packard Company Cassette of lancet cartridges for sampling blood
US6045567A (en) * 1999-02-23 2000-04-04 Lifescan Inc. Lancing device causing reduced pain
US6048352A (en) * 1996-05-17 2000-04-11 Mercury Diagnostics, Inc. Disposable element for use in a body fluid sampling device
US6056765A (en) * 1997-06-24 2000-05-02 Bajaj; Ratan Lancet device
US6063039A (en) * 1996-12-06 2000-05-16 Abbott Laboratories Method and apparatus for obtaining blood for diagnostic tests
US6066103A (en) * 1997-11-21 2000-05-23 Amira Medical Body fluid sampling device
US6183434B1 (en) * 1996-07-03 2001-02-06 Spectrx, Inc. Multiple mechanical microporation of skin or mucosa
US6210421B1 (en) * 1996-02-06 2001-04-03 Roche Diagnostics Gmbh Cutting device for skin for obtaining small blood samples in almost pain-free manner
US20020002344A1 (en) * 1996-05-17 2002-01-03 Douglas Joel S. Methods and apparatus for sampling and analyzing body fluid
US20020004196A1 (en) * 2000-07-10 2002-01-10 Bayer Corporation Thin lance and test sensor having same
US6346114B1 (en) * 1998-06-11 2002-02-12 Stat Medical Devices, Inc. Adjustable length member such as a cap of a lancet device for adjusting penetration depth
US20020022789A1 (en) * 1997-11-21 2002-02-21 Edward Perez Methods and apparatus for expressing body fluid from an incision
US20020029059A1 (en) * 2000-09-01 2002-03-07 Purcell D. Glenn Adjustable endcap for lancing device
US20020040230A1 (en) * 2000-06-21 2002-04-04 Hans-Jurgen Kuhr Blood lancet system for blood withdrawal for diagnostic purposes

Family Cites Families (112)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US254444A (en) 1882-02-28 Chaeles w
US439763A (en) * 1890-11-04 Apparatus
US2074735A (en) * 1935-09-16 1937-03-23 Puttcamp John Applicator and massaging device
US2646799A (en) 1951-02-14 1953-07-28 Jr George W Jacoby Blood lancet
US3068868A (en) 1960-06-08 1962-12-18 Skopyk Joseph Poison extractor
US3221739A (en) 1962-03-26 1965-12-07 Rosenthal Sol Roy Injection device
US3358689A (en) 1964-06-09 1967-12-19 Roehr Products Company Inc Integral lancet and package
US3486504A (en) 1967-11-20 1969-12-30 Lawthan M Austin Jr Device for applying dressing,medication and suction
CH500707A (en) 1968-07-26 1970-12-31 Micromedic Systems Inc Device for performing percutaneous and digital blood sampling
CH522395A (en) 1968-07-26 1972-05-15 Micromedic Systems Inc Test tube intended for percutaneous and digital blood sampling
GB1323675A (en) 1969-07-09 1973-07-18 Nat Res Dev Endoscopes
US3774611A (en) 1972-06-08 1973-11-27 J Tussey Stabilized contamination free surgical evacuator
GB1599654A (en) * 1977-08-05 1981-10-07 Holman R R Automatic lancet
US4235234A (en) 1978-11-30 1980-11-25 Martin John K Iii Subcutaneous injection system
US4360016A (en) 1980-07-01 1982-11-23 Transidyne General Corp. Blood collecting device
US4460354A (en) 1980-07-08 1984-07-17 Snyder Laboratories, Inc. Closed wound suction evacuator
US4535769A (en) * 1981-03-23 1985-08-20 Becton, Dickinson And Company Automatic retractable lancet assembly
US4397643A (en) 1981-05-04 1983-08-09 Sherwood Medical Company Drainage collection device with disposable liner
FR2508305B1 (en) 1981-06-25 1986-04-11 Slama Gerard DEVICE FOR CAUSING A LITTLE BITE TO COLLECT A BLOOD DROP
US4462405A (en) 1982-09-27 1984-07-31 Ehrlich Joseph C Blood letting apparatus
USRE32922E (en) 1983-01-13 1989-05-16 Paul D. Levin Blood sampling instrument
AU90167S (en) 1983-01-19 1985-03-14 Astra Meditec Ab Bellows for a surgical drainage device
DK150403C (en) 1983-07-15 1987-07-13 Radiometer As BLOOD SAMPLING EQUIPMENT
DE3426090A1 (en) 1983-10-06 1985-04-18 Karl Storz GmbH & Co, 7200 Tuttlingen Obstetric apparatus
US4622974A (en) 1984-03-07 1986-11-18 University Of Tennessee Research Corporation Apparatus and method for in-vivo measurements of chemical concentrations
US4616649A (en) 1984-09-20 1986-10-14 Becton, Dickinson And Company Lancet
US4787398A (en) 1985-04-08 1988-11-29 Garid, Inc. Glucose medical monitoring system
US4654513A (en) 1985-07-31 1987-03-31 Hennessy Products, Inc. Newspaper vending machine
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
GB8710470D0 (en) 1987-05-01 1987-06-03 Mumford Ltd Owen Blood sampling devices
US4858607A (en) 1987-10-16 1989-08-22 Pavel Jordan & 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
US4883068A (en) 1988-03-14 1989-11-28 Dec In Tech, Inc. Blood sampling device and method
US5035704A (en) 1989-03-07 1991-07-30 Lambert Robert D Blood sampling mechanism
US4953552A (en) 1989-04-21 1990-09-04 Demarzo Arthur P Blood glucose monitoring system
US4976724A (en) 1989-08-25 1990-12-11 Lifescan, Inc. Lancet ejector mechanism
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
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
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
US6436078B1 (en) 1994-12-06 2002-08-20 Pal Svedman Transdermal perfusion of fluids
US5324302A (en) 1992-10-13 1994-06-28 Sherwood Medical Company Lancet with locking cover
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
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
CA2079192C (en) 1992-09-25 1995-12-26 Bernard Strong Combined lancet and multi-function cap and lancet injector for use therewith
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
US5353806A (en) 1993-03-04 1994-10-11 The Venture Fund Of Washington Liquid collection device
JP2630197B2 (en) 1993-04-28 1997-07-16 株式会社ニッショー Blood suction device
DE4318142C2 (en) 1993-06-02 1995-07-06 Richard Herbst Lancet device for preparing a blood sample
DE4320463A1 (en) 1993-06-21 1994-12-22 Boehringer Mannheim Gmbh Blood lancet device for drawing blood for diagnostic purposes
JP3494183B2 (en) 1993-08-10 2004-02-03 株式会社アドバンス Simple blood collection device
KR960705501A (en) 1993-10-28 1996-11-08 윌리암 모피트 FLUID SAMPLE COLLECTION AND INTRODUCTION DEVICE
US5445611A (en) 1993-12-08 1995-08-29 Non-Invasive Monitoring Company (Nimco) Enhancement of transdermal delivery with ultrasound and chemical enhancers
US5458140A (en) 1993-11-15 1995-10-17 Non-Invasive Monitoring Company (Nimco) Enhancement of transdermal monitoring applications with ultrasound and chemical enhancers
US5423758A (en) 1993-12-16 1995-06-13 Shaw; Thomas J. Retractable fluid collection device
US5397334A (en) 1994-01-11 1995-03-14 Sherwood Medical Company Distal movement limiting assembly for finger stick device
US5549584A (en) 1994-02-14 1996-08-27 The Kendall Company Apparatus for removing fluid from a wound
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
USD371440S (en) 1994-12-12 1996-07-02 Bayer Corporation Analyzer for biological fluids
US5947957A (en) 1994-12-23 1999-09-07 Jmar Technology Co. Portable laser for blood sampling
USD378612S (en) 1995-05-23 1997-03-25 Lifescan, Inc. Blood glucose meter
US5671753A (en) 1995-06-27 1997-09-30 Pitesky; Isadore Disposable multiple allergen testing apparatus
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
WO1997010745A1 (en) 1995-09-08 1997-03-27 Integ, Inc. Body fluid sampler
US5662127A (en) 1996-01-17 1997-09-02 Bio-Plas, Inc. Self-contained blood withdrawal apparatus and method
JP3098971B2 (en) 1996-05-15 2000-10-16 松下電工株式会社 Hair removal 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
US5951492A (en) 1996-05-17 1999-09-14 Mercury Diagnostics, Inc. Methods and apparatus for sampling and analyzing body fluid
EP0958495B1 (en) 1997-02-06 2002-11-13 Therasense, Inc. Small volume in vitro analyte sensor
US5788652A (en) 1997-03-24 1998-08-04 S&H Diagnostics, Inc. Blood sample collection device
US5984940A (en) 1997-05-29 1999-11-16 Atrion Medical Products, Inc. Lancet device
US5916230A (en) 1997-06-16 1999-06-29 Bayer Corporation Blood sampling device with adjustable end cap
US6019735A (en) 1997-08-28 2000-02-01 Visco Technologies, Inc. Viscosity measuring apparatus and method of use
US6071294A (en) 1997-12-04 2000-06-06 Agilent Technologies, Inc. Lancet cartridge for sampling blood
US5971941A (en) 1997-12-04 1999-10-26 Hewlett-Packard Company Integrated system and method for sampling blood and analysis
US6086545A (en) 1998-04-28 2000-07-11 Amira Medical Methods and apparatus for suctioning and pumping body fluid from an incision
ATE408372T1 (en) 1999-01-04 2008-10-15 Terumo Corp LANDZET ARRANGEMENT FOR COLLECTION AND DETECTION OF BODY FLUID
US7077828B2 (en) 1999-03-05 2006-07-18 Roche Diagnostics Gmbh Device for withdrawing blood for diagnostic applications
DE19909602A1 (en) 1999-03-05 2000-09-07 Roche Diagnostics Gmbh Device for drawing blood for diagnostic purposes
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
US6743211B1 (en) * 1999-11-23 2004-06-01 Georgia Tech Research Corporation Devices and methods for enhanced microneedle penetration of biological barriers
US6152942A (en) 1999-06-14 2000-11-28 Bayer Corporation Vacuum assisted lancing device
US6283982B1 (en) 1999-10-19 2001-09-04 Facet Technologies, Inc. Lancing device and method of sample collection
JP2001155826A (en) * 1999-11-30 2001-06-08 Sumitomo Wiring Syst Ltd Mounting structure of connector to panel
CA2394171A1 (en) 1999-12-16 2001-06-21 Alza Corporation Device for enhancing transdermal flux of sampled agents
US6423011B1 (en) 2000-03-02 2002-07-23 Clinical Innovation Associates, Inc. Apparatus and method for fetal scalp blood sampling
PL191428B1 (en) 2000-04-06 2006-05-31 Htl Strefa Sp Z Oo Puncturing depth adjusting assembly for puncturing devices
JP2001321368A (en) 2000-05-16 2001-11-20 Fuji Photo Film Co Ltd Plasma taking tool
US6585952B1 (en) * 2000-05-25 2003-07-01 Board Of Trustees Operating Michigan State University Ultrastable hexagonal, cubic and wormhole aluminosilicate mesostructures
AU6676601A (en) * 2000-06-09 2001-12-24 Inverness Medical Technology Cap for a lancing device
AU2002247008B2 (en) 2001-01-22 2006-02-09 F. Hoffmann-La Roche Ag Lancet device having capillary action
US6752817B2 (en) * 2001-03-26 2004-06-22 Bayer Corporation Split pressure ring for lancing device and method of operation
US6783502B2 (en) * 2001-04-26 2004-08-31 Phoenix Bioscience Integrated lancing and analytic device
US20020188223A1 (en) * 2001-06-08 2002-12-12 Edward Perez Devices and methods for the expression of bodily fluids from an incision
WO2002100253A2 (en) * 2001-06-12 2002-12-19 Pelikan Technologies, Inc. Blood sampling device with diaphragm actuated lancet
US7025774B2 (en) * 2001-06-12 2006-04-11 Pelikan Technologies, Inc. Tissue penetration device
US20060184189A1 (en) * 2002-11-15 2006-08-17 Lorin Olson Cap for a dermal tissue lancing device

Patent Citations (99)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1960889A (en) * 1932-08-13 1934-05-29 Samuel R Benedict Snake bite outfit
US2594621A (en) * 1950-08-03 1952-04-29 George W Derrick Blood obtaining instrument
US3030959A (en) * 1959-09-04 1962-04-24 Praemeta Surgical lancet for blood sampling
US3040744A (en) * 1960-06-17 1962-06-26 Kenneth A Hoggard Syringe plunger ejector
US3235337A (en) * 1962-10-22 1966-02-15 Miles Lab Diagnostic compositions and test indicators
US3741197A (en) * 1970-09-04 1973-06-26 Micromedia Syst Inc Percussion apparatus for blood sampling
US3964482A (en) * 1971-05-17 1976-06-22 Alza Corporation Drug delivery device
US3734085A (en) * 1971-07-30 1973-05-22 T Russell Stimulator
US3933439A (en) * 1974-04-29 1976-01-20 Mcdonald Bernard Blood collection device
US4151832A (en) * 1976-03-19 1979-05-01 Geerd Hamer Serum abstraction device
US4203446A (en) * 1976-09-24 1980-05-20 Hellige Gmbh Precision spring lancet
USD254444S (en) * 1977-09-01 1980-03-11 Levine Robert A Blood sampling needle
US4368738A (en) * 1980-04-05 1983-01-18 Bernd Tersteegen Cannula
US4375815A (en) * 1981-03-23 1983-03-08 Becton Dickinson And Company 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
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
US4637978A (en) * 1983-10-28 1987-01-20 Eastman Kodak Company Assay for analysis of whole blood
US4564513A (en) * 1983-11-11 1986-01-14 Bayer Aktiengesellschaft Process for the production of carbon monoxide
US4648408A (en) * 1984-05-11 1987-03-10 Medscan B.V. Blood sampling unit
US4660570A (en) * 1984-06-28 1987-04-28 Dombrowski Mitchell P Fetal blood sampling instrument
US4653511A (en) * 1984-10-05 1987-03-31 Goch Thomas A Microsample blood collecting device
US4637403A (en) * 1985-04-08 1987-01-20 Garid, Inc. Glucose medical monitoring system
US5279294A (en) * 1985-04-08 1994-01-18 Cascade Medical, Inc. Medical diagnostic system
US4653513A (en) * 1985-08-09 1987-03-31 Dombrowski Mitchell P Blood sampler
US4658821A (en) * 1986-01-08 1987-04-21 Packaging Corporation International A/K/A/ Medicore Ejector for an automatic lancet arm
US5102404A (en) * 1986-12-15 1992-04-07 Uresil Corporation Apparatus and method for collecting body fluids
US5019059A (en) * 1986-12-15 1991-05-28 Uresil Corporation Apparatus and method for collecting body fluids
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
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
US5014718A (en) * 1988-01-22 1991-05-14 Safety Diagnostics, Inc. Blood collection and testing method
US4981473A (en) * 1988-06-22 1991-01-01 Rosenblatt/Ima Invention Enterprises Aspirator without partition wall for collection of bodily fluids including improved safety and efficiency elements
US4925447A (en) * 1988-06-22 1990-05-15 Rosenblatt/Ima Invention Enterprises Aspirator without partition wall for collection of bodily fluids including improved safety and efficiency elements
US4924879A (en) * 1988-10-07 1990-05-15 Brien Walter J O Blood lancet device
US4995402A (en) * 1988-10-12 1991-02-26 Thorne, Smith, Astill Technologies, Inc. Medical droplet whole blood and like monitoring
US4920977A (en) * 1988-10-25 1990-05-01 Becton, Dickinson And Company Blood collection assembly with lancet and microcollection tube
US4895147A (en) * 1988-10-28 1990-01-23 Sherwood Medical Company Lancet injector
USD324423S (en) * 1988-12-24 1992-03-03 Kabivitrum Ab Combined medical syringe and vial for administering subcutaneous injections
US4994073A (en) * 1989-02-22 1991-02-19 United States Surgical Corp. Skin fastener
US5193552A (en) * 1989-03-14 1993-03-16 Eastman Kodak Company Needle device for safely collecting blood or injecting drugs
US5201324A (en) * 1989-03-27 1993-04-13 Remi Swierczek Disposable skin perforator and blood testing device
US4990154A (en) * 1989-06-19 1991-02-05 Miles Inc. Lancet assembly
US4994068A (en) * 1989-11-24 1991-02-19 Unidex, Inc. Combination sterile pad support and lancet containing lancet disposal element
USD332306S (en) * 1990-03-12 1993-01-05 Garth Geoffrey C Manually operated aspirator for emergency medical use
US5402798A (en) * 1991-07-18 1995-04-04 Swierczek; Remi Disposable skin perforator and blood testing device
US5195534A (en) * 1991-08-16 1993-03-23 Helena Laboratories Corporation Biological fluid collection and dispensing apparatus and method
US5607401A (en) * 1991-09-03 1997-03-04 Humphrey; Bruce H. Augmented polymeric hypodermic devices
US5279586A (en) * 1992-02-04 1994-01-18 Becton, Dickinson And Company Reusable medication delivery pen
US5487748B1 (en) * 1992-04-01 1998-04-14 Owen Mumford Ltd Blood sampling device
US5487748A (en) * 1992-04-01 1996-01-30 Owen Mumford Limited Blood sampling device
USRE35803E (en) * 1992-04-13 1998-05-19 Boehringer Mannheim Gmbh Blood lancet device for and method withdrawing blood for diagnostic purposes
US5309924A (en) * 1992-04-29 1994-05-10 Peabody Alan M Spill-proof blood collection device
US5277198A (en) * 1992-07-27 1994-01-11 Ryder International Corporation Blood sampling syringe
US5282822A (en) * 1993-01-19 1994-02-01 Sherwood Medical Company Lancet ejector for lancet injector
US5395387A (en) * 1993-02-26 1995-03-07 Becton Dickinson And Company Lancet blade designed for reduced pain
US5387203A (en) * 1993-06-28 1995-02-07 Goodrich; Hubert J. Subcutaneous extractor
US5304193A (en) * 1993-08-12 1994-04-19 Sam Zhadanov Blood lancing device
US5746217A (en) * 1993-10-13 1998-05-05 Integ Incorporated Interstitial fluid collection and constituent measurement
US5624458A (en) * 1993-10-20 1997-04-29 Anne Marie Varro Lancet device
US5518006A (en) * 1994-08-09 1996-05-21 International Technidyne Corp. Blood sampling device
US5611809A (en) * 1994-11-04 1997-03-18 Owen Mumford Limited Needle devices for medical use
US5628765A (en) * 1994-11-29 1997-05-13 Apls Co., Ltd. Lancet assembly
US5755733A (en) * 1994-11-29 1998-05-26 Apls Co., Ltd. Lancet assembly
US5512158A (en) * 1995-02-28 1996-04-30 Hewlett-Packard Company Capillary electrophoresis method and apparatus for electric field uniformity and minimal dispersion of sample fractions
US5628764A (en) * 1995-03-21 1997-05-13 Schraga; Steven Collar lancet device
US5891053A (en) * 1995-05-25 1999-04-06 Kabushiki Kaisya Advance Blood-collecting device
US5707384A (en) * 1995-06-26 1998-01-13 Teramecs Co., Ltd. Lancet device for obtaining blood samples
US5730753A (en) * 1995-07-28 1998-03-24 Apls Co., Ltd. Assembly for adjusting pricking depth of lancet
US5709699A (en) * 1995-09-01 1998-01-20 Biosafe Diagnostics Corporation Blood collection and testing device
US5885219A (en) * 1996-01-16 1999-03-23 Nightengale; Christopher Interrogation device and method
US5628309A (en) * 1996-01-25 1997-05-13 Raya Systems, Inc. Meter for electrically measuring and recording injection syringe doses
US6210421B1 (en) * 1996-02-06 2001-04-03 Roche Diagnostics Gmbh Cutting device for skin for obtaining small blood samples in almost pain-free manner
US5741291A (en) * 1996-02-23 1998-04-21 Yoo; Tae Woo Acupuncture of the bleeding
US20020002344A1 (en) * 1996-05-17 2002-01-03 Douglas Joel S. Methods and apparatus for sampling and analyzing body fluid
US6048352A (en) * 1996-05-17 2000-04-11 Mercury Diagnostics, Inc. Disposable element for use in a body fluid sampling device
US6352514B1 (en) * 1996-05-17 2002-03-05 Amira Medical Methods and apparatus for sampling and analyzing body fluid
US6183489B1 (en) * 1996-05-17 2001-02-06 Amira Medical Disposable element for use in a body fluid sampling device
US6015392A (en) * 1996-05-17 2000-01-18 Mercury Diagnostics, Inc. Apparatus for sampling body fluid
US5857983A (en) * 1996-05-17 1999-01-12 Mercury Diagnostics, Inc. Methods and apparatus for sampling body fluid
US5879311A (en) * 1996-05-17 1999-03-09 Mercury Diagnostics, Inc. Body fluid sampling device and methods of use
US6056701A (en) * 1996-05-17 2000-05-02 Amira Medical Body fluid sampling device and methods of use
US5613978A (en) * 1996-06-04 1997-03-25 Palco Laboratories Adjustable tip for lancet device
US6183434B1 (en) * 1996-07-03 2001-02-06 Spectrx, Inc. Multiple mechanical microporation of skin or mucosa
US5873887A (en) * 1996-10-25 1999-02-23 Bayer Corporation Blood sampling device
US6027459A (en) * 1996-12-06 2000-02-22 Abbott Laboratories Method and apparatus for obtaining blood for diagnostic tests
US6063039A (en) * 1996-12-06 2000-05-16 Abbott Laboratories Method and apparatus for obtaining blood for diagnostic tests
US6056765A (en) * 1997-06-24 2000-05-02 Bajaj; Ratan Lancet device
US20020022789A1 (en) * 1997-11-21 2002-02-21 Edward Perez Methods and apparatus for expressing body fluid from an incision
US6706000B2 (en) * 1997-11-21 2004-03-16 Amira Medical Methods and apparatus for expressing body fluid from an incision
US6066103A (en) * 1997-11-21 2000-05-23 Amira Medical Body fluid sampling device
US6036924A (en) * 1997-12-04 2000-03-14 Hewlett-Packard Company Cassette of lancet cartridges for sampling blood
US5871494A (en) * 1997-12-04 1999-02-16 Hewlett-Packard Company Reproducible lancing for sampling blood
US6022366A (en) * 1998-06-11 2000-02-08 Stat Medical Devices Inc. Lancet having adjustable penetration depth
US6346114B1 (en) * 1998-06-11 2002-02-12 Stat Medical Devices, Inc. Adjustable length member such as a cap of a lancet device for adjusting penetration depth
US6045567A (en) * 1999-02-23 2000-04-04 Lifescan Inc. Lancing device causing reduced pain
US20020040230A1 (en) * 2000-06-21 2002-04-04 Hans-Jurgen Kuhr Blood lancet system for blood withdrawal for diagnostic purposes
US20020004196A1 (en) * 2000-07-10 2002-01-10 Bayer Corporation Thin lance and test sensor having same
US20020029059A1 (en) * 2000-09-01 2002-03-07 Purcell D. Glenn Adjustable endcap for lancing device

Cited By (152)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7666149B2 (en) 1997-12-04 2010-02-23 Peliken Technologies, Inc. Cassette of lancet cartridges for sampling blood
US7780631B2 (en) 1998-03-30 2010-08-24 Pelikan Technologies, Inc. Apparatus and method for penetration with shaft having a sensor for sensing penetration depth
US8439872B2 (en) 1998-03-30 2013-05-14 Sanofi-Aventis Deutschland Gmbh Apparatus and method for penetration with shaft having a sensor for sensing penetration depth
US8641644B2 (en) 2000-11-21 2014-02-04 Sanofi-Aventis Deutschland Gmbh Blood testing apparatus having a rotatable cartridge with multiple lancing elements and testing means
US8721671B2 (en) 2001-06-12 2014-05-13 Sanofi-Aventis Deutschland Gmbh Electric lancet actuator
US8360991B2 (en) 2001-06-12 2013-01-29 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8845550B2 (en) 2001-06-12 2014-09-30 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US7909775B2 (en) 2001-06-12 2011-03-22 Pelikan Technologies, Inc. Method and apparatus for lancet launching device integrated onto a blood-sampling cartridge
US8679033B2 (en) 2001-06-12 2014-03-25 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8641643B2 (en) 2001-06-12 2014-02-04 Sanofi-Aventis Deutschland Gmbh Sampling module device and method
US7981055B2 (en) 2001-06-12 2011-07-19 Pelikan Technologies, Inc. Tissue penetration device
US9694144B2 (en) 2001-06-12 2017-07-04 Sanofi-Aventis Deutschland Gmbh Sampling module device and method
US8622930B2 (en) 2001-06-12 2014-01-07 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US7682318B2 (en) 2001-06-12 2010-03-23 Pelikan Technologies, Inc. Blood sampling apparatus and method
US7699791B2 (en) 2001-06-12 2010-04-20 Pelikan Technologies, Inc. Method and apparatus for improving success rate of blood yield from a fingerstick
US9802007B2 (en) 2001-06-12 2017-10-31 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
US8382683B2 (en) 2001-06-12 2013-02-26 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9427532B2 (en) 2001-06-12 2016-08-30 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8337421B2 (en) 2001-06-12 2012-12-25 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US7749174B2 (en) 2001-06-12 2010-07-06 Pelikan Technologies, Inc. Method and apparatus for lancet launching device intergrated onto a blood-sampling cartridge
US8282577B2 (en) 2001-06-12 2012-10-09 Sanofi-Aventis Deutschland Gmbh Method and apparatus for lancet launching device integrated onto a blood-sampling cartridge
US9937298B2 (en) 2001-06-12 2018-04-10 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8216154B2 (en) 2001-06-12 2012-07-10 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8211037B2 (en) 2001-06-12 2012-07-03 Pelikan Technologies, Inc. Tissue penetration device
US8206317B2 (en) 2001-06-12 2012-06-26 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US7850622B2 (en) 2001-06-12 2010-12-14 Pelikan Technologies, Inc. Tissue penetration device
US8206319B2 (en) 2001-06-12 2012-06-26 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8123700B2 (en) 2001-06-12 2012-02-28 Pelikan Technologies, Inc. Method and apparatus for lancet launching device integrated onto a blood-sampling cartridge
US8016774B2 (en) 2001-06-12 2011-09-13 Pelikan Technologies, Inc. Tissue penetration device
US7988645B2 (en) 2001-06-12 2011-08-02 Pelikan Technologies, Inc. Self optimizing lancing device with adaptation means to temporal variations in cutaneous properties
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
US8360992B2 (en) 2002-04-19 2013-01-29 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8579831B2 (en) 2002-04-19 2013-11-12 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7901362B2 (en) 2002-04-19 2011-03-08 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7909777B2 (en) 2002-04-19 2011-03-22 Pelikan Technologies, Inc Method and apparatus for penetrating tissue
US9907502B2 (en) 2002-04-19 2018-03-06 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7892183B2 (en) 2002-04-19 2011-02-22 Pelikan Technologies, Inc. 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
US9839386B2 (en) 2002-04-19 2017-12-12 Sanofi-Aventis Deustschland Gmbh Body fluid sampling device with capacitive sensor
US7914465B2 (en) 2002-04-19 2011-03-29 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7938787B2 (en) 2002-04-19 2011-05-10 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US9795334B2 (en) 2002-04-19 2017-10-24 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7976476B2 (en) 2002-04-19 2011-07-12 Pelikan Technologies, Inc. Device and method for variable speed lancet
US7892185B2 (en) 2002-04-19 2011-02-22 Pelikan Technologies, Inc. Method and apparatus for body fluid sampling and analyte sensing
US7981056B2 (en) 2002-04-19 2011-07-19 Pelikan Technologies, Inc. Methods and apparatus for lancet actuation
US7874994B2 (en) 2002-04-19 2011-01-25 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7988644B2 (en) 2002-04-19 2011-08-02 Pelikan Technologies, Inc. Method and apparatus for a multi-use body fluid sampling device with sterility barrier release
US8007446B2 (en) 2002-04-19 2011-08-30 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7875047B2 (en) 2002-04-19 2011-01-25 Pelikan Technologies, Inc. Method and apparatus for a multi-use body fluid sampling device with sterility barrier release
US9724021B2 (en) 2002-04-19 2017-08-08 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8062231B2 (en) 2002-04-19 2011-11-22 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US9498160B2 (en) 2002-04-19 2016-11-22 Sanofi-Aventis Deutschland Gmbh Method for penetrating tissue
US8079960B2 (en) 2002-04-19 2011-12-20 Pelikan Technologies, Inc. Methods and apparatus for lancet actuation
US9339612B2 (en) 2002-04-19 2016-05-17 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9314194B2 (en) 2002-04-19 2016-04-19 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8157748B2 (en) 2002-04-19 2012-04-17 Pelikan Technologies, Inc. Methods and apparatus for lancet actuation
US8197423B2 (en) 2002-04-19 2012-06-12 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8197421B2 (en) 2002-04-19 2012-06-12 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8202231B2 (en) 2002-04-19 2012-06-19 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7862520B2 (en) 2002-04-19 2011-01-04 Pelikan Technologies, Inc. Body fluid sampling module with a continuous compression tissue interface surface
US9248267B2 (en) 2002-04-19 2016-02-02 Sanofi-Aventis Deustchland Gmbh Tissue penetration device
US7833171B2 (en) 2002-04-19 2010-11-16 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US9226699B2 (en) 2002-04-19 2016-01-05 Sanofi-Aventis Deutschland Gmbh Body fluid sampling module with a continuous compression tissue interface surface
US8221334B2 (en) 2002-04-19 2012-07-17 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8235915B2 (en) 2002-04-19 2012-08-07 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
US9089678B2 (en) 2002-04-19 2015-07-28 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
US8267870B2 (en) 2002-04-19 2012-09-18 Sanofi-Aventis Deutschland Gmbh Method and apparatus for body fluid sampling with hybrid actuation
US9072842B2 (en) 2002-04-19 2015-07-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8905945B2 (en) 2002-04-19 2014-12-09 Dominique M. Freeman Method and apparatus for penetrating tissue
US8845549B2 (en) 2002-04-19 2014-09-30 Sanofi-Aventis Deutschland Gmbh Method for penetrating tissue
US8808201B2 (en) 2002-04-19 2014-08-19 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for penetrating tissue
US7731729B2 (en) 2002-04-19 2010-06-08 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8784335B2 (en) 2002-04-19 2014-07-22 Sanofi-Aventis Deutschland Gmbh Body fluid sampling device with a capacitive sensor
US8690796B2 (en) 2002-04-19 2014-04-08 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7717863B2 (en) 2002-04-19 2010-05-18 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8366637B2 (en) 2002-04-19 2013-02-05 Sanofi-Aventis Deutschland Gmbh 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
US7713214B2 (en) 2002-04-19 2010-05-11 Pelikan Technologies, Inc. Method and apparatus for a multi-use body fluid sampling device with optical analyte sensing
US8382682B2 (en) 2002-04-19 2013-02-26 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8388551B2 (en) 2002-04-19 2013-03-05 Sanofi-Aventis Deutschland Gmbh Method and apparatus for multi-use body fluid sampling device with sterility barrier release
US8403864B2 (en) 2002-04-19 2013-03-26 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8414503B2 (en) 2002-04-19 2013-04-09 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
US8430828B2 (en) 2002-04-19 2013-04-30 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a multi-use body fluid sampling device with sterility barrier release
US8435190B2 (en) 2002-04-19 2013-05-07 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7708701B2 (en) 2002-04-19 2010-05-04 Pelikan Technologies, Inc. Method and apparatus for a multi-use body fluid sampling device
US7648468B2 (en) 2002-04-19 2010-01-19 Pelikon Technologies, Inc. Method and apparatus for penetrating tissue
US8491500B2 (en) 2002-04-19 2013-07-23 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
US8496601B2 (en) 2002-04-19 2013-07-30 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
US8556829B2 (en) 2002-04-19 2013-10-15 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8562545B2 (en) 2002-04-19 2013-10-22 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8636673B2 (en) 2002-04-19 2014-01-28 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US7901365B2 (en) 2002-04-19 2011-03-08 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
US8574895B2 (en) 2002-12-30 2013-11-05 Sanofi-Aventis Deutschland Gmbh Method and apparatus using optical techniques to measure analyte levels
US9034639B2 (en) 2002-12-30 2015-05-19 Sanofi-Aventis Deutschland Gmbh Method and apparatus using optical techniques to measure analyte levels
US8262614B2 (en) 2003-05-30 2012-09-11 Pelikan Technologies, Inc. Method and apparatus for fluid injection
US7850621B2 (en) 2003-06-06 2010-12-14 Pelikan Technologies, Inc. Method and apparatus for body fluid sampling and analyte sensing
US8251921B2 (en) 2003-06-06 2012-08-28 Sanofi-Aventis Deutschland Gmbh Method and apparatus for body fluid sampling and analyte sensing
US9144401B2 (en) 2003-06-11 2015-09-29 Sanofi-Aventis Deutschland Gmbh Low pain penetrating member
US10034628B2 (en) 2003-06-11 2018-07-31 Sanofi-Aventis Deutschland Gmbh Low pain penetrating member
US8945910B2 (en) 2003-09-29 2015-02-03 Sanofi-Aventis Deutschland Gmbh Method and apparatus for an improved sample capture device
US8282576B2 (en) 2003-09-29 2012-10-09 Sanofi-Aventis Deutschland Gmbh Method and apparatus for an improved sample capture device
US9351680B2 (en) 2003-10-14 2016-05-31 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a variable user interface
US8668656B2 (en) 2003-12-31 2014-03-11 Sanofi-Aventis Deutschland Gmbh Method and apparatus for improving fluidic flow and sample capture
US8296918B2 (en) 2003-12-31 2012-10-30 Sanofi-Aventis Deutschland Gmbh Method of manufacturing a fluid sampling device with improved analyte detecting member configuration
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
US8828203B2 (en) 2004-05-20 2014-09-09 Sanofi-Aventis Deutschland Gmbh Printable hydrogels for biosensors
US9775553B2 (en) 2004-06-03 2017-10-03 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a fluid sampling device
US9820684B2 (en) 2004-06-03 2017-11-21 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a fluid sampling device
US8343074B2 (en) * 2004-06-30 2013-01-01 Lifescan Scotland Limited Fluid handling devices
US8652831B2 (en) 2004-12-30 2014-02-18 Sanofi-Aventis Deutschland Gmbh Method and apparatus for analyte measurement test time
US7822454B1 (en) 2005-01-03 2010-10-26 Pelikan Technologies, Inc. Fluid sampling device with improved analyte detecting member configuration
WO2007131567A1 (en) 2006-05-15 2007-11-22 F. Hoffmann-La Roche Ag Method and device for stimulating a tissue for the subcutaneous administration of active substances
US20090234272A1 (en) * 2006-05-15 2009-09-17 Gilbert Schiltges Infusion set with a massage-hub
US9084848B2 (en) 2006-05-15 2015-07-21 Roche Diagnostics International Ag Infusion set with a massage-hub
WO2007146913A3 (en) * 2006-06-15 2008-12-04 Abbott Diabetes Care Inc Lancets and methods of use
US20080027474A1 (en) * 2006-06-15 2008-01-31 Abbott Diabetes Care Inc. Adjustable Lancing Devices and Methods
US20080077167A1 (en) * 2006-06-15 2008-03-27 Abbott Diabetes Care Inc. Lancing Devices Having Depth Adjustment Assembly
US20080065132A1 (en) * 2006-06-15 2008-03-13 Abbott Diabetes Care Inc. Lancing Devices and Methods
US8016848B2 (en) 2006-06-15 2011-09-13 Abbott Diabetes Care Inc. Lancets and methods of use
US20080082116A1 (en) * 2006-06-15 2008-04-03 Abbott Diabetes Care Inc. Lancing Devices Having Lancet Ejection Assembly
US20080033468A1 (en) * 2006-06-15 2008-02-07 Abbott Diabetes Care Inc. Lancets and Methods of Use
US7955348B2 (en) 2006-06-15 2011-06-07 Abbott Diabetes Care Inc. Lancing devices and methods
US7867244B2 (en) 2006-06-15 2011-01-11 Abbott Diabetes Care Inc. Lancing devices having lancet ejection assembly
US7909842B2 (en) 2006-06-15 2011-03-22 Abbott Diabetes Care Inc. Lancing devices having depth adjustment assembly
US7914547B2 (en) 2006-06-15 2011-03-29 Abbott Diabetes Care Inc. Adjustable lancing devices and methods
US8702624B2 (en) 2006-09-29 2014-04-22 Sanofi-Aventis Deutschland Gmbh Analyte measurement device with a single shot actuator
GB2467244A (en) * 2007-10-12 2010-07-28 Kin Fai Kam Intravenous injection aid
GB2467244B (en) * 2007-10-12 2012-08-08 Kin Fai Kam Intravenous injection aid
WO2009047512A1 (en) * 2007-10-12 2009-04-16 Kin Fai Kam Intravenous injection aid
US20090112122A1 (en) * 2007-10-26 2009-04-30 Min-Chieh Chuang Bleeding apparatus
US9386944B2 (en) 2008-04-11 2016-07-12 Sanofi-Aventis Deutschland Gmbh Method and apparatus for analyte detecting device
US11090443B2 (en) 2008-06-02 2021-08-17 Sta-Med, Llc Needle cover
US10335554B2 (en) 2008-06-02 2019-07-02 Sta-Med, Llc Needle cover
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
US8926644B2 (en) 2009-07-30 2015-01-06 Becton, Dickinson And Company Lancing device having saddle-shaped tip
US8965476B2 (en) 2010-04-16 2015-02-24 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US8469918B2 (en) * 2010-05-24 2013-06-25 Steve FALLEK Method and apparatus for performing injections while vibrating the skin
US20110288471A1 (en) * 2010-05-24 2011-11-24 Fallek Steve Method and apparatus for performing injections while vibrating the skin
US9795747B2 (en) 2010-06-02 2017-10-24 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
US8747355B2 (en) 2010-06-23 2014-06-10 Sta-Med, Llc Automatic-locking safety needle covers and methods of use and manufacture
US10682470B2 (en) 2010-06-23 2020-06-16 Sta-Med, Llc Automatic-locking safety needle covers and methods of use and manufacture
US9694140B2 (en) 2010-06-23 2017-07-04 Sta-Med, Llc Automatic-locking safety needle covers and methods of use and manufacture
US20120065487A1 (en) * 2010-09-07 2012-03-15 Innova Medical Design LLC Systems, methods, and devices for reducing the pain of glucose monitoring and insulin adminstration in diabetic patients
US8663129B2 (en) * 2011-05-31 2014-03-04 Sta-Med, Llc Blood collection safety devices and methods of use and manufacture
US9848810B2 (en) 2011-05-31 2017-12-26 Sta-Med, Llc Blood collection safety devices and methods of use and manufacture
US20120323142A1 (en) * 2011-05-31 2012-12-20 Sta-Med Llc Blood collection safety devices and methods of use and manufacture
US9445760B2 (en) 2011-05-31 2016-09-20 Sta-Med, Llc Blood collection safety devices and methods of use and manufacture
US11116432B2 (en) 2011-05-31 2021-09-14 Sta-Med, Llc Blood collection safety devices and methods of use and manufacture

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