US20210121110A1 - Sampling assembly - Google Patents
Sampling assembly Download PDFInfo
- Publication number
- US20210121110A1 US20210121110A1 US17/142,041 US202117142041A US2021121110A1 US 20210121110 A1 US20210121110 A1 US 20210121110A1 US 202117142041 A US202117142041 A US 202117142041A US 2021121110 A1 US2021121110 A1 US 2021121110A1
- Authority
- US
- United States
- Prior art keywords
- collector
- assembly
- fluid
- forms
- collection
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000005070 sampling Methods 0.000 title claims abstract description 20
- 239000012530 fluid Substances 0.000 claims abstract description 97
- 238000012360 testing method Methods 0.000 claims abstract description 63
- 210000001124 body fluid Anatomy 0.000 claims abstract description 61
- 230000009471 action Effects 0.000 claims description 16
- 238000009423 ventilation Methods 0.000 claims description 13
- 230000007246 mechanism Effects 0.000 claims description 2
- 239000012528 membrane Substances 0.000 abstract description 57
- 230000035515 penetration Effects 0.000 abstract description 28
- 230000000149 penetrating effect Effects 0.000 abstract description 27
- 239000008280 blood Substances 0.000 description 19
- 210000004369 blood Anatomy 0.000 description 19
- 230000000717 retained effect Effects 0.000 description 15
- 239000000126 substance Substances 0.000 description 9
- 239000000243 solution Substances 0.000 description 7
- 239000000872 buffer Substances 0.000 description 6
- 230000001105 regulatory effect Effects 0.000 description 5
- 239000003085 diluting agent Substances 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 230000015572 biosynthetic process Effects 0.000 description 3
- 238000003745 diagnosis Methods 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 241001465754 Metazoa Species 0.000 description 2
- 230000004520 agglutination Effects 0.000 description 2
- 239000003153 chemical reaction reagent Substances 0.000 description 2
- 230000006835 compression Effects 0.000 description 2
- 238000007906 compression Methods 0.000 description 2
- 238000002405 diagnostic procedure Methods 0.000 description 2
- 238000012125 lateral flow test Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 239000007790 solid phase Substances 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 1
- 230000004913 activation Effects 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 239000012503 blood component Substances 0.000 description 1
- 244000078885 bloodborne pathogen Species 0.000 description 1
- 239000007853 buffer solution Substances 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 238000002716 delivery method Methods 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 238000002032 lab-on-a-chip Methods 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 230000037368 penetrate the skin Effects 0.000 description 1
- 239000011505 plaster Substances 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 238000004393 prognosis Methods 0.000 description 1
- 239000000376 reactant Substances 0.000 description 1
- 238000002791 soaking Methods 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 238000013519 translation Methods 0.000 description 1
- 238000009736 wetting Methods 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150503—Single-ended needles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/150022—Source of blood for capillary blood or interstitial fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150213—Venting means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150358—Strips for collecting blood, e.g. absorbent
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
- A61B5/150541—Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
- A61B5/150549—Protectors removed by rotational movement, e.g. torsion or screwing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
- A61B5/15058—Joining techniques used for protective means
- A61B5/150618—Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
- A61B5/150694—Procedure for removing protection means at the time of piercing
- A61B5/150717—Procedure for removing protection means at the time of piercing manually removed
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15103—Piercing procedure
- A61B5/15107—Piercing being assisted by a triggering mechanism
- A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
- A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
- A61B5/15188—Constructional features of reusable driving devices
- A61B5/1519—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for propelling the piercing unit
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
- A61B5/15188—Constructional features of reusable driving devices
- A61B5/15192—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
- A61B5/15194—Constructional 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150343—Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
- A61B5/150419—Pointed piercing elements, e.g. needles, lancets for piercing the skin comprising means for capillary action
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
- A61B5/150541—Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
- A61B5/150664—Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
Definitions
- the present invention relates generally to devices and methods for sampling and handling of bodily fluids and performing diagnostics in respect of the bodily fluids.
- a fluid sample drawn from a patient is analyzed for the presence of a blood-borne pathogen.
- a blood sample can be used to determine the presence or absence of healthy levels of specific blood components.
- Blood samples are also screened for molecular diagnostics to provide diagnosis, classification, detection, monitoring, prognosis or other molecular inference.
- Samples taken from a patient, animal or organism may be obtained by penetrating the skin of the user using a piercing, slicing, puncturing, pricking, or cutting element such as a lancet device.
- a lancet device typically includes a body and a lancet. The body is typically adapted to be held by the user, the lancet being coupled to the body and being adapted to pierce the skin of the patient so as to draw blood therefrom. In some lancet devices, the lancet extends from the body at all times.
- the lancet is adapted to be moved, when actuated, from a retracted position in which the lancet tip is disposed within the body to an extended position in which the lancet tip extends beyond the body.
- the movement of the lancet from its retracted position to its extended position is effected with a force that means contact of the moving lancet tip with the skin of a patient results in the penetration of the skin of the patient.
- the lancet is automatically drawn back into the body after reaching its extended position in order to minimize the risk of inadvertent lancet sticks.
- the blood After the skin, typically of a finger or heel, is penetrated by the lancet, the blood must be expressed from the user and retained for delivery to a test element.
- an assembly for sampling bodily fluid comprising a membrane penetration device comprising a membrane penetrating element for penetrating a bodily membrane to release a bodily fluid; and, a collector configured in a collection position to take up the released bodily fluid and retain the fluid for delivery to a test element.
- the collector is configured to take up the released bodily fluid by capillary action.
- a collector for taking up and retaining a bodily fluid, the collector configured to be engaged with a membrane penetration device including a membrane penetrating element for penetrating a bodily membrane to release a bodily fluid, the collector adapted in a collection position to take up the released fluid and retain the fluid for delivery to a test element.
- the collector is configured to take up the released bodily fluid by capillary action.
- the collector is configured to take up fluid through a pressure differential.
- the collector is configured to take up the released bodily fluid by suction.
- the collector is configured to take up the released bodily fluid through application of a force.
- FIG. 1 is a perspective view of one embodiment of an assembly
- FIG. 2 is a side view of the assembly of FIG. 1 ;
- FIG. 3 is a cross-sectional view of the assembly of FIG. 1 ;
- FIG. 4 is a detail cross-sectional view of the assembly of FIG. 1 ;
- FIG. 5 is a detail cross-sectional view of a second embodiment of the assembly
- FIG. 6 is a side view of the assembly of FIG. 1 ;
- FIG. 7 is a cross-sectional view of the assembly of FIG. 1 ;
- FIG. 8 is a side view of the assembly of FIG. 1 ;
- FIG. 9 is a cross-sectional view of the assembly of FIG. 1 ;
- FIG. 10 is a cross-sectional view of a third embodiment of an assembly
- FIG. 11 is a cross-sectional view of the assembly of FIG. 10 ;
- FIG. 12 is a side view of a fourth embodiment of an assembly
- FIG. 13 is a side view of the assembly of FIG. 12 ;
- FIG. 14 is a side view of the assembly of FIG. 12 ;
- FIG. 15 is a side view of the assembly of FIG. 12 ;
- FIG. 16 is a cross section view of a collector of one embodiment of the assembly.
- FIG. 17 is a side view of the collector of FIG. 16 ;
- FIG. 18 is a perspective view of the collector of FIG. 16 ;
- FIG. 19 is an end view of the collector of FIG. 16 ;
- FIG. 20 is a cross-sectional view of a fifth embodiment of an assembly
- FIG. 21 is a cross-sectional view of the assembly of FIG. 20 ;
- FIG. 22 is a cut away perspective view of the assembly of FIG. 20 ;
- FIG. 23 is a cut away perspective view of the assembly of FIG. 20 ;
- FIG. 24 is a cut away perspective view of the assembly of FIG. 20 ;
- FIG. 25 is a cross-sectional view of the assembly of FIG. 20 ;
- FIG. 26 is a cross-sectional view of the assembly of FIG. 20 ;
- FIG. 27 is a perspective view of a second embodiment of the collector.
- FIG. 28 is a perspective view of a sixth embodiment of an assembly
- FIG. 29 is a perspective view of the assembly of FIG. 28 ;
- FIG. 30 is a perspective view of the assembly of FIG. 28 ;
- FIG. 31 is a side view of a seventh embodiment of an assembly
- FIG. 32 is a cross-sectional view of the assembly of FIG. 31 ;
- FIG. 33 is a cross-sectional view of the assembly of FIG. 31 ;
- FIG. 34 is a perspective view of an eighth embodiment of the assembly.
- FIG. 35 is a perspective view of the assembly of FIG. 34 ;
- FIG. 36 is a perspective view of the assembly of FIG. 34 ;
- FIG. 37 is a cut away perspective view of a ninth embodiment of an assembly
- FIG. 38 is a cut away perspective view of the assembly of FIG. 37
- FIG. 39 is a lateral cross-sectional view of a tenth embodiment of the assembly.
- FIG. 40 is a cut away perspective view of the assembly of FIG. 39 ;
- FIG. 41 is a top view of an eleventh embodiment of an assembly
- FIG. 42 is a bottom view of the assembly of FIG. 41 ;
- FIG. 43 is a bottom view of the assembly of FIG. 41 with fluid collection element extended;
- FIG. 44 is a top isometric view of the assembly of FIG. 41 ;
- FIG. 45 is a bottom isometric view of the assembly of FIG. 41 .
- This disclosure is directed generally to an assembly for sampling bodily fluids. While the assembly has been frequently described with reference to a lancet, it will be clear to a person skilled in the art that alternatives are available.
- an assembly for sampling bodily fluid comprising a membrane penetration device comprising a membrane penetrating element for penetrating a bodily membrane to release a bodily fluid; and, a collector configured in a collection position to take up the released bodily fluid and retain the fluid for delivery to a test element.
- the collector is configured to take up the released bodily fluid by capillary action. In some forms the collector is configured to take up fluid through a pressure differential. In some forms the collector is configured to take up the released bodily fluid by suction. In some forms the collector is configured to take up the released bodily fluid through application of a force.
- the collector comprises a body defining a cavity configured to generate capillary action.
- the collector includes a capillary channel.
- the capillary channel is a closed channel. In some forms the capillary channel is an open channel.
- the collector comprises a tube.
- the tube extends between an collection opening and a release opening and is tapered toward the collection opening.
- the assembly includes a housing which houses the membrane penetration device and the tube is angled with respect to the housing.
- the collector comprises two substantially parallel plates.
- the collector is moveably engaged with the body
- the collector is pivotably engaged with the body
- the assembly includes a test element and the collector is moveable between the collection position and a delivery position in which the retained fluid is releasable so as to contact the test element.
- the fluid in contact with the test element and the collector.
- the collector comprises at least one opening which, in the delivery position, is in contact with the test element.
- the opening is proximal to the test element.
- the assembly comprises a housing and the membrane penetrating element is actuatable to adopt an actuated position in which the membrane penetrating element extends beyond the housing.
- the membrane penetrating element is configured to adopt a retracted position in which the membrane penetrating element is located within the housing after actuation.
- the collector is inhibited from moving into the delivery position until the membrane penetrating element is actuated.
- the collector includes a ventilation aperture.
- the collector comprises a tube extending between two openings and a ventilation aperture is positioned intermediate the openings.
- the ventilation aperture comprises a slot extending between the openings.
- the collector is configured to take up a predetermined volume of fluid.
- the predetermined volume of fluid is regulated by a dimensional characteristic of the collector.
- the collector includes an interior cavity and the predetermined volume of fluid is regulated by the size and shape of the cavity.
- the collector includes at least one opening for uptake of the fluid and wherein the opening is adapted to facilitate fluid uptake.
- the internal surface of the collector is raked toward the opening.
- the collector includes an internal cavity and the internal diameter of the cavity increases toward the opening.
- the collector comprises at least one collection opening for uptake of the released fluid, the assembly further comprising a cover configured to cover the opening.
- the collector is moveable between the collection position and a delivery position and the cover blocks the collection opening in the delivery position.
- the rate of movement of the collector between the collection position and the delivery position is controlled.
- a collector for taking up and retaining a bodily fluid, the collector configured to be engaged with a membrane penetration device including a membrane penetrating element for penetrating a bodily membrane to release a bodily fluid, the collector adapted in a collection position to take up the released fluid and retain the fluid for delivery to a test element.
- the collector is configured to take up the released bodily fluid by capillary action.
- the collector comprises a body defining a cavity configured to generate capillary action.
- the collector includes a capillary channel.
- the collector is configured to take up a predetermined volume of fluid.
- the predetermined volume of fluid is regulated by a dimensional characteristic of the collector.
- the collector includes an interior cavity and the predetermined volume of fluid is regulated by the size and shape of the cavity.
- an assembly for sampling bodily fluid comprising a membrane penetration device comprising a membrane penetrating element for penetrating a bodily membrane to release a bodily fluid; and, a collector configured to take up and retain the released bodily fluid until moved into a delivery position in which the fluid is releasable for delivery to a test element.
- an assembly comprising a membrane penetration device comprising a membrane penetrating element for penetrating a bodily membrane to release a bodily fluid; and, a collector configured in a collection position to take up the released bodily fluid and deliver the fluid to a test element.
- the collector is configured to take up the fluid by capillary action.
- the collector comprises a tube.
- the collector extends between an collection opening and a discharge opening and wherein a ventilation aperture is positioned intermediate the collection opening and the discharge opening.
- the ventilation aperture comprises a slot extending between the collection opening and the discharge opening.
- an assembly for sampling a bodily fluid comprising a membrane penetration device comprising a membrane penetrating element for penetrating a membrane to release a bodily fluid; and, a retainer adapted to retain a collector adapted for taking up the released bodily fluid.
- the retainer comprises a cavity extending into the body.
- the retainer comprises a clip engaged with the body.
- the retainer comprises a pivotable engagement.
- the retainer is adapted to allow a collector to be retained in a position that is accessible for use.
- the retainer is adapted to allow a collector to be retained with respect to the assembly such that the collector is moveable between a retained position and an operative position.
- the retainer is adapted to allow the removal of the collector from the retainer.
- the collector is a capillary tube.
- the collector is a pipette.
- the collector is a reservoir.
- the collector comprises a loop for collecting fluid.
- the assembly further comprises a collector configured to take up bodily fluid and retain it for delivery to a test element, the collector being engaged with the retainer.
- the collector is a capillary tube.
- the collector is removably engaged with the retainer.
- the collector is moveable between a retained position and an operative position. In some forms the collector is pivotable between a retained position and an operative position.
- the collector is adapted to contain a substance.
- the substance may be a buffer, a reagent or a physiologically acceptable solution. In some forms the substance may be a fluid. In some forms the substance may be effective to react with the bodily fluid.
- the collector comprises a reservoir for containing a substance.
- an assembly for sampling bodily fluid comprising a membrane penetration device comprising a membrane penetrating element for penetrating a bodily membrane to release a bodily fluid; and, a collector configured to adopt a collection position to take up the released bodily fluid and a delivery position to deliver the fluid to a test element.
- the collector is configured to move between the collection position and the delivery position.
- the movement of the collector between the collection position and the delivery position comprises pivoting.
- the movement of the collector between the collection position and the delivery position comprises sliding.
- the movement of the collector between the collection position and the delivery position comprises translation.
- the movement of the collector between the collection position and the delivery position comprises a combination of two or more of pivoting, rotating, sliding or translating.
- the collector in contact with the test element.
- the assembly is configured such that movement of the collector between the collection position and the delivery position is controlled.
- the assembly is configured such that movement of the collector between the collection configuration and the delivery configuration is achieved manually.
- the movement is controlled by means of resistance fit.
- test element is located within the assembly such that in the delivery position the test element gives under pressure placed on the test element by the collector.
- the membrane is skin and the bodily fluid is blood.
- the assembly allows a user to sample a bodily fluid from a penetration site and have the fluid taken up into a collector for delivery to a test element.
- the test element may be integrated into the assembly or may be a separate device or system.
- the volume of fluid taken up can be quantified or regulated through a dimensional characteristic of the collector such as the internal geometry of a channel or cavity extending therethrough.
- the assembly limits the formation of bubbles in the collector through use of a ventilation aperture.
- the assembly restricts a user from adding additional fluid to the test element during or after discharge.
- the assembly allows simple and even one-handed sampling of a bodily fluid.
- the assembly 1 generally comprises a housing 3 which extends from a penetration end 4 and houses a membrane penetration device 5 incorporating a membrane penetrating element 6 .
- the membrane penetrating element 6 is in the form of a lancet 7 adapted to be positioned within the housing 3 prior to actuation of the membrane penetration device 5 .
- the membrane penetration device is actuated by contact with actuator 8 which releases the lancet such that the lancet extends beyond the housing 3 and can be utilized to penetrate a bodily membrane such as skin to release a bodily fluid such as blood. After actuation in the illustrated form the lancet retracts back into the housing to protect a user from further sticks.
- the housing 3 further houses a test element 9 .
- the test element 9 comprises a test strip incorporated into the housing 3 and accessible through delivery window 10 however it will be clear to a person skilled in the art that alternative test elements are available to provide a diagnostic, including but not limited to lateral flow test strips, vertical flow test strips, agglutination, solid-phase technologies, microfludics and lab on a chip technologies.
- the housing further comprises a test results window 12 which allows a user to view the results of a test.
- a collector 14 is engaged with the housing 3 .
- the collector 14 is engaged by means of at least one engagement arm 15 which engages the housing 3 at engagement point 16 .
- the engagement arms 15 are rotatable about an axis centered on engagement point 16 .
- Rotation of engagement arms 15 moves the collector 14 with respect to the body 3 .
- the collector 14 comprises a capillary tube 17 extending between a collection opening 18 and a discharge opening 19 .
- a channel 21 extends through the capillary tube 17 and is adapted to generate capillary action and take up fluid into the collector 14 .
- the collector 14 is moveable by rotation of engagement arms 15 from a collection position as shown in FIGS. 1 through 7 to a delivery position as shown in FIGS. 8 and 9 .
- the collector In the collection position the collector extends at an angle with respect to the housing 3 to allow for easy access to the collection opening 18 .
- the discharge opening 19 of the collector 14 In this position the discharge opening 19 of the collector 14 is spaced apart from the test element 9 situated behind delivery window 10 .
- the capillary tube 16 is tapered toward the collection opening 18 .
- the tip of the capillary tube presents a small cross-sectional area. This limits the fluid that is in contact with the capillary tube body rather than the internal cavity and promotes movement of fluid into the collector 14 rather than on the surface.
- the internal surface of the capillary tube is raked toward the collection opening 18 as shown in FIG. 5 . These features facilitate the uptake of fluid into the collector.
- the collector is sized and shaped to allow a predetermined volume of fluid to be taken up into the capillary tube.
- the internal geometry including diameter and length of the channel 21 regulates the volume of fluid taken up into the collector 14 .
- an indicator can be located on the collector to allow a user to determine the volume of fluid held within the collector 14 .
- the discharge opening 19 of the collector 14 contacts the test element 9 to allow release of the fluid retained within the channel 21 in the capillary tube 16 . Fluid is released through wicking away from the point of contact between the collector 14 and the test element 9 .
- a user positions a bodily membrane at the penetration end 4 of the housing and actuates the membrane penetration device 5 such that the lancet 7 pierces the bodily membrane and is retracted again into the housing 3 .
- the user then positions the finger at the collection opening 18 of the collector and bodily fluid is taken up into the collector 14 by capillary action.
- the discharge opening 19 contacts the test element 9 and fluid retained within the collector by capillary action is released onto the test element.
- the collector 14 still in the form of a capillary tube 16 , is moveable between the collection position shown in FIG. 10 and the delivery position shown in FIG. 11 through sliding the collector 14 longitudinally into contact with the test element 9 .
- the user allows fluid uptake into the collector then slides the collector 14 into contact with the test element to allow release of the retained fluid onto the test element.
- the collector 14 is in the form of a capillary plate 30 which comprises two substantially parallel plates 31 defining a channel or cavity 32 therebetween.
- the collector 14 in the form of the capillary plate 30 is shown best in FIGS. 17 through 19 which disclose parallel plates 31 defining a cavity 32 therebetween which is sized and shaped to generate capillary action.
- a user positions a pierced membrane on collection opening 38 and allows bodily fluid to be taken up into the cavity 32 .
- a ventilation aperture 34 is positioned facing the opening 38 to limit the formation of air bubbles in the cavity as well as reducing problems in the subsequent delivery or release of the fluid due to air entrapment.
- the user then rotates the capillary plate 30 into the delivery position as shown in FIGS. 14 and 15 . In the delivery position the discharge opening 39 contacts the test element (not illustrated in these Figs) allowing release of the fluid onto the test element.
- the collector is again in the form of a capillary tube 16 .
- the capillary tube includes a ventilation aperture 40 .
- the ventilation aperture 40 is in the form of a longitudinally extending slit 41 which extends between the collection opening 18 and the discharge opening 19 .
- the ventilation aperture 40 allows for release of air while the bodily fluid is taken up into the capillary tube 16 . This limits the formation of bubbles within the collector 14 which allows for more accurate volume of fluid to be retained in the collector 14 .
- the collector 14 and engagement arms 15 are independently shown in FIG. 27 which shows the collector 14 engaged with the engagement arms 15 .
- the engagement arms 15 extend from the collector 14 to engagement points 16 at which the engagement arms are pivotally connected with the housing 3 of the assembly 1 by means, in the illustrated form, of flange 17 and hinge pin 45 which engage the housing 3 such that the flange 17 abuts an internal shoulder or wall in the housing 3 .
- the engagement arms 15 define a curved U or C shape which meets at the collector 14 .
- FIGS. 19 through 24 show forms in which the collector 14 is moveable between the collection position and the delivery position only after actuation of the membrane penetration device.
- locking mechanism 50 which comprises a locking plate 51 which blocks movement of flange 17 about its axis.
- the flange 17 includes a flat surface 52 which abuts against locking plate 51 when the locking plate 51 is in a locking position.
- Actuation of the membrane penetration device 5 to release membrane penetration element 6 effects movement of the locking plate 51 away from the penetration end 4 of the housing 3 and into an unlocked position. This moves the locking plate 51 out of abutment with the flange 17 and allows rotation of the flange 17 about its axis which effects rotation of the collector 14 into the delivery position.
- FIGS. 25 and 26 show forms of the assembly in which the movement of the collector into the delivery position is controlled by means of a cantilever effect in order to minimize spillage and protect the test element 9 .
- the housing includes a slot on either side of the test element 9 to allow for flexion in the engagement arms 15 to take up the force of movement of the collector 14 .
- the assembly 1 further includes a flexion element 65 positioned beneath the test element 9 to allow for flexion of the test element 9 and limit compression of the test element. This allows the collector 14 to stop softly at the test element 9 . Compression of the test element can result in the fluid not wicking away from the contact point between the collector 14 and the test element 9 which reduces the accuracy and effectiveness of the assembly. Further, an abrupt stop of the collector 14 against the test element 9 can result in spillage or flicking of the fluid. This feature in some forms has the advantage of soaking up tolerances in the assembly.
- FIGS. 28 through 30 show an assembly 1 where the collector 14 in the form of a capillary tube 16 is prevented from rotating into the discharge position.
- this prevention is by means of a manual locking plate 60 which is manually slideable between a locking position in which it prevents the collector 14 and engagement arms 15 from rotating as shown in FIG. 28 to a position more distal from the penetration end 4 of the housing 3 which allows rotation of the collector 14 and engagement arms 15 as shown in FIGS. 29 and 30 .
- FIGS. 31 through 33 show an assembly 1 in which the collection opening 18 of the capillary tube 16 is moveable into a closed position when delivery of the fluid occurs.
- the collector 14 In the delivery position as shown in FIG. 33 , the collector 14 is located beneath a raised cover 70 which is spaced apart from the delivery window 10 such that when the collector 14 is moved into the delivery position the cover 70 blocks access to the collection opening 18 . This effectively blocks a user from maintaining the membrane on the collector and allowing excess fluid to be taken up by the collector.
- a delivery cover 90 is shown.
- the delivery cover 90 is moveable between a closed position as shown in FIG. 34 in which the cover 90 blocks access to the delivery window 10 and an open position as shown in FIG. 36 .
- rotation of the engagement arms 15 effects movement of the delivery cover 90 to allow the collector 14 to contact the test element 9 through the delivery window 10 .
- movement is actuated by the user by, for example, sliding, unclipping, moving or rotating the cover.
- the movement of the collector into the delivery position is coupled with the movement of a delivery cover in order to encourage the correct sequence of steps for a user. In some forms the movement of the collector into the delivery position is coupled with the movement of a collector cover, similarly in order to encourage the correct step sequence.
- movement of the collector 14 by means of the engagement arms 15 between the collection position and the delivery position is slowed or smoothed through generating a resistance fit between the outer surface 81 of flange 17 and the housing 3 at abutment surface 80 .
- friction between the flange 17 and abutment surface 80 of the housing 3 is utilized to control rotation of the engagement arms limiting the likelihood of spillage of the fluid and reducing the force of the collector 14 on the test element 9 .
- the sampling assembly allows a user to collect a bodily fluid from the site of membrane penetration without additional steps such as finding a collection device or container and expressing the fluid onto the device.
- the fluid collection element allows for easy and safe fluid collection from the piercing site. In some forms the simplicity is increased by allowing a user to prepare the site and removing the necessity of finding an alcohol wipe and a drying or cleansing wipe for treatment afterwards. This significantly simplifies the process of collecting blood either for a health care professional or for a home user.
- the assembly allows a user to collect a bodily fluid with a fluid collection element such as a capillary tube, pipette, reservoir or looped wand and deposit it at a collection point where it and a physiologically acceptable solution are brought into contact with a test material.
- a fluid collection element such as a capillary tube, pipette, reservoir or looped wand and deposit it at a collection point where it and a physiologically acceptable solution are brought into contact with a test material.
- the fluid collection element is integrated and positioned for convenient sample collection near the blood collection site.
- the fluid collection element is moveable between a retained position and an operative position.
- the fluid collection element is moveable between an operative position for collection of a bodily fluid and a delivery position for delivery of the fluid sample to a diagnostic device.
- a user obtains a sterile wipe from the composite system, cleans a penetration site, activates the piercing element to penetrate the user's skin, before or after moving the fluid collection element into an operative position.
- the user will ordinarily wipe away a first drop of blood using a wipe then position the fluid collection element to collect the bodily fluid released from the penetration site.
- the user then, if necessary, positions the fluid collection element to release the bodily fluid onto a collection window.
- the user then actuates a buffer or diluent delivery to carry the fluid across a test or diagnostic strip.
- the sampling assembly displays a result of the diagnostic test.
- delivery onto the test element is by means of dropping, squeezing, spraying or other alternative delivery methods that may or may not include contact with the test element.
- the collector comprises a pipette including a bulb which is squeezed to deliver the fluid to the test element.
- the collector is adapted to contain a substance such as a diluent, a buffer, a reagent, a physiologically acceptable solution, a reactant or other solutions, powders, fluids or substances appropriate for an aspect of the process of testing a bodily fluid.
- the collector comprises a reservoir for containing a substance.
- the reservoir can receive substances either prior or post uptake of the sample.
- the collector includes one opening which acts as collection opening and discharge opening. In some forms the collector also include a ventilation aperture.
- an assembly 101 for collecting and handling a sample of a bodily fluid In an embodiment as shown in FIG. 41 through 45 , disclosed is an assembly 101 for collecting and handling a sample of a bodily fluid.
- the assembly 101 is described with reference to collecting and handling blood samples, though a person skilled in the art will be aware that other bodily fluids may be collected using the assembly.
- the assembly 101 comprises a body 102 comprising a membrane piercing element (not illustrated) which extends from a membrane piercing point 104 to allow a user to pierce skin or another membrane.
- the membrane piercing element comprises a lancet such as a needle or blade or other sharp which disposed prior to use within the body 102 .
- the lancet is moveable from a housed position in which the lancet is substantially disposed within the body 102 . In this position the lancet is protected by the body 102 . This position is shown in the Figures.
- the lancet is moveable to an extended position (not illustrated) in which the lancet extends at least partly from the body 102 . In this position the tip of the lancet is positioned outside the body 102 such that a user can prick, pierce, cut or otherwise penetrate the skin with the lancet.
- the movement of the lancet from the housed position to the extended position is performed with sufficient force to pierce the skin of a user such that if the body 102 is positioned against the skin of the user and movement of the lancet between the housed and the extended position is actuated the skin will be pierced by the lancet.
- the sampling assembly 101 further comprises a collector retainer 107 which is disposed within the body 102 .
- the collector retainer 107 is composed of a cavity extending into the body 102 however a person skilled in the art will be aware that other configurations will allow for retention of a fluid collection element such as a capillary tube, pipette, reservoir or looped wand.
- a fluid collection element such as a capillary tube, pipette, reservoir or looped wand.
- a clip, sheath or hinge can be utilised as the fluid collection element retainer.
- a hinge could be utilised.
- a fluid collection element in the form of a capillary tube 108 is removably positioned within the fluid collection element retainer 107 .
- the capillary tube 108 is configured to allow capillary action and is composed of any material allowing sufficient wetting of the capillary interior for capillary action of a bodily fluid to take place.
- a person skilled in the art will be aware that alternative embodiments not utilizing capillary action will be available.
- a user removes the capillary tube 108 from the retainer 107 before or after locating the piercing membrane point against the skin at the site where the blood is to be sampled.
- the user actuates the device such that the lancet moves from the housed position to the extended position, piercing the skin and allowing blood to be expressed.
- the lancet then returns automatically to the housed position.
- Activation of the device between the housed position and the extended position occurs through depression of the membrane piercing point 104 into the body by the user's finger although a person skilled in the field will be aware that a separate actuation button or lever may be utilised.
- a particular amount of blood can be stored by the tube 108 depending upon the length of the tube, making the device suitable with quantitative diagnostic applications.
- the user then positions the capillary tube over the bodily fluid collection point 112 and bodily fluid, in this case blood, is delivered to the collection point.
- bodily fluid in this case blood
- the fluid collection element is a pipette, a reservoir or a wand having a loop for collection of fluid.
- a person skilled in the art will be aware that other fluid collection elements designed to collect blood from a user and transfer it to the fluid collection point.
- the assembly 101 further comprises a buffer reservoir for holding a physiologically acceptable solution such as a buffer or diluent for supporting the blood or other bodily fluid and aiding in conveying the bodily fluid.
- a solution delivery actuator 113 is positioned on the assembly 101 . Actuation of the solution delivery actuator 113 releases the buffer solution from an internal reservoir and delivers it to a diagnostic device or assay including but not limited to lateral flow test strips, vertical flow test strips or agglutination and solid-phase technologies.
- the diagnostic device further includes a results window 114 which is positioned for easy viewing of the results of any diagnostic test performed.
- the buffer or diluent reservoir and test strip are positioned internally to the device and therefore not illustrated in the Figures.
- a sterile wipe locator 117 and an adhesive plaster locater 118 are positioned on one side of the body 102 to allow for ease of access for a user.
- the fluid collection element is retained by the sampling assembly in a position where the user can contact the penetration site to the fluid collection element after piercing without removing the fluid collection element from the fluid collection element retainer.
- the fluid collection element may be oriented to allow access to the fluid collection element without movement of the fluid collection element.
- the fluid collection element may be oriented to deliver the fluid to the collection point without movement of the fluid collection element.
- the fluid collection element may be moveable between an inoperative and an operative position without removing the fluid collection element from the fluid collection element retainer.
- the fluid collection element may be hingedly retained or in an alternative the fluid collection element may be retained by a cord or biasing means such as a spring.
- the fluid collection element may be associated with a lancet or other penetration device for fluid collection.
- the fluid collection element can then be utilised to collect and transport the fluid for testing and diagnosis at a separate location.
- the membrane penetrating element has been referred to and described in respect of a lancet as illustrated, however persons skilled in the art will be aware that the lancet could be any piercing, slicing, cutting, puncturing or pricking element which allows a user to penetrate a membrane such as the skin to allow a fluid sample to be released.
- capillary action refers to the taking up of a fluid through adhesion of a fluid with a surface of the collector and/or surface tension of that fluid.
Abstract
Description
- This is a continuation of U.S. patent application Ser. No. 13/879,297 filed on Apr. 12, 2013, entitled “SAMPLING ASSEMBLY,” which is a 371 National Stage of International Application No. PCT/AU2011/001321, filed on Oct. 17, 2011, entitled “SAMPLING ASSEMBLY,” which claims priority to International Australian Application No. 2010904615, filed on Oct. 15, 2010, entitled “SAMPLING ASSEMBLY,” the entireties of which are hereby incorporated by reference.
- The present invention relates generally to devices and methods for sampling and handling of bodily fluids and performing diagnostics in respect of the bodily fluids.
- There are many medical conditions in humans and animals for which it is desirable to draw a fluid sample for immediate analysis at the point of sampling. For example, in diagnosis of various diseases, a blood sample drawn from a patient is analyzed for the presence of a blood-borne pathogen. Alternatively a blood sample can be used to determine the presence or absence of healthy levels of specific blood components. Blood samples are also screened for molecular diagnostics to provide diagnosis, classification, detection, monitoring, prognosis or other molecular inference.
- Samples taken from a patient, animal or organism may be obtained by penetrating the skin of the user using a piercing, slicing, puncturing, pricking, or cutting element such as a lancet device. A lancet device typically includes a body and a lancet. The body is typically adapted to be held by the user, the lancet being coupled to the body and being adapted to pierce the skin of the patient so as to draw blood therefrom. In some lancet devices, the lancet extends from the body at all times. In other lancet devices, the lancet is adapted to be moved, when actuated, from a retracted position in which the lancet tip is disposed within the body to an extended position in which the lancet tip extends beyond the body. Typically, the movement of the lancet from its retracted position to its extended position is effected with a force that means contact of the moving lancet tip with the skin of a patient results in the penetration of the skin of the patient. In many such lancet devices having a movable lancet, the lancet is automatically drawn back into the body after reaching its extended position in order to minimize the risk of inadvertent lancet sticks.
- After the skin, typically of a finger or heel, is penetrated by the lancet, the blood must be expressed from the user and retained for delivery to a test element.
- In some forms, disclosed is an assembly for sampling bodily fluid, the assembly comprising a membrane penetration device comprising a membrane penetrating element for penetrating a bodily membrane to release a bodily fluid; and, a collector configured in a collection position to take up the released bodily fluid and retain the fluid for delivery to a test element. In some forms the collector is configured to take up the released bodily fluid by capillary action.
- In some forms disclosed is a collector for taking up and retaining a bodily fluid, the collector configured to be engaged with a membrane penetration device including a membrane penetrating element for penetrating a bodily membrane to release a bodily fluid, the collector adapted in a collection position to take up the released fluid and retain the fluid for delivery to a test element. In some forms the collector is configured to take up the released bodily fluid by capillary action. In some forms the collector is configured to take up fluid through a pressure differential. In some forms the collector is configured to take up the released bodily fluid by suction. In some forms the collector is configured to take up the released bodily fluid through application of a force.
- The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments and features will become apparent by reference to the drawings and the following detailed description.
- A preferred embodiment will now be described by way of example only, with reference to the accompanying drawings in which:
-
FIG. 1 is a perspective view of one embodiment of an assembly; -
FIG. 2 is a side view of the assembly ofFIG. 1 ; -
FIG. 3 is a cross-sectional view of the assembly ofFIG. 1 ; -
FIG. 4 is a detail cross-sectional view of the assembly ofFIG. 1 ; -
FIG. 5 is a detail cross-sectional view of a second embodiment of the assembly; -
FIG. 6 is a side view of the assembly ofFIG. 1 ; -
FIG. 7 is a cross-sectional view of the assembly ofFIG. 1 ; -
FIG. 8 is a side view of the assembly ofFIG. 1 ; -
FIG. 9 is a cross-sectional view of the assembly ofFIG. 1 ; -
FIG. 10 is a cross-sectional view of a third embodiment of an assembly; -
FIG. 11 is a cross-sectional view of the assembly ofFIG. 10 ; -
FIG. 12 is a side view of a fourth embodiment of an assembly; -
FIG. 13 is a side view of the assembly ofFIG. 12 ; -
FIG. 14 is a side view of the assembly ofFIG. 12 ; -
FIG. 15 is a side view of the assembly ofFIG. 12 ; -
FIG. 16 is a cross section view of a collector of one embodiment of the assembly; -
FIG. 17 is a side view of the collector ofFIG. 16 ; -
FIG. 18 is a perspective view of the collector ofFIG. 16 ; -
FIG. 19 is an end view of the collector ofFIG. 16 ; -
FIG. 20 is a cross-sectional view of a fifth embodiment of an assembly; -
FIG. 21 is a cross-sectional view of the assembly ofFIG. 20 ; -
FIG. 22 is a cut away perspective view of the assembly ofFIG. 20 ; -
FIG. 23 is a cut away perspective view of the assembly ofFIG. 20 ; -
FIG. 24 is a cut away perspective view of the assembly ofFIG. 20 ; -
FIG. 25 is a cross-sectional view of the assembly ofFIG. 20 ; -
FIG. 26 is a cross-sectional view of the assembly ofFIG. 20 ; -
FIG. 27 is a perspective view of a second embodiment of the collector; -
FIG. 28 is a perspective view of a sixth embodiment of an assembly; -
FIG. 29 is a perspective view of the assembly ofFIG. 28 ; -
FIG. 30 is a perspective view of the assembly ofFIG. 28 ; -
FIG. 31 is a side view of a seventh embodiment of an assembly; -
FIG. 32 is a cross-sectional view of the assembly ofFIG. 31 ; -
FIG. 33 is a cross-sectional view of the assembly ofFIG. 31 ; -
FIG. 34 is a perspective view of an eighth embodiment of the assembly; -
FIG. 35 is a perspective view of the assembly ofFIG. 34 ; -
FIG. 36 is a perspective view of the assembly ofFIG. 34 ; -
FIG. 37 is a cut away perspective view of a ninth embodiment of an assembly; -
FIG. 38 is a cut away perspective view of the assembly ofFIG. 37 -
FIG. 39 is a lateral cross-sectional view of a tenth embodiment of the assembly; -
FIG. 40 is a cut away perspective view of the assembly ofFIG. 39 ; -
FIG. 41 is a top view of an eleventh embodiment of an assembly; -
FIG. 42 is a bottom view of the assembly ofFIG. 41 ; -
FIG. 43 is a bottom view of the assembly ofFIG. 41 with fluid collection element extended; -
FIG. 44 is a top isometric view of the assembly ofFIG. 41 ; -
FIG. 45 is a bottom isometric view of the assembly ofFIG. 41 . - In the following detailed description, reference is made to accompanying drawings which form a part of the detailed description. The illustrative embodiments described in the detailed description, depicted in the drawings and defined in the claims, are not intended to be limiting. Other embodiments may be utilised and other changes may be made without departing from the spirit or scope of the subject matter presented. It will be readily understood that the aspects of the present disclosure, as generally described herein and illustrated in the drawings can be arranged, substituted, combined, separated and designed in a wide variety of different configurations, all of which are contemplated in this disclosure.
- This disclosure is directed generally to an assembly for sampling bodily fluids. While the assembly has been frequently described with reference to a lancet, it will be clear to a person skilled in the art that alternatives are available.
- In some forms disclosed is an assembly for sampling bodily fluid, the assembly comprising a membrane penetration device comprising a membrane penetrating element for penetrating a bodily membrane to release a bodily fluid; and, a collector configured in a collection position to take up the released bodily fluid and retain the fluid for delivery to a test element.
- In some forms the collector is configured to take up the released bodily fluid by capillary action. In some forms the collector is configured to take up fluid through a pressure differential. In some forms the collector is configured to take up the released bodily fluid by suction. In some forms the collector is configured to take up the released bodily fluid through application of a force.
- In some forms the collector comprises a body defining a cavity configured to generate capillary action.
- In some forms the collector includes a capillary channel. In some forms the capillary channel is a closed channel. In some forms the capillary channel is an open channel.
- In some forms the collector comprises a tube.
- In some forms the tube extends between an collection opening and a release opening and is tapered toward the collection opening.
- In some forms the assembly includes a housing which houses the membrane penetration device and the tube is angled with respect to the housing.
- In some forms the collector comprises two substantially parallel plates.
- In some forms the collector is moveably engaged with the body
- In some forms the collector is pivotably engaged with the body
- In some forms the assembly includes a test element and the collector is moveable between the collection position and a delivery position in which the retained fluid is releasable so as to contact the test element.
- In some forms in the delivery position the fluid is in contact with the test element and the collector.
- In some forms the collector comprises at least one opening which, in the delivery position, is in contact with the test element.
- In some forms the opening is proximal to the test element.
- In some forms the assembly comprises a housing and the membrane penetrating element is actuatable to adopt an actuated position in which the membrane penetrating element extends beyond the housing.
- In some forms the membrane penetrating element is configured to adopt a retracted position in which the membrane penetrating element is located within the housing after actuation.
- In some forms the collector is inhibited from moving into the delivery position until the membrane penetrating element is actuated.
- In some forms the collector includes a ventilation aperture.
- In some forms the collector comprises a tube extending between two openings and a ventilation aperture is positioned intermediate the openings.
- In some forms the ventilation aperture comprises a slot extending between the openings.
- In some forms the collector is configured to take up a predetermined volume of fluid.
- In some forms the predetermined volume of fluid is regulated by a dimensional characteristic of the collector.
- In some forms the collector includes an interior cavity and the predetermined volume of fluid is regulated by the size and shape of the cavity.
- In some forms the collector includes at least one opening for uptake of the fluid and wherein the opening is adapted to facilitate fluid uptake.
- In some forms the internal surface of the collector is raked toward the opening.
- In some forms the collector includes an internal cavity and the internal diameter of the cavity increases toward the opening.
- In some forms the collector comprises at least one collection opening for uptake of the released fluid, the assembly further comprising a cover configured to cover the opening.
- In some forms the collector is moveable between the collection position and a delivery position and the cover blocks the collection opening in the delivery position.
- In some forms the rate of movement of the collector between the collection position and the delivery position is controlled.
- In a second aspect, disclosed is a collector for taking up and retaining a bodily fluid, the collector configured to be engaged with a membrane penetration device including a membrane penetrating element for penetrating a bodily membrane to release a bodily fluid, the collector adapted in a collection position to take up the released fluid and retain the fluid for delivery to a test element.
- In some forms the collector is configured to take up the released bodily fluid by capillary action.
- In some forms the collector comprises a body defining a cavity configured to generate capillary action.
- In some forms the collector includes a capillary channel.
- In some forms the collector is configured to take up a predetermined volume of fluid.
- In some forms the predetermined volume of fluid is regulated by a dimensional characteristic of the collector.
- In some forms the collector includes an interior cavity and the predetermined volume of fluid is regulated by the size and shape of the cavity.
- In a third aspect, disclosed is an assembly for sampling bodily fluid, the assembly comprising a membrane penetration device comprising a membrane penetrating element for penetrating a bodily membrane to release a bodily fluid; and, a collector configured to take up and retain the released bodily fluid until moved into a delivery position in which the fluid is releasable for delivery to a test element.
- In a fourth aspect disclosed is an assembly comprising a membrane penetration device comprising a membrane penetrating element for penetrating a bodily membrane to release a bodily fluid; and, a collector configured in a collection position to take up the released bodily fluid and deliver the fluid to a test element.
- In some forms the collector is configured to take up the fluid by capillary action.
- In some forms the collector comprises a tube.
- In some forms the collector extends between an collection opening and a discharge opening and wherein a ventilation aperture is positioned intermediate the collection opening and the discharge opening.
- In some forms the ventilation aperture comprises a slot extending between the collection opening and the discharge opening.
- In a fifth aspect, disclosed is an assembly for sampling a bodily fluid, the assembly comprising a membrane penetration device comprising a membrane penetrating element for penetrating a membrane to release a bodily fluid; and, a retainer adapted to retain a collector adapted for taking up the released bodily fluid.
- In some forms the retainer comprises a cavity extending into the body.
- In some forms the retainer comprises a clip engaged with the body.
- In some forms the retainer comprises a pivotable engagement.
- In some forms the retainer is adapted to allow a collector to be retained in a position that is accessible for use.
- In some forms the retainer is adapted to allow a collector to be retained with respect to the assembly such that the collector is moveable between a retained position and an operative position.
- In some forms the retainer is adapted to allow the removal of the collector from the retainer.
- In some forms the collector is a capillary tube.
- In some forms the collector is a pipette.
- In some forms the collector is a reservoir.
- In some forms the collector comprises a loop for collecting fluid.
- In some forms the assembly further comprises a collector configured to take up bodily fluid and retain it for delivery to a test element, the collector being engaged with the retainer.
- In some forms the collector is a capillary tube.
- In some forms the collector is removably engaged with the retainer.
- In some forms the collector is moveable between a retained position and an operative position. In some forms the collector is pivotable between a retained position and an operative position.
- In some forms the collector is adapted to contain a substance.
- In some forms the substance may be a buffer, a reagent or a physiologically acceptable solution. In some forms the substance may be a fluid. In some forms the substance may be effective to react with the bodily fluid.
- In some forms the collector comprises a reservoir for containing a substance.
- In a sixth aspect, disclosed is an assembly for sampling bodily fluid, the assembly comprising a membrane penetration device comprising a membrane penetrating element for penetrating a bodily membrane to release a bodily fluid; and, a collector configured to adopt a collection position to take up the released bodily fluid and a delivery position to deliver the fluid to a test element.
- In some forms the collector is configured to move between the collection position and the delivery position.
- In some forms the movement of the collector between the collection position and the delivery position comprises pivoting.
- In some forms the movement of the collector between the collection position and the delivery position comprises sliding.
- In some forms the movement of the collector between the collection position and the delivery position comprises translation.
- In some forms the movement of the collector between the collection position and the delivery position comprises a combination of two or more of pivoting, rotating, sliding or translating.
- In some forms in the delivery position the collector is in contact with the test element.
- In some forms the assembly is configured such that movement of the collector between the collection position and the delivery position is controlled.
- In some forms the assembly is configured such that movement of the collector between the collection configuration and the delivery configuration is achieved manually.
- In some forms the movement is controlled by means of resistance fit.
- In some forms the test element is located within the assembly such that in the delivery position the test element gives under pressure placed on the test element by the collector.
- In some forms the membrane is skin and the bodily fluid is blood.
- In at least some forms the assembly allows a user to sample a bodily fluid from a penetration site and have the fluid taken up into a collector for delivery to a test element. The test element may be integrated into the assembly or may be a separate device or system. In some forms the volume of fluid taken up can be quantified or regulated through a dimensional characteristic of the collector such as the internal geometry of a channel or cavity extending therethrough. In some forms the assembly limits the formation of bubbles in the collector through use of a ventilation aperture. In some forms the assembly restricts a user from adding additional fluid to the test element during or after discharge. In some forms the assembly allows simple and even one-handed sampling of a bodily fluid.
- Referring to the figures, in some forms illustrated in
FIGS. 1 through 9 , disclosed is anassembly 1 for sampling a bodily fluid. Theassembly 1 generally comprises ahousing 3 which extends from apenetration end 4 and houses amembrane penetration device 5 incorporating amembrane penetrating element 6. In the illustrated form themembrane penetrating element 6 is in the form of alancet 7 adapted to be positioned within thehousing 3 prior to actuation of themembrane penetration device 5. The membrane penetration device is actuated by contact withactuator 8 which releases the lancet such that the lancet extends beyond thehousing 3 and can be utilized to penetrate a bodily membrane such as skin to release a bodily fluid such as blood. After actuation in the illustrated form the lancet retracts back into the housing to protect a user from further sticks. - The
housing 3 further houses atest element 9. In the illustrated form thetest element 9 comprises a test strip incorporated into thehousing 3 and accessible throughdelivery window 10 however it will be clear to a person skilled in the art that alternative test elements are available to provide a diagnostic, including but not limited to lateral flow test strips, vertical flow test strips, agglutination, solid-phase technologies, microfludics and lab on a chip technologies. The housing further comprises atest results window 12 which allows a user to view the results of a test. - A
collector 14 is engaged with thehousing 3. In the illustrated form thecollector 14 is engaged by means of at least oneengagement arm 15 which engages thehousing 3 atengagement point 16. Theengagement arms 15 are rotatable about an axis centered onengagement point 16. - Rotation of
engagement arms 15 moves thecollector 14 with respect to thebody 3. - In the illustrated form shown in
FIGS. 1 through 9 , thecollector 14 comprises acapillary tube 17 extending between acollection opening 18 and adischarge opening 19. Achannel 21 extends through thecapillary tube 17 and is adapted to generate capillary action and take up fluid into thecollector 14. - The
collector 14 is moveable by rotation ofengagement arms 15 from a collection position as shown inFIGS. 1 through 7 to a delivery position as shown inFIGS. 8 and 9 . In the collection position the collector extends at an angle with respect to thehousing 3 to allow for easy access to thecollection opening 18. In this position the discharge opening 19 of thecollector 14 is spaced apart from thetest element 9 situated behinddelivery window 10. - As shown best in
FIG. 4 thecapillary tube 16 is tapered toward thecollection opening 18. As a result of the tapering the tip of the capillary tube presents a small cross-sectional area. This limits the fluid that is in contact with the capillary tube body rather than the internal cavity and promotes movement of fluid into thecollector 14 rather than on the surface. In some forms the internal surface of the capillary tube is raked toward thecollection opening 18 as shown inFIG. 5 . These features facilitate the uptake of fluid into the collector. - In the illustrated form the collector is sized and shaped to allow a predetermined volume of fluid to be taken up into the capillary tube. The internal geometry including diameter and length of the
channel 21 regulates the volume of fluid taken up into thecollector 14. Alternatively an indicator can be located on the collector to allow a user to determine the volume of fluid held within thecollector 14. - When the
collector 14 is moved into the delivery position the discharge opening 19 of thecollector 14 contacts thetest element 9 to allow release of the fluid retained within thechannel 21 in thecapillary tube 16. Fluid is released through wicking away from the point of contact between thecollector 14 and thetest element 9. - Thus in use a user positions a bodily membrane at the
penetration end 4 of the housing and actuates themembrane penetration device 5 such that thelancet 7 pierces the bodily membrane and is retracted again into thehousing 3. The user then positions the finger at the collection opening 18 of the collector and bodily fluid is taken up into thecollector 14 by capillary action. - The user then moves the
collector 14 into the delivery position as shown inFIGS. 8 and 9 . In the delivery position the discharge opening 19 contacts thetest element 9 and fluid retained within the collector by capillary action is released onto the test element. - In other forms illustrated in
FIGS. 10 and 11 , thecollector 14, still in the form of acapillary tube 16, is moveable between the collection position shown inFIG. 10 and the delivery position shown inFIG. 11 through sliding thecollector 14 longitudinally into contact with thetest element 9. In this form the user allows fluid uptake into the collector then slides thecollector 14 into contact with the test element to allow release of the retained fluid onto the test element. - In other forms illustrated in
FIGS. 12 through 19 , thecollector 14 is in the form of acapillary plate 30 which comprises two substantiallyparallel plates 31 defining a channel orcavity 32 therebetween. - The
collector 14 in the form of thecapillary plate 30 is shown best inFIGS. 17 through 19 which discloseparallel plates 31 defining acavity 32 therebetween which is sized and shaped to generate capillary action. A user positions a pierced membrane oncollection opening 38 and allows bodily fluid to be taken up into thecavity 32. Aventilation aperture 34 is positioned facing theopening 38 to limit the formation of air bubbles in the cavity as well as reducing problems in the subsequent delivery or release of the fluid due to air entrapment. The user then rotates thecapillary plate 30 into the delivery position as shown inFIGS. 14 and 15 . In the delivery position the discharge opening 39 contacts the test element (not illustrated in these Figs) allowing release of the fluid onto the test element. - In other forms illustrated in
FIGS. 20 through 27 , the collector is again in the form of acapillary tube 16. In this form the capillary tube includes aventilation aperture 40. In the illustrated form theventilation aperture 40 is in the form of a longitudinally extending slit 41 which extends between thecollection opening 18 and thedischarge opening 19. Theventilation aperture 40 allows for release of air while the bodily fluid is taken up into thecapillary tube 16. This limits the formation of bubbles within thecollector 14 which allows for more accurate volume of fluid to be retained in thecollector 14. - The
collector 14 andengagement arms 15 are independently shown inFIG. 27 which shows thecollector 14 engaged with theengagement arms 15. Theengagement arms 15 extend from thecollector 14 toengagement points 16 at which the engagement arms are pivotally connected with thehousing 3 of theassembly 1 by means, in the illustrated form, offlange 17 andhinge pin 45 which engage thehousing 3 such that theflange 17 abuts an internal shoulder or wall in thehousing 3. Theengagement arms 15 define a curved U or C shape which meets at thecollector 14. -
FIGS. 19 through 24 show forms in which thecollector 14 is moveable between the collection position and the delivery position only after actuation of the membrane penetration device. In the illustrated forms rotation of thecollector 14 into the discharge position is prevented by lockingmechanism 50 which comprises a lockingplate 51 which blocks movement offlange 17 about its axis. Theflange 17 includes a flat surface 52 which abuts against lockingplate 51 when the lockingplate 51 is in a locking position. Actuation of themembrane penetration device 5 to releasemembrane penetration element 6 effects movement of the lockingplate 51 away from thepenetration end 4 of thehousing 3 and into an unlocked position. This moves the lockingplate 51 out of abutment with theflange 17 and allows rotation of theflange 17 about its axis which effects rotation of thecollector 14 into the delivery position. -
FIGS. 25 and 26 show forms of the assembly in which the movement of the collector into the delivery position is controlled by means of a cantilever effect in order to minimize spillage and protect thetest element 9. In the illustrated form the housing includes a slot on either side of thetest element 9 to allow for flexion in theengagement arms 15 to take up the force of movement of thecollector 14. Theassembly 1 further includes aflexion element 65 positioned beneath thetest element 9 to allow for flexion of thetest element 9 and limit compression of the test element. This allows thecollector 14 to stop softly at thetest element 9. Compression of the test element can result in the fluid not wicking away from the contact point between thecollector 14 and thetest element 9 which reduces the accuracy and effectiveness of the assembly. Further, an abrupt stop of thecollector 14 against thetest element 9 can result in spillage or flicking of the fluid. This feature in some forms has the advantage of soaking up tolerances in the assembly. -
FIGS. 28 through 30 show anassembly 1 where thecollector 14 in the form of acapillary tube 16 is prevented from rotating into the discharge position. In the illustrated form this prevention is by means of amanual locking plate 60 which is manually slideable between a locking position in which it prevents thecollector 14 andengagement arms 15 from rotating as shown inFIG. 28 to a position more distal from thepenetration end 4 of thehousing 3 which allows rotation of thecollector 14 andengagement arms 15 as shown inFIGS. 29 and 30 . -
FIGS. 31 through 33 show anassembly 1 in which the collection opening 18 of thecapillary tube 16 is moveable into a closed position when delivery of the fluid occurs. In the delivery position as shown inFIG. 33 , thecollector 14 is located beneath a raisedcover 70 which is spaced apart from thedelivery window 10 such that when thecollector 14 is moved into the delivery position thecover 70 blocks access to thecollection opening 18. This effectively blocks a user from maintaining the membrane on the collector and allowing excess fluid to be taken up by the collector. - In some forms as illustrated in
FIGS. 34-36 , adelivery cover 90 is shown. Thedelivery cover 90 is moveable between a closed position as shown inFIG. 34 in which thecover 90 blocks access to thedelivery window 10 and an open position as shown inFIG. 36 . In the illustrated form rotation of theengagement arms 15 effects movement of thedelivery cover 90 to allow thecollector 14 to contact thetest element 9 through thedelivery window 10. In not illustrated forms movement is actuated by the user by, for example, sliding, unclipping, moving or rotating the cover. - In some forms the movement of the collector into the delivery position is coupled with the movement of a delivery cover in order to encourage the correct sequence of steps for a user. In some forms the movement of the collector into the delivery position is coupled with the movement of a collector cover, similarly in order to encourage the correct step sequence.
- In some forms as shown in
FIGS. 37 through 40 , movement of thecollector 14 by means of theengagement arms 15 between the collection position and the delivery position is slowed or smoothed through generating a resistance fit between theouter surface 81 offlange 17 and thehousing 3 at abutment surface 80. Thus friction between theflange 17 and abutment surface 80 of thehousing 3 is utilized to control rotation of the engagement arms limiting the likelihood of spillage of the fluid and reducing the force of thecollector 14 on thetest element 9. - In at least one form the sampling assembly allows a user to collect a bodily fluid from the site of membrane penetration without additional steps such as finding a collection device or container and expressing the fluid onto the device. The fluid collection element allows for easy and safe fluid collection from the piercing site. In some forms the simplicity is increased by allowing a user to prepare the site and removing the necessity of finding an alcohol wipe and a drying or cleansing wipe for treatment afterwards. This significantly simplifies the process of collecting blood either for a health care professional or for a home user. In at least another form, the assembly allows a user to collect a bodily fluid with a fluid collection element such as a capillary tube, pipette, reservoir or looped wand and deposit it at a collection point where it and a physiologically acceptable solution are brought into contact with a test material. In one form the fluid collection element is integrated and positioned for convenient sample collection near the blood collection site. In another form the fluid collection element is moveable between a retained position and an operative position. In one form the fluid collection element is moveable between an operative position for collection of a bodily fluid and a delivery position for delivery of the fluid sample to a diagnostic device.
- In use in one form a user obtains a sterile wipe from the composite system, cleans a penetration site, activates the piercing element to penetrate the user's skin, before or after moving the fluid collection element into an operative position. The user will ordinarily wipe away a first drop of blood using a wipe then position the fluid collection element to collect the bodily fluid released from the penetration site. The user then, if necessary, positions the fluid collection element to release the bodily fluid onto a collection window. The user then actuates a buffer or diluent delivery to carry the fluid across a test or diagnostic strip. The sampling assembly then displays a result of the diagnostic test.
- In not illustrated forms, delivery onto the test element is by means of dropping, squeezing, spraying or other alternative delivery methods that may or may not include contact with the test element. For example, in some forms the collector comprises a pipette including a bulb which is squeezed to deliver the fluid to the test element.
- In some not illustrated forms the collector is adapted to contain a substance such as a diluent, a buffer, a reagent, a physiologically acceptable solution, a reactant or other solutions, powders, fluids or substances appropriate for an aspect of the process of testing a bodily fluid. In some not illustrated forms the collector comprises a reservoir for containing a substance.
- In some not illustrated forms, the reservoir can receive substances either prior or post uptake of the sample.
- In some not illustrated forms, the collector includes one opening which acts as collection opening and discharge opening. In some forms the collector also include a ventilation aperture.
- In an embodiment as shown in
FIG. 41 through 45 , disclosed is anassembly 101 for collecting and handling a sample of a bodily fluid. Theassembly 101 is described with reference to collecting and handling blood samples, though a person skilled in the art will be aware that other bodily fluids may be collected using the assembly. - The
assembly 101 comprises abody 102 comprising a membrane piercing element (not illustrated) which extends from amembrane piercing point 104 to allow a user to pierce skin or another membrane. The membrane piercing element comprises a lancet such as a needle or blade or other sharp which disposed prior to use within thebody 102. The lancet is moveable from a housed position in which the lancet is substantially disposed within thebody 102. In this position the lancet is protected by thebody 102. This position is shown in the Figures. The lancet is moveable to an extended position (not illustrated) in which the lancet extends at least partly from thebody 102. In this position the tip of the lancet is positioned outside thebody 102 such that a user can prick, pierce, cut or otherwise penetrate the skin with the lancet. - The movement of the lancet from the housed position to the extended position is performed with sufficient force to pierce the skin of a user such that if the
body 102 is positioned against the skin of the user and movement of the lancet between the housed and the extended position is actuated the skin will be pierced by the lancet. - The
sampling assembly 101 further comprises acollector retainer 107 which is disposed within thebody 102. Thecollector retainer 107 is composed of a cavity extending into thebody 102 however a person skilled in the art will be aware that other configurations will allow for retention of a fluid collection element such as a capillary tube, pipette, reservoir or looped wand. For example, a clip, sheath or hinge can be utilised as the fluid collection element retainer. Alternatively a hinge could be utilised. - A fluid collection element in the form of a
capillary tube 108 is removably positioned within the fluidcollection element retainer 107. Thecapillary tube 108 is configured to allow capillary action and is composed of any material allowing sufficient wetting of the capillary interior for capillary action of a bodily fluid to take place. However a person skilled in the art will be aware that alternative embodiments not utilizing capillary action will be available. - In use, a user removes the
capillary tube 108 from theretainer 107 before or after locating the piercing membrane point against the skin at the site where the blood is to be sampled. The user actuates the device such that the lancet moves from the housed position to the extended position, piercing the skin and allowing blood to be expressed. The lancet then returns automatically to the housed position. - Activation of the device between the housed position and the extended position occurs through depression of the
membrane piercing point 104 into the body by the user's finger although a person skilled in the field will be aware that a separate actuation button or lever may be utilised. - The user then utilizes the
capillary tube 108 and positions it such that blood which is expressed from the piercing is taken up by thetube 108 merely by contacting the blood with thetube 8. A particular amount of blood can be stored by thetube 108 depending upon the length of the tube, making the device suitable with quantitative diagnostic applications. - The user then positions the capillary tube over the bodily
fluid collection point 112 and bodily fluid, in this case blood, is delivered to the collection point. - In not illustrated forms the fluid collection element is a pipette, a reservoir or a wand having a loop for collection of fluid. A person skilled in the art will be aware that other fluid collection elements designed to collect blood from a user and transfer it to the fluid collection point.
- The
assembly 101 further comprises a buffer reservoir for holding a physiologically acceptable solution such as a buffer or diluent for supporting the blood or other bodily fluid and aiding in conveying the bodily fluid. Asolution delivery actuator 113 is positioned on theassembly 101. Actuation of thesolution delivery actuator 113 releases the buffer solution from an internal reservoir and delivers it to a diagnostic device or assay including but not limited to lateral flow test strips, vertical flow test strips or agglutination and solid-phase technologies. - The diagnostic device further includes a
results window 114 which is positioned for easy viewing of the results of any diagnostic test performed. - The buffer or diluent reservoir and test strip are positioned internally to the device and therefore not illustrated in the Figures.
- A sterile wipe
locator 117 and anadhesive plaster locater 118 are positioned on one side of thebody 102 to allow for ease of access for a user. - In not illustrated embodiments, the fluid collection element is retained by the sampling assembly in a position where the user can contact the penetration site to the fluid collection element after piercing without removing the fluid collection element from the fluid collection element retainer. For example, the fluid collection element may be oriented to allow access to the fluid collection element without movement of the fluid collection element. The fluid collection element may be oriented to deliver the fluid to the collection point without movement of the fluid collection element.
- Alternatively the fluid collection element may be moveable between an inoperative and an operative position without removing the fluid collection element from the fluid collection element retainer. In one example the fluid collection element may be hingedly retained or in an alternative the fluid collection element may be retained by a cord or biasing means such as a spring.
- In a further not illustrated embodiment, the fluid collection element may be associated with a lancet or other penetration device for fluid collection. The fluid collection element can then be utilised to collect and transport the fluid for testing and diagnosis at a separate location.
- Throughout the detailed description, the membrane penetrating element has been referred to and described in respect of a lancet as illustrated, however persons skilled in the art will be aware that the lancet could be any piercing, slicing, cutting, puncturing or pricking element which allows a user to penetrate a membrane such as the skin to allow a fluid sample to be released.
- Throughout the detailed description reference to capillary action is used to refer to the taking up of a fluid through adhesion of a fluid with a surface of the collector and/or surface tension of that fluid.
- In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word “comprise” or variations such as “comprises” or “comprising” is used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.
- Variations and modifications may be made to the parts previously described without departing from the spirit or ambit of the invention.
Claims (11)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US17/142,041 US20210121110A1 (en) | 2010-10-15 | 2021-01-05 | Sampling assembly |
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU2010904615 | 2010-10-15 | ||
AU2010904615A AU2010904615A0 (en) | 2010-10-15 | Diagnostic and Sampling System | |
US201113879297A | 2011-10-17 | 2011-10-17 | |
PCT/AU2011/001321 WO2012048388A1 (en) | 2010-10-15 | 2011-10-17 | Sampling assembly |
US14/180,751 US10881342B2 (en) | 2010-10-15 | 2014-02-14 | Sampling assembly |
US17/142,041 US20210121110A1 (en) | 2010-10-15 | 2021-01-05 | Sampling assembly |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/180,751 Continuation US10881342B2 (en) | 2010-10-15 | 2014-02-14 | Sampling assembly |
Publications (1)
Publication Number | Publication Date |
---|---|
US20210121110A1 true US20210121110A1 (en) | 2021-04-29 |
Family
ID=45937782
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/180,751 Active 2034-02-13 US10881342B2 (en) | 2010-10-15 | 2014-02-14 | Sampling assembly |
US17/142,041 Pending US20210121110A1 (en) | 2010-10-15 | 2021-01-05 | Sampling assembly |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/180,751 Active 2034-02-13 US10881342B2 (en) | 2010-10-15 | 2014-02-14 | Sampling assembly |
Country Status (16)
Country | Link |
---|---|
US (2) | US10881342B2 (en) |
EP (1) | EP2627255B1 (en) |
KR (1) | KR101914025B1 (en) |
CN (1) | CN103260516B (en) |
AU (1) | AU2011316495B2 (en) |
BR (1) | BR112013008903B1 (en) |
CA (1) | CA2814423C (en) |
EA (1) | EA024511B1 (en) |
ES (1) | ES2574405T3 (en) |
HU (1) | HUE028577T2 (en) |
MY (1) | MY166817A (en) |
PL (1) | PL2627255T3 (en) |
PT (1) | PT2627255T (en) |
SG (1) | SG189404A1 (en) |
WO (1) | WO2012048388A1 (en) |
ZA (1) | ZA201303044B (en) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11877848B2 (en) | 2021-11-08 | 2024-01-23 | Satio, Inc. | Dermal patch for collecting a physiological sample |
US11964121B2 (en) | 2021-10-13 | 2024-04-23 | Satio, Inc. | Mono dose dermal patch for pharmaceutical delivery |
Families Citing this family (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7702350B2 (en) | 2002-12-06 | 2010-04-20 | Qualcomm Incorporated | Fast converging power control for wireless communication systems |
EP2777499B1 (en) * | 2013-03-15 | 2015-09-16 | Ortho-Clinical Diagnostics Inc | Rotatable fluid sample collection device |
WO2015020609A1 (en) * | 2013-08-07 | 2015-02-12 | Chee Yen Lim | A blood extraction system for extracting and collecting capillary whole blood |
WO2015075677A1 (en) | 2013-11-21 | 2015-05-28 | Atomo Diagnostics Pty Limited | Fluid control in integrated testing devices |
EP3754011B1 (en) | 2015-09-09 | 2022-02-16 | Drawbridge Health, Inc. | Devices for sample collection, stabilization and preservation |
CN106236112A (en) * | 2016-08-23 | 2016-12-21 | 天津华鸿科技股份有限公司 | Blood sampling collection from heel device |
EP3538452B1 (en) * | 2016-11-11 | 2022-05-11 | Atomo Diagnostics Limited | Integrated fluid module and test device |
JP1754773S (en) | 2017-01-10 | 2023-10-06 | sample collection equipment | |
BR112020007269A2 (en) * | 2017-10-12 | 2020-10-27 | Atomo Diagnostics Pty Limited | integrated test unit |
KR20210129120A (en) * | 2019-02-14 | 2021-10-27 | 벡톤 디킨슨 앤드 컴퍼니 | Capillary collector with rotatable connection |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5298224A (en) * | 1988-01-14 | 1994-03-29 | Novo Nordisk A/S | Apparatus for determination of the coagulation time of a blood sample |
US20030012694A1 (en) * | 2001-03-15 | 2003-01-16 | Bernd Roesicke | System for the analysis of biological liquids |
Family Cites Families (44)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS5127839B1 (en) | 1970-09-17 | 1976-08-14 | ||
US4661319A (en) * | 1984-04-06 | 1987-04-28 | Boehringer Mannheim Diagnostics, Inc. | Blood transfer assembly |
US4787398A (en) | 1985-04-08 | 1988-11-29 | Garid, Inc. | Glucose medical monitoring system |
US4627445A (en) | 1985-04-08 | 1986-12-09 | Garid, Inc. | Glucose medical monitoring system |
US5096669A (en) | 1988-09-15 | 1992-03-17 | I-Stat Corporation | Disposable sensing device for real time fluid analysis |
US5249584A (en) | 1990-05-18 | 1993-10-05 | Karkar Maurice N | Syringe for hematocrit and oxygen saturation blood analyzer |
EP1579814A3 (en) | 1996-05-17 | 2006-06-14 | Roche Diagnostics Operations, Inc. | Methods and apparatus for sampling and analyzing body fluid |
US5879311A (en) * | 1996-05-17 | 1999-03-09 | Mercury Diagnostics, Inc. | Body fluid sampling device and methods of use |
US5714390A (en) | 1996-10-15 | 1998-02-03 | Bio-Tech Imaging, Inc. | Cartridge test system for the collection and testing of blood in a single step |
US9155496B2 (en) | 1997-03-04 | 2015-10-13 | Dexcom, Inc. | Low oxygen in vivo analyte sensor |
US6319209B1 (en) * | 1999-08-23 | 2001-11-20 | European Institute Of Science | Disposable test vial with sample delivery device for dispensing sample into a reagent |
US6264619B1 (en) | 1999-09-01 | 2001-07-24 | Becton, Dickinson And Company | Kit for drawing a blood sample |
JP3985022B2 (en) * | 1999-11-08 | 2007-10-03 | アークレイ株式会社 | Body fluid measuring device and insertion body used by being inserted into the body fluid measuring device |
GB2365526B (en) | 2000-07-31 | 2003-12-03 | Cambridge Life Sciences | Assay apparatus for measuring the amount of an analyte in a biological or environmental sample |
KR100893275B1 (en) | 2001-03-29 | 2009-04-17 | 라이프스캔 스코트랜드 리미티드 | Integrated sample testing meter |
US6833111B2 (en) | 2001-04-13 | 2004-12-21 | Varian, Inc. | Multiple analyte assaying device with a multiple sample introduction system |
US20030013121A1 (en) | 2001-07-12 | 2003-01-16 | Khan Waheed N. | Diagnostic test kit |
US20030028125A1 (en) * | 2001-08-06 | 2003-02-06 | Yuzhakov Vadim V. | Physiological sample collection devices and methods of using the same |
US6634243B1 (en) * | 2002-01-14 | 2003-10-21 | Rapid Medical Diagnostics Corporation | Sample testing device |
US8858434B2 (en) | 2004-07-13 | 2014-10-14 | Dexcom, Inc. | Transcutaneous analyte sensor |
NZ526334A (en) * | 2002-06-25 | 2003-10-31 | Bayer Healthcare Llc | Sensor with integrated lancet for monitoring blood by colorometric or electrochemical test method |
US20040176704A1 (en) | 2003-03-04 | 2004-09-09 | Stevens Timothy A | Collection device adapted to accept cartridge for point of care system |
US8275437B2 (en) | 2003-08-01 | 2012-09-25 | Dexcom, Inc. | Transcutaneous analyte sensor |
US7351213B2 (en) * | 2004-04-15 | 2008-04-01 | Roche Diagnostics Operation, Inc. | Integrated spot monitoring device with fluid sensor |
US7766845B2 (en) * | 2004-06-21 | 2010-08-03 | Roche Diagnostics Operations, Inc. | Disposable lancet and lancing cap combination for increased hygiene |
US7645241B2 (en) * | 2004-09-09 | 2010-01-12 | Roche Diagnostics Operations, Inc. | Device for sampling bodily fluids |
US7488298B2 (en) * | 2004-10-08 | 2009-02-10 | Roche Diagnostics Operations, Inc. | Integrated lancing test strip with capillary transfer sheet |
EP1654985A1 (en) * | 2004-11-09 | 2006-05-10 | F. Hoffmann-La Roche Ag | Sampling device for sample liquid |
US20060127886A1 (en) | 2004-12-15 | 2006-06-15 | Kaylor Rosann M | Sample-efficient lateral flow immunoassay |
US20070100213A1 (en) | 2005-10-27 | 2007-05-03 | Dossas Vasilios D | Emergency medical diagnosis and communications device |
EP1800751A1 (en) | 2005-11-30 | 2007-06-27 | The Jordanian Pharmaceutical Manufacturing Co. | Lateral-flow test device for liquid samples |
CN101500476A (en) | 2006-07-06 | 2009-08-05 | 雷比德克斯有限公司 | Intergrated blood sampling and testing device and method of use thereof |
JP5247714B2 (en) | 2006-11-09 | 2013-07-24 | ジー−センス エルテーデー. | System and method for almost continuously measuring the concentration of metabolites in the mammalian body |
US7938786B2 (en) | 2006-12-13 | 2011-05-10 | Devicor Medical Products, Inc. | Vacuum timing algorithm for biopsy device |
EP1938756A1 (en) | 2006-12-29 | 2008-07-02 | Qiagen GmbH | Method and materials for triggered release of a biological sample |
WO2008085052A2 (en) | 2007-01-11 | 2008-07-17 | Arnoldus Huibert Klapwijk | Testing device |
EP1970006A1 (en) * | 2007-03-14 | 2008-09-17 | Roche Diagnostics GmbH | Analysis system for determining a analyte in a body fluid and disposable integrated sample extraction and analysis element |
US7591791B2 (en) | 2007-06-21 | 2009-09-22 | Inverness Medical Switzerland Gmbh | Diagnostic thimble |
GB0714351D0 (en) | 2007-07-24 | 2007-09-05 | Home Office | A Sampling device |
ATE488179T1 (en) | 2007-10-12 | 2010-12-15 | Hoffmann La Roche | TEST BAND DEVICE FOR EXAMINING BODY FLUID |
DE102007062441A1 (en) | 2007-12-20 | 2009-06-25 | Aj Innuscreen Gmbh | Mobile rapid test system for nucleic acid analysis |
WO2009147680A2 (en) | 2008-06-05 | 2009-12-10 | G-Sense Ltd. | Systems and methods for implementing rapid response monitoring of blood concentration of a metabolite |
WO2010043271A1 (en) | 2008-10-17 | 2010-04-22 | Universite Libre De Bruxelles | Device, kit and method for pulsing biological samples with an agent and stabilising the sample so pulsed |
WO2011053796A2 (en) | 2009-10-30 | 2011-05-05 | Seventh Sense Biosystems, Inc. | Systems and methods for treating, sanitizing, and/or shielding the skin or devices applied to the skin |
-
2011
- 2011-10-17 MY MYPI2013700572A patent/MY166817A/en unknown
- 2011-10-17 AU AU2011316495A patent/AU2011316495B2/en active Active
- 2011-10-17 KR KR1020137009385A patent/KR101914025B1/en active IP Right Grant
- 2011-10-17 PL PL11831862.5T patent/PL2627255T3/en unknown
- 2011-10-17 ES ES11831862.5T patent/ES2574405T3/en active Active
- 2011-10-17 HU HUE11831862A patent/HUE028577T2/en unknown
- 2011-10-17 CN CN201180049529.7A patent/CN103260516B/en active Active
- 2011-10-17 CA CA2814423A patent/CA2814423C/en active Active
- 2011-10-17 SG SG2013028063A patent/SG189404A1/en unknown
- 2011-10-17 WO PCT/AU2011/001321 patent/WO2012048388A1/en active Application Filing
- 2011-10-17 BR BR112013008903-2A patent/BR112013008903B1/en active IP Right Grant
- 2011-10-17 EA EA201391370A patent/EA024511B1/en not_active IP Right Cessation
- 2011-10-17 PT PT118318625T patent/PT2627255T/en unknown
- 2011-10-17 EP EP11831862.5A patent/EP2627255B1/en active Active
-
2013
- 2013-04-25 ZA ZA2013/03044A patent/ZA201303044B/en unknown
-
2014
- 2014-02-14 US US14/180,751 patent/US10881342B2/en active Active
-
2021
- 2021-01-05 US US17/142,041 patent/US20210121110A1/en active Pending
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5298224A (en) * | 1988-01-14 | 1994-03-29 | Novo Nordisk A/S | Apparatus for determination of the coagulation time of a blood sample |
US20030012694A1 (en) * | 2001-03-15 | 2003-01-16 | Bernd Roesicke | System for the analysis of biological liquids |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11964121B2 (en) | 2021-10-13 | 2024-04-23 | Satio, Inc. | Mono dose dermal patch for pharmaceutical delivery |
US11877848B2 (en) | 2021-11-08 | 2024-01-23 | Satio, Inc. | Dermal patch for collecting a physiological sample |
Also Published As
Publication number | Publication date |
---|---|
CA2814423A1 (en) | 2012-04-19 |
EP2627255A4 (en) | 2014-06-04 |
BR112013008903B1 (en) | 2021-07-06 |
EA201391370A1 (en) | 2014-03-31 |
EP2627255A1 (en) | 2013-08-21 |
SG189404A1 (en) | 2013-05-31 |
WO2012048388A1 (en) | 2012-04-19 |
HUE028577T2 (en) | 2016-12-28 |
EP2627255B1 (en) | 2016-04-06 |
MY166817A (en) | 2018-07-23 |
CN103260516B (en) | 2017-05-03 |
BR112013008903A2 (en) | 2016-06-28 |
ES2574405T3 (en) | 2016-06-17 |
AU2011316495B2 (en) | 2014-06-12 |
EA024511B1 (en) | 2016-09-30 |
KR20140012616A (en) | 2014-02-03 |
US20140236044A1 (en) | 2014-08-21 |
ZA201303044B (en) | 2015-03-25 |
CN103260516A (en) | 2013-08-21 |
PT2627255T (en) | 2016-07-13 |
US10881342B2 (en) | 2021-01-05 |
AU2011316495A1 (en) | 2012-08-16 |
CA2814423C (en) | 2019-01-15 |
PL2627255T3 (en) | 2016-10-31 |
KR101914025B1 (en) | 2018-11-01 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US20210121110A1 (en) | Sampling assembly | |
US8628724B2 (en) | Integrated needle and test strip with aspiration apparatus and method of use | |
AU2006202930B2 (en) | Device for shielding a sharp tip of a cannula and method of using the same | |
US9408569B2 (en) | Vascular blood sampling catheter | |
US7766845B2 (en) | Disposable lancet and lancing cap combination for increased hygiene | |
EP1854408B1 (en) | In-situ adapter for an analyte testing device | |
US20090112125A1 (en) | Integrated blood sampling and testing device and method of use thereof | |
EP2547259B3 (en) | Diagnostic system | |
JP2009503542A (en) | Method and apparatus for collecting and diluting liquid samples | |
US20120165697A1 (en) | Sample collecting device | |
KR20110096147A (en) | A lancing device | |
US20230301566A1 (en) | Device, method, and system for collection of blood | |
IL196366A (en) | Integrated blood sampling and testing device and method of use thereof | |
CA2929002A1 (en) | Intravenous blood sampling catheter |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
STPP | Information on status: patent application and granting procedure in general |
Free format text: APPLICATION DISPATCHED FROM PREEXAM, NOT YET DOCKETED |
|
AS | Assignment |
Owner name: ATOMO DIAGNOSTICS PTY LIMITED, AUSTRALIA Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:KELLY, JOHN;SOKOLOV, RICHARD;JOHNSON, IAN FREDRICK;AND OTHERS;SIGNING DATES FROM 20130913 TO 20131206;REEL/FRAME:057264/0310 |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: DOCKETED NEW CASE - READY FOR EXAMINATION |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: NON FINAL ACTION MAILED |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: DOCKETED NEW CASE - READY FOR EXAMINATION |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: NON FINAL ACTION MAILED |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: RESPONSE TO NON-FINAL OFFICE ACTION ENTERED AND FORWARDED TO EXAMINER |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: FINAL REJECTION MAILED |
|
STPP | Information on status: patent application and granting procedure in general |
Free format text: DOCKETED NEW CASE - READY FOR EXAMINATION |