Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
  • A61B10/0045—Devices for taking samples of body liquids
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
  • A61B10/0045—Devices for taking samples of body liquids
  • A61B10/0051—Devices for taking samples of body liquids for taking saliva or sputum samples
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
  • A61B10/0045—Devices for taking samples of body liquids
  • A61B10/007—Devices for taking samples of body liquids for taking urine samples
• • 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
  • A61B5/150236—Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
• • 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
  • A61B5/150244—Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
  • A61B2010/0003—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements including means for analysis by an unskilled person
  • A61B2010/0006—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements including means for analysis by an unskilled person involving a colour change

Definitions

• This disclosure relates to the field of collection and analysis of fluids and, more preferably, the collection of liquids such as urine, saliva or blood.
• the object of the invention is to provide a sample collection device, comprising a support arranged so as to collect and release microbiological liquids, for example blood, the sample collection device further comprising a head, wherein said head is configured to cooperate with a nozzle of an analysis device in such a manner that the cooperation of said head and said nozzle causes the release of microbiological liquid inside the analysis device.
• the sample collection device of this disclosure fills a gap by providing a reliable, easy and cost-effective collection and transfer device.
• This sample collection device makes it possible to collect, by puncturing the skin or otherwise, biological fluids using only one hand and without professional training, which is very advantageous when it is necessary to perform the collection on young children, children, adults, elderly patients and in intensive care, which requires delicate and precise gestures.
• the head of the sample collection device cooperates with the nozzle of the analysis device, by complementarity of shape.
• the sample collection device comprises a piston arranged to move in the support between a first position in which the piston blocks an orifice of the support and a second position in which the piston is spaced from said orifice.
• the head comprises a base head element and a pusher, said pusher being movable between a first position, called upper position, in which the pusher is held so as to rest on an upper stop of the element of head base and a second position, in which the pusher is held so as to rest on a lower stop of the head base element.
• the piston is attached to the head base member of the sample collection device.
• the support is fixed to the pusher.
• the head base element is arranged to receive the nozzle of the blood analysis device.
• the sample collection device includes a capillary tube pressed into one end of a capillary holder.
• the head is arranged so as to move relative to the capillary support.
• the capillary support comprises an end provided with external fins, the head comprising a hollow element intended to receive said end provided with external fins.
• the capillary tube comprises an end in the shape of an arrowhead arranged so as to rest against a constriction of the analysis device.
• the invention also relates to a system comprising a sample collection device according to the invention and an analysis device comprising a nozzle.
• Figure 1 is a view of a sample collection device according to a first embodiment of the invention inserted in an analysis device.
• Figure 2 is a side perspective view of the sample collection device of Figure 1.
• Figure 3 is a longitudinal view of a detail of the sample collection device of Figure 2 in a given position.
• Figure 4 is a longitudinal view of a detail of the sample collection device of Figure 2 in another position.
• Figure 5 is a longitudinal view of a detail of the sample collection device of Figure 2 in yet another position.
• Figure 6 is a side perspective view of the sample collection device according to another embodiment of the present invention, when inserted into the blood analysis bag (only a spout of the analysis device being illustrated).
• Figure 7 is a longitudinal view of the sample collection device of Figure 6.
• Figure 8 is a view of a detail of the sample collection device of Figure 7.
• Figure 9 is a longitudinal view of the sample collection device of Figure 7 in another position.
• Figure 10 is a view of a detail of the sample collection device of Figure 9.
• Figure 11 is a view of a detail of the sample collection device of Figures 7 and 8 during cooperation with a nozzle of the analysis device.
• Figure 12 is a view of a detail of the sample collection device of Figures 9 and 10 during cooperation with the nozzle of the analysis device.
• Figures 1 to 12 represent a sample collection device 1, 100 according to the invention which is configured to collect and transfer a sample of liquid (for example blood) from a puncture site into a chamber of an analysis device 2, which can be a test cartridge or a bag.
• a sample of liquid for example blood
• the analysis device 2 also called analysis bag or test cartridge 2
• the analysis device 2 comprises, in this example, two laminated films in which a fluid circuit 3 has been laser welded.
• the fluid circuit 3 delimits a plurality of communicating chambers 4 into which the liquid sample can flow from an inlet chamber 5 of the analysis device 2.
• the analysis device 2 can be designed in another way such as in the form of a rigid cartridge or the like without departing from the scope of the invention.
• the inlet chamber 5 of the analysis device 2 is provided with a nozzle 6.
• the sample collection device 1, 100 is arranged so as to cooperate with said nozzle 6, as it will be described below.
• the liquid sample is whole blood in this example.
• the sample collection device 1 includes a head 7 and a body 8.
• the head 7 includes a crimped cap 9.
• the body 8 includes a capillary holder 10 and a capillary tube 11 which is pressed into the capillary holder 10.
• the capillary tube 11 may be a standard plastic component designed to hold 30 ⁇ L of blood for example.
• the hair support 10 is preferably a plastic component.
• the capillary holder comprises a body 12 provided with a pencil-shaped gripping portion which extends from a distal end 13 to a proximal end 14. Said gripping portion facilitates manipulations of the sample collection device 1 by an user.
• the capillary support 10 holds the capillary tube 11 in position on its distal end 13.
• the capillary support 10 holds the crimped cap 9 on its proximal end 14.
• the distal end 13 has a point shape arrow where the capillary tube 11 is fixed to act as a stop against a constriction 15 of the inlet chamber 5 when inserted into the cartridge 2.
• the body 12 of the capillary support 10 extends along a longitudinal axis A, the body 12 being cylindrical and having an external diameter decreasing continuously from the proximal end 14 to the distal end 13.
• the proximal end 14 of the capillary support 10 comprises several fins 16 (four in the illustrated embodiment although the invention is not limited to such a number).
• the fins 16 are preferably arranged so as to be diametrically opposed in pairs.
• the fins 16 have an elongated shape and extend mainly parallel to the longitudinal axis A over a length L16. Said length L16 is shorter than a length L14 of the proximal end 14 such that the fins 16 constitute a notched interface of the capillary support 10 relative to the crimped cap 9.
• a length of a cross section of the capillary support 10 where the fins 16 are present is designated by D16, while a length of a cross section of the proximal end 14 beyond the fins 16 is designated by D14, D14 being less than D16.
• the body 12 of the capillary support 10 extends between an external wall 17 and an internal wall 18. As can be seen from Figures 3 to 5, one end 19 of the internal wall 18 is inclined. In other words, the end of body 12 is conical.
• the crimped cap 9 comprises a body 20 provided with a hollow element 21 and a gripping part 22.
• a user manipulates the sample collection device 1 by its part of gripping 22.
• the hollow element 21 defines a cylindrical cavity 23 provided with a central projection 24 which projects from a bottom 25 of the cavity 23.
• the projection 24 is arranged so as to receive the internal wall 18 of the support capillary 10.
• a diameter of the cavity 23 corresponds to the length D16.
• the body 20 of the crimped cap 9 is formed so as to cooperate with the nozzle 6 of the inlet chamber 5.
• the bottom 25 of the hollow element 21 is disc-shaped and comprises an edge 26 which is arranged so as to rest on an edge 27 of a body 28 of the nozzle 6 when the sample collection device 1 is inserted into the cartridge 2.
• the cylindrical hollow element 25 has a first part 29 and a second part 30 which pass through the axis A.
• a shoulder 31 is formed between the parts 29 and 30, an external diameter of the part 30 being less than an external diameter of the part 29.
• the external diameter of the part 29 corresponds to an internal diameter of the nozzle 6 such that the cap 9 can be introduced into the body 28 of the nozzle 6 and rest on this body.
• the cap can slide on the capillary support 10, as described below.
• the sample collection device 1 is inserted into the analysis device 2.
• the user moves the cap 9 forward on the capillary support 10 which is then stationary in this configuration.
• Figure 4 illustrates an intermediate state in which the cap 9 has partially slipped on the fins 16 of the capillary support 10. Since the diameter of the cavity corresponds to the length D16, the pressure increases continuously during the translation of the cap 9 on the capillary support 10 and the blood begins to be expelled (arrow b).
• the sample collection device 1 eliminates the possibility of contamination, before the blood is in the analysis device or after that. Sample collection device 1 does not require qualified healthcare professionals to handle samples.
• the blood sample device 100 comprises a head element 107 and a body 108.
• the body 108 includes a piston support 110 and a piston 111 disposed completely inside the piston support 110.
• the sample collection device 100 is a positive displacement syringe .
• the plunger 111 is arranged to move within the plunger support between a first position in which a pointed end 140 of the plunger 111 plugs a port 141 in the plunger support 110 and a second position in which the tip-shaped end 140 is spaced from the orifice 141.
• the piston 111 constitutes a piston or piston of the sample collection device 100 and is in direct contact with the liquid, c i.e. preferably blood, which is being collected.
• the quantity of liquid sucked depends only on the dimensions of the piston support 110 and the distance of movement of the piston 111 between the first and second positions.
• the piston 111 and the piston support 110 extend along the longitudinal axis A.
• the head 107 comprises a head base element 142 and a pusher 143, the pusher 143 being movable between a first position, called upper position, in which the pusher 143 is held so as to rest on an upper stop 144 of the head base element 142 and a second position, called lower position, in which the pusher 143 is held so as to rest on a lower stop 145 of the head base element 142.
• the piston 111 is attached to the head base member 142, while the piston support 110 is attached to the pusher 143, as will be described in detail below.
• the head base element 142 comprises a cylindrical part 146 and an elongated part 147 provided with three regularly arranged passages for receiving the pusher 143.
• the elongated part 147 extends from the cylindrical part 146 to a conical end 149.
• the pusher 143 comprises three arms 152 extending longitudinally between a first end, called the free end, 153, and a second end 154, called the internal end.
• Each of the three arms 152 includes a notch 155 to cooperate with the nozzle 6 of the inlet chamber 5, as explained in detail below.
• the notch 155 is disposed outside the cylindrical part 146.
• Each of the three arms 152 includes a pin 156 to cooperate with the upper and lower stops 144, 145 of the head base element 142.
• the pin 156 is locally perpendicular to the respective arm 152.
• the piston support 110 is overmolded on the second ends 154 of the pusher 143 so that the pusher 143 and the piston support 110 move together.
• the elongated part 147 of the head base element 142 is overmolded on the piston 111, such that the piston 111 and the part 147 move together.
• the nozzle 6 is illustrated in Figures 6, 11 and 12. It comprises a cylindrical section 57 provided with a circular flange 58 as well as two sides 59 extending from the cylindrical section 57.
• the nozzle comprises a rib 60 arranged with so as to be inserted into the notches 155 of the pusher 143.
• the initial position corresponds to the upper position, in which the pusher 143 protrudes from the head base member 142 ( Figures 7 and 8 ).
• the piston 111 and the piston support 110 are in the sealed position, that is to say the piston 111 blocks the orifice 141 of the piston support 110.
• a user pushes the free ends 153 from the upper position to the lower position, which pulls the piston 111 away from the port 141. Blood is then drawn into the piston holder 110.
• the sample collection device 100 is inserted into the inlet chamber 5 until the flange 58 contacts the pins 56.
• the flange 58 pushes the pins 156 which slide to the upper position, and the piston 111 moves to the orifice 141 of the piston support 110, which expels blood from the sample collection device 100 to the inlet chamber 5.
• the sample collection device 100 ensures the collection and release of a precise quantity of blood, without air between the tip of the piston 111 and the piston holder 110. Furthermore, it is not sensitive to the viscosity of the fluid.
• the sample collection device 100 can be operated with only one hand, making it simple and reliable to use.
• sample collection device 1, 100 of Figures 1 to 12 includes a hydrophobic filter to improve ease of use as well as security in particular in a context of derogation from the amendments relating to the Clinical Laboratory Improvement (CLIA).
• CLIA Clinical Laboratory Improvement
• the sample collection device is easy to use thanks to the interactions between the nozzle of the cartridge and the head of the sample collection device. Additionally, the amount of blood that is sampled and released is precise, ensuring highly reliable analysis results.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Engineering & Computer Science (AREA)
• Medical Informatics (AREA)
• Surgery (AREA)
• Hematology (AREA)
• Veterinary Medicine (AREA)
• Pathology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Public Health (AREA)
• Molecular Biology (AREA)
• General Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Physics & Mathematics (AREA)
• Manufacturing & Machinery (AREA)
• Biophysics (AREA)
• Pulmonology (AREA)
• Sampling And Sample Adjustment (AREA)
• Investigating Or Analysing Biological Materials (AREA)
• Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
• Apparatus Associated With Microorganisms And Enzymes (AREA)

Applications Claiming Priority (2)

Publications (1)

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ID=86099782

Family Applications (1)

Country Status (6)

Family Cites Families (5)

• 2022
  • 2022-12-19 FR FR2213743A patent/FR3143323A1/fr active Pending
• 2023
  • 2023-12-18 CN CN202380081082.4A patent/CN120265209A/zh active Pending
  • 2023-12-18 KR KR1020257023536A patent/KR20250126050A/ko active Pending
  • 2023-12-18 JP JP2025534673A patent/JP2025539604A/ja active Pending
  • 2023-12-18 WO PCT/FR2023/000189 patent/WO2024134036A1/fr not_active Ceased
  • 2023-12-18 EP EP23841601.0A patent/EP4637571A1/de active Pending

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