WO2023135038A1 - Secure blood sampler on extracorporeal circuit - Google Patents

Secure blood sampler on extracorporeal circuit Download PDF

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Publication number
WO2023135038A1
WO2023135038A1 PCT/EP2023/050070 EP2023050070W WO2023135038A1 WO 2023135038 A1 WO2023135038 A1 WO 2023135038A1 EP 2023050070 W EP2023050070 W EP 2023050070W WO 2023135038 A1 WO2023135038 A1 WO 2023135038A1
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WO
WIPO (PCT)
Prior art keywords
needle
support
septum
reservoir
sampling
Prior art date
Application number
PCT/EP2023/050070
Other languages
French (fr)
Inventor
Angeline PENA PRADO
Original Assignee
Pena Prado Angeline
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Pena Prado Angeline filed Critical Pena Prado Angeline
Publication of WO2023135038A1 publication Critical patent/WO2023135038A1/en

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/02Burettes; Pipettes
    • B01L3/021Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/150022Source of blood for capillary blood or interstitial fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/15003Source of blood for venous or arterial blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150236Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150244Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150389Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • A61B5/150396Specific tip design, e.g. for improved penetration characteristics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150503Single-ended needles
    • A61B5/150519Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/15058Joining techniques used for protective means
    • A61B5/150618Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150633Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
    • A61B5/150641Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves comprising means to impede repositioning of protection sleeve from covering to uncovering position
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150748Having means for aiding positioning of the piercing device at a location where the body is to be pierced
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150992Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15103Piercing procedure
    • A61B5/15107Piercing being assisted by a triggering mechanism
    • A61B5/15113Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/367Circuit parts not covered by the preceding subgroups of group A61M1/3621
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150259Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150358Strips for collecting blood, e.g. absorbent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3607Regulation parameters
    • A61M1/3609Physical characteristics of the blood, e.g. haematocrit, urea
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/06Auxiliary integrated devices, integrated components
    • B01L2300/069Absorbents; Gels to retain a fluid
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/08Geometry, shape and general structure
    • B01L2300/0809Geometry, shape and general structure rectangular shaped
    • B01L2300/0825Test strips
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00Moving or stopping fluids
    • B01L2400/04Moving fluids with specific forces or mechanical means
    • B01L2400/0475Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
    • B01L2400/0478Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure pistons

Definitions

  • the present invention relates to a medical device and its use in vitro in the examination of samples of fluids from the human body, in particular blood samples.
  • the present invention falls within the medical field of taking samples of bodily fluids, in particular blood samples.
  • the invention will find a preferential, but in no way limiting, application in the in vitro measurement and quantification of a compound present in said sample taken, such as the blood sugar level.
  • patent document WC03/020134 discloses a device and a method for sampling a bodily fluid by sampling by absorption.
  • the incision stylet more particularly described comprises a hollow longitudinal body, of generally cylindrical shape, forming a casing, inside which is positioned in particular an incision member in the form of a solid needle mounted inside a channel in the form of a capillary tube, channel which allows the transfer of fluid, in particular migration by capillarity, to an opening made in said body.
  • This document thus aims at a superficial sampling, directly in external contact with the skin, the support of the solid needle serving only as a support for the needle, with a space for receiving the fluid sampled on the side of said needle, which does not communicate not with the tank.
  • patent document WO99/55232 is known, which relates to a device for sucking and pumping a sample of bodily fluid from an incision, in the form of a stylet provided with a solid needle, to incise the skin at the surface, in order to to bring out a sample of body fluid.
  • the needle mounted on a movable support is slidable by means of a piston actuated from the opposite end, from an inactive position to an active position protruding inside a housing provided within the distal end , with an elastic return by springs to the inactive position and allows pumping, via a trigger connected to a piston, to expel more fluid from the incision once made.
  • the invention is preferentially aimed at taking samples from a septum.
  • a septum can be present on an extracorporeal circuit, or connected to another medical system, such as for example a urinary catheter.
  • septum corresponds to a self-sealing membrane, generally made of silicone material, hermetically separating and preserving from the outside atmosphere, the interior of a circuit connected to the human body. , especially to its vascular system.
  • the material and thickness of such a septum allow it to be pierced by a needle, and above all to retain its hermetic character once the needle is removed.
  • Such a septum can be mounted along an extracorporeal circuit in the form of sheaths, or else directly at one end of a catheter.
  • the blood sample, of several milliliters, from an extracorporeal circuit is carried out by a carer by means of a needle mounted on a syringe.
  • a needle mounted on a syringe may be a transfer trocar, commonly referred to as a "pink trocar” (because of its distinctive color differentiating the use for sampling, compared to other colors intended for injection), or even “ trocar G18” (with regard to the dimensions of its gauge, i.e. the unit expressing the external diameter of a medical device).
  • a transfer trocar commonly referred to as a "pink trocar” (because of its distinctive color differentiating the use for sampling, compared to other colors intended for injection)
  • trocar G18 with regard to the dimensions of its gauge, i.e. the unit expressing the external diameter of a medical device.
  • It can also be an “orange” needle, also referred to as a “G25 needle”.
  • the caregiver deposits a droplet of blood on a suitable support, such as a blood glucose test strip intended to be analyzed in vitro by a dedicated device.
  • a suitable support such as a blood glucose test strip intended to be analyzed in vitro by a dedicated device.
  • This medical gesture therefore presents a manifest lack of safety for the carer, without ensuring the asepsis of such a medical gesture with any certainty.
  • the quantity of blood taken is much greater than the real needs for the measurements and quantifications envisaged, namely a single drop of blood of the order of 1/20 ml.
  • the object of the invention is to overcome the drawbacks of the state of the art by proposing a device for taking a sample from a septum.
  • a sampling device is intended to be able to ensure safety avoiding any risk of involuntary puncture and septic contamination, by means of a needle provided retracted inside a body of said sampling device.
  • the needle is movably mounted from an inactive position enclosed inside said body, to a protruding active position with a view to taking the sample, while still being entirely contained in said body, and vice versa.
  • the sampling device comprises:
  • a needle provided hollow, in the form of a tube, mounted for fixing on a support,
  • an internal reservoir connected to said needle, said internal reservoir comprising walls delimiting a planned interior volume communicating with the needle,
  • said sampling device is characterized in that at least:
  • said body comprising at its first end, an open housing, said housing providing an interior space for receiving said septum, said needle communicating with said interior space of said housing.
  • said support is mounted to move relative to said body, from an inactive position of said retracted needle relative to said housing, to an active position protruding inside the interior volume of said housing, and vice versa.
  • said support is slidably mounted inside said body, said support being actuated by movement in support of said gripping means provided movable with respect to said opposite end of said body, the movement of said gripping means being operating simultaneously by applying a pressure against said opposite end and a traction of said gripping means towards said opposite end, relatively to one another.
  • said reservoir forms said opposite end of said sampling device.
  • said sampling device comprises a member mounted inside said reservoir, like a piston actuated by said gripping means.
  • said sampling device comprises elastic return means from the active position to the inactive position.
  • said body comprises a window
  • said reservoir comprises a through orifice
  • said window and said orifice being located opposite each other in the active position or in the inactive position.
  • the needle communicates with a reservoir making it possible to recover a dedicated quantity of the sample taken, said reservoir being accessible by a window made through said body. This communication makes it possible to avoid any risk of contact for the caregiver with the sample taken, as well as to prevent any external contamination.
  • the invention also relates to the use of the sampling device according to the invention, for taking a sample from a septum present on an extracorporeal circuit or on another medical system, such as a probe, preferably, for measuring and quantifying a compound present in said sample taken, more preferably to measure the blood sugar level.
  • the invention relates to the use of the sampling device to collect a sample of bodily fluid from a septum.
  • the invention relates to the use for taking a blood sample from a septum present on an extracorporeal circuit.
  • the use aims to measure and quantify a compound present in said blood sample taken.
  • the use aims to measure the blood sugar level in said blood sample taken.
  • the use aims to measure the level of hemoglobin in said blood sample taken.
  • the sampling device improves the care of patients, by promoting a clean and sterile medical procedure, without any risk of accident, including for the caregiver, avoiding for example the risks of injection or projection of Accidents of Exposure to Viruses (AEV) or Accidents of Exposure to Blood (AES).
  • AEV Accidents of Exposure to Viruses
  • AES Accidents of Exposure to Blood
  • the invention complies with the standards in force relating to capillary and arterial glycaemia, authorizing the use of capillary and arterial glycaemia diagnostic apparatus.
  • FIG. 1 schematically represents a perspective view of an embodiment of a sampling device according to the invention, in the active position, showing in particular a slot made in the body of said device;
  • FIG. 2 schematically represents a perspective view of another embodiment of said sampling device, in the inactive position
  • FIG. 3 schematically represents an exploded perspective view of FIG. 2, showing in particular the different parts of said sampling device;
  • FIG.4 schematically represents a view according to a longitudinal median section of an embodiment of the sampling device, showing in a partially exploded manner the various separate elements of said sampling device;
  • FIG. 5 schematically represents a view according to a longitudinal median section of an embodiment of the sampling device, in the inactive position
  • FIG. 6 schematically represents a view similar to FIG. 4, in the active position
  • FIG. 7 schematically represents a simplified view along a longitudinal median section of said sampling device, in the active position in cooperation with a septum of an extracorporeal circuit, showing in particular the flow of blood from said circuit to a reservoir.
  • the invention relates to a device 1 for taking a sample of bodily fluid, in particular a blood sample, also called a “sampler”.
  • the invention specifically relates to a sampling device 1 made from a septum 100.
  • a septum 100 equips a medical system, such as an extracorporeal circuit 101, or even a probe, as mentioned above.
  • a septum 100 is visible in the implementation example of Figure 7.
  • the sampling device 1 comprises a needle 2 fixedly mounted on a support 20.
  • the needle 2 is therefore secured to its support 20.
  • the needle 2 is mounted on one face of the support 20, called the "lower face” with respect to the orientation of the sampling device 1 during its use, namely downwards reference to Figures 4 to 7.
  • the needle 2 is hollow, in the form of a tube.
  • the needle 2 projects in relation to this lower face and passes through the wall of said lower face.
  • the protruding end 200 of said needle 2 comprises a bevel, giving it a piercing or piercing capacity.
  • the opposite end 201 of the needle 2 therefore opens out on the other side of the support 20 with respect to the lower face, namely on the side of the so-called “upper” face.
  • Said needle 2 can be of any type, preferably hypodermic, suitable for taking samples.
  • the needle 2 is identical to that of a transfer trocar or "trocar” or even “trocar”, commonly referred to as “pink trocar” (due to its distinctive color differentiating the use for sampling , compared to other colors intended for injection), or even “trocar G18" (with regard to the dimensions of its gauge, namely the unit expressing the external diameter of a medical device).
  • the needle 2 is identical to that of an “orange needle”, also designated “G25 needle”. According to another particularly preferred embodiment, the needle 2 is a heparinized or anti-coagulated needle, making it possible to leave the device 1 in place for a few hours for secure sampling on the extracorporeal circuit.
  • said support 20 can have any shape. According to the embodiment visible in the figures, said support 20 preferably has a generally cylindrical shape, with a circular section. The underside has a recess 21, within which the needle 2 is sealed over part of its length, ensuring its maintenance.
  • the needle 2 and its support 20 form a non-removable tip with respect to the sampling device 1, for single use.
  • the needle 2 and its support 20 form a removable tip relative to the sampling device 1, allowing it to be replaced for and according to each use.
  • the sampling device 1 also comprises an internal reservoir 3, provided for collecting the sample taken. To do this, the internal reservoir 3 is connected to said needle 2.
  • said internal reservoir 3 comprises walls delimiting an interior volume 30 provided communicating with the needle 2.
  • the opposite end 201 of the needle 2 is connected to the interior volume 30 of said reservoir 3 via a channel 31 formed within the corresponding wall of said reservoir 3, namely the wall located on the side of said end piece (needle 2 and support 20), or even the wall located below.
  • the inside of the channel 31 is sized to receive said end 201 of the needle 2, namely with an internal diameter greater than or substantially equal to the clearance with respect to the external diameter of the said needle 2.
  • the reservoir 3 comprises a distal part 32 shaped to cooperate in interlocking with a complementary space 22 formed within said support 20.
  • the support 20 can be engaged on the reservoir 3, ensuring a removable maintenance of one relative to the other, as well as the connection of the needle 2 to the interior volume 30 for the circulation of the fluid of the sample.
  • the sampling device 1 comprises a hollow body 4 receiving said support 20 and said reservoir 3.
  • the shape and internal dimensions of said body 4 are provided to be complementary, with respect to the external dimensions of said reservoir 3, as well as the tip.
  • Said body 4 can have any shape, preferably a cylindrical shape.
  • the body 4 has an opening at its opposite end, namely the upper or upward end. This opening allows the insertion of the other elements inside the sampling device 1 .
  • said needle 2 is oriented towards a first end 40 of said body 4, namely its lower end or located downwards.
  • the insertion of the reservoir 3 and of the tip is carried out in such a way as to orient the pointed end 200 of the needle 2 towards said first end 40.
  • the sampling device 1 provides at least that when said support 20 is placed inside said body 4, said needle 2 is entirely contained inside said body 4. In short, no part of the needle 2 does not protrude beyond the walls delimiting said body 4, in particular its sharp end 200 . Thus, it is not possible for a user to prick himself inadvertently, ensuring a clean and sterile medical procedure, without any risk of accident, for the caregiver as for the patient.
  • the sampling device 1 comprises gripping means 5 located at an opposite end of said body 4. Said gripping means 5, located on the proximal side of the body 4, allow the carer to hold it in the hand for the purpose of use of the sampling device 1.
  • Said gripping means 5 can have any shape. As visible in the embodiment of Figure 2, the gripping means 5 may be in the form of a simple ring, while they may include fins 50, as visible in the embodiment of Figure 1 .
  • the sampling device 1 provides at least that said body 4 comprises at its first end 40, an open housing 41 .
  • said housing 41 provides an interior space for receiving said septum 100.
  • said housing 41 has a shape complementary to that of septum 100, namely preferably globally cylindrical.
  • the internal dimensions of the housing 41 are shaped complementary to the external dimensions of said septum 100, so as to allow the positioning of the sampling device 1 on the septum 100, including said septum 100 partially within said housing 41, in the body 4.
  • Such a configuration of the sampling device 1 on the septum 100 is particularly visible in Figure 7.
  • housing 41 comprises a passage allowing needle 2, in particular its piercing end 200, to penetrate inside.
  • Such a passage can be in the form of a hole 42 provided passing through, through the bottom 43 of said housing 41.
  • said hole 42 is shaped complementary to receive the end piece, in particular the step 21 of the support 20 located inside said body 4.
  • said needle 2 communicating inside the housing 41, said needle 2 can perforate the septum 100 introduced within said housing 41, until it reaches the inside of the extracorporeal circuit 101, allowing the fluid from the sample to circulate to the internal volume 30 of said reservoir 3, as can be seen in particular in FIG. 7.
  • said support 20 is mounted to move relative to said body 4, from an inactive position of said needle 2 retracted relative to said housing 41, to a protruding active position inside the interior volume of said housing 41, and vice versa. In short, said support 20 moves inside body 4, along a stroke extending from said inactive position to said active position.
  • the perforating end 200 is essentially contained inside the hole 42 passing through the housing 41, its tip being flush with said bottom 43. Due to the dimensions of said housing 41, it is then not possible to inadvertently introduce therein a body part capable of entering it, such as the distal phalanx of a finger.
  • the needle 2 In the active position, as seen in the example of Figure 6, the needle 2 is deployed, but still contained inside the body 4, not protruding outside the housing 41. It is then not possible to inadvertently pricking a predominantly flat body part, such as the caregiver's or patient's skin.
  • said support 20 is slidably mounted inside said body 4.
  • said reservoir 3 is jointly slidably mounted inside said body 4 .
  • the external dimensions of said reservoir 3 correspond, except for clearance, to the internal dimensions of said body 4, ensuring a sliding of one relative to the other.
  • said body 4 forms a guide sleeve in translation of said tank 3 in its stroke, namely a downward vertical translation from the inactive position to the active position (from top to bottom), and conversely an upward vertical translation from the active position to inactive position (from bottom to top).
  • the actuation of the sampling device 1 is carried out by pressing on the reservoir 3, making it possible to manually move the support 20 together from the inactive position to the active position.
  • this support can be conferred by the application of the sampling device 1 in contact with the septum 100, at the time of its insertion into said housing 41 .
  • the septum 100 forms an abutment at the time of application of said sampling device 1, blocking the body 4, only allowing said reservoir 3 to move under the action of said pressure.
  • said support 20 is actuated by movement in support of said gripping means 5 provided to be movable with respect to the opposite end of said body 4.
  • said gripping means 5 are moved simultaneously by applying pressure against said opposite end and pulling said gripping means 5 towards said opposite end, relatively to one another. other.
  • a pinching gesture between the gripping means 5 and the opposite end of said body 4 reflects a thrust bearing against the reservoir 3, which then moves in translation from the inactive position to the active position.
  • said reservoir 3 forms said opposite end of said sampling device 1, namely the upper end or located upwards. In short, reservoir 3 protrudes from body 4 at this upper end.
  • the sampling device 1 comprises a cover 6 ensuring the closure of the body 4, in particular by covering the corresponding end of the said reservoir 3. It is then advantageously against the said cover 6 that the support takes place, as well as possibly the pinching of said gripping means 5.
  • Such a cover 6 can have any shape, in particular an ergonomic shape, for example with a concave outer face, allowing in particular the support of the pulp of the thumb, while the rest of the body 4, in particular the gripping means 5, are held by the other fingers of the caregiver's hand.
  • the gripping means 5 may have a vertical section generally shaped like a T, with side branches 51 connected to a middle part 52. Therefore, the tank 3 internally receives the means 5 for gripping.
  • the tank 3 laterally comprises perforated walls 33, allowing the movement of the side branches 51 of the gripping means 5.
  • perforated walls 33 are provided in a complementary manner with respect to said branches 51, allowing their vertical movement during the movement induced on said means 5 for gripping.
  • the sampling device 1 comprises a member 7 mounted inside said reservoir 3, like a piston actuated by said gripping means 5 .
  • the member 7 is therefore movable relative to said reservoir 3, in particular according to a vertical translation.
  • the member 7 can have any shape, in particular a cylindrical shape with a generally U-shaped vertical section, additionally to receive internally the middle part 52 of said means 5 for gripping.
  • the member 7 may comprise a ring 70, ensuring its closure in the open upper part of its U-shape.
  • This ring 70 fits over the distal ends of the branches of the U-shape.
  • said ring 70 is crossed by the middle part 52 of the gripping means 5, while the branches 51 remain outside.
  • the ring 70 has an annular shape with an oblong hole, allowing the passage of the distal end of the middle part 52, shaped complementary with a lug 53.
  • This lug 53 projects laterally, on both sides. other side of said middle portion 52.
  • the shape of the lug 53 ensures, according to an angular configuration, the insertion of the middle part 52 inside said member 7, as well as its locking according to another angular configuration. , like a foolproof device.
  • the means 5 of grip therefore find themselves entangled with the member 7, the lug 53 being retained by the underside of said ring 70, preventing their disassembly of these elements one by the other.
  • This other configuration nevertheless allows the sliding of the middle part 52 and therefore of the gripping means 5 with respect to the member 7.
  • the gripping means 5 in the inactive position, the gripping means 5 are in the low position, the middle part 52 being found in abutment in the bottom of said member 7, while after pressing, in the active position, the lug 53 comes into abutment against the ring 70, as visible in the example of the figure 6.
  • the member 7 moves within the reservoir 3, applying a positive pressure to the fluid of the sample taken, due to the joint movement of the needle 2. This is how the movements of all of these elements are similar to the operation of a piston.
  • the piston effect makes it possible to create a positive pressure within the reservoir 3, which is necessary at the start of sampling when the needle 2 is plunged through the septum 100, to attract the fluid, for example blood, towards the tank 3.
  • the sampling device 1 is for single use.
  • the sampling device 1 it is possible to disassemble the elements of the sampling device 1, in order to clean and sanitize it, as well as to replace the tip, namely the needle 2 secured to its support 20.
  • the sampling device 1 comprises elastic return means from the active position to the inactive position.
  • elastic return means can be of any type, in particular a spring, preferably compression; said spring is then positioned, between at least two corresponding elements within the sampling device 1, to be compressed during the transition to the active position and ensure the automatic return to the inactive position.
  • the return to the inactive position can take place by the positive pressure applied inside the tank 3 when it contains the fluid of a sample taken.
  • the sampling device 1 makes it possible to perform an in vitro test on the sample taken.
  • a measuring means 102 is positioned to allow contact with the sample taken and contained in the device 1 for taking samples.
  • Such measuring means 102 can be of any type, in particular in the form of a paper dedicated to the absorption of said fluid from the sample, such as for example a test strip, in particular a test strip for blood glucose or blood glucose. of hemoglobin, intended to be analyzed by a dedicated device.
  • said body 4 comprises a window 44
  • said tank 3 comprises a through orifice 34.
  • said window 44 and said orifice 34 are located opposite each other in the active position or in the inactive position, preferably in the active position. In short, the window 44 and the orifice 34 are found aligned in an active or inactive position of the sampling device 1, providing a communication channel between the internal volume 30 of said reservoir 3 and the outside of said body 4.
  • the sampling device 1 allows a secure measurement, in that once the sampling has been carried out, the needle 2 remains in a safe position inside the body 4 without the risk of the user being pricked or the patient being pricked. . Such operation limits the risks of contact with the sample taken, in particular Accidents of Exposure to Viruses (AEV) or Accidents of Exposure to Blood (AES).
  • AEV Accidents of Exposure to Viruses
  • AES Accidents of Exposure to Blood
  • the invention also relates to the use of the sampling device 1, according to one and/or the other of the aforementioned embodiments, for taking a sample of bodily fluid from a septum 100, preferably a blood sample from a septum 100 present on an extracorporeal circuit 101.
  • the use makes it possible to measure and quantify in vitro a compound present in said sample taken, preferably in said blood sample taken.
  • the use makes it possible to measure the blood sugar level in said blood sample taken.
  • the use of the sampling device 1 complies with the standards in force relating to capillary blood sugar, authorizing the use of capillary blood sugar diagnostic devices.
  • the use makes it possible to measure the level of hemoglobin in said blood sample taken.
  • the sampling device 1 improves patient care, by promoting a clean and sterile medical procedure, with easy and risk-free handling.
  • the amount of fluid, preferably blood, collected is minimal and perfectly suited to the uses envisaged.

Abstract

The invention relates to a device for collecting a sample from a septum (100), said device comprising a hollow body (4) that receives a needle (2) securely mounted on a support (20), and comprising an internal reservoir (3) connected to said needle (2), which needle is oriented towards a first end (40) of said body (4), and comprising grasping means (5) located at an opposite end of said body (4). The invention is characterised in that at least said support (20) is placed inside said body (4), said needle (2) being entirely contained within said body (4), which comprises, at the first end (40) thereof, an open recess (41) forming an internal space for receiving said septum (100), said needle (2) communicating with said internal space of said recess (41). The invention also relates to the use of said sampling device (1) for collecting a sample from a septum (100), advantageously for measuring and quantifying a compound present in said collected sample.

Description

PRELEVEUR DE SANG SECURISE SUR CIRCUIT EXTRA-CORPOREL SAFE BLOOD SAMPLER ON EXTRA-BODY CIRCUIT
DOMAINE TECHNIQUE TECHNICAL AREA
La présente invention a pour objet un dispositif médical et son utilisation in vitro dans l’examen d’échantillons de fluides provenant du corps humain, en particulier d'échantillons sanguins. The present invention relates to a medical device and its use in vitro in the examination of samples of fluids from the human body, in particular blood samples.
TECHNIQUE ANTERIEURE PRIOR TECHNIQUE
La présente invention entre dans le domaine médical des prélèvements d'échantillons de fluides corporels, en particulier d'échantillons sanguins. The present invention falls within the medical field of taking samples of bodily fluids, in particular blood samples.
L'invention trouvera une application préférentielle, mais aucunement limitative, dans la mesure et la quantification in vitro d'un composé présent dans ledit échantillon prélevé, comme le taux de glycémie. The invention will find a preferential, but in no way limiting, application in the in vitro measurement and quantification of a compound present in said sample taken, such as the blood sugar level.
On connaît par exemple le document brevet WC03/020134 qui divulgue un dispositif et un procédé d'échantillonnage d'un fluide corporel par prélèvement par absorption. Le stylet d'incision plus particulièrement décrit comprend un corps longitudinal creux, de forme globalement cylindrique, formant un carter, à l'intérieur duquel est notamment positionné un organe d'incision sous forme d'une aiguille pleine montée à l'intérieurd'un canal sous forme de tube capillaire, canal qui permet le transfert du fluide, notamment la migration par capillarité, jusqu'à une ouverture ménagée dans ledit corps. Ce document vise ainsi un prélèvement superficiel, directement au contact extérieur de la peau, le support de l'aiguille pleine ne servant que de support à l'aiguille, avec un espace de réception du fluide prélevé du côté de ladite aiguille, qui ne communique pas avec le réservoir. For example, patent document WC03/020134 is known, which discloses a device and a method for sampling a bodily fluid by sampling by absorption. The incision stylet more particularly described comprises a hollow longitudinal body, of generally cylindrical shape, forming a casing, inside which is positioned in particular an incision member in the form of a solid needle mounted inside a channel in the form of a capillary tube, channel which allows the transfer of fluid, in particular migration by capillarity, to an opening made in said body. This document thus aims at a superficial sampling, directly in external contact with the skin, the support of the solid needle serving only as a support for the needle, with a space for receiving the fluid sampled on the side of said needle, which does not communicate not with the tank.
De même, on connaît le document brevet WO99/55232, qui concerne un dispositif de succion et pompage d'un échantillon de fluide corporel depuis une incision, sous forme de stylet pourvu d'une aiguille pleine, pour inciser la peau en surface, afin de faire ressortir un prélèvement du fluide corporel. L'aiguille montée sur un support mobile est coulissante par l'intermédiaire d'un piston actionné depuis l'extrémité opposée, depuis une position inactive vers une position active saillante à l'intérieur d'un logement ménagé au sein de l'extrémité distale, avec un rappel élastique par ressorts vers la position inactive et permet de pomper, par l'intermédiaire d'une gâchette reliée à un piston, pour faire sortir davantage de fluide depuis l'incision une fois réalisée. Similarly, patent document WO99/55232 is known, which relates to a device for sucking and pumping a sample of bodily fluid from an incision, in the form of a stylet provided with a solid needle, to incise the skin at the surface, in order to to bring out a sample of body fluid. The needle mounted on a movable support is slidable by means of a piston actuated from the opposite end, from an inactive position to an active position protruding inside a housing provided within the distal end , with an elastic return by springs to the inactive position and allows pumping, via a trigger connected to a piston, to expel more fluid from the incision once made.
Or, l'invention vise préférentiellement les prélèvements d'échantillons à partir d'un septum. Un tel septum peut être présent sur un circuit extra-corporel, ou bien relié à un autre système médical, comme par exemple une sonde urinaire. However, the invention is preferentially aimed at taking samples from a septum. Such a septum can be present on an extracorporeal circuit, or connected to another medical system, such as for example a urinary catheter.
Rappelons, au sens de la présente invention, le terme « septum » correspond à une membrane auto-obturante, généralement en matériau siliconé, séparant de façon hermétique et préservant de l'atmosphère extérieure, l'intérieur d'un circuit relié au corps humain, notamment à son système vasculaire. Le matériau et l'épaisseur d'un tel septum lui permettent d'être transpercé par une aiguille, et surtout de conserver le caractère hermétique une fois l'aiguille retirée. Ainsi, il est possible de façon aseptisée d'administrer des solutions et, plus particulièrement, d'effectuer des prélèvements, en particulier des prélèvements sanguins. Recall, within the meaning of the present invention, the term "septum" corresponds to a self-sealing membrane, generally made of silicone material, hermetically separating and preserving from the outside atmosphere, the interior of a circuit connected to the human body. , especially to its vascular system. The material and thickness of such a septum allow it to be pierced by a needle, and above all to retain its hermetic character once the needle is removed. Thus, it is possible in an aseptic manner to administer solutions and, more particularly, to take samples, in particular blood samples.
Un tel septum peut être monté le long d'un circuit extra-corporel sous forme de gaines, ou bien directement à une extrémité d'un cathéter. Such a septum can be mounted along an extracorporeal circuit in the form of sheaths, or else directly at one end of a catheter.
Dans ce contexte, actuellement, le prélèvement sanguin, de plusieurs millilitres, depuis un circuit extra-corporel s'effectue par un soignant au moyen d'une aiguille montée sur une seringue. Il peut s'agir d'un trocart de transfert, communément désigné « trocard rose » (en raison de sa couleur distinctive différenciant l'utilisation pour le prélèvement, par rapport à d'autres couleurs destinées à l'injection), ou encore « trocard G18 » (au regard des dimensions de sa gauge, à savoir l'unité exprimant le diamètre externe d'un dispositif médical). Il peut aussi s'agir d'une aiguille « orange », encore désignée « aiguille G25 ». In this context, currently, the blood sample, of several milliliters, from an extracorporeal circuit is carried out by a carer by means of a needle mounted on a syringe. It may be a transfer trocar, commonly referred to as a "pink trocar" (because of its distinctive color differentiating the use for sampling, compared to other colors intended for injection), or even " trocar G18” (with regard to the dimensions of its gauge, i.e. the unit expressing the external diameter of a medical device). It can also be an “orange” needle, also referred to as a “G25 needle”.
Une fois le prélèvement effectué par transpercement du septum, le soignant dépose une gouttelette de sang sur un support adapté, comme une bandelette de test de glycémie destinée à être analysée in vitro par un appareil dédié. Once the sample has been taken by piercing the septum, the caregiver deposits a droplet of blood on a suitable support, such as a blood glucose test strip intended to be analyzed in vitro by a dedicated device.
Une telle pratique présente des risques non négligeables pour le soignant, comme pour le patient. Such a practice presents significant risks for both the caregiver and the patient.
Tout d'abord, pour le soignant, il existe un risque d'effraction cutanée en se piquant avec l'aiguille saillante, au cours de sa manipulation, notamment quand l'aiguille doit être décapuchonnée manuellement, ou bien après le prélèvement quand elle est jetée. Il est aussi possible de piquer accidentellement le patient. First of all, for the carer, there is a risk of breaking the skin by pricking himself with the protruding needle, during its manipulation, in particular when the needle must be uncapped manually, or after the sample is taken when it is pier. It is also possible to accidentally prick the patient.
Par ailleurs, lors de la dépose de la gouttelette de sang, surtout au moyen d'une seringue, il y a un risque de projection du sang, notamment au contact de muqueuse, comme les yeux, susceptible d'induire une contamination. Furthermore, when depositing the droplet of blood, especially by means of a syringe, there is a risk of blood splashing, in particular in contact with mucous membranes, such as the eyes, liable to induce contamination.
Il existe aussi un risque septique pour le patient avec l'aiguille de prélèvement qui peut toucher des surfaces et devenir contaminante. There is also a septic risk for the patient with the sampling needle which can touch surfaces and become contaminating.
Ce geste médical présente donc un défaut manifeste de sécurité pour le soignant, sans assurer de façon certaine l'asepsie d'un tel geste médical. This medical gesture therefore presents a manifest lack of safety for the carer, without ensuring the asepsis of such a medical gesture with any certainty.
En outre, la quantité de sang prélevée, de plusieurs millilitres (symbole « ml »), est bien supérieure aux besoins réels pour les mesures et quantifications envisagées, à savoir une simple goutte de sang de l'ordre de 1 /20 ml. In addition, the quantity of blood taken, several milliliters (symbol “ml”), is much greater than the real needs for the measurements and quantifications envisaged, namely a single drop of blood of the order of 1/20 ml.
EXPOSE DE L’INVENTION DISCLOSURE OF THE INVENTION
L'invention a pour but de pallier les inconvénients de l’état de la technique en proposant un dispositif de prélèvement d'échantillon, à partir d'un septum. Un tel dispositif de prélèvement se veut à même d'assurer une sécurité évitant tout risque de piqûre involontaire et de contamination septique, au moyen d'une aiguille prévue escamotée à l'intérieur d'un corps dudit dispositif de prélèvement. De surcroît, l'aiguille est montée mobile depuis une position inactive enfermée à l'intérieur dudit corps, vers une position active saillante en vue d'effectuer le prélèvement, en étant toujours entièrement contenue dans ledit corps, et inversement. The object of the invention is to overcome the drawbacks of the state of the art by proposing a device for taking a sample from a septum. Such a sampling device is intended to be able to ensure safety avoiding any risk of involuntary puncture and septic contamination, by means of a needle provided retracted inside a body of said sampling device. In addition, the needle is movably mounted from an inactive position enclosed inside said body, to a protruding active position with a view to taking the sample, while still being entirely contained in said body, and vice versa.
Pour ce faire, le dispositif de prélèvement comprend : To do this, the sampling device comprises:
- une aiguille prévue creuse, sous forme de tube, montée en fixation sur un support, - a needle provided hollow, in the form of a tube, mounted for fixing on a support,
- un réservoir interne connecté à ladite aiguille, ledit réservoir interne comprenant des parois délimitant un volume intérieur prévu communiquant avec l'aiguille, - an internal reservoir connected to said needle, said internal reservoir comprising walls delimiting a planned interior volume communicating with the needle,
- un corps creux recevant ledit support et ledit réservoir, ladite aiguille étant orientée vers une première extrémité dudit corps, - a hollow body receiving said support and said reservoir, said needle being oriented towards a first end of said body,
- des moyens de préhension situés à une extrémité opposée dudit corps. - Gripping means located at an opposite end of said body.
Avantageusement, ledit dispositif de prélèvement se caractérise en ce qu’au moins : Advantageously, said sampling device is characterized in that at least:
- ledit support est placé à l'intérieur dudit corps, ladite aiguille étant intégralement contenue à l'intérieur dudit corps, et - said support is placed inside said body, said needle being entirely contained inside said body, and
- ledit corps comprenant à sa première extrémité, un logement ouvert, ledit logement ménageant un espace intérieur de réception dudit septum, ladite aiguille communiquant avec ledit espace intérieur dudit logement. - said body comprising at its first end, an open housing, said housing providing an interior space for receiving said septum, said needle communicating with said interior space of said housing.
Selon des caractéristiques additionnelles, non limitatives, ledit support est monté mobile par rapport audit corps, depuis une position inactive de ladite aiguille escamotée par rapport audit logement, vers une position active saillante à l'intérieur du volume intérieur dudit logement, et inversement. According to additional, non-limiting features, said support is mounted to move relative to said body, from an inactive position of said retracted needle relative to said housing, to an active position protruding inside the interior volume of said housing, and vice versa.
Selon un mode de réalisation, ledit support est monté en coulissement à l'intérieur dudit corps, ledit support étant actionné par déplacement en appui desdits moyens de préhension prévus mobiles par rapport à ladite extrémité opposée dudit corps, le déplacement desdits moyens de préhension s'opérant simultanément par application d'une pression contre ladite extrémité opposée et d'une traction desdits moyens de préhension vers ladite extrémité opposée, de façon relative l'une par rapport à l'autre. According to one embodiment, said support is slidably mounted inside said body, said support being actuated by movement in support of said gripping means provided movable with respect to said opposite end of said body, the movement of said gripping means being operating simultaneously by applying a pressure against said opposite end and a traction of said gripping means towards said opposite end, relatively to one another.
Selon un mode de réalisation, ledit réservoir forme ladite extrémité opposée dudit dispositif de prélèvement. According to one embodiment, said reservoir forms said opposite end of said sampling device.
Selon un mode de réalisation, ledit dispositif de prélèvement comprend un organe monté à l'intérieur dudit réservoir, à la manière d'un piston actionné par lesdits moyens de préhension. According to one embodiment, said sampling device comprises a member mounted inside said reservoir, like a piston actuated by said gripping means.
Selon un mode de réalisation, ledit dispositif de prélèvement comprend des moyens de rappel élastique de la position active vers la position inactive. According to one embodiment, said sampling device comprises elastic return means from the active position to the inactive position.
Selon un mode de réalisation, ledit corps comprend une fenêtre, tandis que ledit réservoir comprend un orifice traversant, ladite fenêtre et ledit orifice se situant en vis-à- vis en position active ou en position inactive. En outre, en position saillante, l'aiguille communique avec un réservoir permettant de récupérer une quantité dédiée de l'échantillon prélevé, ledit réservoir étant accessible par une fenêtre ménagée au travers dudit corps. Cette communication permet d'éviter tout risque de contact pour le soignant avec l'échantillon prélevé, ainsi que d'empêcher toute contamination extérieure. According to one embodiment, said body comprises a window, while said reservoir comprises a through orifice, said window and said orifice being located opposite each other in the active position or in the inactive position. In addition, in the protruding position, the needle communicates with a reservoir making it possible to recover a dedicated quantity of the sample taken, said reservoir being accessible by a window made through said body. This communication makes it possible to avoid any risk of contact for the caregiver with the sample taken, as well as to prevent any external contamination.
L'invention concerne encore l’utilisation du dispositif de prélèvement selon l’invention, pour prélever un échantillon à partir d'un septum présent sur un circuit extracorporel ou bien sur un autre système médical, comme une sonde, préférentiellement, pour mesurer et quantifier un composé présent dans ledit échantillon prélevé, plus préférentiellement pour mesurer le taux de glycémie dans le sang. The invention also relates to the use of the sampling device according to the invention, for taking a sample from a septum present on an extracorporeal circuit or on another medical system, such as a probe, preferably, for measuring and quantifying a compound present in said sample taken, more preferably to measure the blood sugar level.
En particulier, l'invention concerne l'utilisation du dispositif de prélèvement pour prélever un échantillon de fluide corporel à partir d'un septum. In particular, the invention relates to the use of the sampling device to collect a sample of bodily fluid from a septum.
Selon un mode de réalisation, non limitatif, l'invention vise l'utilisation pour prélever un échantillon sanguin à partir d'un septum présent sur un circuit extra-corporel. According to one non-limiting embodiment, the invention relates to the use for taking a blood sample from a septum present on an extracorporeal circuit.
Selon un mode de réalisation, l'utilisation vise à mesurer et quantifier un composé présent dans ledit échantillon sanguin prélevé. According to one embodiment, the use aims to measure and quantify a compound present in said blood sample taken.
Selon un mode de réalisation, l'utilisation vise à mesurer le taux de glycémie dans ledit échantillon sanguin prélevé. According to one embodiment, the use aims to measure the blood sugar level in said blood sample taken.
Selon un autre mode de réalisation, l'utilisation vise à mesurer le taux d’hémoglobine dans ledit échantillon sanguin prélevé. According to another embodiment, the use aims to measure the level of hemoglobin in said blood sample taken.
Ainsi, le dispositif de prélèvement selon l'invention améliore la prise en charge des patients, en favorisant un geste médical propre et stérile, sans aucun risque d'accident, y compris pour le soignant, évitant par exemple les risques par piqûre ou projection d'Accidents d'Exposition aux Virus (AEV) ou les Accidents d'Exposition au Sang (AES). Thus, the sampling device according to the invention improves the care of patients, by promoting a clean and sterile medical procedure, without any risk of accident, including for the caregiver, avoiding for example the risks of injection or projection of Accidents of Exposure to Viruses (AEV) or Accidents of Exposure to Blood (AES).
En outre, dans le cadre d'un prélèvement en vue d'une quantification de la glycémie, l'invention respecte les normes en vigueur visant la glycémie capillaire et artérielle, autorisant l'utilisation des appareils de diagnostic de glycémie capillaire et artérielle. In addition, in the context of a sample with a view to quantifying glycaemia, the invention complies with the standards in force relating to capillary and arterial glycaemia, authorizing the use of capillary and arterial glycaemia diagnostic apparatus.
BREVE DESCRIPTION DES DESSINS BRIEF DESCRIPTION OF THE DRAWINGS
D'autres caractéristiques et avantages de l'invention ressortiront de la description détaillée qui va suivre des modes de réalisation non limitatifs de l'invention, en référence aux figures annexées, dans lesquelles : Other characteristics and advantages of the invention will emerge from the detailed description which will follow of the non-limiting embodiments of the invention, with reference to the appended figures, in which:
[Fig. 1 ] représente schématiquement une vue en perspective d'un mode de réalisation d'un dispositif de prélèvement selon l'invention, en position active, montrant notamment une fente ménagée dans le corps dudit dispositif ; [Fig. 1] schematically represents a perspective view of an embodiment of a sampling device according to the invention, in the active position, showing in particular a slot made in the body of said device;
[Fig. 2] représente schématiquement une vue en perspective d'un autre mode de réalisation dudit dispositif de prélèvement, en position inactive ; [Fig. 2] schematically represents a perspective view of another embodiment of said sampling device, in the inactive position;
[Fig. 3] représente schématiquement une vue en perspective éclatée de la figure 2, montrant notamment les différentes parties dudit dispositif de prélèvement ; [Fig.4] représente schématiquement une vue selon une coupe médiane longitudinale d'un mode de réalisation du dispositif de prélèvement, montrant de façon partiellement éclatée les différents éléments séparés dudit dispositif de prélèvement ; [Fig. 3] schematically represents an exploded perspective view of FIG. 2, showing in particular the different parts of said sampling device; [Fig.4] schematically represents a view according to a longitudinal median section of an embodiment of the sampling device, showing in a partially exploded manner the various separate elements of said sampling device;
[Fig. 5] représente schématiquement une vue selon une coupe médiane longitudinale d'un mode de réalisation du dispositif de prélèvement, en position inactive; [Fig. 5] schematically represents a view according to a longitudinal median section of an embodiment of the sampling device, in the inactive position;
[Fig. 6] représente schématiquement une vue similaire à la figure 4, en position active ; et [Fig. 6] schematically represents a view similar to FIG. 4, in the active position; And
[Fig. 7] représente schématiquement une vue simplifiée selon une coupe médiane longitudinale dudit dispositif de prélèvement, en position active en coopération avec un septum d'un circuit extra-corporel, montrant notamment l'écoulement du sang depuis ledit circuit jusqu'à un réservoir. [Fig. 7] schematically represents a simplified view along a longitudinal median section of said sampling device, in the active position in cooperation with a septum of an extracorporeal circuit, showing in particular the flow of blood from said circuit to a reservoir.
DESCRIPTION DES MODES DE REALISATION DESCRIPTION OF EMBODIMENTS
L'invention concerne un dispositif 1 de prélèvement d'échantillon de fluide corporel, en particulier d'échantillon sanguin, aussi appelé « préleveur ». The invention relates to a device 1 for taking a sample of bodily fluid, in particular a blood sample, also called a “sampler”.
L'invention vise spécifiquement un dispositif 1 de prélèvement réalisé à partir d'un septum 100. Un tel septum 100 équipe un système médical, comme un circuit extra-corporel 101 , ou encore une sonde, tel que susmentionné. Un tel septum 100 est visible sur l'exemple de mise en œuvre de la figure 7. The invention specifically relates to a sampling device 1 made from a septum 100. Such a septum 100 equips a medical system, such as an extracorporeal circuit 101, or even a probe, as mentioned above. Such a septum 100 is visible in the implementation example of Figure 7.
Avantageusement, le dispositif 1 de prélèvement comprend une aiguille 2 montée en fixation sur un support 20. L'aiguille 2 est donc solidaire de son support 20. Advantageously, the sampling device 1 comprises a needle 2 fixedly mounted on a support 20. The needle 2 is therefore secured to its support 20.
Plus précisément, de façon non limitative, l'aiguille 2 est rapportée en fixation sur une face du support 20, dite « face inférieure » par rapport à l'orientation du dispositif 1 de prélèvement lors de son utilisation, à savoir vers le bas en référence aux figures 4 à 7. L'aiguille 2 est creuse, sous forme d'un tube. L'aiguille 2 s'étend en saillie par rapport à cette face inférieure et traverse la paroi de ladite face inférieure. L'extrémité 200 saillante de ladite aiguille 2 comprend un biseau, lui conférant une capacité perforante ou piquante. L'extrémité 201 opposée de l'aiguille 2 débouche donc de l'autre côté du support 20 par rapport à la face inférieure, à savoir du côté de la face dite « supérieure ». More specifically, in a non-limiting manner, the needle 2 is mounted on one face of the support 20, called the "lower face" with respect to the orientation of the sampling device 1 during its use, namely downwards reference to Figures 4 to 7. The needle 2 is hollow, in the form of a tube. The needle 2 projects in relation to this lower face and passes through the wall of said lower face. The protruding end 200 of said needle 2 comprises a bevel, giving it a piercing or piercing capacity. The opposite end 201 of the needle 2 therefore opens out on the other side of the support 20 with respect to the lower face, namely on the side of the so-called “upper” face.
Ladite aiguille 2 peut être de tout type, préférentiellement hypodermique, adaptée pour des prélèvements d'échantillons. Selon un mode de réalisation, l'aiguille 2 est identique à celle d'un trocart de transfert ou « trocart » ou encore « trocard », communément désigné « trocard rose » (en raison de sa couleur distinctive différenciant l'utilisation pour le prélèvement, par rapport à d'autres couleurs destinées à l'injection), ou encore « trocard G18 » (au regard des dimensions de sa gauge, à savoir l'unité exprimant le diamètre externe d'un dispositif médical). Said needle 2 can be of any type, preferably hypodermic, suitable for taking samples. According to one embodiment, the needle 2 is identical to that of a transfer trocar or "trocar" or even "trocar", commonly referred to as "pink trocar" (due to its distinctive color differentiating the use for sampling , compared to other colors intended for injection), or even "trocar G18" (with regard to the dimensions of its gauge, namely the unit expressing the external diameter of a medical device).
Selon un autre mode de réalisation particulièrement préféré, l'aiguille 2 est identique à celle d'une « aiguille orange », encore désignée « aiguille G25 ». Selon un autre mode de réalisation particulièrement préféré, l'aiguille 2 est une aiguille héparinée ou anti coagulée, permettant de laisser en place pendant quelques heures le dispositif 1 de prélèvement sécurisé sur le circuit extra -corporel. According to another particularly preferred embodiment, the needle 2 is identical to that of an “orange needle”, also designated “G25 needle”. According to another particularly preferred embodiment, the needle 2 is a heparinized or anti-coagulated needle, making it possible to leave the device 1 in place for a few hours for secure sampling on the extracorporeal circuit.
En outre, ledit support 20 peut avoir toute forme. Selon le mode de réalisation visible sur les figures, ledit support 20 présente préférentiellement une forme globalement cylindrique, avec une section circulaire. La face inférieure présente un redent 21 , au sein duquel l'aiguille 2 est scellée sur une partie de sa longueur, assurant son maintien. Furthermore, said support 20 can have any shape. According to the embodiment visible in the figures, said support 20 preferably has a generally cylindrical shape, with a circular section. The underside has a recess 21, within which the needle 2 is sealed over part of its length, ensuring its maintenance.
Selon un mode de réalisation, l'aiguille 2 et son support 20 forment un embout non amovible par rapport au dispositif 1 de prélèvement, à usage unique. According to one embodiment, the needle 2 and its support 20 form a non-removable tip with respect to the sampling device 1, for single use.
Selon un autre mode de réalisation, l'aiguille 2 et son support 20 forment un embout amovible par rapport au dispositif 1 de prélèvement, permettant de le remplacer en vue et en fonction de chaque utilisation. According to another embodiment, the needle 2 and its support 20 form a removable tip relative to the sampling device 1, allowing it to be replaced for and according to each use.
Le dispositif 1 de prélèvement comprend aussi un réservoir 3 interne, prévu pour collecter l'échantillon prélevé. Pour ce faire, le réservoir 3 interne est connecté à ladite aiguille 2. The sampling device 1 also comprises an internal reservoir 3, provided for collecting the sample taken. To do this, the internal reservoir 3 is connected to said needle 2.
Plus précisément, de façon non limitative, ledit réservoir 3 interne comprend des parois délimitant un volume 30 intérieur prévu communiquant avec l'aiguille 2. En particulier, l'extrémité 201 opposée de l'aiguille 2 est connectée au volume 30 intérieur dudit réservoir 3 par l'intermédiaire d'un canal 31 ménagé au sein de la paroi correspondante dudit réservoir3, à savoir la paroi située du côté dudit embout (aiguille 2 et support 20), ou encore la paroi située inférieurement. En outre, l'intérieur du canal 31 est dimensionné pour recevoir ladite extrémité 201 de l'aiguille 2, à savoir avec un diamètre interne supérieur ou sensiblement égal au jeu près par rapport au diamètre externe de ladite aiguille 2. More specifically, in a non-limiting manner, said internal reservoir 3 comprises walls delimiting an interior volume 30 provided communicating with the needle 2. In particular, the opposite end 201 of the needle 2 is connected to the interior volume 30 of said reservoir 3 via a channel 31 formed within the corresponding wall of said reservoir 3, namely the wall located on the side of said end piece (needle 2 and support 20), or even the wall located below. In addition, the inside of the channel 31 is sized to receive said end 201 of the needle 2, namely with an internal diameter greater than or substantially equal to the clearance with respect to the external diameter of the said needle 2.
Selon un mode de réalisation, notamment visible sur les figures 4 à 7, le réservoir 3 comprend une partie 32 distale conformée pour coopérer en emboîtement avec un espace 22 complémentaire ménagé au sein dudit support 20. Ainsi, le support 20 peut être engagé sur le réservoir 3, assurant un maintien amovible de l'un par rapport à l'autre, ainsi que la connexion de l'aiguille 2 vers le volume 30 intérieur en vue de la circulation du fluide du prélèvement. According to one embodiment, particularly visible in Figures 4 to 7, the reservoir 3 comprises a distal part 32 shaped to cooperate in interlocking with a complementary space 22 formed within said support 20. Thus, the support 20 can be engaged on the reservoir 3, ensuring a removable maintenance of one relative to the other, as well as the connection of the needle 2 to the interior volume 30 for the circulation of the fluid of the sample.
Plus avant, le dispositif 1 de prélèvement comprend un corps 4 creux recevant ledit support 20 et ledit réservoir 3. En outre, la forme et les dimensions internes dudit corps 4 sont prévues complémentaires, par rapport aux dimensions externes dudit réservoir 3, ainsi que de l'embout. Further, the sampling device 1 comprises a hollow body 4 receiving said support 20 and said reservoir 3. In addition, the shape and internal dimensions of said body 4 are provided to be complementary, with respect to the external dimensions of said reservoir 3, as well as the tip.
Ledit corps 4 peut avoir toute forme, préférentiellement une forme cylindrique. Le corps 4 présente une ouverture à son extrémité opposée, à savoir l'extrémité supérieure ou située vers le haut. Cette ouverture permet l'insertion des autres éléments à l'intérieur du dispositif 1 de prélèvement. Said body 4 can have any shape, preferably a cylindrical shape. The body 4 has an opening at its opposite end, namely the upper or upward end. This opening allows the insertion of the other elements inside the sampling device 1 .
En outre, une fois positionnée à l'intérieur, ladite aiguille 2 est orientée vers une première extrémité 40 dudit corps 4, à savoir son extrémité inférieure ou située vers le bas. En d'autres termes, l'insertion du réservoir 3 et de l'embout est réalisée de manière à orienter l'extrémité 200 pointue de l'aiguille 2 vers ladite première extrémité 40. Furthermore, once positioned inside, said needle 2 is oriented towards a first end 40 of said body 4, namely its lower end or located downwards. In other words, the insertion of the reservoir 3 and of the tip is carried out in such a way as to orient the pointed end 200 of the needle 2 towards said first end 40.
Selon une caractéristique avantageuse, le dispositif 1 de prélèvement prévoit au moins que lorsque ledit support 20 est placé à l'intérieur dudit corps 4, ladite aiguille 2 est intégralement contenue à l'intérieur dudit corps 4. En somme, aucune partie de l'aiguille 2 ne dépasse hors des parois délimitant ledit corps 4, en particulier son extrémité 200 piquante. Ainsi, il n'est pas possible à un utilisateur de se piquer par inadvertance, assurant un geste médical propre et stérile, sans aucun risque d'accident, pour le soignant comme pour le patient. According to an advantageous characteristic, the sampling device 1 provides at least that when said support 20 is placed inside said body 4, said needle 2 is entirely contained inside said body 4. In short, no part of the needle 2 does not protrude beyond the walls delimiting said body 4, in particular its sharp end 200 . Thus, it is not possible for a user to prick himself inadvertently, ensuring a clean and sterile medical procedure, without any risk of accident, for the caregiver as for the patient.
Plus avant, le dispositif 1 de prélèvement comprend des moyens 5 de préhension situés à une extrémité opposée dudit corps 4. Lesdits moyens 5 de préhension, situés du côté proximal du corps 4, permettent la prise en main par le soignant en vue de l'utilisation du dispositif 1 de prélèvement. Further, the sampling device 1 comprises gripping means 5 located at an opposite end of said body 4. Said gripping means 5, located on the proximal side of the body 4, allow the carer to hold it in the hand for the purpose of use of the sampling device 1.
Lesdits moyens 5 de préhension peuvent avoir toute forme. Comme visible sur l'exemple de réalisation de la figure 2, les moyens 5 de préhension peuvent se présenter sous forme d'une simple bague, tandis qu’ils peuvent comprendre des ailettes 50, comme visible sur l'exemple de réalisation de la figure 1 . Said gripping means 5 can have any shape. As visible in the embodiment of Figure 2, the gripping means 5 may be in the form of a simple ring, while they may include fins 50, as visible in the embodiment of Figure 1 .
Selon une caractéristique avantageuse, le dispositif 1 de prélèvement prévoit au moins que ledit corps 4 comprend à sa première extrémité 40, un logement 41 ouvert. De plus, ledit logement 41 ménage un espace intérieur de réception dudit septum 100. En d'autres termes, ledit logement 41 présente une forme complémentaire à celle du septum 100, à savoir préférentiellement globalement cylindrique. De plus, les dimensions internes du logement 41 sont conformées complémentairement par rapport aux dimensions externes dudit septum 100, de manière à permettre de positionner le dispositif 1 de prélèvement sur le septum 100, englobant ledit septum 100 partiellement au sein dudit logement 41 , dans le corps 4. Une telle configuration du dispositif 1 de prélèvement sur le septum 100 est notamment visible sur la figure 7. According to an advantageous characteristic, the sampling device 1 provides at least that said body 4 comprises at its first end 40, an open housing 41 . In addition, said housing 41 provides an interior space for receiving said septum 100. In other words, said housing 41 has a shape complementary to that of septum 100, namely preferably globally cylindrical. In addition, the internal dimensions of the housing 41 are shaped complementary to the external dimensions of said septum 100, so as to allow the positioning of the sampling device 1 on the septum 100, including said septum 100 partially within said housing 41, in the body 4. Such a configuration of the sampling device 1 on the septum 100 is particularly visible in Figure 7.
De surcroît, ladite aiguille 2 communique avec ledit espace intérieur dudit logement 41. En somme, le logement 41 comprend un passage autorisant l'aiguille 2, en particulier son extrémité 200 perforante, à pénétrer à l'intérieur. In addition, said needle 2 communicates with said interior space of said housing 41. In short, housing 41 comprises a passage allowing needle 2, in particular its piercing end 200, to penetrate inside.
Un tel passage peut se présenter sous la forme d'un trou 42 prévu traversant, au travers du fond 43 dudit logement 41. En outre, ledit trou 42 est conformé complémentairement pour recevoir l'embout, en particulier le redent 21 du support 20 situé à l'intérieur dudit corps 4. Such a passage can be in the form of a hole 42 provided passing through, through the bottom 43 of said housing 41. In addition, said hole 42 is shaped complementary to receive the end piece, in particular the step 21 of the support 20 located inside said body 4.
Ainsi, l'aiguille 2 communiquant à l'intérieur du logement 41 , ladite aiguille 2 peut perforer le septum 100 introduit au sein dudit logement 41 , jusqu'à atteindre l'intérieur du circuit 101 extra-corporel, permettant au fluide du prélèvement de circuler jusqu'au volume 30 interne dudit réservoir 3, comme notamment visible sur la figure 7. Selon un mode de réalisation préféré, ledit support 20 est monté mobile par rapport audit corps 4, depuis une position inactive de ladite aiguille 2 escamotée par rapport audit logement 41 , vers une position active saillante à l'intérieur du volume intérieur dudit logement 41 , et inversement. En somme, ledit support 20 se déplace à l'intérieur du corps 4, selon une course s'étendant depuis ladite position inactive jusqu'à ladite position active. Thus, the needle 2 communicating inside the housing 41, said needle 2 can perforate the septum 100 introduced within said housing 41, until it reaches the inside of the extracorporeal circuit 101, allowing the fluid from the sample to circulate to the internal volume 30 of said reservoir 3, as can be seen in particular in FIG. 7. According to a preferred embodiment, said support 20 is mounted to move relative to said body 4, from an inactive position of said needle 2 retracted relative to said housing 41, to a protruding active position inside the interior volume of said housing 41, and vice versa. In short, said support 20 moves inside body 4, along a stroke extending from said inactive position to said active position.
En outre, en position inactive, comme visible sur l'exemple de la figure 5, l'extrémité 200 perforante est essentiellement contenue à l'intérieur du trou 42 traversant du logement 41 , sa pointe étant en affleurement dudit fond 43. En raison des dimensions dudit logement 41 , il n'est alors pas possible d'y introduire par inadvertance une partie corporelle susceptible d'y entrer, comme la phalange distale d'un doigt. In addition, in the inactive position, as seen in the example of Figure 5, the perforating end 200 is essentially contained inside the hole 42 passing through the housing 41, its tip being flush with said bottom 43. Due to the dimensions of said housing 41, it is then not possible to inadvertently introduce therein a body part capable of entering it, such as the distal phalanx of a finger.
En position active, comme visible sur l'exemple de la figure 6, l'aiguille 2 est déployée, mais toujours contenue à l'intérieur du corps 4, ne dépassant pas en dehors du logement 41. Il n'est alors pas possible de piquer par inadvertance une partie corporelle essentiellement plane, comme la peau du soignant ou du patient. In the active position, as seen in the example of Figure 6, the needle 2 is deployed, but still contained inside the body 4, not protruding outside the housing 41. It is then not possible to inadvertently pricking a predominantly flat body part, such as the caregiver's or patient's skin.
Selon un mode de réalisation, ledit support 20 est monté en coulissement à l'intérieur dudit corps 4. De fait, comme l'embout est monté sur le réservoir 3, ledit réservoir 3 est conjointement monté en coulissement à l'intérieur dudit corps 4. According to one embodiment, said support 20 is slidably mounted inside said body 4. In fact, as the end piece is mounted on reservoir 3, said reservoir 3 is jointly slidably mounted inside said body 4 .
En particulier, les dimensions externes dudit réservoir 3 correspondent, au jeu près, aux dimensions internes dudit corps 4, assurant un glissement de l'un par rapport à l'autre. En somme, ledit corps 4 forme un fourreau de guidage en translation dudit réservoir 3 dans sa course, à savoir une translation verticale descendante depuis la position inactive vers la position active (du haut vers le bas), et inversement une translation verticale ascendante depuis la position active vers la position inactive (depuis le bas vers le haut). In particular, the external dimensions of said reservoir 3 correspond, except for clearance, to the internal dimensions of said body 4, ensuring a sliding of one relative to the other. In short, said body 4 forms a guide sleeve in translation of said tank 3 in its stroke, namely a downward vertical translation from the inactive position to the active position (from top to bottom), and conversely an upward vertical translation from the active position to inactive position (from bottom to top).
Plus avant, l'actionnement du dispositif 1 de prélèvement s'effectue par appui sur le réservoir 3, permettant manuellement de déplacer conjointement le support 20 depuis la position inactive vers la position active. Further on, the actuation of the sampling device 1 is carried out by pressing on the reservoir 3, making it possible to manually move the support 20 together from the inactive position to the active position.
Selon un mode de réalisation, cet appui peut être conféré par l'application du dispositif 1 de prélèvement au contact du septum 100, au moment de son insertion dans ledit logement 41 . En somme, le septum 100 forme une butée au moment de l'application dudit dispositif 1 de prélèvement, bloquant le corps 4, n'autorisant plus que le déplacement dudit réservoir 3 sous l'action dudit appui. According to one embodiment, this support can be conferred by the application of the sampling device 1 in contact with the septum 100, at the time of its insertion into said housing 41 . In short, the septum 100 forms an abutment at the time of application of said sampling device 1, blocking the body 4, only allowing said reservoir 3 to move under the action of said pressure.
Préférentiellement, ledit support 20 est actionné par déplacement en appui desdits moyens 5 de préhension prévus mobiles par rapport à l'extrémité opposée dudit corps 4. Preferably, said support 20 is actuated by movement in support of said gripping means 5 provided to be movable with respect to the opposite end of said body 4.
De plus, le déplacement desdits moyens 5 de préhension s'opère simultanément par application d'une pression contre ladite extrémité opposée et d'une traction desdits moyens 5 de préhension vers ladite extrémité opposée, de façon relative l'une par rapport à l'autre. En somme, un geste de pincement entre les moyens 5 de préhension et l'extrémité opposée dudit corps 4, répercute une poussée en appui contre le réservoir 3, qui se déplace alors en translation depuis la position inactive vers la position active. Selon un mode de réalisation, ledit réservoir 3 forme ladite extrémité opposée dudit dispositif 1 de prélèvement, à savoir l'extrémité supérieure ou située vers le haut. En somme, le réservoir 3 dépasse du corps 4 au niveau de cette extrémité supérieure. In addition, said gripping means 5 are moved simultaneously by applying pressure against said opposite end and pulling said gripping means 5 towards said opposite end, relatively to one another. other. In short, a pinching gesture between the gripping means 5 and the opposite end of said body 4, reflects a thrust bearing against the reservoir 3, which then moves in translation from the inactive position to the active position. According to one embodiment, said reservoir 3 forms said opposite end of said sampling device 1, namely the upper end or located upwards. In short, reservoir 3 protrudes from body 4 at this upper end.
En particulier, comme visible sur les figures, le dispositif 1 de prélèvement comprend un capot 6 assurant la fermeture du corps 4, en particulier par recouvrement de l'extrémité correspondante dudit réservoir 3. C'est alors avantageusement contre ledit capot 6 que l'appui s'opère, ainsi qu'éventuellement le pincement desdits moyens 5 de préhension. In particular, as can be seen in the figures, the sampling device 1 comprises a cover 6 ensuring the closure of the body 4, in particular by covering the corresponding end of the said reservoir 3. It is then advantageously against the said cover 6 that the support takes place, as well as possibly the pinching of said gripping means 5.
Un tel capot 6 peut avoir toute forme, en particulier une forme ergonomique, par exemple avec une face externe concave, permettant notamment l'appui de la pulpe du pouce, tandis que le reste du corps 4, notamment les moyens 5 de préhension, sont maintenus par les autres doigts de la main du soignant. Such a cover 6 can have any shape, in particular an ergonomic shape, for example with a concave outer face, allowing in particular the support of the pulp of the thumb, while the rest of the body 4, in particular the gripping means 5, are held by the other fingers of the caregiver's hand.
Plus avant, les moyens 5 de préhension peuvent présenter une section verticale globalement conformée en T, avec des branches 51 latérales reliées à une partie 52 médiane. Dès lors, le réservoir 3 reçoit intérieurement les moyens 5 de préhension. Further forward, the gripping means 5 may have a vertical section generally shaped like a T, with side branches 51 connected to a middle part 52. Therefore, the tank 3 internally receives the means 5 for gripping.
En outre, le réservoir 3 comprend latéralement des parois 33 ajourées, autorisant le déplacement des branches 51 latérales des moyens 5 de préhension. De telles parois 33 ajourées sont ménagées de façon complémentaire par rapport auxdites branches 51 , autorisant leur mouvement vertical lors du déplacement induit sur lesdits moyens 5 de préhension. In addition, the tank 3 laterally comprises perforated walls 33, allowing the movement of the side branches 51 of the gripping means 5. Such perforated walls 33 are provided in a complementary manner with respect to said branches 51, allowing their vertical movement during the movement induced on said means 5 for gripping.
Selon un mode de réalisation, le dispositif 1 de prélèvement comprend un organe 7 monté à l'intérieur dudit réservoir 3, à la manière d'un piston actionné par lesdits moyens 5 de préhension. L'organe 7 est donc mobile par rapport audit réservoir 3, notamment selon une translation verticale. According to one embodiment, the sampling device 1 comprises a member 7 mounted inside said reservoir 3, like a piston actuated by said gripping means 5 . The member 7 is therefore movable relative to said reservoir 3, in particular according to a vertical translation.
En outre, l'organe 7 peut avoir toute forme, notamment une forme cylindrique avec une section verticale globalement conformée en U, complémentairement pour recevoir intérieurement la partie 52 médiane desdits moyens 5 de préhension. In addition, the member 7 can have any shape, in particular a cylindrical shape with a generally U-shaped vertical section, additionally to receive internally the middle part 52 of said means 5 for gripping.
Plus avant, l'organe 7 peut comprendre une bague 70, assurant sa fermeture en partie supérieure ouverte de sa forme en U. Cette bague 70 vient s'emboîter sur les extrémités distales des branches de la forme en U. Further forward, the member 7 may comprise a ring 70, ensuring its closure in the open upper part of its U-shape. This ring 70 fits over the distal ends of the branches of the U-shape.
De plus, ladite bague 70 est traversée par la partie 52 médiane des moyens 5 de préhension, tandis que les branches 51 restent à l'extérieur. In addition, said ring 70 is crossed by the middle part 52 of the gripping means 5, while the branches 51 remain outside.
Selon un mode de réalisation préféré, la bague 70 présente une forme annulaire avec un trou oblong, permettant le passage de l'extrémité distale de la partie 52 médiane, conformée complémentairement avec un ergot 53. Cet ergot 53 est saillant latéralement, de part et d'autre de ladite partie 52 médiane. According to a preferred embodiment, the ring 70 has an annular shape with an oblong hole, allowing the passage of the distal end of the middle part 52, shaped complementary with a lug 53. This lug 53 projects laterally, on both sides. other side of said middle portion 52.
Ainsi, combiné avec le trou oblong complémentaire de la bague 70, la forme de l'ergot 53 assure selon une configuration angulaire l'insertion de la partie 52 médiane à l'intérieur dudit organe 7, ainsi que son blocage selon une autre configuration angulaire, à la manière d'un détrompeur. Dans ladite autre configuration angulaire, les moyens 5 de préhension se retrouvent donc enchevêtrés avec l'organe 7, l'ergot 53 étant retenu par la face inférieure de ladite bague 70, empêchant leur désassemblage de ces éléments l'un par à l'autre. Cette autre configuration permet néanmoins le coulissement de la partie 52 médiane et donc des moyens 5 de préhension par rapport à l'organe 7. En particulier, comme visible sur l'exemple de la figure 5, en position inactive, les moyens 5 de préhension sont en position basse, la partie 52 médiane se retrouvant en butée dans le fond dudit organe 7, tandis qu'après appui, en position active, l'ergot 53 vient en butée contre la bague 70, comme visible sur l'exemple de la figure 6. A ce moment, l'organe 7 se déplace au sein du réservoir 3, appliquant une pression positive au fluide de l'échantillon prélevé, du fait de déplacement conjoint de l'aiguille 2. C'est ainsi que les déplacements de l'ensemble de ces éléments s'apparentent au fonctionnement d'un piston. Thus, combined with the complementary oblong hole of the ring 70, the shape of the lug 53 ensures, according to an angular configuration, the insertion of the middle part 52 inside said member 7, as well as its locking according to another angular configuration. , like a foolproof device. In said other angular configuration, the means 5 of grip therefore find themselves entangled with the member 7, the lug 53 being retained by the underside of said ring 70, preventing their disassembly of these elements one by the other. This other configuration nevertheless allows the sliding of the middle part 52 and therefore of the gripping means 5 with respect to the member 7. In particular, as can be seen in the example of FIG. 5, in the inactive position, the gripping means 5 are in the low position, the middle part 52 being found in abutment in the bottom of said member 7, while after pressing, in the active position, the lug 53 comes into abutment against the ring 70, as visible in the example of the figure 6. At this moment, the member 7 moves within the reservoir 3, applying a positive pressure to the fluid of the sample taken, due to the joint movement of the needle 2. This is how the movements of all of these elements are similar to the operation of a piston.
En particulier, l'effet de piston permet de créer une pression positive au sein du réservoir 3, nécessaire en début de prélèvement quand l'aiguille 2 est plongée au travers du septum 100, pour attirer le fluide, par exemple le sang, vers le réservoir 3. In particular, the piston effect makes it possible to create a positive pressure within the reservoir 3, which is necessary at the start of sampling when the needle 2 is plunged through the septum 100, to attract the fluid, for example blood, towards the tank 3.
Plus avant, le retour depuis la position active vers la position inactive, peut s'opérer de toute façon, notamment manuellement. Further, the return from the active position to the inactive position can take place anyway, in particular manually.
Selon un mode de réalisation, le dispositif 1 de prélèvement est à usage unique.According to one embodiment, the sampling device 1 is for single use.
Selon un mode de réalisation particulier, il est possible de démonter les éléments du dispositif 1 de prélèvement, en vue de le nettoyer et l'aseptiser, ainsi que de remplacer l'embout, à savoir l'aiguille 2 solidaire de son support 20. According to a particular embodiment, it is possible to disassemble the elements of the sampling device 1, in order to clean and sanitize it, as well as to replace the tip, namely the needle 2 secured to its support 20.
Selon un mode de réalisation, non représenté, le dispositif 1 de prélèvement comprend des moyens de rappel élastique de la position active vers la position inactive. De tels moyens de rappel élastique peuvent être de tout type, notamment un ressort, préférentiellement de compression ; ledit ressort est alors positionné, entre au moins deux éléments correspondants au sein du dispositif 1 de prélèvement, pour être comprimé lors du passage vers la position active et assurer le retour automatiquement vers la position inactive. According to one embodiment, not shown, the sampling device 1 comprises elastic return means from the active position to the inactive position. Such elastic return means can be of any type, in particular a spring, preferably compression; said spring is then positioned, between at least two corresponding elements within the sampling device 1, to be compressed during the transition to the active position and ensure the automatic return to the inactive position.
Préférentiellement, le retour vers la position inactive peut s'opérer par la pression positive appliquée à l'intérieur du réservoir 3 quand il contient le fluide d'un échantillon prélevé. Preferably, the return to the inactive position can take place by the positive pressure applied inside the tank 3 when it contains the fluid of a sample taken.
Une fois le prélèvement effectué, le dispositif 1 de prélèvement permet d'effectuer un test in vitro sur l'échantillon prélevé. Once the sample has been taken, the sampling device 1 makes it possible to perform an in vitro test on the sample taken.
Pour ce faire, un moyen 102 de mesure est positionné pour permettre un contact avec l'échantillon prélevé et contenu dans le dispositif 1 de prélèvement. Un tel moyen 102 de mesure peut être de tout type, en particulier sous forme d'un papier dédié à l'absorption dudit fluide de l'échantillon, comme par exemple une bandelette de test, notamment une bandelette de test de glycémie ou du taux d’hémoglobine, destinée à être analysée par un appareil dédié. Selon un mode de réalisation préféré, ledit corps 4 comprend une fenêtre 44, tandis que ledit réservoir 3 comprend un orifice 34 traversant. De plus, ladite fenêtre 44 et ledit orifice 34 se situent en vis-à-vis en position active ou en position inactive, préférentiellement en position active. En somme, la fenêtre 44 et l'orifice 34 se retrouvent alignés dans une position active ou inactive du dispositif 1 de prélèvement, ménageant une voie de communication entre le volume 30 interne dudit réservoir 3 et l'extérieur dudit corps 4. To do this, a measuring means 102 is positioned to allow contact with the sample taken and contained in the device 1 for taking samples. Such measuring means 102 can be of any type, in particular in the form of a paper dedicated to the absorption of said fluid from the sample, such as for example a test strip, in particular a test strip for blood glucose or blood glucose. of hemoglobin, intended to be analyzed by a dedicated device. According to a preferred embodiment, said body 4 comprises a window 44, while said tank 3 comprises a through orifice 34. In addition, said window 44 and said orifice 34 are located opposite each other in the active position or in the inactive position, preferably in the active position. In short, the window 44 and the orifice 34 are found aligned in an active or inactive position of the sampling device 1, providing a communication channel between the internal volume 30 of said reservoir 3 and the outside of said body 4.
Ainsi, il est possible d'amener le moyen 102 de mesure auprès de la fenêtre 44, pour qu'il rentre en contact avec le fluide de l'échantillon prélevé, contenu dans le réservoir 3 et accessible via l'orifice 34. Thus, it is possible to bring the measuring means 102 close to the window 44, so that it comes into contact with the fluid of the sample taken, contained in the reservoir 3 and accessible via the orifice 34.
Le dispositif 1 de prélèvement permet une mesure sécurisée, en ce que une fois le prélèvement effectué, l'aiguille°2 reste en position de sécurité à l'intérieur du corps 4 sans risque de se piquer pour l’utilisateur ou de piquer le patient. Un tel fonctionnement limite les risques de contact avec l'échantillon prélevé, en particulier d'Accidents d'Exposition aux Virus (AEV) ou les Accidents d'Exposition au Sang (AES). The sampling device 1 allows a secure measurement, in that once the sampling has been carried out, the needle 2 remains in a safe position inside the body 4 without the risk of the user being pricked or the patient being pricked. . Such operation limits the risks of contact with the sample taken, in particular Accidents of Exposure to Viruses (AEV) or Accidents of Exposure to Blood (AES).
L'invention concerne aussi l'utilisation du dispositif 1 de prélèvement, selon l'un et/ou l'autre des modes de réalisation susmentionnés, pour prélever un échantillon de fluide corporel à partir d'un septum 100, de préférence un échantillon sanguin à partir d'un septum 100 présent sur un circuit extra-corporel 101. The invention also relates to the use of the sampling device 1, according to one and/or the other of the aforementioned embodiments, for taking a sample of bodily fluid from a septum 100, preferably a blood sample from a septum 100 present on an extracorporeal circuit 101.
Selon un mode de mise en œuvre, l'utilisation permet de mesurer et quantifier in vitro un composé présent dans ledit échantillon prélevé, préférentiellement dans ledit échantillon sanguin prélevé. According to one mode of implementation, the use makes it possible to measure and quantify in vitro a compound present in said sample taken, preferably in said blood sample taken.
Selon un mode de mise en œuvre, l'utilisation permet de mesurer le taux de glycémie dans ledit échantillon sanguin prélevé. According to one mode of implementation, the use makes it possible to measure the blood sugar level in said blood sample taken.
Dans le cadre d'un prélèvement en vue d'une quantification de la glycémie, l'utilisation du dispositif 1 de prélèvement respecte les normes en vigueur visant la glycémie capillaire, autorisant l'utilisation des appareils de diagnostic de glycémie capillaire. In the context of a sample for quantification of blood sugar, the use of the sampling device 1 complies with the standards in force relating to capillary blood sugar, authorizing the use of capillary blood sugar diagnostic devices.
Selon un autre mode de réalisation, l'utilisation permet de mesurer le taux d’hémoglobine dans ledit échantillon sanguin prélevé. According to another embodiment, the use makes it possible to measure the level of hemoglobin in said blood sample taken.
Ainsi, le dispositif 1 de prélèvement selon l'invention améliore la prise en charge des patients, en favorisant un geste médical propre et stérile, avec une manipulation aisée et sans risque. Thus, the sampling device 1 according to the invention improves patient care, by promoting a clean and sterile medical procedure, with easy and risk-free handling.
En outre, la quantité de fluide, préférentiellement de sang, prélevé est minime et parfaitement adaptée aux utilisations envisagées. In addition, the amount of fluid, preferably blood, collected is minimal and perfectly suited to the uses envisaged.

Claims

REVENDICATIONS Dispositif (1 ) de prélèvement d'échantillon, à partir d'un septum (100), comprenant : Device (1) for taking a sample from a septum (100), comprising:
- une aiguille (2) prévue creuse, sous forme de tube, montée en fixation sur un support (20), - a needle (2) provided hollow, in the form of a tube, fixedly mounted on a support (20),
- un réservoir (3) interne connecté à ladite aiguille (2), ledit réservoir (3) interne comprenant des parois délimitant un volume (30) intérieur prévu communiquant avec l'aiguille - an internal reservoir (3) connected to said needle (2), said internal reservoir (3) comprising walls delimiting an interior volume (30) provided communicating with the needle
(2), (2),
- un corps (4) creux recevant ledit support (20) et ledit réservoir - a hollow body (4) receiving said support (20) and said tank
(3), ladite aiguille (2) étant orientée vers une première extrémité (40) dudit corps (4),(3), said needle (2) being oriented towards a first end (40) of said body (4),
- des moyens (5) de préhension situés à une extrémité opposée dudit corps (4) ; caractérisé en ce que au moins : - Means (5) for gripping located at an opposite end of said body (4); characterized in that at least:
- ledit support (20) est placé à l'intérieur dudit corps (4), ladite aiguille (2) étant intégralement contenue à l'intérieur dudit corps (4), et - said support (20) is placed inside said body (4), said needle (2) being entirely contained inside said body (4), and
- ledit corps (4) comprenant à sa première extrémité (40), un logement (41 ) ouvert, ledit logement (41 ) ménageant un espace intérieur de réception dudit septum (100), ladite aiguille (2) communiquant avec ledit espace intérieur dudit logement (41 ). Dispositif (1 ) de prélèvement selon la revendication 1 , caractérisé en ce que ledit support (20) est monté mobile par rapport audit corps (4), depuis une position inactive de ladite aiguille (2) escamotée par rapport audit logement (41 ), vers une position active saillante à l'intérieur du volume intérieur dudit logement (41 ), et inversement. Dispositif (1 ) de prélèvement selon la revendication 2, caractérisé en ce que ledit support (20) est monté en coulissement à l'intérieur dudit corps (4), ledit support (20) étant actionné par déplacement en appui desdits moyens (5) de préhension prévus mobiles par rapport à ladite extrémité opposée dudit corps (4), le déplacement desdits moyens (5) de préhension s'opérant simultanément par application d'une pression contre ladite extrémité opposée et d'une traction desdits moyens (5) de préhension vers ladite extrémité opposée, de façon relative l'une par rapport à l'autre. - said body (4) comprising at its first end (40), an open housing (41), said housing (41) providing an interior space for receiving said septum (100), said needle (2) communicating with said interior space of said housing (41). Sampling device (1) according to claim 1, characterized in that said support (20) is mounted to move relative to said body (4), from an inactive position of said needle (2) retracted relative to said housing (41), towards a protruding active position inside the interior volume of said housing (41), and vice versa. Sampling device (1) according to claim 2, characterized in that said support (20) is slidably mounted inside said body (4), said support (20) being actuated by movement in support of said means (5) gripping devices provided to be movable with respect to said opposite end of said body (4), the movement of said gripping means (5) taking place simultaneously by applying pressure against said opposite end and pulling said means (5) to grip towards said opposite end, relative to one another.
4. Dispositif (1 ) de prélèvement selon l'une des revendications précédentes, caractérisé en ce que ledit réservoir (3) forme ladite extrémité opposée dudit dispositif (1 ) de prélèvement. 4. Device (1) for sampling according to one of the preceding claims, characterized in that said reservoir (3) forms said opposite end of said device (1) for sampling.
5. Dispositif (1 ) de prélèvement selon l'une des revendications précédentes, caractérisé en ce que qu'il comprend un organe (7) monté à l'intérieur dudit réservoir (3), à la manière d'un piston actionné par lesdits moyens (5) de préhension. 5. Device (1) for sampling according to one of the preceding claims, characterized in that it comprises a member (7) mounted inside said reservoir (3), in the manner of a piston actuated by said gripping means (5).
6. Dispositif (1 ) de prélèvement selon l'une des revendications 2 à 5, caractérisé en ce qu'il comprend des moyens de rappel élastique de la position active vers la position inactive. 6. Device (1) for sampling according to one of claims 2 to 5, characterized in that it comprises elastic return means from the active position to the inactive position.
7. Dispositif (1 ) de prélèvement selon l'une des revendications 2 à 6, caractérisé en ce que ledit corps (4) comprend une fenêtre (44), tandis que ledit réservoir (3) comprend un orifice (34) traversant, ladite fenêtre (44) et ledit orifice (34) se situant en vis-à-vis en position active ou en position inactive. 7. Device (1) for sampling according to one of claims 2 to 6, characterized in that said body (4) comprises a window (44), while said reservoir (3) comprises an orifice (34) passing through, said window (44) and said orifice (34) located opposite each other in the active position or in the inactive position.
8. Utilisation du dispositif (1 ) de prélèvement selon l’une des revendications précédentes, pour prélever un échantillon de fluide corporel à partir d'un septum (100). 8. Use of the sampling device (1) according to one of the preceding claims, for taking a sample of bodily fluid from a septum (100).
9. Utilisation selon la revendication 8, pour prélever un échantillon sanguin à partir d'un septum (100) présent sur un circuit (101 ) extra-corporel. 9. Use according to claim 8, for taking a blood sample from a septum (100) present on a circuit (101) extracorporeal.
10. Utilisation selon la revendication 9, pour mesurer et quantifier un composé présent dans ledit échantillon sanguin prélevé. 10. Use according to claim 9, for measuring and quantifying a compound present in said collected blood sample.
1 1. Utilisation selon la revendication 10, pour mesurer le taux de glycémie ou de l’hémoglobine dans ledit échantillon sanguin prélevé. 1 1. Use according to claim 10, for measuring the level of blood sugar or hemoglobin in said blood sample taken.
PCT/EP2023/050070 2022-01-11 2023-01-03 Secure blood sampler on extracorporeal circuit WO2023135038A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FRFR2200184 2022-01-11
FR2200184A FR3131684A1 (en) 2022-01-11 2022-01-11 Secure blood glucose meter

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WO2023135038A1 true WO2023135038A1 (en) 2023-07-20

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999055232A1 (en) 1998-04-28 1999-11-04 Amira Medical, Inc. Methods and apparatus for suctioning and pumping body fluid from an incision
WO2003020134A2 (en) 2001-08-29 2003-03-13 Roche Diagnostics Gmbh Wicking methods and structures for use in sampling bodily fluids
US20040116830A1 (en) * 2001-08-24 2004-06-17 Trudeau William M Blood testing deivce
US20050232813A1 (en) * 2004-04-16 2005-10-20 Karmali Rashida A Specimen collecting, processing and analytical assembly
WO2013082301A1 (en) * 2011-11-29 2013-06-06 Teleflex Medical, Inc. Device with integrated allergy testing

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999055232A1 (en) 1998-04-28 1999-11-04 Amira Medical, Inc. Methods and apparatus for suctioning and pumping body fluid from an incision
US20040116830A1 (en) * 2001-08-24 2004-06-17 Trudeau William M Blood testing deivce
WO2003020134A2 (en) 2001-08-29 2003-03-13 Roche Diagnostics Gmbh Wicking methods and structures for use in sampling bodily fluids
US20050232813A1 (en) * 2004-04-16 2005-10-20 Karmali Rashida A Specimen collecting, processing and analytical assembly
WO2013082301A1 (en) * 2011-11-29 2013-06-06 Teleflex Medical, Inc. Device with integrated allergy testing

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