US20210137435A1 - Sample collection device, system and method for extracting and collecting a sample of a fluid of a user - Google Patents

Sample collection device, system and method for extracting and collecting a sample of a fluid of a user Download PDF

Info

Publication number
US20210137435A1
US20210137435A1 US17/096,796 US202017096796A US2021137435A1 US 20210137435 A1 US20210137435 A1 US 20210137435A1 US 202017096796 A US202017096796 A US 202017096796A US 2021137435 A1 US2021137435 A1 US 2021137435A1
Authority
US
United States
Prior art keywords
sample
collection device
sample collection
shell
cap
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
US17/096,796
Other languages
English (en)
Inventor
Arthur QUEVAL
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Loop Medical SA
Original Assignee
Loop Medical SA
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 Loop Medical SA filed Critical Loop Medical SA
Publication of US20210137435A1 publication Critical patent/US20210137435A1/en
Assigned to LOOP MEDICAL SA reassignment LOOP MEDICAL SA ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: Queval, Arthur
Priority to US18/148,346 priority Critical patent/US20230146889A1/en
Pending legal-status Critical Current

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150343—Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15103—Piercing procedure
    • A61B5/15107—Piercing being assisted by a triggering mechanism
    • A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061—Means for enhancing collection
    • A61B5/150099—Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150236—Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150267—Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150274—Manufacture or production processes or steps for blood sampling devices
    • A61B5/150282—Manufacture or production processes or steps for blood sampling devices for piercing elements, e.g. blade, lancet, canula, needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150351—Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150442—Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150442—Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
    • A61B5/150458—Specific blade design, e.g. for improved cutting and penetration characteristics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150442—Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
    • A61B5/150465—Specific design of proximal end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150572—Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150664—Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
    • A61B5/150671—Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element comprising means to impede repositioning of protection sleeve from covering to uncovering position
    • A61B5/150679—Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element comprising means to impede repositioning of protection sleeve from covering to uncovering position fully automatically triggered, i.e. the triggering of the pivotable protective sleeve does not require a deliberate action by the user such as terminating the contact with the patient's skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15103—Piercing procedure
    • A61B5/15107—Piercing being assisted by a triggering mechanism
    • A61B5/15109—Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
    • A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15142—Devices intended for single use, i.e. disposable
    • A61B5/15144—Devices intended for single use, i.e. disposable comprising driving means, e.g. a spring, for retracting the piercing unit into the housing

Definitions

  • Embodiments of the subject matter disclosed herein relate to a sample collection device for collecting a sample of a fluid of a user, e.g. blood, in particular capillary blood. Specifically, a system and a method for extracting and collecting this sample.
  • Venipuncture is a blood collection method where the vein is punctured by a hollow needle and blood is collected into a tube. This method allows collection of large and high quality blood samples into tubes. Several tubes can be filled during one blood sampling. Furthermore, these tubes are compatible with highly automated blood analyzers, which can analyze thousands of samples per day. These high throughputs capabilities answer the growing need for fast and clinical grade diagnostics at the lowest cost.
  • this method requires a healthcare professional (e.g. a nurse) with a specific qualification and a dedicated infrastructure.
  • a healthcare professional e.g. a nurse
  • risks are associated with puncturing the vein: if the vein is fragile or if the gesture is not performed properly, it can result in a hematoma.
  • needle-stick injury There is also a risk of needle-stick injury, which may expose the healthcare professionals to blood-borne diseases.
  • the finger prick method consists in the incision of the skin at the fingertip using a lancet.
  • a drop or a few drops of capillary blood can be collected into capillary tubes or into dedicated analytical devices (e.g. microfluidic devices, lab-on-chip, paper-based diagnostic tools, and the like). While this technique does not require highly trained professional and can be performed by the patient himself, it is very difficult to collect more than 100 ⁇ l of blood and to perform many analyses per sample.
  • the blood collected into glass capillaries or through other devices cannot be analyzed by automated analyzers, used by central laboratories, which require a minimum dead volume of blood of 100 ⁇ l to 200 in ⁇ l a single tube.
  • more blood up to 0.5 ml
  • more blood can be collected with the finger prick method.
  • this requires pressing and squeezing the finger in order to collect more blood. Squeezing too hard may result in haemolysis (damage of the red blood cells) and dilution of the blood sample by the interstitial fluid, contained in spaces between the tissue cells.
  • haemolysis damage of the red blood cells
  • dilution of the blood sample by the interstitial fluid contained in spaces between the tissue cells.
  • the use of finger prick is generally limited to the collection of small volumes of blood.
  • the document U.S. Pat. No. 6,283,926 describes a method and a device for obtaining samples of blood for diagnostic purposes.
  • the device comprises a vacuum pump, which requires a source of power, and a micro-controller arranged to drive the pump and the lancet based on the signal from a pressure sensor.
  • the lancet of this device moves in a direction perpendicular to the skin of the user.
  • This device is complicated, as it comprises several electronics components. Moreover, it is arranged to draw relatively small blood volumes (1 ⁇ l).
  • An aim of the present disclosure is to propose a sample collection device which simplifies the collection of a fluid of a user, e.g. blood, while keeping a high-quality standard for its analysis.
  • Another aim of the present disclosure is to propose a sample collection device which is safer for the user or for an operator (e.g. a nurse), as it minimizes the risk of injury by handling it.
  • Another aim of the present disclosure is to propose a sample collection device which reduces the risk of contamination of the collected sample.
  • Another aim of the present disclosure is to propose a sample collection device which is compatible with standard blood analyzers of central laboratories.
  • Another aim of the present disclosure is to propose a system for extracting and collecting a user fluid sample which can be used without the need of high-skill training, for example which can be used by the user him-self (i.e. a patient).
  • Another aim of the present disclosure is to propose a system for extracting and collecting a user fluid sample which requires minimal action from the user.
  • Another aim of the present disclosure is to propose a system for extracting and collecting a user fluid sample which can collect about 0.5 ml to 2 ml of fluid, e.g. 1 ml of fluid.
  • Another aim of the present disclosure is to propose a system for extracting and collecting a user fluid sample which is as painless as possible.
  • Another aim of the present disclosure is to propose a system for extracting and collecting a user fluid sample which avoids and/or prevents cross contamination of the fluid sample.
  • these aims are achieved by means of the sample collection device, the system and the method for extracting and collecting a sample of a fluid of a user according to the attached independent claims.
  • a sample collection device for collecting a blood sample of a patient at least comprising:
  • first partially deformable shell a second at least partially pierceable shell, wherein in the mounted state of the collection device a pre-packaged vacuum is sealed between the first shell and the second shell.
  • the second shell holds, in the mounted state, a sample container and an automatic mechanical cutting mechanism comprising a rotatable cutting blade and an actuator spring, the actuator spring being directly and/or indirectly actuatable by pressing the first shell, thereby releasing and rotating the cutting blade.
  • an automatic mechanical cutting mechanism comprising a rotatable cutting blade and an actuator spring, the actuator spring being directly and/or indirectly actuatable by pressing the first shell, thereby releasing and rotating the cutting blade.
  • the pre-packaged vacuum is released to a collection opening of the second shell such that the vacuum effects a suction effect such that blood coming out of the incision created by the rotatable cutting blade leaks into the sample container.
  • the invention is based on the basic idea that using a minimal cut into the skin of a patient by using a cutting blade that is automatically actuated, the collection of blood can be performed more or less painlessly for the patient. The pain can be further reduced by effecting a tangential cut.
  • a vacuum housing By having the prepackaged vacuum between the first and the second shell, wherein these two shells form in the mounted state a vacuum housing, a sufficient suction force or mechanism is provided, by means of which the blood coming out of the incision created by the rotatable cutting blade is leaked and/or flowing into the sample container.
  • the vacuum can and/or will create a skin deformation, which generates a concentrated vasodilation. Vasodilation then allows excessive amount of blood to be extracted from the wound created by the blade.
  • a cutting blade which is to be understood to also cover blade-like elements
  • an incision into the skin of the patient can be made.
  • the use of a cutting blade provides, according to the experience of the inventors, a more accurate and less painful creation of an opening into the skin of the patient for collecting blood.
  • the blade allows a soft diving and cutting into the skin with less pressure, thereby not creating too much pain. In some cases, even no pain was realized by the patients.
  • This concept is inspired by the experience that cuts created e.g. by a sharp knife or even by a sheet of paper are not realized in the first moment, nevertheless creating enough of an opening to create blood in the amount needed for analysis.
  • the actuator spring can be released for example directly by pressing e.g. a button. However, it is also possible that the actuator spring can be actuated indirectly. This can happen that by pressing the shell, the pierceable shell is punctured, thereby transferring vacuum into the second shell, which has the effect of sucking and stretching the skin. Then, the stretched skin presses against a movable part of the cap, which then releases the spring.
  • the second shell can be at least partially pierceable. It can be e.g. realized by having a part of the second shell formed by a membrane, which is pierceable.
  • the membrane can be e.g. made of aluminum or any other suitable material, e.g. a polymer or plastic material.
  • the whole may be pierceable, e.g. made of a pierceable material.
  • the cutting blade is mounted on and/or part of a rotatable plunger.
  • the plunger may be a rotatable, more or less cylindrical element configured to hold and/or carry the cutting blade.
  • the plunger and the cutting blade may be connected by form-fit or snap-fit only. Also, the form-fit may be used for correct placement during manufacturing only. Then, a connection can be established by gluing or welding.
  • the blade has one or two recesses (or other specially formed portions), which fit into respective counterparts of the plunger.
  • the plunger may further comprise a seal portion, the seal portion being arranged and configured such that after the collection of blood the sample container is and/or may be sealed by the seal portion such that the sample container is closed by the plunger and its seal.
  • the plunger may be used as a closure for the sample container. It may be pressed into the sample container as closure means after the blood collection. In particular, it may be pressed into the opening of the sample container by a finger, e.g. the thumb of the user, thereby closing and sealing the sample container and its opening.
  • the plunger further comprises a septum.
  • the septum may be used to create an opening, when the collected blood in the sample container shall be analyzed.
  • the septum can be pierceable. It is possible that a usual syringe needle can be used to pierce the septum and to remove the blood from the sample container.
  • the septum may be used by automatic analyzing machines and their analyte collectors, probes or sample takers.
  • the plunger and also the cap and the trigger allow an access to the septum.
  • Such access may be formed as a conical hole for guiding the probe for blood analysis.
  • the diameter of the conical hole at the largest opening should be approx. 4.5 mm so as to comply and allow compatibility with standard probes (of e.g. analyzing machines).
  • the cutting blade may comprise a cutting edge, wherein the cutting edge has an acute end and a rounded end.
  • the acute end may be used to dive into the skin of the patient, while doing the rotation and incision movement.
  • the rounded end is provided to create more handling safety of the blade and also to facilitate the rotation movement of the blade, further reducing the needed space of the blade.
  • the cutting edge of the cutting blade has an angle chosen in the range of 15°-25°, especially approx. 19°-21°, in other aspects approx. 20°. This angle has been found to create a very sharp incision, which is however due to its smooth but nevertheless sharp diving and cutting into the skin less painful than other incision or skin-opening or skin-piercing methods.
  • the acute end of the cutting blade has an angle chosen in the range of 45°-55°, especially approx. 47°-53°, in other aspects approx. 50°. This angle forms at the acute end a sharp tip, which will create the first contact with the skin and start the incision.
  • the rounded end of the cutting blade may have the same radius as the outer edge of the cutting blade on the side of the rounded end. This facilitates the rotational movement of the cutting blade. Further, the handling safety is enhanced.
  • FIG. 1 shows a perspective view of a part of the sample collection device according to one embodiment of the invention
  • FIG. 2 shows a perspective view of the system for extracting and collecting a sample of a fluid of a user according to one embodiment of the invention
  • FIG. 3 shows a perspective view of the system of FIG. 2 , and in particular the removing of its lid;
  • FIG. 4 shows a perspective view of the system of FIGS. 2 and 3 , without the lid;
  • FIG. 5 shows a perspective view of the system of FIG. 4 , wherein its vacuum creation mechanism is in a first position
  • FIG. 6 shows a perspective view of the system of FIG. 4 , wherein its vacuum creation mechanism is in a second position
  • FIG. 7 shows a perspective view of one embodiment of the system according to the invention, placed on an arm of a user
  • FIG. 8 shows a perspective view of a part of an embodiment of the system according to the invention, wherein the incision mechanism is in the first incision mechanism position;
  • FIG. 9 shows a perspective view of a part of the embodiment of the system of FIG. 8 , wherein the incision mechanism is in the second incision mechanism position;
  • FIG. 10A shows a perspective view of one embodiment of a part of the sample collection device according to one embodiment of the invention, wherein the cap is in the first cap position;
  • FIG. 10B shows a perspective view of one embodiment of the part of the sample collection device of FIG. 10A , wherein the cap is in the second cap position;
  • FIG. 11A shows a cross-section view of one embodiment of the sample extraction device of the system for extracting and collecting a sample of a fluid of a user according to the invention
  • FIG. 11B shows a cross-section view of one embodiment of the sample collection device according to the invention.
  • FIG. 11C shows a front view of the embodiment of the sample collection device of FIG. 11B ;
  • FIG. 12 shows a cross-section view of one embodiment of the system for extracting and collecting a sample of a fluid of a user according to the invention, wherein the sample collection device is inserted inside the sample extraction device;
  • FIG. 13 shows a cross-section view of the embodiment of the system of FIG. 12 , wherein the lid of the sample collection device is removed;
  • FIG. 14 shows a cross-section view of the embodiment of the system of FIG. 13 , approaching a user, e.g. an arm of the user;
  • FIG. 15 shows a cross-section view of the embodiment of the system of FIG. 14 , wherein the system is placed on the user;
  • FIG. 16 shows a cross-section view of the embodiment of the system of FIG. 15 , wherein the valve control mechanism is activated;
  • FIG. 17 shows a cross-section view of the embodiment of the system of FIG. 16 , wherein the suction created by the vacuum stretches and deforms the user's skin;
  • FIG. 18 shows a cross-section view of the embodiment of the system of FIG. 17 , wherein the incision mechanism is in the second incision mechanism position and the user's skin has been incised by the incision mechanism;
  • FIG. 19 shows a cross-section view of the embodiment of the system of FIG. 18 , wherein the blood is flowing from the incision created by the incision mechanism;
  • FIG. 20 shows a cross-section view of the embodiment of the system of FIG. 19 , wherein according to one embodiment at least one sensor of the system announces the user once the volume of the sample in the sample container has reached a predetermined value;
  • FIG. 21 shows a cross-section view of the embodiment of the system of FIG. 20 , wherein according to one embodiment the valve control mechanism is pressed to re-equilibrate the system to atmospheric pressure;
  • FIG. 22 shows a cross-section view of the embodiment of the system of FIG. 21 , wherein the system is removed from the user;
  • FIG. 23 shows a cross-section view of the embodiment of the system of FIG. 22 , wherein the cap is moved to the second cap position;
  • FIG. 24 shows a cross-section view of the embodiment of the system of FIG. 23 , wherein the cap is in the second cap position and seals the sample container;
  • FIG. 25 shows a cross-section view of the embodiment of the system of FIG. 24 , wherein the sealed sample container is removed from the suction pack;
  • FIG. 26 shows a cross-section view of the embodiment of the system of FIG. 25 , wherein the suction pack is removed from the sample extraction device;
  • FIG. 27A shows a front view of a part of the sample collection device according to one embodiment of the invention.
  • FIG. 27B shows one embodiment of a section view of the part of the sample collection device of FIG. 27A ;
  • FIG. 27C shows another embodiment of a section view of the part of the sample collection device of FIG. 27A ;
  • FIG. 28 shows another embodiment of a cross-section view of the sample extraction device
  • FIG. 29 shows another embodiment of a front view of the sample collection device
  • FIG. 30 shows a perspective view of another embodiment of the sample collection device according to the invention.
  • FIG. 31 shows a cross-section view of the embodiment of the sample collection device of FIG. 30 ;
  • FIG. 32 shows a perspective view of another embodiment of the sample collection device according to the invention.
  • FIG. 33 shows a cross-section view of the embodiment of the sample collection device of FIG. 32 ;
  • FIG. 34 shows another cross-section view of the embodiment of the sample collection device of FIG. 32 ;
  • FIG. 35A shows a cross-section view a part of another embodiment of the sample collection device according to the invention.
  • FIG. 35B shows another cross-section view of the embodiment of the sample collection device of FIG. 35A ;
  • FIG. 36 shows a perspective view of another embodiment of the system for extracting and collecting a sample of a fluid of a user according to the invention.
  • FIG. 37 shows an exploded view of the embodiment of the system of FIG. 36 ;
  • FIG. 38 shows a part of a cross-section view of the embodiment of the system of FIG. 36 ;
  • FIG. 39 shows another part of another cross-section view of the embodiment of the system of FIG. 36 ;
  • FIG. 40 shows a perspective view of one embodiment the triggering and incision mechanisms of system of FIG. 36 ;
  • FIG. 41A shows a perspective view (front side) of one embodiment of the sample collection device of the system of FIG. 36 ;
  • FIG. 41B shows a perspective view (rear side) of the embodiment of the sample collection device of FIG. 41A ;
  • FIG. 42 shows a top view of the system according to the invention, once placed near a user's member as an arm;
  • FIG. 43 shows an exploded view of a further embodiment of a sample collection device for collecting a blood sample of a patient of the present invention
  • FIG. 44A-C show details of the embodiment shown in FIG. 43 , the details being related to the functionality of the device;
  • FIG. 45A-E different view of the device of FIG. 43 ;
  • FIG. 46A-E different views of the sample container of the embodiment shown in FIG. 43 ;
  • FIG. 47A-F different views of the plunger and the cutting blade of the embodiment shown in FIG. 43 ;
  • FIG. 48A-B different views of the cutting blade of the embodiment shown in FIG. 43 ;
  • FIG. 49A-B different views of the torsion spring of the embodiment shown in FIG. 43 .
  • system for collecting and extracting the blood of a user comprising a blood collection device and a blood extraction device.
  • the invention is not limited to such a fluid, but includes also collection devices and extraction devices, both being arranged to collect respectively extract other kinds of fluid, in particular bodily fluids.
  • sample collection device and “sample extraction device”.
  • sample extraction device is a sample of a fluid, in particular a bodily fluid, e.g. blood, in particular capillary blood.
  • FIGS. 1-49 show example configurations with relative positioning of the various components. If shown directly contacting each other, or directly coupled, then such elements may be referred to as directly contacting or directly coupled, respectively, at least in one example. Similarly, elements shown contiguous or adjacent to one another may be contiguous or adjacent to each other, respectively, at least in one example. As an example, components laying in face-sharing contact with each other may be referred to as in face-sharing contact. As another example, elements positioned apart from each other with only a space there-between and no other components may be referred to as such, in at least one example. As yet another example, elements shown above/below one another, at opposite sides to one another, or to the left/right of one another may be referred to as such, relative to one another.
  • topmost element or point of element may be referred to as a “top” of the component and a bottommost element or point of the element may be referred to as a “bottom” of the component, in at least one example.
  • top/bottom, upper/lower, above/below may be relative to a vertical axis of the figures and used to describe positioning of elements of the figures relative to one another.
  • elements shown above other elements are positioned vertically above the other elements, in one example.
  • shapes of the elements depicted within the figures may be referred to as having those shapes (e.g., such as being circular, straight, planar, curved, rounded, chamfered, angled, or the like).
  • elements shown intersecting one another may be referred to as intersecting elements or intersecting one another, in at least one example.
  • an element shown within another element or shown outside of another element may be referred as such, in one example.
  • the system 300 for extracting and collecting a sample of a fluid of a user comprises two parts:
  • a sample extraction device 100 a sample extraction device 100 .
  • the sample collection device 200 is consumable and the sample extraction device 100 is on the contrary reusable.
  • the sample extraction device 100 is also a consumable.
  • the sample collection device 200 and the sample extraction device 100 can form one single system 300 that is consumable. An example of such consumable system 300 will be discussed with reference to FIG. 36 .
  • sample collection device 200 We will describe first the features of sample collection device 200 , secondly the features of sample extraction device 100 and at the end the method and system of collecting and extracting such a sample.
  • FIG. 1 shows a perspective view of a part of the sample collection device 200 according to one embodiment of the invention.
  • the sample collection device 200 according to one embodiment of the invention comprises:
  • a sample container 212 arranged to receive the sample and comprising an open end 2121 ;
  • a cap 202 arranged to cooperate with the sample container 212 so as to close the open end 2121 .
  • the sample container 212 is a tube, having substantially a cylindrical shape and comprising the open end 2121 and a closed end 2122 with a substantially spherical shape.
  • the tube is a “standard” tube, i.e. a tube compatible with standard blood analyzers of central laboratories.
  • the diameter of the standard tube belongs to the range 12 mm-16 mm, e.g. it is equal to 13 mm.
  • the length of the tube is less than a standard length, i.e. a length compatible with standard blood analyzers of central laboratories.
  • the tube can comprise connection means so as to connect it with an extension tube, so that the total length of the set comprising the tube and the extension tube is a standard length, for example a length ranging from 50 mm to 120 mm, e.g. equal to 75 mm.
  • this extension tube could also correct the final diameter of the tube.
  • the diameter of the tube could be smaller than the standard diameter, but it could be adjusted with a larger extension tube, so as to be compatible with standard blood analyzers of central laboratories.
  • connection means for connecting the tube with the extension tube are arranged such that they allow an easy connection of the tube with the extension tube, but they prevent or render difficult the disconnection of the extension tube from the tube. This feature is useful in particular if a label identifying the fluid sample is placed on the outer surface of the extension tube, so as to prevent a user from detaching the extension tube from the tube: the traceability of the fluid sample is then guaranteed.
  • those connection means comprise clip means and/or screwing means.
  • the tube is arranged for receiving at least 0.5 ml, and preferably 1 ml, of fluid sample, as will be discussed.
  • the sample container 212 may be (at least partially) transparent, so as to directly see its content.
  • the cap 202 is also a “standard” cap i.e. a cap compatible with standard blood analyzers of central laboratories.
  • the diameter of the outer part of the standard cap is 15 mm.
  • the sample container 212 and its cap 202 are placed in a suction pack 201 .
  • the size and the shape of the suction pack 201 are therefore arranged to receive the sample container 212 and the cap 202 .
  • the suction pack 201 is made, at least in part, of a flexible material.
  • the suction pack 201 has two main functions: 1) it is used as a packaging for the sample container 212 and its cap 202 ; 2) it serves as a suction cup in which vacuum is applied for user's skin suction and fluid collection, as will be discussed.
  • the suction pack 201 comprises a lid 207 , so as to guarantee the sterilization of its content and/or a barrier from moisture.
  • This lid 207 is removable. In one embodiment, it is a semi-permeable membrane that permits to maintain the inside of the suction pack 201 sterilized, for example Tyvek®.
  • the lid 207 is non-permeable: this allows to keep an airtight environment during storage and/or transport so as to prevent humidity from entering the suction pack 201 and/or the sample container 212 . In fact, humidity could affect the stability of the additives present in the sample container 212 .
  • the suction pack 201 is also (at least partially) transparent, so as to give a good visual indication of the integrity of its content.
  • the user or an operator, e.g. a nurse
  • the lid 207 of the suction pack 201 has not been open yet, as an indication that its content is still sterilized and safe to be used.
  • the suction pack 201 is made for instance of polycarbonate, PET-G, etc. so that a user or an operator can track progress of fluid collection by optically monitoring the level of the fluid sample in the sample container 212 .
  • the suction pack 201 comprises a semi-permeable membrane allowing the vacuum to enter in the suction pack.
  • the suction pack 201 comprises or it is made (at least partially) of materials enhancing the sealing between suction pack 201 and the skin of the user, so as to guarantee a good sealing between the skin and the suction pack 201 .
  • the suction pack 201 is a blister pack.
  • a blister packaging is that it is cost-effective, it can be closed by a removable lid 207 , and can be transported and handled while preserving the sterile condition of its content.
  • the cap 212 comprises:
  • a collection window 205 visible e.g. in FIGS. 8, 11B and 11C and arranged to enter in contact with the area or part of the user to be incised;
  • an incision mechanism movable in the cap 202 by the triggering mechanism from a first incision mechanism position (illustrated for example in FIG. 8 ) to a second incision mechanism position (illustrated for example in FIG. 9 ).
  • the incision mechanism when moving from the first incision mechanism position to the second incision mechanism position, the incision mechanism is arranged to incise the user at the collection window 205 so as to exit the sample from the user.
  • the cap 202 is always in a first cap position, illustrated for example in FIGS. 1, 8, 9 and 10A .
  • the cap 202 itself is arranged to be moved on the sample container 212 from a first cap position (illustrated for example in FIG. 1, 8, 9 or 10A ) to a second cap position (illustrated for example in FIG. 10B ), wherein, in both the first and in the second cap positions, the open end 2121 of the sample container 212 is at least partially in contact with the sample container 212 so as to guide the movement of the cap 202 from the first cap position to the second cap position.
  • the open end 2121 of the sample container 212 is closed by the cap 202 .
  • the cap 202 also includes a sealing mechanism (not illustrated), so as so seal the sample container when the cap is in the second cap position (illustrated for example in FIG. 10B ), so as to safely transport the sample.
  • the cap 202 integrates the incision mechanism
  • the same cap allows to seal the sample container 212 after that the fluid sample has been collected, so as to safely transport this fluid sample;
  • the fluid e.g. blood
  • the sample container 212 used for its transport and analysis, as the fluid falls down directly into the sample container 212 .
  • the movement of the incision mechanism requires no active actions from the user: in fact, it is triggered by a triggering mechanism in an automatic way, as will be described.
  • the movement of the cap 202 is manually performed by the user or by an operator. However, in another embodiment, it is automatically performed as well.
  • the cap 202 includes a first cap portion 2021 and a second cap portion 2022 .
  • the two portions 2021 , 2022 can be two distinct parts connected together by connecting means (not illustrated).
  • the cap 202 is a monobloc, i.e. it is made by a single piece comprising those two portions 2021 , 2022 .
  • the first cap portion 2021 comprises the collection window 205 .
  • the first cap portion 2021 comprises an opening 215 along the main direction of the first cap portion 2021 .
  • this opening 215 since this opening 215 is present, the first cap portion 2021 has a cross section with a substantially C shape.
  • At least a part 2021 ′ of this first cap portion 2021 is inserted during all the time of the working of the system 300 in the sample container 212 , so as to close the open end 2121 of the sample container 212 during the moving of the incision mechanism.
  • Another part 2021 ′′ of this first cap portion 2021 is outside of the sample container 212 , when the cap 202 is in its first position, as illustrated in FIG. 8 .
  • the second cup portion 2022 has a size larger than the size of the first cup portion 2021 . It is not adapted to enter into the sample container 212 , but rather to seal it.
  • the second cup portion 2022 comprises the above-mentioned sealing mechanism.
  • the second cup portion 2022 comprises a cavity 216 , visible in FIGS. 8 and 9 , for receiving the incision mechanism, and in particular the cutting element 206 , once the incision mechanism is in the second incision mechanism position (illustrated in FIG. 9 ), so that the incision mechanism is irreversibly and safely retracted in this cavity 216 so that it can no longer incise the user.
  • At least a part of the cap 202 is accessible by the user or by an operator, so as to manually extract the fluid sample from the sample container 212 , without detaching the cap 202 from the sample container 212 .
  • the incision mechanism comprises:
  • the support element 203 is a piston, which is for example visible in FIGS. 8 and 11B .
  • This support element is connected, preferably directly connected, to a cutting element 206 , so that once the support element 203 is moved, the cutting element 206 is moved as well.
  • the cutting element 206 may be a blade, or any other blade-like element capable of forming an opening in the skin of a user.
  • the elastic element 204 is a spring, which is for example visible in FIGS. 8 and 11B ; this elastic element 204 is blocked before the use of the system according to the invention, for example in a compressed position.
  • the elastic element 204 is free to be decompressed, and this decompression moves the support element 203 and then the cutting element 206 from the first incision mechanism position (visible e.g. in FIG. 8 ) to the second incision mechanism position (visible e.g. in FIG. 9 ).
  • the present invention is not limited to a compression elastic element only, i.e. an elastic element (e.g. a spring) that can be compressed and decompressed, but it also includes other elastic elements, e.g. torsion and/or traction elastic elements, i.e. elastic elements (e.g. springs) that can perform a movement of torsion and/or traction.
  • an elastic element e.g. a spring
  • other elastic elements e.g. torsion and/or traction elastic elements
  • elastic elements e.g. springs
  • the cutting element 206 is in the sample container 212 , so as to ensure the safety of the user and/or of an operator.
  • the movement of the incision mechanism from the first incision mechanism position to the second incision mechanism position is a linear movement (i.e. a translation) performed in a direction parallel to a surface of the user to be incised, as illustrated in FIG. 27B .
  • the movement of the incision mechanism from the first incision mechanism position to the second incision mechanism position is a circular movement (i.e. a rotation), as illustrated in FIG. 27C , wherein the axis of rotation of this circular movement is preferably a main axis of the sample container 212 .
  • this circular movement is possible if the elastic element 204 is a torsion elastic element 204 .
  • Another example of such circular movement will be discussed with reference to the embodiment of FIG. 36 .
  • the triggering mechanism of the sample collection device includes a triggering element, which is visible in for example FIGS. 11B and 11C .
  • This triggering mechanism includes a triggering element 209 , which in the illustrated embodiment is a half-ring surrounding at least a part of the support element 203 .
  • the triggering element 209 includes a protrusion 210 , e.g. a finger, which is arranged to be received by a corresponding cavity 211 in the support element 203 , so as to hold the triggering element 209 in the first triggering element position visible in for example FIG. 11B .
  • a protrusion 210 e.g. a finger
  • the cap 202 includes the triggering mechanism, in particular the triggering element 209 .
  • the support element 203 includes the triggering mechanism, in particular the triggering element 209 .
  • the system 300 is arranged to deform and/or stretch a part of the user's skin so that this deformed and/or stretched part will move the triggering element 209 from a first triggering element position (visible e.g. in FIG. 17 ), wherein it holds the elastic element 204 in a compressed position and the support element 203 in a fixed position in the sample container 212 , to a second triggering element position (visible e.g. in FIG. 18 ), wherein the triggering element 209 no longer holds the elastic element 204 nor the support element 203 .
  • a first triggering element position visible e.g. in FIG. 17
  • a second triggering element position visible e.g. in FIG. 18
  • FIG. 11A it comprises
  • a port 107 e.g. a cavity or a recess arranged to receive at least a part of the sample collection device 200 ;
  • a vacuum creation mechanism 108 arranged to create vacuum in the vacuum chamber 101 ; a non-limitative example of such vacuum creation mechanism is illustrated in FIGS. 5 and 6 ; the vacuum creation mechanism is preferably completely mechanical and devoid of electronics component;
  • valve or an assembly of valves 104 arranged to close and/or open the vacuum chamber 101 and/or to release the sample collection device ( 200 ) to atmospheric pressure;
  • valve control mechanism 102 arranged to command the valve 104 (or the assembly of valves) so as to transfer the vacuum from the vacuum chamber 101 to the sample collection device 200 , but also to release the sample collection device 200 to atmospheric pressure, in particular after collection.
  • vacuum indicates an area with a gaseous pressure much less than the atmospheric pressure, e.g. with a gaseous pressure between ⁇ 70 kPa and ⁇ 20 kPa compared to the atmospheric pressure, e.g. of about ⁇ 40 kPa.
  • the valve control mechanism 102 is a button, e.g. a push button, or an assembly of buttons. In one preferred embodiment, it is arranged to control three modes of the valve 104 , i.e. open, closed, release.
  • the sample extraction device comprising an electronic module 105 , visible e.g. on FIG. 11A , comprising a communication module (not illustrated) and a power supply (not illustrated).
  • the sample extraction device comprises at least a sensor 106 , e.g. an optic sensor, for detecting a predetermined sample volume in the sample container.
  • a sensor 106 e.g. an optic sensor
  • the sample extraction device comprises an alerting mechanism (not illustrated), indicating to the user the end of the sample extraction, e.g. by an audio and/or visible signal.
  • the sample extraction device comprises a gasket 103 , visible e.g. on FIG. 11A , cooperating with the area of the sample collection device 200 comprising a membrane 208 .
  • the membrane 208 is semi-permeable. In another variant, the membrane 208 is non-permeable: maintaining an airtight environment during storage and/or transport so as to prevent humidity from entering the suction pack 201 and/or the sample container 212 . In fact, humidity could affect the stability of the additives present in the sample container 212 .
  • the cap 202 is placed in and/or on the sample container 212 , so as to close its open end 2121 , as illustrated in FIG. 1 .
  • the sample container 212 and the cap 202 are packaged in the suction pack 201 , the suction pack 201 is closed by a lid 207 and the closed suction pack 201 , comprising the sample container 212 and the cap 202 , is sterilized.
  • the sample collection device 200 is consumable and the sample extraction device 100 is not consumable, that is, it is reusable. A new sample collection device 200 is then placed on or in the sample extraction device 100 , in particular in a port 107 of the sample extraction device 100 , visible in FIG. 11A .
  • the sample collection device 200 is then mechanically connected to the sample extraction device 100 , e.g. by using first and second connection means 120 respectively 220 , illustrated in FIGS. 11A and 11B .
  • any other kind of means guarantying a mechanical connection between the sample collection device 200 and the sample extraction device 100 can be used, e.g. and in a non-limiting way a magnet on a device and a ferromagnetic area on the other device, a screw or a rivet in a device and a hole in the other device, docking means, etc.
  • FIG. 12 shows a cross section view of one embodiment of the system for 300 extracting and collecting a sample of a fluid of a user according to the invention, before that the sample collection device 200 is inserted in the port 107 of the sample extraction device 100 .
  • the arrow F 1 indicates the movement of the sample collection device 200 to the sample extraction device 100 .
  • the sample collection device 200 and the sample extraction device 100 form the system 300 according to the invention.
  • FIG. 12 illustrates an embodiment in which the sample collection device 200 is moved to the extraction device 100 in the direction of the arrow F 1
  • this embodiment is not limitative and other possibilities can be imagined by the skilled person.
  • the sample collection device 200 could be slid in some (not illustrated) rails of the extraction device 100 in a direction perpendicular to the direction of the arrow F 1 .
  • the illustrated first and second connection means 120 respectively 220 will be modified accordingly.
  • FIG. 2 shows a perspective view of this system 300 according to one embodiment of the invention.
  • the arrow F 1 indicates the movement of the sample collection device 200 to the sample extraction device 100 .
  • sample collection device 200 and the sample extraction device 100 are arranged so that, when connected, the valve 104 and the possible gasket 103 of the sample extraction device 100 are placed in correspondence of the membrane 208 of the sample collection device 200 ; moreover, where present, the sensor(s) 106 of the sample extraction device 100 is(are) placed in correspondence of the sample container 212 of the sample extraction device 100 .
  • the system 300 according to the invention is portable. Its size allows it to be easily handled by a hand of a user.
  • it is substantially a parallelepiped.
  • other shapes are possible, e.g. a cylindrical shape.
  • its length is in the range of 5 cm to 20 cm, e.g. 10 cm.
  • the user removes the lid 207 of the suction pack 201 , as illustrated in FIG. 3 (arrow F 2 ) or 13 (arrow F 6 ).
  • the lid 207 guarantees the sterility of its content.
  • a membrane 208 of the sample collection device 200 contributes as well to prevent cross contamination of the fluid sample.
  • FIG. 4 An embodiment of the system 300 without the lid 207 is illustrated in FIG. 4 .
  • the suction pack 201 is (at least partially transparent) so that its content is visible.
  • a vacuum creation mechanism 108 (a piston in this case, comprising a rod 109 , which is moved in a direction F 3 and then in the opposite direction F 4 ) in the sample extraction device 100 so as to load vacuum into the vacuum chamber 101 .
  • the creation of the vacuum in the vacuum chamber 101 can be performed also before the removing of the lid 207 .
  • the vacuum does not need to be created by a user, e.g. by activating the vacuum creation mechanism 108 , but it is already pre-packaged in the system 300 according to the invention.
  • the system 300 comprises a chamber that is placed under vacuum in the manufacturing assembly line or in a healthcare facility. An example of this embodiment will be discussed with reference to FIG. 36 .
  • the system 300 approaches the user 400 (as illustrated in FIG. 14 ) and it is placed on the user 400 , as illustrated in FIGS. 7 and 15 .
  • the system 300 according to the invention is placed on the user arm, in particular an arm kept vertical, in particular with an orientation so that the cap 202 is on top and the bottom of the sample container 212 is at the bottom with respect to the vertical.
  • it could be placed also on other parts of the user (e.g. legs, body, etc.), as long as this part is kept is substantially vertical (i.e. substantially parallel to the direction z of the force of gravity g) or forms a predetermined angle ⁇ with this direction z.
  • the angle ⁇ formed by the direction a of the main axis of the system 300 according to the invention and the direction z of the force of gravity g is comprised in the range 0°-45°.
  • the system 300 advantageously exploits also the gravity force (in combination with the vacuum) for extracting the desired volume of the fluid sample.
  • valve control mechanism 102 which in the example of FIG. 16 is a push-button which is pushed in the direction of the arrow F 8 .
  • valve control mechanism 102 can be used instead of a push button, e.g. a rotatory button, etc.
  • the valve control mechanism 102 permits to open the valve 104 so as to transfer the vacuum from the vacuum chamber 101 of the sample extraction device 100 to the suction pack 201 .
  • this transfer is performed through an opening 218 in the suction pack 201 , which is covered by a membrane 208 located in the suction pack 201 .
  • the membrane 208 is made of the same material of the lid 207 (e.g. Tyvek®).
  • This membrane 208 may protect the system 300 from blood contamination that could result in growth of bacteria and cross contamination between patients.
  • the membrane 208 while letting air go through, prevents bodily fluids like blood permeation.
  • the vacuum created into the suction pack 201 permits also to maintain the whole system 300 against the skin of the user.
  • the user's part to be cut 401 is the user's part which enters into contact with the collection window 205 of the sample collection device.
  • the user's part to be cut 401 as stretched and/or deformed by the vacuum transferred in the suction pack 201 , actuates the triggering mechanism which in turn triggers the incision mechanism.
  • the stretching and/or the deformation of the skin in the collection window 205 displaces the triggering element 209 , which in the embodiment of FIG. 17 is a half-ring surrounding at least a part of the support element 23 (the piston in FIG. 17 ), so as to liberate the support element 23 .
  • the loaded elastic element 204 will displace the support element 203 of the incision mechanism inside the cap 202 .
  • the incision mechanism will be moved from a first incision mechanism position in the cap 202 (illustrated e.g. in FIG. 8 or 17 ) to a second incision mechanism position in the cap 202 (illustrated e.g. in FIG. 9 respectively 18 ).
  • this cutting element 206 will section a localized part 401 of the stretched and/or deformed skin in the collection window 205 .
  • the incision is triggered by skin stretching and/or deformation upon applying vacuum in the suction pack 201 : no user action is needed to trigger the incision.
  • the system 300 ensures that the skin is sufficiently stretched and/or deformed before triggering the incision mechanism.
  • the skin when stretched and/or deformed, presses against the triggering element 209 which, when pushed, displaced or deformed, releases the support element 203 onto which the cutting element 206 is connected.
  • the cutting element 206 moves along the (linear or circular) trajectory of the elastic element 204 to which it is attached and incises the skin on its trajectory.
  • the movement of the incision mechanism from the first incision mechanism position to the second incision mechanism position is a linear movement (i.e. a translation) performed in a direction parallel to a surface of the user to be incised.
  • the incision into the skin is relatively shallow (less than 5 mm, in particular less than 3 mm into the skin, in length; the depth varies between 1 mm and 2 mm).
  • the cutting element 206 makes a sharp cut into the skin.
  • the incision is advantageously made while applying vacuum and/or after vacuum is applied: the skin is deformed and/or stretched and/or pinched into the sample collection device 200 before performing the incision, which reduces the feeling of the pain of the incision.
  • At least a part of the edge 219 of the sample container 212 is in contact with the user 400 at a contact point or region P, at or under the incision on the user 400 made by the incision mechanism of the system 300 .
  • This contact point or region P guarantees that there is no space between the user 400 and the sample container 212 , so that the fluid sample can fall down in the sample container 212 .
  • at least a part of the edge 219 is an edge of the collection window.
  • the cutting element 206 is retracted into the cap 202 , in particular into a cavity 216 visible in FIGS. 8 and 9 , with no risk of injury or contamination to anyone handling the sample collection device 200 .
  • the cutting element 206 is placed at an angle ⁇ (illustrated for example in FIG. 34 ) to maximize the surface cut, without increasing the incision depth.
  • the cutting element 206 can be positioned at a 90° angle with the skin, or it can be placed at a 45° angle with regard to the normal axis of the skin, maximizing the surface of the incision without increasing depth of the incision.
  • the plane containing the cutting element 206 can be positioned anywhere between 45° and 90° with regard to the plane of the skin of the user.
  • the length of the trajectory of the cutting element 206 allows to cut more capillaries so as to maximize the blood flow.
  • the vacuum in the system 300 has therefore three main functions: 1) it maintains the system 300 on the user during fluid sample collection; 2) it stretches and/or deforms the skin of the user creating a localized vasodilation of capillaries of the user; and 3) it extracts bodily fluid, e.g. blood from capillaries after the incision has been made.
  • the frictional forces between the skin and the suction pack 201 have to be minimized. This can be done e.g. by using the right surface properties of the suction pack 201 and materials inside the suction pack 201 and/or the coating of the suction pack 201 and materials inside the suction pack 201 and/or coating of the skin with a silicone gel, a silicone spray or any other lubricant.
  • the seal between the skin and the suction pack 201 can be enhanced and better guaranteed if no air can penetrate between the skin and the suction pack 201 .
  • a silicone gel, a silicone spray or any other lubricant placed between the suction pack 201 and the skin can play the role of a sealing agent.
  • the materials chosen and the use of a lubricant on the suction pack 201 or on the skin will be used to enhance vacuum.
  • the fluid e.g. the blood
  • a sealing edge (illustrated for example in FIGS. 31 and 33 , reference number 219 ′) ensures that fluid doesn't flow out of the sample container 212 , the edge of the sample container 212 being positioned near the incision 401 .
  • the drops of fluid 500 formed at the incision point fall into the sample container 212 by exploiting the gravity force g.
  • the system 500 is designed to collect about 1 ml of fluid sample 500 .
  • the sample container 212 has a size similar to the tubes used for venipuncture (e.g. diameter 13 mm), making it compatible with known blood analyzers.
  • the blood extraction device 100 comprises at least a sensor 106 , e.g. an optical sensor in correspondence of the closed end 2121 of the sample container 212 , so as to detect the fluid sample volume.
  • the sensor(s) 106 are placed in alternative or also on the sample collection device 200 .
  • the system 300 indicates to the user (or the operator) the end of fluid sampling, e.g. by a light, a sound or any other appropriated signals.
  • valve control mechanism 102 or another valve control mechanism to put back the system 300 , and in particular the suction pack 201 , at atmospheric pressure.
  • the user removes the system 300 from the skin of the user 400 .
  • the system 300 is arranged to collect a bodily fluid without the need of high-skill training. It could be used by doctors, nurses, non-trained personnel, or by the user (i.e. the patient) himself.
  • the system 300 is designed to require minimal action from the user.
  • the system 300 is positioned on the user, preferably on his arm, kept vertical and pressed against the skin.
  • the user only actuates the valve control mechanism 102 to trigger vacuum.
  • the vacuum stretches and/or deforms the skin into the suction pack 201 , maintaining it in place against the user.
  • the user does not need to hold the system 300 , he waits for the blood to be collected.
  • the user is informed by the system 300 and then actuates again the valve control mechanism 102 to put back the system 300 to atmospheric pressure.
  • the time for collecting about 1 mL of bodily fluid is in the range of 1 min to 8 min, in particular 5 min.
  • the rate with which the fluid, in particular blood, exits from the user once cut by the cutting element 206 of the system 300 is in the range 4 mg/s to 11 mg/s.
  • the user moves the cap 202 onto the sample container 212 to seal it.
  • the cap 202 is moved when it is still in the suction pack 201 , to avoid any spillage.
  • the cap 202 and the sample container 212 are taken out of the suction pack 201 and then the sample container 212 is sealed by the cap 202 .
  • the movement of the cap 202 from the first cap position to the second cap position is a linear movement, the cap 202 sliding onto (the outer surface of) the sample container 212 during this linear movement, as illustrated by the arrow F 12 in FIG. 23 .
  • the movement of the cap from the first cap position to the second cap position is in complement or in alternative a circular movement.
  • the cap 202 can be screwed onto (the outer surface of) the sample container 212 .
  • the sealed sample container 212 can be removed from the suction pack 201 and it is ready for transport and for sample analysis.
  • the suction pack 201 can then be removed from the sample extraction device 100 .
  • the suction pack 201 is first removed from the sample extraction device 100 , and them the sample container 212 with the cap 202 are removed from the suction pack 201 .
  • the sample collection device 100 may be used for combining sample collection and testing.
  • the sample container 212 located in the sample collection device 100 may contain one or several biomarkers pads 214 reacting with the fluid sample, allowing a direct analysis of the fluid sample by the system 300 .
  • the chemical reaction will produce a signal, e.g. a visible signal (light, color, etc.) which is proportional to the concentration the target to the measuring in the fluid sample (non-exhaustive list: e.g. fluorescence, reflectance photometry, etc.).
  • the change in color are captured by the sensor(s) 106 of the sample extraction device and converted into a concentration.
  • the sample collection device 200 in particular the sample container 212 , comprises an ID element 217 , e.g. a QR code, a barcode, a number, a RF tag etc.
  • an ID element 217 e.g. a QR code, a barcode, a number, a RF tag etc.
  • sample collection device 200 and/or the sample extraction device 100 is (are) arranged so as to store data e.g. blood collection data (such as time of blood collection, level of blood collected, etc.), patient information, sample container barcodes, doctor's prescription data, and the like.
  • data e.g. blood collection data (such as time of blood collection, level of blood collected, etc.), patient information, sample container barcodes, doctor's prescription data, and the like.
  • sample collection device 200 and/or the sample extraction device 100 is (are) arranged so as to communicate with external devices, in particular portable devices (e.g. smartphones, tablets, etc.) or also to cloud services to which the data can be transferred.
  • portable devices e.g. smartphones, tablets, etc.
  • cloud services to which the data can be transferred.
  • FIGS. 30 and 31 show a perspective view respectively a cross-section view of another embodiment of the sample collection device 200 according to the invention.
  • the trigger element 209 is a demi-ring over the cap 202 .
  • the blade 206 is inclined at an angle ⁇ with regard to the normal axis of the skin (which correspond to the normal axis of the piston 203 when the system 300 is placed on the user's skin), this angle being different from 90°. This allows the cutting element to enter more tangentially into the user's skin.
  • the cap 202 is over a part of the sample container 212 .
  • the cap 202 does not enter into the sample container 212 , but rather the sample container 212 , in particular at least its end 2121 , enters into the cap 202 .
  • the sample container 212 comprises at least two portions 2123 , 2124 , having different diameters d 1 respectively d 2 .
  • the diameter d 1 is a standard diameter according to the definition given above.
  • FIGS. 30, 31 can be combined with any of the other previously or later described embodiments.
  • FIGS. 32, 33 and 34 show a perspective view respectively cross-section views of another embodiment of the sample collection device 100 according to the invention.
  • the trigger element 209 is not a demi-ring over the cap 202 , as in FIGS. 30 and 31 .
  • the trigger element 209 is a tab 209 ′ in the cap 202 , which is held in place by the finger 210 ′.
  • the skin of the user once deformed by the vacuum, will move the tab 209 ′ in the direction of the arrow F 14 , by liberating the tab 209 ′ from the finger 210 ′ so as to liberate the elastic element 204 and therefor the piston 203 with the cutting element 206 .
  • the blade 206 is inclined at an angle ⁇ with regard to the normal axis of the skin, this angle being different from 90°, as in FIGS. 30 and 31 .
  • the cap 202 is over a part of the sample container 212 , as in FIGS. 30 and 31 .
  • the sample container 212 comprises two portions 2123 , 2124 , having different diameters d 1 respectively d 2 as in FIGS. 30 and 31 .
  • the features illustrated in the embodiment of FIGS. 32, 33 and 34 are not necessarily together present.
  • the embodiment of FIGS. 32, 33 can be combined with any of the other previously or later described embodiments.
  • FIGS. 35A and 35B show cross-section views of another embodiment of the sample collection device 200 according to the invention.
  • the support element 203 comprises a protrusion 230 , which, once the support element is moved in the direction of the arrow F 15 by the triggering mechanism, will enter into contact with the finger 232 of the cap 202 : this will cause a mechanical movement of all the support element 203 , and then of the cutting element 206 , toward the user's skin, so that the cutting element will move toward the user's skin while cutting it. In such a way, a deeper cut could be realized in the user's skin.
  • the shape and the size of the protrusion 230 and/or of the finger 232 are selected so that the movement of the cutting element 206 toward the user's skin is performed while the cutting element 206 is cutting the user's skin.
  • Other means can be imagined in order to move the cutting element 206 toward the user's skin while it cuts the skin. This embodiment can be combined with any of the other previously or later described embodiments.
  • FIG. 36 shows a perspective view of another embodiment of the system 300 for extracting and collecting a sample of a fluid of a user according to the invention.
  • the system 300 is fully consumable/disposable
  • the vacuum is already pre-packaged in the system 300 ;
  • the triggering mechanism is configured so as to perform a circular movement
  • the incision mechanism is configured so as to perform a circular movement
  • the suction pack comprises an opening which is narrow near or at the collection window
  • the lid is not permeable
  • the part(s) in contact with the skin is(are) adapted so as to fit to the shape of the user contacting part; —etc.
  • FIG. 37 shows an exploded view of the embodiment of the system 300 of FIG. 36 .
  • the suction pack 201 present in the previously described embodiments is a first suction pack 201 (or inner suction pack 201 ), and the system 300 comprises a second suction pack 110 (or outer suction pack 110 ).
  • the first suction pack 201 comprises a cavity 2010 arranged to receive the sample container 212 and the cap 202 and having a first thickness.
  • the second suction pack 110 comprises a cavity 1100 having a second thickness, which is greater than the first thickness.
  • the first suction pack 201 is arranged to be received by the second suction pack 110 , so that the difference between the two thicknesses creates a chamber that is placed under vacuum in the manufacturing assembly line or in a healthcare facility.
  • the pre-packaged vacuum is made by adding a second suction pack 110 on top of the first suction pack 201 so to create this chamber.
  • the first and second suction packs are arranged so that, once the second suction pack 110 receives the first suction pack 201 , they can be permanently sealed together.
  • the system 300 of the embodiment of FIG. 37 comprises also means for transferring the vacuum from the chamber placed under vacuum in the manufacturing assembly line or in a healthcare facility (in the following, second vacuum chamber) to the first vacuum chamber 101 , once a user wished to activate the system 300 .
  • the second suction pack 110 comprises a bistable element (as a button) on one of its outer surfaces.
  • a bistable element as a button
  • FIG. 38 shows a part of a cross-section view of the embodiment of the system of FIGS. 36, 37 .
  • the first suction pack 201 comprises also a piercing protrusion (reference 2014 in FIG. 34 ).
  • the bistable element 2012 e.g. pressing on the second suction pack 110
  • the piercing protrusion 2014 will pierce a membrane 208 placed on the first suction pack 201 , thereby transferring the vacuum in the first vacuum chamber or collection chamber. This will start the collection of the liquid sample.
  • this membrane is non-permeable, so as to avoid a vacuum transfer before the use of the system 300 .
  • the second suction pack 110 comprises also one or more holes 2010 , completely covered by a removable cap 140 , e.g. a rubber removable cap 140 .
  • a removable cap 140 e.g. a rubber removable cap 140 .
  • the user can remove, e.g. by pulling, the removable cap 140 so as to lower the pressure in the collection chamber to the atmospheric pressure, thereby stopping the start of the collection of the liquid sample.
  • a (removable) label 130 can cover the back of the second suction pack 110 .
  • FIG. 39 shows another part of another cross-section view of the embodiment of the system of FIG. 36 .
  • the cutting element 206 makes an incision in the skin of the user by moving into a rotational movement around the main central axis of the tube (and cap 202 ). This rotational movement allows to have a more compact triggering and incision mechanism. In fact, by choosing a rotational movement of the cutting element 206 , the overall length of the triggering mechanism is reduced, allowing for a smaller dimension of the cap 202 and a smaller overall system 300 .
  • the cap 202 comprises on its top one or more deformable elements 2020 , visible in FIG. 39 , which is(are) arranged to be deformed in the direction of the arrow F 16 .
  • the deformable element(s) 2020 is(are) part of the triggering mechanism.
  • the skin is sucked into the chamber and presses against the deformable element(s) 2020 on the cap 202 .
  • the deformable element(s) 2020 free the rotational piston 203 previously loaded with a (torsion) spring 204 .
  • FIG. 41A shows a perspective view (front side) of one embodiment of the sample collection device of the system of FIG. 36 .
  • FIG. 41B shows a perspective view (rear side) of the embodiment of the sample collection device of FIG. 41A .
  • the triggering element is part of the cap 202 .
  • the deformable elements 2020 belong to a supplementary piece, fixed (in a movable or unmovable way) to the cap 202 .
  • the deformable elements 2020 are larger than in previous variants, for a wider area of contact between the skin and the triggering mechanism permitting to have more reliability in the triggering mechanism.
  • the cap 202 comprises a liberation notch 2021 .
  • the skin will press the triggering surface 2022 of the cap 202 , by pushing the notch 2021 and setting the piston 203 free.
  • Increasing the length of the collection window 205 allows to improve the skin stretching. Having a rotational movement of the cutting element 206 allows that the length of the incision is not dependent on the length of the collection window 205 (proportional the window's width), as it is the case with a translational movement of the cutting element 206 .
  • the cavity 2010 of the suction pack 201 arranged to receive the collection container 212 , has a waisted shape, which is narrower at or near the collection window 205 , in particular at or near the incision area, so as to allow for a better stretching of the skin.
  • the applicant has noticed that the skin deforms well along the edges 2011 of the cavity 2010 of the suction pack 201 .
  • the edges of the cavity 2010 of the suction pack 201 are arranged closer to the incision area, by making it narrower.
  • FIG. 42 shows a top view of the system 300 according to the invention, once placed near a user's member as an arm.
  • the suction pack 201 in contact with the skin, has a shape and/or a curvature 2013 to fit the shape and/or the curvature of the arm of the user 400 to ensure a better seal between the skin and the suction pack 201 .
  • this shape and/or this curvature can be adapted or changed by the user, so as to better fit with the user, in particular with young users.
  • FIG. 43 to FIG. 49B show a further embodiment of a sample collection device 3200 for collecting a blood sample 3500 of a patient of the present invention.
  • the sample collection device 3200 comprises the same structural and functional features and capabilities as the embodiments described above. It can be combined with one or several of the above described features of the already described sample collection devices.
  • FIG. 43 shows an exploded view of a further embodiment of a sample collection device 3200 for collecting a blood sample of a patient of the present invention.
  • the sample collection device 3200 comprises a first shell 3110 and a second shell 3201 .
  • the first shell 3110 is a partially deformable shell 3110 .
  • the shell 3110 comprises a deformable button 3224 .
  • the deformable button is integrally formed within the shell 3110 . In this area, the shell is deformable in a predefined manner, i.e. such that it allows an elastic or plastic deformation by pressing in this section.
  • the button 3224 has a size that is oriented on the size of human thumbprint. The diameter of the button 3224 in the shown embodiment is approx. 30 mm.
  • the shell 3110 has an electronic module port 3226 .
  • the electronic module port 3226 is formed integrally in the shell 3110 .
  • the electronic module port 3226 is formed by means of a recess.
  • the electronic module port 3226 is configured for receiving and holding an electronic module 3220 .
  • the electronic module 3220 is an optional element. It can be reusable, whereas the rest of the sample collection device 3200 can be a disposable.
  • the electronic module 3220 can comprise the sensors described in this disclosure (cf. especially description parts above).
  • the electronic module 3220 can comprise electronic components configured to execute computer-readable instructions for measuring blood volume, but also may be used for in-situ diagnostics. It can comprise at least one of the following elements, e.g. one or more sensors (of any kind such as temperature sensor, pH-sensor, pressure sensor etc.), one or more power storage units such as a battery, an electronic circuit, at least one communication module, at least one controller, at least one processor, at least one telemetry unit etc.
  • sensors of any kind such as temperature sensor, pH-sensor, pressure sensor etc.
  • power storage units such as a battery
  • an electronic circuit e.g. one or more communication module, at least one controller, at least one processor, at least one telemetry unit etc.
  • the second shell 3201 is a partially pierceable shell 3201 .
  • the partial pierceable portion is, however, provided by the membrane 3208 , which is place in the pierceable membrane position 3238 . In this position, the membrane 3208 is firmly welded to the second shell 3201 .
  • the second shell 3201 is configured such that in the mounted state a sample container 3212 and an automatic mechanical cutting mechanism is held by the second shell 3201 .
  • the second shell 3201 comprises a base plate 3230 with stabilization ribs 3228 and a main holder recess 3229 .
  • the ribs 3228 prevent collapsing of the first shell 3110 under vacuum.
  • ribs there can be also different arrangements and designs of the ribs.
  • a rib design having e.g. at least one circumferential rib encircling the main holder recess 3229 . Then the rib can encircle the main holder recess 3229 with the form of an oval.
  • the rib(s) 3228 can be positioned vertical to the base plate 3230 .
  • the collection opening comprises a narrow portion in the area of the cutting mechanism.
  • the narrow portion is formed by rounded protrusions 3230 a of the base plate 3230 .
  • the function of this narrow portion is already explained above in greater detail. It facilitates the blood collection and incision process.
  • the base plate 3230 is curved to better fit and adjust to the skin surface of e.g. a human arm.
  • the base plate 3230 can be made of a rigid plastic material (medical grade). All elements of the device 3200 are made of plastic (except the electronic module 3220 and the spring 3204 and the cutting blade 3206 ).
  • On the outside of the main holder recess 3229 there is vacuum unlocking element 3234 in the form of a bendable arm carrying a piercing portion of vacuum unlocking element 3236 .
  • the base plate 3230 also comprises a handle portion 3232 . With the handle portion, the sample collection device 3200 can be removed from the sample collection side, when the collection process is finished.
  • the handle portion 3232 or tab 3232 can be also formed on the first shell 3110 or on both the first shell 3110 and the second shell 3201 .
  • lid 3207 To enclose and to ensure sterility of the automatic mechanical cutting mechanism and the sample container within the main holder recess 3229 of the second shell 3201 , there is a lid 3207 (as already described above in connection with lid 207 ).
  • the automatic mechanical cutting mechanism comprises a trigger 3209 , an actuator spring 3204 (here a torsion spring 3204 ), a plunger 3203 holding a cutting blade 3206 , a cap 3202 and a sample container 3212 .
  • the sample container 3212 is formed as a cylindrical tube with a closed and an open end, the open end being oriented to the cap and plunger 3203 .
  • the plunger 3203 further comprises a seal 3203 a and a septum 3203 b .
  • the seal 3203 a is formed as an O-Ring on the radial outside of the plunger 3203 .
  • FIG. 44A-C show details of the device 3200 shown in FIG. 43 , the details being related to the functionality of the device 3200 .
  • step S 1 the user deforms the button 3224 of the blister 3110 (i.e. the first shell 3110 ), after he has put the device 3200 on the collection site, e.g. being located in the arm of the patient.
  • step S 2 the deformable arm 3234 (also deformable beam 3234 ) is deflected by this and pierces the aluminum membrane 3208 (placed in position 3238 ).
  • step S 3 the vacuum is liberated.
  • step S 4 the skin is stretched and pressed on the trigger 3209 .
  • step S 5 the trigger 3209 liberates the spring-loaded plunger 3203 , whereas the spring load is created by the torsion spring 3204 (cf. also FIG. 49A and FIG. 49B ).
  • step S 6 the cutting blade 3206 firmly mounted to the released plunger 3203 rotates and creates an incision in the stretched skin.
  • step S 7 blood is flowing into the tube 3212 and is collected there.
  • step S 8 the user pulls the handle 3232 to stop the blood collection, thereby releasing the device 3200 from the skin.
  • the closure of the tube 3212 is described below.
  • the tube 3212 carrying blood 3500 can be closed and sealed.
  • Closing of the tube 3212 can be effected by simply putting a finger into the interspace 3240 (cf. FIG. 44C ), then pressing all parts together and thereby closing and sealing the sample container.
  • FIG. 45A-E show different views of the device 3200 of FIG. 43 .
  • FIG. 46A-E show different views of the sample container of the embodiment shown in FIG. 43 in connection with extension tubes 3250 (as already described above).
  • FIG. 47A-F show different views of the plunger 3203 and the cutting blade 3206 of the embodiment shown in FIG. 43 .
  • FIG. 48A-B show different views of the metal cutting blade of the embodiment shown in FIG. 43 .
  • the cutting blade 3206 comprises a cutting edge 3206 a , wherein the cutting edge 3206 a has an acute end 3206 b and a rounded end 3206 c .
  • the cutting edge 3206 a of the cutting blade 3206 can have an angle ⁇ chosen in the range of 15°-25°, especially approx. 19°-21°, here of 20°. A deviation of ⁇ 1° is not problematic and will be tolerated in this embodiment.
  • the acute end 3206 b of the cutting blade 3206 can have an angle ⁇ chosen in the range of 45°-55°, especially approx. 47°-53°, here of approx. 50°.
  • the rounded end 3206 c of the cutting blade 3206 has the same radius R as the outer edge of the cutting blade 3206 on the side of the rounded end 3206 c.
  • FIG. 49A-B are different views of the metal torsion spring 3204 of the embodiment shown in FIG. 43 .
  • the torsion spring 3204 is shown it the loaded position Cl and the unloaded position C 3 .
  • a sample container ( 212 ) arranged to receive said sample ( 500 ) and comprising an open end ( 2121 );
  • a triggering mechanism ( 209 , 210 , 209 ′, 210 ′, 211 );
  • a cap ( 202 ) arranged to cooperate with said sample container ( 212 ) so as to close said open end ( 2121 ), said cap ( 202 ) being arranged to be moved in and/or on the sample container ( 212 ) from a first cap position to a second cap position, wherein in the first and in the second cap positions said cap ( 202 ) is at least partially in contact with said sample container ( 212 ) so as to guide the movement of the cap ( 202 ) from the first cap position to the second cap position, said cap ( 202 ) comprising:
  • Aspect 2 The sample collection device ( 200 ) of aspect 1, wherein said cap ( 202 ) comprises a first cap portion ( 2021 ) and a second cap portion ( 2022 ), wherein the first cap portion ( 2021 ) comprises the collection window ( 205 ) arranged to enter into contact with the user.
  • Aspect 3 The sample collection device ( 200 ) of aspect 2, wherein said cap ( 202 ) comprises an opening ( 215 ), the collection window ( 205 ) comprising a part of said opening ( 215 ).
  • Aspect 4 The sample collection device ( 200 ) of one of aspects 2 or 3, wherein at least a part ( 2021 ′) of said first cap portion ( 2021 ) is inserted in the sample container ( 212 ).
  • Aspect 5 The sample collection device ( 200 ) of one of aspects 2 to 4, wherein the second cup portion ( 2022 ) comprises a cavity ( 216 ) for receiving the incision mechanism ( 203 , 204 , 206 ) once it is in said second incision mechanism position, so that the incision mechanism ( 203 , 204 , 206 ) is irreversibly and safely retracted in this cavity ( 216 ) so that it can no longer incise the user.
  • Aspect 6 The sample collection device ( 200 ) of one of aspects 1 to 5, said incision mechanism ( 203 , 204 , 206 ) comprising:—a support element ( 203 ), e.g. a piston, comprising a cutting element ( 206 ), e.g. a blade or blade-like element; —an elastic element ( 204 ), e.g. a spring, being blocked in a compressed position, said elastic element ( 204 ), once the incision mechanism is triggered, being free to be decompressed, said decompression moving the support element ( 203 ) and then the cutting element ( 206 ) from the first incision mechanism position to the second incision mechanism position.
  • a support element ( 203 ) e.g. a piston
  • a cutting element ( 206 ) e.g. a blade or blade-like element
  • an elastic element ( 204 ) e.g. a spring
  • Aspect 7 The sample collection device ( 200 ) of aspect 6, wherein when in the first incision mechanism position, the cutting element ( 206 ) is in the sample container ( 212 ), so as to ensure the safety of the user and/or of an operator.
  • Aspect 8 The sample collection device ( 200 ) of one of aspects 1 to 7, wherein the movement of the incision mechanism ( 203 , 204 , 206 ) from the first incision mechanism position to the second incision mechanism position is a linear movement performed in a direction parallel to the area of the user to be incised.
  • Aspect 9 The sample collection device ( 200 ) of one of aspects 1 to 7, wherein the movement of the incision mechanism ( 203 , 204 , 206 ) from the first incision mechanism position to the second incision mechanism position is a circular movement, wherein the axis of rotation of this circular movement is preferably a main axis of the sample container ( 212 ).
  • Aspect 10 The sample collection device ( 200 ) of one of aspects 1 to 9, wherein the support element comprises a protrusion ( 230 ) cooperating with a finger ( 232 ) of the cap ( 202 ) so that the movement of the incision mechanism ( 203 , 204 , 206 ) from the first incision mechanism position to the second incision mechanism position is toward the user's skin while the incision mechanism ( 203 , 204 , 206 ) cuts the skin.
  • the support element comprises a protrusion ( 230 ) cooperating with a finger ( 232 ) of the cap ( 202 ) so that the movement of the incision mechanism ( 203 , 204 , 206 ) from the first incision mechanism position to the second incision mechanism position is toward the user's skin while the incision mechanism ( 203 , 204 , 206 ) cuts the skin.
  • Aspect 11 The sample collection device ( 200 ) of one of aspects 1 to 10, wherein the movement of the cap ( 202 ) from the first cap position to the second cap position is a linear movement, the cap sliding onto the sample container ( 212 ) during said linear movement.
  • Aspect 12 The sample collection device ( 200 ) of one of aspects 1 to 10, wherein the movement of the cap ( 202 ) from the first cap position to the second cap position is a circular movement.
  • Aspect 13 The sample collection device ( 200 ) of one of aspects 1 to 12, comprising a suction pack ( 201 ) arranged to receive the sample container ( 212 ) and the cap ( 202 ), and to be sterilized, the suction pack ( 201 ) comprising a membrane ( 208 ) allowing the vacuum to enter in the suction pack ( 201 ).
  • Aspect 14 The sample collection device ( 200 ) of aspect 13, the suction pack ( 201 ) comprising a removable lid ( 207 ), in particular a non-permeable removable lid ( 207 ), so as to guarantee a barrier from moisture and ensure sterilization of its content.
  • Aspect 15 The sample collection device ( 200 ) of one of aspects 13 or 14, the suction pack ( 201 ) being at least partially transparent.
  • Aspect 16 The sample collection device ( 200 ) of one of aspects 13 to 15, comprising lubricant materials inside the suction pack ( 201 ) and/or on the suction pack ( 201 ) so as to enhance the sealing between the suction pack ( 201 ) and the user.
  • Aspect 17 The sample collection device ( 200 ) of one of aspects 6 to 16, said triggering mechanism ( 209 , 210 , 209 ′, 210 ′, 211) comprises a triggering element ( 209 ) arranged to be moved from a first triggering element position, wherein it holds the elastic element ( 204 ) in a blocked position, e.g. in a compressed position, and the support element ( 203 ) in a fixed position, to a second triggering element position wherein the triggering element ( 209 ) no longer holds the elastic element ( 204 ) nor the support element ( 203 ).
  • Aspect 18 The sample collection device ( 200 ) of aspects 17, the cap ( 202 ) comprising the triggering element ( 209 ), which for example is a half-ring surrounding at least a part of the support element ( 203 ), or a tab ( 209 ′) in the cap ( 202 ).
  • the triggering element ( 209 ) which for example is a half-ring surrounding at least a part of the support element ( 203 ), or a tab ( 209 ′) in the cap ( 202 ).
  • Aspect 19 The sample collection device ( 200 ) of one of aspects 17 to 18, the triggering element comprising a protrusion ( 211 ), e.g. a finger, the support element comprising a cavity ( 210 ) arranged to receive said protrusion ( 211 ) so as to hold the triggering element ( 209 ) in the first triggering element position.
  • the triggering element comprising a protrusion ( 211 ), e.g. a finger
  • the support element comprising a cavity ( 210 ) arranged to receive said protrusion ( 211 ) so as to hold the triggering element ( 209 ) in the first triggering element position.
  • Aspect 20 The sample collection device ( 200 ) of one of aspects 1 to 19, said cap ( 202 ) being a standard cap arranged to be automatically opened by a blood analysis apparatus.
  • Aspect 21 The sample collection device ( 200 ) of the previous aspect, the diameter of the second portion ( 2022 ) of the standard cap being 15 mm.
  • Aspect 22 The sample collection device ( 200 ) of one of aspects 1 to 21, said sample container ( 212 ) being a tube, in particular a standard tube being arranged to be entered in a blood analysis apparatus.
  • Aspect 23 The sample collection device ( 200 ) of the previous aspect, a diameter (d 1 ) of the standard tube being comprised in the range 12 mm to 16 mm, e.g. 13 mm.
  • Aspect 24 The sample collection device ( 200 ) of one of aspects 1 to 23, said sample container ( 212 ) being arranged for receiving at least 0.5 ml, and preferably 1 ml, of fluid sample ( 500 ).
  • Aspect 25 The sample collection device ( 200 ) of one of aspects 1 to 24, said sample container ( 212 ) being at least partially transparent.
  • Aspect 26 The sample collection device ( 200 ) of one of aspects 1 to 25, said sample collection device ( 100 ) being consumable.
  • Aspect 27 The sample collection device ( 200 ) of one of aspects 1 to 26, the sample container ( 212 ) comprising one or several biomarkers pads ( 214 ) reacting with the fluid sample, allowing a direct analysis of the fluid sample.
  • Aspect 28 The sample collection device ( 200 ) of one of aspects 1 to 27, said cap ( 202 ) comprising said triggering mechanism ( 209 , 210 , 209 ′, 210 ′, 211 ), in particular wherein said triggering mechanism comprises at least one deformable element ( 2020 ).
  • Aspect 29 The sample collection device ( 200 ) of one of aspects 1 to 28, said cap ( 202 ), the suction pack ( 201 ) being a first suction pack ( 201 ), the sample collection device ( 200 ) comprising a second suction pack ( 110 ), wherein the first suction pack ( 201 ) comprises a cavity ( 2010 ) arranged to receive the sample container ( 212 ) and the cap ( 202 ), and having a first thickness, wherein the second suction pack ( 110 ) comprises a cavity ( 1100 ), having a second thickness, which is greater than the first thickness, wherein the first suction pack ( 201 ) is arranged to be received by the second suction pack ( 110 ), so that the difference between the two thicknesses creates a chamber arranged to be placed under vacuum in the manufacturing assembly line or in a healthcare facility.
  • Aspect 30 The sample collection device ( 200 ) of aspect 29, wherein, the second suction pack ( 110 ) comprises a bistable element, wherein the first suction pack ( 201 ) comprises a piercing protrusion ( 2014 ), wherein once a user activates the bistable element ( 2012 ), the piercing protrusion ( 2014 ) pierces a membrane ( 208 ) on the first suction pack ( 201 ), thereby transferring the vacuum in the collection chamber.
  • Aspect 31 The sample collection device ( 200 ) of one of aspects 28 or 29, wherein the second suction pack ( 110 ) comprises also one or more holes ( 2010 ), completely covered by a removable cap ( 140 ).
  • Aspect 32 The sample collection device ( 200 ) of one of aspects 1 to 31, wherein the part of the suction pack ( 201 ) arranged to be placed in contact with a user has a curvature ( 2013 ) to fit the shape and/or the curvature of the user, so as to ensure a better seal between the user and the suction pack ( 201 ).
  • a system ( 300 ) for extracting and collecting a sample ( 500 ) of a fluid of a user comprising:
  • sample collection device ( 200 ) according to one of the aspects 1 to 32;
  • a sample extraction device ( 100 ), comprising:
  • Aspect 34 The system ( 300 ) of the aspect 33, wherein the sample extraction device 100 comprises first connection means ( 120 ), the sample collection device 200 comprises second connection means ( 220 ) so as to perform a mechanical connection between the sample extraction device ( 100 ) and the sample collection device ( 200 ).
  • Aspect 35 The system ( 300 ) of one of the aspects 33 or 34, wherein the sample extraction device ( 100 ) comprises an electronic module ( 105 ) comprising a communication module and a power supply.
  • Aspect 36 The system ( 300 ) of one of the aspects 33 to 35, wherein the sample extraction device ( 100 ) comprises at least a sensor ( 106 ), e.g. an optic sensor, for detecting a predetermined sample volume in the sample container ( 212 ).
  • a sensor e.g. an optic sensor
  • Aspect 37 The system ( 300 ) of one of the aspects 33 to 36, wherein the sample extraction device ( 100 ) comprises an alerting mechanism, indicating to the user the end of the sample extraction, e.g. by an audio and/or visible signal.
  • Aspect 38 The system ( 300 ) of one of the aspects 33 to 37, wherein extraction device comprising a gasket ( 103 ) cooperating with the area of the sample collection device ( 200 ) comprising the membrane ( 208 ).
  • Aspect 39 The system ( 300 ) of one of the aspects 33 to 38, wherein the sample collection device ( 200 ) and the sample extraction device ( 100 ) are arranged so that, when connected, the valve ( 104 ) of the sample extraction device ( 100 ) is placed in correspondence of the membrane ( 208 ) of the sample collection device ( 200 ) and/or the sensor(s) ( 106 ) of the sample extraction device ( 100 ) is(are) placed in correspondence of the sample container ( 212 ) of the sample extraction device ( 100 ).
  • Aspect 40 The system ( 300 ) of one of the aspects 33 to 39, wherein the sample extraction device ( 100 ) is consumable.
  • Aspect 41 The system ( 300 ) of aspect 40, wherein the sample collection device ( 200 ) and the sample extraction device ( 100 ) form a single consumable system ( 300 ).
  • Aspect 42 A method for extracting and collecting a sample ( 500 ) of a fluid of a user by using the system ( 300 ) according to aspects 33 to 40, comprising the following steps:
  • valve control mechanism ( 102 ) actuating the valve control mechanism ( 102 ), so as to open the valve ( 104 ) so as to transfer the vacuum from the vacuum chamber ( 101 ) of the sample extraction device ( 100 ) to the suction pack ( 201 ) of the sample collection device ( 200 ) through an opening ( 218 ) in the suction pack ( 202 ), said opening ( 218 ) being covered by a membrane ( 208 ) located in the suction pack ( 202 );
  • the triggering mechanism ( 209 , 210 , 209 ′, 210 ′, 211 ) which in turn triggers the incision mechanism ( 203 , 204 , 206 );
  • the incision mechanism ( 203 , 204 , 206 ) moves the incision mechanism ( 203 , 204 , 206 ) from a first incision mechanism position in the cap ( 202 ) to a second incision mechanism position in the cap ( 202 ) so that, as the support element ( 203 ) of the incision mechanism is connected to the cutting element ( 206 ), the cutting element ( 206 ) will section the stretched and deformed user's part to be cut ( 401 );
  • Aspect 43 The method of aspect 42, further comprising:
  • Aspect 44 The method of one of aspects 42 or 43, further comprising:
  • a cap ( 202 ) in and/or on the sample container ( 212 ), said cap ( 202 ) being at least partially in contact with said sample container ( 212 );
  • Aspect 45 The method of one of aspects 42 to 44, further comprising:
  • Aspect 46 The method of one of aspects 42 to 45, further comprising:
  • Aspect 47 The method of one of aspects 42 to 46, further comprising:

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medical Informatics (AREA)
  • Surgery (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Manufacturing & Machinery (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
US17/096,796 2019-11-13 2020-11-12 Sample collection device, system and method for extracting and collecting a sample of a fluid of a user Pending US20210137435A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US18/148,346 US20230146889A1 (en) 2019-11-13 2022-12-29 Sample collection device, system and method for extracting and collecting a sample of a fluid of a user

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP19208831 2019-11-13
EP19208831.8 2019-11-13

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US18/148,346 Continuation US20230146889A1 (en) 2019-11-13 2022-12-29 Sample collection device, system and method for extracting and collecting a sample of a fluid of a user

Publications (1)

Publication Number Publication Date
US20210137435A1 true US20210137435A1 (en) 2021-05-13

Family

ID=68581389

Family Applications (2)

Application Number Title Priority Date Filing Date
US17/096,796 Pending US20210137435A1 (en) 2019-11-13 2020-11-12 Sample collection device, system and method for extracting and collecting a sample of a fluid of a user
US18/148,346 Pending US20230146889A1 (en) 2019-11-13 2022-12-29 Sample collection device, system and method for extracting and collecting a sample of a fluid of a user

Family Applications After (1)

Application Number Title Priority Date Filing Date
US18/148,346 Pending US20230146889A1 (en) 2019-11-13 2022-12-29 Sample collection device, system and method for extracting and collecting a sample of a fluid of a user

Country Status (6)

Country Link
US (2) US20210137435A1 (fr)
EP (2) EP4218573A3 (fr)
JP (1) JP2021097998A (fr)
CN (1) CN112790769A (fr)
ES (1) ES2940212T3 (fr)
PL (1) PL3821804T3 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20210106261A1 (en) * 2018-05-14 2021-04-15 Loop Medical Sa Sample collection device, system and method for extracting and collecting a sample of a fluid of a user,
US11266337B2 (en) 2015-09-09 2022-03-08 Drawbridge Health, Inc. Systems, methods, and devices for sample collection, stabilization and preservation
US11298060B2 (en) 2017-01-10 2022-04-12 Drawbridge Health, Inc. Devices for collecting biological samples

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11957465B2 (en) 2022-08-23 2024-04-16 Reddrop Dx, Inc. Accelerated ergonomic collection of capillary blood

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5636640A (en) * 1995-02-06 1997-06-10 Volunteers For Medical Engineering Liquid sampling and test apparatus
US5951582A (en) * 1998-05-22 1999-09-14 Specialized Health Products, Inc. Lancet apparatus and methods
US20040127818A1 (en) * 2002-12-27 2004-07-01 Roe Steven N. Precision depth control lancing tip
US20090192409A1 (en) * 2008-01-28 2009-07-30 Daniel Wong Rapid blood expression and sampling
US20140073992A1 (en) * 2012-09-12 2014-03-13 The Charles Stark Draper Laboratory, Inc. Apparatus and method for manually powered bodily fluid extraction
US9033898B2 (en) * 2010-06-23 2015-05-19 Seventh Sense Biosystems, Inc. Sampling devices and methods involving relatively little pain
US20170122846A1 (en) * 2015-07-21 2017-05-04 Theranos, Inc. Bodily fluid sample collection and transport
US20190000365A1 (en) * 2017-01-10 2019-01-03 Drawbridge Health, Inc. Devices, systems, and methods for sample collection

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6063039A (en) 1996-12-06 2000-05-16 Abbott Laboratories Method and apparatus for obtaining blood for diagnostic tests
US9295417B2 (en) * 2011-04-29 2016-03-29 Seventh Sense Biosystems, Inc. Systems and methods for collecting fluid from a subject
EP2992827B1 (fr) * 2010-11-09 2017-04-19 Seventh Sense Biosystems, Inc. Systèmes et interfaces pour prélèvement de sang
SG182858A1 (en) * 2011-01-07 2012-08-30 Wah Leong Lum Contact activated incision device
EP2802265B1 (fr) * 2012-01-10 2015-11-18 Sanofi-Aventis Deutschland GmbH Appareil comprenant une lancette
EP3689238B1 (fr) * 2015-08-06 2021-09-29 Becton, Dickinson and Company Dispositif de collecte de liquide biologique
CA2992034A1 (fr) * 2015-08-06 2017-02-09 Becton, Dickinson And Company Dispositif de collecte de fluide biologique
WO2020167746A1 (fr) * 2019-02-14 2020-08-20 Becton, Dickinson And Company Collecteur capillaire à connexion rotative

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5636640A (en) * 1995-02-06 1997-06-10 Volunteers For Medical Engineering Liquid sampling and test apparatus
US5951582A (en) * 1998-05-22 1999-09-14 Specialized Health Products, Inc. Lancet apparatus and methods
US20040127818A1 (en) * 2002-12-27 2004-07-01 Roe Steven N. Precision depth control lancing tip
US20090192409A1 (en) * 2008-01-28 2009-07-30 Daniel Wong Rapid blood expression and sampling
US9033898B2 (en) * 2010-06-23 2015-05-19 Seventh Sense Biosystems, Inc. Sampling devices and methods involving relatively little pain
US20140073992A1 (en) * 2012-09-12 2014-03-13 The Charles Stark Draper Laboratory, Inc. Apparatus and method for manually powered bodily fluid extraction
US20170122846A1 (en) * 2015-07-21 2017-05-04 Theranos, Inc. Bodily fluid sample collection and transport
US20190000365A1 (en) * 2017-01-10 2019-01-03 Drawbridge Health, Inc. Devices, systems, and methods for sample collection

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11266337B2 (en) 2015-09-09 2022-03-08 Drawbridge Health, Inc. Systems, methods, and devices for sample collection, stabilization and preservation
US11298060B2 (en) 2017-01-10 2022-04-12 Drawbridge Health, Inc. Devices for collecting biological samples
US20210106261A1 (en) * 2018-05-14 2021-04-15 Loop Medical Sa Sample collection device, system and method for extracting and collecting a sample of a fluid of a user,

Also Published As

Publication number Publication date
JP2021097998A (ja) 2021-07-01
EP3821804B1 (fr) 2022-11-23
CN112790769A (zh) 2021-05-14
PL3821804T3 (pl) 2023-05-08
US20230146889A1 (en) 2023-05-11
ES2940212T3 (es) 2023-05-04
EP4218573A2 (fr) 2023-08-02
EP3821804A1 (fr) 2021-05-19
EP4218573A3 (fr) 2023-08-30

Similar Documents

Publication Publication Date Title
EP3793442B1 (fr) Dispositif de collecte d'échantillon et système d'extraction et de collecte d'un échantillon d'un fluide d'un utilisateur
US20210137435A1 (en) Sample collection device, system and method for extracting and collecting a sample of a fluid of a user
CN210383905U (zh) 一种用于从受试者收集流体样品的装置以及运输套筒
US20210137434A1 (en) Blood Sampling Transfer Device
JP6247380B2 (ja) 血液採取搬送装置
DK2892496T3 (en) BODY LIQUID SAMPLING DEVICES
CN109975071B (zh) 用于体液样品收集的系统、装置和方法
CN213249112U (zh) 用于获取血液样本的装置
JP7090690B2 (ja) 生物学的流体収集デバイス
JP6678729B2 (ja) 生体液採取装置
US20230301566A1 (en) Device, method, and system for collection of blood
ES2960714T3 (es) Dispositivo de recogida de muestras y sistema para extraer y recoger una muestra de un fluido de un usuario
US20240172976A1 (en) Electronic module for a sample collection device and system comprising the same
KR20240024243A (ko) 모세혈관 혈액 수집 디바이스
KR20240027731A (ko) 모세혈관 혈액 수집 디바이스

Legal Events

Date Code Title Description
STPP Information on status: patent application and granting procedure in general

Free format text: APPLICATION DISPATCHED FROM PREEXAM, NOT YET DOCKETED

STPP Information on status: patent application and granting procedure in general

Free format text: DOCKETED NEW CASE - READY FOR EXAMINATION

AS Assignment

Owner name: LOOP MEDICAL SA, SWITZERLAND

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:QUEVAL, ARTHUR;REEL/FRAME:058029/0710

Effective date: 20201125

STPP Information on status: patent application and granting procedure in general

Free format text: NON FINAL ACTION MAILED

STPP Information on status: patent application and granting procedure in general

Free format text: RESPONSE TO NON-FINAL OFFICE ACTION ENTERED AND FORWARDED TO EXAMINER

STPP Information on status: patent application and granting procedure in general

Free format text: FINAL REJECTION MAILED

STPP Information on status: patent application and granting procedure in general

Free format text: DOCKETED NEW CASE - READY FOR EXAMINATION

STPP Information on status: patent application and granting procedure in general

Free format text: FINAL REJECTION MAILED