DE102021002430A1 - System for taking, storing, transporting and further processing blood samples, and methods of use therefor. - Google Patents

System for taking, storing, transporting and further processing blood samples, and methods of use therefor. Download PDF

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Publication number
DE102021002430A1
DE102021002430A1 DE102021002430.3A DE102021002430A DE102021002430A1 DE 102021002430 A1 DE102021002430 A1 DE 102021002430A1 DE 102021002430 A DE102021002430 A DE 102021002430A DE 102021002430 A1 DE102021002430 A1 DE 102021002430A1
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blood
taking
transporting
storing
blood samples
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DE102021002430.3A
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German (de)
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gleich Anmelder Erfinder
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    • 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
    • A61B5/150068—Means for enhancing collection by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
    • 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
    • A61B5/150221—Valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150236—Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150244—Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150977—Arrays of piercing elements for simultaneous piercing
    • A61B5/150984—Microneedles or microblades
    • 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
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/80—Suction pumps
    • A61M1/81—Piston pumps, e.g. syringes
    • A61M1/815—Piston pumps, e.g. syringes the barrel serving as aspiration container, e.g. in a breast pump

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

Abstract

System zur Entnahme, Aufbewahrung, Transport und Weiterverarbeitung von Blutproben, sowie Anwendungsverfahren dafür.Im Stand der Technik sind bereits viele Systeme bekannt, zum Beispiel durch Eistechen der Haut mittels einer Lanzette und danach das Aufsammeln des aus der Einstichstelle austretenden Bluts in ein Behältnis oder Teststreifen. Dabei wird meistens die Fingerkuppe als Stelle zur Blutentnahme verwendet, die Menge des daraus gewonnenen Blutes ist relativ gering und für viele Bluttestverfahren nicht ausreichend.Die andere Variante: Blutentnahme mittels einer Venenkanüle fördert zwar ausreichend Blut, ist jedoch mit Schmerz und Stress für den Patienten verbunden und sieht keine Selbstanwendung vor.Weitere Systeme, wie z. B. „HemoLink“ der Firma Tasso, nutzen andere Körperstellen wie z.B. Oberarm zum Sammeln von Kapillarblut mittels Unterdrucks. Diese Systeme sind schmerzarm und können von dem Patienten selbst angewandt werden, gewinnen aber auch relativ wenig Blut.Die vorliegende Erfindung ermöglicht eine Entnahme von Kapillarblut in ausreichender Menge mittels Unterdrucks. Dieser Unterdruck wird durch eine spritzenähnliche Konstruktion während der Anwendung erzeugt, direkt nach dem die Haut angeschnitten wurde. Der Unterdruck fördert das Blut aus dem Einschnitt in den Spritzenkörper und wird durch gesammeltes Blut allmählich ausgeglichen. Die Erfindung bietet gleichzeitig eine integrierte Verpackung zur Aufbewahrung, Transport und Weiterverarbeitung der Blutprobe im Testlabor.Die Erfindung eignet sich sowohl für professionelle Anwendung durch ausgebildetes Personal in Bereichen Human- und Tiermedizin, als auch für die eigenständige Anwendung durch den Laien.System for taking, storing, transporting and further processing blood samples, as well as methods of use for this. Many systems are already known in the prior art, for example by puncturing the skin with a lancet and then collecting the blood emerging from the puncture site in a container or test strip . The fingertip is usually used as the site for taking blood; the amount of blood drawn from it is relatively small and not sufficient for many blood test procedures. The other variant: taking blood using a vein cannula supplies sufficient blood, but is associated with pain and stress for the patient and does not provide for self-application.Other systems, such as e.g. B. “HemoLink” from the company Tasso, use other parts of the body such as the upper arm to collect capillary blood using negative pressure. These systems are painless and can be used by the patient himself, but they also collect relatively little blood. This negative pressure is generated by a syringe-like construction during application, immediately after the skin has been cut. The negative pressure pulls the blood out of the incision into the body of the syringe and is gradually counterbalanced by collected blood. At the same time, the invention offers integrated packaging for storage, transport and further processing of the blood sample in the test laboratory. The invention is suitable both for professional use by trained personnel in the fields of human and veterinary medicine and for independent use by laypersons.

Description

1.1. Die vorliegende Erfindung betrifft ein System zur Entnahme, Aufbewahrung, Transport und Weiterverarbeitung von menschlichen oder tierischen Blutproben zur Diagnosezwecken.1.1. The present invention relates to a system for taking, storing, transporting and further processing human or animal blood samples for diagnostic purposes.

Im Stand der Technik sind bereits viele Systeme bekannt, die zwei separaten nacheinander folgenden Handhabungsschritte vorsehen:

  1. a) Das Einstechen der Haut mittels einer Lanzette und anschließendes Aufsammeln des aus der Einstichstelle austretenden Blutes in ein Behältnis oder Teststreifen. Dabei wird meistens die Fingerkuppe als Stelle zur Blutentnahme verwendet, die Menge des daraus gewonnenen Blutes ist relativ gering und für viele Bluttestverfahren nicht ausreichend.
  2. b) Die klassische Blutentnahme mittels einer Venenkanüle fördert zwar ausreichend Blut, ist jedoch mit Schmerz und Stress für den Patienten verbunden und sieht keine Selbstanwendung vor.
Many systems are already known in the state of the art that provide for two separate subsequent handling steps:
  1. a) Pricking the skin with a lancet and then collecting the blood escaping from the puncture site in a container or test strip. The fingertip is usually used as the site for taking blood, the amount of blood drawn from it is relatively small and not sufficient for many blood test procedures.
  2. b) The classic method of taking blood using a vein cannula delivers sufficient blood, but it is associated with pain and stress for the patient and does not provide for self-administration.

Weitere Systeme, wie z. B. „HemoLink“ der Firma Tasso, nutzen andere Körperstellen wie z.B. Oberarm zum Sammeln von Kapillarblut mittels Unterdrucks. Diese Systeme sind schmerzarm und können vom Patienten selbst angewandt werden, gewinnen aber auch relativ wenig BlutOther systems such as B. “HemoLink” from the company Tasso, use other parts of the body such as the upper arm to collect capillary blood using negative pressure. These systems are painless and can be used by the patient themselves, but they also collect relatively little blood

1.2. Die vorliegende Erfindung erzeugt einen temporären Unterdruck innerhalb des Systems während der Anwendung. Dieser Unterdruck wird zur Gewinnung von Kapillarblut in variabler und ausreichender Menge genutzt. Die Erfindung bietet zusätzlich eine integrierte Verpackung zur Aufbewahrung, Transport und Weiterverarbeitung der Blutprobe im Testlabor.1.2. The present invention creates a temporary negative pressure within the system during use. This negative pressure is used to obtain capillary blood in variable and sufficient quantities. The invention also offers integrated packaging for storage, transport and further processing of the blood sample in the test laboratory.

1.3. Die Erfindung eignet sich sowohl für professionelle Blutentnahme durch ausgebildetes Personal in Bereichen Human- und Tiermedizin, als auch für die eigenständige Anwendung durch den Laien.1.3. The invention is suitable both for professional blood taking by trained personnel in the fields of human and veterinary medicine and for independent use by laypersons.

Claims (8)

System zur Entnahme, Aufbewahrung, Transport und Weiterverarbeitung von Blutproben, sowie Anwendungsverfahren dafür, umfassend: einen Kolbenkörper mit einer Saugglocke an einem Ende und einer Dichtung am anderen Ende, eine darin gleitende Kolbenstage mit einem Kolben, wobei die Kolbenstange einen Hohlraum, einen Einwegventil und eine oder mehrere Öffnungen aufweist (Bild 1).A system for collecting, storing, transporting and processing blood samples, and methods of use therefor, comprising: a piston body having a suction cup at one end and a seal at the other end, a piston rod having a piston slidable therein, the piston rod having a cavity, a one-way valve and has one or more openings (Figure 1). System zur Entnahme, Aufbewahrung, Transport und Weiterverarbeitung von Blutproben nach Anspruch 1, wobei die im Anspruch 1 beschriebenen Elemente so angeordnet sind, dass die relative Verschiebung der Kolbenstange mit dem Kolben im Kolbenkörper einen Raum zwischen der Kolbenstange und dem Kolbenkörper erzeugt oder vergrößert, wodurch dort ein Unterdruck entsteht. (Bild 2).System for taking, storing, transporting and processing blood samples claim 1 , where the im claim 1 elements described are arranged so that the relative displacement of the piston rod with the piston in the piston body creates or enlarges a space between the piston rod and the piston body, whereby a vacuum is created there. (Picture 2). System zur Entnahme, Aufbewahrung, Transport und Weiterverarbeitung von Blutproben nach Anspruch 1, wobei der Einwegventil so angeordnet ist, dass er den Rückfluss des gesammelten Blutes verhindert. (Bild 3).System for taking, storing, transporting and processing blood samples claim 1 wherein the one-way valve is arranged to prevent backflow of the collected blood. (Picture 3). System zur Entnahme, Aufbewahrung, Transport und Weiterverarbeitung von Blutproben nach Anspruch 1 und 3, wobei der Einwegventil ein Bestandteil der Kolben ist.System for taking, storing, transporting and processing blood samples claim 1 and 3 , where the one-way valve is an integral part of the pistons. System zur Entnahme, Aufbewahrung, Transport und Weiterverarbeitung von Blutproben nach Anspruch 1, 3 und 4, wobei der Einwegventil die Entnahme der Blutprobe aus dem System im Labor mit einer Pipette oder einer anderen dafür üblichen Vorrichtung ermöglicht.System for taking, storing, transporting and processing blood samples claim 1 , 3 and 4 wherein the one-way valve allows the blood sample to be removed from the system in the laboratory using a pipette or other conventional device. System zur Entnahme, Aufbewahrung, Transport und Weiterverarbeitung von Blutproben nach Anspruch 1, wobei unter der Sagglocke eine Schneid- oder Stech-Vorrichtung so angebracht ist, dass während der Anwendung durch den Unterdruck in die Saugglocke angesaugtes Hautgewebe geschnitten oder gestochen wird. (Bild 4).System for taking, storing, transporting and processing blood samples claim 1 , wherein a cutting or lancing device is attached under the suction cup in such a way that skin tissue sucked into the suction cup by the negative pressure is cut or punctured during use. (picture 4). System zur Entnahme, Aufbewahrung, Transport und Weiterverarbeitung von Blutproben nach Anspruch 1, wobei der Kolbenkörper mit einer Scala versehen ist, die eine relative Verschiebung der Kolbenstage im Kolbenkörper darstellt, welche mit dem Unterdruck-Volumen und somit mit dem gewünschten Blutvolumen korreliert.System for taking, storing, transporting and processing blood samples claim 1 , wherein the piston body is provided with a scale that represents a relative displacement of the piston rods in the piston body, which correlates with the vacuum volume and thus with the desired blood volume. Anwendungsverfahren für das System zur Entnahme, Aufbewahrung, Transport und Weiterverarbeitung von Blutproben nach Anspruch 1, das folgende wesentlichen Anwendungsschritte aufweist: a. Einstellen des benötigten Blutvolumen durch die relative Verschiebung der Kolbenstange und den Kolbenkörper zueinander; b. Aufsetzen des Systems mit der Saugglocke auf die Haut; c. Drucken der Kolbenstange bis zum Anschlag; d. Warten bis die gewünschte Blutmenge im System gesammelt wird.Procedure for using the system for collecting, storing, transporting and processing blood samples claim 1 , which has the following essential application steps: a. Adjusting the required blood volume by the relative displacement of the piston rod and the piston body to each other; b. placing the system with the suction cup on the skin; c. push the piston rod to the stop; i.e. Wait until the desired amount of blood is collected in the system.
DE102021002430.3A 2021-05-07 2021-05-07 System for taking, storing, transporting and further processing blood samples, and methods of use therefor. Pending DE102021002430A1 (en)

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DE102021002430.3A DE102021002430A1 (en) 2021-05-07 2021-05-07 System for taking, storing, transporting and further processing blood samples, and methods of use therefor.

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DE102021002430.3A DE102021002430A1 (en) 2021-05-07 2021-05-07 System for taking, storing, transporting and further processing blood samples, and methods of use therefor.

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116519968A (en) * 2023-06-25 2023-08-01 成都云芯医联科技有限公司 Integrated multi-reagent sample mixing and adding device

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116519968A (en) * 2023-06-25 2023-08-01 成都云芯医联科技有限公司 Integrated multi-reagent sample mixing and adding device
CN116519968B (en) * 2023-06-25 2023-09-08 成都云芯医联科技有限公司 Integrated multi-reagent sample mixing and adding device

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