WO2012007614A2 - Blood-extraction negative-pressure regulator system - Google Patents

Blood-extraction negative-pressure regulator system Download PDF

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Publication number
WO2012007614A2
WO2012007614A2 PCT/ES2011/000231 ES2011000231W WO2012007614A2 WO 2012007614 A2 WO2012007614 A2 WO 2012007614A2 ES 2011000231 W ES2011000231 W ES 2011000231W WO 2012007614 A2 WO2012007614 A2 WO 2012007614A2
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WO
WIPO (PCT)
Prior art keywords
negative pressure
vein
test tube
pressure regulator
regulator system
Prior art date
Application number
PCT/ES2011/000231
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Spanish (es)
French (fr)
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WO2012007614A4 (en
WO2012007614A3 (en
Inventor
Manuel Francisco Lopez
Original Assignee
Manuel Francisco Lopez
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 Manuel Francisco Lopez filed Critical Manuel Francisco Lopez
Publication of WO2012007614A2 publication Critical patent/WO2012007614A2/en
Publication of WO2012007614A3 publication Critical patent/WO2012007614A3/en
Publication of WO2012007614A4 publication Critical patent/WO2012007614A4/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/15003Source of blood for venous or arterial blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150053Details 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
    • A61B5/150061Means for enhancing collection
    • A61B5/150099Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150221Valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150946Means for varying, regulating, indicating or limiting the speed or time of blood collection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/153Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154Devices using pre-evacuated means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/141Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor with capillaries for restricting fluid flow

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Manufacturing & Machinery (AREA)
  • Fluid Mechanics (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Control Of Fluid Pressure (AREA)

Abstract

Negative-pressure regulator device used to regulate blood-extraction fluid for preventing obstruction and/or rupture of the vein. This device should be placed between the needle inserted into the vein and the negative-pressure tube such that the health professional is able to regulate the necessary extraction fluid in accordance with the user's characteristics. In the event of a user with a narrow vein and/or low blood flow, this negative-pressure regulator system will facilitate extraction without injury to the patient.

Description

SISTEMA REGULADOR DE PRESIÓN NEGATIVA EN LA EXTRACCIÓN DE SANGREREGULATORY SYSTEM OF NEGATIVE PRESSURE IN BLOOD EXTRACTION
OBJ ETO DE LA INVENCIÓN OBJECT OF THE INVENTION
Uno de los sistemas que más se utiliza en la actualidad en la extracción de sangre es el sistema de tubos de ensayos con presión negativa. Esta presión negativa puede provocar la saturación y/o obstrucción de la vena, con consecuencias negativas para el paciente; como puede ser la imposibilidad de extracción de sangre o rotura de la vena como consecuencia de dicha presión. One of the most commonly used systems in blood collection is the test tube system with negative pressure. This negative pressure can cause saturation and / or obstruction of the vein, with negative consequences for the patient; such as the impossibility of blood collection or rupture of the vein as a result of said pressure.
Para evitar esta problemática, que es provocada por la presión negativa continua, se debe de regular dicha presión de forma que esta no sea tan negativa y que en definitiva se consiga la extracción de sangre, atendiendo especialmente a la salud del paciente. To avoid this problem, which is caused by continuous negative pressure, this pressure must be regulated so that it is not so negative and that the blood draw is ultimately achieved, paying special attention to the patient's health.
El objeto de esta invención regula dicha presión negativa, a través de un reductor o sistema regulador, que dependiendo de la necesidad del paciente o usuario, el profesional sanitario puede abrir o cerrar dejando pasar el flujo necesario. De esta forma conseguimos dos ventajas importantes; primero que no pase toda la presión negativa directamente a la vena y segundo nos aseguramos de la eliminación de la obstrucción en la vena o en el peor de los casos rotura de la misma. The object of this invention regulates said negative pressure, through a reducer or regulating system, which depending on the need of the patient or user, the healthcare professional can open or close by allowing the necessary flow to pass. In this way we get two important advantages; First, do not pass all the negative pressure directly to the vein, and second, we ensure the removal of the obstruction in the vein or, in the worst case, rupture of the vein.
ANTECEDENTE DE LA INVENCIÓN Los sistemas de extracción actuales se componen principalmente de jeringa y un sistema de tubos de ensayos de presión negativa. BACKGROUND OF THE INVENTION Current extraction systems are mainly composed of syringes and a negative pressure test tube system.
El primer dispositivo para la extracción fue la jeringa; dentro de sus múltiples formas, tamaños y capacidades, donde la aplicación de la presión negativa es irregular, debido que dicha presión negativa se realiza a través del propio personal sanitario y se realiza adecuadamente en función de la experiencia o profesional i dad. En el caso del sistema del tubo de ensayo con presión negativa provoca una presión negativa continúa y esta no es regulable. Si lo que estamos buscando es una extracción de sangre de manera más segura, las ventajas e inconvenientes de ambos sistemas podría ser paliados si en ambos métodos de extracción fuese de una presión continua negativa regulable y/o controlable, que hasta ahora no ha existe. The first device for extraction was the syringe; within its multiple forms, sizes and capacities, where the application of negative pressure is irregular, because said negative pressure is carried out by the health personnel themselves and is properly carried out based on experience or professionalism. In the case of the test tube system with negative pressure it causes a continuous negative pressure and this is not adjustable. If what we are looking for is a safer blood collection, the advantages and disadvantages of both systems could be mitigated if in both methods of extraction it was a continuous negative pressure adjustable and / or controllable, which until now does not exist.
LO novedoso de esta patente es que el sistema de tubos de ensayos con presión negativa continua se puede controlar con este sistema regulador de tal forma, que la presión negativa sea regulable y/o controlable. The novelty of this patent is that the test tube system with continuous negative pressure can be controlled with this regulator system in such a way that the negative pressure is adjustable and / or controllable.
DESCRIPCIÓN DETALLADA DE UN EJEMPLO DE EJECUCIÓN DE LA INVENCIÓN DETAILED DESCRIPTION OF AN EXECUTION EXECUTION OF THE INVENTION
Este sistema regulador de presión negativa debe ser colocado en el sistema de tubos de ensayos de presión negativa o vacío 13 , entre el tubo flexible conductor del fluido sanguíneo que conecta el tubo de ensayo con presión negativa 14 y la aguja biselada que es lo que se conecta a la vena 12 . er Figura 1. This negative pressure regulator system must be placed in the negative or vacuum pressure test tube system 13, between the conductive flexible tube of the blood fluid that connects the test tube with negative pressure 14 and the beveled needle which is what is connect to vein 12. Figure 1.
Este nuevo sistema regula la presión de la siguiente forma: una vez conectada la vena con la aguja biselada 12 se conecta el tubo de ensayo con la presión negativa 14 , pasando toda la presión negativa por aguja a la vena. Esta presión negativa puede producir una obstrucción por presión negativa y/o en el peor de los casos rotura de la vena. This new system regulates the pressure in the following way: once the vein is connected with the beveled needle 12, the test tube is connected with the negative pressure 14, passing all the negative pressure through the needle to the vein. This negative pressure can produce a negative pressure obstruction and / or in the worst case vein rupture.
Entre la aguja 12 y el tubo con presión negativa 14 se coloca este sistema de regulación de presión negativa 13 , que estará conectado a través de los tubos 15 y 16. El objeto de esta regulación es evitar que la presión negativa entre directamente en vena y se controle para facilitar la extracción sanguínea. Between the needle 12 and the negative pressure tube 14, this negative pressure regulation system 13 is placed, which will be connected through the tubes 15 and 16. The purpose of this regulation is to prevent the negative pressure from directly entering the vein and It is controlled to facilitate blood collection.
El sistema regulador de la presión negativa deberá de estar en posición cero, es decir la apertura de la membrana 5 no deberá de coincidir con los agujeros de la membrana 4 , no dejando pasar ninguna fluido. Según la necesidad del profesional y fisiología del paciente, se procederá a abrir con las pestañas 8 y 9 que deben ser girados en sentido opuestos para proceder a la apertura de las membranas 4 y 5 dejando pasar la presión negativa o fluido necesario. Este giro provoca que la apertura de la membrana 4 que coincide con los distintos agujeros de la membrana 5 de forma que a mayor presión coincida con la mayor apertura de la ventana con los orificio. La entrada de fluido sanguíneo entra a través de la aguja biselada 12 que al recorrer por el tubo 15 pasa a la pieza 1 por la entrada 10 del s stema regulador, una vez que entra el fluido contacta con la membrana 4 que dependiendo si la apertura de la ventana o puerta coinciden con los orificios de la membrana 5, este deja pasar fluido o no. Para una mayor o menor presión negativa se procede a la apertura o cierre de la membrana 4. The negative pressure regulating system must be in the zero position, that is, the opening of the membrane 5 must not coincide with the holes in the membrane 4, not allowing any fluid to pass through. According to the need of the professional and physiology of the patient, it will proceed to open with tabs 8 and 9 that must be turned in opposite directions to proceed to the opening of membranes 4 and 5 allowing the necessary negative pressure or fluid to pass. This rotation causes the opening of the membrane 4 that coincides with the different holes of the membrane 5 so that at higher pressure it coincides with the greater opening of the window with the holes. The blood fluid inlet enters through the beveled needle 12 which, as it travels through the tube 15, passes to the piece 1 through the inlet 10 of the regulating system, once the fluid enters it contacts the membrane 4 which depending on whether the opening of the window or door coincide with the holes of the membrane 5, this allows fluid to pass or not. For a greater or lesser negative pressure, the membrane is opened or closed 4.
Una vez que ha pasado por el /los orificios de la membrana 5 este pasa por el cuerpo 7 y la salida 11 que conecta con el tubo 16 que se acopla con el tubo de ensayo de presión negativa 14. Once it has passed through the hole (s) of the membrane 5, it passes through the body 7 and the outlet 11 that connects with the tube 16 that is coupled with the negative pressure test tube 14.
Todo el sistema está diseñado para que sea estanco y pueda unirse gracias al elemento 2, 3, 4, 5, 6 y las piezas 1 y 7 formando un cuerpo único. The entire system is designed to be tight and can be joined thanks to element 2, 3, 4, 5, 6 and parts 1 and 7 forming a unique body.
BREVE ENUNCIADO DE LAS FIGURAS Figura 1. Esquema de la disposición del sistema regulador en el sistema de extracción con tubos con presión negativa. BRIEF STATEMENT OF THE FIGURES Figure 1. Scheme of the arrangement of the regulator system in the extraction system with negative pressure tubes.
Figura 2. vista en perspectiva del sistema regulador inventado. Figura 3. ista en perspectiva y explosiva de los elementos del sistema regulador inventado. Figure 2. Perspective view of the invented regulatory system. Figure 3. Ista in perspective and explosive of the elements of the invented regulatory system.

Claims

REIVINDICACIONES
1. -. Sistema regulador de presión negativa utilizado para la extracción de sangre que se colocará entre el dispositivo de tubo de ensayo al vacio y la aguja introducida en vena, caracterizado por permitir la regulación de la presión negativa generada por el tubo de ensayo con presión negativa o vacio 14. one. -. Negative pressure regulator system used for blood collection to be placed between the vacuum test tube device and the needle inserted into a vein, characterized by allowing the regulation of the negative pressure generated by the negative or empty pressure test tube 14.
2. - Sistema regulador de presión negativa utilizado para la extracción de sangre que se colocará entre el dispositivo de tubo de ensayo al vacio y la aguja introducida en vena, según indicado en la reivindicación 1, constituido por dos cuerpos 1 y 7, que unidos a través de la pieza 2 y 6 forman un resalte que al unirse a la pieza 3 forman un solo cuerpo cerrado y estanco.  2. - Negative pressure regulator system used for blood collection to be placed between the vacuum test tube device and the needle inserted into a vein, as indicated in claim 1, consisting of two bodies 1 and 7, which together through the piece 2 and 6 they form a projection that when joining the piece 3 form a single closed and sealed body.
3. - Sistema regulador de presión negativa utilizado para la extracción de sangre que se colocará entre el dispositivo de tubo de ensayo al vacio y la aguja introducida en vena, según indicado en las reivindicaciones 1 y 2, caracterizado por las piezas 4 y 5 que giran según su eje horizontal, de forma que las membranas al girar se produce una apertura que coincide con la apertura de la puerta 5 y los orificios de las membranas 4 facilitando la entrada de un mayor o menor flujo. El g ro trasversal deberá de realizarse a través de fuerzas opuestas en las pestañas 8 y 9.3. - Negative pressure regulator system used for blood collection to be placed between the vacuum test tube device and the needle inserted into a vein, as indicated in claims 1 and 2, characterized by parts 4 and 5 which they rotate along their horizontal axis, so that when the membranes rotate there is an opening that coincides with the opening of the door 5 and the holes of the membranes 4 facilitating the entry of a greater or lesser flow. The crosscut should be done through opposing forces on tabs 8 and 9.
4. - Sistema regulador de presión negativa utilizado para la extracción de sangre que se colocará entre el dispositivo de tubo de ensayo al vacio y la aguja introducida en vena, según indicado en las reivind caciones de la 1 a la 3, caracterizado por ser un sistema de fácil manejo, ya que su apertura y cierre de las membranas 4 y 5 permite un giro no mayor de un cuarto de vuelta, es decir; 90° en un recorrido de 1 centímetro. 4. - Negative pressure regulator system used for blood collection to be placed between the vacuum test tube device and the needle inserted into a vein, as indicated in claims 1 to 3, characterized by being a easy to use system, since its opening and closing of membranes 4 and 5 allows a turn of not more than a quarter turn, that is; 90 ° in a path of 1 centimeter.
5.- Sistema regulador de presión negativa utilizado para la extracción de sangre que se colocará entre el dispositivo de tubo de ensayo al vac o y la aguja introducida en vena, según indicado en las rei ndicaciones de la 1 a la 4, caracterizado por ser un elemento transparente, fabricado de poli carbonato o del mismo material que las jeringas o de cualquier otro material que se pueda ser construido de forma que guarde todas sus característica de transparencia y estanqueidad. 5.- Negative pressure regulator system used for blood collection that will be placed between the vacuum test tube device and the needle inserted into a vein, as indicated in the claims from 1 to 4, characterized by being a transparent element, made of polycarbonate or of the same material as the syringes or any other material that can be constructed in such a way that it keeps all its characteristic of transparency and tightness.
6. - Sistema regulador de presión negativa utilizado para la extracción de sangre que se colocará entre el dispositivo de tubo de ensayo al vacio y la aguja introducida en vena, según indicado en las reivindicaciones de la 1 a la 5, caracterizado por ser de la misma sección que el tubo 15 y 16 que conecta a su vez la aguja biselada 12 y el tubo de ensayo con presión negativa 14. 6. - Negative pressure regulator system used for blood collection that will be placed between the vacuum test tube device and the needle inserted into a vein, as indicated in claims 1 to 5, characterized by being of the same section as the tube 15 and 16 which in turn connects the beveled needle 12 and the test tube with negative pressure 14.
7. - Sistema regulador de presión negativa utilizado para la extracción de sangre que se colocará entre el dispositivo de tubo de ensayo al vacio y la aguja introducida en vena, según indicado en las reivindicaciones de la 1 a la 6, caracterizado por disponer unas indicaciones 17 de medidas en función de la apertura de la membrana 4 y la membrana 5 determinando el flujo de paso. 7. - Negative pressure regulator system used for blood collection to be placed between the vacuum test tube device and the needle inserted into a vein, as indicated in claims 1 to 6, characterized by having indications 17 of measurements based on the opening of the membrane 4 and the membrane 5 determining the flow of passage.
PCT/ES2011/000231 2010-07-16 2011-07-15 Blood-extraction negative-pressure regulator system WO2012007614A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ESP201000941 2010-07-16
ES201000941A ES2394783B1 (en) 2010-07-16 2010-07-16 NEGATIVE PRESSURE REGULATORY SYSTEM FOR BLOOD EXTRACTION

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WO2012007614A2 true WO2012007614A2 (en) 2012-01-19
WO2012007614A3 WO2012007614A3 (en) 2012-03-08
WO2012007614A4 WO2012007614A4 (en) 2012-04-26

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WO (1) WO2012007614A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2013389303B2 (en) * 2013-05-15 2018-11-08 Becton, Dickinson And Company Manual flow regulation for blood collection

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1586087A (en) * 1968-12-10 1970-02-06
US4280509A (en) * 1977-11-11 1981-07-28 Bethkenhagen Juergen Valved blood sampling device
US4409991A (en) * 1980-02-04 1983-10-18 Becton Dickinson And Company Fluid flow control device for use with an evacuated blood collection container
ES2259897A1 (en) * 2004-12-13 2006-10-16 Jose Castillo Vaquera Blood sampler with negative pressure tubes includes two interconnected hollow cylinders with a manual safety system and a hollow needle protecting against contamination

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6355019B1 (en) * 1996-12-18 2002-03-12 Science Incorporated Variable rate infusion apparatus with indicator and adjustable rate control
US7169128B2 (en) * 2003-08-04 2007-01-30 Bioquiddity, Inc. Multichannel fluid delivery device
US20050277883A1 (en) * 2004-05-26 2005-12-15 Kriesel Marshall S Fluid delivery device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1586087A (en) * 1968-12-10 1970-02-06
US4280509A (en) * 1977-11-11 1981-07-28 Bethkenhagen Juergen Valved blood sampling device
US4409991A (en) * 1980-02-04 1983-10-18 Becton Dickinson And Company Fluid flow control device for use with an evacuated blood collection container
ES2259897A1 (en) * 2004-12-13 2006-10-16 Jose Castillo Vaquera Blood sampler with negative pressure tubes includes two interconnected hollow cylinders with a manual safety system and a hollow needle protecting against contamination

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2013389303B2 (en) * 2013-05-15 2018-11-08 Becton, Dickinson And Company Manual flow regulation for blood collection
US10646149B2 (en) 2013-05-15 2020-05-12 Becton, Dickinson And Company Manual flow regulation for blood collection
US11395613B2 (en) 2013-05-15 2022-07-26 Becton, Dickinson And Company Manual flow regulation for blood collection

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ES2394783B1 (en) 2013-12-11
WO2012007614A4 (en) 2012-04-26
ES2394783A1 (en) 2013-02-05
WO2012007614A3 (en) 2012-03-08

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