WO2018194439A1 - Isolated usb interface for connecting medical instruments to a computer and usb speed sensor - Google Patents

Isolated usb interface for connecting medical instruments to a computer and usb speed sensor Download PDF

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Publication number
WO2018194439A1
WO2018194439A1 PCT/MX2017/000049 MX2017000049W WO2018194439A1 WO 2018194439 A1 WO2018194439 A1 WO 2018194439A1 MX 2017000049 W MX2017000049 W MX 2017000049W WO 2018194439 A1 WO2018194439 A1 WO 2018194439A1
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WO
WIPO (PCT)
Prior art keywords
usb
isolated
computer
speed
isolator
Prior art date
Application number
PCT/MX2017/000049
Other languages
Spanish (es)
French (fr)
Inventor
Gaspar GONZÁLEZ BRICEÑO
Original Assignee
Gonzalez Briceno Gaspar
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 Gonzalez Briceno Gaspar filed Critical Gonzalez Briceno Gaspar
Publication of WO2018194439A1 publication Critical patent/WO2018194439A1/en

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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01FMEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
    • G01F3/00Measuring the volume flow of fluids or fluent solid material wherein the fluid passes through the meter in successive and more or less isolated quantities, the meter being driven by the flow
    • G01F3/36Measuring the volume flow of fluids or fluent solid material wherein the fluid passes through the meter in successive and more or less isolated quantities, the meter being driven by the flow with stationary measuring chambers having constant volume during measurement
    • G01F3/38Measuring the volume flow of fluids or fluent solid material wherein the fluid passes through the meter in successive and more or less isolated quantities, the meter being driven by the flow with stationary measuring chambers having constant volume during measurement having only one measuring chamber
    • HELECTRICITY
    • H05ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05KPRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS
    • H05K1/00Printed circuits
    • HELECTRICITY
    • H05ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05KPRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS
    • H05K3/00Apparatus or processes for manufacturing printed circuits
    • H05K3/40Forming printed elements for providing electric connections to or between printed circuits
    • H05K3/42Plated through-holes or plated via connections

Definitions

  • the present invention relates to the electronic means and devices for connection, communication and power supply in general.
  • it refers to an isolated USB interface for the connection of medical instrumentation with a computer and USB speed sensor.
  • USB Universal Serial Bus
  • peripherals and electronic devices such as keyboards, mice, USB sticks, scanners, digital cameras, mobile phones, media players, printers, multifunctional devices, data acquisition systems, modems, medical equipment, various cards, among many others.
  • USB electronic devices present inconveniences in their industrial and hospital use, first, due to the generation of electronic noise that is given by the coupling of its components, the design of the support plate and the capacitance or parasitic inductances and secondly due to its lack of insulation.
  • insulators that provide electrical protection to medical equipment when they are connected to a personal computer that basically consist of:
  • Insulators that are applied in the power stage of the personal computer medical grade isolation transformers, batteries
  • Insulators that are applied at the stage of acquisition of the medical equipment signal (isolation transformers, isolation amplifiers, optical isolation, insulating materials);
  • the insulation that is applied in the power stage of the personal computer uses batteries or medical grade transformers in the power stage of the personal computer.
  • medical grade transformers reduces the portability of the personal computer and the batteries limit the time of use of the medical equipment.
  • Other designs use isolation amplifiers, isolation transformers or composite sensors with insulating materials at the stage of signal acquisition and although they protect the patient from an electric shock, they leave the operator at risk (doctor if necessary).
  • Isolation methods have also been developed in the communication stage, such as RS232.
  • the hardware for communication via RS232 has decreased day by day in the devices.
  • the isolation through the USB cable has also been carried out, however, the results do not show the electrical safety to be used as a medical grade interface.
  • An advantage of medical grade isolation by means of the USB cable over other wireless communication means WiFi, Bluetooth, ZigBee, etc. is that no additional programming is needed for data transfer. In addition to providing isolated power to the medical team that intends to connect.
  • the ambulatory medical device includes a first infusion control circuit of a medication to the patient through a fluid conduit that can be connected to the patient and a second communications control circuitry when an active communication cable is connected to the medical device. Both circuits are electrically isolated with a pair of isolation transceivers, in which the first pair of isolation transceivers communicate a control signal and the second pair of isolation transceivers are magneto-resistive transceivers that communicate at least one data signal.
  • a suitable isolation barrier is placed on the printed circuit board (also known as PCB) according to the corresponding dielectric strength tests, so that the interface It can be used in different kinds of medical equipment containing accessible parts and applied parts (electrodes, probes, pacemakers, etc.).
  • the circuit described uses magneto-resistive transceivers to isolate the signal from the USB port that is intended to be connected to the computer.
  • the signal isolates the USB stage, it does not focus on the isolation barrier of the PCB in which the components are welded, which is of utmost importance to know what kinds of medical equipment can be connected and if it can have accessible parts (as they indicate with the insufflator).
  • the present invention provides importance in the material and distances that are used in the "PCB", to ensure a insulation that provides a medical grade electrical protection.
  • an integrated USB isolator circuit which includes: an isolation barrier arranged between an ascending part and a descending part of the integrated circuit to provide galvanic isolation between them; a first USB 2.0 interface configured to receive and transmit compatible USB 2.0 serials between the ascending part of the integrated circuit and an ascending USB entity; a second USB 2.0 interface configured to receive and transmit compatible USB 2.0 signals between the downstream part of the integrated circuit and a downstream USB entity; a plurality of signal coupling components configured to allow communication between the upstream and downstream part of the integrated circuit to allow the upstream and downstream USB entity of the USB entity to communicate with each other using a USB 2.0 protocol, while maintaining galvanic isolation between them; and the ascending and descending portions of the integrated circuit that includes respective modules configured to automatically detect a speed of the USB 2.0 ascending or descending entities and responding to said detection to automatically place the integrated circuit in a corresponding one of a plurality
  • the referenced patent discloses an integrated circuit that isolates the data bus (O - * - and D-) between two devices connected through the USB port. Although the device isolates the USB data, the main difference with the present invention is that the insulator presented here is an integrated circuit and our invention is based not only on isolating the USB data, but the power stage and placing all the components on a plate with an insulation barrier made on the PCB necessary for a medical application.
  • the present invention was developed, which consists of an isolated USB interface with a USB speed sensor that is placed between a personal computer and a medical device (EM), and that allows the communication of bidirectional way protecting the operator, the patient and the EM itself from an electric shock from the personal computer.
  • EM medical device
  • the present invention has as its main objective to make available an isolated USB interface for the connection of medical instrumentation with a personal computer, allowing two-way communication and protecting the operator, the patient and the medical team itself from an electric shock from the computer. personal.
  • Another objective of (to invention is to provide said isolated USB interface for connection of medical equipment with a computer, which also allows galvanic isolation of the primary side (connected to the personal computer) with respect to the secondary (connected to a medical equipment).
  • Another object of the invention is also to offer a resistance dielectric that allows its use as an interface to connect to a medical device, by presenting a force of 3 KV of resistance for a supply voltage of 120 VRMS, offering a reinforced insulation, necessary to connect medical equipment with accessible parts and parts applied to the patient .
  • Another objective of the invention is to provide said isolated USB interface for connection of medical equipment with a computer, which also helps to energize other external devices since it contains an efficiency of 65% (which can change with respect to the converter or power source that is placed ) generated by the USB host, compared to the one delivered by the host.
  • Another objective of the invention is to provide said isolated USB interface for connection of medical equipment with a computer, which also offers two-color lighting means to show if the device connected through the interface is operating at the correct speed (12 Mbps or 1.5 Mbps ) according to the indicator color (green for correct communication and red for other speed equipment).
  • the isolated USB interface for connection of medical instrumentation with a computer consists of an arrangement defining a primary side and a secondary side, comprising a USB connection port on said primary side adapted to connect a personal computer via a first USB cable (also seen as a USB host) that connects to an electrical power supply source, and a USB connection port on the secondary side adapted to connect a medical device that monitors and / or controls a patient's biosignals via a second USB cable optionally connected to an isolated medical grade power supply; between said primary sides and secondary side a first isolation barrier defined by a bi-directional digital data isolator for isolation between the D + and D- data; Optionally a second barrier defined by a power isolator that integrates a DC-DC converter with voltage regulator and a third isolation barrier defined by a PCB isolation gap made of a non-conductive material, preferably FR4 and created between said sides primary and secondary interface, with a certain thickness, which helps protect against electric shock and provides reinforced insulation
  • the power isolator which is preferably a DC-DC converter that feeds the USB data receiver of the two-way digital data isolator on the primary side and exchanges power to the isolated power source that is responsible for energizing the USB data isolator; in turn, the bidirectional digital data isolator exchanges information between the primary and secondary side that correspond to the communication between the personal computer and the medical equipment.
  • said PCB of the isolated USB interface that defines said primary side and said secondary side, they carry an upper layer and a lower layer of copper between which intermediate layers of the PCB are comprised where said isolation gap made of a non-material is defined.
  • conductor like FR4 and has a low relative permittivity, and in the central zone of said PCB isolation gap a capacitor built within it is optionally defined.
  • said capacitor created within the intermediate layers of the PCB consists of a floating metal structure that overlaps the power plane and this in turn to the ground plane and defines a first capacitive region (w1) and a second capacitive region (w2), creating a capacitive effect using the non-conductive material FR4, which separates the planes, as a dielectric material.
  • Said PCB insulation gap made of FR4 is able to withstand the passage of currents created by a large electrical potential, between both primary and secondary sides and guarantees the electrical safety that may be affected by this effect; In the mode where the capacitor is not integrated in the PCB isolation gap, it is able to withstand greater passage of currents created by a large electrical potential because there is a greater distance between the primary side and the secondary side.
  • the two-color LED (green, red) surface mount speed indicator shows by means of the light indicator one when a low speed USB controller is connected to the personal computer through the isolated USB interface and by the light indicator two when a Full-speed USB controller connects to the personal computer through an isolated USB interface.
  • the control arrangement for the USB speed indicator is responsible for sensing and comparing the D + and D- data signals of the USB device that is connected and activates the one or two light indicator corresponding to the speed of the USB device in question.
  • Said control arrangement for USB speed indicator includes an operational amplifier that is connected to the bi-directional digital data isolator where the 1.5 Mbps or 12 Mbps signal comes from. So that when a 12 Mbps signal passes through the data isolator , the operational amplifier sends a bias current next to the green LED, and when it passes A signal of 1.5 Mbps by the data isolator, the operational amplifier sends a bias current to the side of the red LED. This is how you get the speed of the device that connects to the USB isolator (1.5 Mbps or 12 Mbps).
  • the PCB is manufactured on a two-sided plate with ground planes on both sides to reduce parasitic capacitances and reduce electrical noise interference.
  • an insulating gap of 6.8 mm was made, on a FR4 dielectric with 1.6 mm thickness, which separates the primary side (high voltage) from the secondary (low voltage).
  • the standard specifies a distance between conductors in solid insulation of a minimum of 6 mm and a distance between conductors in air of a minimum of 3.2 mm in relation to a working voltage of 125 Vrms that is connected to the personal computer.
  • USB isolator can function as a medical-grade insulator interface and distinguish the device that is connected according to its transmission speed, such as:
  • Isolate data from the USB port • Isolate the power stage of the USB port and power the device itself.
  • the signals from different USB devices connected to the PC were taken through the isolated USB interface with an oscilloscope with which the input signal was compared with the output signal of the isolator.
  • a 1300 VAC voltage was applied to said isolated USB interface and gradually increased over a period of 10 s until reaching 3000 VAC, which was maintained for 1 min, finally the voltage was gradually reduced to 1300 VAC over a period of 10 s.
  • the current obtained in the high-potential test equipment was 0.12 mA during the first 10 s, then rose to 0.31 mA in the next 60 s and ended at 0.12 mA during the last 10 s. Because the current flowing as a result does not increase rapidly or uncontrollably, there is no break in the insulation of the PCB made of FR4 produced by the voltage applied between the input and output stage of the isolated USB interface.
  • the dielectric strength tests according to IEC60601-1 were satisfactory, reaching a degree of isolation for protection of network parts, of up to two patient protection means (two MOPP) that equivalent to 3 KV AC with a maximum working voltage of 125 V rms (176 V peak).
  • USB devices low speed and full speed
  • the connection arrangement works for full speeds, and comprises a green indicator light, which. Indicates when a device is connected at 12 Mbps and a red indicator light, which indicates when a device that operates at 1.5 Mbps is connected. This is observed when the correct device is connected.
  • FIG 1 shows a schematic diagram of the interconnection of the isolated USB interface with a personal computer and a medical instrument or equipment that monitors one or several biosignals of a patient.
  • Figure 2 shows a schematic diagram of the constitution and components of the USB isolator and its control for USB speed indicator, in accordance with the present invention.
  • Figures 3, 3a and 3b show an isometric view, a front view and a top view, respectively, of a graphic representation illustrating the isolation gap in the PCB, in accordance with the present invention.
  • Figures 4, 4a, 4b and 4c show an isometric view, a top view, a front view and a bottom view, respectively, of a graphical representation illustrating a capacitor created within the PCB, in accordance with the present invention.
  • FIG. 5 illustrates an electrical diagram of the control unit for detecting USB data signals of the isolated USB interface, in accordance with the present invention.
  • Figure 6 illustrates a block diagram of the control method for visualizing the speed of the USB device connected to the isolated USB interface of the present invention.
  • Figure 1 illustrates the interconnection of the isolated USB interface (1) of the present invention with a personal computer (2) connected to an electrical power supply (3) and with a medical device (4) that monitors and / or controls the biosignals of a patient (5), said medical equipment (4) also connected to an isolated medical grade power supply (6); said isolated USB interface (1) being connected via the USB port (7) on its primary side (A) with said personal computer (2) and via the USB port (8) on its secondary side (B) with said medical equipment (4) via USB cables (9, 10), thus allowing bidirectional communication and protecting the operator (not shown), the patient (5) and the medical team (4) from an electric shock from the personal computer (2) when it is connected to the electrical contact of the power supply (3).
  • the isolated USB interface (1) galvanically isolates the primary side (A) (connected to the personal computer (2)) from the secondary side (B) (connected to a medical device (4)). Although the medical equipment (4) provides adequate electrical protection because it has an isolated medical grade power supply (6). A risk of electric shock may come from the personal computer (2) and pass through the USB cable (10) to the medical device (4), in case the isolated USB interface is not connected.
  • FIG. 2 shows a schematic diagram of the constitution and components of the isolated USB interface (1) and its control for the USB speed indicator, showing the primary side (A) and the secondary side (B), with the USB port (7) of type "B" on the primary side (A) connected to a first isolation barrier defined by a two-way digital data isolator (11) where the transmission data D + and D- are electrically isolated using a circuit preferably integrated with an ADUM4160 integrated circuit which is compatible with USB ports (7) 2.0 and handles low speed and full speed data operation speeds; and which establishes a USB data receiver (11a) on the primary side (A) and a USB data isolator (11b) on the secondary side (B); said USB port (7) also being connected to a second barrier defined by a power isolator (12) that establishes a non-isolated power source (12a) on the primary side (A) and a isolated energy source (12b); wherein said power isolator (12) is interconnected with said bidirectional digital data isolator (11) and with
  • the five-pin connection can be connected in high state for full speed and low state for low speed, performing the same operation with the thirteen connection pin (SPD) that acts in the same way for the output data. If low speed devices are connected, these two pins must be connected to their low state (GND1 and GND2) respectively and if a full speed device is connected, these two pins must be connected in high state (VBUS1 and VBUS2). In the proposed design, the SPU and SPD were connected in a high state to perform a digital isolation at full speeds.
  • Both the power isolator (12) and the two-way digital data isolator (11) are interconnected to a control arrangement for USB speed indicator (14) with a two-color LED (green, red) speed indicator (14a) defined by a green light indicator one (15) and a red light indicator two (16) and wherein said control arrangement for USB speed indicator (14) is connected to the USB port (8) on the secondary side (B).
  • a control arrangement for USB speed indicator (14) with a two-color LED (green, red) speed indicator (14a) defined by a green light indicator one (15) and a red light indicator two (16) and wherein said control arrangement for USB speed indicator (14) is connected to the USB port (8) on the secondary side (B).
  • the power isolator (12) which is preferably a DC-DC converter that feeds the USB data receiver (11a) of the bi-directional data isolator (11) on the primary side (A) and exchanges power to the isolated power source (12b ) which is responsible for energizing the USB data isolator (11b, see figure 2);
  • the two-way digital data isolator (11) exchanges information between the primary (A) and secondary (B) sides that correspond to the communication between the personal computer (2) and the medical equipment (4) (see fig. one).
  • the exchange of energy and isolated data is due to Faraday's induction law, since it creates an electromotive force in the coil that is located on the secondary side (B) of the power isolator (12) and the digital data isolator bidirectional (11) with respect to the coil that is located on side A of the power isolator (12) and the digital bidirectional data isolator (11).
  • the bi-color LED (green, red) surface mount speed indicator (14a) shows via the light indicator one (15) when a low speed USB controller is connected to the personal computer (2) through the isolated USB interface (1) and through the light indicator two (16) when a USB full speed controller is connected to the personal computer (2) through an isolated USB interface (1).
  • the control arrangement for USB speed indicator (14) is responsible for sensing and comparing the data signals D + and D- of the USB device that is connected and activates the light indicator one or two (15, 16) corresponding to the speed of the USB device in question.
  • Said two-color LED (green, red) speed indicator (14a) is in the same surface mount package. Therefore, if a voltage greater than the polarization voltage is delivered, the diode becomes saturated and lets the signal that is saturating it through.
  • a surface mount resistor of 200 Ohms is connected to the bi-color LED (green, red) surface mount speed (14a), which limits the current that reaches the LED so that it does not give it.
  • the bi-color LED (green, red) surface mount speed indicator (14a) is manufactured so that the current that arrives to polarize both LEDs, enters through a single direction of the LED. Therefore, an arrangement in the PCB connection is required so that a polarization current for the green LED arrives in one direction and the polarization current of the red LED arrives in the opposite direction.
  • an operational amplifier is needed that is connected to the two-way digital data isolator (11), where the 1.5 Mbps signal comes from or 12 Mbps. So when a 12 Mbps signal passes through the bidirectional digital data isolator (11), the operational amplifier sends a bias current to the side of the green LED. And when a 1.5 Mbps signal passes through the data isolator, the operational amplifier sends a bias current to the side of the red LED. This is how you get the speed of the device that connects to the USB isolator (1.5 Mbps or 12 Mbps).
  • the above points enable the bi-color LED (green, red) speed indicator (14a) so that when a device that works with operating speeds is connected, low speed (1.5 Mbps) goes through the LED polarizing the red color and when it is connected a device that works with full speed operation speeds (12Mbps) turn on the green LED indicator.
  • the isolated USB interface (1) defining said primary side (A) and said secondary side (B) carrying an upper layer and a lower copper layer (18) and between which an isolation gap (17) of the PCB made of FR4 is defined and in the central area of said isolation gap (17) of the PCB a capacitor (19) constructed within the PCB is defined.
  • the breakdown of an electrical insulation occurs when an electrical potential generated or applied between the insulation causes the current flowing as a result to increase rapidly and in an uncontrolled way.
  • the FR4 material of the insulation gap (17) of the PC6 is not conductive and has a low relative permittivity (of approximately 5.4), it is used as the insulation gap (17) of the PCB between the primary side (A ) and the secondary side (B) of the isolated USB interface (1).
  • the insulation gap (17) of the PCB made of FR4 is capable of supporting the passage of currents created by a large electrical potential between both primary and secondary sides (A, B) and guarantees the electrical safety that can be affected by this effect .
  • Leakage currents on the secondary side (B) of the isolated USB interface (1) can be affected by electromagnetic interference noise (EMI), so that these currents do not represent a hazard, the capacitor is created (19) within the intermediate layers of the PCB.
  • EMI electromagnetic interference noise
  • the capacitor (19) created within the intermediate layers of the PCB is observed and consists of a floating metal structure (20) that overlaps the power plane (21) and this in turn to the ground plane (22) and that defines a first capacitive region (A1) and a second capacitive region (A2).
  • a capacitive effect is created using the FR4 material, which separates the planes, as a dielectric material.
  • the total capacitive coupling is calculated with basic rules of series capacitors, where capacitor calculation one and two are given by: where C is the capacitance of the capacitor in question, A is the area of the capacitive region, c is the permittivity and d is the separation between the plates.
  • the permittivity and the area are calculated by:
  • «o is the vacuum permittivity and ⁇ r is the relative permittivity of the dielectric (FR4 in this case), w is the plate width of the area in question is the length of the
  • the control arrangement for the USB speed indicator (14) being used serves to determine the USB speed through one or two light indicators (15, 16) that are activated depending on the state of the signals.
  • the advantage offered by the isolated USB interface (1, see fig. 2) and that no other existing device allows, is the display of the device speed through a D + and 0- signal sensor that uses two follow-up amplifiers (23, 24 ) to identify the signal level and compare the data signals through a bridge (25) created in the two-color LED (green, red) speed indicator (14a).
  • the predominant signal causes the light indicator that corresponds to the low or full USB data rate to be activated (speed indicator with a light indicator one (15) and a light indicator two ( 16)
  • a follow-up amplifier (23 or 24) contains a high input impedance, so if the differential data signal arrives from the USB port, it will not be affected by losses in the current
  • the one or two light indicator (15, 16) that is polarized directly is the one that activates and visually shows the speed of the USB device that is connected, either low or full.
  • the method for speed detection of the USB device that is connected to a personal computer (2, see fig. 1) through the isolated USB interface (1, see figs. 1 and 2) It is characterized in that it comprises the following stages.
  • the speed depends on the USB device that is connected and which is preferably a medical device (4, see fig. 1) and can be low or full USB speeds.
  • step c) Activate the USB data rate indicator to determine if the USB data rate is low or full. If the USB data rate is low, then step c2 is executed; If the USB data rate is not low, then step c1 is executed. c1) Activate light indicator two (16, see figure 5) if the USB data rate is complete.

Abstract

The invention relates to an isolated USB interface for connecting medical instruments to a computer and USB speed sensor, comprising a printed circuit board (PCB) which defines a primary side and a secondary side, with a USB connection port on each side for connecting a personal computer and medical equipment that monitors and/or checks biosignals from a patient, characterised in that between said primary and secondary sides is arranged a first isolating barrier defined by a bidirectional digital data isolator for isolation between data D+ and D-; a second barrier defined by a power isolator that integrates a DC-DC converter with a voltage regulator; wherein said bidirectional digital data isolator and said power isolator are interconnected with one another and with the USB port; also comprising a third isolating barrier defined by an isolation trench in the PCB made of a non-conductive material and created between said primary and secondary sides of the interface; also comprising a control arrangement for a USB speed indicator connected to said bidirectional digital data isolator and said power isolator; also comprising a speed-indicating LED and wherein said control arrangement for the USB speed indicator is connected to the USB port on the secondary side; one of the embodiments thereof comprises a capacitor inside the PCB.

Description

INTERFAZ USB AISLADA PARA CONEXIÓN DE  ISOLATED USB INTERFACE FOR CONNECTION OF
INSTRUMENTACIÓN MÉDICA CON COMPUTADORA Y SENSOR DE MEDICAL INSTRUMENTATION WITH COMPUTER AND SENSOR
VELOCIDAD USB CAMPO DE LA INVENCIÓN USB SPEED FIELD OF THE INVENTION
La presente invención se relaciona con los medios y dispositivos electrónicos de conexión, comunicación y suministro de alimentación de energía eléctrica en lo general. En lo particular se refiere a una interfaz USB aislada para la conexión de instrumentación médica con computadora y sensor de velocidad USB. The present invention relates to the electronic means and devices for connection, communication and power supply in general. In particular, it refers to an isolated USB interface for the connection of medical instrumentation with a computer and USB speed sensor.
ANTECEDENTES DE LA INVENCIÓN BACKGROUND OF THE INVENTION
Cómo es sabido el Bus de Serie Universal, más conocido por sus siglas en inglés como USB, es un protocolo estándar industrial que define los cables, conectores y medio de comunicación usados en un bus para conectar, comunicar y proveer de alimentación eléctrica entre computadoras, periféricos y dispositivos electrónicos diversos, tales como teclados, ratones, memorias USB, escáneres, cámaras digitales, teléfonos móviles, reproductores multimedia, impresoras, dispositivos multifuncionales, sistemas de adquisición de datos, módems, equipo médico, tarjetas diversas, entre muchos otros. How the Universal Serial Bus is known, better known by its acronym in English as USB, is an industrial standard protocol that defines the cables, connectors and media used in a bus to connect, communicate and provide power between computers, various peripherals and electronic devices, such as keyboards, mice, USB sticks, scanners, digital cameras, mobile phones, media players, printers, multifunctional devices, data acquisition systems, modems, medical equipment, various cards, among many others.
Los estándares de interconexión de dispositivos electrónicos USB presentan inconvenientes en su uso industrial y hospitalario, primero por la generación de ruido electrónico que está dado por el acoplamiento de sus componentes, el diseño de la placa de soporte y las capacitancias o inductancias parásitas y segundo por su falta de aislamiento. The interconnection standards of USB electronic devices present inconveniences in their industrial and hospital use, first, due to the generation of electronic noise that is given by the coupling of its components, the design of the support plate and the capacitance or parasitic inductances and secondly due to its lack of insulation.
Enfocándose en las interfaces USB empleadas con equipos médicos para su conexión a una computadora personal, actualmente se conocen aisladores que brindan protección eléctrica a los equipos médicos cuando éstos se encuentran conectados a una computadora personal que consisten básicamente en: Focusing on the USB interfaces used with medical equipment for connection to a personal computer, insulators are now known that provide electrical protection to medical equipment when they are connected to a personal computer that basically consist of:
• Aisladores que se aplican en la etapa de energía de la computadora personal (transformadores de aislamiento de grado médico, pilas); • Insulators that are applied in the power stage of the personal computer (medical grade isolation transformers, batteries);
Aisladores que se aplican en la etapa de adquisición de la sefíal de equipo médico (transformadores de aislamiento, amplificadores de aislamiento, aislamiento óptico, materiales aislantes);  Insulators that are applied at the stage of acquisition of the medical equipment signal (isolation transformers, isolation amplifiers, optical isolation, insulating materials);
· Aisladores en la etapa de comunicación entre la computadora personal y el Equipo Médico (Aisladores de puerto serial, WiFi, Bluetooth, aisladores USB). · Isolators in the communication stage between the personal computer and the Medical Equipment (Serial port isolators, WiFi, Bluetooth, USB isolators).
Por otro lado, los procesos que usan para realizar indicadores de luz para sensar y distinguir las velocidades USB se realizan de dos maneras:  On the other hand, the processes they use to make light indicators to sense and distinguish USB speeds are done in two ways:
• Digital: en la cual se emplean contadores, comparadores para la señal y compuertas lógicas. Analógica: en la cual se utilizan dispositivos convertidores de frecuencia a voltaje o similares. • Digital: in which counters, signal comparators and logic gates are used. Analog: in which frequency to voltage converting devices or the like are used.
El aislamiento que se aplica en la etapa de energía de la computadora personal usan baterías o transformadores de grado médico en la etapa de potencia de la computadora personal. No obstante usar transformadores de grado médico reduce la portabilidad de la computadora personal y las pilas limitan el tiempo de uso del equipo médico. Otros diseños utilizan amplificadores de aislamiento, transformadores de aislamiento o sensores compuestos con materiales aislantes en la etapa de adquisición de la señal y aunque protegen al paciente de una descarga eléctrica dejan en riesgo al operador (médico si es el caso). The insulation that is applied in the power stage of the personal computer uses batteries or medical grade transformers in the power stage of the personal computer. However, using medical grade transformers reduces the portability of the personal computer and the batteries limit the time of use of the medical equipment. Other designs use isolation amplifiers, isolation transformers or composite sensors with insulating materials at the stage of signal acquisition and although they protect the patient from an electric shock, they leave the operator at risk (doctor if necessary).
También se han desarrollado métodos de aislamiento en la etapa de comunicación, como el RS232. Sin embargo, el hardware para la comunicación por medio de RS232 ha disminuido día con día en los dispositivos. El aislamiento a través del cable USB también se ha realizado, sin embargo, los resultados no muestran la seguridad eléctrica para ser usado como interfaz de grado médico. Una ventaja del aislamiento de grado médico por medio del cable USB sobre otros medios de comunicación inalámbrico (WiFi, Bluetooth, ZigBee, etc.) es que no se necesita programación adicional para transferencia de datos. Además de que proporciona energía aislada al equipo médico que pretenda conectarse. Isolation methods have also been developed in the communication stage, such as RS232. However, the hardware for communication via RS232 has decreased day by day in the devices. The isolation through the USB cable has also been carried out, however, the results do not show the electrical safety to be used as a medical grade interface. An advantage of medical grade isolation by means of the USB cable over other wireless communication means (WiFi, Bluetooth, ZigBee, etc.) is that no additional programming is needed for data transfer. In addition to providing isolated power to the medical team that intends to connect.
Para determinar el estado de la técnica más cercano referente a una interfaz USB aislada para conexión de instrumentación médica con computadora y sensor de velocidad USB, se realizó una búsqueda localizando los siguientes documentos: To determine the closest state of the art concerning An isolated USB interface for connection of medical instrumentation with computer and USB speed sensor, a search was performed by locating the following documents:
Se encontró el documento EP2266069A1 de Michael Welsch et al. del 06 de marzo de 2009, el cual divulga métodos y aparatos para aislar eléctricamente un dispositivo médico ambulatorio para infundir materiales de tratamiento en un paciente cuando el dispositivo médico está conectado a un dispositivo periférico a través de un cable de comunicación activo. El dispositivo médico ambulatorio incluye una primera circuiterla de control de la infusión de un medicamento al paciente por un conducto de fluido que se puede conectar al paciente y una segunda circuiteria de control de comunicaciones cuando un cable de comunicación activo está conectado con el dispositivo médico. Ambos circuitos están aislados eléctricamente con un par de transceptores de aislamiento, en el que el primer par de transceptores de aislamiento comunican una señal de control y el segundo par de transceptores de aislamiento son transceptores magneto-resistivo que comunican al menos una señal de datos. Document EP2266069A1 by Michael Welsch et al. of March 6, 2009, which discloses methods and apparatus for electrically isolating an ambulatory medical device to infuse treatment materials into a patient when the medical device is connected to a peripheral device through an active communication cable. The ambulatory medical device includes a first infusion control circuit of a medication to the patient through a fluid conduit that can be connected to the patient and a second communications control circuitry when an active communication cable is connected to the medical device. Both circuits are electrically isolated with a pair of isolation transceivers, in which the first pair of isolation transceivers communicate a control signal and the second pair of isolation transceivers are magneto-resistive transceivers that communicate at least one data signal.
Luego entonces dicho documento revela un dispositivo que entrega una señal USB aislada que proviene de un dispositivo médico. Lo cual indica que la invención aisla la señal de control USB antes de que llegue a un transceptor (presentado como una bomba de infusión). La principal diferencia radica en que la interfaz de la presente invención se coloca entre los dos dispositivos USB y aisla los datos y la energía USB que viajan a través del cable. Además de que se presenta una etapa de LEDs como indicadores de velocidad que cambian de color según la velocidad del dispositivo que se esta usando. A diferencia de este documento de patente que no identifica que el dispositivo USB se esta conectando (de acuerdo a las velocidades velocidad baja o velocidad completa). Then said document reveals a device that delivers an isolated USB signal that comes from a medical device. This indicates that the invention isolates the USB control signal before it reaches a transceiver (presented as an infusion pump). The main difference is that the interface of the present invention is placed between the two USB devices and isolates the data and USB power that travel to through the cable In addition to presenting a stage of LEDs as speed indicators that change color according to the speed of the device being used. Unlike this patent document that does not identify that the USB device is connecting (according to the low speed or full speed).
Una observación importante es que en la interfaz de la presente invención se coloca una barrera de aislamiento adecuada en la placa de circuito impreso (también conocido como PCB por sus siglas en inglés) de acuerdo a las pruebas de resistencia dieléctrica correspondientes, para que la interfaz pueda ser usada en diferentes clases de equipos médicos que contengas partes accesibles y partes aplicadas (electrodos, sondas, marcapasos, etc.). An important observation is that at the interface of the present invention a suitable isolation barrier is placed on the printed circuit board (also known as PCB) according to the corresponding dielectric strength tests, so that the interface It can be used in different kinds of medical equipment containing accessible parts and applied parts (electrodes, probes, pacemakers, etc.).
En la figura 6 del referido documento el circuito que se describe utiliza transceptores magneto-resistivos para aislar la señal del puerto USB que se pretende conectar a la computadora. Sin embargo, aunque la señal aisla la etapa del USB, no se enfoca en la barrera de aislamiento de la PCB en la cual van soldados los componentes, lo cual es de suma importancia para saber con que clases de equipos médicos se puede conectar y si puede tener partes accesibles (como ellos lo indican con el insuflador). In Figure 6 of the aforementioned document, the circuit described uses magneto-resistive transceivers to isolate the signal from the USB port that is intended to be connected to the computer. However, although the signal isolates the USB stage, it does not focus on the isolation barrier of the PCB in which the components are welded, which is of utmost importance to know what kinds of medical equipment can be connected and if it can have accessible parts (as they indicate with the insufflator).
La presente invención brinda importancia en el material y las distancias que se utilizan en la "PCB", para asegurar un aislamiento que brinde una protección eléctrica de grado médico. The present invention provides importance in the material and distances that are used in the "PCB", to ensure a insulation that provides a medical grade electrical protection.
Se ubicó también el documento US20140211862A1 de Moghe Yashodhan Vijay y Brinkhoff James, presentada el 25 de mayo de 2012, el cual revela de manera general un circuito aislador USB integrado, que incluye: una barrera de aislamiento dispuesta entre una parte ascendente y una parte descendente del circuito integrado para proporcionar aislamiento galvánico entre las mismas; una primera interfaz USB 2.0 configurado para recibir y transmitir seriales de USB 2.0 compatibles entre la parte ascendente del circuito integrado y una entidad USB ascendente; una segunda interfaz USB 2.0 configurada para recibir y transmitir señales de USB 2.0 compatibles entre la parte descendente del circuito integrado y una entidad de USB descendente; una pluralidad de componentes de acoplamiento de señal configurados para permitir la comunicación entre la parte ascendente y la parte descendente del circuito integrado para permitir que la entidad USB ascendente y descendente de la entidad USB se comuniquen entre ellos utilizando un protocolo USB 2.0, mientras se mantiene el aislamiento galvánico entre los mismos; y las porciones ascendente y descendente del circuito integrado que incluye módulos respectivos configurados para detectar automáticamente una velocidad de las entidades USB ascendente o descendente USB 2.0 y que responde a dicha detección para poner automáticamente el circuito integrado en una correspondiente de una pluralidad de modos de comunicación USB 2.0 de alta velocidad entre las entidades USB ascendente y descendente, la pluralidad de modos de velocidad USB 2.0 incluyendo un modo USB de velocidad baja, un modo USB velocidad completa, y un modo de alta velocidad USB 2.0. La patente referida divulga un circuito integrado que aisla el bus de datos (O-*- y D-) entre dos dispositivos conectados a través del puerto USB. Si bien el dispositivo aisla los datos USB la principal diferencia con la presente invención radica en que el aislador aqui presentado es un circuito integrado y nuestra invención se basa no solo en aislar los datos USB, sino la etapa de potencia y en colocar todos los componentes en una placa con una barrera aislamiento hecha en la PCB necesaria para una aplicación médica. No existe evidencia suficiente en la información divulgada tanto en el primer documento, como en el segundo documento, como para que una persona con conocimientos medios en la materia pueda inferir o deducir, en base a la información divulgada en los referidos documentos la interfaz USB aislada para conexión de instrumentación médica con computadora y sensor de velocidad USB, que se pretende proteger y por lo tanto la invención tiene actividad inventiva sobre dichos documentos. Document US20140211862A1 by Moghe Yashodhan Vijay and Brinkhoff James, filed on May 25, 2012, was also located, which generally reveals an integrated USB isolator circuit, which includes: an isolation barrier arranged between an ascending part and a descending part of the integrated circuit to provide galvanic isolation between them; a first USB 2.0 interface configured to receive and transmit compatible USB 2.0 serials between the ascending part of the integrated circuit and an ascending USB entity; a second USB 2.0 interface configured to receive and transmit compatible USB 2.0 signals between the downstream part of the integrated circuit and a downstream USB entity; a plurality of signal coupling components configured to allow communication between the upstream and downstream part of the integrated circuit to allow the upstream and downstream USB entity of the USB entity to communicate with each other using a USB 2.0 protocol, while maintaining galvanic isolation between them; and the ascending and descending portions of the integrated circuit that includes respective modules configured to automatically detect a speed of the USB 2.0 ascending or descending entities and responding to said detection to automatically place the integrated circuit in a corresponding one of a plurality of communication modes Hi-Speed USB 2.0 between the ascending and descending USB entities, the plurality of USB 2.0 speed modes including a low speed USB mode, a full speed USB mode, and a high speed USB 2.0 mode. The referenced patent discloses an integrated circuit that isolates the data bus (O - * - and D-) between two devices connected through the USB port. Although the device isolates the USB data, the main difference with the present invention is that the insulator presented here is an integrated circuit and our invention is based not only on isolating the USB data, but the power stage and placing all the components on a plate with an insulation barrier made on the PCB necessary for a medical application. There is insufficient evidence in the information disclosed both in the first document, and in the second document, so that a person with average knowledge in the field can infer or deduce, based on the information disclosed in the aforementioned documents, the isolated USB interface for connection of medical instrumentation with computer and USB speed sensor, which is intended to be protected and therefore the invention has inventive activity on said documents.
Derivado del análisis de los documentos analizados, es importante hacerles saber que hay evidencias importantes como para entender que la invención que se pretende proteger cumple con novedad y actividad inventiva, y que los documentos aqui citados no son suficientes para negar una patente a la invención referida. Así la invención cumple con los criterios de patentabílidad y la misma es meritoria de una patente. Ante la necesidad de resolver los inconvenientes antes enunciados, fue que se desarrolló la presente invención que consiste en una interfaz USB aislada con sensor de velocidad USB que se coloque entre una computadora personal y un equipo médico (EM), y que permita la comunicación de manera bidireccional protegiendo al operador, al paciente y al propio EM de una descarga eléctrica proveniente de la computadora personal. Derived from the analysis of the documents analyzed, it is important to let them know that there is important evidence to understand that the invention that is intended to protect meets novelty and inventive activity, and that the documents cited here they are not sufficient to deny a patent to the referred invention. Thus the invention meets the patentability criteria and it is worthy of a patent. In view of the need to solve the aforementioned problems, it was that the present invention was developed, which consists of an isolated USB interface with a USB speed sensor that is placed between a personal computer and a medical device (EM), and that allows the communication of bidirectional way protecting the operator, the patient and the EM itself from an electric shock from the personal computer.
OBJETIVOS DE LA INVENCIÓN OBJECTIVES OF THE INVENTION
La presente invención tiene como objetivo primordial hacer disponible una interfaz USB aislada para la conexión de instrumentación médica con una computadora personal, permitiendo la comunicación de manera bidireccional y protegiendo al operador, al paciente y al propio equipo médico de una descarga eléctrica proveniente de la computadora personal. The present invention has as its main objective to make available an isolated USB interface for the connection of medical instrumentation with a personal computer, allowing two-way communication and protecting the operator, the patient and the medical team itself from an electric shock from the computer. personal.
Otro objetivo de (a invención es proveer dicha interfaz USB aislada para conexión de equipo médico con computadora, que además permita un aislamiento galvánico del lado primario (conectado a la computadora personal) con respecto del secundario (conectado a un equipo médico). Another objective of (to invention is to provide said isolated USB interface for connection of medical equipment with a computer, which also allows galvanic isolation of the primary side (connected to the personal computer) with respect to the secondary (connected to a medical equipment).
Otro objetivo de la invención es además ofrecer una resistencia dieléctrica que permita su uso como interfaz para conectarse a un equipo medico, al presentar una fuerza de 3 KV de resistencia para un voltaje de alimentación de 120 VRMS, ofreciendo un aislamiento reforzado, necesario para conectar equipos médicos con partes accesibles y partes aplicadas al paciente. Another object of the invention is also to offer a resistance dielectric that allows its use as an interface to connect to a medical device, by presenting a force of 3 KV of resistance for a supply voltage of 120 VRMS, offering a reinforced insulation, necessary to connect medical equipment with accessible parts and parts applied to the patient .
Otro objetivo de la invención es proveer dicha interfaz USB aislada para conexión de equipo médico con computadora, que además ayude a energizar otros dispositivos externos ya que contiene una eficiencia de 65% (la cual puede cambiar respecto al convertidor o fuente de energía que se coloque) generada por el host USB, respecto a la entregada por el anfitrión. Another objective of the invention is to provide said isolated USB interface for connection of medical equipment with a computer, which also helps to energize other external devices since it contains an efficiency of 65% (which can change with respect to the converter or power source that is placed ) generated by the USB host, compared to the one delivered by the host.
Otro objetivo de la invención es proveer dicha interfaz USB aislada para conexión de equipo médico con computadora, que además ofrezca medios de iluminación bicolor para mostrar si el dispositivo conectado a través de la interfaz, esta funcionando a la velocidad correcta (12 Mbps o 1.5 Mbps) de acuerdo al color indicador (verde para comunicación correcta y rojo para equipo de otra velocidad). Another objective of the invention is to provide said isolated USB interface for connection of medical equipment with a computer, which also offers two-color lighting means to show if the device connected through the interface is operating at the correct speed (12 Mbps or 1.5 Mbps ) according to the indicator color (green for correct communication and red for other speed equipment).
Y todas aquellas cualidades y objetivos que se harán aparentes al realizar una descripción de la presente invención apoyados en las modalidades ilustradas. And all those qualities and objectives that will become apparent when making a description of the present invention supported by the illustrated modalities.
BREVE DESCRIPCIÓN DEL INVENTO BRIEF DESCRIPTION OF THE INVENTION
De manera general la interfaz USB aislada para conexión de instrumentación médica con computadora, de conformidad con la presente invención, consta de un arreglo que define un lado primario y un lado secundario, comprendiendo un puerto de conexión USB en dicho lado primario adaptado para conectar mediante un primer cable USB una computadora personal (también visto como anfitrión USB) que se conecta a una fuente de suministro de energía eléctrica, y un puerto de conexión USB en el lado secundario adaptado para conectar mediante un segundo cable USB un equipo médico que monitorea y/o controla bioseñales de un paciente y que estará conectado opcionalmente a una fuente aislada de grado médico de alimentación de energía eléctrica; disponiéndose entre dichos lados primarios y lado secundario una primera barrera de aislamiento definida por un aislador digital de datos bidireccional para el aislamiento entre los datos D+ y D-; Opcionalmente una segunda barrera definida por un aislador de potencia que integra un convertidor DC-DC con regulador de voltaje y una tercera barrera de aislamiento definida por una brecha de aislamiento de la PCB hecha de un material no conductor, preferentemente FR4 y creada entre dichos lados primario y secundario de la interfaz, con determinado espesor, la cual ayuda a la protección contra una descarga eléctrica y brinda un aislamiento reforzado a la interfaz; comprendiendo además un arreglo de control para indicador de velocidad USB interconectado con dicho aislador digital de datos bidireccional y dicho aislador de potencia y que comprende preferentemente un LED bicolor (verde, rojo) indicador de velocidad con un indicador de luz uno y un indicador de luz dos y en donde dicho arreglo de control para indicador de velocidad USB está conectado al puerto USB del lado secundario. In general, the isolated USB interface for connection of medical instrumentation with a computer, in accordance with the present invention, consists of an arrangement defining a primary side and a secondary side, comprising a USB connection port on said primary side adapted to connect a personal computer via a first USB cable (also seen as a USB host) that connects to an electrical power supply source, and a USB connection port on the secondary side adapted to connect a medical device that monitors and / or controls a patient's biosignals via a second USB cable optionally connected to an isolated medical grade power supply; between said primary sides and secondary side a first isolation barrier defined by a bi-directional digital data isolator for isolation between the D + and D- data; Optionally a second barrier defined by a power isolator that integrates a DC-DC converter with voltage regulator and a third isolation barrier defined by a PCB isolation gap made of a non-conductive material, preferably FR4 and created between said sides primary and secondary interface, with a certain thickness, which helps protect against electric shock and provides reinforced insulation to the interface; further comprising a control arrangement for USB speed indicator interconnected with said two-way digital data isolator and said power isolator and preferably comprising a two-color LED (green, red) speed indicator with a light indicator one and a light indicator two and where said control arrangement for USB speed indicator is connected to the USB port on the secondary side.
El aislador de potencia que preferentemente es un convertidor DC- DC que alimenta al receptor de datos USB del aislador digital de datos bidireccional del lado primario e intercambia energía a la fuente de energía aislada que se encarga de energizar el aislador de datos USB; a su vez el aislador digital de datos bidireccional intercambia información entre el lado primario y el secundario que corresponden a la comunicación entre la computadora personal y el equipo médico. The power isolator which is preferably a DC-DC converter that feeds the USB data receiver of the two-way digital data isolator on the primary side and exchanges power to the isolated power source that is responsible for energizing the USB data isolator; in turn, the bidirectional digital data isolator exchanges information between the primary and secondary side that correspond to the communication between the personal computer and the medical equipment.
En dicha PCB de la interfaz USB aislada que define dicho lado primario y dicho lado secundario, llevan una capa superior y una capa inferior de cobre entre las que se comprenden capas intermedias de la PCB donde se define dicha brecha de aislamiento hecha de un material no conductor como FR4 y tiene una permitividad relativa baja, y en la zona central de dicha brecha de aislamiento de la PCB se define opcionalmente un capacitor construido dentro de la misma.  In said PCB of the isolated USB interface that defines said primary side and said secondary side, they carry an upper layer and a lower layer of copper between which intermediate layers of the PCB are comprised where said isolation gap made of a non-material is defined. conductor like FR4 and has a low relative permittivity, and in the central zone of said PCB isolation gap a capacitor built within it is optionally defined.
En una modalidad preferida de la invención dicho capacitor creado dentro de las capas intermedias de la PCB consiste en una estructura de metal flotante que solapa al plano de alimentación y éste a su vez al plano de tierra y que define una primera región capacitiva (w1) y una segunda región capacitiva (w2), creando un efecto capacitivo usando el material no conductor FR4, que separa a los planos, como material dieléctrico. Dicha brecha de aislamiento de la PCB hecha de FR4 es capaz de soportar el paso de corrientes creadas por un gran potencial eléctrico, entre ambos lados primario y secundario y garantiza la seguridad eléctrica que puede verse afectada por este efecto; en la modalidad donde no se integra el capacitor en la brecha de asilamiento de la PCB, es capaz de soportar mayor paso de corrientes creadas por un gran potencial eléctrico debido a que existe una distancia mayor entre el lado primario y el lado secundario. In a preferred embodiment of the invention said capacitor created within the intermediate layers of the PCB consists of a floating metal structure that overlaps the power plane and this in turn to the ground plane and defines a first capacitive region (w1) and a second capacitive region (w2), creating a capacitive effect using the non-conductive material FR4, which separates the planes, as a dielectric material. Said PCB insulation gap made of FR4 is able to withstand the passage of currents created by a large electrical potential, between both primary and secondary sides and guarantees the electrical safety that may be affected by this effect; In the mode where the capacitor is not integrated in the PCB isolation gap, it is able to withstand greater passage of currents created by a large electrical potential because there is a greater distance between the primary side and the secondary side.
El LED bicolor (verde, rojo) indicador de velocidad de montaje superficial muestra mediante el indicador de luz uno cuando un controlador USB de velocidad baja se conecta a la computadora personal a través de la interfaz USB aislada y mediante el indicador de luz dos cuando un controlador USB de velocidad completa se conecta a la computadora personal a través de interfaz USB aislada. El arreglo de control para indicador de velocidad USB se encarga de sensar y comparar las señales de datos D+ y D- del dispositivo USB que se conecta y activa el indicador de luz uno o dos que corresponde a la velocidad del dispositivo USB en cuestión. The two-color LED (green, red) surface mount speed indicator shows by means of the light indicator one when a low speed USB controller is connected to the personal computer through the isolated USB interface and by the light indicator two when a Full-speed USB controller connects to the personal computer through an isolated USB interface. The control arrangement for the USB speed indicator is responsible for sensing and comparing the D + and D- data signals of the USB device that is connected and activates the one or two light indicator corresponding to the speed of the USB device in question.
Dicho arreglo de control para indicador de velocidad USB incluye un amplificador operacional que esta conectado al aislador digital de datos bidireccional por donde procede la señal de 1.5 Mbps o 12 Mbps. De tal modo que cuando pasa una señal de 12 Mbps por el aislador de datos, el amplificador operacional envía una corriente de polarización al lado del LED verde, y cuando pasa una señal de 1.5 Mbps por el aislador de datos, el amplificador operacional envia una corriente de polarización al lado del LED rojo. Es asi como se obtiene la velocidad del dispositivo que se conecta al aislador USB (1.5 Mbps o 12 Mbps). Said control arrangement for USB speed indicator includes an operational amplifier that is connected to the bi-directional digital data isolator where the 1.5 Mbps or 12 Mbps signal comes from. So that when a 12 Mbps signal passes through the data isolator , the operational amplifier sends a bias current next to the green LED, and when it passes A signal of 1.5 Mbps by the data isolator, the operational amplifier sends a bias current to the side of the red LED. This is how you get the speed of the device that connects to the USB isolator (1.5 Mbps or 12 Mbps).
La PCB está fabricada en una placa de dos caras con planos de tierra en ambos lados para disminuir las capacitancias parásitas y reducir la interferencia del ruido eléctrico. En el diseño se realizó una brecha aislante de 6.8 mm, sobre un dieléctrico de FR4 con 1.6 mm de espesor, que separa al lado primario (tensión de alta) del secundario (tensión de baja). The PCB is manufactured on a two-sided plate with ground planes on both sides to reduce parasitic capacitances and reduce electrical noise interference. In the design, an insulating gap of 6.8 mm was made, on a FR4 dielectric with 1.6 mm thickness, which separates the primary side (high voltage) from the secondary (low voltage).
Aunque los componentes para aislar los datos y la potencia están acreditados por la norma IEC60601-1, es necesario tomar las consideraciones necesarias en el diseño de la PCB, ya que la norma debe de cubrir el prototipo en general. La norma especifica una distancia entre conductores en aislamiento sólido de 6 mm minima y una distancia entre conductores en aire de 3.2 mm mínima en relación a un voltaje de trabajo de alimentación de 125 Vrms que es al que se conecta la computadora personal. Although the components for isolating data and power are accredited by the IEC60601-1 standard, it is necessary to take the necessary considerations in the design of the PCB, since the standard must cover the prototype in general. The standard specifies a distance between conductors in solid insulation of a minimum of 6 mm and a distance between conductors in air of a minimum of 3.2 mm in relation to a working voltage of 125 Vrms that is connected to the personal computer.
De acuerdo con la invención antes descrita cuatro fueron las etapas que se resolvieron para demostrar que el aislador USB puede funcionar como interfaz aislador de grado médico y distinguir el dispositivo que se conecta de acuerdo a su velocidad de transmisión, como: According to the invention described above, four were the steps that were solved to demonstrate that the USB isolator can function as a medical-grade insulator interface and distinguish the device that is connected according to its transmission speed, such as:
Aislar los datos del puerto USB. • Aislar la etapa de energía del puerto USB y alimentar al propio dispositivo. Isolate data from the USB port. • Isolate the power stage of the USB port and power the device itself.
• Resistencia dieléctrica de la interfaz.  • Dielectric resistance of the interface.
• Luz de LEDs indicadores para relacionar la conexión de la interfaz con un dispositivo compatible con la transmisión de datos.  • LED indicator light to connect the interface connection with a device compatible with data transmission.
Para ratificar que el aislador digital de datos bidireccional funciona adecuadamente se tomaron las señales provenientes de diferentes dispositivos USB conectados a la PC a través de la interfaz USB aislada con un osciloscopio con el cual se comparó la señal de entrada con la de salida del aislador.  To confirm that the bi-directional digital data isolator works properly, the signals from different USB devices connected to the PC were taken through the isolated USB interface with an oscilloscope with which the input signal was compared with the output signal of the isolator.
Una vez que se tomó la señal proveniente del anfitrión USB (computadora) se comparó con la que llega al dispositivo, en donde se observó que la señal es transparente (iguales en la entrada y la salida de la interfaz USB aislada). Once the signal from the USB host (computer) was taken, it was compared to the one that arrives at the device, where it was observed that the signal is transparent (same at the input and output of the isolated USB interface).
Para saber que la interfaz USB aislada ayuda a la seguridad eléctrica cuando se conecta un equipo médico a una computadora a través de dicha interfaz, se aplicó a dicha interfaz USB aislada un voltaje de 1300 VAC y se incrementó gradualmente durante un periodo de 10 s hasta alcanzar los 3000 VAC, que se mantuvieron durante 1 min, finalmente se redujo la tensión de manera gradual a 1300 VAC en un periodo de 10 s. La corriente obtenida en el equipo de prueba de alto potencial fue de 0.12 mA durante los primeros 10 s, posteriormente se elevo a 0.31 mA en los siguientes 60 s y finalizó en 0.12 mA durante los últimos 10 s. Debido a que la corriente que fluye como resultado no aumenta rápidamente ni de manera incontrolada, no existe un rompimiento en el aislamiento de la PCB hecha de FR4 producida por el voltaje aplicado entre la etapa de entrada y de salida de la interfaz USB aislada. Por lo que las pruebas de resistencia dieléctrica de acuerdo a la norma IEC60601 - 1 fueron satisfactorias, alcanzando un grado de aislamiento para protección de partes de red, de hasta dos medios de protección de paciente (dos MOPP, por sus siglas en ingles) que equivalen a 3 KV AC con un voltaje de trabajo máximo de 125 V rms (176 V pico). To know that the isolated USB interface helps electrical safety when a medical device is connected to a computer through said interface, a 1300 VAC voltage was applied to said isolated USB interface and gradually increased over a period of 10 s until reaching 3000 VAC, which was maintained for 1 min, finally the voltage was gradually reduced to 1300 VAC over a period of 10 s. The current obtained in the high-potential test equipment was 0.12 mA during the first 10 s, then rose to 0.31 mA in the next 60 s and ended at 0.12 mA during the last 10 s. Because the current flowing as a result does not increase rapidly or uncontrollably, there is no break in the insulation of the PCB made of FR4 produced by the voltage applied between the input and output stage of the isolated USB interface. Therefore, the dielectric strength tests according to IEC60601-1 were satisfactory, reaching a degree of isolation for protection of network parts, of up to two patient protection means (two MOPP) that equivalent to 3 KV AC with a maximum working voltage of 125 V rms (176 V peak).
Para la prueba de luz indicadora, se conectaron diferentes dispositivos USB (velocidad baja y velocidad completa) a una computadora personal a través de la interfaz USB aislada. El arreglo de conexión funciona para velocidades completas, y comprende una luz indicadora verde, que. indica cuando se conecta un dispositivo a 12 Mbps y una luz indicadora roja, que indica cuando se conecta un dispositivo que funciona a 1.5 Mbps. De esta manera se observa cuando se conecta el dispositivo correcto. For the indicator light test, different USB devices (low speed and full speed) were connected to a personal computer through the isolated USB interface. The connection arrangement works for full speeds, and comprises a green indicator light, which. Indicates when a device is connected at 12 Mbps and a red indicator light, which indicates when a device that operates at 1.5 Mbps is connected. This is observed when the correct device is connected.
Para comprender mejor las características de la invención se acompaña a la presente descripción, como parte integrante de la misma, los dibujos con carácter ilustrativo más no limitativo, que se describen a continuación.  To better understand the characteristics of the invention, the present description is attached, as an integral part thereof, to the drawings with illustrative but not limitative character, which are described below.
BREVE DESCRIPCIÓN DE LAS FIGURAS BRIEF DESCRIPTION OF THE FIGURES
La figura 1 muestra un diagrama esquemático de la interconexión de la ¡nterfaz USB aislada con una computadora personal y un instrumento o equipo médico que monitorea una o varias bioseñales de un paciente. La figura 2 muestra un diagrama esquemático de la constitución y componentes del aislador USB y su control para indicador de velocidad USB, de conformidad con la presente invención. Figure 1 shows a schematic diagram of the interconnection of the isolated USB interface with a personal computer and a medical instrument or equipment that monitors one or several biosignals of a patient. Figure 2 shows a schematic diagram of the constitution and components of the USB isolator and its control for USB speed indicator, in accordance with the present invention.
Las figuras 3, 3a y 3b muestran una vista isométríca, una vista frontal y una vista superior, respectivamente, de una representación gráfica que ilustra la brecha de aislamiento en la PCB, de conformidad con la presente invención. Figures 3, 3a and 3b show an isometric view, a front view and a top view, respectively, of a graphic representation illustrating the isolation gap in the PCB, in accordance with the present invention.
Las figuras 4, 4a, 4b y 4c muestran una vista isométríca, una vista superior, una vista frontal y una vista inferior, respectivamente, de una representación gráfica que ilustra un capacitor creado dentro de la PCB, de conformidad con la presente invención. Figures 4, 4a, 4b and 4c show an isometric view, a top view, a front view and a bottom view, respectively, of a graphical representation illustrating a capacitor created within the PCB, in accordance with the present invention.
La figura 5 ilustra un diagrama eléctrico de la unidad de control para detección de señales de datos USB de la interfaz USB aislada, de conformidad con la presente invención. Figure 5 illustrates an electrical diagram of the control unit for detecting USB data signals of the isolated USB interface, in accordance with the present invention.
La figura 6 ilustra un diagrama de bloques del método de control para visuaiización de la velocidad del dispositivo USB conectado a la interfaz USB aislada de la presente invención. Figure 6 illustrates a block diagram of the control method for visualizing the speed of the USB device connected to the isolated USB interface of the present invention.
Para una mejor comprensión del invento, se pasará a hacer la descripción detallada de alguna de las modalidades del mismo, mostrada en los dibujos que con fines ilustrativos mas no limitativos se anexan a la presente descripción. For a better understanding of the invention, a detailed description of some of the modalities thereof will be made, shown in the drawings that are illustrative but not limited to this description.
DESCRIPCIÓN DETALLADA DEL INVENTO DETAILED DESCRIPTION OF THE INVENTION
Los detalles característicos de la interfaz USB aislada para conexión de instrumentación médica con computadora, se muestra claramente en la siguiente descripción y en los dibujos ilustrativos que se anexan, sirviendo los mismos signos de referencia para señalar las mismas partes. The characteristic details of the isolated USB interface for connection of medical instrumentation with a computer, is clearly shown in the following description and in the accompanying illustrative drawings, serving the same reference signs to indicate the same parts.
En la figura 1 se ilustra la interconexión de la interfaz USB aislada (1) de la presente invención con una computadora personal (2) conectada a una fuente de suministro de energía eléctrica (3) y con un equipo médico (4) que monitorea y/o controla bioseñales de un paciente (5), conectado también dicho equipo médico (4) a una fuente aislada de grado médico de alimentación de energia eléctrica (6); estando ¡nterconectados dicha interfaz USB aislada (1) mediante el puerto USB (7) de su lado primario (A) con dicha computadora personal (2) y mediante el puerto USB (8) de su lado secundario (B) con dicho equipo médico (4) a través de cables USB (9, 10), permitiendo de esta manera la comunicación de manera bid ireccional y protegiendo al operador (no mostrado), al paciente (5) y al propio equipo médico (4) de una descarga eléctrica proveniente de la computadora personal (2) cuando ésta se encuentra conectada al contacto eléctrico de fuente de suministro de energía eléctrica (3). La interfaz USB aislada (1) aisla de manera galvánica el lado primario (A) (conectado a la computadora personal (2)) del lado secundario (B) (conectado a un equipo médico (4)). Aunque el equipo médico (4) brinda la protección eléctrica adecuada debido a que tiene una fuente aislada de grado médico de alimentación de energía eléctrica (6). Un riesgo de choque eléctrico puede provenir de la computadora personal (2) y pasar a través del cable USB (10) hacia el equipo médico (4), en caso de que la interfaz USB aislada no este conectada. Figure 1 illustrates the interconnection of the isolated USB interface (1) of the present invention with a personal computer (2) connected to an electrical power supply (3) and with a medical device (4) that monitors and / or controls the biosignals of a patient (5), said medical equipment (4) also connected to an isolated medical grade power supply (6); said isolated USB interface (1) being connected via the USB port (7) on its primary side (A) with said personal computer (2) and via the USB port (8) on its secondary side (B) with said medical equipment (4) via USB cables (9, 10), thus allowing bidirectional communication and protecting the operator (not shown), the patient (5) and the medical team (4) from an electric shock from the personal computer (2) when it is connected to the electrical contact of the power supply (3). The isolated USB interface (1) galvanically isolates the primary side (A) (connected to the personal computer (2)) from the secondary side (B) (connected to a medical device (4)). Although the medical equipment (4) provides adequate electrical protection because it has an isolated medical grade power supply (6). A risk of electric shock may come from the personal computer (2) and pass through the USB cable (10) to the medical device (4), in case the isolated USB interface is not connected.
En la figura 2 se muestra un diagrama esquemático de la constitución y componentes de la interfaz USB aislada (1) y su control para indicador de velocidad USB, donde se muestra el lado primario (A) y el lado secundario (B), estando el puerto USB (7) del tipo "B" del lado primario (A) conectado a una primera barrera de aislamiento definida por un aislador digital de datos bidireccional (11) en donde los datos de transmisión D+ y D- se aislan eléctricamente utilizando un circuito integrado preferentemente un circuito integrado ADUM4160 el cual es compatible con puertos USB (7) 2.0 y maneja velocidades de operación de datos de velocidad baja y velocidad completa; y que establece un receptor de datos USB (11a) del lado primario (A) y un aislador de datos USB (11b) del lado secundario (B); dicho puerto USB (7) estando también conectado con una segunda barrera definida por un aislador de potencia (12) que establece una fuente de energía no aislada (12a) del lado primario (A) y una fuente de energía aislada (12b); en donde dicho aislador de potencia (12) está interconectado con dicho aislador digital de datos bidireccional (11) y con un LED indicador de conexión anfitrión (13) del lado primario (A). Figure 2 shows a schematic diagram of the constitution and components of the isolated USB interface (1) and its control for the USB speed indicator, showing the primary side (A) and the secondary side (B), with the USB port (7) of type "B" on the primary side (A) connected to a first isolation barrier defined by a two-way digital data isolator (11) where the transmission data D + and D- are electrically isolated using a circuit preferably integrated with an ADUM4160 integrated circuit which is compatible with USB ports (7) 2.0 and handles low speed and full speed data operation speeds; and which establishes a USB data receiver (11a) on the primary side (A) and a USB data isolator (11b) on the secondary side (B); said USB port (7) also being connected to a second barrier defined by a power isolator (12) that establishes a non-isolated power source (12a) on the primary side (A) and a isolated energy source (12b); wherein said power isolator (12) is interconnected with said bidirectional digital data isolator (11) and with a host connection indicator LED (13) on the primary side (A).
En el aislador digital de datos bidireccional (11), el pin de conexión cinco (SPU) se puede conectar en estado alto para velocidad completa y estado bajo para velocidad baja, realizando la misma operación con el pin de conexión trece (SPD) que actúa de la misma manera para los datos de salida. Si se conectan dispositivos de velocidad baja, estos dos pines se deben conectar a su estado bajo (GND1 y GND2) respectivamente y si un dispositivo velocidad completa se conecta, estos dos pines se deben de conectar en estado alto (VBUS1 y VBUS2). En el diseno propuesto se conectó el SPU y SPD en estado alto para realizar un aislamiento digital a velocidades completas. In the two-way digital data isolator (11), the five-pin connection (SPU) can be connected in high state for full speed and low state for low speed, performing the same operation with the thirteen connection pin (SPD) that acts in the same way for the output data. If low speed devices are connected, these two pins must be connected to their low state (GND1 and GND2) respectively and if a full speed device is connected, these two pins must be connected in high state (VBUS1 and VBUS2). In the proposed design, the SPU and SPD were connected in a high state to perform a digital isolation at full speeds.
Tanto el aislador de potencia (12) como el aislador digital de datos bidireccional (11) están interconectados a un arreglo de control para indicador de velocidad USB (14) con un LED bicolor (verde, rojo) indicador de velocidad (14a) definido por un indicador de luz verde uno (15) y un indicador de luz rojo dos (16) y en donde dicho arreglo de control para indicador de velocidad USB (14) está conectado al puerto USB (8) del lado secundario (B). Both the power isolator (12) and the two-way digital data isolator (11) are interconnected to a control arrangement for USB speed indicator (14) with a two-color LED (green, red) speed indicator (14a) defined by a green light indicator one (15) and a red light indicator two (16) and wherein said control arrangement for USB speed indicator (14) is connected to the USB port (8) on the secondary side (B).
Entre el lado primario (A) y el lado secundario (B) se comprende una tercera barrera de aislamiento definida por una brecha de aislamiento de la PCB (17) hecha de FR4 (misma que se exhibe y explica en las figuras). El aislador de potencia (12) que preferentemente es un convertidor DC-DC que alimenta al receptor de datos USB (11a) del aislador de datos bidireccional (11) del lado primario (A) e intercambia energía a la fuente de energía aislada (12b) que se encarga de energizar el aislador de datos USB (11b, ver figura 2); a su vez ef aislador digital de datos bidireccional (11) intercambia información entre el lado primario (A) y el secundario (B) que corresponden a la comunicación entre la computadora personal (2) y el equipo médico (4) (ver fig. 1). El intercambio de energía y de datos aislados se debe a la ley de inducción de Faraday, ya que crea una fuerza electromotriz en la bobina que se encuentra en el lado secundario (B) del aislador de potencia (12) y del aislador digital de datos bidireccional (11) con respecto a la bobina que se encuentra en el lado A del aislador de potencia (12) y del aislador digital de datos bidireccional (11). El LED bicolor (verde, rojo) indicador de velocidad (14a) de montaje superficial muestra mediante el indicador de luz uno (15) cuando un controlador USB de velocidad baja se conecta a la computadora personal (2) a través de la interfaz USB aislada (1) y mediante el indicador de luz dos (16) cuando un controlador USB de velocidad completa se conecta a la computadora personal (2) a través de interfaz USB aislada (1). El arreglo de control para indicador de velocidad USB (14) se encarga de sensar y comparar las señales de datos D + y D- del dispositivo USB que se conecta y activa el indicador de luz uno o dos (15, 16) que corresponde a la velocidad del dispositivo USB en cuestión. Between the primary side (A) and the secondary side (B) is comprised a third isolation barrier defined by an isolation gap of the PCB (17) made of FR4 (same as shown and explained in the figures). The power isolator (12) which is preferably a DC-DC converter that feeds the USB data receiver (11a) of the bi-directional data isolator (11) on the primary side (A) and exchanges power to the isolated power source (12b ) which is responsible for energizing the USB data isolator (11b, see figure 2); In turn, the two-way digital data isolator (11) exchanges information between the primary (A) and secondary (B) sides that correspond to the communication between the personal computer (2) and the medical equipment (4) (see fig. one). The exchange of energy and isolated data is due to Faraday's induction law, since it creates an electromotive force in the coil that is located on the secondary side (B) of the power isolator (12) and the digital data isolator bidirectional (11) with respect to the coil that is located on side A of the power isolator (12) and the digital bidirectional data isolator (11). The bi-color LED (green, red) surface mount speed indicator (14a) shows via the light indicator one (15) when a low speed USB controller is connected to the personal computer (2) through the isolated USB interface (1) and through the light indicator two (16) when a USB full speed controller is connected to the personal computer (2) through an isolated USB interface (1). The control arrangement for USB speed indicator (14) is responsible for sensing and comparing the data signals D + and D- of the USB device that is connected and activates the light indicator one or two (15, 16) corresponding to the speed of the USB device in question.
Dicho LED bicolor (verde, rojo) indicador de velocidad (14a) se encuentran en un mismo encapsulado de montaje superficial. Por lo que, si se entrega un voltaje mayor al de polarización, el diodo se satura y deja pasar la señal que lo esta saturando. Said two-color LED (green, red) speed indicator (14a) is in the same surface mount package. Therefore, if a voltage greater than the polarization voltage is delivered, the diode becomes saturated and lets the signal that is saturating it through.
Al LED bicolor (verde, rojo) indicador de velocidades (14a) de montaje superficial se conecta una resistencia de montaje superficial de 200 Ohms, que limita la corriente que llega al LED para que ésta no lo darle. A surface mount resistor of 200 Ohms is connected to the bi-color LED (green, red) surface mount speed (14a), which limits the current that reaches the LED so that it does not give it.
El LED bicolor (verde, rojo) indicador de velocidades (14a) de montaje superficial, está fabricado para que la corriente que llega para polarizar a ambos LEDs, entre por un solo sentido del LED. Por lo que se requiere un arreglo en la conexión en la PCB para que una corriente de polarización para el LED verde llegue por un sentido y la corriente de polarización del LED rojo llegue por el sentido opuesto. The bi-color LED (green, red) surface mount speed indicator (14a), is manufactured so that the current that arrives to polarize both LEDs, enters through a single direction of the LED. Therefore, an arrangement in the PCB connection is required so that a polarization current for the green LED arrives in one direction and the polarization current of the red LED arrives in the opposite direction.
Para que la corriente de polarización que llega al LED bicolor (verde, rojo) llegue por sentidos opuestos, se necesita un amplificador operacional que esta conectado al aislador digital de datos bidireccional (11), por donde procede la señal de 1.5 Mbps o 12 Mbps. De tal modo que cuando pasa una señal de 12 Mbps por el aislador digital de datos bidireccional (11), el amplificador operacional envia una corriente de polarización al lado del LED verde. Y cuando pasa una señal de 1.5 Mbps por el aislador de datos, el amplificador operacional envía una corriente de polarización al lado del LED rojo. Es asi como se obtiene la velocidad del dispositivo que se conecta al aislador USB (1.5 Mbps o 12 Mbps). Los puntos anteriores habilitan al LED bicolor (verde, rojo) indicador de velocidad (14a) para que cuando se conecte un dispositivo que trabaja con velocidades de operación, velocidad baja (1.5 Mbps) pase por el LED polarizando el color rojo y cuando se conecte un dispositivo que trabaja con velocidades de operación velocidad total (12Mbps) encienda el LED indicador verde. For the polarization current that reaches the two-color LED (green, red) to arrive in opposite directions, an operational amplifier is needed that is connected to the two-way digital data isolator (11), where the 1.5 Mbps signal comes from or 12 Mbps. So when a 12 Mbps signal passes through the bidirectional digital data isolator (11), the operational amplifier sends a bias current to the side of the green LED. And when a 1.5 Mbps signal passes through the data isolator, the operational amplifier sends a bias current to the side of the red LED. This is how you get the speed of the device that connects to the USB isolator (1.5 Mbps or 12 Mbps). The above points enable the bi-color LED (green, red) speed indicator (14a) so that when a device that works with operating speeds is connected, low speed (1.5 Mbps) goes through the LED polarizing the red color and when it is connected a device that works with full speed operation speeds (12Mbps) turn on the green LED indicator.
Con respecto a las figuras 3, 3a y 3b la interfaz USB aislada (1) que define dicho lado primario (A) y dicho lado secundario (B) que llevan una capa superior y una capa inferior de cobre (18) y entre los cuales se define una brecha de aislamiento (17) de la PCB hecha de FR4 y en la zona central de dicha brecha de aislamiento (17) de la PCB se define un capacitor (19) construido dentro de la PCB. El rompimiento de un aislamiento eléctrico se produce cuando un potencial eléctrico generado o aplicado entre el aislamiento hace que la corriente que fluye como resultado aumente rápidamente y de manera incontrolada. Debido a que el material FR4 de la brecha de aislamiento (17) de la PC6 no es conductor y tiene una permitividad relativa baja (de 5.4 aproximadamente), se utiliza como brecha de aislamiento (17) de la PCB entre el lado primario (A) y el lado secundario (B) de la interfaz USB aislada (1). With respect to figures 3, 3a and 3b the isolated USB interface (1) defining said primary side (A) and said secondary side (B) carrying an upper layer and a lower copper layer (18) and between which an isolation gap (17) of the PCB made of FR4 is defined and in the central area of said isolation gap (17) of the PCB a capacitor (19) constructed within the PCB is defined. The breakdown of an electrical insulation occurs when an electrical potential generated or applied between the insulation causes the current flowing as a result to increase rapidly and in an uncontrolled way. Because the FR4 material of the insulation gap (17) of the PC6 is not conductive and has a low relative permittivity (of approximately 5.4), it is used as the insulation gap (17) of the PCB between the primary side (A ) and the secondary side (B) of the isolated USB interface (1).
La brecha de aislamiento (17) de la PCB hecha de FR4 es capaz de soportar el paso de corrientes creadas por un gran potencial eléctrico entre ambos lados primario y secundario (A, B) y garantiza la seguridad eléctrica que puede verse afectada por este efecto. The insulation gap (17) of the PCB made of FR4 is capable of supporting the passage of currents created by a large electrical potential between both primary and secondary sides (A, B) and guarantees the electrical safety that can be affected by this effect .
Las corrientes de fuga del lado secundario (B) de la interfaz USB aislada (1) se pueden ver afectadas por el ruido de interferencia electromagnética (EMI, por sus siglas en ingles), para que éstas corrientes no representen un peligro se crea el capacitor (19) dentro de las capas intermedias de la PCB. Leakage currents on the secondary side (B) of the isolated USB interface (1) can be affected by electromagnetic interference noise (EMI), so that these currents do not represent a hazard, the capacitor is created (19) within the intermediate layers of the PCB.
Haciendo referencia a las figuras 4, 4a, 4b y 4c, se observa el capacitor (19) creado dentro de las capas intermedias de la PCB y consiste en una estructura de metal flotante (20) que solapa al plano de alimentación (21) y este a su vez al plano de tierra (22) y que define una primera región capacitiva (A1) y una segunda región capacitiva (A2). De esta manera se crea un efecto capacitivo usando el material FR4, que separa a los planos, como material dieléctrico.  Referring to Figures 4, 4a, 4b and 4c, the capacitor (19) created within the intermediate layers of the PCB is observed and consists of a floating metal structure (20) that overlaps the power plane (21) and this in turn to the ground plane (22) and that defines a first capacitive region (A1) and a second capacitive region (A2). In this way a capacitive effect is created using the FR4 material, which separates the planes, as a dielectric material.
El acoplamiento capacitivo total se calcula con reglas básicas de capacitores en serie, donde el cálculo del capacitor uno y dos se dan por:
Figure imgf000026_0001
donde C es la capacitancia del capacitor en cuestión, A es el área de la región capacitiva, c es la permitividad y d es la separación entre las placas. La permitividad y el área se calculan mediante:
The total capacitive coupling is calculated with basic rules of series capacitors, where capacitor calculation one and two are given by:
Figure imgf000026_0001
where C is the capacitance of the capacitor in question, A is the area of the capacitive region, c is the permittivity and d is the separation between the plates. The permittivity and the area are calculated by:
Figure imgf000026_0002
Figure imgf000026_0002
donde «o es la permitividad del vacío y εr es la permitividad relativa del dieléctrico (FR4 en este caso), w es el ancho de la placa del área en cuestión es el largo de la
Figure imgf000026_0005
where «o is the vacuum permittivity and ε r is the relative permittivity of the dielectric (FR4 in this case), w is the plate width of the area in question is the length of the
Figure imgf000026_0005
placa. Ahora bien, la capacitancia total se da por la suma de Ci y C2 en serie:
Figure imgf000026_0003
license plate. Now, the total capacitance is given by the sum of Ci and C 2 in series:
Figure imgf000026_0003
Para obtener una capacitancia óptima las áreas de los planos primarios y secundarios hechos dentro de la PCB deben de ser iguales. Entonces, si w1 = w2 y sustituyendo (2 y 3) en (1) y (1) en (4), se obtiene la capacitancia total, que.es:  To obtain optimum capacitance the areas of the primary and secondary planes made within the PCB must be equal. Then, if w1 = w2 and substituting (2 and 3) in (1) and (1) in (4), the total capacitance is obtained, which is:
Figure imgf000026_0004
Con referencia a la figura 5, dado que las señales de datos D+ y D- del puerto USB tienen relación directa con la velocidad, el arreglo de control para indicador de velocidad USB (14) que se esta usando sirve para determinar la velocidad del USB a través de indicadores de luz uno o dos (15, 16) que se activan dependiendo del estado de las señales.
Figure imgf000026_0004
With reference to Figure 5, since the data signals D + and D- of the USB port are directly related to the speed, the control arrangement for the USB speed indicator (14) being used serves to determine the USB speed through one or two light indicators (15, 16) that are activated depending on the state of the signals.
La ventaja que ofrece la interfaz USB aislada (1, ver fig. 2) y que ningún otro dispositivo existente permite, es la visualización de la velocidad del dispositivo mediante un sensor de señales D+ y 0- que utiliza dos amplificadores seguidores (23, 24) para identificar el nivel de la señal y compara a través de un puente (25) creado en el LED bicolor (verde, rojo) indicador de velocidad (14a), las señales de datos. Una vez que las señales son comparadas, la señal predominante hace que se active el indicador de luz que corresponde a la velocidad de datos USB baja o completa (indicador de velocidad con un indicador de luz uno (15) y un indicador de luz dos (16). Un amplificador seguidor (23 o 24) contiene una alta impedancia de entrada, por lo que, si llega la señal de datos diferencial del puerto USB, ésta no se verá afectada por pérdidas en la corriente. Una vez que la señal es sensada pasa a través de un puente (25) creado entre el indicador de luz uno (15) y el indicador de luz dos (16), que por naturaleza se comportan como un diodo, de este modo la señal que llega D- llega al punto 1 del indicador de luz uno (15) y al punto 3 del indicador de luz dos (16), y la señal D+ llega al punto 4 del indicador de luz dos (16), y al punto 2 del indicador de luz uno (15). De manera que si una serial es predominante hace que uno de los indicadores de luz uno y dos (15, 16) se polarice de manera directa y el otro indicador se polarice de manera inversa haciendo que el diodo actué como circuito cerrado o abierto respectivamente. El indicador de luz uno o dos (15, 16) que se polariza de manera directa es el que se activa y muestra de manera visual la velocidad del dispositivo USB que se conecta, ya sea baja o completa. The advantage offered by the isolated USB interface (1, see fig. 2) and that no other existing device allows, is the display of the device speed through a D + and 0- signal sensor that uses two follow-up amplifiers (23, 24 ) to identify the signal level and compare the data signals through a bridge (25) created in the two-color LED (green, red) speed indicator (14a). Once the signals are compared, the predominant signal causes the light indicator that corresponds to the low or full USB data rate to be activated (speed indicator with a light indicator one (15) and a light indicator two ( 16) A follow-up amplifier (23 or 24) contains a high input impedance, so if the differential data signal arrives from the USB port, it will not be affected by losses in the current Once the signal is sensed passes through a bridge (25) created between the light indicator one (15) and the light indicator two (16), which by nature behave like a diode, thus the signal that arrives D- reaches the point 1 of light indicator one (15) and point 3 of light indicator two (16), and the D + signal it reaches point 4 of light indicator two (16), and point 2 of light indicator one (15). So if a serial is predominant it causes one of the one and two light indicators (15, 16) to be polarized directly and the other indicator to be polarized in a reverse way causing the diode to act as a closed or open circuit respectively. The one or two light indicator (15, 16) that is polarized directly is the one that activates and visually shows the speed of the USB device that is connected, either low or full.
Con referencia a la figura 6, el método para la detección de velocidad del dispositivo USB que se encuentra conectado a una computadora personal (2, ver fig. 1) a través de la interfaz USB aislada (1, ver fígs. 1 y 2) se caracteriza porque comprende las siguientes etapas. With reference to figure 6, the method for speed detection of the USB device that is connected to a personal computer (2, see fig. 1) through the isolated USB interface (1, see figs. 1 and 2) It is characterized in that it comprises the following stages.
a) Sensar la velocidad del arreglo de control para indicador de velocidad USB (14, ver fig. 2) que se conecta a una computadora personal (2, ver fig. 1) a través la interfaz USB aislada (1, ver figs. 1 y 2). La velocidad depende del dispositivo USB que se conecta y que preferentemente es un equipo médico (4, ver fig. 1) y pueden ser velocidades de USB bajas o completas.  a) Sensing the speed of the control array for the USB speed indicator (14, see fig. 2) that is connected to a personal computer (2, see fig. 1) via the isolated USB interface (1, see figs. 1 and 2). The speed depends on the USB device that is connected and which is preferably a medical device (4, see fig. 1) and can be low or full USB speeds.
b) Comparar las señales de datos D+ y D- mediante el puente (25, ver fig. 5) creado entre las cuatro terminales de los indicadores de luz uno o dos (15, 16, ver fig.5) b) Compare the data signals D + and D- using the bridge (25, see fig. 5) created between the four terminals of the one or two light indicators (15, 16, see fig. 5)
(que por su naturaleza funcionan como un diodo), el dato sensado del amplificador seguidor (23, ver fig. 5) con el dato de entrada del amplificador seguidor (24, ver fig. 5) de la etapa a). (which by their nature function as a diode), the sensed data of the follow-up amplifier (23, see fig. 5) with the input data of the follow-up amplifier (24, see fig. 5) of stage a).
c) Activar el indicador de velocidad de datos USB para determinar si la velocidad de datos USB es baja o completa. Si la velocidad de datos USB es baja, entonces se ejecuta la etapa c2; si la velocidad de datos USB no es baja, entonces se ejecuta la etapa c1. c1) Activar el indicador de luz dos (16, ver figura 5) si la velocidad de datos USB es completa.  c) Activate the USB data rate indicator to determine if the USB data rate is low or full. If the USB data rate is low, then step c2 is executed; If the USB data rate is not low, then step c1 is executed. c1) Activate light indicator two (16, see figure 5) if the USB data rate is complete.
c2) Activar el indicador de luz uno (15, ver fig. 5) si la velocidad de datos USB del dispositivo conectado es baja.  c2) Activate light indicator one (15, see fig. 5) if the USB data rate of the connected device is low.
El invento ha sido descrito suficientemente como para que una persona con conocimientos medios en la materia pueda reproducir y obtener los resultados que mencionamos en la presente invención. Sin embargo, cualquier persona hábil en el campo de la técnica que compete el presente invento puede ser capaz de hacer modificaciones no descritas en la presente solicitud. No obstante, si para la aplicación de estas modificaciones en una estructura determinada o en el proceso de manufactura del mismo, se requiere de la materia reclamada en las siguientes reivindicaciones, dichas estructuras deberán ser comprendidas dentro del alcance de la invención.  The invention has been described sufficiently that a person with average knowledge in the field can reproduce and obtain the results mentioned in the present invention. However, any skilled person in the field of the art that is in charge of the present invention may be able to make modifications not described in the present application. However, if for the application of these modifications in a given structure or in the manufacturing process thereof, the matter claimed in the following claims is required, said structures must be included within the scope of the invention.

Claims

REIVINDICACIONES Habiendo descrito suficientemente la invención, se considera como novedad y por lo tanto se reclama como propiedad lo expresado y contenido en las siguientes cláusulas reivindicatorías. CLAIMS Having sufficiently described the invention, it is considered as a novelty and therefore the expressed and contained in the following claims clauses are claimed as property.
1.- Una interfaz USB aislada para conexión de instrumentación médica con computadora, de conformidad con la presente invención, conformado por una tarjeta de circuito impreso (PCB por sus siglas en inglés) que define un lado primario y un lado secundario, con un puerto de conexión USB en dicho lado primario adaptado para conectar mediante un primer cable USB una computadora personal que se conecta a una fuente de suministro de energía eléctrica, y un puerto de conexión USB en el lado secundario adaptado para conectar mediante un segundo cable USB un equipo médico que monitorea y/o controla bioseñales de un paciente y que estará conectado opcionalmente a una fuente aislada de grado médico de alimentación de energía eléctrica; caracterizada porque entre dichos lado primario y lado secundario se comprende una primera barrera de aislamiento definida por un aislador digital de datos bidíreccional para el aislamiento entre los datos D+ y D-; opcionalmente una segunda barrea definida por un aislador de potencia que integra un convertidor DC-DC con regulador de voltaje; en donde dicho aislador digital de datos bidíreccional y dicho aislador de potencia se encuentran interconectados entre sí y al puerto USB del lado primario; comprendiendo además una tercera barrera de aislamiento definida por una brecha de aislamiento de la PCB hecha de un material no conductor y creada entre dichos lados primario y secundario de la interfaz, con determinado espesor, la cual ayuda a la protección contra una descarga eléctrica y brinda un aislamiento reforzado a la interfaz. 1.- An isolated USB interface for connection of medical instrumentation with a computer, in accordance with the present invention, consisting of a printed circuit board (PCB) that defines a primary side and a secondary side, with a port USB connection on said primary side adapted to connect a personal computer via a first USB cable that connects to a power source, and a USB connection port on the secondary side adapted to connect a computer via a second USB cable doctor who monitors and / or controls a patient's biosignals and who will be optionally connected to an isolated medical grade power supply; characterized in that between said primary side and secondary side a first isolation barrier is defined defined by a bi-directional digital data isolator for isolation between the D + and D- data; optionally a second barrier defined by a power isolator that integrates a DC-DC converter with voltage regulator; wherein said two-way digital data isolator and said power isolator are interconnected with each other and to the USB port on the primary side; further comprising a third isolation barrier defined by an isolation gap of the PCB made of a non-conductive material and created between said primary and secondary sides of the interface, with a certain thickness, which helps protect against electric shock and provides a reinforced interface isolation.
2. - La interfaz USB aislada para conexión de instrumentación médica con computadora, de acuerdo con la reivindicación 1, caracterizado porque además comprende un arreglo de control para indicador de velocidad USB interconectado con dicho aislador digital de datos bidireccional y dicho aislador de potencia y que comprende preferentemente un LED indicador de velocidad y en donde dicho arreglo de control para indicador de velocidad USB está conectado al puerto USB del lado secundario. 2. - The isolated USB interface for connection of medical instrumentation with computer, according to claim 1, characterized in that it further comprises a control arrangement for USB speed indicator interconnected with said two-way digital data isolator and said power isolator and that it preferably comprises a speed indicator LED and wherein said control arrangement for USB speed indicator is connected to the USB port of the secondary side.
3. - La interfaz USB aislada para conexión de instrumentación médica con computadora, de acuerdo con la reivindicación 1; caracterizada porque dicha PCB de la interfaz USB aislada que define dicho lado primario y dicho lado secundario, lleva una capa superior y una capa inferior de cobre entre las que se comprenden capas intermedias de la PCB donde se define una dicha brecha de aislamiento hecha de un material no conductor y que tiene una permitividad relativa baja, y en la zona central de dicha brecha de aislamiento de la PCB se define un capacitor construido dentro de la misma. 3. - The isolated USB interface for connection of medical instrumentation with computer, according to claim 1; characterized in that said PCB of the isolated USB interface defining said primary side and said secondary side, carries an upper layer and a lower layer of copper between which intermediate layers of the PCB are comprised where a said isolation gap made of a non-conductive material and having a low relative permittivity, and in the central zone of said PCB insulation gap a capacitor constructed within it is defined.
4. - La interfaz USB aislada para conexión de instrumentación médica con computadora, de acuerdo con las reivindicaciones 1 y 3; caracterizada porque dicho capacitor creado dentro de las capas intermedias de la PCB consiste en una estructura de metal flotante que solapa al plano de alimentación y este a su vez al plano de tierra y que define una primera región capacitiva (A1) y una segunda región capacitiva (A2), creando un efecto, capacitivo usando el material no conductor, que separa a los planos, como material dieléctrico. 4. - The isolated USB interface for instrumentation connection medical computer, according to claims 1 and 3; characterized in that said capacitor created within the intermediate layers of the PCB consists of a floating metal structure that overlaps the power plane and this in turn to the ground plane and defines a first capacitive region (A1) and a second capacitive region (A2), creating a capacitive effect using the non-conductive material, which separates the planes, as a dielectric material.
5.· La interfaz USB aislada para conexión de instrumentación médica con computadora, de acuerdo con la reivindicación 1; caracterizada porque la PCB está fabricado en una placa de dos caras con planos de tierra en ambos lados para disminuir las capacitancias parásitas y reducir la interferencia del ruido eléctrico. 5. The isolated USB interface for connection of medical instrumentation with computer, according to claim 1; characterized in that the PCB is manufactured on a two-sided plate with ground planes on both sides to reduce parasitic capacitance and reduce electrical noise interference.
6.- La interfaz USB aislada para conexión de instrumentación médica con computadora, de acuerdo con la reivindicación 1; caracterizada porque dicha segunda barrera definida por un aislador de potencia que establece una fuente de energia no aislada del lado primario y una fuente de energía aislada del lado secundario, integra un LED indicador de conexión del estado anfitrión del lado primario. 6. The isolated USB interface for connection of medical instrumentation with computer, according to claim 1; characterized in that said second barrier defined by a power isolator that establishes an energy source not isolated from the primary side and an energy source isolated from the secondary side, integrates an indicator LED for connecting the host state of the primary side.
7.- La interfaz USB aislada para conexión de instrumentación médica con computadora, de acuerdo con la reivindicación 2; caracterizada porque dicho LED indicador de velocidad consiste en un LED bicolor (verde, rojo) con un indicador de luz uno que muestra cuando un controlador USB de velocidad baja se conecta a una computadora a través de dicha interfaz USB aislada y un indicador de luz dos que muestra cuando un controlador USB de velocidad completa se conecta a la computadora personal a través de dicha interfaz USB aislada. 7. The isolated USB interface for connection of medical instrumentation with a computer, according to claim 2; characterized in that said speed indicator LED consists in a two-color LED (green, red) with a light indicator one that shows when a low speed USB controller is connected to a computer through said isolated USB interface and a two light indicator that shows when a USB speed controller complete connects to the personal computer through said isolated USB interface.
8. - La interfaz USB aislada para conexión de instrumentación médica con computadora, de acuerdo con la reivindicación 2; caracterizada porque dicho arreglo de control para indicador de velocidad USB incluye dos amplificadores operacionales que esta conectado al aislador digital de datos bidireccional por donde procede la señal de 1.5 Mbps para el encendido del LED rojo o 12 Mbps para el encendido del LED verde. 8. - The isolated USB interface for connection of medical instrumentation with a computer, according to claim 2; characterized in that said control arrangement for the USB speed indicator includes two operational amplifiers which is connected to the two-way digital data isolator where the 1.5 Mbps signal for the red LED illumination or 12 Mbps for the green LED illumination comes from.
9. - La interfaz USB aislada para conexión de instrumentación médica con computadora, de acuerdo con la reivindicación 1; caracterizada porque dicho arreglo de control para indicador de velocidad USB incluye dos amplificadores seguidores para sensar e identificar el nivel de la señal y comparar a través de un puente creado en el LED bicolor a base de diodos como indicador de velocidad de las señales de datos; en donde la señal predominante activa el indicador de luz que corresponde a la velocidad de datos USB baja o completa. 9. - The isolated USB interface for connection of medical instrumentation with a computer, according to claim 1; characterized in that said control arrangement for USB speed indicator includes two follow-up amplifiers for sensing and identifying the signal level and comparing through a bridge created in the diode-based bi-color LED as a speed indicator of the data signals; where the predominant signal activates the light indicator that corresponds to the low or full USB data rate.
10.- La interfaz USB aislada para conexión de instrumentación médica con computadora, de acuerdo con la reivindicación 1; caracterizada porque dicho aislador digital de datos bidireccional aisla eléctricamente los datos de transmisión D+ y D- utilizando un circuito integrado, el cual es compatible con puertos USB 2.0 y maneja velocidades de operación de datos de velocidad baja y velocidad completa de 1.5Mbps y 12Mbps respectivamente. 10. The isolated USB interface for connection of medical instrumentation with a computer, according to claim 1; characterized in that said two-way digital data isolator Electrically isolates the D + and D- transmission data using an integrated circuit, which is compatible with USB 2.0 ports and handles low speed and full speed data operation speeds of 1.5Mbps and 12Mbps respectively.
11.- Un método para la detección y comparación de señales digitales o analógicas, caracterizado porque comprende las etapas: a) Sensar.- La velocidad del arreglo de control para indicador de velocidad USB que se conecta a una computadora personal a través la interfaz USB aislada. b) Comparar.- Las señales de datos D+ y D- mediante el puente creado entre las cuatro terminales de los indicadores de luz uno o dos (que por su naturaleza funcionan como un diodo), el dato sensado del amplificador seguidor con el dato de entrada del amplificador seguidor de la etapa a). 11.- A method for the detection and comparison of digital or analog signals, characterized in that it comprises the steps: a) Sensing.- The speed of the control arrangement for USB speed indicator that is connected to a personal computer through the USB interface isolated. b) Compare.- The data signals D + and D- by means of the bridge created between the four terminals of the one or two light indicators (which by their nature function as a diode), the sensed data of the follow-up amplifier with the data of amplifier input follower stage a).
c) Activar el indicador de velocidad de datos USB para determinar si la velocidad de datos USB es baja o completa. Si la velocidad de datos USB es baja, entonces se ejecuta la etapa c2; si la velocidad de datos USB no es baja, entonces se ejecuta la etapa c1. c1) Activar el indicador de luz dos, si la velocidad de datos USB es completa.  c) Activate the USB data rate indicator to determine if the USB data rate is low or full. If the USB data rate is low, then step c2 is executed; If the USB data rate is not low, then step c1 is executed. c1) Activate indicator light two, if the USB data rate is complete.
c2) Activar el indicador de luz uno, si la velocidad de datos USB del dispositivo conectado es baja.  c2) Activate indicator light one, if the USB data rate of the connected device is low.
PCT/MX2017/000049 2017-04-20 2017-04-21 Isolated usb interface for connecting medical instruments to a computer and usb speed sensor WO2018194439A1 (en)

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