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WO2016034910A1 - Device for assisting in the detection of body cavities - Google Patents

Device for assisting in the detection of body cavities Download PDF

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Publication number
WO2016034910A1
WO2016034910A1 PCT/IB2014/001684 IB2014001684W WO2016034910A1 WO 2016034910 A1 WO2016034910 A1 WO 2016034910A1 IB 2014001684 W IB2014001684 W IB 2014001684W WO 2016034910 A1 WO2016034910 A1 WO 2016034910A1
Authority
WO
WIPO (PCT)
Prior art keywords
electrodes
stylet
electrode
needle
penetrating
Prior art date
Application number
PCT/IB2014/001684
Other languages
Spanish (es)
French (fr)
Inventor
Andrés Ernesto SALGUERO BELTRÁN
Augusto BUENDÍA RESTREPO
Original Assignee
Salguero Beltrán Andrés Ernesto
Buendía Restrepo Augusto
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 Salguero Beltrán Andrés Ernesto, Buendía Restrepo Augusto filed Critical Salguero Beltrán Andrés Ernesto
Priority to PCT/IB2014/001684 priority Critical patent/WO2016034910A1/en
Publication of WO2016034910A1 publication Critical patent/WO2016034910A1/en
Priority to CONC2017/0002996A priority patent/CO2017002996A2/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/42—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode

Definitions

  • the present invention relates to a device for the detection of body cavities by means of puncture elements.
  • this device can be used to assist in the detection of epidural space.
  • anesthesia is one of the most frequent procedures in medicine, in particular, epidural anesthesia that is used in the preparation of major procedures such as labor and various types of surgery, be they gynecological, urological or orthopedic; being indicated primarily for elderly patients.
  • epidural anesthesia is of the highest occurrence because the birth rate worldwide exceeds 134 million people 1 and in developed countries 60% of deliveries are performed with epidural anesthesia 2 , while in developing countries the percentage It reaches up to 40%.
  • the insertion of the epidural needle is a surgical act, during which the doctor experiences sensory feedback of the mechanical resistance that the tissues oppose to the passage of the needle, which can be modified, in some cases, by the softening of the ligaments in parturient women and others, due to excess fat in obese patients or to particular pathological conditions.
  • the most important sensory component is the experience of loss of resistance to injection of media, liquids or gaseous, through the needle.
  • Such sensory feedback conditioned to multiple variants makes epidural puncture risky due to the high probability of causing perforating trauma to the meninges. Reducing this risk is the responsibility of the anesthesiologist, who for this must develop surgical skills that are challenged by anatomical and physiological variations according to the patient's conditions.
  • the loss of resistance as the main evidence in the location of the epidural space is a practical method with a high success rate.
  • the risk of accidental perforation of the meninges is also high for the following reasons:
  • the needle In the first place, it is common for the needle to drag tissue debris into its interior, such as fat, muscle fragments or ligaments, creating a tamponade - which will not allow resistance to air or liquid flow to be reduced, leading to the doctor to erroneously conclude that it has not reached space and, consequently, to continue advancing the needle until the meninges are perforated.
  • Another cause is the uncontrolled penetrating movement due to the abrupt change of the force exerted by the doctor on the needle when crossing the ligament yellow, since in the direction of advance of the needle, this is a dense but thin fabric, the perforation is abrupt and the transient to move from a force control to a position in the manipulation of the needle, can cause a delay in the recovery of movement control, which results in unwanted puncture of the meninges.
  • the second event that will occasionally lead the doctor to an erroneous conclusion consists of the intra-vascular puncture that occurs when the tip of the needle enters a blood vessel, compared to the pressure exerted by the doctor on the plunger of the syringe, the pressure there will be low presenting loss of resistance, so the doctor could conclude that it is in the epidural space and would proceed with the application of the anesthetic, which will be injected into the blood vessel without reaching the nerve roots that are sought to block.
  • patents No. US 4,801, 293 and US 4,9 9,653 which teach respectively, the detection of the negative pressure to inject a pressurized gas and a sensor to detect the pressure drop when entering the epidural space and with this signal retract the sharp means and avoid perforation of the meninges.
  • Similar mechanisms are disclosed in patents US 5,205,828, US 5,902,273, US 6,773,417 and in the patent application with publication number US 201 1/0060229.
  • - US 3682162 discloses a device comprising a syringe and a hypodermic needle with electrodes and means for electrical stimulation.
  • US Patent 64401 18 discloses a device based on bioimpedance, as well as methods of manufacturing special needles for carrying electrodes for such measurements.
  • the patent application with publication No. US 2010/0286507 reveals an epidural needle with permanently incorporated electros to perform bio-impedance measurements.
  • the embodiments that are based on the bioimpedance measurement require special piercing means that permanently integrate the conductors and electrodes for measurement, leading to the modification of the usual means such as epidural needles.
  • Another important aspect that is not addressed in these embodiments is the measurement error associated with the application and measurement of electrical signals through electrodes of reduced size in biological media.
  • the electrical means for calculating the bioimpedance are incorporated into a manual unit that the physician must support, modifying the ergonomics of the traditional medical technique.
  • external cables are used to connect the electrical bioimpedance calculation means with the conduction means incorporated in the penetrating means, adding complexity in the assembly and possible sources of measurement error.
  • the problem posed in the present application is the need to provide a device to assist the anesthesiologist in the timely detection of the epidural space that complements the standard technique of loss of resistance, increasing the safety of the procedure, both for the patient, as For the anesthesiologist, be this expert or be in the early stages of your learning curve. Consequently, said device allowing the appropriate location of the epidural space.
  • User of the device the anesthesiologist
  • User of the device continues to perform the traditional technique of loss of resistance, it provides an increased certainty in the detection of the epidural space because the device indicates the discontinuity of the tissue that occurs when reaching the epidural space.
  • the minimum dimensions of the device allow its assembly inside the traditional needle in a non-disruptive way.
  • the syringe and epidural needle of the standard and commercially available method can be continued.
  • said device does not require cable connections for electrodes, for example, external reference, or cannulas outside of said protocol.
  • the user anesthesiologist
  • the device is removed from the needle and discarded, to continue the application of the anesthetic.
  • the invention presented here offers a set of advantages that allows its inclusion in the standard epidural space detection protocol in a slow manner.
  • the experienced anesthesiologist remains in control of the procedure by applying and increasing his expertise while, the anesthesiologist in training or with little experience will continue to be trained in the standard technique with additional information to support his decisions.
  • the inclusion of the device in the standard package for epidural anesthesia does not require modification of existing materials and supplies.
  • the device is manufactured by means of current methods and materials in the medical supplies industry, so its cost is low. In the same way, it is considered to be of a single use, maintaining the safety conditions for the patient.
  • the above characteristics allow it to be used, in facilities and clinical situations of varying complexity.
  • a first aspect that the present invention focuses on is to reduce the accumulation of biological material on the stimulus / registration electrodes when the needle is penetrating the tissues in its path to the epidural space.
  • the present application provides a medical device for detecting body cavities, with electronic means for measuring the bioimpedance of the tissue in contact with the tip of penetrating means by means of electrodes that are removably inserted by means of a stylet; in the hollow portion of said penetrating means and within the stylet there are conductive means that connect the electrodes with said electronic means, which in turn produce a signal indicating the detection of the body cavity.
  • Said medical device comprises:
  • each facet is formed with a rigid substrate, which is an electrical insulator, which embeds the electrode, and exposes only the electrode region for contact with the biological tissue, so that the substrate forms a surrounding area from the electrode to the edges of the facet that contains it.
  • the plane formed by the surface of each facet is not to co-plan with the planes formed by the surfaces of the other facets of the arrangement.
  • the planes formed by the surfaces of adjacent facets with common edge have an angle, measured in the normal plane (625) to said common edge, greater than 180 °, where said faceted arrangement (612) of non-coplanar electrodes reduces the creation of short circuits between electrodes due to the formation of conductive films of body fluids.
  • Figure 1 illustrates the way in which the doctor takes the needle and epidural syringe in his hands to perform the technique of loss of resistance to detect the epidural space.
  • Figure 2 illustrates the temporal assembly line of the invention between the syringe and the epidural needle, as well as a perspective view of how the system looks with the epidural cavity detection device mounted in the syringe and needle kit.
  • Figure 3 illustrates how the epidural space detector incorporated into the syringe and needle pair does not affect the way in which the doctor takes said assembly into his hands compared to the traditional technique pair (illustrated in Fig.
  • Figure 4 shows three views of the device: (i) the first in perspective, (ii) the second is a perspective cut of the syringe, detector and syringe assembly, and (ii) the third is a sectional view of how The hollow shaft of the needle concentrically contains the stylus of the sensing device.
  • Figure 5 shows a longitudinal section of the temporary assembly of the syringe, detector device and the epidural needle.
  • Figure 6 presents three views of the tip of the epidural needle with assembly of the electrode array whose substrate is faceted, wherein said array has two electrodes for bioimpedance measurement.
  • Figure 7 presents two views of the tip of the epidural needle with assembly of the faceted array of electrodes, wherein said arrangement has four electrodes for bioimpedance measurement. 5.
  • Figure 1 shows the prior state of the art, for location. of the epidural space in which the traditional 10-needle syringe pair 20 (which constitutes a penetrating medium) is used.
  • the traditional 10-needle syringe pair 20 which constitutes a penetrating medium
  • the plunger 101 of the syringe presses the plunger 101 of the syringe to try to inject the air, or liquid. If there is no flow of said content, the plunger returns to its initial position due to the elastic decompression of the air, or in the case that there is only liquid, it will not move due to the incompressibility of the same.
  • the doctor will consider such resistance as evidence that the surrounding tissue blocks the tip of the needle and the epidural space has not been reached as long as the depth reached by the needle and the specific conditions of the patient support such a conclusion. Therefore, it will continue to sink the needle until there is no blockage in the tip and there is no resistance to the flow of air, or liquid, as the case may be; which generally indicates that the epidural space has been reached.
  • FIG. 2 A preferred embodiment 60 of the present invention is shown in Figure 2, in which the syringe 10 and the assembly 50 are inserted between the syringe 10 and the doctor performs the manipulation described above, however, now the device will emit a signal through indicators 606 that the tip of the needle 203 is in the epidural cavity. With this information the doctor will have more evidence to conclude if he has reached the epidural space. Once this conclusion is reached, the device and the syringe are removed and discarded, to continue the application of the anesthetic.
  • Figure 3 shows that the inclusion of the device is minimally disruptive, allowing the doctor to perform the standard protocol maneuvers.
  • FIG. 4A A view of embodiment 60 is shown in Figure 4A whose external body has a base 601, indicators 606, a concentrator 610 with flow outlets 609, stylet 602, centering fins 61 1 and at tip 603 the electrode array 620
  • Figure 4B shows a sectional view of the assembly 50 composed of a syringe 10, device for detecting the epidural space 60 and the epidural needle 20, where it is shown in detail how the tip 102 of the syringe is tightly coupled with port 607 at base 601.
  • Said port connects with the ducts 608 of the concentrator 610 which, in turn, is tightly coupled with the Luer type connection port 204 of the epidural needle, continuity is created in the pavilion of this port 204 of flow with the syringe through the perforations 609 of the concentrator 610 of the device.
  • This The concentrator serves as a support from which the stylet 602 is projected to its distal end, whose tip 603 houses an array of electrodes 620, described below, which in turn is aligned with the tip of the needle 203.
  • the cross section 652 of the needle is shown which, concentrically, embeds the cross section 651 of the stylet 602, of the latter projecting at least three centering fins 61 1, which position the stylet so that its entire path is concentric with the needle and a hollow runner 653 is formed, through which the air or liquid from the syringe flows with low resistance.
  • the constructive characteristics mentioned allow the physician to continue executing the technique of resistance loss, in the presence of the preferred embodiment described herein.
  • the base 601 there is a concentric chamber 632 that houses the electronic means with its energy source, to perform bioimpedance measurements, which are widely known in the state of the art, so that They are detailed in this description.
  • the electrode arrangement 620 and the metallic axis 202 of the needle are connected through the conductive means 630, embedded along the stylet, all in its entirety to perform the bioimpedance measurements of the tissue in contact with the tip of the entire assembly 50.
  • the electrodes 631 are exposed, which make electrical contact with the metallic axis 202 of the epidural needle.
  • Preferred embodiments of the present invention are characterized in that they identify with certainty the epidural space. To achieve this it is necessary to reduce the sources of contamination of the stimulus / measurement signals.
  • One of the main causes of contamination lies in the accumulation of tissue debris on the electrodes. When it comes to blood or other body fluid, liquid layers will appear that short-circuit them, producing a false measure of low impedance.
  • the inventive principle exemplified below, is applied to break with the continuity of such conductive layers. An embodiment of such a principle is presented in Figure 6.
  • part A shows the array of electrodes 620 inserted in the tip 202 of the epidural needle and surrounded by its bezel 204, where it is observed that the two electrodes 621 and 622 are embedded in different facets / planes 620i and 620j, respectively, of the rigid faceted layer, which is electrical insulator, only the electrode region being exposed for contact with the biological tissue .
  • Each facet forms a polygon with adjacent edges with other facets, when one of these embeds an electrode, it does not touch any of the edges of the electrode, leaving for or so many areas of guard substrate that extend from the respective electrode to the edges of the facets that contain them.
  • each facet is not co-planar with the planes formed by the surfaces of the other facets of the arrangement.
  • profile view of Figure 6C it is shown how adjacent facets 620i and 620j, with common edge, have an angle ⁇ , greater than 180 °, measured in a normal plane 625 to said common edge. This angulation between facets prevents the continuity of conductive layers between two or more electrodes since in the boundaries between facets forces are created that are greater than the surface tension of the liquid.
  • the measured impedance includes the impedance of the tissue of interest plus the impedance that occurs at the electrode / tissue interface, which in general is much greater than the tissue impedance. This phenomenon is exacerbated for electrodes with small contact area and in preferred embodiments of the present invention, the electrode diameters are between 100 ⁇ to 200 ⁇ . This is due to the fact that the sizes of the epidural needles, for regular use, are smaller than 17Ga.
  • an 18Ga epidural needle has an approximate internal diameter of 0.84mm; with an equivalent cross-sectional area of less than 0.55mm 2 and additionally, the electrodes must have an approximate separation of twice their diameter in order to establish the impedance of the tissue in the presence of contaminating sources of the measurement.
  • another embodiment of the present invention uses the metal axis of the epidural needle, connected to the electrical means, as a third electrode 631, as a reference electrode (see Figures 5 and 6 ).
  • the bevel 204 at the tip of the needle forms an electrode of elliptical geometry which surrounds the array of electrodes, and given its proximity to it, receives the majority of the current flow injected by the active electrode of the current source, which for this embodiment is defined as electrode 622.
  • the voltage measurement between electrode 621 and the electrode formed by bevel 204 is defined.
  • FIG. 7 Another preferred embodiment for the arrangement of electrodes in the present invention is shown in Figure 7 wherein four electrodes 622,623, 624, and 625, are aligned with the longitudinal axis 618 of the needle, using the same inventive concepts described above to remove contaminants. on the electrodes (both tissue detritus and liquid films).
  • the four electrode configuration is used for impedance measurement, well known in the state of the art, where electrodes 622 and 625 are used as input and output of the stimulus current and between electrodes 623 and 624 the voltage is measured.

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Abstract

The invention relates to a medical device for the detection of body cavities, comprising electronic means for measuring the bio-impedance of the tissue in contact with the tip of penetrating means, by means of electrodes that are removably inserted, using a stylus, in the hollow portion of said penetrating means.

Description

DISPOSITIVO PARA ASISTIR EN LA DETECCIÓN DE CAVIDADES  DEVICE FOR ASSISTING IN THE DETECTION OF CAVITY
CORPORALES  BODIES
1. CAMPO DE LA INVENCIÓN 1. FIELD OF THE INVENTION
La presente invención está relacionada con un dispositivo para la detección de cavidades corporales por medio de elementos de punción. Por ejemplo, este dispositivo se puede utilizar para asistir en la detección del espacio epidural. The present invention relates to a device for the detection of body cavities by means of puncture elements. For example, this device can be used to assist in the detection of epidural space.
2. ANTECEDENTES DE LA INVENCION 2. BACKGROUND OF THE INVENTION
En el estado de la técnica, la correcta localización de cavidades corporales cerradas para realizar algún tipo de procedimiento diagnóstico o terapéutico tal como el suministro de un agente farmacológico, o realizar in situ procedimientos quirúrgicos, se realiza de manera indirecta a través de soporte instrumental. En muy pocos casos el médico puede realizar una constatación de tal localización, exclusivamente a través de sus sentidos. La anestesia es uno de los procedimientos más frecuentes en medicina, en particular, la anestesia epidural que se usa en la preparación de procedimientos mayores como labores de parto y varios tipos de cirugía, sean estas ginecológicas, urológicas u ortopédicas; siendo indicada prioritariamente para pacientes de edad avanzada. La anestesia epidural es de altísima ocurrencia debido a que la tasa de nacimientos a nivel mundial supera a los 134 millones de personas 1 y en países desarrollados el 60% de los partos se realizan con anestesia epidural2, mientras que en países en desarrollo el porcentaje alcanza hasta el 40%. In the state of the art, the correct location of closed body cavities to perform some type of diagnostic or therapeutic procedure such as the supply of a pharmacological agent, or perform surgical procedures in situ, is performed indirectly through instrumental support. In very few cases the doctor can make a verification of such location, exclusively through his senses. Anesthesia is one of the most frequent procedures in medicine, in particular, epidural anesthesia that is used in the preparation of major procedures such as labor and various types of surgery, be they gynecological, urological or orthopedic; being indicated primarily for elderly patients. Epidural anesthesia is of the highest occurrence because the birth rate worldwide exceeds 134 million people 1 and in developed countries 60% of deliveries are performed with epidural anesthesia 2 , while in developing countries the percentage It reaches up to 40%.
1 The World Factbook 2013-14. Washington, DC: Central Intelligence Agency, 2013, USA. 1 The World Factbook 2013-14. Washington, DC: Central Intelligence Agency, 2013, USA.
2 Michelle J.K. Osterman, M.H.S.; and Joyce A. Martin, M.P.H "Epidural and Spinal Anesthesia Use During Labor: 27-state Reporting Area, 2008". In National Vital Statistics Reports, Vol. 59, No. 5, April 6, 2011. U.S. Dept. ofhealth & human services. Hyattsville, -MD, USA. La aplicación de anestesia epidural requiere localizar el espacio que deja la medula espinal en su recorrido por el conducto interno que tiene la columna vertebral. Dicho espacio contiene principalmente las raíces nerviosas proyectadas desde la médula espinal, arterias, una red vascular extensa de vasos menores, tejido conectivo laxo y grasa semilíquida distribuida. 2 Michelle JK Osterman, MHS; and Joyce A. Martin, MPH "Epidural and Spinal Anesthesia Use During Labor: 27-state Reporting Area, 2008". In National Vital Statistics Reports, Vol. 59, No. 5, April 6, 2011. US Dept. ofhealth & human services. Hyattsville, -MD, USA. The application of epidural anesthesia requires locating the space left by the spinal cord in its path through the internal duct that has the spine. This space mainly contains the nerve roots projected from the spinal cord, arteries, an extensive vascular network of minor vessels, loose connective tissue and distributed semi-liquid fat.
La inserción de la aguja epidural es una acto quirúrgico, durante el cual el médico experimenta realimentación sensorial de la resistencia mecánica que oponen los tejidos al paso de la aguja, la cual puede ser modificada, en algunos casos, por el ablandamiento de los ligamentos en parturientas y en otros, por el exceso de grasa en pacientes obesos o a condiciones patológicas particulares. Sin embargo, el componente sensorial más importante es la experiencia de la perdida de la resistencia a la inyección de medios, líquidos o gaseosos, a través de la aguja. Dicha realimentación sensorial condicionada a múltiples variantes hace que la punción epidural sea riesgosa por la alta probabilidad de causar traumatismos perforantes a las meninges. Reducir este riesgo es responsabilidad del anestesiólogo, el cual para esto debe desarrollar habilidades quirúrgicas que son desafiadas por variaciones anatómicas y fisiológicas según las condiciones del paciente. La perdida de la resistencia como principal evidencia en la localización del espacio epidural es un método práctico con un alto porcentaje de éxito. Sin embargo, el riesgo de una perforación accidental de las meninges es también alto por las siguientes razones: The insertion of the epidural needle is a surgical act, during which the doctor experiences sensory feedback of the mechanical resistance that the tissues oppose to the passage of the needle, which can be modified, in some cases, by the softening of the ligaments in parturient women and others, due to excess fat in obese patients or to particular pathological conditions. However, the most important sensory component is the experience of loss of resistance to injection of media, liquids or gaseous, through the needle. Such sensory feedback conditioned to multiple variants makes epidural puncture risky due to the high probability of causing perforating trauma to the meninges. Reducing this risk is the responsibility of the anesthesiologist, who for this must develop surgical skills that are challenged by anatomical and physiological variations according to the patient's conditions. The loss of resistance as the main evidence in the location of the epidural space is a practical method with a high success rate. However, the risk of accidental perforation of the meninges is also high for the following reasons:
- En primer lugar, es frecuente que en su recorrido la aguja arrastre hacia su interior detritus tisulares como grasa, fragmentos de músculo o ligamentos, creando un taponamiento -que no permitirá que la resistencia al flujo en aire o líquido se reduzca, llevando al médico a concluir erróneamente que no ha llegado al espacio y en consecuencia, a continuar avanzando la aguja hasta perforar las meninges. - In the first place, it is common for the needle to drag tissue debris into its interior, such as fat, muscle fragments or ligaments, creating a tamponade - which will not allow resistance to air or liquid flow to be reduced, leading to the doctor to erroneously conclude that it has not reached space and, consequently, to continue advancing the needle until the meninges are perforated.
Otra causa es el movimiento penetrante no controlado debido al cambio abrupto de la fuerza que ejerce el médico sobre la aguja al atravesar el ligamento amarillo, puesto que en el sentido de avance de la aguja, este es un tejido denso pero delgado, la perforación es abrupta y el transitorio para pasar de un control de fuerza a uno de posición en la manipulación de la aguja, puede ocasionar un retardo en la recuperación del control del movimiento, lo cual resulta en la punción indeseada de las meninges. Another cause is the uncontrolled penetrating movement due to the abrupt change of the force exerted by the doctor on the needle when crossing the ligament yellow, since in the direction of advance of the needle, this is a dense but thin fabric, the perforation is abrupt and the transient to move from a force control to a position in the manipulation of the needle, can cause a delay in the recovery of movement control, which results in unwanted puncture of the meninges.
-El segundo evento que ocasionalmente llevará al médico a una conclusión errónea, consiste en la punción intra-vascular que ocurre cuando la punta de la aguja ingresa a un vaso sanguíneo, frente a la presión ejercida por el médico sobre el émbolo de la jeringa, la presión allí será baja presentándose pérdida de la resistencia, por lo que el médico podría concluir que se encuentra en el espacio epidural y procedería con la aplicación del anestésico, que será inyectado dentro del vaso sanguíneo sin que llegue a las raíces nerviosas que se buscan bloquear. -The second event that will occasionally lead the doctor to an erroneous conclusion, consists of the intra-vascular puncture that occurs when the tip of the needle enters a blood vessel, compared to the pressure exerted by the doctor on the plunger of the syringe, the pressure there will be low presenting loss of resistance, so the doctor could conclude that it is in the epidural space and would proceed with the application of the anesthetic, which will be injected into the blood vessel without reaching the nerve roots that are sought to block.
En la búsqueda de soluciones instrumentales a estos problemas, se han divulgado métodos basados en dos mecanismos principales: El primero, al igual que en la perdida de la resistencia se basa en diferenciales de presiones y el segundo se basa en la caracterización de la impedancia eléctrica del tejido circundante en la punta. A continuación se presentan realizaciones en dichas categorías: In the search for instrumental solutions to these problems, methods based on two main mechanisms have been disclosed: The first, as in the loss of resistance is based on pressure differentials and the second is based on the characterization of electrical impedance of the surrounding tissue at the tip. Below are realizations in these categories:
Entre los mecanismos basados en diferenciales de presión (pérdida de presión), se encuentra aquel descrito en la patente US 4,175,567. En dicha patente se revela un dispositivo que indica a través de la deflexión de una membrana, si el diferencial de presión entre la punta de la aguja epidural frente al exterior es negativo o positivo. En particular, al emplear dicho dispositivo, cuando se llega al espacio epidural la membrana indicará un diferencial negativo, emulando le técnica de la "gota colgante" basada en que la presión en el espacio epidural es negativa con respecto a la presión atmosférica. Among the mechanisms based on pressure differentials (pressure loss), is that described in US Patent 4,175,567. In said patent a device is revealed that indicates through the deflection of a membrane, if the pressure differential between the tip of the epidural needle facing the outside is negative or positive. In particular, when using said device, when the epidural space is reached the membrane will indicate a negative differential, emulating the technique of the "hanging drop" based on the fact that the pressure in the epidural space is negative with respect to atmospheric pressure.
Igualmente, existen otros documentos de patentes tales como las patentes No. US 4,801 ,293 y US 4,9 9,653 que enseñan respectivamente, la detección de la presión negativa para inyectar un gas presurizado y un sensor para detectar la caída de presión al entrar al espacio epidural y con dicha señal retraer el medio punzante y evitar perforación de las meninges. Mecanismos similares se encuentran divulgados en las patentes US 5,205,828, US 5,902,273, US 6,773,417 y en la solicitud de patente con número de publicación US 201 1/0060229. Likewise, there are other patent documents such as patents No. US 4,801, 293 and US 4,9 9,653 which teach respectively, the detection of the negative pressure to inject a pressurized gas and a sensor to detect the pressure drop when entering the epidural space and with this signal retract the sharp means and avoid perforation of the meninges. Similar mechanisms are disclosed in patents US 5,205,828, US 5,902,273, US 6,773,417 and in the patent application with publication number US 201 1/0060229.
En la solicitud de patente EP058259 se presenta un dispositivo medidor de presión, con indicador auditivo, que se adapta a la jeringa y aguja con el que se realiza la técnica de la perdida de la resistencia. Otra realización se divulga en la publicación US201 1/0224623 que usa una cámara hermética a la que se incorpora un émbolo y mecanismo con resorte y medios conductores de flujo hacia una aguja epidural, el mecanismo aplica presión al émbolo para que cuando en la punta de la aguja no haya bloqueo el líquido se inyecte y se genere una alarma. Un método y dispositivo de supervisión de cambio de la presión se presenta en la publicación WO2008/03890. In patent application EP058259 a pressure measuring device is presented, with an auditory indicator, which adapts to the syringe and needle with which the technique of resistance loss is performed. Another embodiment is disclosed in publication US201 1/0224623 that uses a sealed chamber to which a spring-loaded plunger and mechanism and conductive flow means are incorporated into an epidural needle, the mechanism applies pressure to the plunger so that when at the tip of the needle has not blocked the liquid is injected and an alarm is generated. A method and device for monitoring pressure change is presented in WO2008 / 03890.
Sin embargo, los dispositivos basados solamente en mecanismos que usan diferenciales de presión están sujetos a las mismas fuentes de error en la detección del cambio de presión, como lo son el taponamiento de los medios perforantes debido a la acumulación de detritus tisulares y la punción intra- vascular accidental. Otra desventaja de tales métodos es la eliminación de la realimentación sensorial del anestesiólogo en la detección de la pérdida de la resistencia, excluyendo su experticia en la correcta valoración del fenómeno, y relegando dicha detección al accionamiento del mecanismo. However, devices based only on mechanisms that use pressure differentials are subject to the same sources of error in the detection of pressure change, such as plugging of perforating media due to the accumulation of tissue detritus and intra puncture. - accidental vascular. Another disadvantage of such methods is the elimination of the sensory feedback of the anesthesiologist in the detection of the loss of resistance, excluding their expertise in the correct assessment of the phenomenon, and relegating said detection to the actuation of the mechanism.
De otro lado, entre los mecanismos basados en la bio-impedancia, se encuentran descritos los mismos en las siguientes patentes y solicitudes de patente: On the other hand, among the mechanisms based on bio-impedance, they are described in the following patents and patent applications:
- La patente US 3682162 divulga un dispositivo que comprende una jeringa y una aguja hipodérmica con electrodos y medios para estimulación eléctrica. - La patente US 64401 18 divulga un dispositivo basado en bioimpedancia, así como los métodos de fabricación de agujas especiales para portar los electrodos para tales medidas. - La solicitud de patente con publicación No. US 2010/0286507, revela una aguja epidural con electros incorporados permanentemente para realizar medidas de bio-impedancia. - US 3682162 discloses a device comprising a syringe and a hypodermic needle with electrodes and means for electrical stimulation. - US Patent 64401 18 discloses a device based on bioimpedance, as well as methods of manufacturing special needles for carrying electrodes for such measurements. - The patent application with publication No. US 2010/0286507, reveals an epidural needle with permanently incorporated electros to perform bio-impedance measurements.
- La solicitud de patente con número de publicación WO20090 9707 se refiere a un equipo médico de mano, que reemplaza los materiales y métodos de la técnica de la pérdida de la resistencia y aquellos para la medición de la impedancia por medio de una aguja hueca con electrodos incorporados en la misma. Este tipo de dispositivos, también se encuentran revelados en la solicitud de patente No. US 2003/0083641 y US2006/0167404 y este último tiene cómo propósito principal la detección de ingreso en vasos sanguíneos. - The patent application with publication number WO20090 9707 refers to a hand-held medical device, which replaces the materials and methods of the resistance loss technique and those for the measurement of impedance by means of a hollow needle with electrodes incorporated in it. Such devices are also disclosed in patent application No. US 2003/0083641 and US2006 / 0167404 and the latter has as main purpose the detection of blood vessel entry.
Sin embargo, las realizaciones que se basan en la medición de la bioimpedancia, arriba mencionadas, requieren medios perforantes especiales que integran de forma permanente los conductores y electrodos para la medida, conllevando la modificación de los medios habituales como lo son las agujas epidurales. Otro aspecto importante que no se aborda en dichas realizaciones es el error de medida asociado a la aplicación y medida de señales eléctricas a través de electrodos de tamaño reducido en medios biológicos. En algunas de dichas realizaciones los medios eléctricos para realizar el cálculo de la bioimpedancia se incorporan en una unidad manual que el médico debe sostener, modificando la ergonomía de la técnica médica tradicional. En otras realizaciones, se usan cables externos para conectar los medios eléctricos de cálculo de bioimpedancia con los medios de conducción incorporados en los medios penetrantes, adicionando complejidad en el montaje y eventuales fuentes de error en la medida. However, the embodiments that are based on the bioimpedance measurement, mentioned above, require special piercing means that permanently integrate the conductors and electrodes for measurement, leading to the modification of the usual means such as epidural needles. Another important aspect that is not addressed in these embodiments is the measurement error associated with the application and measurement of electrical signals through electrodes of reduced size in biological media. In some of these embodiments, the electrical means for calculating the bioimpedance are incorporated into a manual unit that the physician must support, modifying the ergonomics of the traditional medical technique. In other embodiments, external cables are used to connect the electrical bioimpedance calculation means with the conduction means incorporated in the penetrating means, adding complexity in the assembly and possible sources of measurement error.
A partir de los problemas técnicos presentados con los dispositivos, métodos y mecanismos conocidos para la detección del espacio epidural en el estado de la técnica tales como el riesgo de arrastrar hacia el interior de la aguja del dispositivo detritus tisulares como grasa, fragmentos de músculo o ligamentos, movimiento penetrante no controlado debido al cambio abrupto de la fuerza que r. From the technical problems presented with the known devices, methods and mechanisms for the detection of the epidural space in the state of the art such as the risk of dragging into the needle of the tissue detritus device such as fat, muscle fragments or ligaments, uncontrolled penetrating movement due to the abrupt change in the force that r.
ejerce el médico sobre la aguja al atravesar el ligamento amarillo, aumento en la incidencia de punciones en las meninges y la punción intravascular que ocurre cuando la punta de la aguja ingresa a un vaso sanguíneo frente a la presión ejercida por el médico sobre el émbolo de la jeringa, existe la necesidad de un dispositivo para la detección del espacio epidural que no presente estas consecuencias indeseadas y que no aumenten la incertidumbre en la detección de dicho espacio o imponga un aumento en la complejidad del procedimiento en comparación con el método tradicional de detección de la perdida de resistencia. the doctor exerts on the needle when crossing the yellow ligament, increase in the incidence of punctures in the meninges and the intravascular puncture that occurs when the tip of the needle enters a blood vessel against the pressure exerted by the doctor on the plunger of the syringe, there is a need for a device for the detection of epidural space that does not present these unwanted consequences and that does not increase uncertainty in the detection of said space or impose an increase in the complexity of the procedure compared to the traditional method of detection of the loss of resistance.
3. DESCRIPCION GENERAL DE LA INVENCIÓN 3. GENERAL DESCRIPTION OF THE INVENTION
El problema planteado en la presente solicitud consiste en la necesidad de proporcionar un dispositivo para asistir al médico anestesiólogo en la detección oportuna del espacio epidural que complemente la técnica estándar de la perdida de la resistencia aumentando la seguridad del procedimiento, tanto para el paciente, como para el anestesiólogo, sea este experto o se encuentre en fases tempranas de su curva de aprendizaje. En consecuencia, permitiendo dicho dispositivo la localización apropiada del espacio epidural. Si bien, e| usuario del dispositivo (el anestesiólogo) sigue ejecutando la técnica tradicional de la perdida de la resistencia, este proporciona una certeza aumentada en la detección del espacio epidural debido a que el dispositivo indica la discontinuidad del tejido que se presenta al llegar al espacio epidural. Las dimensiones mínimas del dispositivo permiten su montaje dentro de la aguja tradicional de forma no disruptiva. Por lo anterior, se puede continuar usando la jeringa y la aguja epidural del método estándar y disponible comercialmente. Además, de forma ventajosa, dicho dispositivo no requiere conexiones de cables para electrodos, por ejemplo, de referencia externos, o cánulas ajenas a dicho protocolo. De tal menara que, el usuario (médico anestesiólogo) sigue con la manipulación habitual de la aguja y de la jeringa y una vez localizado el espacio epidural, el dispositivo es retirado de la aguja y desechado, para continuar la aplicación del anestésico. La invención aquí presentada ofrece un conjunto de ventajas que permite su inclusión en el protocolo estándar de detección del espacio epidural de una manera lenta. El anestesiólogo experimentado sigue en control del procedimiento aplicando e incrementando su experticia mientras que, el anestesiólogo en formación o con poca experiencia seguirá formándose en la técnica estándar con información adicional para soportar sus decisiones. La inclusión del dispositivo en el paquete estándar para anestesia epidural no requiere modificación de los materiales e insumos existentes. La fabricación del dispositivo se realiza por medio de métodos y materiales corrientes en la industria de insumos médicos, por lo que su costo es bajo. De igual forma, está considerado para ser de un solo uso, manteniendo las condiciones de seguridad para, el paciente. Las características anteriores permiten que sea usado, en instalaciones y situaciones clínicas de diversa complejidad. Un primer aspecto en el que se centra la presente invención es reducir la acumulación de material biológico sobre los electrodos de estimulo/registro cuando la aguja está penetrando los tejidos en su recorrido hacia el espacio epidural. Los principales efectos adversos que tiene dicha acumulación son la formación de cortos circuitos entre los electrodos debido a películas conductoras de fluidos corporales entre los mismos, y el apantallamiento de los electrodos debido a la acumulación de detritus tisulares. En los dos casos se bloquean o distorsiona las señales eléctricas ya sea, de estímulo o registro, sobre los tejidos, impidiendo así la caracterización de su bioimpedancia. Otro aspecto en el que se enfoca la presente invención es en las características constructivas apropiadas para que el médico ejecute la técnica de la pérdida de la resistencia en presencia de la realización aquí descrita. Lo anterior, implica que el aire o líquido en la jeringa pueda fluir sin que el dispositivo oponga resistencia al flujo de aire o líquido proveniente de la jeringa cuando el médico aplique presión al embolo. The problem posed in the present application is the need to provide a device to assist the anesthesiologist in the timely detection of the epidural space that complements the standard technique of loss of resistance, increasing the safety of the procedure, both for the patient, as For the anesthesiologist, be this expert or be in the early stages of your learning curve. Consequently, said device allowing the appropriate location of the epidural space. Although, e | User of the device (the anesthesiologist) continues to perform the traditional technique of loss of resistance, it provides an increased certainty in the detection of the epidural space because the device indicates the discontinuity of the tissue that occurs when reaching the epidural space. The minimum dimensions of the device allow its assembly inside the traditional needle in a non-disruptive way. Therefore, the syringe and epidural needle of the standard and commercially available method can be continued. In addition, advantageously, said device does not require cable connections for electrodes, for example, external reference, or cannulas outside of said protocol. In such a way that, the user (anesthesiologist) continues with the usual manipulation of the needle and syringe and once the epidural space is located, the device is removed from the needle and discarded, to continue the application of the anesthetic. The invention presented here offers a set of advantages that allows its inclusion in the standard epidural space detection protocol in a slow manner. The experienced anesthesiologist remains in control of the procedure by applying and increasing his expertise while, the anesthesiologist in training or with little experience will continue to be trained in the standard technique with additional information to support his decisions. The inclusion of the device in the standard package for epidural anesthesia does not require modification of existing materials and supplies. The device is manufactured by means of current methods and materials in the medical supplies industry, so its cost is low. In the same way, it is considered to be of a single use, maintaining the safety conditions for the patient. The above characteristics allow it to be used, in facilities and clinical situations of varying complexity. A first aspect that the present invention focuses on is to reduce the accumulation of biological material on the stimulus / registration electrodes when the needle is penetrating the tissues in its path to the epidural space. The main adverse effects of this accumulation are the formation of short circuits between the electrodes due to conductive films of body fluids between them, and the shielding of the electrodes due to the accumulation of tissue debris. In both cases, electrical signals are blocked or distorted, either from stimulation or registration, on the tissues, thus preventing the characterization of their bioimpedance. Another aspect that the present invention focuses on is the appropriate constructive characteristics for the physician to perform the technique of resistance loss in the presence of the embodiment described herein. This implies that the air or liquid in the syringe can flow without resistance to the flow of air or liquid from the syringe when the doctor applies pressure to the embolus.
En particular, para solucionar los problemas técnicos arriba mencionados, la presente solicitud proporciona un dispositivo médico para detección de cavidades corporales, con medios electrónicos para medir la bioimpedancia del tejido en contacto con la punta de unos medios penetrantes por medio de electrodos que se insertan, de forma removible, por medio de un estilete; en la porción hueca de dichos medios penetrantes y dentro del estilete hay medios conductores que conectan los electrodos con dichos medios electrónicos, que a su vez producen una señal de indicación de detección de la cavidad corporal. Dicho dispositivo médico comprende: In particular, to solve the technical problems mentioned above, the present application provides a medical device for detecting body cavities, with electronic means for measuring the bioimpedance of the tissue in contact with the tip of penetrating means by means of electrodes that are removably inserted by means of a stylet; in the hollow portion of said penetrating means and within the stylet there are conductive means that connect the electrodes with said electronic means, which in turn produce a signal indicating the detection of the body cavity. Said medical device comprises:
Un arreglo de electrodos no coplanares cada uno embebido en un plano o faceta distinta, la superficie de cada faceta se forma con un sustrato rígido, que es aislante eléctrico, el cual embebe al electrodo, y deja expuesta solamente la región del electrodo para contacto con el tejido biológico, de tal forma que el sustrato forma un área circundante desde el electrodo hasta los bordes de la faceta que lo contiene. El plano formado por la superficie de cada faceta es no co-planar con los planos formados por las superficies de las demás facetas del arreglo. Los planos formados por las superficies de facetas adyacentes con borde común, tiene un ángulo, medido en el plano normal (625) a dicho borde común, mayor a 180°, en donde dicho arreglo facetado (612) de electrodos no coplanares reduce la creación de cortos circuitos entre electrodos debido a la formación de películas conductoras de fluidos corporales. An array of non-coplanar electrodes each embedded in a different plane or facet, the surface of each facet is formed with a rigid substrate, which is an electrical insulator, which embeds the electrode, and exposes only the electrode region for contact with the biological tissue, so that the substrate forms a surrounding area from the electrode to the edges of the facet that contains it. The plane formed by the surface of each facet is not to co-plan with the planes formed by the surfaces of the other facets of the arrangement. The planes formed by the surfaces of adjacent facets with common edge, have an angle, measured in the normal plane (625) to said common edge, greater than 180 °, where said faceted arrangement (612) of non-coplanar electrodes reduces the creation of short circuits between electrodes due to the formation of conductive films of body fluids.
Medios de centrado para que el estilete recorra de forma concéntrica la porción hueca de los medios penetrantes, creando lumen entre la pared interna de dichos medios penetrantes y el estilete, para que el gas o líquido inyectado desde la jeringa fluya con poca oposición. De esta manera, el anestesiólogo sigue en control del procedimiento realizando la técnica de la pérdida de la resistencia.  Centering means for the stylus to concentrically travel the hollow portion of the penetrating means, creating lumen between the inner wall of said penetrating means and the stylet, so that the gas or liquid injected from the syringe flows with little opposition. In this way, the anesthesiologist remains in control of the procedure by performing the technique of resistance loss.
4. BREVE DESCRIPCIÓN DE LOS DIBUJOS 4. BRIEF DESCRIPTION OF THE DRAWINGS
La invención para asistir en la detección de cavidades corporales, por ejemplo del espacio epidural aquí presentada, se entenderá con mayor facilidad con la descripción detallada acompañada del siguiente conjunto de dibujos, en los cuales: La Figura 1 ilustra la forma en que el médico toma en sus manos la aguja y jeringa epidural para la ejecución de la técnica de la pérdida de la resistencia para detección del espacio epidural. La Figura 2 ilustra la línea de ensamble temporal de la invención entre la jeringa y la aguja epidural, así como una vista en perspectiva de cómo queda el sistema con el dispositivo de detección de la cavidad epidural montado en el kit de jeringa y aguja. La Figura 3 ilustra cómo el detector de espacio epidural incorporado al par de jeringa y aguja no afecta la forma en que el médico toma en sus manos dicho ensamble en comparación con el par de la técnica tradicional (ilustrado en la Fíg. The invention to assist in the detection of body cavities, for example of the epidural space presented here, will be more easily understood with the detailed description accompanied by the following set of drawings, in which: Figure 1 illustrates the way in which the doctor takes the needle and epidural syringe in his hands to perform the technique of loss of resistance to detect the epidural space. Figure 2 illustrates the temporal assembly line of the invention between the syringe and the epidural needle, as well as a perspective view of how the system looks with the epidural cavity detection device mounted in the syringe and needle kit. Figure 3 illustrates how the epidural space detector incorporated into the syringe and needle pair does not affect the way in which the doctor takes said assembly into his hands compared to the traditional technique pair (illustrated in Fig.
La Figura 4 muestra tres vistas del dispositivo: (i) la primera en perspectiva, (ii) la segunda es un corte en perspectiva del ensamble de jeringa, detector y jeringa, y (iíi) la tercera es una vista de la sección de cómo el eje hueco de la aguja contiene concéntricamente el estilete del dispositivo detector. Figure 4 shows three views of the device: (i) the first in perspective, (ii) the second is a perspective cut of the syringe, detector and syringe assembly, and (ii) the third is a sectional view of how The hollow shaft of the needle concentrically contains the stylus of the sensing device.
La Figura 5 muestra un corte longitudinal del ensamble temporal de la jeringa, dispositivo detector y la aguja epidural. Figure 5 shows a longitudinal section of the temporary assembly of the syringe, detector device and the epidural needle.
La Figura 6 presenta tres vistas de la punta de la aguja epidural con ensamble del arreglo de electrodos cuyo sustrato está facetado, en donde dicho arreglo tiene dos electrodos para medición de bioimpedancia Figure 6 presents three views of the tip of the epidural needle with assembly of the electrode array whose substrate is faceted, wherein said array has two electrodes for bioimpedance measurement.
La Figura 7 presenta dos vistas de la punta de la aguja epidural con ensamble del arreglo facetado de electrodos, en donde dicho arreglo tiene cuatro electrodos para medición de bioimpedancia. 5. DESCRIPCIÓN DETALLADA DE LA INVENCIÓN Figure 7 presents two views of the tip of the epidural needle with assembly of the faceted array of electrodes, wherein said arrangement has four electrodes for bioimpedance measurement. 5. DETAILED DESCRIPTION OF THE INVENTION
En figura 1 se muestra el estado previo de la técnica, para la localización . del espacio epidural en la que se emplea el par tradicional jeringa10-aguja 20 ( la cual constituye un medio penetrante). En esta técnica, conforme el médico anestesiólogo empuja las aletas de sujeción 201 de la aguja hacia el interior del cuerpo, presiona el embolo 101 de la jeringa para tratar inyectar el aire, o líquido. Si no hay flujo de dicho contenido, el émbolo retorna a su posición inicial debido a la descompresión elástica del aire, o en el caso de que haya solamente líquido, éste no se moverá por la incompresibilidad del mismo. El médico considerará dicha resistencia como evidencia de que el tejido circundante tapona la punta de la aguja y no se ha alcanzado el espacio epidural siempre y cuando la profundidad alcanzada por la aguja y las condiciones específicas del paciente soporten tal conclusión. Por lo tanto, continuará hundiendo la aguja hasta que no haya bloqueo en la punta y no haya resistencia al flujo de aire, o líquido, según sea el caso; lo que en general indica que se ha llegado al espacio epidural. Figure 1 shows the prior state of the art, for location. of the epidural space in which the traditional 10-needle syringe pair 20 (which constitutes a penetrating medium) is used. In this technique, according to the doctor Anesthesiologist pushes the holding fins 201 of the needle into the body, presses the plunger 101 of the syringe to try to inject the air, or liquid. If there is no flow of said content, the plunger returns to its initial position due to the elastic decompression of the air, or in the case that there is only liquid, it will not move due to the incompressibility of the same. The doctor will consider such resistance as evidence that the surrounding tissue blocks the tip of the needle and the epidural space has not been reached as long as the depth reached by the needle and the specific conditions of the patient support such a conclusion. Therefore, it will continue to sink the needle until there is no blockage in the tip and there is no resistance to the flow of air, or liquid, as the case may be; which generally indicates that the epidural space has been reached.
En la figura 2 se muestra una realización preferida 60 de la presente invención, en la cual se inserta entre la jeringa 10 y la aguja epidural 20 con el ensamble 50 y el médico realiza la manipulación descrita anteriormente más sin embargo, ahora el dispositivo emitirá una señal a través de los indicadores 606 de que la punta de la aguja 203 está en la cavidad epidural. Con esta información el médico tendrá mayor evidencia para concluir sí ha alcanzado el espacio epidural. Una vez llega a esta conclusión, el dispositivo y la jeringa son retirados y desechados, para continuar con la aplicación del anestésico. En la figura 3 se aprecia que la inclusión del dispositivo es mínimamente disruptiva, permitiendo al médico realizar las maniobras del protocolo estándar. A preferred embodiment 60 of the present invention is shown in Figure 2, in which the syringe 10 and the assembly 50 are inserted between the syringe 10 and the doctor performs the manipulation described above, however, now the device will emit a signal through indicators 606 that the tip of the needle 203 is in the epidural cavity. With this information the doctor will have more evidence to conclude if he has reached the epidural space. Once this conclusion is reached, the device and the syringe are removed and discarded, to continue the application of the anesthetic. Figure 3 shows that the inclusion of the device is minimally disruptive, allowing the doctor to perform the standard protocol maneuvers.
En la figura 4A se muestra una vista de la realización 60 cuyo cuerpo externo presenta una base 601 , indicadores 606, un concentrador 610 con salidas 609 de flujo, estilete 602, aletas de centrado 61 1 y en la punta 603 el arreglo de electrodos 620. En la figura 4B se muestra una vista de corte del ensamble 50 compuesto de una jeringa 10, dispositivo para detectar el espacio epidural 60 y la aguja epidural 20, en donde se muestra en detalle cómo la punta 102 de la jeringa se acopla herméticamente con el puerto 607 en la base 601. Dicho puerto conecta con los conductos 608 del concentrador 610 que, a su vez, se acopla herméticamente con el puerto de conexión tipo Luer 204 de la aguja epidural, en el pabellón de este puerto 204 se crea continuidad de flujo con la jeringa a través de las perforaciones 609 del concentrador 610 del dispositivo. Este concentrador sirve como soporte a partir del cual se proyecta el estilete 602 hasta su extremo distal, en cuya punta 603 se aloja un arreglo de electrodos 620, descrito más adelante, la cual a su vez se alinea con punta de la aguja 203. En la vista de detalle 65 de la figura 4C, se muestra la sección transversal 652 de la aguja que, de forma concéntrica, embebe a la sección transversal 651 del estilete 602, De este último se proyectan radiairnente al menos tres aletas de centrado 61 1 , las cuales posicionan al estilete para que todo su recorrido sea concéntrico con la aguja y se forme un corredor hueco 653, por el cual fluya con baja resistencia el aire o líquido de la jeringa. Las características constructivas mencionadas, permiten al médico seguir ejecutando la técnica de la pérdida de la resistencia, en presencia de la realización preferida 60 aquí descrita. A view of embodiment 60 is shown in Figure 4A whose external body has a base 601, indicators 606, a concentrator 610 with flow outlets 609, stylet 602, centering fins 61 1 and at tip 603 the electrode array 620 Figure 4B shows a sectional view of the assembly 50 composed of a syringe 10, device for detecting the epidural space 60 and the epidural needle 20, where it is shown in detail how the tip 102 of the syringe is tightly coupled with port 607 at base 601. Said port connects with the ducts 608 of the concentrator 610 which, in turn, is tightly coupled with the Luer type connection port 204 of the epidural needle, continuity is created in the pavilion of this port 204 of flow with the syringe through the perforations 609 of the concentrator 610 of the device. This The concentrator serves as a support from which the stylet 602 is projected to its distal end, whose tip 603 houses an array of electrodes 620, described below, which in turn is aligned with the tip of the needle 203. In the detail view 65 of figure 4C, the cross section 652 of the needle is shown which, concentrically, embeds the cross section 651 of the stylet 602, of the latter projecting at least three centering fins 61 1, which position the stylet so that its entire path is concentric with the needle and a hollow runner 653 is formed, through which the air or liquid from the syringe flows with low resistance. The constructive characteristics mentioned, allow the physician to continue executing the technique of resistance loss, in the presence of the preferred embodiment described herein.
En la figura 5, se detalla que en la base 601 hay una cámara concéntrica 632 que alberga los medios electrónicos con su fuente de energía, para realizar medidas de bíoimpedancia, los cuales son ampliamente conocidos en el estado de la técnica, por lo que no son detallados en la presente descripción . A dichos medios se conectan el arreglo de electrodos 620 y el eje metálico 202 de la aguja a través de los medios conductores 630, embebidos a lo largo del estile, todo en su conjunto para realizar las medidas de bíoimpedancia del tejido en contacto con la punta de todo el ensamble 50. En las aletas de centrado 61 1 proxímales al concentrador 610 del dispositivo, van expuestos los electrodos 631 , los cuales realizan contacto eléctrico con el eje metálico 202 de la aguja epidural. Las realizaciones preferidas de la presente invención se caracterizan porque identifican con certeza al espacio epidural. Para lograr esto es necesario reducir las fuentes de contaminación de las señales de estímulo/medida. Una de las principales causas de contaminación radica en la acumulación de restos tisulares sobre los electrodos. Cuando se trata de sangre u otro líquido corporal, aparecerán capas líquidas que los cortocircuitan, produciendo una falsa medida de baja impedancia. El principio inventivo, ejemplificado a continuación, se aplica para romper con la continuidad de tales capas conductoras. Una realización de tal principio se presenta en la figura 6. y en la parte A se muestra el arreglo de electrodos 620 insertado en la punta 202 de la aguja epidural y rodeado por su bisel 204, en donde se observa que los dos electrodos 621 y 622 están embebidos en facetas/planos distintos 620i y 620j, respectivamente, del estrato rígido facetado, que es aislante eléctrico, quedando expuesta solamente la región del electrodo para contacto con el tejido biológico. Cada faceta forma un polígono con bordes adyacentes con otras facetas, cuando una de estas embebe un electrodo, este no toca ninguno de los bordes de la misma, quedando por ¡o tanto áreas de sustrato de guarda que se extienden desde el respectivo electrodo hasta los bordes de las facetas que los contienen. A partir del conjunto de vistas .de la figura 6 se observa como el plano formado por la superficie de cada faceta es no co-planar con los planos formados por las superficies de las demás facetas del arreglo. En la vista de perfil de la figura 6C se muestra como las facetas adyacentes 620i y 620j, con borde común, tienen un ángulo Θ, mayor a 180°, medido en un plano normal 625 a dicho borde común. Esta angulación entre facetas impide la continuidad de capas conductoras entre dos o más electrodos puesto que en los límites entre facetas se crean fuerzas que son mayores que la tensión superficial del líquido. In Figure 5, it is detailed that in the base 601 there is a concentric chamber 632 that houses the electronic means with its energy source, to perform bioimpedance measurements, which are widely known in the state of the art, so that They are detailed in this description. To said means the electrode arrangement 620 and the metallic axis 202 of the needle are connected through the conductive means 630, embedded along the stylet, all in its entirety to perform the bioimpedance measurements of the tissue in contact with the tip of the entire assembly 50. In the centering fins 61 1 proximal to the concentrator 610 of the device, the electrodes 631 are exposed, which make electrical contact with the metallic axis 202 of the epidural needle. Preferred embodiments of the present invention are characterized in that they identify with certainty the epidural space. To achieve this it is necessary to reduce the sources of contamination of the stimulus / measurement signals. One of the main causes of contamination lies in the accumulation of tissue debris on the electrodes. When it comes to blood or other body fluid, liquid layers will appear that short-circuit them, producing a false measure of low impedance. The inventive principle, exemplified below, is applied to break with the continuity of such conductive layers. An embodiment of such a principle is presented in Figure 6. and part A shows the array of electrodes 620 inserted in the tip 202 of the epidural needle and surrounded by its bezel 204, where it is observed that the two electrodes 621 and 622 are embedded in different facets / planes 620i and 620j, respectively, of the rigid faceted layer, which is electrical insulator, only the electrode region being exposed for contact with the biological tissue . Each facet forms a polygon with adjacent edges with other facets, when one of these embeds an electrode, it does not touch any of the edges of the electrode, leaving for or so many areas of guard substrate that extend from the respective electrode to the edges of the facets that contain them. From the set of views of Figure 6 it can be seen that the plane formed by the surface of each facet is not co-planar with the planes formed by the surfaces of the other facets of the arrangement. In the profile view of Figure 6C it is shown how adjacent facets 620i and 620j, with common edge, have an angle Θ, greater than 180 °, measured in a normal plane 625 to said common edge. This angulation between facets prevents the continuity of conductive layers between two or more electrodes since in the boundaries between facets forces are created that are greater than the surface tension of the liquid.
En la realización mostrada en la figura 6, con al menos dos electrodos 621 y 622, estos se alinean con el eje longitudinal 618 de la aguja. Tal alineación divide en dos porciones simétricas de estrato facetado del arreglo de electrodos, la primera porción con las facetas 620a hasta la 620d, y la segunda porción simétrica con las facetas 620e hasta la 620h. Entre el electrodo distal 621 y la punta del estilete, el sustrato tiene dos facetas simétricas 620a y 620e con borde adyacente común. Esta disposición, a manera de quilla, tiene el propósito de separar el tejido corporal a medida que la aguja avanza hacia el espacio epidural, de tal manera que al ingresar a este, cualquier resto de tejido es retirado de los electrodos. In the embodiment shown in Figure 6, with at least two electrodes 621 and 622, these align with the longitudinal axis 618 of the needle. Such alignment divides into two symmetrical portions of the faceted stratum of the electrode array, the first portion with facets 620a through 620d, and the second symmetrical portion with facets 620e through 620h. Between the distal electrode 621 and the tip of the stylet, the substrate has two symmetrical facets 620a and 620e with a common adjacent edge. This arrangement, in the form of a keel, has the purpose of separating the body tissue as the needle advances into the epidural space, so that upon entering it, any remaining tissue is removed from the electrodes.
Si bien es posible realizar medidas de bioimpedancia usando solo dos electrodos 621 y 622, es conocido en el estado de la técnica 3' 4 que, en dicha configuración While it is possible to bioimpedance measurements using only two electrodes 621 and 622, is known in the prior art 3 '4 which in this configuration
3 YÉLA OS, D., CASAS, Ó., BRAGÓS, R. and ROSELL, J. (1999), Improvement of a Front End for Bioimpedance Spectroscopy. Annals of the New York Academy of Sciences, 873: 306-312. la impedancia medida incluye la impedancia del tejido de interés más la impedancia que se produce en la interfaz electrodo/tejido, la cual en general, es mucho mayor que la impedancia del tejido. Este fenómeno se agudiza para electrodos con área de contacto pequeña y en las realizaciones preferidas de la presente invención, los diámetros de los electrodos están entre 100μιη a 200μηι. Esto se debe a que los tamaños de las agujas epiduraies, de uso reguiar, son menores que 17Ga. Por ejemplo, una aguja epidural 18Ga, tiene un diámetro interno aproximado de 0,84mm; con un área transversal equivalente menor a 0,55mm2 y adicionalmente, los electrodos deben tener una separación aproximada de dos veces su diámetro para que sea viable establecer la impedancia del tejido en presencia de fuentes contaminantes de la medida. Para mejorar la medición de la impedancia del medio de interés, otra realización de la presente invención, usa el eje metálico de la aguja epidural, conectado a los medios eléctricos, como un tercer electrodo 631 , como electrodo de referencia (ver figuras 5 y 6). De esta manera, el bisel 204 en la punta de la aguja, conforma un electrodo de geometría elíptica el cual rodea al arreglo de electrodos, y dada su cercanía con el mismo, recibe la mayoría del flujo de corriente inyectada por el electrodo activo de la fuente de corriente, que para esta realización se define como el electrodo 622. Igualmente, para la presente realización se define la medición del voltaje entre el electrodo 621 y el electrodo formado por el bisel 204. 3 YÉLA OS, D., CASAS, Ó., BRAGÓS, R. and ROSELL, J. (1999), Improvement of a Front End for Bioimpedance Spectroscopy. Annals of the New York Academy of Sciences, 873: 306-312. The measured impedance includes the impedance of the tissue of interest plus the impedance that occurs at the electrode / tissue interface, which in general is much greater than the tissue impedance. This phenomenon is exacerbated for electrodes with small contact area and in preferred embodiments of the present invention, the electrode diameters are between 100μιη to 200μηι. This is due to the fact that the sizes of the epidural needles, for regular use, are smaller than 17Ga. For example, an 18Ga epidural needle has an approximate internal diameter of 0.84mm; with an equivalent cross-sectional area of less than 0.55mm 2 and additionally, the electrodes must have an approximate separation of twice their diameter in order to establish the impedance of the tissue in the presence of contaminating sources of the measurement. To improve the measurement of the impedance of the medium of interest, another embodiment of the present invention uses the metal axis of the epidural needle, connected to the electrical means, as a third electrode 631, as a reference electrode (see Figures 5 and 6 ). In this way, the bevel 204 at the tip of the needle, forms an electrode of elliptical geometry which surrounds the array of electrodes, and given its proximity to it, receives the majority of the current flow injected by the active electrode of the current source, which for this embodiment is defined as electrode 622. Similarly, for the present embodiment, the voltage measurement between electrode 621 and the electrode formed by bevel 204 is defined.
Otra realización preferida para el arreglo de electrodos en la presente invención se muestra en la figura 7 en donde cuatro electrodos 622,623, 624, y 625, están alineados con el eje longitudinal 618 de la aguja, usando los mismos conceptos inventivos descritos anteriormente para eliminar contaminantes sobre los electrodos ( tanto detritus tisulares como películas líquidas). En esta realización, se usa la configuración de cuatro electrodos para medida de la impedancia, bien conocida en el estado de la técnica, en donde los electrodos 622 y 625 se usan como entrada y salida de la corriente de estímulo y entre los electrodos 623 y 624 se mide el voltaje. En otras posibles realizaciones de la presente invención, Steendijk, P.; ur, Gerrit; van der Velde, E.T.; Baan, Jan "The four-electrode resistivity technique in anisotropic media: theoretical analysis and application on myocardial tissue in vivo", Biomedical Engineering, IEEE Transactions on, On page(s): 1138 - 148 Volume: 40, Issue: 11 , Nov. 1993 el eje metálico de la aguja se puede conectar o no, para hacer que funcione como tierra eléctrica del sistema o dejarlo sin conectar. Another preferred embodiment for the arrangement of electrodes in the present invention is shown in Figure 7 wherein four electrodes 622,623, 624, and 625, are aligned with the longitudinal axis 618 of the needle, using the same inventive concepts described above to remove contaminants. on the electrodes (both tissue detritus and liquid films). In this embodiment, the four electrode configuration is used for impedance measurement, well known in the state of the art, where electrodes 622 and 625 are used as input and output of the stimulus current and between electrodes 623 and 624 the voltage is measured. In other possible embodiments of the present invention, Steendijk, P .; ur, Gerrit; van der Velde, ET; Baan, Jan "The four-electrode resistivity technique in anisotropic media: theoretical analysis and application on myocardial tissue in vivo", Biomedical Engineering, IEEE Transactions on, On page (s): 1138 - 148 Volume: 40, Issue: 11, Nov 1993 The metallic axis of the needle can be connected or not, to make it work as an electrical ground of the system or leave it unconnected.

Claims

REIVINDICACIONES
1. Un dispositivo médico para detección de cavidades corporales, con medios electrónicos para medir la bioimpedancia del tejido en contacto con la punta de unos medios penetrantes, por medio de electrodos que se insertan de forma re ovible, por medio de un estilete, en ¡a porción hueca de dichos medios penetrantes; dentro del estilete hay medios conductores que conectan los electrodos con dichos medios electrónicos, que a su vez producen una señal de indicación de detección de la cavidad corporal, en donde dicho dispositivo comprende: 1. A medical device for detecting body cavities, with electronic means to measure the bioimpedance of the tissue in contact with the tip of penetrating means, by means of electrodes that are inserted in a removable way, by means of a stylus, in a hollow portion of said penetrating means; Inside the stylet there are conductive means that connect the electrodes with said electronic means, which in turn produce a signal indicating the detection of the body cavity, wherein said device comprises:
- Un arreglo de electrodos no coplanares cada uno embebido en un plano o faceta distinta, en donde la superficie de cada faceta se forma con un sustrato rígido, que es aislante eléctrico, el cual embebe al electrodo, y deja expuesta solamente la región del electrodo para contacto con el tejido biológico, de tal forma que el sustrato forma un área circundante desde el electrodo hasta los bordes de la faceta que lo contiene, el plano formado por la superficie de cada faceta es no co-planar con los planos formados por las superficies de las demás facetas del arreglo; y los planos formados por las superficies de facetas adyacentes con borde común, tiene un ángulo, medido en el plano normal (625) a dicho borde común, mayor a 180°, en donde dicho arreglo facetado (612) de electrodos no coplanares reduce la creación de cortos circuitos entre electrodos debido a la formación de películas conductoras de fluidos corporales. - An arrangement of non-coplanar electrodes each embedded in a different plane or facet, where the surface of each facet is formed with a rigid substrate, which is an electrical insulator, which embeds the electrode, and exposes only the electrode region for contact with the biological tissue, so that the substrate forms a surrounding area from the electrode to the edges of the facet that contains it, the plane formed by the surface of each facet is not co-planar with the planes formed by the surfaces of the other facets of the arrangement; and the planes formed by the surfaces of adjacent facets with common edge, have an angle, measured in the normal plane (625) to said common edge, greater than 180 °, where said faceted arrangement (612) of non-coplanar electrodes reduces the creation of short circuits between electrodes due to the formation of conductive films of body fluids.
2. Un dispositivo según la reivindicación 1 , en donde el estilete (602) tiene aletas para centrado (611) en al menos el extremo distal, un punto intermedio y el extremo proximal de la porción que recorre el eje hueco (202) de los medios penetrantes, con lo cual el estilete está embebido en forma concéntrica en dichos medios penetrantes sin tocar su superficie interna a excepción de los puntos donde se apoyan las aletas de centrado, siendo el área transversal (651 ) del estilete menor que el área transversal (652) de la sección hueca de dichos medios penetrantes, con lo cual permite el flujo de gas u algún líquido a través del corredor hueco (653) así formado. 2. A device according to claim 1, wherein the stylet (602) has fins for centering (611) at least the distal end, an intermediate point and the proximal end of the portion that travels the hollow shaft (202) of the penetrating means, whereby the stylet is concentrically embedded in said penetrating means without touching its internal surface except for the points where the centering fins rest, the transverse area (651) of the stylet being smaller than the transverse area (652) of the hollow section of said penetrating means, thereby allowing the flow of gas or some liquid through the hollow corridor (653) thus formed.
3. Un dispositivo según ia reivindicación 1 o 2 en el que su base (610) tiene un puerto (607) para acople hermético con una jeringa, y que por medio de conductos (608) crea continuidad de flujo con dicha jeringa a través de un concentrador (610) que se inserta herméticamente en el conector de los medios penetrantes. 3. A device according to claim 1 or 2 wherein its base (610) has a port (607) for hermetic coupling with a syringe, and which through ducts (608) creates continuity of flow with said syringe through a concentrator (610) that is tightly inserted into the connector of the penetrating means.
4. Un dispositivo según la reivindicación 1 en donde el arreglo de electrodos solo tiene dos electrodos (621 , 622), que están alineados con el eje longitudinal (618) de los medios penetrantes, en donde: 4. A device according to claim 1 wherein the electrode array has only two electrodes (621, 622), which are aligned with the longitudinal axis (618) of the penetrating means, wherein:
- tal alineación define un eje longitudinal para el sensor, que lo divide en dos porciones de estrato facetado (620) simétricas a cada lado del arreglo de electrodos, - el sustrato entre el electrodo distal (621) y la punta del estilete, tiene dos facetas simétricas (620a, 620e) cuyo borde adyacente esta alineado con el eje longitudinal del sensor, dicho borde común se aproxima al eje (618) conforme se acerca a la punta del estilete donde dicha disposición simétrica del sustrato alrededor de la alineación de electrodos y en la punta, separa el tejido corporal removiendo detritus tisulares que se acumulen- sobre el arreglo de electrodos durante la inserción de los medios penetrantes con el estilete. - such alignment defines a longitudinal axis for the sensor, which divides it into two portions of symmetrical faceted layer (620) on each side of the electrode array, - the substrate between the distal electrode (621) and the tip of the stylet, has two symmetric facets (620a, 620e) whose adjacent edge is aligned with the longitudinal axis of the sensor, said common edge approaches the axis (618) as it approaches the tip of the stylet where said symmetrical arrangement of the substrate around the alignment of electrodes and at the tip, it separates the body tissue by removing tissue debris that accumulates - on the electrode array during insertion of the penetrating media with the stylet.
5. Un dispositivo según cualquiera de las reivindicaciones 1 , 2, 3 y 4 , en donde la porción proximal del estilete (602), tiene al menos un electrodo (631 ) que realiza contacto eléctrico con el eje metálico hueco (202) de los medios penetrantes, de manera que el bisel (204) en la punta se convierte en un electrodo elíptico que rodea al arreglo de electrodos (620). 5. A device according to any one of claims 1, 2, 3 and 4, wherein the proximal portion of the stylet (602) has at least one electrode (631) that makes electrical contact with the hollow metal shaft (202) of the penetrating means, so that the bevel (204) at the tip becomes an elliptical electrode surrounding the array of electrodes (620).
6. Un dispositivo según la reivindicación 5 en donde se conecta una jeringa con aire o líquido y cuyo estilete se inserta en una aguja epidural a manera de medio penetrante, para inserción en el tejido corporal, y para realizar conjuntamente la técnica de la perdida de la resistencia para ubicación del espacio epidural simultáneamente con la detección basada en bioimpedancia del dispositivo. 6. A device according to claim 5 wherein a syringe is connected with air or liquid and whose stylet is inserted into an epidural needle as a penetrating medium, for insertion into the body tissue, and to jointly perform the technique of loss of resistance to epidural space location simultaneously with the device's bioimpedance based detection.
MGM\MG \!D-270912\WPC21370 MGM \ MG \! D-270912 \ WPC21370
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