WO2018172817A1 - Needle for supplying an anaesthetic with luminous orienting device - Google Patents
Needle for supplying an anaesthetic with luminous orienting device Download PDFInfo
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- WO2018172817A1 WO2018172817A1 PCT/IB2017/051672 IB2017051672W WO2018172817A1 WO 2018172817 A1 WO2018172817 A1 WO 2018172817A1 IB 2017051672 W IB2017051672 W IB 2017051672W WO 2018172817 A1 WO2018172817 A1 WO 2018172817A1
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- needle
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- the present invention relates to the field of needles for anesthesia delivery, in particular, it relates to needles that require specific orientation to reach a target site and, more particularly, relates to a needle for delivering a light-oriented anesthetic.
- anesthesia there are different ways of applying anesthesia to a patient, on the one hand, there is general anesthesia where the central nervous system is depressed, inducing, in the patient, a state of unconsciousness, muscle relaxation and loss of sensitivity, through supply of a general anesthetic. On the other hand, there is also local anesthesia, where the sensitivity of a small area of the body, such as a finger or a tooth, is eliminated.
- epidural anesthesia where the spinal column is approached in the lumbar part and the epidural space is located inside.
- some of the localization techniques are used to locate the epidural space, such as the Resistance Loss Techniques, Gutiérrez Gout Techniques, Dogliotti, etc.
- the anesthesiologist must orient the needle to achieve an effective anesthetic procedure, this adjustment of the needle direction is performed to deliver an anesthetic to either a cephalic region or a caudal region.
- epidural anesthesia anesthesia is supplied in the vicinity of the medulla in the epidural space and without perforating the meninges.
- the needles used for these purposes there are needles with various shapes and characteristics in their cannula, that is, in the normally metallic conduit whose interior is called lumen, through which the medications flow to be administered to the patient body
- the needles for anesthesia are differentiated at the end of the cannula, which has a generally bevelled tip, the "Tuohy” type needles being among the most commonly used, which have the characteristic that said tip is slightly curved.
- the anesthesiologist knows at all times the orientation of the bevel to avoid excessive manipulation of the needle that can accidentally cause , the puncture of the dura mater and / or arachnoid meninges or damage the tissue through which the needle passes.
- needle devices for anesthesia delivery with light indicators that are designed to locate the epidural space
- needle devices with light indicators involve assemblies with complex electrical and / or electronic devices that include sensors and indicators of pressure to detect the change in pressure once the epidural space has been reached.
- WO 2009/066972 discloses an electronic needle with spinal injection safety system
- said electronic needle comprises a housing that has a light alarm that the user activates through a switch, wherein said alarm changes color when a pressure change is recorded when the epidural space has been reached.
- this electronic needle is designed to detect when the bevel reaches the epidural space, however the light alarm of this device does not indicate bevel orientation, so the anesthesiologist needs to remember the orientation in which you initially inserted the needle. Likewise, as mentioned above, there is a risk that the anesthesiologist will forget to operate the switch or that, by mistake, said switch will be deactivated, making it even more difficult to know the orientation of the bevel.
- WO 2012/089223 discloses a device for the detection of epidural space; However, this device is completely independent of the needle to deliver anesthesia, so it only detects the change in pressure in the needle and emits a visual or audible alarm to indicate that the epidural space has been reached. However, this device also presents the aforementioned problems, since it is a device that corresponds to a control or command box that is operated by a user, which is connected to the needle by wired systems and a pressure sensor connected to the needle lumen. Likewise, in this type of systems it is not possible to prevent the needle from being oriented improperly when it is introduced into the patient, which causes the cutting of tissue and the generation of bruises where the puncture was made. In addition, with the device disclosed in WO 2012/089223, it is not possible to know the orientation of the bevel once the needle is within the epidural space, which would cause the aforementioned problems.
- WO 92/15256 discloses a device very similar to that disclosed in WO 2012/089223, since it is also a detection device that corresponds to a control or command box that is operated by a user, which is connected to the needle through wired systems and a pressure sensor connected to the needle lumen. Therefore, the device disclosed by WO 92/15256 has the same problems as the device of WO 2012/089223.
- needles with tactile bevel orientators in the state of the art comprising a notch or flange located on the surface of the needle clamping element, wherein said notch or flange has the function of indicating the orientation of the bevel of the tip of the needle cannula.
- this type of tactile indicators present several problems, one of the main ones being the difficulty to feel or feel this notch or flange due to the gloves used by anesthesiologists.
- palpation of the device to locate the notch can cause excessive manipulation thereof causing the above problems.
- said notch or flange is normally made of the same material as the fastener, which is commonly transparent, it is also difficult to locate said notch or flange visually. Therefore, if these systems are also combined with luminous elements such as those described in the state of the art described above, this further complicates the visual location of the touch marks.
- USD 378,130 which shows a universal pavilion for an anesthesia needle, which comprises as a visual indicator a notch and arrow that are made of the same material and color of said pavilion.
- the needle for delivering a luminous bevel-oriented anesthetic of the present invention solves the problems and disadvantages of the state of the art, more particularly, the needle of the present invention comprises: a cannula having a proximal cannula end and a distal end of cannula with a tip that has a bevel; a holding element for holding the needle during its insertion and in which the proximal end of the cannula is received; a cannula protector covering the entire length of the cannula and having a proximal protector end comprising a coupling element that engages the clamping element, and a distal protector end extending beyond the bevel of the cannula; finally the needle of the The present invention comprises a lighting system that emits a light signal that is perceived by a bevel light guide.
- the lighting system is within the clamping element, and has an off position when the cannula protector is coupled to the clamping element and an ignition position when the cannula protector is disengaged from the clamping element.
- the needle of the present invention comprises a tactile indicator of the orientation of the bevel that is in the same plane in which the light signal is visible, thus, the position of the bevel can be known not only visually but also through touch when the user takes the needle.
- the lighting system is preferably formed by a circuit comprising a light emitting source that emits the light signal, a power source in operative communication with the light emitting source that emits said light signal when the lighting system is on, wherein said circuit is opened or closed by a switch that is actuated by the coupling element of the cannula protector.
- the light emitting source is a light emitting diode (LED), which can be low or high brightness.
- LED light emitting diode
- the light emitting source can be selected from the group comprising: an organic LED, an incandescent lamp, an electroluminescent material or a fluorescent lamp.
- the ignition switch is selected from pressure switches, metallic, magnetic, capacitive, optical contact sensors, radiofrequency identifiers (RFID), or any other that can be operated by the coupling element of the protective shield.
- RFID radiofrequency identifiers
- the coupling between the clamping element and the cannula protector can be carried out through mechanisms preferably selected from the group comprising: a male element and a female element, threaded elements, hook and flange crimping systems, snap fit, notch and flange, magnetic or electromechanical coupling
- the needle is a "Tuhoy” type needle
- the holding element comprises a connector which may preferably be a female Luer type connector (known in the state of the art as “Luer hub "as a female as a fluid receptor).
- the holding element comprises a housing that contains the lighting system and even more preferably contains the female connector element, this offers the advantage of not requiring cables or elements external to the needle for operation.
- the coupling element is a ring placed at the proximal end of the cannula protector, wherein the inner circumference of said ring is sized to engage with the clamping element by means of a snap fit.
- a relief projection provided in the coupling element is used as actuator.
- Said relief projection is received in a hole provided in the clamping element, wherein said bore provides a path to the lighting system circuit such that the relief projection activates the switch to turn on or off the emitting source of light when pushing a switch blade that opens the lighting system circuit when the cannula protector attaches to the clamping element and, when the cannula protector is removed, the raised projection stops pressing the switch blade and therefore the circuit of the lighting system closes, automatically activating the light source and making visible the light signal indicating the orientation of the bevel.
- the principles of the present invention can be applied in needles to deliver anesthetics of any type, preferably of the type comprising needles for epidural or epidural / subdural or subdural anesthesia, such as Tuhoy and Whitacre needles.
- Figure 1 is a top perspective view of the preferred embodiment of the needle of the present invention.
- Figure 2 is an exploded view of the needle shown in Figure 1.
- Figure 3 is a perspective view of the needle of Figure 1 without the cannula protector.
- Figure 4 is a top plan view of the cannula protector of the preferred embodiment of the present invention.
- Figure 5 is a cross-sectional view along the line L-L 'of the needle shown in Figure 3.
- Figure 6 is a cross-sectional view of a spine showing the target site for delivery of an anesthetic using the preferred needle mode of the present invention, the needle being oriented in a cephalic position.
- Figure 7 is the same view as Figure 6 only that the needle is oriented in a caudal position.
- a needle 1000 can be seen comprising a cannula 1 100, with a clamping element 1200, a cannula protector 1400, and a luminous bezel orientator 1310, which in this mode, at the same time is also a tactile orientator since it is in relief with respect to the surrounding surface thereof.
- the orientator 1310 has an arrow shape that can be detected by touch by the user.
- the needle 1000 is observed, where it is noted that the cannula 1 100 having a proximal end of cannula 1 1 10 and a distal end cannula 1 120.
- the proximal end 1 1 10 of the cannula 1 100 is integrally attached to clamping element 1200; which in turn comprises a pair of lateral fins 1210 that serve as a support and grip means to manipulate the needle at the time of insertion into the body of a patient;
- the clamping element 1200 further comprises a tubular element 1220 that is located in the center of the clamping element 1200 running from proximal to distal direction.
- the clamping element 1200 additionally comprises at its proximal end a female Luer type 1230 connector that extends from the opposite side of the tubular element 1220.
- Said Luer type connector comprises in its internal diameter a conical section 1231 which is in fluid communication with an inner conduit of the clamping element, where said inner conduit runs from the tubular element 1220 to the female connector type Luer 1230, and is in fluid communication with the proximal end of cannula 1 1 10 to allow communication of fluid with the lumen or inner duct of the cannula.
- the smallest diameter of the conical section 1231 of the Luer 1230 type connector is coincident with the inner diameter of the inner duct or lumen of the cannula 1 100 providing fluid communication between them, so that said conical section has the function of serving as guide for the insertion of a catheter through the inner lumen of the cannula 1 100 to deliver anesthetics.
- said clamping element 1200 may comprise a circumferential flange or plate around it, or any other suitable grip surface in place of the fins, which facilitates the manipulation of the needle when inserted into the body of a patient.
- the clamping element 1200 comprises a housing 1300 disposed in the proximal part of the clamping element, the housing accommodates said Luer type 1230 connector.
- said housing 1300 is formed by an upper part 1320 and a lower part 1330, wherein, said upper part 1320 and said lower part 1330 are coupled forming a chamber that houses part of the female connector type Luer 1230, and a window 1350 in the distal part of said housing 1300 where they fit the fins 1210.
- the opening in the proximal part of the housing has a notch to receive a cover 1500 that covers the female type connector 1230 to protect the conduit and prevent the entry of any contaminant within conic section 1231.
- Said cover 1500 comprises in its distal part a protuberance arranged to be inserted in said notch of the proximal part of the housing, wherein said protuberance has a shape complementary to the shape of the notch for inserting said protuberance into said notch.
- the housing 1300 additionally comprises in its upper part 1320, an opening 1340 to receive the bevel light orientator 1310, which is made of a transparent, translucent or similar material, to allow the light signal to pass through, said light orientator it can be placed in such a way that it is placed on relief or under relief of the upper surface of the upper part 1320, so that, in this way, said light indicator also functions as a tactile indicator.
- the bevel light orientator 1310 which is made of a transparent, translucent or similar material, to allow the light signal to pass through, said light orientator it can be placed in such a way that it is placed on relief or under relief of the upper surface of the upper part 1320, so that, in this way, said light indicator also functions as a tactile indicator.
- the housing 1300 also houses in its interior, a lighting system 1600 (shown assembled in Figure 5), which in the preferred embodiment of the invention comprises a battery 1610, a switch formed from a switch sheet 1620, and a source light emitter that can be a light emitting diode or LED 1630 having a first and second terminals 1631 and 1632, wherein said LED 1630 is powered by battery 1610 through said switch sheet 1620 completing the circuit electrical by means of said first and second terminals 1631 and 1632 thus providing a light beam through the bevel light orientator 1310.
- Figure 4 shows the cannula protector 1400 having a distal end of protector 1410 and a proximal end of protector 1420 covering the entire cannula, and wherein the proximal end of protector 1420 is coupled to the clamping element 1200 by means of a ring 1421 integrally coupled to said proximal end of the cannula protector 1400 which has a diameter greater than said cannula protector 1400 and which receives the tubular element 1220 of the clamping element 1200, wherein said ring 1421 is pressure adjusted to the fastener 1200.
- the cannula protector also comprises an actuator, which in the embodiment described is a relief projection 1430, which extends beyond said proximal end of the cannula protector in the proximal direction, the projection coinciding in the same orientation as bezel 1 121; said projection 1430 functions as an actuator of the switch sheet 1620, wherein said projection 1430 passes through a hole 121 1 provided in the clamping element 1200 to penetrate the housing and thus turn on or off the lighting system 1600 allowing or not the current flow when pushing the switch sheet 1620 in such a way that the circuit is opened.
- Said cannula protector may include a protective cap 1440.
- the housing 1300 has a substantially parallelepiped shape
- said housing can have any configuration, such as cylindrical, pyramidal, substantially spherical, or any other suitable shape as long as the clear and easy way is appreciated light signal.
- a cut of the needle is shown along the LU line, wherein said cannula 1 100 comprises at the distal end of cannula 1 120, a tip 1 122 which is slightly curved towards the front side or face of the cannula 1 100, wherein said tip comprises a cavity or bezel 1 121 through which the catheter is passed for anesthetic delivery or the anesthetic is passed directly through the cannula when it is made by a single dose.
- This figure 5 allows to appreciate the lighting system 1600 which in the preferred embodiment of the invention, comprises a battery 1610, a switch sheet 1620 and LED 1630 which is energized by the battery 1610 through said switch sheet 1620 thus providing a light beam through bezel light guide 1310.
- the relief projection 1430 is introduced into said housing 1300 through the hole 121 1 and it has the function of pushing the switch sheet 1620 separating it from the second terminal 1632 of the LED 1630 and interrupting the electrical circuit thus keeping the LED in the off state while said projection 1430 is inside said housing.
- the LED 1630 located inside the housing 1300 is in an off state when the cannula protector 1400 is coupled to the clamping element 1200, due to the interruption of the electrical circuit by the projection 1430 that separates the switch sheet 1620 of the second terminal 1632 of LED 1630.
- the emitting source 1630 goes into a state of ignition, caused by the decoupling of the cannula protector 1400 from the clamping element 1200 when said protector 1400 is decoupled by the user, removing the projection 1430 inside the housing 1300, causing the switch sheet 1620 to come into contact with the second terminal 1632 of the LED 1630, thus closing the electrical circuit and emitting the light signal.
- a light beam is provided through the bezel light guide 1310 that is aligned with the bezel 1 121, and which emits the light signal indicating the orientation of the bevel so that positioning can be performed adequate needle, as well as allowing it to be oriented and directed along a path during its insertion into the patient's body, without error range, in the appropriate direction, either cephalic as shown in Figure 6 or flow rate as It is shown in figure 7.
- said bevel luminous orientator 1310 allows to know the current orientation of the bevel, although the bevel is no longer visible, so that said rotation of the needle can be performed without need of excessive needle handling.
- the needle is removed from the patient's body and LED 1630 returns to its off state when the cannula protector is placed again for needle disposal, since the projection of the element Cannula protector is reintroduced into housing 1300 and once again separates the switch sheet from the second terminal to interrupt the electrical circuit.
- said needle 1000 addresses or passes through the different layers of the skin and tissues of the patient's body to deliver the anesthetic in the desired direction, either cephalic ( Figure 6) or caudal ( Figure 7), in this sense, said needle passes through: Fat Tissue A, Spinous Supra Ligament B, Flavum Ligament C, Spiny Intra Ligament D, before reaching the epidural space E, which is where the needle will be oriented or directed in position cephalic (figure 6) or caudal (figure 7) so that an epidural catheter is placed in the previously established orientation and the anesthetic is supplied to the desired region.
- the needle of the present invention avoids or eliminates excessive manipulation of said needle, which is very important to eliminate the possibility of accidental punctures or Subarachnoid punctures, that is, punctures to the dura, to the body.
- vertebral F, the Intervertebral Disc G, and the Anterior H and Posterior I Ligaments in order to avoid headaches or other side effects to the patient.
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- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
Description
AGUJA PARA SUMINISTRAR UN ANESTÉSICO NEEDLE TO SUPPLY AN ANESTHETIC
CON ORIENTADOR LUMINOSO WITH LIGHTING GUIDANCE
CAMPO DE LA INVENCIÓN FIELD OF THE INVENTION
La presente invención se refiere al campo de las agujas para suministrar anestesia, en particular, se refiere a agujas que requieren una orientación específica para llegar a un sitio objetivo y, más particularmente, se refiere a una aguja para suministrar un anestésico con orientador luminoso. ANTECEDENTES DE LA INVENCIÓN The present invention relates to the field of needles for anesthesia delivery, in particular, it relates to needles that require specific orientation to reach a target site and, more particularly, relates to a needle for delivering a light-oriented anesthetic. BACKGROUND OF THE INVENTION
En la anestesiología, existen diferentes maneras de aplicar anestesia a un paciente, por un lado, existe la anestesia general en donde se deprime el sistema nervioso central induciendo, en el paciente, un estado de inconsciencia, relajación muscular y pérdida de sensibilidad, mediante el suministro de un anestésico general. Por otro lado, también existe la anestesia local, en donde se elimina la sensibilidad de una pequeña zona del cuerpo, como puede ser un dedo o un diente. In anesthesiology, there are different ways of applying anesthesia to a patient, on the one hand, there is general anesthesia where the central nervous system is depressed, inducing, in the patient, a state of unconsciousness, muscle relaxation and loss of sensitivity, through supply of a general anesthetic. On the other hand, there is also local anesthesia, where the sensitivity of a small area of the body, such as a finger or a tooth, is eliminated.
Sin embargo, existen procedimientos en los cuales no es necesario aplicar anestesia general y en donde la anestesia local no es suficiente para el objetivo médico, en estos casos, se aplica anestesia regional para mantener tanto al paciente en estado consciente así como en un estado anestésico la región del cuerpo que va a ser sometida a alguna intervención quirúrgica. However, there are procedures in which it is not necessary to apply general anesthesia and where local anesthesia is not sufficient for the medical purpose, in these cases, regional anesthesia is applied to keep both the patient in a conscious state as well as in an anesthetic state the region of the body that is going to undergo some surgical intervention.
Dentro de la anestesia regional, uno de los procedimientos anestésicos más empleados es la anestesia epidural en donde se aborda la columna vertebral en su parte lumbar y se localiza en su interior el espacio epidural. Para realizar este abordaje, es necesario que el anestesiólogo use alguna aguja especialmente diseñada para ese fin, además se usa alguna de las técnicas de localización para localizar el espacio epidural, como son las Técnicas de Pérdida de Resistencia, Técnicas de la Gota de Gutiérrez, Dogliotti, etc. Within regional anesthesia, one of the most commonly used anesthetic procedures is epidural anesthesia where the spinal column is approached in the lumbar part and the epidural space is located inside. To perform this approach, it is necessary for the anesthesiologist to use a needle specially designed for that purpose, in addition some of the localization techniques are used to locate the epidural space, such as the Resistance Loss Techniques, Gutiérrez Gout Techniques, Dogliotti, etc.
Una vez ubicada la aguja en el espacio epidural, el anestesiólogo debe orientar la aguja para conseguir un procedimiento anestésico eficaz, este ajuste de la dirección de la aguja se realiza para suministrar un anestésico ya sea a una región cefálica o a una región caudal. En la anestesia epidural, se suministra la anestesia en las proximidades de la médula en el espacio epidural y sin perforar las meninges. Once the needle is located in the epidural space, the anesthesiologist must orient the needle to achieve an effective anesthetic procedure, this adjustment of the needle direction is performed to deliver an anesthetic to either a cephalic region or a caudal region. In epidural anesthesia, anesthesia is supplied in the vicinity of the medulla in the epidural space and without perforating the meninges.
Entre las agujas utilizadas para estos fines, existen agujas con diversas formas y características en su cánula, es decir, en el conducto normalmente metálico cuyo interior se denomina lumen, a través del cual los medicamentos fluyen para ser administrados al cuerpo del paciente. En particular, las agujas para suministrar anestesia se diferencian en el extremo de la cánula, que tiene una punta generalmente biselada, estando entre las más utilizadas las agujas tipo "Tuohy", que tienen la característica de que dicha punta está ligeramente curvada. Among the needles used for these purposes, there are needles with various shapes and characteristics in their cannula, that is, in the normally metallic conduit whose interior is called lumen, through which the medications flow to be administered to the patient body In particular, the needles for anesthesia are differentiated at the end of the cannula, which has a generally bevelled tip, the "Tuohy" type needles being among the most commonly used, which have the characteristic that said tip is slightly curved.
Debido a las distintas características de las agujas, resulta fundamental que una vez que la aguja se introduce dentro del cuerpo del paciente, el anestesiólogo sepa en todo momento la orientación del bisel para evitar la manipulación excesiva de la aguja que puede provocar, de manera accidental, la punción de las meninges duramadre y/o de la aracnoides o dañar el tejido por el que atraviesa la aguja. Due to the different characteristics of the needles, it is essential that once the needle is inserted into the patient's body, the anesthesiologist knows at all times the orientation of the bevel to avoid excessive manipulation of the needle that can accidentally cause , the puncture of the dura mater and / or arachnoid meninges or damage the tissue through which the needle passes.
Sin embargo, lo anterior no es una tarea fácil ya que el área quirúrgica generalmente tiene poca iluminación, lo que impacta negativamente en la manipulación de la aguja. However, the above is not an easy task since the surgical area generally has poor lighting, which negatively impacts the manipulation of the needle.
En el estado de la técnica existen diversos dispositivos para aguja para suministro de anestesia con indicadores luminosos que están diseñados para localizar el espacio epidural, dichos dispositivos para aguja con indicadores luminosos involucran ensambles con dispositivos eléctricos y/o electrónicos complejos que incluyen sensores e indicadores de presión para detectar el cambio de presión una vez que se ha alcanzado el espacio epidural. In the state of the art there are various needle devices for anesthesia delivery with light indicators that are designed to locate the epidural space, such needle devices with light indicators involve assemblies with complex electrical and / or electronic devices that include sensors and indicators of pressure to detect the change in pressure once the epidural space has been reached.
Un ejemplo de lo anterior, se describe en el documento WO 2009/066972, que divulga una aguja electrónica con sistema de seguridad para inyección espinal, dicha aguja electrónica comprende un alojamiento que tiene una alarma luminosa que el usuario activa a través de un interruptor, en donde dicha alarma cambia de color cuando se registra un cambio de presión cuando se ha alcanzado el espacio epidural. An example of the above is described in WO 2009/066972, which discloses an electronic needle with spinal injection safety system, said electronic needle comprises a housing that has a light alarm that the user activates through a switch, wherein said alarm changes color when a pressure change is recorded when the epidural space has been reached.
Este tipo de agujas electrónicas presentan varias desventajas. En primer lugar, son muy susceptibles al error humano, ya que para que la alarma empiece a funcionar es necesario que el dispositivo sea encendido por el usuario mediante el interruptor, por lo que en caso de olvido o distracción por parte del usuario para encender el dispositivo electrónico, se podría alcanzar el espacio epidural sin ser notado por el anestesiólogo o se podría notar muy tarde, ocasionando la penetración de la duramadre con la aguja, provocando la liberación de fluido espinal lo que ocasiona cefaleas al paciente. These types of electronic needles have several disadvantages. First of all, they are very susceptible to human error, since for the alarm to start working it is necessary that the device be turned on by the user through the switch, so in case of forgetting or distraction by the user to turn on the electronic device, the epidural space could be reached without being noticed by the anesthesiologist or it could be noticed very late, causing the penetration of the dura with the needle, causing spinal fluid release causing headaches to the patient.
Asimismo, debido a la cantidad de elementos y el volumen requerido para detectar una pérdida de presión, este tipo de dispositivos se vuelven voluminosos, lo cual dificulta su manipulación, provocando incluso que resbalen fácilmente de la mano del médico, resultando en una manipulación excesiva que causa molestias posteriores al paciente. Also, due to the amount of elements and the volume required to detect a loss of pressure, these types of devices become bulky, which makes handling difficult, even causing them to easily slip from the doctor's hand, resulting in excessive handling that It causes discomfort after the patient.
Es importante mencionar que esta aguja electrónica está diseñada para detectar cuando el bisel alcanza el espacio epidural, sin embargo la alarma luminosa de este dispositivo no indica orientación del bisel, por lo que el anestesiólogo requiere recordar la orientación en la que inicialmente introdujo la aguja. Asimismo, como se mencionó anteriormente, existe el riesgo de que el anestesiólogo olvide accionar el interruptor o que, por error, dicho interruptor sea desactivado, por lo que se dificulta aún más conocer la orientación del bisel. It is important to mention that this electronic needle is designed to detect when the bevel reaches the epidural space, however the light alarm of this device does not indicate bevel orientation, so the anesthesiologist needs to remember the orientation in which you initially inserted the needle. Likewise, as mentioned above, there is a risk that the anesthesiologist will forget to operate the switch or that, by mistake, said switch will be deactivated, making it even more difficult to know the orientation of the bevel.
De igual forma, el documento WO 2012/089223, divulga un dispositivo para la detección del espacio epidural; sin embargo, este dispositivo es completamente independiente de la aguja para suministrar la anestesia, por lo que únicamente detecta el cambio de presión en la aguja y emite una alarma visual o sonora para indicar que se ha alcanzado el espacio epidural. Sin embargo, este dispositivo presenta de igual forma los problemas antes mencionados, ya que es un dispositivo que corresponde a una caja de control o mando que es accionada por un usuario, la cual es conectada a la aguja mediante sistemas alámbricos y un sensor de presión conectado al lumen de la aguja. Asimismo, en este tipo de sistemas no se puede evitar que la aguja sea orientada de manera inadecuada cuando es introducida dentro del paciente, lo que provoca el corte de tejido y la generación de hematomas en donde se hizo la punción. Además, con el dispositivo divulgado en el documento WO 2012/089223, tampoco se logra conocer la orientación del bisel una vez que la aguja se encuentra dentro del espacio epidural, lo que provocaría los problemas antes mencionados. Similarly, WO 2012/089223 discloses a device for the detection of epidural space; However, this device is completely independent of the needle to deliver anesthesia, so it only detects the change in pressure in the needle and emits a visual or audible alarm to indicate that the epidural space has been reached. However, this device also presents the aforementioned problems, since it is a device that corresponds to a control or command box that is operated by a user, which is connected to the needle by wired systems and a pressure sensor connected to the needle lumen. Likewise, in this type of systems it is not possible to prevent the needle from being oriented improperly when it is introduced into the patient, which causes the cutting of tissue and the generation of bruises where the puncture was made. In addition, with the device disclosed in WO 2012/089223, it is not possible to know the orientation of the bevel once the needle is within the epidural space, which would cause the aforementioned problems.
El documento WO 92/15256 divulga un dispositivo muy similar al divulgado por el documento WO 2012/089223, ya que también se trata de un dispositivo de detección que corresponde a una caja de control o mando que es accionada por un usuario, la cual es conectada a la aguja mediante sistemas alámbricos y un sensor de presión conectado al lumen de la aguja. Por lo tanto, el dispositivo divulgado por el documento WO 92/15256 presenta los mismos problemas que el dispositivo del documento WO 2012/089223. WO 92/15256 discloses a device very similar to that disclosed in WO 2012/089223, since it is also a detection device that corresponds to a control or command box that is operated by a user, which is connected to the needle through wired systems and a pressure sensor connected to the needle lumen. Therefore, the device disclosed by WO 92/15256 has the same problems as the device of WO 2012/089223.
Como se puede observar de los documentos arriba citados, aunque algunos de estos cuentan con indicadores luminosos o sonoros para alertar sobre cambios de presión u otros parámetros indicativos de la localización de la punta de la cánula en el cuerpo del paciente, ninguno de ellos permite conocer al mismo tiempo la orientación del bisel de la punta de la cánula cuando ya no es visible para el anestesiólogo. As can be seen from the aforementioned documents, although some of these have light or sound indicators to warn about pressure changes or other parameters indicative of the location of the tip of the cannula in the patient's body, none of them allows us to know at the same time the orientation of the bevel of the tip of the cannula when it is no longer visible to the anesthesiologist.
Para resolver el problema de la orientación, existen en el estado de la técnica agujas con orientadores de bisel táctiles que comprenden una muesca o reborde ubicados sobre la superficie del elemento de sujeción de la aguja, en donde dicha muesca o reborde tiene la función de indicar la orientación del bisel de la punta de la cánula de la aguja. Sin embargo, este tipo de indicadores táctiles, presentan diversas problemáticas, siendo una de las principales la dificultad para sentir o palpar dicha muesca o reborde debido a los guantes que utilizan los anestesiólogos. Además, la palpación del dispositivo para ubicar la muesca puede provocar una manipulación excesiva del mismo ocasionando los problemas anteriores. Asimismo, debido a que dicha muesca o reborde están hechos normalmente del mismo material que el elemento de sujeción, el cual comúnmente es transparente, también es difícil ubicar dicha muesca o reborde de manera visual. Por lo tanto, si además se combinan estos sistemas con elementos luminosos como los descritos en el estado de la técnica arriba descritos, esto complica aún más la localización visual de las marcas táctiles. To solve the orientation problem, there are needles with tactile bevel orientators in the state of the art comprising a notch or flange located on the surface of the needle clamping element, wherein said notch or flange has the function of indicating the orientation of the bevel of the tip of the needle cannula. However, this type of tactile indicators, present several problems, one of the main ones being the difficulty to feel or feel this notch or flange due to the gloves used by anesthesiologists. In addition, palpation of the device to locate the notch can cause excessive manipulation thereof causing the above problems. Also, because said notch or flange is normally made of the same material as the fastener, which is commonly transparent, it is also difficult to locate said notch or flange visually. Therefore, if these systems are also combined with luminous elements such as those described in the state of the art described above, this further complicates the visual location of the touch marks.
Un ejemplo de lo anterior es el documento USD 378,130, que muestra un pabellón universal para una aguja de anestesia, el cual comprende como indicador visual una muesca y flecha que están hechas del mismo material y color de dicho pabellón. An example of the above is USD 378,130, which shows a universal pavilion for an anesthesia needle, which comprises as a visual indicator a notch and arrow that are made of the same material and color of said pavilion.
Durante un proceso de anestesia, las agujas con este tipo de pabellones tienen la problemática de que comúnmente no se aprecia de manera clara el indicador, puesto que no resalta del cuerpo del pabellón, provocando que tanto la inserción de la aguja en el cuerpo del paciente como la orientación de la dirección del bisel de la aguja se hagan erróneamente, es decir, se genera una manipulación excesiva de la aguja. During an anesthesia process, needles with these types of pavilions have the problem that the indicator is not clearly visible, since it does not protrude from the body of the pavilion, causing both the insertion of the needle into the patient's body as the orientation of the direction of the needle bevel is made erroneously, that is, excessive manipulation of the needle is generated.
Por consecuencia de lo anterior, se ha buscado suprimir los inconvenientes que presentan las agujas para suministrar anestesia regional a un paciente utilizadas en la actualidad, desarrollando una aguja con orientador luminoso que, además de permitir conocer permanentemente la orientación del bisel de la cánula una vez que la punta de ésta dentro del cuerpo de un paciente, no dependa del usuario para la activación de algún orientador ni de la sensibilidad del usuario a través de guantes de protección para la determinación de la orientación del bisel, evitando dañar al paciente a lo largo de una trayectoria de inserción de la aguja. As a result of the above, it has been sought to suppress the inconveniences presented by needles to provide regional anesthesia to a patient currently used, developing a needle with a light guide that, in addition to allowing the orientation of the cannula bevel permanently once that the tip of this inside the body of a patient, does not depend on the user for the activation of a counselor or the sensitivity of the user through protective gloves to determine the orientation of the bevel, avoiding damage to the patient along of a needle insertion path.
BREVE DESCRIPCIÓN DE LA INVENCIÓN BRIEF DESCRIPTION OF THE INVENTION
La aguja para suministrar un anestésico con orientador de bisel luminoso de la presente invención resuelve los problemas y desventajas del estado de la técnica, más particularmente, la aguja de la presente invención comprende: una cánula que tiene un extremo proximal de cánula y un extremo distal de cánula con una punta que tiene un bisel; un elemento de sujeción para sostener la aguja durante su inserción y en el cual se recibe el extremo próxima la cánula; un protector de cánula que cubre la totalidad de la longitud de la cánula y que tiene un extremo proximal de protector que comprende un elemento de acoplamiento que se acopla al elemento de sujeción, y un extremo distal de protector que se extiende más allá del bisel de la cánula; finalmente la aguja de la presente invención comprende un sistema de iluminación que emite una señal luminosa que se percibe mediante un orientador luminoso de bisel. The needle for delivering a luminous bevel-oriented anesthetic of the present invention solves the problems and disadvantages of the state of the art, more particularly, the needle of the present invention comprises: a cannula having a proximal cannula end and a distal end of cannula with a tip that has a bevel; a holding element for holding the needle during its insertion and in which the proximal end of the cannula is received; a cannula protector covering the entire length of the cannula and having a proximal protector end comprising a coupling element that engages the clamping element, and a distal protector end extending beyond the bevel of the cannula; finally the needle of the The present invention comprises a lighting system that emits a light signal that is perceived by a bevel light guide.
Particularmente, el sistema de iluminación se encuentra dentro del elemento de sujeción, y tiene una posición de apagado cuando el protector de cánula está acoplado al elemento de sujeción y una posición de encendido cuando el protector de cánula esté desacoplado del elemento de sujeción. Particularly, the lighting system is within the clamping element, and has an off position when the cannula protector is coupled to the clamping element and an ignition position when the cannula protector is disengaged from the clamping element.
En una modalidad preferida de la presente invención, la aguja de la presente invención comprende un indicador táctil de la orientación del bisel que se encuentra en el mismo plano en el que es visible la señal luminosa, de este modo, la posición del bisel puede conocerse no solamente de manera visual sino también a través del tacto cuando el usuario toma la aguja. In a preferred embodiment of the present invention, the needle of the present invention comprises a tactile indicator of the orientation of the bevel that is in the same plane in which the light signal is visible, thus, the position of the bevel can be known not only visually but also through touch when the user takes the needle.
El sistema de iluminación está preferiblemente conformado por un circuito que comprende a una fuente emisora de luz que emite la señal luminosa, una fuente de energía en comunicación operativa con la fuente emisora de luz que emite dicha señal luminosa cuando el sistema de iluminación está encendido, en donde dicho circuito es abierto o cerrado mediante un interruptor que es accionado mediante el elemento de acoplamiento del protector de cánula. The lighting system is preferably formed by a circuit comprising a light emitting source that emits the light signal, a power source in operative communication with the light emitting source that emits said light signal when the lighting system is on, wherein said circuit is opened or closed by a switch that is actuated by the coupling element of the cannula protector.
En una modalidad preferida, la fuente emisora de luz es un diodo emisor de luz (LED), el cual puede ser de baja o alta luminosidad. Asimismo, un técnico en la materia comprenderá que se pueden utilizar otro tipo de fuentes emisoras de luz, por ejemplo la fuente emisora de luz puede seleccionarse del grupo que comprende: un LED orgánico, una lámpara incandescente, un material electroluminiscente o una lámpara fluorescente. In a preferred embodiment, the light emitting source is a light emitting diode (LED), which can be low or high brightness. Also, a person skilled in the art will understand that other types of light emitting sources can be used, for example the light emitting source can be selected from the group comprising: an organic LED, an incandescent lamp, an electroluminescent material or a fluorescent lamp.
El interruptor para encendido, se selecciona entre interruptores de presión, sensores de contacto metálico, magnético, capacitivo, óptico, identificadores de radiofrecuencia (RFID, por sus siglas en inglés), o cualquier otro que se pueda accionar por el elemento acoplamiento del protector de cánula. The ignition switch is selected from pressure switches, metallic, magnetic, capacitive, optical contact sensors, radiofrequency identifiers (RFID), or any other that can be operated by the coupling element of the protective shield. cannula
El acoplamiento entre el elemento de sujeción y el protector de cánula puede ser realizado a través de mecanismos seleccionados preferiblemente del grupo que comprende: un elemento macho y un elemento hembra, elementos roscados, sistemas de engarzado gancho y pestaña, de ajuste a presión, muesca y reborde, acoplamiento magnético o electromecánico The coupling between the clamping element and the cannula protector can be carried out through mechanisms preferably selected from the group comprising: a male element and a female element, threaded elements, hook and flange crimping systems, snap fit, notch and flange, magnetic or electromechanical coupling
En una modalidad preferida de la invención, la aguja es una aguja tipo "Tuhoy", y el elemento de sujeción comprende un conector el cual de manera preferente puede ser un conector tipo Luer hembra (conocido en el estado de la técnica como "Luer hub" en su función de hembra como receptor de fluidos). De manera preferida, el elemento de sujeción comprende un alojamiento que contiene al sistema de iluminación y de forma aún más preferida contiene al elemento conector hembra, esto ofrece la ventaja de no requerir cables o elementos externos a la aguja para su funcionamiento. In a preferred embodiment of the invention, the needle is a "Tuhoy" type needle, and the holding element comprises a connector which may preferably be a female Luer type connector (known in the state of the art as "Luer hub "as a female as a fluid receptor). Preferably, the holding element comprises a housing that contains the lighting system and even more preferably contains the female connector element, this offers the advantage of not requiring cables or elements external to the needle for operation.
Asimismo, en la modalidad preferida de la presente invención, el elemento de acoplamiento es un anillo colocado en el extremo proximal del protector de cánula, en donde la circunferencia interior de dicho anillo está dimensionada para acoplar con el elemento de sujeción mediante un ajuste a presión. Also, in the preferred embodiment of the present invention, the coupling element is a ring placed at the proximal end of the cannula protector, wherein the inner circumference of said ring is sized to engage with the clamping element by means of a snap fit. .
Adicionalmente, en la modalidad preferida de la presente invención se utiliza como accionador una proyección en relieve provista en el elemento de acoplamiento. Dicha proyección en relieve se recibe en un agujero provisto en el elemento de sujeción, en donde dicho agüero proporciona una ruta de acceso al circuito del sistema de iluminación de tal manera que la proyección en relieve acciona el interruptor para encender o apagar la fuente emisora de luz al empujar una lámina interruptora que abre el circuito del sistema de iluminación cuando el protector de cánula se acopla al elemento de sujeción y, al retirarse el protector de cánula, la proyección en relieve deja de presionar la lámina interruptora y por lo tanto el circuito del sistema de iluminación se cierra, activando automáticamente la fuente emisora de luz y haciendo visible la señal luminosa que indica la orientación del bisel. Additionally, in the preferred embodiment of the present invention, a relief projection provided in the coupling element is used as actuator. Said relief projection is received in a hole provided in the clamping element, wherein said bore provides a path to the lighting system circuit such that the relief projection activates the switch to turn on or off the emitting source of light when pushing a switch blade that opens the lighting system circuit when the cannula protector attaches to the clamping element and, when the cannula protector is removed, the raised projection stops pressing the switch blade and therefore the circuit of the lighting system closes, automatically activating the light source and making visible the light signal indicating the orientation of the bevel.
Los principios de la presente invención pueden aplicarse en agujas para suministrar anestésicos de cualquier tipo, preferiblemente del tipo que comprende agujas para anestesia epidural o epidural/subdural o subdural, tales como las agujas tipo Tuhoy y Whitacre. BREVE DESCRIPCIÓN DE LOS DIBUJOS The principles of the present invention can be applied in needles to deliver anesthetics of any type, preferably of the type comprising needles for epidural or epidural / subdural or subdural anesthesia, such as Tuhoy and Whitacre needles. BRIEF DESCRIPTION OF THE DRAWINGS
Los aspectos novedosos que se consideran característicos de la presente invención, se establecerán con particularidad en las reivindicaciones anexas. Sin embargo, la operación, conjuntamente con otros objetos y ventajas de la misma, se comprenderá mejor en la descripción detallada de una modalidad específica, cuando se lea en relación con los dibujos anexos, en los cuales: The novel aspects that are considered characteristic of the present invention will be established with particularity in the appended claims. However, the operation, together with other objects and advantages thereof, will be better understood in the detailed description of a specific modality, when read in relation to the attached drawings, in which:
La figura 1 es una vista en perspectiva superior de la modalidad preferida de la aguja de la presente invención. Figure 1 is a top perspective view of the preferred embodiment of the needle of the present invention.
La figura 2 es una vista en explosión de la aguja mostrada en la figura 1 . Figure 2 is an exploded view of the needle shown in Figure 1.
La figura 3 es una vista en perspectiva de la aguja de la figura 1 sin el protector de cánula. La figura 4 es una vista en planta superior del protector de cánula de la modalidad preferida de la presente invención. Figure 3 is a perspective view of the needle of Figure 1 without the cannula protector. Figure 4 is a top plan view of the cannula protector of the preferred embodiment of the present invention.
La figura 5 es una vista de corte en sección transversal a lo largo de la línea L-L' de la aguja mostrada en la figura 3. Figure 5 is a cross-sectional view along the line L-L 'of the needle shown in Figure 3.
La figura 6 es una vista de corte en sección transversal de una columna vertebral mostrando el sitio objetivo para suministro de un anestésico usando la modalidad preferida de aguja de la presente invención, la aguja estando orientada en posición cefálica. Figure 6 is a cross-sectional view of a spine showing the target site for delivery of an anesthetic using the preferred needle mode of the present invention, the needle being oriented in a cephalic position.
La figura 7 es la misma vista que la figura 6 sólo que la aguja se encuentra orientada en posición caudal. Figure 7 is the same view as Figure 6 only that the needle is oriented in a caudal position.
DESCRIPCIÓN DETALLADA DE LA INVENCIÓN DETAILED DESCRIPTION OF THE INVENTION
Con referencia a las figuras 1 a 3, se muestra una modalidad preferida de la presente invención, en la cual se puede apreciar una aguja 1000 que comprende una cánula 1 100, con un elemento de sujeción 1200, un protector de cánula 1400, y un orientador luminoso de bisel 1310, que en esta modalidad, al mismo tiempo también es un orientador táctil puesto que se encuentra en relieve respecto a la superficie circundante del mismo. El orientador 1310 tiene forma de flecha que puede ser detectada mediante el tacto por el usuario. With reference to Figures 1 to 3, a preferred embodiment of the present invention is shown, in which a needle 1000 can be seen comprising a cannula 1 100, with a clamping element 1200, a cannula protector 1400, and a luminous bezel orientator 1310, which in this mode, at the same time is also a tactile orientator since it is in relief with respect to the surrounding surface thereof. The orientator 1310 has an arrow shape that can be detected by touch by the user.
Particularmente, en las figura 2 y 3 se observa a la aguja 1000, en donde se nota que la cánula 1 100 que tiene un extremo proximal de cánula 1 1 10 y un extremo distal cánula 1 120. El extremo proximal 1 1 10 de la cánula 1 100 está unido de manera integral al elemento de sujeción 1200; el cual por su parte comprende un par de aletas laterales 1210 que sirven como medio de soporte y agarre para manipular la aguja al momento de insertarla al cuerpo de un paciente; el elemento de sujeción 1200 comprende además un elemento tubular 1220 que está ubicado en el centro del elemento de sujeción 1200 corriendo de dirección proximal a distal. Particularly, in figures 2 and 3 the needle 1000 is observed, where it is noted that the cannula 1 100 having a proximal end of cannula 1 1 10 and a distal end cannula 1 120. The proximal end 1 1 10 of the cannula 1 100 is integrally attached to clamping element 1200; which in turn comprises a pair of lateral fins 1210 that serve as a support and grip means to manipulate the needle at the time of insertion into the body of a patient; the clamping element 1200 further comprises a tubular element 1220 that is located in the center of the clamping element 1200 running from proximal to distal direction.
Como se muestra en la figura 2, el elemento de sujeción 1200 comprende adicionalmente en su extremo proximal un conector hembra tipo Luer 1230 que se extiende del lado contario del elemento tubular 1220. Dicho conector tipo Luer comprende en su diámetro interno una sección cónica 1231 que está en comunicación de fluido con un conducto interior del elemento de sujeción, donde dicho conducto interior corre desde el elemento tubular 1220 hasta el conector hembra tipo Luer 1230, y está en comunicación de fluido con el extremo proximal de cánula 1 1 10 para permitir comunicación de fluido con el lumen o conducto interior de la cánula. El diámetro más pequeño de la sección cónica 1231 del conector tipo Luer 1230 es coincidente con el diámetro interior del conducto interior o lumen de la cánula 1 100 proporcionando comunicación de fluido entre los mismos, de forma que dicha sección cónica tiene la función de servir de guía para la inserción de un catéter a través del lumen interno de la cánula 1 100 para suministrar anestésicos. As shown in Figure 2, the clamping element 1200 additionally comprises at its proximal end a female Luer type 1230 connector that extends from the opposite side of the tubular element 1220. Said Luer type connector comprises in its internal diameter a conical section 1231 which is in fluid communication with an inner conduit of the clamping element, where said inner conduit runs from the tubular element 1220 to the female connector type Luer 1230, and is in fluid communication with the proximal end of cannula 1 1 10 to allow communication of fluid with the lumen or inner duct of the cannula. The smallest diameter of the conical section 1231 of the Luer 1230 type connector is coincident with the inner diameter of the inner duct or lumen of the cannula 1 100 providing fluid communication between them, so that said conical section has the function of serving as guide for the insertion of a catheter through the inner lumen of the cannula 1 100 to deliver anesthetics.
En modalidades adicionales de la invención, dicho elemento de sujeción 1200 puede comprender un reborde o placa circunferencial alrededor del mismo, o cualquier otra superficie de agarre adecuada en sustitución de las aletas, que facilite la manipulación de la aguja al insertarla dentro del cuerpo de un paciente. In additional embodiments of the invention, said clamping element 1200 may comprise a circumferential flange or plate around it, or any other suitable grip surface in place of the fins, which facilitates the manipulation of the needle when inserted into the body of a patient.
Como se puede apreciar en las figuras 1 , 2 y 3, el elemento de sujeción 1200 comprende un alojamiento 1300 dispuesto en la parte proximal del elemento de sujeción, el alojamiento aloja a dicho conector tipo Luer 1230. Como se muestra especialmente en la figura 2, dicho alojamiento 1300 está conformado por una parte superior 1320 y una parte inferior 1330, en donde, dicha parte superior 1320 y dicha parte inferior 1330 se acoplan formando una cámara que aloja parte del conector hembra tipo Luer 1230, y una ventana 1350 en la parte distal de dicho alojamiento 1300 en donde se acoplan a las aletas 1210. La abertura en la parte proximal del alojamiento, tiene una muesca para recibir una tapa 1500 que cubre el conector tipo hembra 1230 para proteger el conducto y evitar el ingreso de cualquier contaminante dentro de la sección cónica 1231 . Dicha tapa 1500 comprende en su parte distal una protuberancia dispuesta para ser insertada en dicha muesca de la parte proximal del alojamiento, en donde dicha protuberancia tiene una forma complementaria a la forma de la muesca para insertar dicha protuberancia en dicha muesca. As can be seen in Figures 1, 2 and 3, the clamping element 1200 comprises a housing 1300 disposed in the proximal part of the clamping element, the housing accommodates said Luer type 1230 connector. As shown especially in Figure 2 , said housing 1300 is formed by an upper part 1320 and a lower part 1330, wherein, said upper part 1320 and said lower part 1330 are coupled forming a chamber that houses part of the female connector type Luer 1230, and a window 1350 in the distal part of said housing 1300 where they fit the fins 1210. The opening in the proximal part of the housing has a notch to receive a cover 1500 that covers the female type connector 1230 to protect the conduit and prevent the entry of any contaminant within conic section 1231. Said cover 1500 comprises in its distal part a protuberance arranged to be inserted in said notch of the proximal part of the housing, wherein said protuberance has a shape complementary to the shape of the notch for inserting said protuberance into said notch.
El alojamiento 1300 comprende adicionalmente en su parte superior 1320, una abertura 1340 para recibir el orientador luminoso de bisel 1310, el cual está hecho de un material transparente, translúcido o similar, para permitir el paso de luz de la señal luminosa, dicho orientador luminoso puede ser colocado de tal manera que quede colocado sobre relieve o bajo relieve de la superficie superior de la parte superior 1320, para que de esta manera, dicho indicador luminoso también funcione como indicador táctil. The housing 1300 additionally comprises in its upper part 1320, an opening 1340 to receive the bevel light orientator 1310, which is made of a transparent, translucent or similar material, to allow the light signal to pass through, said light orientator it can be placed in such a way that it is placed on relief or under relief of the upper surface of the upper part 1320, so that, in this way, said light indicator also functions as a tactile indicator.
El alojamiento 1300 además aloja en su interior, un sistema de iluminación 1600 (mostrado ensamblado en la figura 5), el cual en la modalidad preferida de la invención, comprende una batería 1610, un interruptor formado de una lámina interruptora 1620, y una fuente emisora de luz que puede ser un diodo emisor de luz o LED 1630 que tiene una primera y segunda terminales 1631 y 1632, en donde dicho LED 1630 es energizada por la batería 1610 a través de dicha lamina interruptora 1620 completando el circuito eléctrico por medio de dichas primera y segunda terminales 1631 y 1632 proporcionando así un haz luminoso a través del orientador luminoso de bisel 1310. The housing 1300 also houses in its interior, a lighting system 1600 (shown assembled in Figure 5), which in the preferred embodiment of the invention comprises a battery 1610, a switch formed from a switch sheet 1620, and a source light emitter that can be a light emitting diode or LED 1630 having a first and second terminals 1631 and 1632, wherein said LED 1630 is powered by battery 1610 through said switch sheet 1620 completing the circuit electrical by means of said first and second terminals 1631 and 1632 thus providing a light beam through the bevel light orientator 1310.
En la figura 4 se muestra el protector de cánula 1400 que tiene un extremo distal de protector 1410 y un extremo proximal de protector 1420 que cubren la totalidad de la cánula, y en donde el extremo proximal de protector 1420 se acopla al elemento de sujeción 1200 mediante un anillo 1421 acoplado de manera integral a dicho extremo proximal del protector de cánula 1400 que tiene un diámetro mayor que dicho protector de cánula 1400 y que recibe al elemento tubular 1220 del elemento de sujeción 1200, en donde dicho anillo 1421 se ajusta a presión al elemento de sujeción 1200. El protector de cánula también comprende un accionar, que en la modalidad que se describe es una proyección en relieve 1430, que se extiende más allá de dicho extremo proximal de protector de cánula en dirección proximal, la proyección coincidiendo en la misma orientación que el bisel 1 121 ; dicha proyección 1430 funciona como accionador de la lámina interruptora 1620, en donde dicha proyección 1430 pasa a través de un agujero 121 1 provisto en el elemento de sujeción 1200 para penetrar el alojamiento y así encender o apagar el sistema de iluminación 1600 permitiendo o no el paso de corriente al empujar la lámina interruptora 1620 de tal manera que se abre el circuito. Dicho protector de cánula puede incluir un tapón protector 1440. Figure 4 shows the cannula protector 1400 having a distal end of protector 1410 and a proximal end of protector 1420 covering the entire cannula, and wherein the proximal end of protector 1420 is coupled to the clamping element 1200 by means of a ring 1421 integrally coupled to said proximal end of the cannula protector 1400 which has a diameter greater than said cannula protector 1400 and which receives the tubular element 1220 of the clamping element 1200, wherein said ring 1421 is pressure adjusted to the fastener 1200. The cannula protector also comprises an actuator, which in the embodiment described is a relief projection 1430, which extends beyond said proximal end of the cannula protector in the proximal direction, the projection coinciding in the same orientation as bezel 1 121; said projection 1430 functions as an actuator of the switch sheet 1620, wherein said projection 1430 passes through a hole 121 1 provided in the clamping element 1200 to penetrate the housing and thus turn on or off the lighting system 1600 allowing or not the current flow when pushing the switch sheet 1620 in such a way that the circuit is opened. Said cannula protector may include a protective cap 1440.
Aunque en las figuras se muestra que el alojamiento 1300 tiene una forma sustancialmente de un paralelepípedo, dicho alojamiento puede tener cualquier configuración, tal como cilindrica, piramidal, sustancialmente esférica, o cualquier otra forma adecuada siempre y cuando se aprecie de manera clara y fácil la señal luminosa. Although the figures show that the housing 1300 has a substantially parallelepiped shape, said housing can have any configuration, such as cylindrical, pyramidal, substantially spherical, or any other suitable shape as long as the clear and easy way is appreciated light signal.
En la figura 5, se muestra un corte de la aguja a lo largo de la línea L-U, donde dicha cánula 1 100 comprende en el extremo distal de cánula 1 120, una punta 1 122 la cual está ligeramente curvada hacia el lado o cara frontal de la cánula 1 100, en donde dicha punta comprende una cavidad o bisel 1 121 por donde se hace pasar el catéter para el suministro del anestésico o se hace pasar el anestésico directamente por la cánula cuando se hace mediante una dosis única. In Fig. 5, a cut of the needle is shown along the LU line, wherein said cannula 1 100 comprises at the distal end of cannula 1 120, a tip 1 122 which is slightly curved towards the front side or face of the cannula 1 100, wherein said tip comprises a cavity or bezel 1 121 through which the catheter is passed for anesthetic delivery or the anesthetic is passed directly through the cannula when it is made by a single dose.
Esta figura 5 permite apreciar el sistema de iluminación 1600 el cual en la modalidad preferida de la invención, comprende una batería 1610, una lámina interruptora 1620 y el LED 1630 que es energizada por la batería 1610 a través de dicha lamina interruptora 1620 proporcionando así un haz luminoso a través del orientador luminoso de bisel 1310. This figure 5 allows to appreciate the lighting system 1600 which in the preferred embodiment of the invention, comprises a battery 1610, a switch sheet 1620 and LED 1630 which is energized by the battery 1610 through said switch sheet 1620 thus providing a light beam through bezel light guide 1310.
Ahora bien volviendo a las figuras 1 y 2, con respecto al funcionamiento del sistema de iluminación, la proyección en relieve 1430 se introduce dentro de dicho alojamiento 1300 a través del agujero 121 1 y tiene la función de empujar la lámina interruptora 1620 separándola de la segunda terminal 1632 del LED 1630 e interrumpiendo el circuito eléctrico manteniendo de esta manera el LED en estado apagado mientras dicha proyección 1430 se encuentra dentro de dicho alojamiento. Now returning to Figures 1 and 2, with respect to the operation of the lighting system, the relief projection 1430 is introduced into said housing 1300 through the hole 121 1 and it has the function of pushing the switch sheet 1620 separating it from the second terminal 1632 of the LED 1630 and interrupting the electrical circuit thus keeping the LED in the off state while said projection 1430 is inside said housing.
Cuando se desacopla el protector de cánula del elemento de sujeción, dicha proyección en relieve 1430 es retirada del alojamiento 1300, de tal manera que la lámina interruptora 1620 se mueve hasta hacer contacto con la segunda terminal 1632 del LED 1630 cerrando el circuito eléctrico y manteniendo de este LED 1630 en estado encendido de manera permanente, hasta que dicha lámina interruptora 1620 se separe nuevamente de la segunda terminal 1632 al introducir la proyección en relieve 1430 por el agujero 121 1 . When the cannula protector of the clamping element is disengaged, said relief projection 1430 is removed from the housing 1300, such that the switch sheet 1620 moves until it makes contact with the second terminal 1632 of the LED 1630 closing the electrical circuit and maintaining of this LED 1630 in a permanently lit state, until said switch sheet 1620 is separated again from the second terminal 1632 when the relief projection 1430 is introduced through hole 121 1.
La operación del sistema de encendido/apagado del orientador luminoso se realiza de la siguiente manera. The operation of the on / off system of the light guide is carried out as follows.
Antes de su uso, el LED 1630 ubicado dentro del alojamiento 1300 se encuentra en un estado apagado cuando el protector de cánula 1400 está acoplado al elemento de sujeción 1200, debido a la interrupción del circuito eléctrico mediante la proyección 1430 que separa la lámina interruptora 1620 de la segunda terminal 1632 del LED 1630. Before use, the LED 1630 located inside the housing 1300 is in an off state when the cannula protector 1400 is coupled to the clamping element 1200, due to the interruption of the electrical circuit by the projection 1430 that separates the switch sheet 1620 of the second terminal 1632 of LED 1630.
Posteriormente, durante el uso de la aguja 1 100, la fuente emisora 1630 pasa a un estado de encendido, provocado por el desacoplamiento del protector de cánula 1400 del elemento de sujeción 1200 cuando dicho protector 1400 es desacoplado por el usuario, extrayendo la proyección 1430 del interior del alojamiento 1300, provocando que la lámina interruptora 1620 entre en contacto con la segunda terminal 1632 del LED 1630, cerrando así el circuito eléctrico y emitiendo la señal luminosa. Subsequently, during the use of the needle 1 100, the emitting source 1630 goes into a state of ignition, caused by the decoupling of the cannula protector 1400 from the clamping element 1200 when said protector 1400 is decoupled by the user, removing the projection 1430 inside the housing 1300, causing the switch sheet 1620 to come into contact with the second terminal 1632 of the LED 1630, thus closing the electrical circuit and emitting the light signal.
Una vez encendido el LED 1630 se proporciona un haz luminoso a través del orientador luminoso de bisel 1310 que está alineado con el bisel 1 121 , y el cual emite la señal luminosa que indica la orientación del bisel de tal manera que se puede realizar un posicionamiento adecuado de la aguja, así como permitir orientarla y dirigirla a lo largo de una trayectoria de recorrido durante su inserción al cuerpo del paciente, sin rango de error, en la dirección apropiada, ya sea cefálica como se muestra en la figura 6 o caudal como se muestra en la figura 7. Once the LED 1630 is on, a light beam is provided through the bezel light guide 1310 that is aligned with the bezel 1 121, and which emits the light signal indicating the orientation of the bevel so that positioning can be performed adequate needle, as well as allowing it to be oriented and directed along a path during its insertion into the patient's body, without error range, in the appropriate direction, either cephalic as shown in Figure 6 or flow rate as It is shown in figure 7.
Debido a que dicha señal luminosa permanece encendida durante todo el proceso de anestesia, ya que dicha fuente emisora de luz no puede apagarse mientras el protector de aguja se encuentre desacoplado del elemento de sujeción 1200, esto ayuda a mantener la misma dirección y orientación durante toda la trayectoria de inserción de la aguja, permitiendo una menor cantidad de manipulación de la aguja al momento de abordar al paciente. Asimismo, en caso de que sea necesario rotar la aguja para orientarla a la región que se desea aplicar el anestésico, dicho orientador luminoso de bisel 1310 permite conocer la orientación actual del bisel, aunque el bisel ya no se encuentre a la vista, de tal manera que dicha rotación de la aguja se puede realizar sin necesidad de una manipulación excesiva de la aguja. Because said light signal remains on throughout the anesthesia process, since said light emitting source cannot be turned off while the needle guard is uncoupled from the clamping element 1200, this helps to maintain the same direction and orientation throughout the needle insertion path, allowing a smaller amount of needle manipulation when approaching the patient. Also, in case it is necessary to rotate the needle to orienting it to the region that the anesthetic is to be applied, said bevel luminous orientator 1310 allows to know the current orientation of the bevel, although the bevel is no longer visible, so that said rotation of the needle can be performed without need of excessive needle handling.
Finalmente, al terminar con el suministro de anestésico, la aguja se retira del cuerpo del paciente y el LED 1630 regresa nuevamente a su estado apagado cuando se coloca el protector de cánula nuevamente para el desecho de la aguja, toda vez que la proyección del elemento protector de cánula se introduce nuevamente en el alojamiento 1300 y separa una vez más la lámina interruptora de la segunda terminal para interrumpir el circuito eléctrico. Finally, at the end of the anesthetic supply, the needle is removed from the patient's body and LED 1630 returns to its off state when the cannula protector is placed again for needle disposal, since the projection of the element Cannula protector is reintroduced into housing 1300 and once again separates the switch sheet from the second terminal to interrupt the electrical circuit.
Con referencia a las figuras 6 y 7, durante su uso, dicha aguja 1000 aborda o atraviesa las diferentes capas de la piel y tejidos del cuerpo del paciente para suministrar el anestésico en la dirección deseada, ya sea cefálica (figura 6) o caudal (figura 7), en este sentido, dicha aguja pasa por: Tejido Graso A, Ligamento Supra espinoso B, Ligamento Flavum C, ligamento Intra espinoso D, antes de llegar al espacio epidural E, que es donde la aguja será orientada o direccionada en posición cefálica (figura 6) o caudal (figura 7) para que un catéter epidural se coloque en la orientación previamente establecida y se suministre el anestésico a la región deseada. With reference to Figures 6 and 7, during use, said needle 1000 addresses or passes through the different layers of the skin and tissues of the patient's body to deliver the anesthetic in the desired direction, either cephalic (Figure 6) or caudal ( Figure 7), in this sense, said needle passes through: Fat Tissue A, Spinous Supra Ligament B, Flavum Ligament C, Spiny Intra Ligament D, before reaching the epidural space E, which is where the needle will be oriented or directed in position cephalic (figure 6) or caudal (figure 7) so that an epidural catheter is placed in the previously established orientation and the anesthetic is supplied to the desired region.
Como se mencionó anteriormente, con la aguja de la presente invención se evita o elimina la manipulación excesiva de dicha aguja, lo cual es muy importante para eliminar la posibilidad de realizar Punciones Durales o Subaracnoideas accidentales, es decir, punciones a la duramadre, al cuerpo vertebral F, al Disco Intervertebral G, y a los Ligamentos Anterior H y Posterior I, con el fin de evitar cefaleas u otros efectos secundarios al paciente. As mentioned above, the needle of the present invention avoids or eliminates excessive manipulation of said needle, which is very important to eliminate the possibility of accidental punctures or Subarachnoid punctures, that is, punctures to the dura, to the body. vertebral F, the Intervertebral Disc G, and the Anterior H and Posterior I Ligaments, in order to avoid headaches or other side effects to the patient.
Además, es muy importante dirigir y orientar la aguja en una misma dirección de acuerdo a las fibras de los tejidos a lo largo de toda la trayectoria de recorrido, para llegar al sitio objetivo, y en ese sitio orientar el bisel en la dirección deseada, cefálica o caudal, y suministrar el anestésico, sin dañar las capas de tejido que se deben atravesar puesto que, un giro inesperado de la aguja durante la trayectoria, puede rasgar los tejidos y provocar mayores malestares al paciente, así como retrasos en el procedimiento quirúrgico. In addition, it is very important to direct and orient the needle in the same direction according to the fibers of the tissues along the entire path, to reach the target site, and at that site orient the bevel in the desired direction, cephalic or caudal, and supply the anesthetic, without damaging the layers of tissue that must be traversed since, an unexpected turn of the needle during the trajectory, can tear the tissues and cause greater discomfort to the patient, as well as delays in the surgical procedure .
De acuerdo con lo anteriormente descrito, será evidente para un técnico en la materia que la modalidad de aguja, arriba ilustrada se presenta con fines únicamente ilustrativos, pues un técnico en la materia puede realizar numerosas variaciones a la misma, siempre y cuando se diseñen de conformidad con los principios de la presente invención. Por consecuencia de lo anterior, la presente invención incluye todas las modalidades que un técnico en la materia puede plantear a partir de los conceptos contenidos en la presente descripción, de conformidad con las siguientes reivindicaciones. In accordance with the above, it will be evident to a person skilled in the art that the needle mode, illustrated above is presented for illustrative purposes only, since a person skilled in the art can make numerous variations thereto, provided they are designed in accordance with the principles of the present invention. As a consequence of the foregoing, the present invention includes all modalities that a person skilled in the art can propose based on the concepts contained in this description, in accordance with the following claims.
LISTA DE REFERENCIASREFERENCE LIST
Aguja Needle
1100 Cánula 1100 cannula
1110 Extremo Proximal de Cánula 1110 Proximal Cannula End
1120 Extremo Distal de Cánula 1120 Cannula Distal End
1121 Bisel 1121 Bevel
1122 Punta 1122 Tip
1200 Elemento de Sujeción 1200 Clamping Element
1210 Aletas Laterales 1210 Lateral Fins
1211 Agujero 1211 Hole
1220 Elemento Tubular 1220 Tubular Element
1230 Conector Hembra 1230 Female Connector
1231 Sección cónica 1300 Alojamiento 1231 Conical section 1300 Accommodation
1310 Orientador luminoso de bisel 1310 Bevel light guide
1320 Parte superior 1320 Top
1330 Parte inferior 1330 Bottom
1340 Abertura 1340 Opening
1350 Ventana 1350 Window
1400 Protector de cánula 1400 Cannula Protector
1410 Extremo Distal de protector 1410 Protective Distal End
1420 Extremo Proximal de protector 1420 Proximal Protector End
1421 Anillo 1421 Ring
1430 Proyección en relieve 1430 Relief Projection
1440 Tapón protector 1440 Protective Cap
1500 Tapa 1500 cover
1600 Sistema de iluminación 1600 lighting system
1610 Batería 1610 Battery
1620 Lámina interruptora 1620 Switch Sheet
1630 LED 1630 LED
1631 Primera terminal 1631 First terminal
1632 Segunda terminal A Tejido Graso 1632 Second terminal A Fat Tissue
B Ligamento Supra espinoso B Ligament Supra Spiny
C Ligamento Flavum, C Ligament Flavum,
D Ligamento Intra espinoso D Intra spiny ligament
E Espacio epidural E Epidural space
F Cuerpo Vertebral F Vertebral Body
G Disco Intervertebral, G Intervertebral Disc,
H Ligamento Anterior H Anterior Ligament
1 Ligamento Posterior, 1 Posterior Ligament,
Claims
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PCT/IB2017/051672 WO2018172817A1 (en) | 2017-03-23 | 2017-03-23 | Needle for supplying an anaesthetic with luminous orienting device |
Applications Claiming Priority (1)
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PCT/IB2017/051672 WO2018172817A1 (en) | 2017-03-23 | 2017-03-23 | Needle for supplying an anaesthetic with luminous orienting device |
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WO2018172817A1 true WO2018172817A1 (en) | 2018-09-27 |
Family
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PCT/IB2017/051672 Ceased WO2018172817A1 (en) | 2017-03-23 | 2017-03-23 | Needle for supplying an anaesthetic with luminous orienting device |
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Cited By (1)
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CN115998389A (en) * | 2023-03-24 | 2023-04-25 | 浙江伽奈维医疗科技有限公司 | Composite guiding front-end device of surgical robot and positioning method |
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WO2008149205A1 (en) * | 2007-06-06 | 2008-12-11 | Velez-Rivera Hector De Jesus | Spinal needle including a chamber for identifying cerebrospinal fluid |
WO2009066972A1 (en) * | 2007-11-20 | 2009-05-28 | Innovamédica S.A.P.I. De C.V. | Electronic syringe with safety system for spinal injections |
WO2010029428A1 (en) * | 2008-09-12 | 2010-03-18 | Velez Rivera Hector De Jesus | Epidural space locating device |
US20120172805A1 (en) * | 2011-01-04 | 2012-07-05 | Stevenson Jon R | Rotational orientation indicating hollow needle assembly |
ES2485497T3 (en) * | 2007-11-21 | 2014-08-13 | Becton, Dickinson And Company | Stylus handle connection device |
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US20020099335A1 (en) * | 2001-01-25 | 2002-07-25 | Zohmann Walter A. | Spinal needle |
WO2008149205A1 (en) * | 2007-06-06 | 2008-12-11 | Velez-Rivera Hector De Jesus | Spinal needle including a chamber for identifying cerebrospinal fluid |
WO2009066972A1 (en) * | 2007-11-20 | 2009-05-28 | Innovamédica S.A.P.I. De C.V. | Electronic syringe with safety system for spinal injections |
ES2485497T3 (en) * | 2007-11-21 | 2014-08-13 | Becton, Dickinson And Company | Stylus handle connection device |
WO2010029428A1 (en) * | 2008-09-12 | 2010-03-18 | Velez Rivera Hector De Jesus | Epidural space locating device |
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CN115998389A (en) * | 2023-03-24 | 2023-04-25 | 浙江伽奈维医疗科技有限公司 | Composite guiding front-end device of surgical robot and positioning method |
CN115998389B (en) * | 2023-03-24 | 2023-07-28 | 浙江伽奈维医疗科技有限公司 | Composite guiding front-end device of surgical robot and positioning method |
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