WO2021214352A1 - Foetal extraction device - Google Patents

Foetal extraction device Download PDF

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Publication number
WO2021214352A1
WO2021214352A1 PCT/ES2021/070176 ES2021070176W WO2021214352A1 WO 2021214352 A1 WO2021214352 A1 WO 2021214352A1 ES 2021070176 W ES2021070176 W ES 2021070176W WO 2021214352 A1 WO2021214352 A1 WO 2021214352A1
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WO
WIPO (PCT)
Prior art keywords
fetal
blades
extraction device
head
handle
Prior art date
Application number
PCT/ES2021/070176
Other languages
Spanish (es)
French (fr)
Inventor
Germán MERINO MARTÍN
Victor MERINO KOSINA
Original Assignee
Merino Martin German
Merino Kosina Victor
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Filing date
Publication date
Application filed by Merino Martin German, Merino Kosina Victor filed Critical Merino Martin German
Publication of WO2021214352A1 publication Critical patent/WO2021214352A1/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
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A61B17/44—Obstetrical forceps

Definitions

  • the object of the present invention is an original fetal extraction device that allows efficient extraction of the fetus, as well as a great ease of handling the tool and a reduction in the risks to the health of the fetus and the mother inherent in this type of procedure. maneuvers.
  • the device allows the fetal head to be grasped, by means of vacuum cups with which it is fixed to the parietal bones.
  • the fetal extraction device object of the present invention has application in the industry of design and manufacture of clinical material and equipment, more specifically in the field of obstetrics.
  • vaginal delivery should be the preferred choice; it is desirable that the cesarean section be carried out at its standard of 15% recommended by the WHO.
  • the two obstetric instruments that have been used for centuries throughout the world for surgical vaginal delivery are: forceps with their various modalities and the disposable manual or metallic obstetric suction cup.
  • the humanization of delivery care with the administration of epidural anesthesia in early periods of labor at high doses favor the fetal head to adopt dystocic positions when descending and not rotating adequately in the birth canal, which requires many times of an instrumented delivery due to a delayed delivery period due to positional dystocia, usually occipital posterior or occipital dystociae, without listing flexion dystocia or asynclitism.
  • the latter will prolong the expulsive period and may alter the recording of fetal heartbeats in electronic monitoring, with the risk of loss of fetal well-being (RPBF) and the need to extract the fetus quickly.
  • RPBF risk of loss of fetal well-being
  • vacuum extractor vacuum
  • forceps forceps
  • CST transverse segmental caesarean section
  • the obstetric suction cup it may be contraindicated in those cases in which a fetal scalp pH has previously been carried out, and it has been seen that the use of the suction cup could cause injuries, cephalohematomas or tears of the skin of the fetus in the dangerous area of the interparietal sagittal suture and fontanelles.
  • the present invention refers to an original fetal extraction device.
  • the fetal extraction device object of the present invention comprises a handle and two blades.
  • Each of the blades comprises a flexible body attached to the handle in correspondence with a proximal end of the blade.
  • each of the blades comprises a spoon located in correspondence with a distal end of the blade.
  • the handle comprises a vacuum pump, as well as an actuator of the vacuum pump, and;
  • Each spoon comprises a concave surface that forms a hollow bowl open only towards the spoon of the other blade of the device.
  • the distal ends of the blades are not fenestrated.
  • the bowl is in fluid connection with the vacuum pump through a conduit that runs through the interior of each of the blades (running through the body of each blade, from the vacuum pump to the bowls of the scoops).
  • each conduit that connects each cup with the vacuum pump can be made by means of a plastic tube.
  • the described device allows the fetus head to be positioned and rotated correctly and to be pulled out of the vaginal canal, exerting a firm and non-aggressive grip on the fetus's head.
  • the outer surface of the spoon is flat.
  • the bodies of each blade have an elliptical geometry, with a first convex section divergent between the two blades in correspondence with the proximal ends of the blades and a second convergent concave section between the two blades at correspondence with the distal ends of the blades, thus forming the so-called cephalic curvature that contains the fetal head.
  • each spoon comprises a pad in the bowl (eg, at the edges of the bowl). This pad allows padded contact between the spoon and the fetus head, facilitating gliding along the surface of the fetus head and preventing injury to the skin of the fetus head.
  • each pad is made of a soft plastic material (deformable, eg, EVA).
  • EVA deformable, eg, EVA
  • the cups contain on their internal surface some rough points that prevent solid or liquid objects from blocking the outlet of the suction duct and, on the other hand, allow the vacuum to be more uniform.
  • the paddle bodies are made of a hard plastic material. This allows facilitating, not only the flexible nature of the paddle bodies, but also due to their low weight (and therefore ease of transport and handling) it also allows a reduction in the risk of damaging the mother or fetus, and a cheapness and simplicity in the manufacture of the device.
  • the handle is made of a similar hard plastic material.
  • the paddles comprise blunt edges (rounded edges or without edges). This also reduces the risk of injury to the mother or the fetus.
  • the device object of the present invention offers the same or greater extraction efficiency than any of the instruments of the state of the art (forceps or vacuum), but reducing complications and undesirable effects both for the health of the mother and for the health of the baby. fetus.
  • the device object of the present invention thus has a mixed or hybrid functionality, which is fundamentally characterized by the original biparietal and symmetric capture of the fetal head by means of a combination of a forceps-type forceps (formed by the two blades of the fetal extraction device). that each spoon has a built-in vacuum bowl to hold firmly to the parietal bones of the fetal head.
  • the device of the invention can act as a tractor and rotator instrument for the extraction of the fetal head when it is embedded in the lower pelvis during complicated natural delivery, thereby improving the efficiency of the obstetric instruments used up to now.
  • vaginal tears and fetal injuries such as spoon marks, bruises, cephalohematomas and ecchymoses, erosions, wounds and subsidence, caused by the prey of fenestrated spoons or by the vacuum of the Vacuum.
  • the present invention therefore refers to a novel device that improves the efficiency and speed of handling current obstetric instruments, avoiding potentially serious fetal and maternal injuries that can originate with instruments such as forceps and obstetric suction cup (Vacuum). It combines the advantages of the forceps and the Vacuum in a single device, but minimizing its complications and risks.
  • This new device facilitates the removal of the head and avoids the potential damage caused to some extent by the metal instruments that have been used for this purpose until now.
  • the invention is therefore based on the idea of providing a simple and atraumatic instrument, easy and quick to apply, for the doctor, mother and fetus.
  • the indications for use are to facilitate the practice of urgent obstetric care during the second period of labor due to the risk of loss of fetal well-being, or in prolonged delivery due to mechanical dystocia due to a malposition of the embedded fetal head, either in the low transverse or occipitosacral position, or, due to maternal exhaustion. It is also indicated in those cases in which a fetal scalp pH has previously been performed, in which the suction cup is contraindicated.
  • the fetal extraction device object of the present invention can even be very useful in facilitating difficult extraction during caesarean section, in large fetuses, in high heads that are not easy to extract, or in special situations such as the conduplicatio corporis of the second twin, with the in order to avoid the corporal incisions on the uterus and that condition the future reproductive life of the patients.
  • the benefits derived from the use of the fetal extraction device object of the present invention are numerous, there is less damage to the maternal and fetal tissues, the cesarean section incisions can be smaller and the delivery and delivery times can be shortened. And therefore also the rates of caesarean section can be reduced.
  • the fetal extraction device object of the present invention combines the philosophy of a parallel forceps, albeit of much shorter length and with two short and wide spoons, solid without fenestrating and symmetrical.
  • the device acts as a clamping, tractor and rotator instrument, with suction cups made up of the scoops of the scoops.
  • the paddles are inserted into a handle that serves as a conventional suction pump.
  • the objective that is achieved is a symmetrical and non-displaceable fixation dam on both parietals of the fetal head.
  • Said biparietal diameter represents the ideal location where the head should be held in order not to cause injury to the fetus.
  • the pelvic curvature is preferably zero, as it is an instrument to be applied only in the low or exit planes, where said curvature no longer exists.
  • the fetal extraction device object of the invention has multiple advantages over Forceps and Vacuum that make it novel, unique and singular, with its own characteristics.
  • the original symmetrical Biparietal socket provides an ideal holding capacity, avoiding the dangerous parietomalar hold of the classic forceps.
  • This original biparietal intake is carried out by means of two vacuum cups located in the device's spoons.
  • fixing the vacuum to the parietal region fixing the vacuum in vulnerable areas of the fetal head such as sutures and fontanelles, as occurs with the classic suction cup, is avoided.
  • the placement of the suction cup in the puncture site for pH of the fetal shell is also avoided (contraindication of the obstetric suction cup).
  • the fetal extraction device object of the present invention has prehension, non-slip and atraumatic action.
  • the head grip is firm and atraumatic due to the double padded suction cup around its circumference, which prevents the spoons from sliding and fixes them in the parietal region, which is the least vulnerable to head injuries.
  • the fetal extraction device object of the present invention provides firm tractive action without skidding, providing a traction force of 8-12 Kg (ideal) synchronous with contraction and pushing, without breaking.
  • the fetal extraction device that is the object of the present invention enables a facilitated rotary action to be carried out by pulling on two support points on both spoons, which makes a great difference with the obstetric suction cup, which fixes only at one point.
  • the traction from the handle is closer to the lowest point of the fetal head to achieve a more physiological descent of the head by means of the appropriate traction vectors. Therefore, it eliminates unsuccessful traction vectors, which can occur with the classic suction cup, due to its traction in the same direction as the blades.
  • the fetal extraction device of the invention allows a better adaptation to the various series of fetal heads of different dimensions over its entire surface, due to its flexibility, its internal concavity and the cephalic curvature it possesses.
  • the device has little weight, so the compression is much less on the baby's skull (it does not deform the head, it only maintains and preserves the physiological molding). It is, therefore, less aggressive towards the baby. Does not compress the zygomatic bone (does not produce forceps marks).
  • the mechanism of action of the present fetal extraction device is much simpler than that of the devices of the state of the art, so both maternal and fetal injuries are largely avoided, whether they are vaginal and cervical lacerations and tears, as well such as injuries due to slipping of the branches on the fetal face and those produced by compressing and deforming the head with forceps.
  • the fetal extraction device of the invention is easily reproducible, thus facilitating teaching and learning.
  • the fetal retrieval device of the invention can be actuated and applied rapidly. It can be operated with one hand from the handle. Being a much shorter instrument than Thierry spatulas, it allows direct traction from the handle with one hand, handling the internal rotation of the head better and closer to its axis, when necessary or allowing its physiological rotation.
  • the fetal extraction device object of the present invention collaborates in reducing the number of caesarean sections by assisting vaginal delivery. Prevents injuries to the pelvic floor by making a lower prey and due to the perineal curvature of the spoons. Forceps delivery is associated with an increased risk of pelvic organ prolapse and muscle trauma, due to its greater length and ellipse angle (cephalic curvature).
  • the blades have blunt, rounded and non-sharp edges. In this way, tears in the perineum are less fearsome than with forceps or spatulas.
  • Figure 1a Shows a schematic side view of a possible embodiment of the fetal extraction device.
  • Figure 1b Shows a schematic front view of the fetal extraction device of Figure 1a.
  • Figure 2a Shows a schematic sectional profile view (according to section AA of Figure 2b) of the spoon of one of the blades, according to a possible embodiment of the fetal extraction device.
  • Figure 2b Shows a schematic view of the spoon of one of the blades of Figure 2a.
  • Figure 3a Shows a schematic view of an embodiment of the fetal extraction device, where the two blades of the device are in an open position or separated from each other.
  • Figure 3b Shows a schematic view of the fetal extraction device of Figure 3a, where the two paddles are brought closer to each other by means of a user with his hand.
  • Figure 3c Shows a schematic view of the fetal extraction device of Figure 3b, where the two paddles are glued to each other by means of the action exerted by a user with his hand.
  • Figure 4a Shows a schematic view of an embodiment of the fetal extraction device approaching the head of a fetus.
  • Figure 4b Shows a schematic view of the fetal extraction device of Figure 4a, where the paddles contact the fetus head and begin to slide open around the parietal bones of the fetus head.
  • Figure 4c Shows a schematic view of the fetal extraction device of Figure 4b, where the spoons of the two blades are positioned on the parietal bones of the fetal head, in an optimal position to begin the fetus extraction maneuver.
  • the present invention relates, as mentioned above, to a fetal extraction device.
  • the fetal extraction device comprises, as seen in Figure 1 a and Figure 1 b, a handle (1) and paddles (2).
  • each of the blades (2) comprises a body (4) and a spoon (3).
  • the handle (1) and the blades (2) have a mostly straight lateral profile, without pelvic curvature. The perineal curvature is only seen in the spoons (3).
  • the proximal end of the body (4) of the blades (2) is embedded in the handle (1), while the spoon (3) is located in correspondence with the distal end of the body (2) of the blades (2) .
  • the body (4) of the blades (2) is made of flexible material (preferably hard plastic) corrugated inside to increase the resistance to breakage, which allows the blades (2) to be flexed by opening or closing them, depending on the needs specific.
  • the body (2) of the blades is flexible and elongated.
  • the body (4) of each blade (2) has a length of 18-20 cm and a width of 20 mm (to facilitate that there is no flexibility in that longitudinal axis) and a thickness that varies from 3- 5 mm in the distal area and furthest from the handle (1) so that flexibility is allowed when opening and closing the blades (2), up to 5-10 mm in the proximal area closest to the handle (1) to give robustness to the device in that area, depending on the material.
  • the spoons (3) of the blades (2) are configured to be arranged in correspondence with the parietal bones of the fetal head, thus embracing the fetal head.
  • the user of the device presses the two paddles (2), one against the other, to bring them together (as shown in Figure 3b and Figure 3c), which allows its introduction into the mother's vulva or vagina.
  • the user stops pressing the two paddles (2), so that they are free to separate from each other as much as the mother's vaginal cavity where the fetus's head is allowed to do so.
  • the scoops (3) of the paddles (2) approach the head of the fetus ( Figure 4a).
  • the paddles (2) open around the head of the fetus ( Figure 4b) sliding along its surface, and the spoons (3) of the paddles (2) go through the head of the fetus (as a massager) until they are positioned in correspondence with the parietal bones of the fetal head ( Figure 4c).
  • Each of the scoops (3) of the blades (2) comprises a bowl (5) or vacuum chamber (see Figure 2a and Figure 2b).
  • Each cup (5) or vacuum chamber is in fluid connection, by means of a vacuum conduit (6), with a vacuum pump (not shown) located inside the handle.
  • each of the two vacuum conduits (6) runs through the interior of the corresponding blade (2), from the bowl (5) until it enters the handle (1) and connects with the vacuum pump.
  • each suction or vacuum duct (6) has a section of 2-3 mm 2 .
  • the handle (1) has a manual actuator (7) of the vacuum pump.
  • the actuator (7) can be of the plunger or piston type.
  • the vacuum pump houses a double air inlet and outlet valve. By manually pressing the actuator (7), the vacuum pump creates a suction between the spoon (3) of each paddle (2) and the corresponding parietal lobe of the fetal head.
  • Each of the cups (5) comprises a soft plastic pad (8) (for example, sponge or EVA rubber type) that provides a padded contact between the spoon (3) of each paddle (2) and the head of the fetus.
  • these two pads (8) allow that, by contacting the paddles (2) with the head of the fetus during the introduction of the device into the vaginal cavity, the spoons (3) can slide smoothly over the head of the fetus without causing any kind of of wounds.
  • the scoops (3) of the blades (2) have a suction surface of 14 cm 2 , and each bowl (5) has a volume of 5 cm 3 .
  • the spoons (3) have a standard separation between them, at the tips of 5 mm at rest, which can reach up to 10-11 mm as they cover the fetal head. This distance is adjusted manually by gently pressing the center of the blades (2), as they are flexible.
  • the fetal extraction device object of the present invention has been made with a lower perineal curvature at the level of the junction of each spoon (3) with the body (4) of the blade (2)).
  • the two blades (2) are anchored in the handle (1) (in which the manual vacuum pump is located), thus achieving a one-piece instrument, to be able to pull as close to the lowest point of the head.
  • the vacuum of the cups (5) is generated by a negative manual pressure pump, 200-800 mbar. located on the handle (1), to allow the doctor to pull gently from the fetal head and assist synchronously with the mother's efforts during vaginal surgical deliveries.
  • a negative manual pressure pump 200-800 mbar. located on the handle (1), to allow the doctor to pull gently from the fetal head and assist synchronously with the mother's efforts during vaginal surgical deliveries.
  • the insertion of the blades (2) of the device through the vulva is carried out in a single movement without dismantling the blades (2), in a very simple and easy-to-learn way. It is necessary to know in advance, as in the rest of the obstetric instruments, the position of the head, the degree of fit and flexion.
  • the blades (2) with rounded edges, being flexible, open easily and symmetrically when they collide with the fetal cephalic pole, sliding parallel and laterally like cranial massagers, due to the flexibility of the plastic material, to allow its introduction.
  • the direction of insertion of the blades (2) is marked by an arrow marked on the handle (1), pointing like a peephole towards the interparietal sagittal suture, and therefore adopting the spoons (3) a situation correct, symmetrical, covering and adapting to both parietals (lateral biparietal meridian).
  • the vacuum is carried out using the vacuum pump. The process can take approximately 30 seconds maximum.
  • the initial angle for traction depends on the plane of the fetal head within the pelvis, but is generally downward, then progressively extends upward as the head emerges through the introitus. After the head is removed, the vacuum pressure is released, the device is removed, and standard techniques are followed to complete the vaginal delivery.

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  • Gynecology & Obstetrics (AREA)
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Abstract

A foetal extraction device comprising a handle (1) and two blades (2), where each of the blades (2) comprises a flexible body (4) and a curved portion (3) at the distal end of the blade (2). The handle (1) comprises a vacuum pump and an actuator (7) for the vacuum pump. Each curved portion (3) comprises a smooth concave surface forming a bowl (5). The bowl (5) is fluidly connected to the vacuum pump by means of a conduit (6) extending inside each of the blades (2). Once the two curved portions (3) are aligned with the parietal bones of the foetal head, respectively, operation of the actuator (7) produces a vacuum inside each bowl (5), between the corresponding curved portion (3) and the foetal head.

Description

DESCRIPCIÓN DESCRIPTION
Dispositivo de extracción fetal Fetal retrieval device
Objeto de la invención Object of the invention
La presente invención tiene por objeto un original dispositivo de extracción fetal que permite una extracción eficiente del feto, así como una gran facilidad de manejo de la herramienta y una disminución de los riesgos para la salud del feto y de la madre inherentes a este tipo de maniobras. The object of the present invention is an original fetal extraction device that allows efficient extraction of the fetus, as well as a great ease of handling the tool and a reduction in the risks to the health of the fetus and the mother inherent in this type of procedure. maneuvers.
El dispositivo permite la prehensión de la cabeza fetal, mediante unas cazoletas de vacío con las que se fija a los huesos parietales. The device allows the fetal head to be grasped, by means of vacuum cups with which it is fixed to the parietal bones.
El dispositivo de extracción fetal objeto de la presente invención tiene aplicación en la industria del diseño y fabricación de material y equipamiento clínico, más concretamente en el ámbito de la obstetricia. The fetal extraction device object of the present invention has application in the industry of design and manufacture of clinical material and equipment, more specifically in the field of obstetrics.
Antecedentes de la invención y problema técnico a resolver Background of the invention and technical problem to be solved
En el mundo moderno, el parto por vía vaginal debe ser la elección preferente; es deseable que la operación cesárea se lleve a cabo en su estándar del 15% recomendado por la OMS. In the modern world, vaginal delivery should be the preferred choice; it is desirable that the cesarean section be carried out at its standard of 15% recommended by the WHO.
Ningún parto vaginal asistido está completamente libre de riesgos para la madre y el bebé. Las cuestiones importantes a tener en cuenta incluyen la evaluación del riesgo para la salud del feto y de la madre y la consideración de las opciones existentes en procedimientos o técnicas que podrían reducir el riesgo una vez que los procesos naturales del parto fracasen o si el parto debe ser acelerado para las indicaciones maternas o fetales. No assisted vaginal birth is completely risk-free for mother and baby. Important issues to consider include assessing the risk to the health of the fetus and the mother and considering existing options in procedures or techniques that could reduce risk once the natural processes of childbirth fail or if delivery it should be expedited for maternal or fetal indications.
Los dos instrumentos obstétricos que se han venido utilizando durante siglos en todo el mundo para el parto vaginal quirúrgico son: los fórceps con sus diversas modalidades y la ventosa obstétrica metálica o manual desechable. La humanización en la atención del parto con la administración de anestesia epidural en períodos precoces del trabajo de parto a dosis altas, favorecen que la cabeza fetal adopte posiciones distócicas al descender y no rotar adecuadamente en el canal del parto, lo que requiere muchas veces de un parto instrumentado debido a un periodo expulsivo detenido por distocia de posición, habitualmente distocias occípitoposteriores u occípitosacras, sin enumerar las distocias de flexión o asinclitismos. Esto último prolongará el periodo expulsivo y puede alterar el registro de los latidos cardiofetales en la monitorización electrónica, con riesgo de pérdida del bienestar fetal (RPBF) y la necesidad de extraer al feto rápidamente. The two obstetric instruments that have been used for centuries throughout the world for surgical vaginal delivery are: forceps with their various modalities and the disposable manual or metallic obstetric suction cup. The humanization of delivery care with the administration of epidural anesthesia in early periods of labor at high doses, favor the fetal head to adopt dystocic positions when descending and not rotating adequately in the birth canal, which requires many times of an instrumented delivery due to a delayed delivery period due to positional dystocia, usually occipital posterior or occipital dystociae, without listing flexion dystocia or asynclitism. The latter will prolong the expulsive period and may alter the recording of fetal heartbeats in electronic monitoring, with the risk of loss of fetal well-being (RPBF) and the need to extract the fetus quickly.
Cuando se requiere una intervención quirúrgica en la segunda etapa del parto, deben considerarse y sopesarse las opciones, los riesgos y los beneficios del vacuoextractor (ventosa o vacuum), los fórceps y de la CST (cesárea segmentaria transversa). El éxito individual y social de la asistencia del proceso de parto ha de tener como resultado una madre y un niño sanos y saludables. When surgical intervention is required in the second stage of labor, the options, risks, and benefits of vacuum extractor (vacuum), forceps, and CST (transverse segmental caesarean section) should be considered and weighed. The individual and social success of assisting in the birthing process must result in a healthy and healthy mother and child.
Los riesgos inherentes al uso del fórceps engloban complicaciones como los desgarros vaginales y las lesiones fetales como son la marca de las cucharas, los hematomas y equimosis, las erosiones, heridas y hundimientos, provocados por la presa de cucharas fenestradas The risks inherent in the use of forceps include complications such as vaginal tears and fetal injuries such as the mark of the spoons, bruises and ecchymoses, erosions, wounds and subsidence, caused by the prey of fenestrated spoons.
En cuanto al uso de la ventosa obstétrica, ésta puede estar contraindicada en aquellos casos en los que previamente se ha realizado un pH de cuero cabelludo fetal, y se ha visto que el uso de la ventosa podría causar lesiones, cefalohematomas o desgarros de la piel del feto en la peligrosa zona de la sutura sagital interparietal y fontanelas. Regarding the use of the obstetric suction cup, it may be contraindicated in those cases in which a fetal scalp pH has previously been carried out, and it has been seen that the use of the suction cup could cause injuries, cephalohematomas or tears of the skin of the fetus in the dangerous area of the interparietal sagittal suture and fontanelles.
Por tanto, se ha visto que la instrumentación utilizada hasta ahora para la extracción del feto en partos vaginales tenía algunos inconvenientes por sus dificultades en el aprendizaje de manejo y por posibles complicaciones graves tanto para la madre como para el niño con los métodos de extracción fetal usados hasta el momento, ya sean fórceps o ventosa obstétrica. Therefore, it has been seen that the instrumentation used up to now for the extraction of the fetus in vaginal deliveries had some drawbacks due to its difficulties in learning how to handle it and due to possible serious complications for both the mother and the child with the methods of fetal extraction. used so far, either forceps or obstetric suction cup.
Descripción de la invención Con objeto de solucionar los inconvenientes anteriormente mencionados, la presente invención se refiere a un original dispositivo de extracción fetal. Description of the invention In order to solve the aforementioned drawbacks, the present invention refers to an original fetal extraction device.
Al igual que ocurre con los tradicionales fórceps, el dispositivo de extracción fetal objeto de la presente invención comprende un mango y dos palas. Cada una de las palas comprende un cuerpo flexible unido al mango en correspondencia con un extremo proximal de la pala. Asimismo, cada una de las palas comprende una cuchara situada en correspondencia con un extremo distal de la pala. As with traditional forceps, the fetal extraction device object of the present invention comprises a handle and two blades. Each of the blades comprises a flexible body attached to the handle in correspondence with a proximal end of the blade. Likewise, each of the blades comprises a spoon located in correspondence with a distal end of the blade.
De manera novedosa, en el dispositivo de extracción fetal objeto de la presente invención: el mango comprende una bomba de vacío, así como un accionador de la bomba de vacío, y; cada cuchara comprende una superficie cóncava que forma una cazoleta hueca abierta únicamente en dirección hacia la cuchara de la otra pala del dispositivo. Al contrario que en el fórceps tradicional, en el dispositivo de la invención los extremos distales de las palas (las cucharas) no están fenestrados. Por su parte, la cazoleta está en conexión fluida con la bomba de vacío por medio de un conducto que recorre el interior de cada una de las palas (recorriendo el cuerpo de cada pala, desde la bomba de vacío hasta las cazoletas de las cucharas). In a novel way, in the fetal extraction device object of the present invention: the handle comprises a vacuum pump, as well as an actuator of the vacuum pump, and; Each spoon comprises a concave surface that forms a hollow bowl open only towards the spoon of the other blade of the device. Contrary to traditional forceps, in the device of the invention the distal ends of the blades (the spoons) are not fenestrated. For its part, the bowl is in fluid connection with the vacuum pump through a conduit that runs through the interior of each of the blades (running through the body of each blade, from the vacuum pump to the bowls of the scoops). .
Así pues, al hacer uso del dispositivo de extracción fetal, cuando las dos cucharas se sitúan respectivamente en correspondencia con los huesos parietales de la cabeza del feto, el accionamiento del accionador produce un vacío aspirativo (una fuerza de aspiración) en el interior de cada cazoleta, entre la cuchara correspondiente y la cabeza del feto. Esto permite fijar mediante aspiración, la cuchara correspondiente y los huesos parietales de la cabeza del feto, con el fin de rotar y traccionar sobre ella, para la extracción fetal. Cada conducto que conecta cada cazoleta con la bomba de vacío puede estar realizado mediante un tubo de plástico. Thus, when making use of the fetal extraction device, when the two spoons are respectively placed in correspondence with the parietal bones of the fetal head, the actuation of the actuator produces a suction vacuum (a suction force) inside each bowl, between the corresponding spoon and the head of the fetus. This allows to fix by means of aspiration, the corresponding spoon and the parietal bones of the fetal head, in order to rotate and pull on it, for the fetal extraction. Each conduit that connects each cup with the vacuum pump can be made by means of a plastic tube.
Mediante el dispositivo descrito anteriormente, se permite un correcto asido de la cabeza del feto por medio de la fuerza del vacío, sin necesidad de presionar las palas contra el cráneo del feto. By means of the device described above, a correct grasp of the fetus 'head is allowed by means of the force of the vacuum, without the need to press the paddles against the fetus' skull.
El dispositivo descrito permite colocar y rotar correctamente la cabeza del feto y traccionarla hacia el exterior del conducto vaginal ejerciendo una sujeción firme y no agresiva de la cabeza del feto. The described device allows the fetus head to be positioned and rotated correctly and to be pulled out of the vaginal canal, exerting a firm and non-aggressive grip on the fetus's head.
Mientras que la cazoleta tiene una superficie interior cóncava, la superficie exterior de la cuchara es plana. While the bowl has a concave inner surface, the outer surface of the spoon is flat.
Mediante la geometría elíptica de las cucharas, se consigue un guiado y una colocación rápida y eficiente de ambas cucharas en correspondencia con los huesos parietales de la cabeza del feto en el momento de introducción del dispositivo en el conducto vaginal. By means of the elliptical geometry of the spoons, a quick and efficient guiding and positioning of both spoons is achieved in correspondence with the parietal bones of the fetal head at the moment of introduction of the device into the vaginal canal.
Según una posible forma de realización de la invención, los cuerpos de cada pala tienen una geometría elíptica, con un primer tramo convexo divergente entre las dos palas en correspondencia con los extremos proximales de las palas y un segundo tramo cóncavo convergente entre las dos palas en correspondencia con los extremos distales de las palas, formando de esta forma la llamada curvatura cefálica que contiene la cabeza fetal. According to a possible embodiment of the invention, the bodies of each blade have an elliptical geometry, with a first convex section divergent between the two blades in correspondence with the proximal ends of the blades and a second convergent concave section between the two blades at correspondence with the distal ends of the blades, thus forming the so-called cephalic curvature that contains the fetal head.
Esta geometría preformada de las palas permite facilitar su manipulación por parte del médico asistente al parto, permitiendo maximizar el aprovechamiento del carácter flexible de los cuerpos de las palas para juntar ambas palas a la hora de introducir las palas en el conducto vaginal, y permitiendo su separación y flexión de las palas dentro del conducto vaginal durante la introducción progresiva de las palas en el conducto vaginal, mientras las cucharas van deslizando a lo largo de la superficie de la cabeza del feto. De manera preferente, cada cuchara comprende una almohadilla en la cazoleta (por ejemplo, en los bordes de la cazoleta). Esta almohadilla permite un contacto acolchado entre la cuchara y la cabeza del feto, facilitando el deslizamiento a lo largo de la superficie de la cabeza del feto y previniendo lesiones en la piel de la cabeza del feto. This preformed geometry of the paddles makes it easier for the delivery physician to handle them, allowing to maximize the use of the flexible nature of the paddle bodies to join both paddles when inserting the paddles into the vaginal canal, and allowing them to be separation and flexing of the paddles within the vaginal canal during the progressive introduction of the paddles into the vaginal canal, while the spoons slide along the surface of the fetal head. Preferably, each spoon comprises a pad in the bowl (eg, at the edges of the bowl). This pad allows padded contact between the spoon and the fetus head, facilitating gliding along the surface of the fetus head and preventing injury to the skin of the fetus head.
De manera más preferente, cada almohadilla está hecha de un material plástico blando (deformable, p.ej., goma EVA). Esto permite el máximo aprovechamiento de la fuerza de vacío ejercida por la bomba de vacío al accionar el accionador, ya que dicha fuerza de vacío se reparte de manera más eficiente a lo largo de la superficie de contacto de la almohadilla con la cabeza al ser dicha almohadilla de plástico blando. Asimismo, las cazoletas contienen en su superficie interna unos puntitos rugosos que permiten evitar que objetos sólidos o líquidos bloqueen la salida del conducto de succión y por otra parte permite que el vacío sea más uniforme. More preferably, each pad is made of a soft plastic material (deformable, eg, EVA). This allows the maximum use of the vacuum force exerted by the vacuum pump when actuating the actuator, since said vacuum force is distributed more efficiently along the contact surface of the pad with the head when said soft plastic pad. Likewise, the cups contain on their internal surface some rough points that prevent solid or liquid objects from blocking the outlet of the suction duct and, on the other hand, allow the vacuum to be more uniform.
Según una posible forma de realización del dispositivo de extracción fetal, los cuerpos de las palas están fabricados en un material plástico duro. Esto permite facilitar, no sólo el carácter flexible de los cuerpos de las palas, sino que por su bajo peso (y por tanto facilidad de transporte y manipulación) permite también una disminución del riesgo de producir daños a la madre o al feto, y un abaratamiento y simplicidad en la fabricación del dispositivo. According to a possible embodiment of the fetal extraction device, the paddle bodies are made of a hard plastic material. This allows facilitating, not only the flexible nature of the paddle bodies, but also due to their low weight (and therefore ease of transport and handling) it also allows a reduction in the risk of damaging the mother or fetus, and a cheapness and simplicity in the manufacture of the device.
Asimismo, según una posible forma de realización del dispositivo de extracción fetal, el mango está fabricado en un material plástico duro similar. Also, according to a possible embodiment of the fetal extraction device, the handle is made of a similar hard plastic material.
Según una forma de realización preferente del dispositivo de extracción fetal, las palas comprenden bordes romos (bordes redondeados o sin aristas). Esto permite también disminuir el riesgo de lesiones sobre la madre o sobre el feto. According to a preferred embodiment of the fetal extraction device, the paddles comprise blunt edges (rounded edges or without edges). This also reduces the risk of injury to the mother or the fetus.
El dispositivo objeto de la presente invención ofrece la misma o mayor eficacia de extracción que cualquiera de los instrumentos del estado de la técnica (fórceps o vacuum), pero reduciendo las complicaciones y efectos indeseables tanto para la salud de la madre como para la salud del feto. El dispositivo objeto de la presente invención presenta pues una funcionalidad mixta o híbrida, que se caracteriza fundamentalmente por la original toma biparietal y simétrica de la cabeza fetal mediante una combinación de una pinza tipo fórceps (formada por las dos palas del dispositivo de extracción fetal) que en cada cuchara lleva incorporada una cazoleta de vacío para asirse firmemente a los huesos parietales de la cabeza fetal. The device object of the present invention offers the same or greater extraction efficiency than any of the instruments of the state of the art (forceps or vacuum), but reducing complications and undesirable effects both for the health of the mother and for the health of the baby. fetus. The device object of the present invention thus has a mixed or hybrid functionality, which is fundamentally characterized by the original biparietal and symmetric capture of the fetal head by means of a combination of a forceps-type forceps (formed by the two blades of the fetal extraction device). that each spoon has a built-in vacuum bowl to hold firmly to the parietal bones of the fetal head.
De esta forma, el dispositivo de la invención puede actuar como un instrumento tractor y rotador para la extracción de la cabeza fetal cuando se enclava en la pelvis inferior durante el parto natural complicado, por lo que mejora la eficiencia del instrumental obstétrico utilizado hasta ahora. In this way, the device of the invention can act as a tractor and rotator instrument for the extraction of the fetal head when it is embedded in the lower pelvis during complicated natural delivery, thereby improving the efficiency of the obstetric instruments used up to now.
Además, minimiza las complicaciones como los desgarros vaginales y las lesiones fetales como son la marca de las cucharas, los hematomas, cefalohematomas y equimosis, las erosiones, heridas y hundimientos, provocados por la presa de cucharas fenestradas o por el vacío del Vacuum. In addition, it minimizes complications such as vaginal tears and fetal injuries such as spoon marks, bruises, cephalohematomas and ecchymoses, erosions, wounds and subsidence, caused by the prey of fenestrated spoons or by the vacuum of the Vacuum.
La presente invención hace pues referencia a un artilugio novedoso que mejora la eficacia y rapidez de manejo de los instrumentos obstétricos vigentes, evitando las lesiones fetales y maternas potencialmente graves que pueden originarse con instrumentos como fórceps y ventosa obstétrica (Vacuum). Combina las ventajas del fórceps y del Vacuum en un solo artilugio, pero minimizando sus complicaciones y riesgos. The present invention therefore refers to a novel device that improves the efficiency and speed of handling current obstetric instruments, avoiding potentially serious fetal and maternal injuries that can originate with instruments such as forceps and obstetric suction cup (Vacuum). It combines the advantages of the forceps and the Vacuum in a single device, but minimizing its complications and risks.
Este nuevo dispositivo facilita la salida de la cabeza y evita el daño potencial que en cierta medida ocasionan los instrumentos metálicos que hasta ahora se han venido utilizando al efecto. La invención se basa pues en la idea de aportar un instrumento sencillo y atraumático, de aplicación fácil y rápida, para médico, madre y feto. This new device facilitates the removal of the head and avoids the potential damage caused to some extent by the metal instruments that have been used for this purpose until now. The invention is therefore based on the idea of providing a simple and atraumatic instrument, easy and quick to apply, for the doctor, mother and fetus.
Las indicaciones de uso son, facilitar la práctica de la atención obstétrica urgente durante el segundo periodo del parto por riesgo de pérdida del bienestar fetal, o bien, en los expulsivos prolongados debido a distocia mecánica por malposición de la cabeza fetal encajada, bien en la posición transversa baja u occipitosacra, o bien, por agotamiento materno. También está indicado en aquellos casos en los que previamente se ha realizado un pH de cuero cabelludo fetal, en los que la ventosa está contraindicada. The indications for use are to facilitate the practice of urgent obstetric care during the second period of labor due to the risk of loss of fetal well-being, or in prolonged delivery due to mechanical dystocia due to a malposition of the embedded fetal head, either in the low transverse or occipitosacral position, or, due to maternal exhaustion. It is also indicated in those cases in which a fetal scalp pH has previously been performed, in which the suction cup is contraindicated.
El dispositivo de extracción fetal objeto de la presente invención puede incluso tener gran utilidad en facilitar la extracción dificultosa durante la cesárea, en fetos grandes, en cabezas altas no fáciles de extraer, o en situaciones especiales como la conduplicatio corporis del segundo gemelo, con el fin de evitar las incisiones corporales sobre el útero y que condicionan la vida reproductiva futura de las pacientes. The fetal extraction device object of the present invention can even be very useful in facilitating difficult extraction during caesarean section, in large fetuses, in high heads that are not easy to extract, or in special situations such as the conduplicatio corporis of the second twin, with the in order to avoid the corporal incisions on the uterus and that condition the future reproductive life of the patients.
Los beneficios derivados del empleo del dispositivo de extracción fetal objeto de la presente invención son numerosos, se producen menos daños en los tejidos maternos y fetales, las incisiones de cesárea pueden ser más pequeñas y los tiempos de parto y del expulsivo pueden acortarse. Y también por ende puede reducirse las tasas de cesárea. The benefits derived from the use of the fetal extraction device object of the present invention are numerous, there is less damage to the maternal and fetal tissues, the cesarean section incisions can be smaller and the delivery and delivery times can be shortened. And therefore also the rates of caesarean section can be reduced.
Así pues, el dispositivo de extracción fetal objeto de la presente invención combina la filosofía de un fórceps paralelo, si bien de longitud mucho más corta y con dos cucharas cortas y anchas, sólidas sin fenestrar y simétricas. El dispositivo actúa como un instrumento prehensor, tractor y rotador, con sendas ventosas constitudas por las cazoletas de las cucharas. Thus, the fetal extraction device object of the present invention combines the philosophy of a parallel forceps, albeit of much shorter length and with two short and wide spoons, solid without fenestrating and symmetrical. The device acts as a clamping, tractor and rotator instrument, with suction cups made up of the scoops of the scoops.
Las palas se insertan en un mango que sirve como una bomba de aspiración convencional. The paddles are inserted into a handle that serves as a conventional suction pump.
El objetivo que se consigue es una presa de fijación simétrica y no desplazable sobre ambos parietales de la cabeza fetal. Dicho diámetro biparietal, representa la localización ideal donde se debe realizar la presa de la cabeza para no causar lesiones al feto. The objective that is achieved is a symmetrical and non-displaceable fixation dam on both parietals of the fetal head. Said biparietal diameter represents the ideal location where the head should be held in order not to cause injury to the fetus.
En situaciones en que la cabeza fetal se encuentre detenida en la pelvis media o baja, la denominada curvatura pélvica del fórceps clásico ya no es deseable. In situations where the fetal head is stopped in the mid or lower pelvis, the so-called pelvic curvature of classic forceps is no longer desirable.
Por tanto, en el dispositivo de extracción fetal objeto de la presente invención, la curvatura pélvica es preferentemente nula, al ser un instrumento para aplicarlo únicamente en planos bajos o de salida, donde ya no existe dicha curvatura. Así pues, el dispositivo de extracción fetal objeto de la invención presenta múltiples ventajas sobre Fórceps y Vacuum que lo hacen novedoso, único y singular, con características propias. Therefore, in the fetal extraction device object of the present invention, the pelvic curvature is preferably zero, as it is an instrument to be applied only in the low or exit planes, where said curvature no longer exists. Thus, the fetal extraction device object of the invention has multiple advantages over Forceps and Vacuum that make it novel, unique and singular, with its own characteristics.
La original toma Biparietal simétrica proporciona una capacidad de presa ideal, evitando la peligrosa presa parietomalar del fórceps clásico. Esta original toma biparietal se realiza mediante sendas cazoletas de vacío situadas en las cucharas del dispositivo. Al fijar el vacío a la región parietal se evita la fijación del vacío en zonas vulnerables de la cabeza fetal como son suturas y fontanelas, como ocurre con la ventosa clásica. Y se evita también la colocación de la ventosa en el lugar de punción para pH de la calota fetal (contraindicación de la ventosa obstétrica). The original symmetrical Biparietal socket provides an ideal holding capacity, avoiding the dangerous parietomalar hold of the classic forceps. This original biparietal intake is carried out by means of two vacuum cups located in the device's spoons. By fixing the vacuum to the parietal region, fixing the vacuum in vulnerable areas of the fetal head such as sutures and fontanelles, as occurs with the classic suction cup, is avoided. And the placement of the suction cup in the puncture site for pH of the fetal shell is also avoided (contraindication of the obstetric suction cup).
El dispositivo de extracción fetal objeto de la presente invención posee acción prehensora, antideslizante y atraumática. La prehensión de la cabeza es firme y atraumática por la doble ventosa almohadillada en su circunferencia, que impide el deslizamiento de las cucharas y fija las mismas en la región parietal que es la menos vulnerable a las lesiones cefálicas. The fetal extraction device object of the present invention has prehension, non-slip and atraumatic action. The head grip is firm and atraumatic due to the double padded suction cup around its circumference, which prevents the spoons from sliding and fixes them in the parietal region, which is the least vulnerable to head injuries.
El dispositivo de extracción fetal objeto de la presente invención aporta acción tractora firme sin derrapes, proporcionando una fuerza de tracción de 8-12 Kg (ideal) sincrónica con la contracción y el pujo, sin romperse. The fetal extraction device object of the present invention provides firm tractive action without skidding, providing a traction force of 8-12 Kg (ideal) synchronous with contraction and pushing, without breaking.
El dispositivo de extracción fetal objeto de la presente invención permite llevar a cabo una acción rotadora facilitada al traccionar sobre dos puntos de apoyo en ambas cucharas, que marca la gran diferencia con la ventosa obstétrica, que fija sólo en un punto. Al tener una doble fijación simétrica biparietal, permite la rotación y flexión fisiológica de la cabeza fetal, siendo la tracción más potente y efectiva por el doble vacío. The fetal extraction device that is the object of the present invention enables a facilitated rotary action to be carried out by pulling on two support points on both spoons, which makes a great difference with the obstetric suction cup, which fixes only at one point. By having a double symmetric biparietal fixation, it allows the rotation and physiological flexion of the fetal head, being the most powerful and effective traction due to the double vacuum.
Por la flexibilidad lateral de las palas del dispositivo se facilita la extracción fetal de forma normal y fisiológica, sin compresión cefálica. Due to the lateral flexibility of the device's blades, fetal extraction is facilitated in a normal and physiological way, without cephalic compression.
La tracción desde el mango es más cercana al punto más inferior de la cabeza fetal para conseguir descender la cabeza más fisiológicamente mediante los vectores de tracción adecuados. Elimina por tanto vectores fallidos de tracción, que pueden ocurrir con la ventosa clásica, por su tracción en la misma dirección de las palas. El dispositivo de extracción fetal de la invención permite una mejor adaptación a las variadas series de cabezas fetales de distintas dimensiones en toda su superficie, debido a su flexibilidad, a su concavidad interna y a la curvatura cefálica que posee. The traction from the handle is closer to the lowest point of the fetal head to achieve a more physiological descent of the head by means of the appropriate traction vectors. Therefore, it eliminates unsuccessful traction vectors, which can occur with the classic suction cup, due to its traction in the same direction as the blades. The fetal extraction device of the invention allows a better adaptation to the various series of fetal heads of different dimensions over its entire surface, due to its flexibility, its internal concavity and the cephalic curvature it possesses.
El dispositivo tiene poco peso, por lo que la compresión es mucho menor sobre el cráneo del bebé (no deforma la cabeza, sólo mantiene y preserva el moldeamiento fisiológico). Es, por tanto, menos agresivo con el bebé. No comprime el hueso cigomático (no produce las marcas del fórceps). The device has little weight, so the compression is much less on the baby's skull (it does not deform the head, it only maintains and preserves the physiological molding). It is, therefore, less aggressive towards the baby. Does not compress the zygomatic bone (does not produce forceps marks).
El mecanismo de acción del presente dispositivo de extracción fetal es mucho más sencillo que el de los dispositivos del estado de la técnica, por lo que se evitan en gran medida, tanto lesiones maternas como fetales, ya sean laceraciones y desgarros vaginales y cervicales, así como lesiones por deslizamiento de las ramas sobre la cara fetal y aquellas producidas al comprimir y deformar la cabeza con los fórceps. The mechanism of action of the present fetal extraction device is much simpler than that of the devices of the state of the art, so both maternal and fetal injuries are largely avoided, whether they are vaginal and cervical lacerations and tears, as well such as injuries due to slipping of the branches on the fetal face and those produced by compressing and deforming the head with forceps.
El dispositivo de extracción fetal de la invención es de fácil reproductibilidad, con lo que se facilita la enseñanza y el aprendizaje. The fetal extraction device of the invention is easily reproducible, thus facilitating teaching and learning.
El dispositivo de extracción fetal de la invención puede ser accionado y aplicado rápidamente. Se puede manejar con una sola mano desde el mango. Al ser un instrumento mucho más corto que las espátulas de Thierry, permite la tracción directa desde el mango con una sola mano, manejando mejor y más cercana a su eje, la rotación interna de la cabeza, cuando sea necesaria o permitiendo su rotación fisiológica. The fetal retrieval device of the invention can be actuated and applied rapidly. It can be operated with one hand from the handle. Being a much shorter instrument than Thierry spatulas, it allows direct traction from the handle with one hand, handling the internal rotation of the head better and closer to its axis, when necessary or allowing its physiological rotation.
El dispositivo de extracción fetal objeto de la presente invención colabora en reducir el número de cesáreas al ayudar al parto vaginal. Previene las lesiones del suelo pélvico por realizar una presa más baja y debido a la curvatura perineal que poseen las cucharas. El parto con fórceps se asocia con un mayor riesgo de prolapso de órganos pélvicos y trauma muscular, debido a que su longitud y el ángulo de la elipse (curvatura cefálica) es mayor. The fetal extraction device object of the present invention collaborates in reducing the number of caesarean sections by assisting vaginal delivery. Prevents injuries to the pelvic floor by making a lower prey and due to the perineal curvature of the spoons. Forceps delivery is associated with an increased risk of pelvic organ prolapse and muscle trauma, due to its greater length and ellipse angle (cephalic curvature).
Además, las palas tienen bordes romos, redondeados y no cortantes. De esta forma los desgarros del perineo son menos temibles que con el fórceps o las espátulas. In addition, the blades have blunt, rounded and non-sharp edges. In this way, tears in the perineum are less fearsome than with forceps or spatulas.
Breve descripción de las figuras Como parte de la explicación de al menos una forma de realización de la invención se han incluido las siguientes figuras. Brief description of the figures As part of the explanation of at least one embodiment of the invention, the following figures have been included.
Figura 1a: Muestra una vista lateral esquemática de una posible forma de realización del dispositivo de extracción fetal. Figura 1b: Muestra una vista frontal esquemática del dispositivo de extracción fetal de la Figura 1a. Figure 1a: Shows a schematic side view of a possible embodiment of the fetal extraction device. Figure 1b: Shows a schematic front view of the fetal extraction device of Figure 1a.
Figura 2a: Muestra una vista esquemática de perfil seccionada (según la sección AA de la Figura 2b) de la cuchara de una de las palas, según una posible forma de realización del dispositivo de extracción fetal. Figura 2b: Muestra una vista esquemática de la cuchara de una de las palas de la Figura 2a. Figure 2a: Shows a schematic sectional profile view (according to section AA of Figure 2b) of the spoon of one of the blades, according to a possible embodiment of the fetal extraction device. Figure 2b: Shows a schematic view of the spoon of one of the blades of Figure 2a.
Figura 3a: Muestra una vista esquemática de una forma de realización del dispositivo de extracción fetal, en donde las dos palas del dispositivo están en posición abierta o separada entre sí. Figura 3b: Muestra una vista esquemática del dispositivo de extracción fetal de la Figura 3a, en donde las dos palas son aproximadas entre sí por medio de un usuario con su mano. Figure 3a: Shows a schematic view of an embodiment of the fetal extraction device, where the two blades of the device are in an open position or separated from each other. Figure 3b: Shows a schematic view of the fetal extraction device of Figure 3a, where the two paddles are brought closer to each other by means of a user with his hand.
Figura 3c: Muestra una vista esquemática del dispositivo de extracción fetal de la Figura 3b, en donde las dos palas se encuentran pegadas la una a la otra por medio de la acción ejercida por un usuario con su mano. Figura 4a: Muestra una vista esquemática de una forma de realización del dispositivo de extracción fetal aproximándose a la cabeza de un feto. Figure 3c: Shows a schematic view of the fetal extraction device of Figure 3b, where the two paddles are glued to each other by means of the action exerted by a user with his hand. Figure 4a: Shows a schematic view of an embodiment of the fetal extraction device approaching the head of a fetus.
Figura 4b: Muestra una vista esquemática del dispositivo de extracción fetal de la Figura 4a, en donde las palas contactan con la cabeza del feto y comienzan a abrirse deslizándose en torno a los huesos parietales de la cabeza del feto. Figura 4c: Muestra una vista esquemática del dispositivo de extracción fetal de la Figura 4b, en donde las cucharas de las dos palas se encuentran posicionadas sobre los huesos parietales de la cabeza del feto, en posición óptima para comenzar la maniobra de extracción del feto. Figure 4b: Shows a schematic view of the fetal extraction device of Figure 4a, where the paddles contact the fetus head and begin to slide open around the parietal bones of the fetus head. Figure 4c: Shows a schematic view of the fetal extraction device of Figure 4b, where the spoons of the two blades are positioned on the parietal bones of the fetal head, in an optimal position to begin the fetus extraction maneuver.
Descripción detallada Detailed description
La presente invención se refiere, tal y como se ha mencionado anteriormente, a un dispositivo de extracción fetal. The present invention relates, as mentioned above, to a fetal extraction device.
El dispositivo de extracción fetal comprende tal y como se aprecia en la Figura 1 a y en la Figura 1 b, un mango (1 ) y unas palas (2). A su vez, cada una de las palas (2) comprende un cuerpo (4) y una cuchara (3). Tal y como se aprecia en la vista lateral de la Figura 1a, el mango (1 ) y las palas (2) tienen un perfil lateral mayormente recto, sin curvatura pélvica. Únicamente se aprecia la curvatura perineal en las cucharas (3). The fetal extraction device comprises, as seen in Figure 1 a and Figure 1 b, a handle (1) and paddles (2). In turn, each of the blades (2) comprises a body (4) and a spoon (3). As can be seen in the side view of Figure 1a, the handle (1) and the blades (2) have a mostly straight lateral profile, without pelvic curvature. The perineal curvature is only seen in the spoons (3).
El extremo proximal del cuerpo (4) de las palas (2) está incrustado en el mango (1), en tanto que la cuchara (3) se sitúa en correspondencia con el extremo distal del cuerpo (2) de las palas (2). The proximal end of the body (4) of the blades (2) is embedded in the handle (1), while the spoon (3) is located in correspondence with the distal end of the body (2) of the blades (2) .
El cuerpo (4) de las palas (2) está hecho de material flexible (preferentemente plástico duro) ondulado en su interior para aumentar la resistencia a la rotura, que permite flexionar las palas (2) abriéndolas o cerrándolas, en función de las necesidades específicas. The body (4) of the blades (2) is made of flexible material (preferably hard plastic) corrugated inside to increase the resistance to breakage, which allows the blades (2) to be flexed by opening or closing them, depending on the needs specific.
El cuerpo (2) de las palas es flexible y alargado. Según una posible forma de realización, el cuerpo (4) de cada pala (2) tiene una longitud de 18-20 cm y 20 mm de anchura (para facilitar que no exista flexibilidad en ese eje longitudinal) y un grosor variable desde 3-5 mm en la zona distal y más alejada del mango (1 ) para que sí se permita flexibilidad a la hora de abrir y cerrar las palas (2), hasta 5-10 mm en la zona proximal más cercana al mango (1) para dar robustez al dispositivo en esa zona, dependiendo del material. The body (2) of the blades is flexible and elongated. According to a possible embodiment, the body (4) of each blade (2) has a length of 18-20 cm and a width of 20 mm (to facilitate that there is no flexibility in that longitudinal axis) and a thickness that varies from 3- 5 mm in the distal area and furthest from the handle (1) so that flexibility is allowed when opening and closing the blades (2), up to 5-10 mm in the proximal area closest to the handle (1) to give robustness to the device in that area, depending on the material.
Las cucharas (3) de las palas (2) están configuradas para disponerse en correspondencia con los huesos parietales de la cabeza del feto, abrazando así a la cabeza del feto. Para realizar esta maniobra, partiendo del dispositivo con sus dos palas (2) abiertas o separadas (ver Figura 3a) el usuario del dispositivo (el médico o asistente al parto) presiona las dos palas (2), la una contra la otra, para juntarlas (tal y como se muestra en la Figura 3b y en la Figura 3c), lo cual permite su introducción en la vulva o vagina de la madre. The spoons (3) of the blades (2) are configured to be arranged in correspondence with the parietal bones of the fetal head, thus embracing the fetal head. To perform this maneuver, starting from the device with its two blades (2) open or separated (see Figure 3a) the user of the device (the doctor or birth attendant) presses the two paddles (2), one against the other, to bring them together (as shown in Figure 3b and Figure 3c), which allows its introduction into the mother's vulva or vagina.
Posteriormente, el usuario deja de presionar las dos palas (2), por lo que éstas se ven libres para separarse entre sí todo lo que se lo permita la cavidad vaginal de la madre en donde se encuentra la cabeza del feto. Subsequently, the user stops pressing the two paddles (2), so that they are free to separate from each other as much as the mother's vaginal cavity where the fetus's head is allowed to do so.
Las cucharas (3) de las palas (2) se aproximan a la cabeza del feto (Figura 4a). Al contactar las cucharas (3) de las palas (2) con la cabeza del feto y al presionar con el dispositivo hacia el interior de la cavidad vaginal, las palas (2) van abriéndose en torno a la cabeza del feto (Figura 4b) deslizándose por su superficie, y las cucharas (3) de las palas (2) van recorriendo la cabeza del feto (a modo de masajeador) hasta posicionarse en correspondencia con los huesos parietales de la cabeza del feto (Figura 4c). The scoops (3) of the paddles (2) approach the head of the fetus (Figure 4a). By contacting the spoons (3) of the paddles (2) with the head of the fetus and pressing the device into the vaginal cavity, the paddles (2) open around the head of the fetus (Figure 4b) sliding along its surface, and the spoons (3) of the paddles (2) go through the head of the fetus (as a massager) until they are positioned in correspondence with the parietal bones of the fetal head (Figure 4c).
Cada una de las cucharas (3) de las palas (2) comprende una cazoleta (5) o cámara de vacío (ver Figura 2a y Figura 2b). Each of the scoops (3) of the blades (2) comprises a bowl (5) or vacuum chamber (see Figure 2a and Figure 2b).
Cada cazoleta (5) o cámara de vacío está en conexión fluida, por medio de un conducto (6) de vacío, con una bomba de vacío (no representada) situada en el interior del mangoEach cup (5) or vacuum chamber is in fluid connection, by means of a vacuum conduit (6), with a vacuum pump (not shown) located inside the handle.
O Í- I HEARD-
Cada uno de los dos conductos (6) de vacío recorre el interior de la pala (2) correspondiente, desde la cazoleta (5) hasta introducirse en el mango (1) y conectar con la bomba de vacío. Según una posible forma de realización, cada conducto (6) de succión o de vacío tiene una sección de 2-3 mm2. Each of the two vacuum conduits (6) runs through the interior of the corresponding blade (2), from the bowl (5) until it enters the handle (1) and connects with the vacuum pump. According to a possible embodiment, each suction or vacuum duct (6) has a section of 2-3 mm 2 .
De manera preferente, el mango (1) dispone de un accionador (7) manual de la bomba de vacío. El accionador (7) puede ser de tipo émbolo o pistón. Preferably, the handle (1) has a manual actuator (7) of the vacuum pump. The actuator (7) can be of the plunger or piston type.
Según una posible forma de realización, la bomba de vacío alberga una doble válvula de entrada y salida de aire. Al presionar manualmente el accionador (7), la bomba de vacío crea una aspiración entre la cuchara (3) de cada pala (2) y el correspondiente lóbulo parietal de la cabeza del feto. According to a possible embodiment, the vacuum pump houses a double air inlet and outlet valve. By manually pressing the actuator (7), the vacuum pump creates a suction between the spoon (3) of each paddle (2) and the corresponding parietal lobe of the fetal head.
Este vacío creado permite la adherencia firme de cada una de las dos cucharas (3) de las palas (2) a la cabeza del feto, sin necesidad de ejercer presión alguna de las palas (2) contra la cabeza del feto, evitándose así los riesgos asociados a hematomas, cefalohematomas y hundimientos sobre el cráneo del feto. This created vacuum allows the firm adherence of each of the two spoons (3) of the paddles (2) to the head of the fetus, without the need to exert any pressure of the paddles (2) against the head of the fetus, thus avoiding the risks associated with hematomas, cephalohematomas and subsidence on the fetal skull.
Cada una de las cazoletas (5) comprende una almohadilla (8) de plástico blando (por ejemplo, esponja o tipo goma EVA) que proporciona un contacto acolchado entre la cuchara (3) de cada pala (2) y la cabeza del feto. Asimismo, estas dos almohadillas (8) permiten que, al contactar las palas (2) con la cabeza del feto durante la introducción del dispositivo en la cavidad vaginal, las cucharas (3) puedan deslizar suavemente sobre la cabeza del feto sin provocar ningún tipo de heridas. Each of the cups (5) comprises a soft plastic pad (8) (for example, sponge or EVA rubber type) that provides a padded contact between the spoon (3) of each paddle (2) and the head of the fetus. Likewise, these two pads (8) allow that, by contacting the paddles (2) with the head of the fetus during the introduction of the device into the vaginal cavity, the spoons (3) can slide smoothly over the head of the fetus without causing any kind of of wounds.
Según una posible forma de realización, las cucharas (3) de las palas (2) presentan una superficie de succión de 14 cm2, y cada cazoleta (5) presenta un volumen de 5 cm3. According to a possible embodiment, the scoops (3) of the blades (2) have a suction surface of 14 cm 2 , and each bowl (5) has a volume of 5 cm 3 .
Según una posible forma de realización, las cucharas (3) tienen entre sí una separación estándar, en las puntas de 5 mm en reposo que puede llegar hasta 10-11 mm según van abarcando la cabeza fetal. Esta distancia se ajusta manualmente presionando suavemente el centro de las palas (2), ya que son flexibles. According to a possible embodiment, the spoons (3) have a standard separation between them, at the tips of 5 mm at rest, which can reach up to 10-11 mm as they cover the fetal head. This distance is adjusted manually by gently pressing the center of the blades (2), as they are flexible.
El dispositivo de extracción fetal objeto de la presente invención se ha confeccionado con una curvatura perineal inferior a nivel de la unión de cada cuchara (3) con el cuerpo (4) de la pala (2)). The fetal extraction device object of the present invention has been made with a lower perineal curvature at the level of the junction of each spoon (3) with the body (4) of the blade (2)).
Las dos palas (2) se anclan en el mango (1 ) (en el que se sitúa la bomba de vacío manual), consiguiéndose así un instrumento de una sola pieza, para poder traccionar lo más cerca del punto más bajo de la cabeza. The two blades (2) are anchored in the handle (1) (in which the manual vacuum pump is located), thus achieving a one-piece instrument, to be able to pull as close to the lowest point of the head.
El vacío de las cazoletas (5) se genera mediante una bomba de presión manual negativa, de 200-800 mbar. situada en el mango (1), para permitir que el médico traccione suavemente de la cabeza fetal y ayude sincrónicamente con los esfuerzos de la madre durante los partos quirúrgicos vaginales. The vacuum of the cups (5) is generated by a negative manual pressure pump, 200-800 mbar. located on the handle (1), to allow the doctor to pull gently from the fetal head and assist synchronously with the mother's efforts during vaginal surgical deliveries.
La introducción de las palas (2) del dispositivo a través de la vulva se realiza en un solo movimiento sin desarticular las palas (2), de forma muy sencilla y de fácil aprendizaje. Es necesario conocer previamente, como en el resto del instrumental obstétrico, la posición de la cabeza, el grado de encajamiento y de flexión. The insertion of the blades (2) of the device through the vulva is carried out in a single movement without dismantling the blades (2), in a very simple and easy-to-learn way. It is necessary to know in advance, as in the rest of the obstetric instruments, the position of the head, the degree of fit and flexion.
Las palas (2), de bordes redondeados, al ser flexibles se abren fácil y simétricamente al chocar con el polo cefálico fetal resbalando en paralelo y lateralmente a modo de los masajeadores craneales, por la propia flexibilidad del material plástico, para permitir su introducción. The blades (2), with rounded edges, being flexible, open easily and symmetrically when they collide with the fetal cephalic pole, sliding parallel and laterally like cranial massagers, due to the flexibility of the plastic material, to allow its introduction.
Según una posible forma de realización, la dirección de introducción de las palas (2) la marca una flecha marcada en el mango (1), apuntando como una mirilla hacia la sutura sagital interparietal, y adoptando por tanto las cucharas (3) una situación correcta, simétrica, abarcando y adaptándose a ambos parietales (meridiano biparietal lateral). Una vez fijado el dispositivo en la posición correcta biparietal se procede a realizar el vacío mediante la bomba de vacío. El proceso puede llevar un tiempo aproximado de unos 30 segundos como máximo. According to a possible embodiment, the direction of insertion of the blades (2) is marked by an arrow marked on the handle (1), pointing like a peephole towards the interparietal sagittal suture, and therefore adopting the spoons (3) a situation correct, symmetrical, covering and adapting to both parietals (lateral biparietal meridian). Once the device is fixed in the correct biparietal position, the vacuum is carried out using the vacuum pump. The process can take approximately 30 seconds maximum.
El ángulo inicial para la tracción depende del plano en que se encuentre la cabeza fetal dentro de la pelvis, pero generalmente es hacia abajo, luego se extiende progresivamente hacia arriba a medida que emerge la cabeza por el introito. Una vez extraída la cabeza, se libera la presión de vacío, se retira el dispositivo y se siguen las técnicas habituales para completar el parto vaginal. The initial angle for traction depends on the plane of the fetal head within the pelvis, but is generally downward, then progressively extends upward as the head emerges through the introitus. After the head is removed, the vacuum pressure is released, the device is removed, and standard techniques are followed to complete the vaginal delivery.

Claims

REIVINDICACIONES
1. Dispositivo de extracción fetal que comprende un mango (1 ) y dos palas (2), donde cada una de las palas (2) comprende un cuerpo (4) flexible unido al mango (1) en correspondencia con un extremo proximal de la pala (2) y donde cada una de las palas (2) comprende una cuchara (3) en correspondencia con un extremo distal de la pala (2), caracterizado por que: 1. Fetal extraction device comprising a handle (1) and two paddles (2), where each of the paddles (2) comprises a flexible body (4) attached to the handle (1) in correspondence with a proximal end of the blade (2) and where each of the blades (2) comprises a spoon (3) in correspondence with a distal end of the blade (2), characterized in that:
- el mango (1) comprende una bomba de vacío y un accionador (7) de la bomba de vacío; - the handle (1) comprises a vacuum pump and a vacuum pump actuator (7);
- cada cuchara (3) comprende una superficie cóncava que forma una cazoleta (5) hueca abierta únicamente en dirección hacia la cuchara (3) de la otra pala (2) del dispositivo, donde la cazoleta (5) está en conexión fluida con la bomba de vacío por medio de un conducto (6) que recorre el interior de cada una de las palas (2); de manera que, cuando las dos cucharas (3) se sitúan respectivamente en correspondencia con los huesos parietales de la cabeza del feto, el accionamiento del accionador (7) produce un vacío aspirativo en el interior de cada cazoleta (5), entre la cuchara (3) correspondiente y la cabeza del feto. - Each spoon (3) comprises a concave surface that forms a hollow bowl (5) open only towards the spoon (3) of the other blade (2) of the device, where the bowl (5) is in fluid connection with the vacuum pump by means of a conduit (6) that runs inside each of the blades (2); so that, when the two spoons (3) are respectively placed in correspondence with the parietal bones of the fetal head, the actuation of the actuator (7) produces a suction vacuum inside each bowl (5), between the spoon (3) corresponding and the head of the fetus.
2. Dispositivo de extracción fetal según la reivindicación 1 , caracterizado por que los cuerpos (4) de cada pala (2) tienen una geometría elíptica, con un primer tramo convexo divergente entre las dos palas (2) en correspondencia con los extremos proximales de las palas (2) y un segundo tramo cóncavo convergente entre las dos palas (2) en correspondencia con los extremos distales de las palas (2). Fetal extraction device according to claim 1, characterized in that the bodies (4) of each blade (2) have an elliptical geometry, with a first divergent convex section between the two blades (2) in correspondence with the proximal ends of the blades (2) and a second convergent concave section between the two blades (2) in correspondence with the distal ends of the blades (2).
3. Dispositivo de extracción fetal según cualquiera de las reivindicaciones anteriores, caracterizado por que cada cuchara (3) comprende una almohadilla (8) en la cazoleta (5). Fetal extraction device according to any of the preceding claims, characterized in that each spoon (3) comprises a pad (8) in the bowl (5).
4. Dispositivo de extracción fetal según la reivindicación 3, caracterizado por que cada almohadilla (8) está hecha de un material plástico blando. Fetal extraction device according to claim 3, characterized in that each pad (8) is made of a soft plastic material.
5. Dispositivo de extracción fetal según cualquiera de las reivindicaciones anteriores, caracterizado por que los cuerpos (4) de las palas (2) están fabricados en material plástico duro. 5. Fetal extraction device according to any of the preceding claims, characterized in that the bodies (4) of the paddles (2) are made of hard plastic material.
6. Dispositivo de extracción fetal según cualquiera de las reivindicaciones anteriores, caracterizado por que el mango (1) está fabricado en material plástico duro. 6. Fetal extraction device according to any of the preceding claims, characterized in that the handle (1) is made of hard plastic material.
7. Dispositivo de extracción fetal según cualquiera de las reivindicaciones anteriores, caracterizado por que las palas (2) comprenden bordes romos y redondeados. 7. Fetal extraction device according to any of the preceding claims, characterized in that the paddles (2) comprise blunt and rounded edges.
PCT/ES2021/070176 2020-04-20 2021-03-11 Foetal extraction device WO2021214352A1 (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103845103A (en) * 2012-12-03 2014-06-11 张光慧 Multifunctional obstetric forceps for gynaecological and obstetric department
CN106798589A (en) * 2017-03-22 2017-06-06 王桂香 A kind of urgent midwifery device of obstetrics and gynecology department
CN108464856A (en) * 2018-05-31 2018-08-31 陈志龙 A kind of gynemetrics's Obstetric forceps

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103845103A (en) * 2012-12-03 2014-06-11 张光慧 Multifunctional obstetric forceps for gynaecological and obstetric department
CN106798589A (en) * 2017-03-22 2017-06-06 王桂香 A kind of urgent midwifery device of obstetrics and gynecology department
CN108464856A (en) * 2018-05-31 2018-08-31 陈志龙 A kind of gynemetrics's Obstetric forceps

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