Fetal retrieval device (Machine-translation by Google Translate, not legally binding)

专利摘要:
Fetal extraction device comprising a handle (1) and two blades (2), where each of the blades (2) comprises a flexible body (4) and a spoon (3) in correspondence with a distal end of the blade (2). The handle (1) comprises a vacuum pump and a vacuum pump actuator (7). Each spoon (3) comprises a smooth concave surface that forms a bowl (5). 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). When the two spoons (3) are respectively positioned in correspondence with the parietal bones of the fetal head, the actuation of the actuator (7) produces a vacuum inside each bowl (5), between the corresponding spoon (3) and the head of the fetus. (Machine-translation by Google Translate, not legally binding)
公开号:ES2868426A1
申请号:ES202030322
申请日:2020-04-20
公开日:2021-10-21
发明作者:Martin Germán Merino；Kosina Victor Merino
申请人:Merino Martin German；Kosina Victor Merino；
IPC主号:

专利说明:

[0002] Fetal retrieval device
[0004] Object of the invention
[0006] 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.
[0008] The device allows the fetal head to be grasped, by means of vacuum cups with which it is fixed to the parietal bones.
[0010] 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.
[0012] Background of the invention and technical problem to be solved
[0014] 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.
[0016] 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.
[0018] The two obstetric instruments that have been used for centuries around the world for surgical vaginal delivery are: forceps with their various modalities and the disposable manual or metallic obstetric suction cup.
[0019] 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 it descends and does not rotate properly in the birth canal, which many times requires 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.
[0021] 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.
[0023] 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.
[0025] 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.
[0027] 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.
[0028] Description of the invention
[0029] In order to solve the aforementioned drawbacks, the present invention refers to an original fetal extraction device.
[0031] 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.
[0033] In a novel way, in the fetal extraction device object of the present invention:
[0035] - the handle comprises a vacuum pump, as well as a vacuum pump actuator, and;
[0037] - 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). .
[0039] 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 the corresponding spoon and the parietal bones of the fetal head to be fixed by suction, in order to rotate and pull on it, for fetal extraction.
[0041] Each conduit that connects each cup with the vacuum pump can be made by means of a plastic tube.
[0042] 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.
[0044] 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.
[0046] While the bowl has a concave inner surface, the outer surface of the spoon is flat.
[0048] 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.
[0050] 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.
[0052] 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 spacing 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.
[0054] 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.
[0055] 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.
[0057] 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.
[0059] Also, according to a possible embodiment of the fetal extraction device, the handle is made of a similar hard plastic material.
[0061] 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.
[0063] 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.
[0065] The device object of the present invention thus has a mixed or hybrid functionality, which is fundamentally characterized by the original biparietal and symmetrical 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.
[0066] 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.
[0068] 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.
[0070] 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.
[0072] 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.
[0074] 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.
[0076] It is also indicated in those cases in which a fetal scalp pH has previously been performed, in which the suction cup is contraindicated.
[0078] The fetal extraction device object of the present invention can even be very useful in facilitating difficult extraction during cesarean section, in large fetuses, in high heads that are not easy to extract, or in special situations such as conduplication. corporis of the second twin, in order to avoid the corporal incisions on the uterus and that condition the future reproductive life of the patients.
[0080] 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.
[0082] 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.
[0084] The paddles are inserted into a handle that serves as a conventional suction pump.
[0086] 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.
[0088] 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.
[0090] 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.
[0092] 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.
[0094] 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 void to the parietal region avoids the fixation of the void in vulnerable areas of the head fetal such as sutures and fontanelles, as occurs with the classic suction cup. 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).
[0096] 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.
[0098] 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.
[0100] 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.
[0102] Due to the lateral flexibility of the device's blades, fetal extraction is facilitated in a normal and physiological way, without cephalic compression.
[0104] 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.
[0106] 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.
[0108] 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).
[0109] 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.
[0111] The fetal extraction device of the invention is easily reproducible, thus facilitating teaching and learning.
[0113] 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's spatulas, it allows direct traction from the handle with one hand, handling better and closer to its axis, the internal rotation of the head, when necessary or allowing its physiological rotation.
[0115] The fetal extraction device object of the present invention collaborates in reducing the number of caesarean sections by assisting vaginal delivery. It prevents injuries to the pelvic floor by making a lower prey and due to the perineal curvature that the spoons have. Forceps delivery is associated with an increased risk of pelvic organ prolapse and muscle trauma, due to the greater length and angle of the ellipse (cephalic curvature).
[0117] 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.
[0119] Brief description of the figures
[0121] As part of the explanation of at least one embodiment of the invention, the following figures have been included.
[0123] Figure 1a: Shows a schematic side view of a possible embodiment of the fetal extraction device.
[0125] Figure 1b: Shows a schematic front view of the fetal extraction device of Figure 1a.
[0126] 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.
[0128] Figure 2b: Shows a schematic view of the spoon of one of the blades of Figure 2a.
[0130] 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.
[0132] 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.
[0134] 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.
[0136] Figure 4a: Shows a schematic view of an embodiment of the fetal extraction device approaching the head of a fetus.
[0138] 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.
[0140] 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.
[0142] Detailed description
[0144] The present invention relates, as mentioned above, to a fetal extraction device.
[0145] The fetal extraction device comprises, as seen in Figure 1a and Figure 1b, 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).
[0147] 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) .
[0149] 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.
[0151] 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.
[0153] The scoops (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 paddles (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 put them together (as shown in Figure 3b and Figure 3c), which allows their introduction into the mother's vulva or vagina.
[0155] 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.
[0157] The scoops (3) of the paddles (2) approach the head of the fetus (Figure 4a). When the spoons (3) of the paddles (2) come into contact with the head of the fetus and when the device is pressed into the vaginal cavity, the paddles (2) open around the head of the fetus. 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 ).
[0159] Each of the scoops (3) of the blades (2) comprises a bowl (5) or vacuum chamber (see Figure 2a and Figure 2b).
[0161] 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 (1).
[0163] 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 conduit (6) has a section of 2-3 mm2.
[0165] Preferably, the handle (1) has a manual actuator (7) of the vacuum pump. The actuator (7) can be of the plunger or piston type.
[0167] According to a possible embodiment, the vacuum pump houses a double air inlet and outlet valve.
[0169] 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.
[0171] 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.
[0173] 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 in the vaginal cavity, the spoons (3) can slide gently on the head of the fetus without causing any type of injury.
[0175] According to a possible embodiment, the scoops (3) of the blades (2) have a suction surface of 14 cm2, and each bowl (5) has a volume of 5 cm3.
[0177] 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.
[0179] 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)).
[0181] 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.
[0183] 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 gently pull on the fetal head and help synchronously with the mother's efforts during vaginal deliveries.
[0185] 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.
[0187] 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.
[0188] 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).
[0190] 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.
[0192] 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.

权利要求:
Claims (7)
[1]
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:
- the handle (1) comprises a vacuum pump and a vacuum pump actuator (7);
- 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]
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]
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]
Fetal extraction device according to claim 3, characterized in that each pad (8) is made of a soft plastic material.
[5]
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]
6. Fetal extraction device according to any of the preceding claims, characterized in that the handle (1) is made of hard plastic material.
[7]
7. Fetal extraction device according to any of the preceding claims, characterized in that the paddles (2) comprise blunt and rounded edges.

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同族专利:

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公开号 | 公开日

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ES2868426B2|2022-02-25|

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WO2021214352A1|2021-10-28|

引用文献:

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公开号 | 申请日 | 公开日 | 申请人 | 专利标题

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CN103845103A|2012-12-03|2014-06-11|张光慧|Multifunctional obstetric forceps for gynaecological and obstetric department|

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CN106798589A|2017-03-22|2017-06-06|王桂香|A kind of urgent midwifery device of obstetrics and gynecology department|

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CN108464856A|2018-05-31|2018-08-31|陈志龙|A kind of gynemetrics's Obstetric forceps|

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法律状态:
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优先权:

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申请号 | 申请日 | 专利标题

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ES202030322A|ES2868426B2|2020-04-20|2020-04-20|Fetal extraction device|ES202030322A| ES2868426B2|2020-04-20|2020-04-20|Fetal extraction device|

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PCT/ES2021/070176| WO2021214352A1|2020-04-20|2021-03-11|Foetal extraction device|