ES2810949B2 - OBSTETRIC DEVICE AND PROCEDURE FOR THE MANUFACTURE OF SAID OBSTETRIC DEVICE - Google Patents

Description

DESCRIPTION

OBSTETRIC DEVICE AND PROCEDURE FOR MANUFACTURING SAID

OBSTETRIC DEVICE

OBJECT OF THE INVENTION

The object of the present invention is framed in the field of medical devices. An obstetric forceps is described that facilitates delivery during the second stage and minimizes the risks inherent to the procedure for the mother and the baby, while presenting a pleasant aesthetic appearance to achieve the psychological acceptance of the mother for the use of the device. during the delivery.

TECHNICAL PROBLEM TO BE SOLVED AND BACKGROUND OF THE INVENTION

At present, numerous types of obstetric forceps dated between 1600 and 1925 are known and used. Although there are differences between them, they are all designed following the same pattern, with very similar measurements and made of stainless steel.

The problem with these designs is that, although the forceps technique has not changed over the years, the restrictions and conditions for its use have. Recent studies on the consequences of the use of forceps on the woman's pelvic floor advise against using it with the presentation (fetal head) in plane III (median plane), reserving its use for the low and exit planes. This makes the existence of traditional forceps unnecessary, which would be reserved for exceptional situations.

Likewise, on an emotional level, the use of forceps has generated in recent years a general rejection by many pregnant women and the general population. Although this rejection is often supported by the injuries that the forceps can generate, the data and analysis show that despite the risk of injury exists (as in any surgical procedure), the rejection is derived from the little aesthetic attraction that they provoke the designs that are available so far.

Therefore, an obstetric device is necessary to ensure the delivery of the baby when a forceps has to be used during the delivery procedure, which complies with the measures and indications currently allowed in instrumental deliveries. and whose external appearance does not generate rejection. This device should minimize the possibility of injury during childbirth.

DESCRIPTION OF THE INVENTION

The invention refers to an obstetric device that facilitates the expulsive period in instrumental deliveries and guarantees maximum safety for the mother and the baby. This device is smaller than the forceps of the state of the art. This reduction in size is one of the key aspects of the proposed device. Currently, to be able to perform an extraction with a forceps, a series of requirements must be met. Among others, only third and fourth plane forceps are allowed, that is, when the baby is already descending and practically leaving the interior of the mother. Due to this placement, the forceps should not be inserted slightly inside (previously they were inserted to the bottom) so that the length currently required is much less than that existing in current forceps. Broadly speaking, the length of this device has been reduced by 25% compared to traditional forceps.

It is also not metallic and can be manufactured in different colors. These characteristics help to improve the mother's psychological acceptance of the use of the obstetric device during childbirth, that is, the device is more pleasant for mothers, helping to eliminate the stigma and fear that has been generated in society regarding the use of obstetric forceps.

The proposed device is an obstetric forceps comprising two branches, a right branch and a left branch, which are introduced independently into the birth canal of the mother and which are subsequently articulated with each other by means of a connecting element that links both branches. . The branches comprise spoons, preferably fenestrated, through which the fetus's head is taken, that is, the spoons have a configuration that allows the fetus's head to be housed between them when they face each other. At the opposite end of each branch there are handles that make it easier for the obstetrician to individually place each branch partially inside the mother (the spoon is inserted into the birth canal).

When the obstetrician has introduced the spoons of the branches into the mother's birth canal and has placed them in the correct position, around the head of the fetus, the the linking of the branches to each other by means of the joining element. This connecting element allows a slight rotational movement of the branches about their longitudinal axes, which is limited by the position of the fetal head between the spoons. The fact of being able to introduce the branches independently in the birth canal provides, compared to the forceps of the state of the art, greater comfort for the obstetrician. It also gives you the possibility of placing each of the spoons in the ideal position that best suits the morphology of the fetal head.

Likewise, on each branch there are projections that allow the obstetrician to exert traction once the two branches have been joined together by means of the joining element (preferably joining pieces arranged each on a branch and which are joined together). The traction exerted by the obstetrician is the traction necessary to favor the extraction of the fetus (that is, the second stage of labor). Preferably said projections are arranged between the spoons and the connecting element.

Today's forceps are made of stainless steel. The proposed obstetric device is made of polymeric resin. This change of material allows not only a more economical, simple and sustainable manufacturing process, since it will be manufactured using 3D printing, but also to obtain a lighter and more flexible product. The use of polymeric resin reduces the pressure exerted on the baby's head, thus reducing the possibility of maternal and fetal injuries. Thus, the method of manufacturing said obstetric device by means of 3D printing is also an object of the invention. More specifically, each of the elements of the device is printed in 3D, preferably in photopolymerizable resin, and subsequently the elements of each of the branches are assembled to form said branches. The connecting element is also added during the manufacturing process, in one or both branches depending on the type of connecting element used.

BRIEF DESCRIPTION OF THE FIGURES

To complete the description and in order to help a better understanding of the characteristics of the invention, this specification is accompanied, as an integral part thereof, by a set of drawings where, with an illustrative and non-limiting nature, it has been represented the next:

A general perspective view of the obstetric device is shown in figure 1.

A side view of the obstetric device is shown in Figure 2.

Figure 3 shows a top view of the obstetric device.

Figure 4 shows a perspective view of the right side of the obstetric device before assembly.

Figure 5 shows a perspective view of the left side of the obstetric device before assembly.

In Figures 6A-B the connecting pieces are shown in a position in which they are separated and in a position in which they are engaged.

Figure 7 shows an exploded view of the obstetric device.

Below is a list of the different elements represented in the figures that make up the invention:

1. Right branch

2. Left branch

3. Spoon

4. Connecting element

5. Right connecting piece

6. Left connecting piece

7. Handle

8. Outgoing

DETAILED DESCRIPTION

The present invention should not be limited to the embodiment described herein. Other configurations can be made by those skilled in the art in light of the present description. Accordingly, the scope of the invention is defined by the following claims.

Figure 1 shows the obstetric device with fixation in a perspective view. The device is made of photopolymerizable resin and comprises a right branch (1) and a left branch (2) each of which has a main body with a spoon-shaped end (3) with pelvic curvatures. and cephalic necessary so that they can be inserted comfortably into the birth canal and can engage the head of the fetus between them. Throughout the specification, the reference spoon (3) is used to refer to the end of the main body of the spoon-shaped branches (1, 2). Preferably said spoons (3) are fenestrated spoons (3).

The branches (1, 2) also comprise, each one, a handle (7) which is an element that the healthcare professional manipulates in order to be able to place the spoons (3) in the appropriate position in the birth canal, around the head of the fetus. . In an embodiment, said handle (7) is arranged around the end of the main body, opposite the spoons (3).

The device also comprises a connecting element (4) configured to join both branches (1, 2) to be able to perform traction during the second stage of labor. It is preferably a mechanical connection. This connecting element (4) can have different configurations. In an exemplary embodiment, it could be an element irremovably linked to one of the branches (1, 2) and which can be connected to the opposite branch (1, 2) whenever necessary. In another embodiment, shown in the figures, the connecting element comprises a right connecting piece (5) and a left connecting piece (6).

Figure 2 shows a side view of the obstetric device of the invention in which the profile of one of the spoons (3) is observed and a first curvature of the spoon (3) can be seen, the pelvic curvature, configured to facilitate the introduction of the spoon (3) into the birth canal. Figure 3 shows a top view of the device in which a second curvature of the spoons (3) is observed, the head curvature, in this case configured to adapt to the head of the fetus.

When the device is fully assembled, that is, the connecting element (4) is joining the right and left branches (1, 2), the pelvic curvature of the spoons (3) is an upward curvature from the plane formed by the bodies main branches (1, 2) and the connecting element (4) (as seen in figure 2). The cephalic curvature of the spoon (3) of the right branch (1) is complementary to the cephalic curvature of the spoon (3) of the left branch (2) so that, when both branches (1,2) face each other, A space is generated between the spoon (3) of the right branch (1) and the spoon (3) of the left branch (2) destined to receive the head of the fetus. When the device is assembled, the cephalic curvatures of the right branch (1) and left (2) are symmetrical with respect to an imaginary plane that passes between the two branches (1,2).

Figures 4 and 5 show the right (1) and left (2) branches respectively. In this case, you can see the spoons (3), the handles (7) and there are also projections (8) on which the healthcare professional supports his hands (fingers) to perform the necessary traction to extract the fetus. It is an embodiment in which the connecting element (4) is formed by a right connecting piece (5), shown in Figure 4, and a left connecting piece (6), shown in Figure 5.

The projections (8) can be elements manufactured independently of the main body of the branches (1, 2) and which are subsequently irremovably attached to them or they can be part of the main body of the corresponding branch (1,2) itself.

Preferably the projections (8) are arranged between the spoons (3) and the connecting element (4) (which are the right and left connecting pieces (5, 6) in this case). Also preferably the connecting element (4) is arranged between the spoon (3) and the handle (7) or, if there is one, between the projection (8) and the handle (7). In the embodiments in which there is no protrusion (8) the traction can be made directly on the connecting element (4).

Figures 6A-B show the right (5) and left (6) connecting pieces. In this case, both pieces have the possibility of rotation and it is precisely through the rotation of the pieces (5, 6) that the engagement or separation between the two (and therefore between the branches (1, 2)) is carried out. However, the right and left connecting pieces (5, 6) have limited movement in the longitudinal direction of the handle (7). This is why I know It could be used as a point of support for the traction that the healthcare professional must perform when there are no supports (8) on the branches (1, 2). Furthermore, since the movement in the longitudinal direction is limited, possible displacements that cause a change in the position of the spoons (3) or any other modification of the ideal conditions are avoided.

The right and left connecting pieces (5, 6) are arranged on the branches (1, 2) in a position in which they face each other after the positioning of the spoons (3) around the head of the fetus. This allows easy hooking. The union of the branches (1,2) gives rigidity to the device to proceed with the extraction safely.

As can be seen in said figures 6A-B, preferably the right connecting piece (5) comprises a tubular body (intended to be placed around the main body of the right branch (1) by introducing said main body through the gap of the tubular body) and comprises a projection at the end of which there is a groove (9) with a retention projection (10). Preferably, the left connecting piece (6) comprises a tubular body and a protection at the end of which is a hook-shaped element (11) configured to be housed in the groove (9) and to be retained therein by contact with the projection. retention (10). These elements can be seen in Figure 6A and how they remain, once joined, in Figure 6B.

In a preferred embodiment the handles (7) also have a tubular configuration. The handles (7) have a closed end to prevent movement of the handle (7) along the main body during handling.

The projections (8) also comprise a tubular body, to be arranged around the main body of the corresponding branch (1, 2). They also include projections, which are the projections on which the healthcare professional relies to perform traction. Preferably said projections are oriented facing each other. To avoid injuries or possible major complications, said projections have limited movement in the longitudinal direction of the main body of the corresponding branch (1, 2). They preferably do not have the possibility of rotary movement either.

Figure 7 shows an exploded view of the obstetric device in which all the elements that comprise it can be seen.

The method of manufacturing the obstetric device comprises making a 3D impression of the elements of the device and assembling them together to form the branches (1,2) in photopolymerizable resin. The main bodies of the branches (1, 2) are formed with the spoons (3) with their corresponding pelvic curvature and cephalic curvature, the projections (8) (when there are any), the connecting element (4) (preferably the piece right connecting piece (5) and the left connecting piece (6)) and the handles (7).

That is, the procedure comprises the following stages:

- 3D printing with photopolymerizable resin some main bodies with a spoon-shaped end (3) with a pelvic curvature and a head curvature;

- 3D printing with photopolymerizable resin at least one connecting element (4);

- 3D printing with photopolymerizable resin some handles (7);

- irremovably join the main bodies with the joining elements (4) and with the handles (7) so that the joint element (s) (4) are arranged after the spoons (3), around the bodies main, and the handles (7) are arranged around the at least one connecting element (4) and around the corresponding main body, at the end opposite the end where the spoon (3) is located.

The step of 3D printing with photopolymerizable resin at least one connecting element (4) comprises printing a right connecting piece (5) and a left connecting piece (6). It also comprises a step of irremovably joining the joining element (4) to the main body, comprising joining the right joining piece (5) to the main body of the right branch (1) and joining the left joining piece (6) to the main body of the left branch (2).

The method comprises an additional step of 3D printing with photopolymerizable resin some projections (8) and a step of joining said projections irremovably to the branches (1,2) between the spoons (3) and the joining element (4) .

The assembly of each of the branches (1,2) is carried out by first placing the projection (8), then the spoon (3), then the connecting piece (right (5) or left (6) as appropriate) , and later the handle (7). Preferably the projection (8) and the handle (7) are attached with adhesive to the main body of the corresponding branch (1,2).

The obstetric device described is cheaper than those known up to now, both for the cost of the material and for the cost of the manufacturing process. It is also a material and a procedure that are respectful with the environment. On the other hand, the light-curing resin shows very good technical results.

1

Claims (6)

1. Obstetric device characterized in that it comprises a right branch (1) and a left branch (2) with a main body that has a spoon-shaped end (3) with a pelvic curvature configured to facilitate the partial introduction of the branch (1, 2) in the birth canal of the mother and a cephalic curvature configured to receive, between the spoon (3) of the right branch (1) and the spoon (3) of the left branch (2), the head of the fetus, and the device comprises a handle (7) on each branch (1, 2) and has a connecting element (4) that links both branches (1, 2) such that the branches (1, 2) are inserted in the birth canal independently and subsequently articulated by the joining element (4), and both the main body with the spoon (3), as well as the handle (7) and the joining element (4) are made of resin light-curing, and the connecting element (4) comprises a right connecting piece (5), arranged on the right branch (1) with a fixed position in the direction longitudinal axis of the main body of said right branch (1) and possibility of rotation around the longitudinal axis of said main body, and comprises a left connecting piece (6), arranged on the left branch (2) with a fixed position in the longitudinal direction of the main body of said left branch (2) and with the possibility of rotation around the longitudinal axis of said main body. 2. Obstetric device according to claim 1, in which the right connecting piece (5) comprises a tubular body intended to be positioned around the main body of the right branch (1) and comprises a projection at the end of which there is a groove ( 9) with a retention projection (10), and the left connecting piece (6) comprises a tubular body and a protection at the end of which is a hook-shaped element (11) configured to be housed in the groove (9) and being retained therein by contact with the retention projection (10). Obstetric device according to any one of the preceding claims 1 to 2, characterized in that the connecting element (4) is arranged on the branches (1, 2) between the spoons (3) and the handles (7). 4. Obstetric device according to any one of the preceding claims, comprising projections (8) arranged on the branches (1, 2) in a fixed position configured to receive the hands of the healthcare professional so that they can perform a traction force during the delivery period. Obstetric device according to claim 4, in which the projections (8) are made of photopolymerizable resin. Obstetric device according to claim 4, in which the projections (8) are arranged, one on each branch (1,2) between the spoons (8) and the connecting element (4).