ES2390320B1 - PROTECTIVE DEVICE FOR THE CLIT AREA AND PROCEDURE ASSOCIATED WITH THE SAME. - Google Patents

Abstract

Protective device for the area of the clitoris (3), comprising an elastic sheet (1) elastic and adaptable to the area of the clitoris (3), comprising an internal surface (1a) in contact with the clitoris (3) and a sheet lower (2) elastic and adaptable to the upper area of the vagina (4), which comprises an internal face (2a) in contact with the anterior wall of the vagina (4); so that it protects the clitoris (3) against tears and lacerations at the right time when the fetal presentation crowns the vulvar introite and is expelled abroad; additionally it has a simple conformation and with the possibility of being easily automated, ergonomic for the user, disposable and individual for each use.

Description

Protective device for the area of the clitoris and associated procedure.

Technical Field of the Invention

The present invention relates to a protective device for the area of the clitoris, and to the method for the protection of the clitoris in the expulsion period of a fetus associated with said protective device; where the device has application in the sanitary-maternal sector.

This protective device has the purpose of protecting the clitoris against tears and lacerations at the right time when the fetal presentation (usually in cases is a cephalic presentation) crowns the vulvar introite and is expelled abroad; so that to avoid these tears, the device object of the invention is used, which is shaped in a simple and perfectly automated way, where it is also an ergonomic device for the user, disposable and individual for each use.

Background of the invention

Traditionally, when a woman is going to give birth, the vulvar area will undergo sufficient dilation so that the fetus is expelled correctly, this dilation can lead to tears or lacerations in areas with more tendency to suffer them, such as the area perineal and clitoris.

The clitoris is currently being protected with the little finger of the non-dominant hand of the person attending the delivery, in the right hand the left hand and in the left hand the right hand. But inadequate protection of the clitoris can result in its tearing, and fatal consequences if such a tear occurs such as:

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When the clitoris tears, being a small organ, it does not admit the administration of local anesthetic because, although the dose is small, it causes the organ to become edematized and the stitches that are practiced to suture the tears, when reabsorbed local anesthesia, are loose or tight.

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And additionally, being a highly vascular organ, it can cause bleeding or bleeding that is difficult to drain.

On the other hand, different applications are known in which a protective device for the perineal area is described, such as:

The English patent application number GB-1127548, which describes a perineal protective device that is placed in said area and externally with respect to the vagina and anus.

International application number WO-200920660 describing a perineal protective element, whose placement is located inside the vagina and has a pressure clamping system.

Similarly, with the international application number WO-2009101186, a perineal protective element with pressure clamping system is described.

Then it is observed, how the perineal area is normally protected by already known products; and where this perineal area may be subject to a surgical tear or intentional episiotomy by the health personnel when there is a commitment to space outside the fetus at the time of delivery, in order to be the only area to tear to get The fetus can be extracted correctly.

But on the contrary, the clitoris is an organ that must always be protected to avoid tears or lacerations due to the aforementioned inconveniences, and where the applicant does not know in the state of the art protective devices exclusively for the area of the clitoris, this being extremely delicate and complicated to be surgically operated in case of tearing.

In addition to the pressure, shape, purpose and size of the background devices, to protect the perineum and perineal hairpin, these are not valid to protect the clitoris; in fact, in each of the antecedents there is no reference to the possibility of protecting said area; and the morphological differences of the perineal area and the clitoris in terms of tissues must also be taken into account:

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In the perineal area, muscles and tendon raphe form a powerful floor of the perineum.

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In the clitoris, this is configured by very innervated, irrigated tissue, consisting of small erectile cavernous bodies, covered by the ischiocavernosal muscle that fuses in the midline forming the

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glans of the clitoris, subject to the pubis by the suspensory ligament; and it is covered by squamous epithelium without glands or dermal papillae, in addition to having a large number of sensitive receptors.

In view of the aforementioned background, of the differences between the perineal area and the clitoris, and of the existing problems related to the protection of said clitoris, it is necessary the appearance of a new protective device that avoids the aforementioned inconveniences, in the line of preventing such tears by means of a simple configuration device, easily formed, with the possibility of being manufactured in series, ergonomic for the user, disposable and individual for each use.

Description of the invention

The present invention relates to a protective device for the area of the clitoris, and to the method for the protection of the area of the clitoris in the expulsion period of a fetus associated with said device, which notably resolves the drawbacks described above, and allows avoid tears and lacerations caused at the time of delivery in the area of the clitoris, all this by means of a simple, ergonomic, disposable device with great applicability in the health-mother sector.

The protective device for the area of the clitoris that the invention proposes comprises:

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an elastic upper sheet adaptable to the area of the clitoris, which comprises an internal surface in contact with the clitoris; Y

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an elastic bottom sheet adaptable to the upper area of the vagina, which comprises an internal face in contact with the anterior wall of the vagina.

It is observed, therefore, that the protective device object of the invention is formed by two sheets, upper and lower, and that said sheets comprise internal faces that come into contact, respectively, with the clitoris and with the anterior wall of the vagina; getting that the clitoris, which is the area to be protected, is covered and pressed by the upper lamina thanks, in part, to the pressure exerted by the fetal head, to the lower lamina at the time of delivery.

And therefore, the procedure for the protection of the area of the clitoris in the period of expulsion of a fetus in labor, is divided into the following stages:

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place the elastic and adaptable upper sheet, belonging to the protective device, in the area of the clitoris; Y

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place the elastic and adaptable bottom sheet, belonging to the protective device, on the anterior wall of the vagina.

So the placement of these sheets just before the fetal head crowns during childbirth, leaves the device perfectly anchored and adjusted; and in this way, said pressure exerted by the fetal head, in its expulsion, presses the lower sheet of the device on the anterior wall of the vagina in its outermost third, pressing and in turn holding the upper sheet towards the clitoris.

Preferably, both sheets are joined together; being able to be joined by a third element or formed by the same piece, so that its manufacture is carried out in a single step and perfectly automatable for its manufacture in large series.

The possibility that the upper sheet is smaller than the lower sheet is contemplated; the lower sheet being the one that is introduced into the anterior wall of the vagina, and therefore the larger the size of the vagina, the greater the support of the device at the moment when the fetal head slides through the vagina.

Regarding the surface finish of the surfaces of the sheets that form the device object of the invention, different surface finishes are contemplated according to the type of surface, which may include:

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The inner surface of the upper sheet in contact with the clitoris comprises a rough surface finish, in order to improve adhesion to said organ, and minimizing the overstress of its tissue and, therefore, the possibility of tearing.

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The inner face of the lower sheet, in contact with the upper area of the vagina, comprises a rough surface finish; ensuring, therefore, the correct hold of the entire device.

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And where the bottom sheet comprises an outer face (the opposite side being the inner face of the bottom sheet), wherein said outer face is smooth and hydrophilic; so that a perfect sliding of the fetal head is achieved at the time of departure.

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The possibility is contemplated that the protective device for the clitoris area comprises a clamping element located between the upper sheet and the lower sheet; plastic clamp systems or the like can be contemplated, but paying special attention to the fact that the clamping element must not interfere in the correct exit of the fetal head at the time of delivery. And where the clamping element substantially improves the clamping of the device object of the invention.

As for a preferred embodiment, the possibility is contemplated that both the upper and the lower sheet respectively comprise a triangular geometry with a rounded upper vertex; without sharp edges that bother the patient or hinder their fixation in the respective organs, vagina and clitoris.

And additionally, both sheets respectively comprise a curved geometry; in order to adapt to the anatomy of the upper part of the vagina and the clitoris; where this technical characteristic is perfectly combinable with the triangular geometry with rounded top vertex described above.

Finally, the possibility is contemplated that both the upper sheet and the lower sheet are formed with silicone material, disposable and sanitized; granting a high degree of flexibility in order to adapt properly to both organs; and being disposable and sterilized, it results in high industrial applicability in the maternal and sanitary field.

Thus, according to the described invention, the protective device for the area of the clitoris that the invention proposes, and the method associated therewith, constitutes an advance in the protective devices known up to now, and fully solves the problem previously satisfactory. exposed, in the line of avoiding tears and lacerations in the area of the clitoris by means of a simple configuration device, easily shaped, with the possibility of being manufactured in series, ergonomic for the user, disposable and individual for each use.

Description of the drawings

To complement the description that is being made and in order to help a better understanding of the characteristics of the invention, according to a preferred example of practical implementation thereof, an integral set of said description is attached, a set of drawings in which In an illustrative and non-limiting manner, the following has been represented:

Figure 1 shows a schematic elevation view of two preferred embodiments of the protective device object of the invention.

Figure 2.- Shows a schematic profile view of the protective device object of the invention.

Figure 3.- Shows a three-dimensional schematic view of two preferred embodiments of the protective device object of the invention.

Figure 4.- Shows a schematic profile view of the protective device object of the invention together with the clamping element.

Figure 5.- Shows a schematic view of the placement of the protective device object of the invention at the moment when the head of the baby is in the ejector.

Figure 6 shows a schematic view of the protective device object of the invention once placed in the area of the clitoris.

Preferred Embodiment of the Invention

In view of Figures 1 to 3, it can be seen how in one of the possible embodiments of the protective device for the area of the clitoris that the invention proposes comprises:

an elastic upper sheet (1) and adaptable to the area of the clitoris (3), comprising an internal surface (1a) in contact with the clitoris (3); a lower sheet (2) elastic and adaptable to the upper area of the vagina (4), comprising an inner face (2a) in contact with the anterior wall of the vagina (4), where said upper sheet (1) is of smaller than the bottom sheet (2); Y

where both sheets (1, 2) are joined together forming the same piece, as a bent piece.

And where the main faces of each sheet (1, 2) comprise the following geometries:

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the inner surface (1a) of the top sheet (1) is rough;

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the inner face (2a) of the bottom sheet (2) is rough; Y

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The outer face (2b) of the bottom sheet (2) is smooth and hydrophilic.

So that the surface finishes give the device improvements in relation to a high capacity of fixation to the respective organs, as well as the ability not to hinder the sliding and expulsion of the fetal head at the time of delivery, thanks to the surface finish of the outer layer (2b) of the bottom sheet (2).

According to Figures 1 and 3, it can be seen how in a preferred embodiment both the upper sheet (1) and the lower sheet (2) respectively comprise a triangular geometry with rounded upper vertex; and particularly in Figures 1B and 3B, the bases of the lower sheet (2) comprise bevels in order to increase the contact surface of said lower sheet (2) with the clitoris (3).

Additionally, and in relation to Figure 2, it can be seen how both the upper sheet (1) and the lower sheet (2) respectively comprise a curved geometry, from a profile view; so that said geometry adapts ergonomically to the respective organs and its design, clamp type, guarantees a correct grip.

And in view of Figure 4, in a preferred embodiment, the protective device comprises a fastener.

(5) located between the upper sheet (1) and the lower sheet (2), this clamping element (5) being clamp type, which does not prevent or hinder the passage of the fetal head at the time of delivery, as it does not extend the clamp on the outer face (2b) of the bottom sheet (2).

Based on the procedure for the protection of the area of the clitoris (3) in the period of expulsion of a fetus (6) in labor, it is observed in Figure 5 how to proceed to place the upper lamina (1), elastic and adaptable of the protective device, in the area of the clitoris (3); and how to proceed to place the lower lamina (2) on the anterior wall of the vagina (4), just before the head of the fetus (6) crowns the vulva of the vagina (4) in the period of expulsion of the fetus (6).

And finally, in view of Figure 6, the protective device object of the invention is observed once placed and protecting the area of the clitoris (3), just at the moment when the head of the fetus (6) crowns the vulva of the vagina (4) in its expulsion period.

In view of this description and set of figures, the person skilled in the art will be able to understand that the embodiments of the invention that have been described can be combined in multiple ways within the scope of the invention. The invention has been described according to some preferred embodiments thereof, but it will be apparent to the person skilled in the art that multiple variations can be introduced in said preferred embodiments without exceeding the object of the claimed invention.

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Claims (11)

1. Protective device for the area of the clitoris (3), characterized in that it comprises: an elastic upper sheet (1) and adaptable to the area of the clitoris (3), comprising an internal surface (1a) in contact with the clitoris (3); Y a bottom sheet (2) elastic and adaptable to the upper area of the vagina (4), comprising an inner face (2a) in contact with the anterior wall of the vagina (4).

2.

 Protective device for the area of the clitoris (3), according to the first claim, characterized in that both sheets (1, 2) are joined together.

3.

 Protective device for the area of the clitoris (3), according to any of the preceding claims, characterized in that the upper sheet (1) is smaller than the lower sheet (2).

Four.

 Protective device for the area of the clitoris (3), according to any of the preceding claims, characterized in that the inner surface (1a) of the upper sheet (1) is rough.

5.

 Protective device for the area of the clitoris (3), according to any of the preceding claims, characterized in that the inner face (2a) of the lower sheet (2) is rough.

6.

 Protective device for the area of the clitoris (3), according to any of the preceding claims, characterized in that the lower sheet (2) comprises an outer face (2b), wherein said outer face (2b) is smooth and hydrophilic.

7.

 Protective device for the area of the clitoris (3), according to any of the preceding claims, characterized in that it comprises a fastener (5) located between the upper sheet (1) and the lower sheet (2).

8.

 Protective device for the area of the clitoris (3), according to any of the preceding claims, characterized in that both the upper sheet (1) and the lower sheet (2) respectively comprise a triangular geometry with a rounded upper vertex.

9.

 Protective device for the area of the clitoris (3), according to any of the preceding claims, characterized in that both the upper sheet (1) and the lower sheet (2) respectively comprise a curved geometry.

10.

 Protective device for the area of the clitoris (3), according to any of the preceding claims, characterized in that both the upper sheet (1) and the lower sheet (2) are formed with silicone material, disposable and sanitized sterilized.

ES 2 390 320 Al ES 2 390 320 Al ES 2 390 320 Al SPANISH OFFICE OF THE PATENTS AND BRAND Application no .: 201001571 SPAIN Date of submission of the application: 30.11.2010 Priority Date: REPORT ON THE STATE OF THE TECHNIQUE 51 Int. Cl.: A61B17 / 42 (2006.01) RELEVANT DOCUMENTS

Category

56 Documents cited Claims Affected

TO

WO 2009101186 A1 (HAADEM) 20.08.2009, 1-10

page 4, line 4 - page 15, line 2; Figures 2a-3.

TO

WO 2009020660 A1 (IMS LAUNCH, LLC.) 12.02.2009, 1-10

paragraphs [2080-2130], [2390-2510]; Figures 1-4,81-85.

TO

WO 2007131109 A2 (PLEXUS BIOMEDICAL INC.) 15.11.2007, one

page 1, line 15 - page 2, line 12; figures.

TO

GB 1127548 A (DUMERGUE et al.) 18.09.1968, one

page 1, line 12 - page 2, line 50; figures.

TO

MX 2010002594 A (CLODIUS-TALMADGE) 04.08.2010, one

page 9, line 21 - page 10, line 8; page 12, lines 3-9; page 15, lines 2-8; page 24,

lines 4-10; figures.

TO

EN 2244942 T3 (OCULARISTE INC.) 16.12.2005, one

column 3, line 48 - column 4, line 32; Figures 3-5.

Category of the documents cited X: of particular relevance Y: of particular relevance combined with other / s of the same category A: reflects the state of the art O: refers to unwritten disclosure P: published between the priority date and the date of priority submission of the application E: previous document, but published after the date of submission of the application

This report has been prepared • for all claims • for claims no:

Date of realization of the report 25.10.2012

Examiner J. Square Prados Page 1/5

REPORT OF THE STATE OF THE TECHNIQUE Minimum documentation sought (classification system followed by classification symbols) A61b Electronic databases consulted during the search (name of the database and, if possible, terms of search used) INVENES, EPODOC, WPI, PAJ, ECLA.  WRITTEN OPINION Date of Completion of Written Opinion: 25.10.2012 Statement

Novelty (Art. 6.1 LP 11/1986)

Claims Claims 1-10 IF NOT

Inventive activity (Art. 8.1 LP11 / 1986)

Claims Claims 1-10 IF NOT

The application is considered to comply with the industrial application requirement. This requirement was evaluated during the formal and technical examination phase of the application (Article 31.2 Law 11/1986).  Opinion Base. This opinion has been made on the basis of the patent application as published. WRITTEN OPINION  1. Documents considered.- The documents belonging to the state of the art taken into consideration for the realization of this opinion are listed below.

Document

Publication or Identification Number publication date

D01

WO 2009101186 A1 (HAADEM) 08/20/2009

D02

WO 2009020660 A1 (IMS LAUNCH, LLC.) 12.02.2009

D03

WO 2007131109 A2 (PLEXUS BIOMEDICAL INC.) 11.15.2007

D04

GB 1127548 A (DUMERGUE et al.) 18.09.1968

D05

MX 2010002594 A (CLODIUS-TALMADGE) 04.08.2010

D06

ES 2244942 T3 (OCULARISTE INC.) 16.12.2005

 2. Statement motivated according to articles 29.6 and 29.7 of the Regulations for the execution of Law 11/1986, of March 20, on Patents on novelty and inventive activity; quotes and explanations in support of this statement The request refers to a protective device for the area of the clitoris during the expulsion phase of childbirth, whose purpose is the protection of the clitoris against tears and lacerations that may occur at the time when the fetus, usually in a cephalic presentation, crown the vulvar introite to be expelled outside in a vaginal delivery. In this way it is intended to solve the problem posed by a lack of protection or inadequate protection, which can result in the tearing of the clitoris. The request states in relation to the state of the art that “currently the clitoris is being protected with the little finger of the non-dominant hand of the person attending the delivery (see page 2, lines 3-4)”, that is, does not recognize the existence of products or devices for this purpose, however admitting the existence of devices or products to protect the perineal area. From the search result it can be concluded that no examples of devices or products specifically conceived for the purpose of the device of the application have been found, that is, for use in the protection of the clitoris against possible tears during the expulsion period of a delivery . However, document D01, cited by the applicant himself as an example of the state of the art in the application, presents a device for the protection of the perineal area during childbirth, which is similar to the device that emerges from the object of the main claim of the application. In this document, considering the closest state of the art, the structural characteristics present in the main claim are anticipated, since the device of D01 (see parts cited in the report) discloses a:

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Protective device of the perineal area (see summary) comprising:

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an elastic bottom sheet adaptable to the perineal area, which comprises an internal surface in contact with the perineal area (see figures 5a, 5b, 9-13);

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an elastic upper sheet and adaptable to the lower area of the vagina comprising an internal face in contact with the posterior wall of the vagina (see figures 5a, 5b, 9-13).

The principle of operation turns out to be as in the device of the request, with a restraint system aided by the pressure caused by the head of the fetus. However, document D01 differs in a series of features included in the object of the main claim, which are characteristics relating to the mode of use or place in which the device is applied:

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in D01 the clitoris is not protected but the perineum,

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in D01 one of the sheets does not fit with an internal surface in contact with the clitoris, but with the perineum,

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in D01 the other sheet does not adapt to the upper area of the vagina by entering the inner face in contact with its anterior wall, but instead adapts to the lower area and comes into contact with the posterior wall.

However, it could be considered that the device presented in D01 would serve to protect the area of the clitoris by only modifying the orientation or position in which it is disposed (towards the area of the clitoris instead of towards the perineal area) without performing in the that the minor modifications necessary to adapt it to its use in the protection of the clitoris, which would be evident to a person skilled in the art trying to solve the problem of how to protect the clitoris from possible tears during delivery. The possible lack of inventive activity of the device to be protected in the main claim in relation to that presented in D01 could then be considered.  WRITTEN OPINION But when assessing the inventive activity, it is necessary to consider whether the person skilled in the art, based on the totality of the knowledge gathered in the state of the art and without using any inventive capacity at any time, would have recognized the underlying problem and would have solved it in the manner indicated. As specified in the "Patent Application Examination Guidelines, SPTO" (see Chapter 6: Patentability, section 6.6: Criteria for evaluating inventive activity, pages 164-165), when assessing inventive activity:

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“The question is whether the person skilled in the art would have reached a result within the claimed object without using his inventive capacity. It is not enough to demonstrate that the person skilled in the art could have reached that result. Indeed, the question that the examiner must answer is whether there is a teaching in the state of the art considered globally that he would have induced (not that he could have induced, but really would have induced) to the expert in the field, faced with the technical problem posed , to modify or adapt said state of the art taking into account said teaching and arriving at a result that falls within the scope of the claims, thus achieving the same purpose as the invention. The importance of looking for indicators in the state of the art that point in the direction of the invention must be highlighted ”.

Well, the result of the search does not show that the problem of protecting the clitoris during childbirth by some kind of special device to prevent tearing has not even been raised. The background cited in the Report (documents D01 to D04) proposed for the protection of the perineum does not suggest or imply the possibility of protecting the clitoris. On the other hand, only some background of devices proposed for the protection of the clitoris and its adjacent area have been found (see documents D05 and D06) but for other types of situations and not for the purpose of preventing tears, but basically to protect the area Female genital to prevent damage in procedures such as laser hair removal in the area. Thus, they are antecedents that do not deserve to be taken into consideration and that an expert in the field would not have taken into account when considering and solving the problem. In this way, the absence of antecedents that have been found in the state of the art and that raise the problem of the application, could be considered an indication in favor of accepting the existence of inventive activity in the object of the main claim. Thus, documents D01 to D06 cited in the Report only show the general state of the art and are not considered of particular relevance. It would not be obvious for a person skilled in the art to apply the features included in the cited documents and arrive at the invention as disclosed in the first claim. Therefore, the object of this main claim meets the requirements of novelty and inventive activity. Dependent claims 2 to 10 delimit additional optional features and as the first general also meet the requirements regarding novelty and inventive activity.