ES2362919B1 - INERCIAL DEVICE FOR STIMULATION OF MUSCLES OF THE PELVIC FLOOR WITH ENERGY ACCUMULATION. - Google Patents

Abstract

Inertial device (1) for the stimulation of the pelvic floor muscles, intended to be introduced into the vagina of a user, comprising at least one hollow body (2) within which at least one inner ball (3) capable is freely disposed of moving due to the effect of gravity and the inertia of the user's movements and impacting on an internal surface (4) of the hollow body (2). The inner surface (4) of the hollow body (2) comprises facets (5, 6) that form a certain angle with adjacent facets (5, 6) so that the inner ball (3) supported on a facet (5, 6) you must accumulate a certain energy to move and hit an adjacent facet (5, 6). The device is effective and simple to manufacture, and is also preferably symmetrical, which is equally effective regardless of its placement and the morphology of the user.

Description

responsible for stimulating the pelvic floor muscles

Inertial device for the stimulation of pelvic floor muscles with energy accumulation. Technical sector

The invention refers to an inertial device for the stimulation of the pelvic floor muscles of a woman, of the type that is introduced into the vagina and as a consequence of the inertia of the woman's movements are able to stimulate muscle activity of the muscles adjacent to the device and help in its toni fi cation. State of the art

The pelvic floor is a set of muscles and aponeurosis inserted in the lower pelvis that close the abdominal cavity through the lower and lateral part and whose functions are to allow a visceral support (bladder, uterus, vagina and rectum), dampen the abdominal pressure in the effort, intervene in urinary and rectal continence and excretion, intervene in sexual function and, it is estimated, perform obstetric functions. Due to various risk factors (pregnancy, vaginal births, episiotomy, menopause, etc.) it is common for the woman's pelvic floor to lose tone and ability to contract, thereby favoring the appearance of pathologies at that level, such as the decrease of the urinary bladder, the descent of the rectum and the descent of the uterus, and in turn causing various dysfunctions such as stress urinary incontinence, among others. Therefore, it is important to have means to maintain the tone of the pelvic floor so that the appearance of these pathologies that so negatively affect the quality of life of women can be avoided.

With the aim of toning the muscles that form the pelvic floor, the use of mechanical stimulation devices of the vibratory type in the form of one or more spherical bodies that are introduced into a user's vagina to stimulate and achieve a motor response at the level of smooth musculature of the vagina and tonic perineal striatum. If, in addition, the user performs a collaborative action by voluntarily contracting the pelvic floor muscles, said devices increase their toning efficiency and the user of the device gains strength in said muscles (i.e., gains contractile capacity to perform sphincter closure), as evidenced by the applicants of the present patent itself.

Particularly useful are a type of device known as "inertial" in which the spherical bodies are hollow and inside they house a ball of a certain weight capable of moving generating vibrations that stimulate the vibratory receptors of the vagina and cause the reflex (involuntary) contraction. ) of the pelvic floor muscles.

Among the inertial devices, the "passive" inertial devices are known, which are devices in which the movement or displacement of the inner ball is caused by the movements of the user herself.

An example of a very simple passive inertial device is one in which the spherical bodies contain a ball of a certain weight that is free, capable of rolling on the smooth and spherical internal surface of the spherical bodies. Then, when the user moves, the ball rolls inside the esvico body.

A second example of passive inertial device is described in patent ES2226590B1. Said inertial device comprises a hollow body within which an inner ball is disposed, with the particularity that said inner ball hangs from a cord connected to the inner surface of the hollow body, as a pendulum. When the user of the device moves, the inner ball swings and hits the inner surface of the hollow body. Unlike the previous one, this device has the peculiarity that to function correctly it must be placed in a certain position inside the vagina (with the pendulum in favor of gravity).

The fact that an inertial device must be placed in a certain position inside the vagina to function properly constitutes an inconvenience for various reasons. On the one hand, it forces extreme attention and precision during its introduction and placement, making the process difficult; and in fact, despite the extreme attention and precision, it is not always possible to place the device in a correct and exact position that guarantees that the device works as effectively as possible. On the other hand, it should be borne in mind that the position in which the device is to be placed may vary depending on the morphology of the surrounding tissue. Thus, on the one hand, for the same user, the fact that their morphology may vary for whatever reason, for example due to the success of the treatment; Due to such variation, a device of the type to be placed in a certain position will not always be correctly positioned and consequently may decrease its effectiveness. On the other hand, the morphology between different users is different, which results in the undesirable effect that a device of the type to be placed in a certain position has a better efficiency in some users than in others.

Passive inertial devices are also known, provided with a hollow body within which an inner ball is freely disposed, known as inertial devices with energy accumulation. In these devices the inner ball must acquire a certain energy to move; consequently, the impact of the inner ball against the inner surface of the hollow body is produced with a certain energy above a threshold, increasing and improving the stimulation of the tissues adjacent to the device.

An example of a passive inertial device with energy accumulation is one in which the inner surface of the hollow body has protruding ribs arranged parallel to each other and along a meridian. These ribs serve as an obstacle to the inner ball, so that it must accumulate some energy to overcome each rib to the next or to pass to the side of the ribs, and continue its movement. This device has the same drawback as the ES2226590B1 device, and it only works if it is placed in the correct position inside the vagina. In case of not being placed correctly, among other effects there may be the fact that the device does not behave as an energy storage device or even the fact that the ball cannot move.

The present invention aims to provide an inertial device of mechanical stimulation and vibratory type for the stimulation of pelvic floor, passive and with accumulation of energy, which presents means of accumulation of energy alternative to those known, simple to manufacture and very effective in its operation.

In addition, the device according to the invention is intended to guarantee, at least in its preferred embodiments, an optimal accumulation of energy and stimulation regardless of the position or orientation of the device within the vagina. Consequently, the placement of the device in the vagina will be facilitated since it can be introduced in any position. In addition, it will be achieved that the effectiveness of the device is not affected by possible changes in the morphological conditions of the user and that the device is equally effective for different users. Brief Description of the Invention

The object of the invention is an inertial device for the stimulation of pelvic floor muscles with energy accumulation, intended to be introduced into a user's vagina, which, like other inertial devices, comprises at least one hollow body, where within at least one hollow body is freely disposed at least one inner ball capable of moving due to the force of gravity and the inertia of the user's movements and impacting on an internal surface of said hollow body. The inertial device according to the invention also has the peculiarity that the inner surface of the hollow body is provided with facets, where the facets form a certain angle with adjacent facets so that the inner ball supported on a facet must accumulate a certain energy to move and hit an adjacent facet.

The use of facets as elements that prevent to a certain extent the displacement of the inner ball or balls is advantageous since they allow to simplify the process and manufacturing cost of the hollow body compared to conventional devices with energy accumulation in which the hollow body is provided with protruding ribs. In addition, the control of the energy of movement of the inner ball or balls is better than in such conventional devices, due to the fact that it is possible to adjust more precisely the angle formed by the facets than the height and width of the inner ribs.

In a preferred embodiment of the invention, the internal surface of the housing is fully faceted and in addition the internal surface of the housing is substantially spherically symmetrical. In this way, a main body is achieved - and therefore an inertial device - equally effective regardless of its placement in the vagina and the morphology of the user. The inner ball or balls will always be placed, regardless of the placement of the device or the morphology of the user, in the lowest position and willing to accumulate and release the energy due to the inertia of the movements of the user during the treatment, guaranteeing An optimal treatment in all practical cases.

In addition, the device guarantees that the energy that the ball carries when changing facets is above a minimum threshold value, which is given by the shape of the edges of the facets and the angle formed by the facets; thus, the inner ball or balls are held by the facets until the angle of the vector adds up to the weight and the inertia of the movement exceeds that of the facets, at which point the inner ball or balls begin their movement, in a controlled manner towards adjacent facets. This ensures that the impact (involuntary and automatic response that occurs in the pelvic floor muscles as a result of the energy of the inner ball or balls) is also above a minimum threshold value, so that the device provides a better, more stable and effective stimulation of nerve receptors of tissues in contact with the device.

Brief description of the fi gures

The details of the invention can be seen in the accompanying figures, not intended to be limiting of the scope of the invention:

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Figure 1 shows a perspective of an embodiment of the device according to the invention.

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Figure 2 shows a sectional perspective of the device of the previous figure. Detailed description of the invention

Figure 1 shows an embodiment of the inertial device (1) for the stimulation of the pelvic floor with energy accumulation of the invention. The embodiment shown is characterized by presenting a single hollow body (2), made for example of injectable technical plastic, and an extraction means, in this case in the form of a closed loop (7) and made of an elastomer

or an injectable silicone. The extraction means is projected from the hollow body (2) and whose end opposite the hollow body (2) is intended to be accessible from the outside of the vagina when the device (1) is inserted into it so that the user You can remove the device (1) simply by pulling the cord (7).

Figure 2 shows a sectional perspective of the device (1) of Figure 1. As can be seen, inside the hollow body (2) an inner ball (3) freely able to move due to the forces of gravity and inertia of the user's movements and impacting on an internal surface (4) of the hollow body (2). The inner surface (4) of the hollow body (2) is provided with facets (5, 6), that is, it is at least partially faceted. The facets (5, 6) form a certain angle with adjacent facets (5, 6) so that the inner ball (3) supported on a facet (5, 6) must accumulate a certain energy to move and hit a facet (5 , 6) adjacent. That is, the movement does not start until it is from a certain entity and therefore the stimulus or impact will also have a minimum.

The shape, geometry and edges of each facet (5, 6) can be con fi gured to choose the energy that accumulates before allowing the movement of the inner ball (3) until the forces resulting from gravity and inertia form a certain angle , exceeded which the inner ball (3) moves with an accumulated energy. It has been found that the particular design of the edges of the facets (5, 6) have a great influence on how they receive the impact of the inner ball (5, 6) that has moved from the adjacent facets (5, 6).

Preferably, the inner surface (4) of the hollow body (2) is completely faceted. Thus, in all areas of the inner surface (4), an accumulation of energy from the inner ball (3) can occur; that is, there are no areas of the inner surface (4) that allow the movement of the inner ball (3) freely, without accumulation of energy. Preferably, the internal surface (4) is in the form of an icosahedron or dodecahedron.

Preferably, the inner surface (4) of the hollow body (2) is substantially spherically symmetrical. This means that the behavior of the inner ball (3) inside the hollow body (2) is independent of how the hollow body (2) is oriented inside the vagina. This guarantees optimal treatment in all users, and even when the same user undergoes morphological changes during treatment.

Preferably, as shown in Figure 2, the faceted inner surface (4) has substantially pentagonal facets (5) and substantially hexagonal facets (6). The combination of facets of both types is the most effective combination for the manufacture of the internal surface (4), especially if it is to be fully faceted and with a spherical symmetry.

If the above technical characteristics are combined, that is, the fact that a complete facet is combined with the fact that the internal surface (4) is substantially spherically symmetrical and the fact that the internal surface (4) is combined ) Faceted features substantially pentagonal facets (5) and substantially hexagonal facets (6), resulting in an internal surface (4) substantially in the form of a truncated icosahedron. This embodiment is considered to have all the advantages simultaneously: equal effectiveness regardless of the orientation of the device (1), manufacturing cost efficiency, non-appearance of areas without energy accumulation, etc.

In the embodiment shown, all facets (5, 6) are substantially flat. This ensures that the equilibrium point where the ball will stay

or inner balls (3) either at the edges of the facets (5, 6). Thus, if on the contrary the facets (5, 6) had some concave curvature inside, the inner ball or balls (3) could remain inside the facets (5, 6) and the energy accumulation would be less.

In one embodiment, all facets are not equal in size and geometry. The difference in size allows to achieve some particular effects. For example, if the difference in size between the facets is sufficient, some may act as receptors and others as support. The receiving facets are responsible for receiving the balls when only gravity acts (they would be smaller facets, only responsible for stopping the inner ball but without the ball resting on them). On the other hand, the support facets, larger, serve to receive the energy of the inner ball after its movement, and therefore are responsible for stimulating the outer tissue.

Preferably, the outer surface of the inner ball (3) is hard, so that the blow of the inner ball (3) against the inner surface is not damped

(4) of the hollow body (2). Thus, it is possible to maximize the energy of the blow, which is what is definitely interesting to stimulate the surrounding tissues to the maximum. However, it is also contemplated that the inner ball (3) has a coating of a softer material, for example rubber, to mitigate the noise produced when the inner ball (3) strikes the inner surface (4) of the hollow body (2).

The invention contemplates various embodiments other than that shown.

For example, the device (1) may comprise more than one hollow body (2), in which case the hollow bodies (2) would be joined together by a joining means, for example a cord.

The shape of the hollow body (2) can be not only spherical, as shown, but in any applicable way, for example with a certain eccentricity that facilitates its insertion into the vagina and its subsequent removal. In any case, the outer shape of the hollow body (2) is not relevant to the present invention.

The hollow body (2) or the hollow bodies (2) may comprise in its interior more than one inner ball (3). In case the device (1) comprises several hollow bodies (2), each hollow body (2) can comprise an equal number of inner balls (3)

or different than the others. It is even contemplated that the invention does not apply to all hollow bodies

(2)

of a device (1) but to some (s).

In addition, the extraction means that projects from the hollow body (2) can be not only a cord (7) but more than one cord (7), in closed loop or not, or another type of element that protrudes outside of the vagina and allow the user to pull it to remove the device (1).

In the embodiment shown, all facets (5, 6) are flat. Alternatively, only one or more facets (5, 6) may be flat, not entirely. In case of being one or more facets (5, 6) noplanas, the invention contemplates that there may be a

or more facets (5, 6) substantially curved (with concavities and / or convexities). With these or other variants, the beginning of the movement of the inner ball or balls (3) and the reception of said balls by adjacent facets (5, 6) are determined at will.

It is also possible, in combination with the above or independently, that at least one facet (5, 6) has an internal irregularity that serves as an additional obstacle to the inner ball (3) or inner balls (3).

The invention also contemplates the possibility that a projection or protuberance is arranged between at least two facets (5, 6). This would increase the threshold energy value that the inner ball (3) must accumulate at that point to pass to the adjacent facet (5, 6), thereby increasing the impact on the pelvic floor muscles.

Claims (13)

1. Device (1) inertial for the stimulation of pelvic floor muscles with energy accumulation, intended to be introduced into the vagina of a user, comprising at least one hollow body (2), where within at least one body hollow (2) there is freely disposed at least one inner ball (3) capable of moving due to the force of gravity and inertia of the user's movements and of impacting against an internal surface (4) of the hollow body (2), where the device (1) is characterized by:

-

the inner surface (4) of the hollow body (2) is provided with facets (5, 6), where

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the facets (5, 6) form a certain angle with adjacent facets (5, 6) so that the inner ball (3) supported on a facet (5, 6) must accumulate a certain energy to move and hit a facet (5 , 6) adjacent.

2.

Device (1) according to claim 1, characterized in that the inner surface (4) of the hollow body (2) is completely faceted.

3.

Device (1) according to claim 2, characterized in that the internal surface (4) is substantially icosahedron shaped.

4. Device (1) according to claim 2, characterized in that the internal surface (4) is substantially shaped as a dodecahedron.

5.

Device (1) according to claim 1, characterized in that the inner surface (4) of the hollow body (2) is substantially spherically symmetrical.

6.

Device (1) according to claim 1, characterized in that the faceted inner surface (4) has substantially pentagonal facets

(5) and substantially hexagonal facets (6).

7.

Device (1) according to claim 1, characterized in that at least one facet (5, 6) is substantially flat.

8.

Device (1) according to claim 7, characterized in that all facets (5, 6) are substantially flat.

9.

Device (1) according to claim 1, characterized in that at least one facet (5, 6) is substantially non-flat.

10.

Device (1) according to claim 9, characterized in that at least one facet (5, 6) is substantially curved.

eleven.

Device (1) according to claim 1, characterized in that at least one facet (5, 6) has an internal irregularity that serves as an additional obstacle to the inner ball or inner balls.

12.

Device (1) according to claim 1, characterized in that between at least two facets (5, 6) there is a projection or protuberance.

SPANISH OFFICE OF THE PATENTS AND BRAND Application no .: 201100595 SPAIN Date of submission of the application: 30.05.2011 Priority Date: REPORT ON THE STATE OF THE TECHNIQUE 51 Int. Cl.: See Additional Sheet RELEVANT DOCUMENTS

Category

Documents cited Claims Affected

TO

US 2003040688 A1 (BAUER) 27.02.2003, summary; paragraphs [1-9], [19-20]; figures. one

TO

DE 202009010633 U1 (WEFO-TEC DEUTSCHLAND GMBH) 27.01.2011, summary; figures. one

TO

KR 100684927 B1 (YOO SHIN JEWERLY CO. LTD.) 13.02.2007, summary; figures. one

TO

DE 202006009826 U1 (BÖHM) 12.10.2006, summary; Figure 1. one

TO

KR 200434789 Y1 (HYEON-JEONG JANG et al.) 27.12.2006, summary; figures. one

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 06.30.2011

Examiner J. Square Prados Page 1/5

REPORT OF THE STATE OF THE TECHNIQUE CLASSIFICATION OBJECT OF THE APPLICATION A63B23 / 20 (2006.01) A61H21 / 00 (2006.01) A61H19 / 00 (2006.01) Minimum documentation sought (classification system followed by classification symbols) A63B, A61H 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: 06.30.2011 Statement

Novelty (Art. 6.1 LP 11/1986)

Claims Claims 1-12 IF NOT

Inventive activity (Art. 8.1 LP11 / 1986)

Claims Claims 1-12 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

US 2003040688 A1 (BAUER) 02.27.2003

D02

DE 202009010633 U1 (WEFO-TEC DEUTSCHLAND GMBH) 01.21.2011

D03

KR 100684927 B1 (YOO SHIN JEWERLY CO. LTD.) 02/13/2007

D04

DE 202006009826 U1 (BÖHM) 12.10.2006

D05

KR 200434789 Y1 (HYEON-JEONG JANG et al.) 12.27.2006

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 present application refers to an inertial device for the stimulation of the pelvic floor muscles of a woman, of the type that is introduced into the vagina and as a consequence of the inertia of the woman's movements are able to stimulate the activity muscle muscles adjacent to the device and help in toning. Documents D01 to D05 cited in the report only show the general state of the art and are not considered of particular relevance. As recognized in the description of the application, in the state of the art "the use of mechanical stimulation devices of the vibratory type in the form of one or more spherical bodies that are introduced into a user's vagina has been known for some time to stimulate and achieve a motor response at the level of smooth musculature of the vagina and tonic perineal striatum. Particularly useful are a type of devices known as "inertial" in which the spherical bodies are hollow and inside they house a ball of a certain weight capable of moving generating vibrations that stimulate the vibratory receptors of the vagina and cause the reflex (involuntary) contraction of the pelvic floor muscles. Among the inertial devices are known inertial devices "passive", which are devices in which the movement or displacement of the inner ball is caused by the movements of the user herself. Well, documents D01 to D05 refer to devices for stimulating the pelvic floor muscles of a woman, which have some similarities with the object of the main claim of the application, but none of these documents anticipate all the features that limit it. Document D01 is considered the state of the art closest to the object of the main claim, and it anticipates the characteristics of the preamble thereof (see the figures), since in D01 a (references in brackets are presented apply to that document):

-

Inertial device for the stimulation of the pelvic floor muscles with energy accumulation, intended to be introduced into a user's vagina (paragraph 4), which comprises at least one hollow body (10), where within at least one hollow body (10) there is freely available at least one inner ball (13) capable of moving due to the force of gravity and the inertia of the user's movements and impacting on an internal surface (20, 21) of the hollow body ( 10).

However, in D01 it is not anticipated that:

-

The inner surface of the hollow body is provided with facets, where the facets form a certain angle with adjacent facets so that the inner ball resting on a facet must accumulate a certain energy to move and hit an adjacent facet.

The feature of the internal surface with facets has not been found anticipated by the prior art, neither in D01 nor in the rest of the documents cited in the report. As indicated in the description of the application, among other effects and advantages with the solution given by that characteristic, “The use of facets in the device guarantees that the energy that the ball carries when changing facets is above a minimum threshold value, which is given by the shape of the edges of the facets and the angle that the facets form; thus, the inner ball or balls are held by the facets until the angle of the vector adds up to the weight and the inertia of the movement exceeds that of the facets, at which point the inner ball or balls begin their movement, in a controlled manner towards adjacent facets. This ensures that the impact (involuntary and automatic response that occurs in the pelvic floor muscles as a result of the energy of the inner ball or balls) is also above a minimum threshold value, so that the device provides a better, more stable and effective stimulation of the nerve receptors of the tissues in contact with the device ”.  WRITTEN OPINION Thus, with this characteristic a technical effect is achieved that is not considered obvious to a person skilled in the art. Thus, the documents cited 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. The second to twelfth claims, all dependent on the principal, delimit additional optional and non-essential features, and like the first claim, these dependent claims also meet the requirements with respect to novelty and inventive activity.