FR3095336A1 - Pelvic diaphragm stretching and muscle training device - Google Patents

Abstract

TITLE: Device for stretching and muscle training of the pelvic diaphragm The invention relates to a device (10) for stretching and training the pelvic muscular diaphragm. The device includes: a base body (12) extending between a distal end and a proximal end, the base body (12) including a distal end portion and a gripping member, the distal end portion defining the distal end and having two opposite lateral faces (28, 30) in a transverse direction (T), the gripping element defining the proximal end, and two lateral balloons (14, 16), each lateral balloon (14, 16) being attached to one of the respective lateral faces (28, 30), each lateral balloon (14, 16) being designed to be inflated, in particular with air or physiological serum, to come to rest laterally on the pelvic muscular diaphragm. Figure for abstract: figure 2

Description

Device for stretching and muscle training of the pelvic diaphragm

The present invention relates to a device for stretching the pelvic muscular diaphragm for its preparation prior to childbirth.

During childbirth, the bony posterior part of the small pelvis constituted by the sacrum and the coccyx moves backwards (bony nutation), and the lateral and postero-inferior tissues which create a viscoelastic assembly undergo a stretching towards the down and back.

Such tissues are elastic up to a certain limit and then become anelastic, which means that the tissues do not return to their original shape and there is still elongation. If the stretching is too great, the tissue limit known as the compliance limit is reached and tissue rupture and irreversible tears occur, which can have serious consequences.

These tissues include on the one hand the perineum, made up of a set of soft tissues, and on the other hand the pelvic muscular diaphragm.

The perineum is located below the pelvic muscular diaphragm and includes the rectum and anal canal below the pubococcygeal muscles, as well as the vertical lower part of the vagina. During childbirth, the perineum is very stretched and can be the seat of tears.

To prevent such tears or the need for an episiotomy, perineal preparation stretching devices of the EPI-NO Delphine Plus ® type have been developed.

However, perineal tears are not all of the injuries that can occur during childbirth.

The pelvic muscular diaphragm also undergoes significant stretching during childbirth and can be the site of significant trauma during childbirth, such as muscle tearing, destruction of a more or less important part of the muscles, disinsertion pubic wall muscles and/or denervation of muscles. Trauma is likely to lead to disorders such as genito-pelvic prolapse, stress urinary incontinence and/or chronic neurological pain. This diaphragm is also essential for balancing abdominal pressure and abdominopelvic balance.

These muscle tissues are located too high to be the subject of preventive episiotomies. Moreover, episiotomies of the perineum do not prevent trauma to the pelvic muscular diaphragm which is located higher. Training with a device of the EPI-NO Delphine Plus ® type does not prevent such injuries either.

The object of the invention is to propose a device for stretching and training the pelvic muscular diaphragm making it possible to avoid muscular ruptures by pushing back the elastic stretching limit and the limit of compliance of the tissues of the pelvic muscular diaphragm, as well as 'by thickening muscle tissue, prior to childbirth.

To this end, the subject of the invention is a device for stretching and muscular training of the pelvic muscular diaphragm, comprising:

a base body extending between a distal end and a proximal end, the base body comprising a distal end portion and a gripping element, the distal end portion defining the distal end and having two opposite side faces in a transverse direction , the gripping element defining the proximal end, and

two lateral balloons, each lateral balloon being attached to one of the respective lateral faces, each lateral balloon being intended to be inflated, in particular with air or saline, to come to bear laterally on the pelvic muscular diaphragm.

The side balloons are configured to press on the pelvic muscular diaphragm, in particular the levator pubococcygeus muscles, to allow controlled stretching of said muscles, so as to gradually stretch, more particularly from session to session, the muscular tissues and push back their elastic and complacency limits, as well as a weight training exercise for said muscles in counter-thrust on the side balloons, in particular so as to thicken the muscles concerned. The rigid basic body makes it possible to place the side balloons facing said pubococcygeal levator muscles.

This then makes it possible to limit the risk of tearing of muscle tissue, but also is likely to strengthen muscle or fibro-fascial attachments.

The stretching and muscle training device may also have one or more of the characteristics below, considered individually or in all technically possible combinations:

each of the side balloons is capable of being inflated to a dimension in the transverse direction greater than 4.0 centimeters;

the base body comprises a telescopic system configured to modify the distance between the distal end and the proximal end;

the telescopic system is integrated in the gripping element so that a main dimension of the gripping element is variable;

the basic body is provided with a visual cue corresponding to a vaginal depression of the lateral faces at the level of the pelvic muscular diaphragm;

the device comprises at least one supply channel for the side balloons, the base body defining a central orifice, the supply channel passing through the base body through the central orifice;

the distal end portion has the shape of a bowl;

the device has a median plane of symmetry, the transverse direction being perpendicular to the median plane;

the gripping element extends along a proximal main axis, the distal end portion extending along a distal main axis

the distal main axis and the proximal main axis form between them an angle of between 130° and 140°, more particularly equal to 135°.

The invention further relates to a method of using and muscle training a device for stretching the pelvic muscle diaphragm prior to childbirth, comprising the following steps:

provision of a stretching and muscle training device as described above,

grasping the handle,

inserting the stretching and muscle training device into a vagina through the distal end until reaching the pelvic muscle diaphragm of a user, and

side balloon inflation.

Other characteristics and advantages of the invention will emerge from the detailed description given below, by way of indication and in no way limiting, with reference to the appended figures, among which:

- Figure 1 is a schematic side view of the base body of a stretching and muscle training device according to one embodiment of the invention,

- Figure 2 is a schematic top view of the device of Figure 1, and

- Figure 3 is a schematic view of a use of the device of Figures 1 and 2.

A device 10 for stretching and muscular training of the pelvic diaphragm according to a first embodiment is shown in the figures.

Device 10 has a median plane P of symmetry.

The device 10 is designed to be inserted such that the median plane P of symmetry corresponds substantially to the median sagittal plane of a user.

The device 10 comprises a base body 12 and two side balloons 14, 16.

A side view of the base body 12 is shown in Figure 1.

The base body 12 is symmetrical with respect to the median plane P of symmetry.

In the example shown, the base body 12 is rigid, i.e. it maintains its shape during intended use of the device.

The base body 12 is made of a biocompatible material.

The base body 12 is, for example, made of medical silicone.

Alternatively, the base body 12 is made of an alternative biocompatible sterilizable material.

The base body 12 has an anterior face A intended to face the anterior wall of the vagina and a posterior face P intended to face the posterior wall of the vagina. The base body 12 extends between a distal end 18 and a proximal end 20.

The device 10 is intended to be inserted into the vagina through the distal end 18.

The distal end 18 and the proximal end 20 are spaced apart by a distance strictly greater than 5.0 centimeters.

More particularly, the base body 12 comprises, more particularly consists of, a distal end portion 22 defining the distal end 18 and a gripping element 24 defining the proximal end 20.

The front face A is here convex between the gripping element 24 and the distal end portion 22 and the front face P concave between the gripping element 24 and the distal end portion 22.

This allows in particular to adapt to the female morphology.

The distal end portion 22 having two opposite side faces 28, 30 along a transverse axis T extending in a transverse direction.

The transverse direction is perpendicular to the median plane.

Each side face 28, 30 here has a through hole.

Each side face 28, 30 has an attachment interface I.

The distal end portion 22 extends mainly along a distal main axis Dd. The distal main axis Dd is perpendicular to the transverse direction.

The distal end portion 22, more particularly the anterior face A of the distal end portion, delimits a bowl shape 26.

The bowl 26 is defined hollow in the distal end portion 22

The bowl 26 has a dimension in the direction of the distal main axis Dd of between 4.0 centimeters and 5.0 centimeters, more particularly equal to 4.5 centimeters.

The bowl 26 has, for example, an elliptical flat shape.

The gripping body 24 extends mainly along a main proximal axis Dp. The proximal main axis Dp is perpendicular to the transverse direction.

The gripping body 24 has a dimension strictly greater than 6.0 centimeters, more particularly between 6 centimeters and 12 centimeters, along the proximal main axis Dp.

More particularly, the gripping body 24 is a cylindrical section having as its axis the main proximal axis Dp.

The distal main axis Dd and the proximal main axis Dp form between them an angle α of between 130° and 140°, more particularly equal to 135°. This makes it possible in particular to adapt particularly to the female anatomy, in particular to spare the urethral canal at the front of the device 10.

The base body 12, more particularly here the gripping element, is advantageously provided with a visual marker 32 corresponding to a vaginal depression of the lateral faces 28, 30 at the level of the pelvic muscular diaphragm.

Mark 32 is, in the example shown, a mark on the grip body spaced 5.0 centimeters from distal end 18.

The marker 32 is, for example, a mark on the base body 12 to be aligned with the entrance to the vagina or to be inserted into the vagina until it disappears only to obtain the desired depression.

In the embodiment shown, the base body 12 defines a central orifice 34.

The central orifice 34 here extends from the proximal end 20 to each of the side faces 28, 30.

This allows in particular the passage of duct(s) as seen below.

More particularly, the base body 12 is here hollow.

This also makes it possible to limit the mass of the base body 12.

The base body 12 further comprises a telescopic system 36 configured to modify the distance between the distal end 18 and the proximal end 20 of the base body 12.

The telescopic system 36 is, for example, integrated into the gripping element 24, so that the dimension of the gripping element along the proximal main axis Dp is variable.

This makes it possible in particular to adjust the size of the device to the morphology of the user.

Each side balloon 14, 16 is attached to one of the respective side faces 28, 30, more particularly on the whole of the attachment interface I of the corresponding side face.

Each side balloon 14, 16 is designed to be inflated, in particular with air or physiological saline.

Each of the side balloons 14, 16 is capable of being inflated to a dimension in the maximum transverse direction of between 4.0 centimeters and 5.0 centimeters.

In particular, this makes it possible to achieve an overall volume corresponding to the head of a baby at birth, which has a diameter of approximately 9 cm.

The lateral balloons 14, 16 are configured to come to rest laterally on the pelvic muscular diaphragm, more particularly on the pubococcygeal levator muscles.

In the example shown, each side balloon 14, 16 is attached to the base body 12 at a respective side face 28, 30.

Alternatively, in an embodiment not shown, each side balloon is an integral part of the respective side face. The respective side face has, for example, an elasticity allowing it to swell.

Each side balloon 14, 16 is made of a biocompatible material.

Each side balloon 14, 16 is, for example, medical silicone.

Alternatively, each side balloon 14, 16 is made of an alternative biocompatible material that can be sterilized or is disposable.

The device 10 further comprises at least one supply channel 38 of the side balloons 14, 16.

More particularly, the device includes a single supply channel 38 for the side balloons. The single supply channel is here able to inflate the side balloons simultaneously.

The supply channel 38 passes through the base body 12 through the central orifice 34. The supply channel 38 extends from each orifice passing through the side faces, through the central orifice 32 and emerges outside from the central orifice 32 after the proximal end 20.

In one embodiment, the inflation of the balloons is provided to be carried out manually, for example using a manual pump connected to the supply channel 38. This in particular allows a user to control the inflation of the balloons according to the feelings felt.

The device 10 further comprises, for example, a display of one or more parameters related to the inflation of the lateral balloons, such as the volume of each balloon or balloons and/or the pressure exerted by the balloons on the tissues.

In particular, this allows a user to have feedback to verify proper use of the device or to visualize progress in muscle training.

Alternatively, the device comprises automated management members allowing the command, control and regulation of the inflation of the balloons.

In an alternative embodiment not shown, the stretching device further comprises a central balloon, the central balloon being intended to be inflated. The central balloon is placed symmetrically with respect to the median plane of symmetry of the device.

The central balloon is attached to the base body at an attachment interface, more particularly on the posterior surface. More particularly, the central balloon is fixed on a posterior face of the basic body, that is to say intended to press on the posterior wall of the vagina of a user at the level of the pelvic muscular diaphragm.

The central balloon is farther from the distal end than are the side balloons. Thus, when the device is inserted into a vagina, the central balloon extends under the side balloons.

The central balloon is capable of being inflated to a maximum total diameter of between 6.0 and 8.0 centimeters.

The central balloon makes it possible to exert additional pressure on the pelvic muscular diaphragm by pressing on the side balloons on either side so as to move their respective geometric center towards the distal end.

The device includes a secondary central balloon supply channel. The secondary supply channel crosses the base body from the proximal end to the central balloon attachment interface. The central balloon is capable of being inflated independently of the side balloons and vice versa.

A method of stretching and muscular training of the pelvic muscular diaphragm prior to childbirth using a device according to the embodiment shown will now be described.

The process includes the following steps:

provision of a stretching and muscle training device as described above,

grasping the handle,

insertion of the device from the distal end until it reaches the pelvic muscular diaphragm of a user, for example using marker 32, and

inflation of the side balloons, for example with air or saline.

Figure 3 shows a schematic view of an inserted device.

More particularly, the device 10 is used regularly during different sessions by a user so as to train the pelvic muscular diaphragm prior to childbirth.

The sessions are, for example, spaced out by a time interval of between 24 hours and three days.

The inflation of the side balloons 14, 16 gradually increases during the sessions.

During the last sessions scheduled before delivery, each lateral balloon 14, 16 is here inflated to a dimension in the transverse direction of between 4.0 centimeters and 5.0 centimeters, more particularly equal to 4.5 centimeters.

In particular, this makes it possible to achieve an overall volume corresponding to the head of a baby at birth, which has a diameter of approximately 9 cm.

Furthermore, the device 10 is placed so that the side balloons 14, 16 press against the pelvic muscular diaphragm, more particularly against the levator pubococcygeus muscles 100, and not against the perineum 110.

The telescopic system 36 of the base body 12 is adjusted, such that the marker 32 is correctly placed, for example that the marker 32 is aligned with the entry orifice of the vagina or that the marker is just inside the vagina.

The process of using and muscle training a pelvic muscle diaphragm stretching device prior to childbirth with a central balloon is similar, with the central balloon also being gradually inflated in an increasing manner over the sessions.

The active muscular exercise in counter-thrust on the balloons of a device according to the invention allows a training, more particularly a thickening, of the muscles of the muscular diaphragm, but also a reinforcement of the muscular attachments. This allows in particular a greater stretching of the muscles and thus an easier birth.

The stretching pressure is also exerted evenly on the muscle mass of the levator muscles without weighing on the perineum.

The aim sought in accordance with the invention is to obtain, after several sessions of progressive stretching in the inflated state, an assembly consisting of the basic body and the balloons which can reach without resistance a diameter of 9 cm corresponding to the head of a baby at birth.

The device thus makes it possible to bring, step by step and in several sessions, the pelvic muscular diaphragm to a level of stretching and preventive muscular thickening allowing the passage of a baby's head without the complacency threshold having been able to be reached, therefore without irreversible tissue tearing.

The stretching is done in a progressive and differential way on the muscular posterolateral parts of the thickest pelvis.

After birth, the tissues regain their elasticity potential while retaining part of the elongation caused; there will then occur a physiological involution without sequelae scar of a rupture.

The device thus makes it possible to gradually reach the required dimensions without tearing and/or tearing of the muscles which constitute non-reversible scars. On the contrary, a non-torn but distended tissue can regain most of its qualities during hormonal decline or accompanied by therapeutic physical stimulation or muscular exercise.

Claims (10)

Apparatus (10) for stretching and muscular training of the pelvic muscular diaphragm, comprising:
a base body (12) extending between a distal end (18) and a proximal end (20), the base body (12) comprising a distal end portion (22) and a gripping element (24), the distal end portion (22) defining the distal end (18) and having two opposite side faces (28, 30) in a transverse direction (T), the gripping element (24) defining the proximal end (20), And
two side balloons (14, 16), each side balloon (14, 16) being attached to one of the respective side faces (28, 30), each side balloon (14, 16) being intended to be inflated, in particular by air or physiological serum, to come to rest laterally on the pelvic muscular diaphragm. A stretching and muscle training device (10) according to claim 1, wherein each of the side balloons (14, 16) is capable of being inflated to a dimension in the transverse direction of between 4.0 centimeters and 5 .0 centimeters. A stretching and muscle training device (10) according to claim 1 or 2, wherein the base body (12) includes a telescopic system (36) configured to vary the distance between the distal end (18) and the proximal end (20). A stretching and muscle training device (10) according to claim 3, wherein the telescoping system (36) is integrated into the gripping element (24) such that a major dimension of the gripping element ( 24) is variable. Device (10) for stretching and muscle training according to any one of claims 1 to 4, in which the base body (12) is provided with a visual mark (32) corresponding to a vaginal depression of the lateral faces (28, 30) at the level of the pelvic muscular diaphragm. Device (10) for stretching and muscle training according to any one of claims 1 to 5, comprising at least one supply channel (38) of the side balloons (14, 16), the base body (12) defining a central orifice (34), the supply channel (38) passing through the base body (12) through the central orifice (34). A stretching and muscle training device (10) according to any one of claims 1 to 6, wherein the distal end portion (22) is cup-shaped. Device (10) for stretching and muscle training according to any one of claims 1 to 7, having a median plane (P) of symmetry, the transverse direction being perpendicular to the median plane. Device (10) for stretching and muscle training according to any one of claims 1 to 8, in which the gripping element (24) extends along a main proximal axis (Dp), the distal end portion ( 22) extending along a distal main axis (Dd). Device (10) for stretching and muscle training according to claim 9, in which the distal main axis (Dd) and the proximal main axis (Dp) form between them an angle (α) comprised between 130° and 140° °, more particularly equal to 135°.