WO2023031867A1

WO2023031867A1 - Device for the rehabilitation of the perineal plane of a patient

Info

Publication number: WO2023031867A1
Application number: PCT/IB2022/058254
Authority: WO
Inventors: Marco Testa; Ottavia BUCCARELLA
Original assignee: Marco Testa; Buccarella Ottavia
Priority date: 2021-09-06
Filing date: 2022-09-02
Publication date: 2023-03-09
Also published as: IT202100022925A1

Abstract

Device for the rehabilitation of the perineal plane of a patient comprising a perineal contact element (1) comprising an outer casing (10) and an inner chamber (11), which inner chamber (11) is filled with a pressurised fluid. The perineal contact element (1) is configured to be positioned at the patient's pelvic floor, with the outer casing (10) in contact with the patient's body, there being present detection means (12) for detecting the pressure of said fluid, there also being present acquisition means for acquiring the signal detected by said detection means (12).

Description

DEVICE FOR THE REHABILITATION OF THE PERINEAL PLANE OF A PATIENT

The present invention relates to a device for the rehabilitation of the perineal plane of a patient .

The perineal plane is a supporting musculo-fascial structure that plays a fundamental role in the visceral functions of urination and defecation and in the sexual function .

Numerous pathological conditions can lead to a dysfunctional state of the perineal musculature with dramatic consequences for the quality of life of the affected individual .

Among these , urinary incontinence has a high prevalence , particularly among menopausal women , but it is also present in men as a result of radical prostatectomy .

The perineum is a muscular structure and its correct functioning requires it to be able to express an adequate level of strength , resistance and coordination of the muscles that compose it , in relation to the different functions it expresses . A too high muscle tone is often associated with chronic pelvic pain , whereas decreased muscle tone , contraction strength , and resistance are associated with urinary incontinence .

In such situations , perineal rehabilitation , which basically consists of regaining strength , resistance and coordination of the contraction of the perineal musculature , constitutes the primary therapeutic intervention .

Pelvic floor re-education is commonly carried out by using electromyographic or pressure biofeedback instrumentations that record respectively the electrical activity generated by the muscle contraction or the narrowing of the vaginal or rectal ostium through endovaginal or endorectal probes .

In addition , these devices are often provided with an electrostimulator for the perineal muscles , thus envisaging electrical stimulation of the perineum as a treatment for the recovery of strength . This type of intervention is invasive and often poorly tolerated and is generally carried out under the direct control of the operator in specialised facilities , limiting the applicability thereof and increasing the costs of the intervention .

However , the patients generally have difficulty in contracting the perineum, as they cannot control it directly and precisely .

There is therefore a need, not satisfied by the devices known in the state of the art , to realize a device for the rehabilitation of a perineal plane that solves the disadvantages set out above , in particular that allows an effective rehabilitation to be carried out by helping the patient to manage the perineal contraction , in a non-invasive manner and with maximum autonomy .

The present invention achieves the above purposes by realizing a device for the rehabilitation of a perineal plane of a patient comprising a perineal contact element with an outer casing and an inner chamber , filled with a pressurised fluid . The perineal contact element is configured to be positioned at the patient ’ s pelvic floor , with the outer casing in contact with the patient ’ s body .

It is specified that the perineal contact element is configured to be positioned outside the user ’ s body , in contact with the pelvic floor .

Furthermore , there are detection means for detecting the pressure of the fluid, as well as acquisition means for acquiring the signal detected by the detection means .

The contact element is an element aimed at detecting and recording the contractions of the muscles of the perineal plane leading to volumetric and morphological variations of the surface of the perineal plane that cause pressure variations in the contact element placed in contact with the perineal plane .

For this reason , the perineal contact element may have any form, functional to the detection of pressure variations .

As will be described below, through the illustration of some exemplary embodiments , the contact element may consist of an elongated element .

The present invention realizes a device that has a part to be positioned at the perineal plane of a patient and that allows recording the contractions of the patient ’ s perineum.

The contractions of the perineum have in fact repercussions on the anatomical shape of the perineal plane and of the surrounding area .

In particular , the contraction and the release of the perineal musculo-fascial plane are respectively associated with its ascent and its descent with respect to the pelvic bone structures on which it is inserted . A variation in the surface associated with the contraction and release condition is therefore highlighted .

In humans , the variation in the surface of the perineum is made even more evident by the increased prominence of the cavernous bulb muscle that enters into synergistic contraction with the rest of the perineal plane (which at the same time ascends) .

It follows that , by positioning the contact element between a seated patient and a rest plane , variations in the shape of the anatomical surface will cause a variation in the pressure of the fluid present in the inner chamber , thanks to the contact between the outer casing and the patient .

The recordings of the variations in the pressure of the inner chamber , will therefore allow to evaluate the contraction of the perineum of a patient , in a simple and non-invasive way .

As described and as will be illustrated below, the device subject-matter of the present invention is designed for external use only .

The pressure variation detected by the device is not the result of the narrowing of the surrounding orifice , but it is based on the anatomical -functional observation that includes , during a contraction of the pelvic floor muscles , that there is a swelling of the outer surface of the pelvic floor .

This stiffening is recorded externally, through a reliable evaluation of the pressure variations caused by the swelling , or by modifications , of the pelvic floor during contraction .

Furthermore , the device subject-matter of the present invention does not envisage using any electrical stimulus , but it is limited to measuring exclusively the voluntary contractions of the user , which result in pressure variations , which can , as will be seen later , be made visible to the user , so as to perform a correct rehabilitation of the musculature , through a strengthening of the pelvic floor .

The device subject-matter of the present invention , unlike the systems known in the state of the art, does not record intra-abdominal pressure , but the variation of the outer surface of the pelvic floor .

As will be apparent from the description of some features of the device subject-matter of the present invention , such a device facilitates the rehabilitation of the patients , which can be carried out comfortably in any place and at any time , without the presence of specialised personnel .

For this reason , one of the numerous advantages of the device subject-matter of the present invention is its portability .

In fact , according to a first embodiment , the contact element comprises a portion consisting of an outer box of rigid material , inside which at least the acquisition means and a supply unit of said detection means are housed .

As will be described later , through the illustration of some embodiments , such an outer rigid box may be provided in combination with a housing intended to house the outer casing .

A reclosable device is thus realized inside a housing to increase the portability thereof and above all to obtain a rigid housing capable of avoiding impacts of the sensitive part , i . e . of the outer casing , with objects that may damage its operation . The presence of the housing also allows to confer privacy to the device subject-matter of the present invention , realizing an "anonymous" device , whose characteristics and functionality are hidden by the housing .

As anticipated, the detection means for detecting the pressure in the inner chamber are intended to transform the pressure variations caused by the muscle contraction of the perineal plane into a variation of an electrical signal , which is then transmitted to the acquisition means .

It is possible to envisage that the device subject-matter of the present invention processes the information detected and stores it within the designated storage units , which can then be connected to a remote unit for further processing , a display or an analysis for diagnostic/rehabilitation purposes .

As an alternative or in combination with the configuration just described, with the aim of realizing a simple and more reliable device , the processing and the storage of the data can be delegated to a remote unit .

For this reason , according to a preferred embodiment , there are communication means for communicating the signal detected by the detection means to a remote unit .

Preferably, such communication means are wireless communication means .

In addition to the advantages set out above , the presence of communication means for communicating the detected data makes it possible to realize a "telerehabilitation" and "tele-diagnosis" system, in which a doctor or a specialised operator , in synchronous or asynchronous mode , can provide the patient with instructions on the basis of the detected data , which are detected and transmitted in real time to the specialised personnel and in combination or alternatively can be made known to the patient .

As described, the device subject-matter of the present invention takes care of recording the contractions of the perineal musculature of a patient to carry out perineal plane rehabilitation .

In the rehabilitation process , the evaluation and monitoring of the correctness of the rehabilitation exercise , both by the operators and, above all , by the users , is of fundamental importance .

For this reason , according to an implementation variant , there are response signal generating means based on the pressure values detected by the detection means .

These means generate feedback signals that allow an immediate evaluation to be obtained regarding the correct execution of the rehabilitation exercise .

Such means may be integrated within the device and/or within the remote unit .

A possible example of such response signal generating means may consist of audio signal generating means .

For example , it may be possible to envisage that the device and/or a remote unit , emit an acoustic signal in case a correct contraction of the perineal musculature is detected .

In addition , the acoustic signal may vary frequency/volume based on the intensity of the detected contraction . As an alternative or in combination with the configuration just described, all response signal generating means known in the state of the art can be envisaged .

Among these , video signals , which can be generated through a display unit in communication with the device subject-matter of the present invention , are particularly advantageous .

Also in this case , the display unit allows to evaluate not only the presence of the contraction , but above all the intensity of the same .

As described above , the inner chamber is filled with a pressurised fluid, so that variations in the anatomical shape cause volumetric variations of the inner chamber and consequent pressure variations .

The pressure detection means are therefore an advantageous way to evaluate the contraction of the perineal musculature and the most reliable solution , able to detect even minimal variations .

The pressure variation is caused by a volumetric variation of the inner chamber .

In a view of recording pressure variations , it would be preferable for the outer casing to be as non- extensible as possible , so as to prevent the yieldability of the walls of the outer casing from absorbing , even partially, pressure variations .

However , if dimensional variations of the outer casing were detected, directly connected to the volumetric variations , a device of the strain gauge type or the like , in combination or as an alternative to the pressure detection means may be envisaged .

Regardless of the detection means used, it is possible to envisage any fluid for filling the inner chamber , provided that it allows a volumetric variation to be obtained from the contact element in the event of a variation in the forces acting on the contact element itself .

Fluids at different densities , such as , for example , water , viscous silicone , air , or the like , may thus be provided .

However , the use of air has specific advantages .

In fact , in combination with the filling of the inner chamber with air , it is possible to envisage inflation/deflation means configured to introduce air into the inner chamber .

The activation/deactivation of the inflation/deflation means allows to switch from a collapsed condition to an expanded condition of the elongated element .

It is evident that in the collapsed condition of the contact element , the device subject-matter of the present invention further increases the portability of the device itself , thanks to a significant decrease in the overall dimensions .

This feature is particularly advantageous in combination with the presence of the outer housing , described above , since the sizes of the housing can be reduced, in order to house the contact element exclusively in the collapsed condition .

According to an improvement , as will be illustrated later , the inflation/deflation means are arranged inside the outer box of rigid material .

According to a further embodiment , the detection means comprise a plurality of pressure sensors arranged along the surface of the casing . This expedient makes it possible to detect not only the intensity of the contraction , but also the distribution along the casing , that is , along the contact element .

This characteristic is an important improvement compared to the rehabilitation techniques known in the state of the art .

In fact , the invasive rehabilitation techniques known in the state of the art require a generalized contraction of the perineal plane , they can lead to an undesirable hypertonus at the expense of the anal sphincter and fail to direct the muscle contraction to a precise portion of the perineal plane , necessary for an effective rehabilitation , whereby an evaluation of the distribution of the pressures is particularly useful .

The variation of the pressures along the outer casing , i . e . the distribution of the loads , can also be analysed using a plurality (matrices) of pressure sensors arranged on the surface of the casing in contact with the user ’ s body .

In addition , muscle contraction can be mapped by positioning a matrix of electromyographic electrodes on the elongated element in contact with the patient ’ s perineal plane .

In practice , a surface electromyographic recording is obtained by applying the device directly on the patient ’ s skin .

These and other features and advantages of the present invention will become clearer from the following disclosure of some exemplary embodiments illustrated in the accompanying drawings in which : figure 1 illustrates an exemplary diagram of a possible embodiment of the device subject-matter of the present invention ; figure 2 illustrates a further embodiment of the device subject-matter of the present invention ; figure 3 illustrates a flowchart relating to the operation of the device subj ect-matter of the present invention .

It is specified that the figures appended to this patent application illustrate only some possible embodiments of a device for the rehabilitation of the perineal plane of a patient subject-matter of the present invention , to better understand the advantages and characteristics described .

Such embodiments are therefore to be understood for purely illustrative purposes and not limited to the inventive concept of the present invention , namely to provide a device capable of performing rehabilitation on the patient in a non-invasive manner and of obtaining a recording of the contraction of the perineal musculature through the detection of the volumetric variation of the elongated element .

With particular reference to figure 1 , an embodiment of the device subject-matter of the present invention is illustrated .

The device has an elongated element 1 comprising an outer casing 10 and an inner chamber 11 , filled with a pressurised fluid.

The elongated element 1 may be of any shape , it consists of an anatomical bearing consistent with the anatomy of the lower pelvic outlet, preferably a generically elongated oval -shaped structure , so that it can be positioned at the patient ’ s pelvic floor , with the outer casing 10 in contact with the patient ’ s body .

The elongated element 1 thus follows the anatomical profile of the perineal area of the patient and, in particular in men , must rest on the front part of the pelvic floor .

In women , the recording of the pressure variations of the outer casing takes place in the central area of the perineal plane , particularly in the area between the vagina and the anus , as these variations are caused by an ascent of the tendon centre .

As anticipated, the elongated element 1 is configured to detect pressure variations of the fluid, which represent a timely indication of the variation in the state of muscle contraction .

For the fluid pressure variations in the inner chamber 11 to be detected , the elongated member 1 has a pressure sensor 12 .

As anticipated, a plurality of pressure sensors evenly distributed along the elongated element , preferably at the part of the outer casing 10 in contact with the patient ’ s body, can be envisaged .

With particular reference to figure 1 , the sensor 12 is positioned inside the inner chamber 11 , but it is possible to envisage any positioning , depending on the type of pressure sensor 12 used .

In fact , the fluid pressure variations are detected independently of the point of the outer casing 10 disturbed by the contraction of the perineal musculature .

The most effective contraction is the one which is performed in the anterior portion of the perineum and in men it manifests itself through a thrust of the outer casing 10 in the direction of the inner chamber

10 , with consequent increase in the fluid pressure , whereas in women it manifests itself as a lift of the perineal plane , with consequent decrease in the fluid pressure .

With particular reference to figure 1 , the device subject-matter of the present invention has a soft part , consisting of the casing 10 and the inner chamber

11 , and a rigid part, consisting of the outer box 2 , adapted to contain all the electronics necessary for the operation of the device .

In particular , there is a battery 20 intended to power at least the pressure sensor 12 .

Inside the element 20 it is possible to integrate , in addition to the battery, also acquisition means for acquiring the signals detected by the pressure sensor 12 .

The pressure variation signal is thus transmitted from the sensor 12 to the acquisition means , which , according to the illustrated embodiment , do not take care of any processing of the signals , except , preferably, for a transformation of the electrical signals into digital signals .

The outer box 2 also has signal transmission means , consisting of a transmission module 21 of the Bluetooth® type or the like , aimed at transmitting the detected data to a remote unit 3 , such as a personal computer or the like .

The remote unit 3 comprises processor means for the execution of a logic program, intended for processing the data received from the device subjectmatter of the present invention and displaying them through a display interface 31 . The display unit 31 allows for immediate feedback about the rehabilitation exercises carried out by the patient .

The operation of the device subject-matter of the present invention will be described in detail later and in relation to figure 3 , but it is evident as of now, how both the patient and a specialised operator can view the extent of the contractions carried out by the patient during the rehabilitation exercise , both in presence and remotely, in synchronous or asynchronous mode , in the event of tele-rehabilitation .

The display interface 31 will specifically show a graph relating to the trend of the contractions : it will therefore be possible to evaluate the muscle contraction and release , as well as the relative contraction times and/or interval between the contractions and constitute a source of retroactive information to correct the mode and intensity of the perineal contraction in support of a specific rehabilitation process .

It is evident how this configuration allows a patient to perform exercises of the perineal plane even in the absence of a specialised operator .

In fact , once the values of the contractions , specific to the patient , have been recorded, it is possible to envisage a software application that checks the correctness of the contractions performed, in terms of the amplitude of the contractions and of the release/stimulus intervals .

Starting from this concept , it is then possible to envisage all the features of rehabilitation software applications known in the state of the art , such as audible warning signals in case the desired contraction values are reached or not , programming of rehabilitation exercises and similar characteristics .

For example , the processing means of the remote unit 3 could be configured to load software applications related to video games to support the rehabilitation process .

According to the embodiment illustrated in figure 1 , the inner chamber 11 is filled with air .

The use of air as filling fluid of the inner chamber 11 has no particular advantages on pressure detection compared to other fluids , but it is particularly advantageous as it is possible to provide for inflation/deflation means of the inner chamber 11 .

In this case , the inflation/deflation means consist of a small-sized compressor 22 , also powered by the battery 20 .

The compressor 22 draws ambient air through special slots provided in the rigid outer box 2 and introduces this air inside the inner chamber 11 for the inflation thereof , until the desired pressure is reached .

The operation of the compressor 22 may be completely similar to the compressors present within the electronic sphygmomanometers known to the state of the art .

The presence of the compressor 22 may also be provided in combination with a filling fluid of the inner chamber 11 other than air .

In this case , however , the realization of the device subject-matter of the present invention would be more complex , since it would be necessary to envisage a fluid tank , integrated or connectable to the outer box 2 , worsening the portability characteristics of the device itself .

In any case , the presence of the compressor 22 allows switching the outer casing 10 and the inner chamber 11 from an expanded condition , in which air has been blown inside the inner chamber 11 until the desired pressure has been reached, to a collapsed condition , in which a large part of the air has been expelled from the inner chamber 11 .

Figure 1 illustrates the expanded condition of the outer casing 10 and of the inner chamber 11 , i . e . the operating condition , in which it can be used to perform the processing exercises .

In the collapsed condition , the outer casing 10 and the inner chamber 11 decrease in size due to the absence of the fluid pressure .

Figure 2 illustrates such a condition , in which the casing 10 and the inner chamber 11 are in a collapsed condition and can be inserted into a housing 4 .

The housing 4 can be constituted by a box-like element , which has the same section as the outer box 2 , so as to cooperate with the edges thereof and form a single solid, as shown in figure 2 .

The fixing between the housing 4 and the outer box 2 can be done in any of the ways known in the state of the art , such as for example shape coupling , screw or bayonet interlock , magnetic fixing or with special removable fixing means .

The shape taken by the outer casing 10 and by the inner chamber 11 illustrated in figure 2 is only shown by way of example to illustrate that these parts can be folded inside the housing 4 to occupy as little space as possible.

It is also evident that, even in case of absence of the compressor 22, it is possible to envisage a housing 4, simply by varying the sizes thereof, which completely encloses the outer casing 10 and the inner chamber 11, with no need for them to be provided in a collapsed condition.

Based on the characteristics described above, figure 3 illustrates a flowchart suitable for describing a possible operation of the device subjectmatter of the present invention.

The device, in an expanded condition, is positioned at the perineal plane of a patient, in contact with the patient, who is in a seated position on a rest plane, step 100.

As described above, in case of presence of electromyographic sensors on the outer casing 10, it is necessary for this casing to be in direct contact with the patient’s skin.

Alternatively, the patient may also be dressed to perform the rehabilitation exercises.

Once the device has been positioned, an offset is performed, step 101.

Preferably the offset step 101 is carried out via software, i.e. through the software application loaded on the remote unit 3.

A command that resets the system is then envisaged, i.e. when the patient is still, with the device positioned, the pressure value of the fluid inside the inner chamber 11 is identified and the subsequent pressure variations are compared on the basis of this value. Once the offset is initiated, the patient may start rehabilitation exercises , through voluntary contractions of the perineal musculature , step 102 .

Each contraction is recorded, step 103 and displayed on the display unit 31 , step 104 .

Steps 102 and 103 will then be repeated throughout the duration of the rehabilitation exercise , so that the display unit 31 displays a graph indicating the trend of the contractions , as described above .

Based on the characteristics described above , the pressure sensor converts the pressure variations into an electrical signal , which is preferably converted into a digital signal , through an analogue/digital conversion .

For this reason , according to the embodiment variant illustrated in figure 3 , an amplification step 105 is envisaged .

The amplification step 105 allows a correct display of the recorded signal to be obtained, i . e . so as to make the signal graphically representable and interpretable , especially by the patient and by the operator .

Furthermore , the presence of the amplification step 105 is also advantageous in the case of a female patient .

In fact , as described above , in women the contraction of the perineal musculature causes only the perineal plane to lift without the protrusion of the anterior portion of the cavernous bulb muscle present in men .

A slight decrease in fluid pressure is thus obtained and not an increase thereof , which is more difficult to detect . The amplification step 105 is therefore done via software , but it is possible , alternatively or in combination , to vary the mechanical characteristics of the device subject-matter of the present invention , so as to make this decrease in fluid pressure more detectable .

For example , it is possible to modify the shape of the elongated element , which may consist of a rounded structure pre-filled with fluid to be positioned below the tendon centre of the perineum.

Once the detected data relating to the contractions are displayed and recorded, they can be stored and possibly sent to a specialised operator .

The specialised operator can also assist live in the execution of the rehabilitation exercises , as the recording is carried out in real time .

Finally, it is specified that it is possible to envisage an integrated storage unit within the device subject-matter of the present invention , so that the patient can carry out his exercises at any time and transmit them at a later time to the remote unit .

From this viewpoint , the remote unit can also consist of a portable device of the smartphone , tablet type or the like .

While the invention is susceptible to various modifications and alternative constructions , some preferred embodiments have been shown in the drawings and disclosed in detail .

It should be understood, however , that there is no intention to limit the invention to the specific illustrated embodiment but , on the contrary, the aim is to cover all the modifications , alternative constructions and equivalents falling within the scope of the invention as defined in the claims.

The use of "for example", "etc." or "or" refers to non-exclusive non-limiting alternatives, unless otherwise stated.

The use of "includes" means "includes but is not limited to", unless otherwise stated.

Claims

1. Device for the rehabilitation of the perineal plane of a patient, characterized in that said device comprises a perineal contact element (1) comprising an outer casing (10) and an inner chamber (11) , which inner chamber (11) is filled with a pressurised fluid, said perineal contact element (1) being configured to be positioned at the patient’s pelvic floor, with the outer casing (10) in contact with the patient’s body, there being present detection means (12) for detecting the pressure of said fluid, there being present acquisition means for acquiring the signal detected by said detection means (12) .

2. Device according to claim 1, wherein said perineal contact element (1) comprises a portion consisting of an outer box (2) of rigid material, inside of which box (2) the acquisition means and a supply unit (20) for said detection means (12) are housed.

3. Device according to claim 1 or claim 2, wherein there are communication means (21) for communicating the signal detected by the detection means (2) to a remote unit (3) .

4. Device according to one or more of the preceding claims , wherein there are response signal generating means based on the pressure values detected by said detection means (12) .

5. Device according to claim 4, wherein said response signals consist of a video signal, displayed through a display unit (31) .

6. Device according to one or more of the preceding claims, wherein said inner chamber (11) is filled with air, there being present inflation/deflation means (22) of said inner chamber (11) , so that said contact element (1) switches from a collapsed condition to an expanded condition and vice versa .

7. Device according to one or more of the preceding claims, wherein said inflation/deflation means (22) are arranged inside said outer box (2) of rigid material .

8. Device according to one or more of the preceding claims, wherein there is a housing (4) intended to house said outer casing (10) , which housing (4) is configured to cooperate with said outer box (2) of rigid material .

9. Device according to one or more of the preceding claims, wherein said detection means comprise a plurality of pressure sensors arranged along the surface of said outer casing (10) .

10. Device according to one or more of the preceding claims, wherein a plurality of electromyographic electrodes are arranged on the surface of said outer casing (10) in contact with the patient’s body.