OF SEXUAL DYSFUNCTIONS

DESCRIPTION

Field of the invention

The present invention refers to the field of medical devices, and more precisely it refers to an apparatus that can be worn by a patient for use in the diagnosis and treatment of sexual ejaculatory dysfunctions.

State of the art

One of the greatest problems that has been found when diagnosing and treating sexual types of pathologies, in particular ejaculatory dysfunctions, is the difficulty of obtaining objective data, considering that the diagnosis procedures to this day have been carried out based upon information based exclusively on the subjective experience of the patient or on the use of timing systems, like chronometers (known as "stopwatch" method). A further problem that has been found in this field is the influence that the therapeutic approach itself can have on the sexual life of the patient, sometimes even worsening the sexual performance thereof even though it may be theoretically suitable for treating the pathology.

In this way, among the sexual dysfunctions that are more problematic to treat there is the class of pathologies related to orgasm. Such dysfunctions mostly affect a wide portion of the male population and are manifested in various pathological conditions like delayed ejaculation, impossibility of ejaculation (or anejaculation) and premature ejaculation; the latter in particular, is the most common sexual dysfunction, with a prevalence rate of 25-40%, and an indiscriminate distribution among men of all ages. Despite the considerable impact on the daily lives and on the interpersonal relationships, people affected by such a dysfunction have a great reluctance to talk to their doctor about it, as occurs moreover for all the other sexual types of disorders, because of embarrassment or for lack of trust in professional help. This has strongly limited to this day the development of diagnostic methods and classifications inherent to such a pathology based on control studies. The classifications and the definition itself of this pathology vary greatly, are often vague, resulting from the consensus of experts and authorities, which are never based on control studies and therefore on objective data. Also the attempts at explaining the aetiology of such a pathology have included a wide range of biological and psychological theories, the majority of which are not based upon facts and solely relate to speculation. Here, we refer to anxiety, first sexual experiences, frequency of intercourse, ejaculation control techniques, hypersensitivity of the penis, hyperexcitability of the ejaculatory reflex, excitability, genetic predisposition (McMahon C.G. et al. "Disorders of orgasm and ejaculation in men" J. Sex Med. 2004; 1 : 58-65; Waldinger, Marcel D. "Premature ejaculation: Advantages of a new classification for understanding etiology and prevalence rates" Sexologies 17.1 (2008): 30-35; McMahon, Chris G. "Dapoxetine: a new option in the medical management of premature ejaculation" Therapeutic Advances in Urology 4.5 (2012): 233-251 ).

In this context it is extremely difficult for the doctor to understand in an unequivocal manner whether and to what extent the patient is sick, and to consequently devise a suitable treatment plan. As in all types of pathologies the main objective is indeed that of being able to solve the problem in the best way possible and quickly. In this case, however, it is impossible to this day to have systems that are secure and reliable that make it possible to classify the patients and thus carry out a correct diagnosis and prescribe a suitable cure. In this context the parameters that are used are few and rather rudimentary:

> Intravaginal ejaculation latency time (IELT); usually calculated by the patient himself by activating a stopwatch;

> number of penetrations between the start of intercourse and ejaculation, evaluated through a special pulsing element, which activates at each thrust of the partner; > the level of satisfaction of the partner;

> evaluation of the voluntary ejaculation control by the patient.

If the first two parameters are based upon data which is in some way objective, since they are measured by the same patient, the same cannot be said for the other parameters, which are related to considerations that are completely personal and thus unsuitable for forming medical advice, due also to the reluctance with which certain topics are tackled by patients. Many studies aim at making questionnaires for diagnostic purposes, like for example Premature Ejaculation Diagnostic Tool (PEDT) described by Symonds T. et al. in Development and validation of a premature ejaculation diagnostic tool. Eur. Urol. 2007; 52: 565-573, but their role is to this day only optional in normal clinical practice.

Also the parameter IELT, which today is actually the most used classification parameter in the studies on premature ejaculation, was treated in various ways concerning the maximum duration for classifying a patient, which varies from 1 to 7 minutes, also due to the absence of an unequivocal definition that provides a fixed maximum duration; for this reason such a parameter is not sufficient to define premature ejaculation.

Moreover, concerning the measuring of such an IELT parameter or the number of penetrations, the devices used to this day are mostly simple stopwatches or thrust counters; in any case these are highly invasive devices, which increase the discomfort of the patient during sexual intercourse, in addition to evaluating parameters that, as explained above, are completely unsuitable in characterising the pathology.

There is therefore a strong desire in the field to have reliable devices, which are not invasive, and that are capable of measuring physiological parameters objectively, unrelated to the subjectivity of the patient and therefore useful to the doctor in order to obtain reliable information for the purpose of carrying out a diagnosis or establishing the most suitable treatment.

Summary of the invention

According to the present invention the state of the art previously described has been improved upon, by providing an apparatus which can be worn by the patient comprising a first device for the application in the lumbosacral area of said patient and a second device for the application at the genital organ of the same patient and connected to said first device by means of a wired or a wireless connection. The first device, which is possibly also suitable for being used by itself, is capable of recording inertial parameters of the movement of the patient and of providing an acoustic, visual or tactile type of feedback to the patient with the purpose of controlling the ejaculatory act, whereas the second device, also suitable for being used by itself, is capable of detecting the dilation of the genital organ to which it is applied and possibly of detecting the inertial parameters of the movement, and/or generating a squeezing or vibration movement on it, again with the purpose of controlling the ejaculatory act.

Therefore, the object of the present invention is an apparatus having essential characteristics according to the first of the attached claims. Further important characteristics are contained in the dependent claims.

A kit comprising the present apparatus, or the aforementioned first device by itself, or the aforementioned second device by itself, and a pharmaceutical product for the treatment of sexual ejaculatory dysfunctions, represents a further object of the invention.

It is a further object of the present invention a method for the diagnosis and/or treatment of male sexual ejaculatory dysfunctions by means of an apparatus or a single device of the abovementioned type.

Thanks to the fact that it can be worn, capable of adhering perfectly to the body of the patient, and having small weight and bulk, the apparatus according to the invention makes it possible to monitor the sexual performance of the patient without interfering in any way with said performance; it is a device that is highly non-invasive, which does not condition either sexual intercourse or the relative diagnostic evaluation of the ejaculatory act in any way. It is moreover easily used by anyone thanks to mechanisms that are easy to use and intuitive.

At the same time the proposed apparatus ensures high accuracy in measuring the relevant physiological parameters, by providing information that is useful to the doctor so as to be able to carry out a diagnosis and decide an approach for the treatment (often also only of the psychological, behavioural, dietary type), then monitoring the effects. The present apparatus is moreover suitable for being used for carrying out self-diagnosis, directly by the patient, who can evaluate his level of sexual performance, observe or exclude a pathological state, without needing external help if not at the moment in which he may need a medical treatment. Of course, this is a great advantage due to the reluctance of men in handling these types of topics: in addition to having a positive impact on the population in physiopathological terms, the present apparatus and its use would especially have a positive effect in terms of a psychological point of view.

Brief description of the figures

The characteristics and the advantages of the apparatus according to the present invention shall become clearer form the following description of an embodiment thereof that is given as an example and not for limiting purposes with reference to the attached drawings, in which:

figure 1 schematically illustrates an embodiment of a first device according to the present invention;

figures 2 and 3 schematically illustrate an embodiment of an apparatus according to the invention, comprising the first device of figure 1 and a second device connected to it, respectively with a wired and a wireless connection;

figure 4 is a view of an embodiment of the invention of the apparatus of figure 2, comprising a first device in which all the components are included in a platelike container, which is connected with wires to a second ring-shaped device;

figure 5 is a view of an embodiment of the apparatus of figure 2, in which the device is included in an adhesive plaster;

figure 6 is a view of an embodiment of the apparatus of figure 2, in which the second device is substantially cylindrical.

Detailed description of the invention

With reference to said figures hereinafter an apparatus according to the invention is described comprising a first device 1 and a second device 2, which are connected through wired or wireless connection and both can be worn by a male who has the need of carrying out a diagnosis and/or a treatment of a sexual dysfunction related to the act of ejaculating. With particular reference to figure 1 , a first device 1 of an apparatus according to the invention comprises two main components, i.e. an inertial sensor 11 , for instance an accelerometric sensor, for detecting the movements of the patient, and means for the generation of feedback signals 12 which, as mentioned above, can be of various nature, visual, acoustic or tactile, for instance it may generate a vibratory, luminous or acoustic signal with the purpose of educating the patient to control ejaculation. Such means for the generation of feedback signals 12 are selected for example from LEDs, loudspeakers and motors.

Again with reference to figure 1 , the device 1 according to the invention may comprise a battery 13 for supplying the device with power, a microprocessor 14 with relative programs for collecting and elaborating data, an integrated memory 15 for recording the data detected by the sensor 1 1 , and communication means 16, that can be connected by means of a wired or a wireless connection to a remote station 17, selected for example from a computer, mobile phone, tablet and the like. Of course, in order to limit the invasivity of the measurement during the sexual act, the wired connection between the device 1 and the remote station 17 is made only at the end of the act for downloading the data detected during the act itself.

The downloading of data detected in the remote station 17 has the purpose of collecting information that is useful for medical-diagnostic purposes, but it is also foreseen for the patient to be able to act upon the remote station 17 for transmitting a control signal to the device, including the turning on and off signals, or voluntary stimulation or squeezing signals on demand by the patient. The data recorded in different sessions are acquired by the device and elaborated in the remote station 17 obtaining behavioural laws that, once loaded onto the microprocessor 14, are used in the following sessions to foresee the specific moment of ejaculation and generate precise actions that are useful for therapeutic purposes, as a function of the data detected during the single sessions.

Such a device 1 , thanks to its functions described above for detecting the movements and generating a corresponding feedback signal to the patient, has both diagnostic and therapeutic purposes: the data detected with the present device are indeed analysed and elaborated so as to obtain information and a behavioural law useful for diagnostic and therapeutic purposes, both after the analysis and critical examination by doctors and for obtaining an immediate feedback from the device itself which is used for educating the patient to exert a control on the ejaculatory act. The apparatus of the invention, through the elaboration of data recorded by a series of previous sexual acts, makes it possible, not only to study the habits of the patient with diagnostic purposes, but also to obtain behavioural laws that can be used for therapeutic purposes during subsequent sexual acts to educate the patient for example to lengthen or shorten the time necessary to obtain the ejaculatory act. The present means for generating feedback signals 12 generate a signal as a function of the history of the sexual performances of the patient and of the predictive behavioural laws from the analysis and elaboration of the data recorded previously and during the sex act in progress, so as to warn the patient and to educate him to a certain frequency and intensity of movements so as to possibly increase the duration of the intercourse until an acceptable ejaculatory act is reached.

The present device 1 is therefore useful both for providing a means for the objective diagnosis of the sexual performances of the patient based upon inertial data, and for educating the patient to time his ejaculation in an acceptable manner so as to vary the sexual performance itself, regulating his activity.

The present device 1 has very small weight and size, with the components included inside an ergonomic container, so as to be easily applied in the lumbosacral area of the patient and make it adhere, for example by means of an adhesive plaster. According to one particularly preferred embodiment of the present device 1 , it may be included directly in a plaster.

The specific position where the device 1 is applied in the lumbosacral area allows an accurate recordal of the acceleration signal related to the patient's movements during sexual activities; as a matter of fact, such an area of the patient's body is in optimal position for recording the oscillatory movement of the patient and contains in average a minimal amount of bodily fat, which could interfere in the detection of the movement.

A second device 2 that is suitable for being applied to the base of the genital organ of the patient, may be connected, through a wired or wireless connection, to the device 1 described above, with diagnostic and therapeutic purposes on the sexual performance of the patient, making the apparatus according to the invention; with particular reference to figures 2 and 3, such a device 2 indeed comprises an actuator 21 that is suitable for generating a compression movement of the channel of the urethra so as to delay the ejaculatory act or, alternatively, a vibration movement for promoting and accelerating the ejaculation according to the type of ejaculatory dysfunction the patient is affected by. Such compression or vibration movements are activated and controlled in intensity and in the duration by the information coming from the device 1 , in particular from the data detected by the inertial sensor, already memorised during previous sessions and/or detected during the sexual intercourse in progress. In the devices 2 intended for patients suffering from premature ejaculation, the device 2 comprises an actuator 21 that is made up of a mechanical or pneumatic system that is suitable for generating the compression on the channel of the urethra; in auxiliary devices intended for patients suffering from ejaculatory latency, the device 2 comprises an actuator 21 that consists of a motor with an eccentric mass that is capable of generating vibration movements for stimulating the genital organ and cause the ejaculation.

The present device 2 is preferably ring-shaped, with dimensions that are suitable for surrounding the base of the genital organ, or has a substantially cylindrical shape with dimensions that are suitable for containing at least one portion of the genital organ starting from its base, or foresees the inclusion of the mechanical or electrical components inside an adhesive plaster, which can be easily applied in the same position so that the squeezing or compression movements, or the electro-stimulation signal, are exerted at the base of the organ. Figure 4 illustrates a device 1 according to the invention in which the components are included inside a plate-like container 3, which is connected with a wired connection 4 to a second device 2 in the shape of a ring 5. In figure 5 the device 1 is provided with an adhesive plaster 6 so as to facilitate the application and the adhesion of the container 3 to the body of the patient. Figure 6 illustrates a variant of the device of figure 5, in which the device 2 has the form of a hollow cylinder 7. A further variant of the device 2 may be in the form of a condom, sensorized with suitable conductors sensitive to deformation, immerged in the material of which the condom is made, for instance latex or silicone.

According to a preferred embodiment of the invention the device 2 is connected to the device 1 with a wireless connection, so as to further reduce invasivity towards the patient; in this case, schematically illustrated in figure 3, the device 2 comprises, in addition to the actuator 21 , a battery 22, a microprocessor 23 for encoding and elaborating the received signals and communication means 24 that are suitable for communicating and exchanging wireless signals with the communication means 16 of the device 1.

According to one particular embodiment of the apparatus of the invention, the device 2 further comprises an inertial sensor, for example an accelerometer or a gyroscope, for detecting the movement data of the patient wearing the device; such data is collected and elaborated inside the remote station 17 together with the data detected by the device 1 , so as to improve the diagnostic ability of the instrument and the generation of a more precise and reliable therapeutic trigger. The movement data detected by the two devices are processed as a function of the predictive laws that have been previously obtained in previous sessions in which the performance of the patient has been parametrized so as to obtain behavioural laws. The apparatus of the invention thus operates according to a first training phase of the patient in which the data from the sensors are detected, finally creating a sort of historical archive which, when suitably elaborated and analysed, generates a behavioural pattern of that single patient, which is useful for diagnostic purposes and, if loaded again in device 1 or device 2, is also useful for therapeutic purposes for generating feedback signals as a function of the data detected during the single sexual act. Alternatively, again for therapeutic purposes, in the present device 1 , or in the device 2, different patterns can be loaded from the behavioural pattern of the same patient, for example a pattern of stimulation or squeezing of the penis set at predetermined intervals by a doctor or by the patient himself.

According to a further particular embodiment of the apparatus of the invention the present device 2, in the shape of a ring or to be applied at the base of the genital organ, can comprise pressure or force sensors along the circumference of the ring, that are suitable for monitoring the diameter of the organ during sexual intercourse. Alternatively, the device 2 in the form of a hollow ring full of air is provided with one or more outlet pressure sensors so as to detect the variation in pressure as a function of the dilation of the genital organ during the act. The increase of the diameter, related to an increase in the inner pressure of the shaft of the penis, can take up a predictive value of the ejaculatory event and, together with the movement data detected by the aforementioned inertial sensor, can form further data for generating the therapeutic signal of feedback to the patient, for example for generating the squeezing event to delay the ejaculatory act or the vibration movement for its stimulation, according to the type of dysfunction that is intended to be cured. Also in this case, the availability of different sensorial data, from different sources, allows the laws of prediction of the ejaculatory event in the patient under examination to be more reliably obtained.

The device 2 comprising at least one sensor, a microprocessor, an actuator and communication means suitable for exchanging data among the other components, in addition to a battery for providing the energy necessary for the components to operate, is moreover suitable to be used by itself, independently from the device 1 , again for the diagnostic and therapeutic purposes described above.

The present apparatus makes it possible to monitor and analyse the sexual performance of patients with dysfunctions relating to the ejaculatory act in a quantitative manner, through the use of a system that is not invasive for detecting inertial and/or force data, and then make it possible, based upon such detected data, to generate a signal or a mechanical action that is suitable for modifying the timing of the ejaculatory act, delaying it or stimulating the ejaculation according to the type of dysfunction to be cured.

The present apparatus represents a complete and reliable means for the diagnostic evaluation of every type of dysfunction relating to the ejaculatory act, thanks to a device for recording significant and objective data that can be worn by the patient, and is absolutely non-invasive, and to a system for elaborating the recorded data for diagnostic and therapeutic purposes. In particular, concerning the diagnostic aspects, the present apparatus makes it possible to define in a totally objective manner the severity of the pathologies relating to the sexual field, like premature ejaculation, and to monitor the progress over time due for example to taking medicine or following a treatment. The present apparatus can moreover have therapeutic effects if, in addition to recording and processing data, there is also at least one component for generating a visual, tactile or acoustic feedback signal towards the patient for controlling the ejaculatory act, and/or at least one actuator for generating different actions on the patient, according to the type of dysfunction to be cured, for example an electrostimulation or vibration signal that are exerted on the genital organ so as to accelerate the ejaculatory act or a signal for squeezing the channel of the urethra so as to delay the same act.

The present apparatus is moreover easily used by anyone thanks to usage mechanisms that are easy and intuitive. One particular type of actuation is for example that which exploits the presence of sensitive elements to a permanent electromagnetic field, like for example Hall effect magnetic sensors, and the activation/deactivation of the device is obtained by passing a magnetic card over the device itself.

The present apparatus, or only the first device 1 or only the second device 2, can be included in a kit further comprising one or more pharmaceutical products that are useful in the therapeutic approach of the sexual dysfunctions, in particular of dysfunctions. The presence of the apparatus or of the device 1 of the invention inside such a kit has the purpose of monitoring the efficiency of the treatment based on taking the pharmaceutical product belonging to the kit itself.

A diagnostic method of male sexual ejaculatory dysfunctions may be carried out by applying to a patient in need of such a diagnosis, the single devices 1 or 2 on their own or the whole apparatus of the present invention comprising the device 1 and the device 2 connected between each other, respectively for the registration of acceleration signals or for the registration of pressure variations on the male genital organ, mainly on the duct of the urethra, or for the registration of both during the sexual activity of the patient, as an index of evaluation of the ejaculatory event. The diagnostic method then comprises a step of evaluation of signals or of pressure values recorded for their comparison with the respective standard values, corresponding to health persons, not suffering of the sexual dysfunctions in question.

A method of therapeutic treatment of male sexual ejaculatory dysfunctions may be carried out by applying the device 2 or the whole apparatus according to the present invention to a patient suffering of such dysfunctions, wherein an actuator, based on the acceleration signals recorded by the device 1 or following to an action by the patient himself or following to both of them, will order the device 2 to mechanically contract around the male organ of the patient on which it is applied, for instance by a hydraulic or electric contraction mechanism, or alternatively an actuator will order the device 2 to emit an electric signal, so as to induce a delay in the ejaculatory event. The present invention has been described with reference to a preferred embodiment thereof. It should be understood however that other embodiments may exist belonging to the same inventive core, all covered by the scope of protection of the following claims.