Wireless handheld self-stimulation device

Abstract

The present invention relates to a handheld self-stimulation device (100) comprising a vibrating portion (10) provided with a stimulating probe (11) at its end adapted to transmit predetermined stimulating vibrations to a human body region (300) of a user, a handling portion (20) adapted to be gripped by a hand (400) of the user, and electronics adapted to generate said predetermined stimulating vibration of the stimulating probe (11), characterized by comprising a vibration attenuation module (31) adapted to prevent said predetermined stimulating vibration from reaching the hand (400) of the user holding the device.

Description

[0001] Wireless handheld self-stimulation device

[0002] Technical Field

[0003] The present invention relates to the technology of stimulation devices and more particularly to a wireless handheld self-stimulation device adapted to generate vibrations preferably for the self-assessment of sensitivity and even more preferably somatosensory sensitivity.

[0004] Background of the invention

[0005] Many conditions affect the somatosensory system, including peripheral neuropathy, diabetes, multiple sclerosis, spinal cord injuries, nerve compression syndromes (such as carpal tunnel syndrome), and complications from surgical interventions, medical procedures, injuries or human imposed mutilation. These conditions can impair vibrotactile sensation, which refers to the ability to sense vibration across different regions of the body, such as the fingertips, arms, feet, and the genitals.

[0006] Assessing vibrotactile sensitivity involves applying controlled vibratory stimuli to specific regions of the body and recording the amplitude and / or the frequency at which the individual can no longer perceive the vibration or starts perceiving the vibration. This method permits diagnosis and tracking of somatosensory function. However, frequent clinical assessments to track the progression more accurately are often impractical due to limited access to healthcare providers and require specialized testing equipment. For instance, quantitative sensory testing, which comprises several diagnostic assessments, typically requires up to an hour and must be administered by a trained physician.

[0007] In addition, assessment and monitoring of more private areas of the body like the genitalia following surgical interventions such as genital reconstructions for women with female genital mutilation, gender identity affirmation surgery, assessing perceptual perturbations during vulvodynia or vaginismus, or sensation changes following childbirth, disease or in normal ageing among others, can be complicated by the intimate nature of this region of the body.

[0008] A self-monitoring device that allows individuals to assess their vibrotactile sensitivity, including in private areas such as the genitals, offers a convenient solution. Such a device coupled with an adapted analysis tool would empower individuals to assess basic function and track changes over time, facilitating earlier detection of somatosensory changes or deterioration, and enabling timely interventions.

[0009] Devices capable of assessing vibrotactile sensitivity already exist, particularly for the assessment and diagnosis of peripheral neuropathy. These devices are typically designed for use by a clinician, who applies the stimulus to specific regions of the patient's body to determine sensation thresholds. Traditionally, physicians have employed tuning forks to assess the point at which an individual stops perceiving vibration. The hand is exquisitely sensitive to vibratory stimuli and typically outperforms other body regions in detecting vibrations. Therefore, it is important to note that the patient cannot hold the tuning fork, or some other device, themselves, as the vibrating stimulus propagates to the handle and would be sensed by the hand holding and handling the device. This, in turn, would interfere with an accurate measurement of the vibration threshold at the targeted body part. Furthermore, traditionally used tuning forks typically operate at only one frequency and rely on the physician to consistently strike the tuning fork with the same force for each measurement, which compromises both reliability and accuracy.

[0010] Other, digital and automated devices permitting an assessment of sensitivity are known in the art. For example, document WO2017034468A1 describes a device and a method for generating sensory stimuli for the evaluation of neuropathy. This device includes an element that prevents the transmission of vibration to areas of the skin outside the point of contact area of the device that is being tested. However, the device described here is not suited for self-assessment, as the hand operating the device may still perceive vibrations generated in the device. Therefore, it does not solve the above-mentioned problem, preventing its use as a precise self-assessment tool. Furthermore, document US11678834B2 describes a device and a method for neuropathy diagnosis with a wireless feedback mechanism and more particularly, a vibration perception testing unit module comprising a combination of vibration motors, a spring and a damping mechanism. In this device, the vibration perception testing module is configured to induce a set of vibrations at the predetermined locations on the limb of the person and record feedback through the feedback module. Although the described damping mechanism may reduce vibrations, it does not isolate them to the tip, allowing residual vibrations to be perceived by the user holding the device. Consequently, this design is unsuitable for accurate self-assessment, as the user’s perception of these vibrations interferes with precise determination of vibrotactile threshold levels.

[0011] From the above we understand that no device permitting a reliable selfassessment of somatosensory sensitivity exists, as no existing device can be effectively self-operated by the user. There is therefore a need for a handheld selfstimulation device adapted to generate vibration, preferably for the self-assessment of somatosensory sensitivity.

[0012] In this regard, the primary aim of the invention is to solve the above-mentioned problems and more particularly to provide a self-stimulation device permitting individuals to reliably self-assess vibrotactile sensitivity on any body part, with no interference from residual vibrations being emitted from the handle.

[0013] Summary of the invention

[0014] As presented above, commercially available tools for somatosensory assessment do not feature sufficient vibration isolation and require a second user to hold the device while conducting measurements to ensure accuracy and precision.

[0015] The present invention solves the above-mentioned problems by providing a handheld self-stimulation device comprising a vibrating element which can deliver defined and calibrated vibrations of varying amplitudes and frequencies to different body parts through a dedicated tip. In addition, it permits the self-assessment of somatosensory sensitivity by isolating the vibration generated in the test probe presenting the tip, from the rest of the device to allow objective self-testing of vibration perception thresholds which are unbiased by vibrations felt in the hand which holds the device.

[0016] A first aspect of the invention is a handheld self-stimulation device comprising a vibrating portion provided with a stimulating probe at its end adapted to transmit predetermined stimulating vibration to a human body region of a user, a handling portion adapted to be gripped by a hand of the user, and an intermediary portion provided between the handling portion and the vibrating portion to connect them, characterized in that the intermediary portion comprises a vibration attenuation module adapted to prevent said predetermined stimulating vibration of the vibrating portion from reaching the handling portion.

[0017] Preferably, the vibration attenuation module comprises at least one vibration damping element or at least one vibration isolation element or a combination of at least one of each, which can consist of materials of variable softness or other mechanisms including rubber, foam, spring configurations, masses, fluids, gases or active moving elements.

[0018] Preferably, multiple elements of the vibration attenuation module are combined to cumulate the attenuation effect.

[0019] Preferably, the electronic circuit comprises a power source, a controller, an amplifier, an actuator and sensors.

[0020] Advantageously, the sensors are chosen from the group comprising accelerometers, pressure sensors and interactive feedback modules.

[0021] According to a preferred embodiment of the present invention, at least said sensor and said actuator are provided in the vibrating portion.

[0022] Advantageously, the stimulating probe of the vibrating portion is a removable tip. Therefore, it can be changed between uses. Also, by using a small probe tip the device can be used in multiple positions of one area of the body to generate precise spatial maps of sensory features. In a preferred manner, the handling portion further comprises vibration attenuation layers on the outside. These layers can be provided as sheaths or gloves and can be removable.

[0023] According to a preferred embodiment of the present invention, the vibration attenuation module provides an amplitude reduction factor of preferably at least 40 dB, to the hand of the user.

[0024] Advantageously, the handheld self-stimulation device further comprises a system of response buttons adapted to allow the user to communicate perceptual limits or control the stimulus via a control module.

[0025] In a preferred manner, the vibrating actuator may consist of voice coils, linear actuators, eccentric mass vibration motors or piezoelectric elements.

[0026] Advantageously, the power source is a rechargeable battery system which can be charged via charging port or a wireless induction-based charging system. In this manner, the device is compact and battery powered, suitable for use in homes, clinics, and research environments and by users for objective self-testing.

[0027] Advantageously, the handheld self-stimulation device further comprises a wireless communication module such as Bluetooth, Wi-Fi, radio waves or infrared light.

[0028] Preferably, the device delivers vibrotactile stimuli across a broad frequency and amplitude range to be able to target different mechanoreceptors such as Pacinian corpuscles (250-300 Hz), slowly adapting afferents (20-40 Hz), Ruffini endings and Meissner’s and Krause corpuscles (40-80 Hz) at their peak sensitivities. This enables precise and specific somatosensory sensitivity mapping combined with identification of different nerve fiber populations.

[0029] A second aspect of the invention is a handheld self-stimulation kit comprising the handheld self-stimulation device according to the first aspect and a computer, characterized in that said computer is adapted to run a computer implemented method comprising the steps of a) guiding the user to the specific body region, b) deliver a selected set of predetermined vibration stimuli via the device, c) establish sensitivity measurements through user responses via response button tap, and d) provide response maps and usage information to the user, with the option to transmit data to a secure database which is accessible for healthcare professionals or for personal monitoring. The advantages of this device of the invention, being like the ones outlined above in the first aspect, will not be repeated here.

[0030] Brief description of the drawings

[0031] Further particular advantages and features of the invention will become more apparent from the following non-limitative description of at least one embodiment of the invention which will refer to the accompanying drawings, wherein the same reference numerals indicate the same feature. In particular,

[0032] - Figure 1 a schematically illustrates a cross-section view of the handheld selfstimulation device of the present invention;

[0033] - Figure 1 b schematically illustrates an outside view of the handheld selfstimulation device of the present invention; and

[0034] - Figure 2 schematically shows a view of the handheld self-stimulation kit of the second aspect of the present invention.

[0035] Detailed Description

[0036] The invention will be described, for better understanding, with reference to specific embodiments. It will however be understood that the invention is not limited to the embodiments described herein but is defined by the claims and encompasses all embodiments which are within the scope of the claims.

[0037] The handheld self-stimulation device 100 of the present invention is adapted to deliver defined and calibrated vibrations of varying amplitudes and frequencies to different body parts 300. Due to attenuation elements 31 , 311 , 312 embedded between the vibration generating actuator 13 and the handle 20, the vibration stimuli can only be felt in the stimulating tip 11 of the device, but not in the handle 20, which renders the device uniquely suited for self-assessment. Here, the invention comprising the vibration attenuation module 31 provides amplitude reduction factor of preferably at least 40 dB, to the hand 400 of the user. This permits to solve the technical problem explained above since the abovedescribed available tools for somatosensory assessment do not feature sufficient vibration isolation and require a second user to hold the device while conducting measurements to ensure accuracy and precision.

[0038] In addition to the device of the present invention 100, another aspect of the invention relates to a kit comprising the device 100 and a computer 500, such as a connected smartphone application which is adapted to provide usage instructions, stimulus control, implement vibration perception threshold measurement protocols, manage the recordings and analysis of the psychophysical responses, allow input of qualitative responses, and securely store and / or transmit the collected data to the secure online database and the healthcare practitioner or researchers.

[0039] As it now clearly appears from the present description, the device of the present invention is intended for use as a tool in the diagnosis and monitoring of conditions of somatosensory function, including but not limited to loss of sensation, or enhanced or painful sensitivity to innocuous stimuli following disease, injury, or surgical interventions, in various external regions of the body, in particular as a method of selfassessment and monitoring. It is further suitable for assessment of intimate regions of the body including genital sensation.

[0040] The device may also be used on other regions of the body to objectively measure pallesthesia (sense of vibration), which is crucial for diagnosing and monitoring numerous medical conditions. These include assessment and treatment of patients with neuropathic pain and neuropathy following diabetes, rheumatoid arthritis, inflammatory arthralgias, fibromyalgia, chemotherapy, and multiple sclerosis. Rehabilitation and physical therapists concerned with monitoring a patient's progress during recovery from head injuries, strokes, limb transplants or other events affecting somatosensory function can also use the device of the present invention as a pre- peri- and post-intervention measurement tool.

[0041] A preferred embodiment of the device of the present invention will now be described in detail in reference to Figure 1 a. Figure 1 a shows a schematically cut view of the handheld self-stimulation device 1 comprising a vibrating portion 10 provided with a stimulating probe 11 at its end, such as a plastic removable tip which can be replaced with sterile tips between each use, adapted to transmit predetermined stimulating vibration to a human body region 300 of a user, a handling portion 20 adapted to be gripped by a hand 400 of the user, and electronics 12, 13, 21 , 22, 23, comprising a power source 23, a controller 22, an amplifier 21 , an actuator 13 and sensors 12 chosen from the group comprising accelerometers, pressure sensors and interactive feedback modules, adapted to generate predetermined vibratory stimuli and transmit it to the vibrating portion 10.

[0042] In addition, we can see that it further comprises an intermediary portion 30 provided between the handling portion 20 and the vibrating portion 10, such that the handling portion 20 is connected to the vibrating portion 10 through said intermediary portion 30.

[0043] Thus intermediary portion 30 comprises or is preferably constituted by a vibration attenuation module 31 adapted to prevent the entire stimulating vibration in the vibrating portion or of the vibrating portion from reaching the handling portion 20to isolate and / or dampen the vibration provided to the vibrating portion 10 from the hand 400 of the user. This means that the intermediary portion (30) is adapted to isolate said predetermined stimulating vibration of the vibrating portion (10) in the vibrating portion (10). A preferred embodiment showed an amplitude reduction factor of at least forty to the handling portion 20.

[0044] The sensor 12 and actuator 13 are provided in the vibrating portion 10 below the tip 11 to generate vibrations at predetermined frequencies and amplitudes and ensure consistency of the applied vibratory stimuli.

[0045] The vibration attenuation module 31 preferably comprises at least one vibration damping element 311 or at least one vibration isolation element 312 or a combination of at least one of each, which can be of various materials and mechanisms.

[0046] This means that the actuator 13, and more generally the whole vibrating portion 10, is mechanically isolated from the handling portion 20 by the absorbing elements 31 including, for example, layers of rubber and silicones of various thicknesses to further limit the transmission of vibration to the handling portion 20.

[0047] This intermediate portion 30 comprising the vibration damping or isolation elements 311 , 312 which can comprise of alternating elements including soft silicone portions or other mechanisms including rubber, foam, spring configurations, masses, fluids, gases and others. Also, the vibration attenuation module 31 may take the form of a system comprising the device and an external element such as a glove (not represented) or a sheath 27 mounted on the case 24 of the device 100 and can be made of silicone or other vibration attenuation materials and which can be used to hold the device 100.

[0048] As an alternative configuration not represented in the drawings, the handling portion 20 of the device may include a module such as a handle to attach the device to the user's hand 400 without contacting the regions of the hand most sensitive to vibrations, thus preventing the perception of vibrations in the holding hand.

[0049] The handheld device 100 is powered by a battery system 23, which is preferably rechargeable, and controlled via a wireless communication channel using Bluetooth technology or similar, and driving said vibrating actuator 13 which may have the form of a voice coil, piezoelectric element or similar, via the microprocessor 22 and the matched amplifier system 21 .

[0050] As one can see from figure 1 b, the handling portion 20 can comprise silicone grips 22 on the outside with the combined purpose of vibration attenuation and correct / ergonomic hand placement during usage. This figure further shows that it comprises a response button 28 adapted to communicate with the controller 22 that the user has perceived the stimuli. Furthermore, the device may incorporate a curved, angled, or otherwise contoured structural form to enhance ergonomic handling during self-testing. The inclusion of such contours and articulations may additionally serve to mechanically isolate vibrational energy within the device structure.

[0051] Figure 2 shows a handheld self-stimulation kit comprising two parts: (1 ) the handheld, battery powered, wirelessly controlled self-stimulation device 100 of the first embodiment of the invention capable of delivering calibrated vibratory stimuli and (2) a computer 500 running a computer-implemented method such as smartphone application communicating with the device 100.

[0052] The device 100 may have buttons to activate and interact with the device and smartphone application. The buttons can be positioned at multiple locations to ensure the user can easily reach it with their finger of the holding hand, regardless of how the device is held.

[0053] The computer-implemented method mentioned above provides the following features.

[0054] It is first used to guide the user to the specific body region 300 and provides a graphical user interface to guide users through a series of vibration stimuli applied via the wireless self-stimulation device 100. Using a series of graphical and schematic representations, the computer-implemented method will instruct individuals to apply the self-stimulation device to the depicted region on their own body. The user will then be guided through a sensitivity assessment protocol consisting of predetermined stimuli of combinations of various frequencies and amplitudes being applied to generate vibration threshold sensitivity curves. More particularly, it provides a series of calibrated vibratory stimuli to a restricted area of the body. It uses actuator technologies, which may include voice coils, piezoelectric motors, linear resonant actuators, eccentric rotating masses, for independent generation of vibration frequency and amplitude, and indentation forces. A small probe with a rounded tip (of 3 mm diameter for example) will limit the stimulation to a restricted body area and thus allow for mapping with high spatial precision. The device can be held to the body part and stimuli will be delivered at various intensities. Furthermore, the device includes sensors to monitor the consistent output of the stimuli or contact with the body part.

[0055] Furthermore, the device will establish sensitivity measurements through user responses via button press. This means that the user can respond according to their detection of the vibratory stimuli by using the button on the device, an external handheld button, or the touchscreen on their smartphone application. The various response options ensure this device can be comfortably used by an individual user without outside assistance. The user can also be asked to rate the stimulus according to qualitative ratings including pain, tingling, pleasure etc. A threshold for each type of stimulus will be determined by one or multiple repeating rounds of stimulations with varying intensities.

[0056] Finally, it provides response maps and usage information to the user, with the option to transmit data to a secure database which is accessible for healthcare professionals, researchers or for personal monitoring. This means that the user responses will be analyzed and graphically represented on the smartphone or transmitted, analyzed and stored on a secure online server. According to use type (clinical, research, personal), data may be transmitted to medical databases for remote access by clinicians or researchers for monitoring and analysis. Taken together, the kit framework will permit individuals to self-assess sensory function using quantitative, objective measurements.

[0057] While the embodiments have been described in conjunction with several embodiments, it is evident that many alternatives, modifications and variations would be or are apparent to those of ordinary skill in the applicable arts. Accordingly, this disclosure is intended to embrace all such alternatives, modifications, equivalents and variations that are within the scope of this disclosure. This for example is particularly the case regarding the different apparatuses which can be used.

Claims

CLAIMS1 . A handheld self-stimulation device (100) comprising. a vibrating portion (10) provided with a stimulating probe (11 ) at its end adapted to transmit predetermined stimulating vibration to a human body region (300) of a user, a handling portion (20) adapted to be gripped by a hand (400) of the user, and an intermediary portion (30) provided between the handling portion (20) and the vibrating portion (10) to connect them, characterized in that the intermediary portion (30) comprises a vibration attenuation module (31 ) adapted to prevent said predetermined stimulating vibration of the vibrating portion (10) from reaching the handling portion (20).

2. The handheld self-stimulation device according to claim 1 , characterized in that the intermediary portion (30) is adapted to isolate said predetermined stimulating vibration of the vibrating portion (10) in the vibrating portion (10).

3. The handheld self-stimulation device according to claim 1 or 2, characterized in that the vibration attenuation module (31 ) comprises at least one vibration damping element (311 ) or at least one vibration isolation element (312) or a combination of at least one of each, which both comprises silicone or materials of variable softness or other mechanisms including rubber, foam, spring configurations, masses, fluids, gases or active moving elements.

4. The handheld self-stimulation device according to any one of claims 1 to3, characterized in that the vibration attenuation element (312) may consist of materials of variable softness or other mechanisms including rubber, foam, spring configurations, masses, fluids, gases or active elements provided in an intermediary portion (30) between the vibrating portion (10) and the handling portion (20).

5. The handheld self-stimulation device according to any one of claims 1 to4, characterized in that it comprises an electronic circuit adapted to generate said predetermined stimulating vibration of the stimulating probe (11 ) and comprising apower source (23), a controller (22), an amplifier (21 ), an actuator (13) and sensors (12) wherein the sensors (12) are chosen from the group comprising accelerometers, pressure sensors and can function as interactive feedback modules.

6. The handheld self-stimulation device according to claim 5, characterized in that at least said sensor (12) and said actuator (13) are provided in the vibrating portion (10).

7. The handheld self-stimulation device according to any one of claims 1 to6, characterized in that the stimulating probe (11 ) of the vibrating portion (10) is a removable tip.

8. The handheld self-stimulation device according to any one of claims 1 to7, characterized in that the handling portion (20) further comprises vibration attenuation layers (27) on the outside.

9. The handheld self-stimulation device according to any one of claims 1 to8, characterized in that the vibration attenuation module (31 ) provides a vibration amplitude reduction factor of preferably at least 40 dB to the hand (400) of the user.

10. The handheld stimulation device according to any one of claims 1 to 9, characterized in that it further comprises a response button system (28) adapted to allow the user to communicate perceptual limits or control the stimulus via a control module (22).11 . The handheld self-stimulation device according to any one of claims 1 to10, characterized in that the vibrating actuator (13) may consist of voice coils, linear actuators, eccentric mass vibration motors or piezoelectric elements.

12. The handheld self-stimulation device according to any one of claims 1 to11 , characterized in that the power source (23) is a battery system which can be rechargeable via a charging port (26) or a wireless induction-based charging system.

13. The handheld self-stimulation device according to any one of claims 1 to12, characterized in that it further comprises a wireless communication module (22) such as Bluetooth, Wi-Fi, radio waves.

14. or infrared light.

15. The handheld self-stimulation device according to any one of claims 1 to13, characterized in that it delivers vibrotactile stimuli across a broad frequency and amplitude range to be able to target different mechanoreceptors such as Pacinian corpuscles (250-300 Hz), slowly-adapting afferents (20-40 Hz), Ruffini endings and Meissner’s and Krause corpuscles (40-80 Hz) at their peak sensitivities. This enablesprecise and specific somatosensory sensitivity mapping combined with identification of different nerve fiber populations.

16. A handheld self-stimulation kit comprising the handheld stimulation device (100) according to any one of claims 1 to 14 and a computer (500), characterized in that said computer is adapted to run a computer implemented method comprising the steps of a) guiding the user to the specific body region (300), b) deliver a selected set of calibrated vibration stimuli via the device (100), c) establish sensitivity measurements through user responses via response button press (28), d) option to input qualitative user responses, and e) provide response maps and usage information to the user, with the option to transmit data to a secure database which is accessible for healthcare professionals, researchers, or for personal monitoring.

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