WO2022077116A1 - Feedback-enhanced acoustic apparatus for medical treatment - Google Patents

Abstract

An acoustic wave medical device has a sensor measuring the output acoustic wave and/or vibrations at the applicator's end and providing a feedback to the person performing the treatment. The feedback provided can be audio or visual, such that the person performing the treatment knows that the output acoustic wave and vibrations are either optimal or not for the treatment. The feedback sensor can be used to control and adjust the acoustic wave source to provide similar benefits as providing the audio and/or visual feedback to the person performing the treatment.

Description

FEEDBACK-ENHANCED ACOUSTIC APPARATUS FOR MEDICAL TREATMENT

[001] This application claims priority of US provisional patent application 63/092,124 filed October 15, 2020, the contents of which are hereby incorporated by reference.

Technical Field

[002] The present application relates to medical devices, and, more particularly, to medical devices producing acoustic waves for medical treatment.

[001] Acoustic therapy is a treatment known in the art as an efficient way to treat, or supplement conventional treatments, numerous medical conditions. For example, extracorporeal shock wave therapy (ESWT) are typically ultrasonic shock wave therapies used to remove kidney stones and gallstones and infrasonic therapies are used in physiotherapy to treat musculoskeletal conditions (e.g. plantar fasciitis, tendonitis, bursitis, etc.). Another example of acoustic therapy includes pulmonary treatments to dislodge phlegm and other secretions using acoustic waves at about 40 Hz.

[002] While some acoustic treatments may be delivered with the acoustic device being at a distance from the patient, some applications necessitate a contact between the device and the patient. The contact between device and patient may provide additional benefits for the treatment, such as the transfer of the vibrations induced in the device by the acoustic wave. For example, the device and method from the applicant’s patent application WO 2017/087824 presents one such device and medical application. [003] Current acoustic wave devices are designed to produce an acoustic wave at a desired frequency and intensity. The frequency and intensity are determined as being the ones best suited to treat a certain type of condition. While these may be varied in a certain band around the theoretical optimal value for the treatment, such as to account for different patient characteristics (e.g. weight, sex, etc.), they typically are not varied for considerations of the interactions between the device and the patient. In acoustic wave therapies, it is essential to deliver the acoustic wave at the desired intensity at the targeted area inside the patient. However, prior art acoustic wave devices disregard the effect of the interactions between the device applicator (i.e. the end of the device in contact with the patient) and the patient. This interaction may have a detrimental effect on both the vibrations and the acoustic signal being transferred to the patient and may therefore impact the treatment (e.g. may lose efficiency, may require longer sessions or more sessions, may require higher intensities, etc.).

[004] Acoustic treatment devices that are designed to treat a patient with the device being in contact with the patient may provide guidelines for the physician or technician operating the device to qualify the force at which the device should be applied to the patient (e.g. set device against patient skin, push device against patient skin, etc.). However, these guidelines may either not be followed by the medical personnel or, since the guidelines may be subjectively defined, they may not be adequately and uniformly interpreted by all medical personnel. [005] Thus, there is a need for an enhanced acoustic wave device capable of providing objective feedback to the medical personnel performing the treatment, such that acoustic wave and vibrations with their desired characteristics are transferred to the patient’s treatment target area.

Summary

[006] Applicant has found that an acoustic wave medical device in which a sensor measures the output acoustic wave and/or vibrations at the applicator’s end and provides a feedback to the person performing the treatment is a significant improvement over the state of the art. The feedback provided may be audio or visual, such that the person performing the treatment knows that the output acoustic wave and vibrations are either optimal or not for the treatment.

[007] Additionally, the applicant has found that using an acoustic wave medical device with a feedback sensor used to control and adjust the acoustic wave source may provide similar benefits as providing the audio and/or visual feedback to the person performing the treatment.

[008] A first broad aspect is an acoustic wave treatment device including: an acoustic wave generator operable to receive an input frequency and intensity and to generate an acoustic wave at the input frequency and intensity; an applicator configured to apply the acoustic wave to a patient; a sensor module including at least one of a vibration and an acoustic sensor measuring at least one of the acoustic wave being applied to the patient and a vibration caused by the acoustic wave; a controller module in communication with the acoustic wave generator and the sensor module, the controller module being operable to compare the sensor module measuring to the input frequency and intensity and to adjust the input frequency and intensity.

[009] In some embodiments, the acoustic wave generator comprises at least one speaker.

[0010] In some embodiments, the acoustic wave is at a frequency between 20 to 120 Hz.

[0011] In some embodiments, the acoustic sensor is a microphone.

[0012] In some embodiments, the vibration sensor is an accelerometer.

[0013] In some embodiments, the sensor module is one of a manometer and a current sensor configured to sense a current variation in a coil of the acoustic wave generator.

[0014] A second broad aspect is an acoustic wave treatment device including: an acoustic wave generator operable to receive an input frequency and intensity and to generate an acoustic wave at the input frequency and intensity; an applicator configured to apply the acoustic wave to a patient; a sensor module including at least one of a vibration and an acoustic sensor measuring at least one of the acoustic wave being applied to the patient and a vibration caused by the acoustic wave; a feedback module in communication with the acoustic wave generator and the sensor module, the feedback module being operable to compare the sensor module measuring to the input frequency and intensity and to provide one of an audio and a visual feedback. [0015] In some embodiments, the acoustic wave generator comprises at least one speaker.

[0016] In some embodiments, the acoustic wave is at a frequency between 20 to 60 Hz for adults and between 20 to 120 Hz for neonates.

[0017] In some embodiments, the acoustic sensor is a microphone.

[0018] In some embodiments, the vibration sensor is an accelerometer.

[0019] In some embodiments, the audio feedback provides a different tonal response based on the comparing the sensor module measuring to the input frequency and intensity.

[0020] In some embodiments, the visual feedback comprises at least one colored status light.

[0021] In some embodiments, the at least one colored status light is red or green.

[0022] In some embodiments, the visual feedback comprises displaying at least one of an image and text on a display.

[0023] In some embodiments, the visual feedback provides a different visual response based on the comparing the sensor module measuring to the input frequency and intensity.

[0024] In some embodiments, the acoustic wave treatment device further includes at least one additional applicator configured to apply the acoustic wave to one of a second patient or a second target area of the patient and at least one of an additional vibration and acoustic sensor measuring at least one of the acoustic wave being applied to the second patient or second target area and an additional vibration caused by the acoustic wave, the feedback module being operable to provide at least one additional audio and visual feedback for the additional vibration and acoustic sensor.

[0025] A third broad aspect is a method of treating a patient with acoustic waves including: setting initial acoustic treatment parameters on an acoustic wave treatment device; starting the acoustic treatment; measuring at least one of an acoustic wave being applied to the patient and a vibration caused by the acoustic wave; comparing the measured acoustic wave to the initial acoustic treatment parameters; adjusting acoustic treatment parameters based on the comparing results; continuing the acoustic treatment while continuously repeating the measuring, comparing and adjusting; and completing the acoustic treatment.

[0026] A fourth broad aspect is a method of treating a patient with acoustic waves including: setting initial acoustic treatment parameters on an acoustic wave treatment device; starting the acoustic treatment; measuring at least one of an acoustic wave being applied to the patient and a vibration caused by the acoustic wave; comparing the measured acoustic wave to the initial acoustic treatment parameters; providing at least one of an audio or visual feedback based on the comparing results; continuing the acoustic treatment while continuously repeating the measuring, comparing and providing feedback; and completing the acoustic treatment. Brief Description of the Drawings

[0027] The invention will be better understood by way of the following detailed description of embodiments of the invention with reference to the appended drawings, in which:

[0028] Figure 1 is a prior art acoustic device without feedback;

[0029] Figure 2 is an exemplary feedback-enhanced acoustic device in which the feedback provides acoustic wave input adjustment;

[0030] Figure 3 is an exemplary method of performing an acoustic wave treatment with a feedback adjustment of the acoustic wave;

[0031] Figure 4 is an exemplary feedback-enhanced acoustic device in which the feedback is provided to the person performing the treatment;

[0032] Figure 5 is an exemplary method of performing an acoustic wave treatment with feedback provided to the person performing the treatment;

[0033] Figure 6A is a plot of current as a function of time under the conditions of direct coupling between the acoustic generator and the applicator (i.e. a short filter); and

[0034] Figure 6B is a plot of current as a function of time under the conditions of hose coupling between the acoustic generator and the applicator (i.e. a long filter).

Detailed Description

[0035] The present disclosure relates to an improved device for acoustic treatments requiring acoustic waves at a given frequency and intensity. In current devices, the desired frequency and intensity are set prior to starting the device to provide the treatment. They may subsequently be adjusted by the person performing the treatment, or automatically using an automatic controller, depending on the patient’s response to the treatment. During the acoustic treatment, the device has an applicator’s end pressed against the patient’s, such that the output acoustic waves and the vibrations from the device may be transferred to the patient at a target location. As is known in the field of dynamics, the pressure with which the device’s end (i.e. the applicator) is applied against the patient will impact the vibrations being transferred.

[0036] The structure of the applicator may generally be approximated as a cantilever beam. When the applicator is pressed against the patient, the free end of the beam becomes the equivalent of a guided-end. As the force with which the applicator is pressed against the patient increases, the axial load (compression) of the beam is increased and will necessarily introduce a change in natural frequencies of the beam. The difference in compression may also impact the intensity at which the vibrations are transferred to the patient (i.e. change in resulting stiffness of the beam and thus of the amplitude of the deflection). As such, the vibrations transferred to the patient may not be at the desired levels.

[0037] Similar considerations may be applied to the acoustic wave being transferred to the patient. However, in the case of the acoustic waves, the main differences between the characteristics of the output acoustic wave and the desired characteristics entered as inputs to the systems may be essentially explained by the potential losses and interactions inside the system. As a matter of fact, in typical acoustic wave devices, an acoustic wave is created at a desired frequency and intensity and is then propagated through the device and to/through the patient. Depending on the acoustic wave device being used, there may be parts guiding the acoustic wave and transforming the acoustic wave to have different characteristics.

[0038] For example, the prior art device of Figure 1 may have a waveguide of a certain length with a certain cross-section width/form which may propagate the acoustic wave created by an electroacoustic transducer to an applicator part which may further have internal ways to modify the acoustic wave (e.g. a diaphragm). In this example, the acoustic wave may experience significant changes, such as changes to its amplitude, during the propagation inside the device (due to interference, losses, damage to the acoustic transducer, incorrect assembly, etc.).

[0039] Moreover, the physiology of the patient undergoing the acoustic wave therapy may have a significant impact on the acoustic wave and the vibrations at the desired target location. As such, characteristics of patients, such as weight (and muscle-fat ratios), age, medical conditions, and other parameters may have a significant impact on the treatment at the target location.

[0040] Therefore, adding a feedback loop to ensure optimal acoustic wave and vibrations in an acoustic medical device may be a significant improvement over the devices as detailed in the prior art. In some embodiments, the feedback loop may be connected to a controller such as to automatically adjust the inputs being provided to the acoustic wave generator based on the readings from a sensor. When the output acoustic wave and/or vibrations are sensed as being outside a predefined threshold, the inputs to the acoustic wave generator may be adjusted such as to reach the desired values.

[0041] In some embodiments, the feedback may also instead be given directly to the person performing the treatment, such that this person may take the necessary actions. For example, there may be an audio and/or visual alert to advise the person performing the treatment that the pressure at which the applicator is being applied to the patient is inadequate (e.g. a buzzer may identify a situation where the person presses the device too hard on the patient). Similarly, an indication of an adequate treatment may be given as feedback (e.g. a green light, a certain buzzer tone, etc.).

[0042] Prior art

[0043] Figure 1 illustrates a prior art device (i.e. a device providing acoustic treatments at 40 Hz as found in the applicant’s patent application WO 2017/087824) in which a signal generator 210 is provided to an amplifier 220 driving a transducer 230. The transducer, which includes an electroacoustic converter 232 also includes a flute/adapter 235 focusing and guiding the acoustic wave produced by the electroacoustic converter 232 to the acoustic waveguide 240. The device further includes an acoustic applicator 250 used to provide the acoustic treatment to the patient.

[0044] The acoustic applicator 250 may include various structures, such as a membrane 254 which may modify the input acoustic wave into a different output acoustic wave. [0045] Feedback-enhanced acoustic device

[0046] While the prior art devices may provide sufficient control on the frequency and intensities of the acoustic waves being propagated to the patient, such that the person performing the treatment may adjust these inputs depending on the response to the treatment by the patient, it may not be optimal in cases where any result of the treatment may be seen during the treatment itself. In order for an acoustic therapy to be efficient, the acoustic wave must reach a target location with a certain frequency and a certain intensity. Depending on the method of delivery of the acoustic wave, the physiology of the patient may have a significant impact on the wave at the target site. As a matter of fact, inhomogeneous material (such as the human body) with multiple different densities, elastic constants, and other characteristics may have a non-negligible effect on the acoustic wave and the vibrations propagated from the medical device to the patient.

[0047] While it may not be possible to directly measure the resulting acoustic wave and vibration at the target site of the treatment (e.g. inside the pulmonary system), it may be possible to approximate the effect of physiology and account for such. This may be done by calculating a damping and attenuation factor on the acoustic wave and vibration directly propagated to the patient. However, as detailed herein, the acoustic wave and vibration directly contacting the patient (i.e. output wave and vibration) may not always be at the desired characteristics set as inputs in the acoustic medical device. As such, having a sensor reading the output wave and vibration, ensuring that their levels are adequate with respect to the inputs entered in the system, may improve the characteristics of the acoustic wave and vibrations reaching the treatment’s target site.

[0048] Now referring to Figure 2, which is an exemplary feedback-enhanced acoustic device in which the feedback provides acoustic wave input adjustment. In this embodiment, there may be an acoustic wave generator 51 being controlled by a controller module 57. The initial settings of the acoustic wave for the treatment (e.g. frequency, intensity, duration, etc.) may be input in the controller module 57. The controller module 57 may therefore have a user interface allowing the person performing the treatment to set the parameters of the acoustic treatment.

[0049] As such, the controller module 57 may be any type of electronic device being operable to receive inputs (e.g. user inputs, inputs from other systems and modules of the device, etc.), perform calculations (e.g. implemented through software, firmware or otherwise) and produce outputs to control other parts of the medical device, such as the acoustic wave generator 51 . Someone skilled in the art will appreciate that the controller module 57 may therefore be any electronic device such as a computer, a mobile device, a tablet, a micro-controller, etc. The controller module 57 may thus comprise components such as a processor, memory (e.g. non-transitory, random-access memory, read only memory, flash memory, hard disk drive, etc.), I/O interface, graphic processor, etc.

[0050] In some embodiments, the acoustic wave generator may include all the necessary components to produce an acoustic wave with the desired characteristics being specified as inputs. As such, the acoustic wave generator 51 may include a signal generator, calibration components, an amplifier, and an electroacoustic transducer. It will be understood by someone skilled in the art that other methods and devices producing an acoustic wave at a desired frequency and intensity may be used without departing from the teachings of this disclosure. For example, the acoustic wave generator 51 may use piezoelectric or rotary motor methods of producing the acoustic wave, as is known in the art.

[0051] The acoustic wave generator 51 may thereafter propagate the acoustic wave (and accompanying vibrations) to an applicator 53. The applicator 53 may be the part of the medical device that contacts the patient in order to transfer the acoustic wave and the vibrations to the treatment target site. As is known in the art, the applicator 53 may have internal structure to further modify the acoustic wave and vibration (e.g. a diaphragm, diffuser, stiffeners, etc.) originating from the acoustic wave generator 51 .

[0052] The feedback-enhanced acoustic device may further include a sensor module 55 to measure the acoustic wave and/or the vibrations being propagated from the applicator 53 to the patient under treatment. The sensor module 55 may be any suitable sensor to measure the frequencies and amplitudes of the acoustic wave and/or the vibrations being propagated. For example, the sensor module 55 may be one or more accelerometers fixed to the applicator 53 in a manner as to measure the vibrations being transferred to the patient through the applicator’s 53 casing. In some embodiments, the sensor module 55 may be a microphone operable to measure the acoustic wave inside the applicator’s 53 casing. It will be appreciated that the sensor module 55 may not necessarily be mounted on the applicator 53 as measuring the acoustic waves in the area surrounding the applicator 53 may provide sufficient data for the feedback loop.

[0053] As such, in some embodiments, the sensor module 55 may be separate from the applicator 53 and may be separately connected to the medical device (e.g. separate microphone connected to the controller module 57). In yet another embodiment, the sensor module 55 may be an accelerometer, or any other vibration sensor, installed directly on the patient (e.g. the sensor may be installed such as to measure the vibrations of the rib cage). Additionally, the sensor module 55 may include multiple sensors of the same or different types.

[0054] In some embodiments, the sensor module 55 may be a manometer (pressure sensor) to sense the change in pressure at a predetermined point (e.g. fixed distance from the device applicator or from the patient). Additionally, the sensor module 55 may include an ampere meter to measure the current variation in the coil of the electrical transducer of the acoustic wave generator 51.

[0055] Applicant has found that measurement of the current in the acoustic wave generator, as for example an audio speaker, changes with applicator coupling differently between the use of an elongated hose to connect an acoustic source to an applicator (as in the prior art example of Figure 1) or the case of direct coupling between the acoustic source and the applicator for physical contact with the chest, back, abdomen, etc. As illustrated in Figure 6A, in the case of direct coupling, when the applicator contacts the body at 18 seconds to 33 seconds, the current in the acoustic generator increases from the level when no contact was made. In the case of an elongated hose being used, for example about 2 cm to 3 cm in diameter and about 60 cm to 120 cm in length, no contact with the body consumes more current in the acoustic wave generator than when contact with the body is made.

[0056] One hypothesis to explain this phenomenon would be the fact that, since the hose is long enough, the exchange of air required to exit the applicator in order to create an acoustic wave is more difficult when the hose is open. When pressed on the chest (or other body part), it is connected to a closed chamber, which decreases the air exchange necessary for the speaker or acoustic source to generate a signal. This greater work of the speaker when not pressed on the chest would then explain why the current is higher in this condition than when well placed on the patient.

[0057] In any event, detection of proper coupling is dependent on the structure of the coupler between the acoustic wave source and the applicator. When an elongated hose is used, good coupling can be detected as a lowering of the average or filtered current signal, while in the case of a direct application of the acoustic source to the body without a hose, good coupling can be detected as an increase in the average or filtered current signal.

[0058] The sensor module 55 may be in communication with the controller module 57 to provide its readings of the output acoustic wave and/or vibrations. When the sensor module 55 includes multiple sensors, it may aggregate the information to transfer it as such to the controller module 57. Upon receiving and assessing the sensor’s information, the controller module 57 may adjust the controls being provided to the acoustic wave generator 51.

[0059] Now referring to Figure 3, which is an exemplary method of performing an acoustic wave treatment with a feedback adjustment of the acoustic wave. In some embodiments, the first step of the treatment, for a patient ready to receive the acoustic wave treatment, may be to set the desired acoustic treatment parameters 61. In setting parameters as the desired frequency, intensity, duration, and other, the person performing the treatment may control the acoustic wave and vibrations being propagated to the patient.

[0060] With the initial parameters set at step 61 , the acoustic wave treatment may thereafter begin 63. As described herein at Figure 2, the medical device may include an acoustic wave and/or vibration sensor module 55 to measure the acoustic wave and/or vibration being propagated to the patient. As such, once the treatment has begun, the sensor module 55 may measure the outputs 65 of the medical device (i.e. the acoustic wave and/or vibration being supplied to the patient through the device’s applicator).

[0061] The data of the measured outputs 65 may then be communicated to the controller module 57, in which they may be assessed. The controller module 57 may thus compare the measured levels (frequency, intensity, etc.) to the parameters initially set in the system during step 61 . If the measured levels are outside tolerance thresholds for the parameters, the controller module 57 may adjust the acoustic treatment parameters 67

(e.g. the controller module 57 may increase or decrease the amplitude of the acoustic wave being produced, such that it reaches the patient at the desired intensity). If the measured levels are within the threshold of the initially set values, the controller module 57 may not modify the inputs provided to the acoustic wave generator 51 .

[0062] In some embodiments, the measured levels may go through a signal processing module, such that the acquired data may be interpreted by the controller. Additionally, noise filtering may be applied to the acquired data from the sensors. This may ensure that the controller module 57 does not vary unnecessarily the parameters of the acoustic wave being provided.

[0063] The acoustic wave treatment may thereafter continue 69. The measuring 65, adjusting 67 and continuing of the treatment 69 may be done continuously throughout the duration of the treatment. As such, the feedback loop may adjust the inputs provided to the acoustic wave generator 51 throughout the entire duration of the treatment, such that the treatment remains at the desired parameters at all time. The acoustic wave treatment may be completed 71 either when the prescribed treatment time is reached (e.g. the duration treatment that may have been initially entered in the medical device) or when the person performing the treatment stops the medical device.

[0064] Figure 4 illustrates another embodiment of the feedback-enhanced acoustic device in which the feedback is provided to the person performing the treatment. In this embodiment, there may be an acoustic wave generator and controller 79 having an input interface, electronic components for controlling the generator and the generator. The initial settings of the acoustic wave for the treatment (e.g. frequency, intensity, duration, etc.) may be input through the input interface of the acoustic wave generator and controller 79.

[0065] As such, the controller of the acoustic wave generator and controller 79 may be any type of electronic device being operable to receive inputs (e.g. user inputs, inputs from other systems and modules of the device, etc.), perform calculations (e.g. implemented through software, firmware or otherwise) and produce outputs to control the acoustic wave generator. Someone skilled in the art will appreciate that the controller may therefore be any electronic device such as a computer, a mobile device, a tablet, a microcontroller, etc. The controller may thus comprise components such as a processor, memory (e.g. random-access memory, read only memory, flash memory, hard disk drive, etc.), I/O interface, graphic processor, etc.

[0066] In some embodiments, the acoustic wave generator may include all the necessary components to produce an acoustic wave with the desired characteristics being specified as inputs. As such, the acoustic wave generator may include a signal generator, calibration components, an amplifier, and an electroacoustic transducer. It will be understood by someone skilled in the art that other methods and devices producing an acoustic wave at a desired frequency and intensity may be used without departing from the teachings of this disclosure. For example, the acoustic wave generator may use piezoelectric methods of producing acoustic waves, as is known in the art.

[0067] The acoustic wave generator may thereafter propagate the acoustic wave (and accompanying vibrations) to an applicator 53. The applicator 53 may be the part of the medical device that contacts the patient in order to transfer the acoustic wave and the vibrations to the treatment target site. As is known in the art, the applicator 53 may have internal structure to further modify the acoustic wave and vibration (e.g. a diaphragm, diffuser, stiffeners, etc.) originating from the acoustic wave generator and controller 79.

[0068] The feedback-enhanced acoustic device may further include a sensor module 55 to measure the acoustic wave and/or the vibrations being propagated from the applicator 53 to the patient under treatment. The sensor module 55 may be any suitable sensor to measure the frequencies and amplitudes of the acoustic wave and/or the vibrations being propagated. For example, the sensor module 55 may be one or more accelerometers fixed to the applicator 53 in a manner as to measure the vibrations being transferred to the patient through the applicator’s 53 casing. In some embodiments, the sensor module 55 may be a microphone operable to measure the acoustic wave inside the applicator’s 53 casing.

[0069] In some embodiments, there may be more than one applicator 53 connected to the acoustic wave generator. In such embodiments, there may be multiple sensors part of the sensor module 55, such that each applicator 53 may have its related sensors. Additionally, there may be a single set of sensors gathering environmental information of the surroundings of the multiple applicators 53.

[0070] It will be appreciated that the sensor module 55 may not necessarily be mounted on the applicator 53 as measuring the acoustic waves in the area surrounding the applicator 53 may provide sufficient data for the feedback loop. As such, in some embodiments, the sensor module 55 may be separate from the applicator 53 and may be separately connected to the medical device (e.g. separate microphone connected to the feedback module 81). In yet another embodiment, the sensor module 55 may be an accelerometer, or any other vibration sensor, installed directly on the patient (e.g. the sensor may be installed such as to measure the vibrations of the rib cage). Additionally, the sensor module 55 may include multiple sensors of the same or different types.

[0071] The sensor module 55 may be in communication with the feedback module 81 to provide its readings of the output acoustic wave and/or vibrations. Additionally, the feedback module 81 may receive the initial settings of the acoustic wave generator and controller 79. Upon receiving and assessing the sensor’s information, the feedback module 81 may provide feedback to the person performing the treatment. In some embodiments, the feedback module 81 may include an audio feedback device (e.g. a speaker providing an audible tone, a buzzer, etc.) and/or may include a visual feedback device (e.g. one or more colored lights, a screen providing instructions/feedback, etc.).

The feedback module 81 may further be composed of multiple feedback modes, such as to increase awareness of the state of the treatment.

[0072] In embodiments where there are multiple applicators 53, the feedback module 81 may provide independent feedback for each applicators 53, such that the status of the adequacy for each treatment may be assessed.

[0073] Figure 5 presents another embodiment of an exemplary method of performing an acoustic wave treatment with feedback provided to the person performing the treatment. In some embodiments, the first step of the treatment, for a patient ready to receive the acoustic wave treatment, may be to set the desired acoustic treatment parameters 61. In setting parameters as the desired frequency, intensity, duration, and other, the person performing the treatment may control the acoustic wave and vibrations being propagated to the patient.

[0074] With the initial parameters set at step 61 , the acoustic wave treatment may thereafter begin 63. As described herein at Figure 4, the medical device may include an acoustic wave and/or vibration sensor module 55 to measure the acoustic wave and/or vibration being propagated to the patient. As such, once the treatment has begun, the sensor module 55 may measure the outputs 65 of the medical device (i.e. the acoustic wave and/or vibration being supplied to the patient through the device’s applicator).

[0075] The data of the measured outputs 65 may then produce a feedback for the person performing the treatment (e.g. a visual and/or audio feedback) 83 depending on the measured values. The feedback module 81 may thus compare the measured levels (frequency, intensity, etc.) to the parameters initially set in the system during step 61. If the measured levels are outside tolerance thresholds for the parameters, the feedback module 81 may provide the feedback on the treatment 83 (e.g. the feedback module 81 may have a buzzer alerting the person performing the treatment if the vibrations at the applicator are lower than expected, such that it may be representative of a situation in which the applicator is pressed too firmly against the patient). If the measured levels are within the threshold of the initially set values, the feedback module 81 may either not provide any feedback or it may provide an indication that the treatment is currently being performed adequately (e.g. there may be a visual indication that the treatment is performed adequately, such as a green light being lit).

[0076] The acoustic wave treatment may thereafter continue 69. The measuring 65, providing feedback 83 and continuing of the treatment 69 may be done continuously throughout the duration of the treatment. As such, the feedback loop may provide feedback to the treating personnel throughout the entire duration of the treatment, such that the treatment remains at the desired parameters at all time. The acoustic wave treatment may be completed 71 either when the prescribed treatment time is reached (e.g. the duration treatment that may have been initially entered in the medical device) or when the person performing the treatment stops the medical device.

Claims

What is claimed is:

1 . An acoustic wave treatment device comprising: an acoustic wave generator operable to receive an input frequency and intensity and to generate an acoustic wave at said input frequency and intensity; an applicator configured to apply said acoustic wave to a patient; a sensor module comprising at least one of: a current sensor associated with said acoustic wave sensor; a pressure sensor associated with said acoustic wave sensor or said applicator; a vibration sensor measuring a vibration caused by said acoustic wave; and an acoustic sensor measuring said acoustic wave being applied to said patient; a controller module in communication with said acoustic wave generator and said sensor module, said controller module being operable to compare said sensor module measuring to said input frequency and intensity and to perform one of: adjusting said input frequency and intensity; and providing one of an audio and a visual feedback.

2. The acoustic wave treatment device of claim 1 , wherein said acoustic wave generator comprises at least one speaker.

3. The acoustic wave treatment device of claim 1 or 2, wherein said acoustic wave is at

23 a frequency between 20 to 60 Hz.

4. The acoustic wave treatment device of any one of claims 1 to 3, wherein said sensor module comprises said acoustic sensor, and said acoustic sensor is a microphone.

5. The acoustic wave treatment device of any one of claims 1 to 4, wherein said sensor module comprises said vibration sensor, and said vibration sensor is an accelerometer.

6. The acoustic wave treatment device of any one of claims 1 to 5, wherein said controller module is operable to compare said sensor module measuring to adjust said input frequency and intensity.

7. The acoustic wave treatment device of any one of claims 1 to 6, wherein said sensor module comprises said current sensor associated with said acoustic wave sensor.

8. The acoustic wave treatment device of claim 7, further comprising a hose interconnecting said acoustic wave generator and said applicator, said sensor module being configured to use an increase in current to determine poor coupling and a decrease in current to determine good coupling.

9. The acoustic wave treatment device of claim 7, further comprising a direct coupling between said acoustic wave generator and said applicator, said sensor module being configured to use a decrease in current to determine poor coupling and an increase in current to determine good coupling.

10. The acoustic wave treatment device of any one of claims 1 to 6, wherein said sensor module comprises said pressure sensor associated with said acoustic wave sensor.

11. The acoustic wave treatment device of any one of claims 1 to 10, wherein said controller module is operable to compare said sensor module measuring to said input frequency and intensity to provide one of an audio and a visual feedback, and said audio feedback provides a different tonal response based on said comparing said sensor module measuring to said input frequency and intensity.

12. The acoustic wave treatment device of any one of claims 1 to 11 , wherein said controller module is operable to compare said sensor module measuring to said input frequency and intensity to provide one of an audio and a visual feedback, and said visual feedback comprises at least one colored status light.

13. The acoustic wave treatment device of claim 12, wherein said at least one colored status light is red or green.

14. The acoustic wave treatment device of any one of claims 1 to 11 , wherein said controller module is operable to compare said sensor module measuring to said input frequency and intensity to provide one of an audio and a visual feedback, and said visual feedback comprises displaying at least one of an image and text on a display.

15. The acoustic wave treatment device of any one of claims 1 to 14, wherein said controller module is operable to compare said sensor module measuring to said input frequency and intensity to provide one of an audio and a visual feedback, and said visual feedback provides a different visual response based on said comparing said sensor module measuring to said input frequency and intensity.

16. The acoustic wave treatment device of any one of claims 1 to 15, further comprising at least one additional applicator configured to apply said acoustic wave to one of a second patient or a second target area of said patient and at least one of an additional vibration and acoustic sensor measuring at least one of said acoustic wave being applied to said second patient or second target area and an additional vibration caused by said acoustic wave, said feedback module being operable to provide at least one additional audio and visual feedback for said additional vibration and acoustic sensor.

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