A therapeutic device for acoustic wave stimulation.

Abstract

The present invention relates to the field of cell stimulation by mechanical energy, particularly acoustic energy, e.g., ultrasound, such as focused ultrasound (FUS). The present invention relates to a therapeutic device and its components, as well as methods for configuring or manufacturing such a device or component. One objective of the present invention is to make devices for cell stimulation by mechanical energy more user-friendly and applicable to a wider range of people and additional applications. The therapeutic device for acoustic wave stimulation of a body part is portable and includes a carrier element 1, at least one transducer 2, and communication means 6 configured to receive operating parameters of the at least one transducer from a remote computerized device 7, 11. The method for configuring the therapeutic device for acoustic wave stimulation includes a step S3 of receiving operating parameters of the at least one transducer from the remote computerized device 7, 11.

Description

Technical Field

[0001] The present invention relates to the field of cell stimulation by mechanical energy, particularly by ultrasonic waves such as focused ultrasound (FUS) by acoustic energy. The present invention relates to an apparatus for acoustic wave stimulation of a body part and a method for setting such an apparatus.

Background Art

[0002] US Patent Application Publication No. 2017 / 0291044 discloses an ultrasonic deep brain stimulation method and an ultrasonic deep brain system. The disclosed system includes an ultrasonic transducer array provided in a magnetic resonance imaging (MRI) system and an eastern fixing and positioning device. The system of US Patent Application Publication No. 2017 / 0291044 further includes medical imaging equipment for taking a head image, and in a step following the taking of the head image, a 3D digital model of the head is generated according to the head image. This complex and large-scale system implements the ultrasonic deep brain method disclosed in US Patent Application Publication No. 2017 / 0291044 and is used to finely adjust and control stimulation based on this method.

[0003] The deep brain ultrasound method disclosed in U.S. Patent Application Publication No. 2017 / 0291044 is a time-reversal method comprising the steps of: creating a 3D digital model of the head from head images; creating a 3D digital model of an ultrasound transducer array; determining a voltage signal applied to a “real” ultrasound transducer array used to generate a specific ultrasound field in the brain by placing virtual sound sources at one or more locations where focusing is required; simulating the propagation behavior of ultrasound emitted from virtual sound sources in the 3D digital model of the head; and simulating the voltage signal of the ultrasound transducer array as ultrasound propagates to a virtual spatial location where the ultrasound transducer array is located. In one embodiment, a model of the skull is printed, “real” sound sources are placed at one or more locations, and the voltage generated by the ultrasound transducer array placed on the printed skull is measured to determine the voltage signal applied to the ultrasound transducer array.

[0004] U.S. Patent Application Publication No. 2012 / 0029352 aims to provide an ultrasound apparatus that enables the use of ultrasound in medical fields where it was previously unavailable, particularly for the treatment of tumors. The ultrasound apparatus is an apparatus for specialized medical facilities and can only be operated by specialists. The teachings in U.S. Patent Application Publication No. 2012 / 0029352 aim to overcome, in particular, the problem that the curvature of the body part being treated, such as the head, is patient-specific and therefore individual. The ultrasound apparatus disclosed in U.S. Patent Application Publication No. 2012 / 0029352 has a transducer formed by a plurality of transducer elements housed in a flexible carrier, a measuring device, and a control device. The measuring device is formed to determine the distance and rotation of the transducer from a reference point from a test series, and thus determine the patient-specific position of the transducer elements, and the individual transducer elements emit sound waves during the test series. The control device can determine the sound introduction angle and focus required for treating a location specified by a physician, such as a tumor site, and the control device uses the patient-specific position of the transducer element provided by the measuring device. In embodiments, the control device may be configured to vary the sound introduction angle and / or focus depending on the application. In one embodiment, the determination of the distance and rotation of individual transducer elements may be the result of the patient's past date. U.S. Patent Application Publication No. 2012 / 0029352 further discloses relevant methods for determining the activation of an ultrasound device.

[0005] European Patent Application Publication No. 2085119 discloses a low-energy ultrasound therapy device capable of multi-point transmission and having high utilization efficiency of ultrasonic energy, which means increased therapeutic effect combined with a reduced risk of damaging healthy areas with a given ultrasonic energy. The device includes a substrate on which an ultrasonic transducer array is arranged, and each ultrasonic transducer of the ultrasonic transducer array can be focused independently. This makes it possible to avoid undesirable interference between ultrasonic transducers.

[0006] U.S. Patent Application Publication No. 2018 / 0130457 discloses a deformable ultrasonic device comprising an array of multiple ultrasonic transducer elements. The device thus includes a carrier having an actuator device made of a material having a shape adjustable in response to electromagnetic stimulation. The actuator device allows for changes in the orientation of the ultrasonic transducer elements, thus facilitating beam shaping and / or body contour alignment of the device.

[0007] U.S. Patent Application Publication No. 2006 / 0241522 relates to a medical ultrasound apparatus and method for stimulating angiogenesis and / or reducing ischemia in human or veterinary patients. The apparatus comprises a substrate and a plurality of individual transducer elements arranged on the substrate. The apparatus is intended for professional use and allows for individual control of each ultrasound transducer element to provide the most effective personalized treatment for the patient.

[0008] For example, the requirements for an ultrasound device configured for imaging, as disclosed in U.S. Patent Application Publication No. 2009 / 0024034, differ from those for an ultrasound device used for stimulation. Therefore, prior art relating to ultrasound devices for imaging has limited relevance to the present invention.

[0009] State-of-the-art methods for cell stimulation by acoustic waves, such as those disclosed in U.S. Patent Publication No. 2017 / 0291044, U.S. Patent Publication No. 2012 / 0029352, European Patent Publication No. 2085119, U.S. Patent Publication No. 2018 / 0130457, and U.S. Patent Publication No. 2006 / 0241522, have various drawbacks. In particular, the devices used for stimulation are complex, expensive, and large. This also means that acoustic wave stimulation can only be performed in specialized, and therefore equipped, medical facilities, and cannot be performed outside of such specialized medical facilities. Furthermore, the aforementioned drawbacks prevent acoustic wave stimulation from being used in medical cases that are often considered less serious, such as those related to muscle tone, migraines, tension / relaxation, learning problems, sleep problems, etc. Moreover, the components of the systems used to carry out state-of-the-art methods for cell stimulation by acoustic waves have a highly specialized design that can only be adapted to medical cases in a limited way and has very limited operability.

[0010] In other words, state-of-the-art devices are too complex, too expensive, and too limited in their design and implementation to be used by a wider range of people and / or for a wide range of applications, here for a wide range of medical and non-medical cases.

[0011] Applications in the fields of brain therapy, trauma treatment (e.g., bone stimulation, muscle stimulation), pain treatment (e.g., chronic pain, back pain, migraines), or drug delivery (e.g., topical drug delivery, gene therapy) are examples of applications related to medical cases. Applications in the fields of health (e.g., relaxation, and less severe cases such as insomnia, migraines, and muscle tension) or learning are examples of applications related to non-medical cases.

[0012] One significant problem in the field of cell stimulation using mechanical energy, particularly acoustic energy such as (focused) ultrasonic energy, is the enormous parameter space to consider, even if the device is configured for a single application—here, only a single medical or non-medical indication. Some of the drawbacks mentioned above stem from this problem, which is also why ultrasonic devices used for stimulation are initially provided to professionals (e.g., practitioners) and are therefore not individualized, here designed for specific body parts of a defined (given) individual. However, especially when the device and / or professional provides treatment for multiple indications (applications), it can be difficult even for the professional to process the parameter space and identify and apply the most appropriate parameters for medical or non-medical indications.

[0013] For successful stimulation of a body part, it is crucial that the therapeutic device used for stimulation is configured to deliver a specific acoustic wave stimulus at at least one specific point on the body part being stimulated. In other words, an acoustic field must be generated at a point within the body part being stimulated, and the location of that point and the characteristics of the acoustic field at that point depend on the application.

[0014] The enormous parameter space is established by at least the following: • The geometric characteristics of the body part being stimulated, particularly its shape, for example, its shape in the area where the stimulation is applied. • Arrangement of at least one transducer used to generate a stimulus. This arrangement may include, for example, the position and orientation of the transducers relative to a body part and / or relative to each other if two or more transducers are used. This may further include, for example, the contact pressure between the transducer and the body part.

[0015] Examples of transducer operating parameters include frequency, intensity, pulse duration, pulse length, and pulse repetition rate.

[0016] • Types of transducers that can be used • Interaction between transducer and body part • The body part being stimulated, in this case, for example, the tissue from which it is made, the arrangement of these tissues, and the properties of the tissue (especially its mechanical properties). Needless to say, the parameter space will expand with any additional uses (medical or non-medical indications) that the device may address.

[0017] For example, it is crucial to select the optimal number and placement of transducers, as well as their operating parameters, for a particular treatment. However, this selection is based on expertise in state-of-the-art equipment and methods.

[0018] For example, when configuring (setting up) a system or therapeutic device that generates acoustic wave stimulation by placing at least one transducer on the surface of a body part, it is important to consider the geometric characteristics of the body part to be stimulated. Otherwise, it would be impossible to satisfy the requirements for a specific acoustic wave stimulation at at least one specific point on the body part to be treated.

[0019] For example, some state-of-the-art systems and apparatus, such as those disclosed in U.S. Patent Application Publication No. 2017 / 0291044, use complex, large-scale medical imaging equipment, such as MRI systems or computed tomography (CT) systems, to determine the geometric properties of a body part being stimulated.

[0020] For example, some of the most advanced systems and devices disclosed in U.S. Patent Application Publication No. 2017 / 0291044 use complex, large-scale medical devices, such as functional magnetic resonance imaging (fMRI) systems, to control and adjust the configuration (settings) of a system or therapeutic device used for stimulation. [Overview of the project] [Problems that the invention aims to solve]

[0021] The objective of this invention is to overcome the shortcomings of state-of-the-art devices and methods. In particular, an object of the present invention is to provide a treatment device for more user-friendly acoustic wave stimulation. In particular, the device can be more user-friendly by assisting the user in dealing with the huge parameter space associated with acoustic wave stimulation.

[0022] For example, an object of the present invention is to provide a treatment device for acoustic wave stimulation that can be applied to one or various applications and can be applied by a wider range of people. The applications can be medical applications and / or applications in the field of well-being.

[0023] In particular, an object of the present invention is to provide a portable treatment device that enables acoustic wave stimulation without requiring complex and large-scale medical equipment.

[0024] A further object of the present invention is to provide a method for setting a device for acoustic wave stimulation, particularly a device for acoustic wave stimulation that can be applied to one or various applications and can be applied by a wider range of people, although not exclusively. The applications can be medical applications and / or applications in the field of well-being.

[0025] In particular, an object of the present invention is to provide a method for setting a device for acoustic wave stimulation that enables acoustic wave stimulation without requiring complex and large-scale medical equipment.

Means for Solving the Problems

[0026] At least one of these objects is achieved by the treatment device and method described in the claims.

[0027] Examples of potential users of therapeutic devices and / or those responsible for performing the method or steps of the method include providers of mechanical energy cell stimulation for medical cases, such as medical energy cell stimulation specialists or practitioners; providers of mechanical energy cell stimulation for non-medical cases, such as institutions in the fields of well-being or sports; and users of therapeutic devices who use the device for themselves or people in their social environment.

[0028] Regardless of the embodiments of the apparatus and method, the following terms have the following meanings unless otherwise specified:

[0029] A "carrier element" is a carrier structure (support element, support structure) for at least one transducer (and potentially other elements and means). In other words, it is an element that extends in at least two dimensions on which at least one transducer (and potentially other elements and means) can be placed, and in particular, fixed.

[0030] A set of therapeutic parameters or an object such as a body part is "object-specific" if it relates to an individual (human or animal) object, such as a patient. For example, measures can be taken to ensure that the object is relevant to or suitable for an individual patient.

[0031] The “set of therapeutic parameters for acoustic wave stimulation” (abbreviated as “therapeutic parameters”) includes the operating parameters of the transducer used to generate a sound wave field in the body part to be stimulated, and information regarding the placement of the transducer relative to the body part. The latter may include, for example, information regarding the orientation of the transducer relative to the body part, the contact pressure between the transducer and the body part, and at least one of the types of transducers used. The orientation of the transducer can be given, for example, by the angle between the transducer axis, particularly the vibration axis, and the surface normal of the body part at the location where the transducer is positioned. Frequency, intensity, pulse duration, pulse length, and pulse repetition rate are examples of operating parameters.

[0032] A method for determining, verifying, and / or adjusting a set of therapeutic parameters for acoustic wave stimulation is described in detail in an application filed on the same date by the same applicant entitled “Therapeutic Parameters for Acoustic Wave Stimulation” (Chinese Patent Application Publication No. 00394 / 19). The disclosures of the said application are incorporated herein by reference.

[0033] In many embodiments, the "acoustic wave" is ultrasound (abbreviated as ultrasound). "Body part" can be any body part, such as the head, neck, limbs, or parts thereof.

[0034] "Library" refers to an electronic library, and unless otherwise specified, it means an electronic database.

[0035] The therapeutic device according to the present invention is portable and includes a carrier element, at least one transducer, and communication means, in particular a communication unit configured to receive operating parameters of at least one transducer from a remote computerized device.

[0036] The received motion parameters may include any motion parameters necessary for a given stimulus on the body part being stimulated.

[0037] The received operating parameters may be specific to the application and target. The received operating parameters may be determined, for example, by the practitioner or by a computer implementation configured to select operating parameters from a set of operating parameters stored in a library. Details regarding the received operating parameters are given below, in particular with respect to the method of setting up the treatment device.

[0038] The operating parameters, or optionally the set of therapeutic parameters received, may be the operating parameters of a set of therapeutic parameters (a set of therapeutic parameters) determined as disclosed in the application entitled “Therapeutic Parameters for Acoustic Wave Stimulation” (Chinese Patent Application Publication No. 00394 / 19), filed by the same applicant, particularly on page 5, line 12 to page 25, line 11. In summary, the operating parameters (a set of therapeutic parameters) received may be subject-specific and may be determined by a method that includes the step of selecting a set of operating parameters (a set of therapeutic parameters) from at least two different sets of operating parameters (different sets of therapeutic parameters), the selection step being performed before the step of applying any set of therapeutic parameters to a body part. The method further includes the step of generating subject-specific data, the step of generating subject-specific data including the step of measuring the geometric characteristics of a body part and the step of determining the target sound field distribution in the body part, the step of determining the target sound field distribution including the selection of application. Optionally, at least one of the following may be applied:

[0039] The step of selecting a set of treatment parameters may include comparing a first expected sound field distribution with a target sound field distribution associated with a first set of treatment parameters, and comparing a second expected sound field distribution with a target sound field distribution associated with a second set of treatment parameters.

[0040] The step of generating subject-specific data includes a substep of adding tissue characteristics of the body part to the measured geometric characteristics, and a substep of generating a digital (virtual) 3D model of the body part based on the measured geometric characteristics and the added tissue characteristics. The digital 3D model can then be used to iteratively approximate optimized operating parameters (a set of treatment parameters).

[0041] The procedure involves transmitting target-specific data to an electronic library, the electronic library being configured to perform the steps of determining a target sound field distribution and selecting a set of treatment parameters.

[0042] The operating parameters, or optionally the set of therapeutic parameters, may be verified by a method for verification as disclosed on page 26, line 4 to page 33, line 13 of the above application entitled “Therapeutic Parameters for Acoustic Wave Stimulation,” and / or adjusted as disclosed on page 33, line 19 to page 34, line 11. The teachings of the above application are appended herein by reference.

[0043] In particular, the operating parameters (set of treatment parameters) can be verified before or after being received by the treatment device by a method that includes the steps of generating a target-specific 3D model of the body part to be stimulated (treated) and determining the difference between the target sound field distribution and the sound field distribution determined by the target-specific 3D model. The target-specific 3D model may be a physical ("real", non-virtual) 3D model or a digital (virtual) 3D model, and may be a sound field distribution determined by a measured or calculated sound field distribution.

[0044] The operating parameters (set of treatment parameters) can be adjusted before or after being received by the treatment device, by a method that includes a step of reducing the difference between the target sound field distribution and the sound field distribution determined in the target-specific 3D model, in particular, when the difference is greater than a preset value.

[0045] The verification and / or adjustment methods disclosed in the aforementioned application and summarized above may be part of any embodiment of a method for setting up a therapeutic device as disclosed below.

[0046] In a preferred embodiment, the therapeutic device itself does not include a computerized device for determining any parameter of the set of therapeutic parameters. However, the therapeutic device may include a controller configured to translate the received operating parameters into commands for the transducer. The therapeutic device may also include a computerized device capable of performing any computer implementation method disclosed with respect to the function of the therapeutic device in any embodiment.

[0047] In other words, the parameter space that must be processed by the user of the treatment device is reduced by configuring the device to receive the operating parameters necessary for treatment from or via a remote computerized device.

[0048] In the embodiment, in order to reduce the parameter space, at least one of the following embodiments is implemented in the treatment device.

[0049] According to the first embodiment, the treatment device includes means for determining the geometric properties of a body part when a carrier element is fastened to the body part, wherein the properties of the means for determining the geometric properties depend on at least one of the shape of the carrier element and the deformation of the carrier element.

[0050] In the embodiment according to the first aspect, the therapeutic device is configured to transmit the geometric characteristics of a body part to a computerized device. In the method for setting up the therapeutic device according to these embodiments, the received operating parameters may depend on the transmitted geometric characteristics.

[0051] Embodiments of the first aspect of the present invention are particularly suitable for therapeutic devices that affect a body part when fastened to that body part. For example, the shape and / or density of the body part are affected.

[0052] However, the present invention also relates to a therapeutic device for acoustic wave stimulation of a body part that does not affect the body part when fastened.

[0053] The treatment device according to the second embodiment allows for the determination of the position of at least one transducer relative to a body part when the carrier element is fastened to the body part.

[0054] In embodiments of the second aspect, the therapeutic device is configured to transmit the position of at least one transducer relative to a body part to a computerized device. In the methods for configuring the therapeutic device according to these embodiments, the received operating parameters may depend on the transmitted position.

[0055] The treatment device according to the third embodiment has a carrier element having a shape specific to the body part of each individual target.

[0056] The carrier element can have a shape specific to each individual body part because the shape of the body part is determined before the carrier element is manufactured, for example, by using less sophisticated imaging devices such as specialized medical imaging equipment or commercially available 3D scanners, or by using routines that can approximate the shape of a body part from multiple images of that body part. The method for determining the shape of the body part is usually application-dependent.

[0057] In many embodiments, the carrier element is manufactured by a specialized manufacturer. However, the carrier element may also be manufactured by a platform owned, for example, by the end user, distributor, or practitioner.

[0058] Further embodiments that may be presented in lieu of or in addition to at least one of the first to third embodiments relate, in particular, to a reduction of the parameter space handled by the operator of the therapeutic device by generating a digital (virtual) 3D model of the body part to be treated, as disclosed in the application filed by the same applicant and summarized above entitled “Therapeutic Parameters for Acoustic Wave Stimulation” (Chinese Patent Application Publication No. 00394 / 19). In this regard, in particular, lines 8 on page 17 to line 13 on page 20 and lines 21 on page 21 to line 12 on page 22, as well as the verification and / or adjustments referred to above, should be considered.

[0059] Further embodiments relating to the generation of digital 3D models may be particularly advantageous in methods for setting up a treatment device, but may also be particularly advantageous in methods for manufacturing carrier elements or treatment devices. Any data necessary for generating the digital 3D model can be generated, for example, by a practitioner in a medical facility when determining the shape of the body part to be treated.

[0060] Embodiments of therapeutic devices and related methods can be envisioned that exist without including communication means (communication unit) configured to receive operating parameters of at least one transducer from a remote computerized device, wherein at least one of the first, second, third, and further embodiments exists. In this case, the operating parameters or even a set of therapeutic parameters may be determined, for example, by the computerized device of the therapeutic device.

[0061] In a particular embodiment according to the first aspect of the present invention, a carrier element may be included that is elastic or includes an elastic element and is fastened to the body portion by a force generated by the elastic deformation of the carrier element or its elastic element when it is positioned on the body portion.

[0062] However, the force acts on the body portion and can deform the body portion, particularly in the area of ​​at least one transducer and / or the fixed element for at least one transducer. Therefore, it is necessary to determine the geometric properties of the body portion after the placement of the carrier elements.

[0063] However, in one embodiment, the carrier element may include a rigid material formed according to at least a portion of the body part being treated. For example, the carrier element may include a surface region which is a negative surface region of the body part being treated. The rigid material may be formed according to a specific body part in a manner that is not specific to a given individual.

[0064] Rigid materials can be formed according to the shape of a specific body part of a given individual. In such embodiments, the fastening of the carrier element to the body part does not affect the properties of the body part. Therefore, means for determining the geometric properties of the body part when the carrier element is fastened to the body part are not essential in such embodiments. Furthermore, for example, the shape of the body part is known because it was necessary to provide a carrier element comprising a rigid material formed according to at least a portion of the body part to be treated.

[0065] However, since the relative positions of the carrier element and thus the transducers can change, in many embodiments, the position of at least one transducer relative to the body part must be verified when the carrier element is fastened to the body part. Furthermore, the position and orientation of at least one transducer may differ for different applications.

[0066] In one embodiment, if it is a reasonable embodiment of the therapeutic device that a carrier element is fastened to a body part, the therapeutic device includes means for determining the geometric properties of the body part when the carrier element is fastened to the body part, which enables the determination of the position of at least one transducer relative to the body part.

[0067] For example, the determined geometric properties can be used as input to determine a set of therapeutic parameters, the observed position of at least one transducer relative to a body part can be used as validation for the position of at least one transducer which is the target position, or as further input to determine a set of therapeutic parameters.

[0068] Generally, the target position of a transducer is the position of the transducer relative to a body part, and this position is required to generate a target sound field distribution within the body part when a set of therapeutic parameters is applied. In many embodiments, the target position is part of the set of therapeutic parameters.

[0069] At least one transducer is a transducer that, when placed on a body part, can stimulate that body part with acoustic waves such as ultrasound.

[0070] The determined geometric properties can be used for at least one of the following: determining a set of treatment parameters, verifying a set of treatment parameters, and adjusting a set of treatment parameters.

[0071] The treatment device can perform the setting of treatment parameters, particularly target-specific sets of treatment parameters.

[0072] In the embodiment, means for determining the geometric characteristics of a body part include means for determining the shape of the body part to be stimulated.

[0073] Means for determining the geometric properties of a body part may consist of means for determining the shape of the body part being stimulated.

[0074] In other words, the determined geometric properties may include the shape of the body part being stimulated, or the geometric properties may be the shape of the body part being stimulated.

[0075] However, geometric properties different from the shape of the body part being stimulated can be determined additionally or alternatively by the means described above. For example, the shape of a part of the body, such as the shape of bones like the skull or long bones, or the arrangement of muscles, body fat, etc., can be determined. This can be done, for example, by means including second and potentially third types of transducers, as described below.

[0076] Alternatively or additionally, geometric properties different from the shape of a body part can be determined by using medical imaging systems such as CT or MRI systems.

[0077] The advantage of a therapeutic device that includes means for determining geometric properties is that, by determining the geometric properties (of the body part being stimulated) by the therapeutic device, it is possible to ensure that at least one transducer has a known position relative to the body part when the carrier element is placed on the body part and at least one transducer is fixed in a known position on the therapeutic device.

[0078] In other words, if a treatment device is configured to determine the geometric properties of a body part when it is attached to that body part, an additional medical imaging system is not necessary. This is because the position on the treatment device attached to the body part can be associated with the position relative to the body part.

[0079] The instrument for determining the properties of the means for determining geometric properties does not need to be an integral part of the treatment device. For example, the instrument for determination may be a handheld device owned by the potential user in any form, such as a mobile phone, or it may be delivered as a separate part of the treatment device.

[0080] A 3D scanner may be an instrument for determining the properties of means for determining geometric properties, or an instrument for determining the shape of at least one of the following: a body part, a carrier element attached to a body part, and the position of at least one transducer attached to the carrier element when the carrier element is attached to the body part.

[0081] A 3D scanner can be a portable 3D scanner. A treatment device can be designed so that the geometric properties of the body part are determined by determining the geometric properties of the treatment device itself.

[0082] In one embodiment, the carrier element includes means for determining the geometric properties of a body part.

[0083] Carrier elements can be made from elastic materials. In particular, carrier elements may be elastic so that they sit firmly on the body part when placed on it.

[0084] Alternatively, the carrier element can be made from a rigid material and may optionally include, for example, a flexible portion or a pivot portion that can be used for fastening or tightening.

[0085] The carrier element can have a certain thickness, at least when it is in a relaxed state. The carrier element can be made thin in the sense that changes in thickness due to elongation (stretching) can be ignored when determining the geometric properties of the body part from the geometric properties of the treatment device.

[0086] The therapeutic device may be portable to the subject due to its size and weight. The size of the therapeutic device may be essentially the size of the carrier element, excluding wiring and elements integrated with or connected to the carrier element, such as at least one transducer or optional sensors, emitters, and second types of transducers (described later).

[0087] The size of the treatment device (carrier element) can essentially be the approximate surface area of ​​the largest body part to be stimulated in the intended application. For example, the size of the treatment device (carrier element) can be adapted to the size of the head, neck, shoulder-neck region, upper arm, forearm, constricted area, lower leg, and foot.

[0088] It may also be conceivable to provide therapeutic devices for specific applications and / or groups of users. Therefore, therapeutic devices, particularly carrier elements and / or transducer types, may differ, for example, in size, and possibly in shape and fastening elements.

[0089] For example, one treatment device can be adapted to the size and shape of the head. Another treatment device can be adapted to the size and shape of one or more limbs. Yet another treatment device can be adapted to the torso or parts thereof, such as the chest, back, pelvis, shoulder, or shoulder-neck region.

[0090] The size of the treatment device (carrier element) can be adapted to the largest body part to which the treatment device is fitted. Generally, the largest body part is the body part with the largest surface area to which the treatment device must be placed during stimulation.

[0091] For example, the carrier element that essentially defines the size of the treatment device is 2.25m 2 Less than, for example, 2m 2 , 1.5m 2 or 1m 2 It has a surface area of ​​less than 1 m². 2 A surface area of ​​less than this may be sufficient for most applications.

[0092] However, the treatment device (carrier element) can be designed for continuous treatment of body parts. In this case, the size of the treatment device can have a surface area smaller than the surface area provided by the body parts.

[0093] The carrier material can be made from a fabric (woven material). The fabric may be, for example, a synthetic fabric, a non-synthetic fabric, or a combination thereof. Therefore, the thickness of the carrier element may be less than 2 cm, for example less than 1 cm or less than 0.5 cm, in many embodiments.

[0094] The carrier material may include or consist of plastics, such as rigid plastics.

[0095] The carrier material may include or consist of lightweight materials. The carrier material may include or consist of a material suitable for skin contact or wound contact.

[0096] The carrier element can be molded or 3D printed. The treatment device can be wearable, meaning it can be positioned on and secured to a body part, for example, by tightening around that body part. For example, the carrier element can be a cuff, a hood, or any other garment that can be positioned around a body part. The carrier element is "plastercast" in nature, but in many embodiments it may include elements not made from plaster.

[0097] The weight of a therapeutic device is essentially given by the carrier element, the transducer placed on it, and any other elements such as sensors, emitters, and second-type transducers (see below) potentially placed on it. The weight of a therapeutic device is such that an adult can carry and / or wear it. For example, the weight of a therapeutic device is less than 10 kg, e.g., less than 5 kg or less than 2 kg.

[0098] The treatment device may include hollow sections to reduce its weight. The carrier element may include fastening elements configured to fasten the carrier element to a body part, particularly those configured to securely fasten the carrier element to a body part.

[0099] In one embodiment, in particular, in an embodiment where the means for determining the geometric characteristics of the body part to be stimulated is the means for determining the shape of the body part to be stimulated, the means may include at least one of the following:

[0100] A marker device is provided, wherein the marker device is placed on a carrier element, and the marker device changes its appearance according to the shape of the carrier element.

[0101] A marker device may include multiple elements, such as positioning points and / or lines. Positioning points and / or lines may be detectable by optical systems, such as cameras.

[0102] If the marker device includes positioning points, the distance between the positioning points determined from the image can, for example, indicate the appearance of the marker device. In other words, the changing characteristic could be, for example, distance (or rather, multiple distances).

[0103] If the marker device includes a line, the shape of the line, its length, and its relative arrangement, the shape, length, and relative arrangement are determined from an image and can, for example, represent the appearance of the marker device. That is, the changing characteristics are, for example, at least one of the line's shape, length, and relative arrangement.

[0104] For example, positioning points and / or lines can form a grid on a carrier element, and the appearance of the grid depends on the shape of the carrier element.

[0105] Positioning points and / or lines can be placed on the surface of the carrier element, which is the outer surface of the carrier element when the carrier element is fastened to a body part.

[0106] The marker device can be positioned on the carrier element so that a program can calculate the shape of the carrier element based on at least one image taken from the carrier element when it is fastened to a body part.

[0107] The shape calculation can be based further on information from the marker device, such as the arrangement of positioning points and / or lines, which can be stored in a library communicating with a computerized device, and the program can be executed by the computerized device or extracted from at least one or another image.

[0108] For example, a marker device may include an element containing information necessary to calculate the shape of a carrier element. A QR code (registered trademark) or barcode is an example of such an element. Alternatively or additionally, such information may be present in the marker device and / or in elements of length and orientation specific to the arrangement of the positioning point and / or line.

[0109] A treatment device may include an element that identifies the device. This can be used to obtain further information from a library.

[0110] • Multiple sensors are present, and the sensors are arranged on a carrier element. The output of the sensors depends on the arrangement of the sensors on the carrier element, in this case, the arrangement of the sensors in 3D space.

[0111] A distance sensor is an example of a sensor that can be used as a means for detecting the geometric characteristics of a body part, particularly the shape of a body part being stimulated. In this case, the characteristic is the distance between sensors. The distance can be the output of the sensors.

[0112] A position sensor is another example of a sensor that can be used as a means for detecting the geometric characteristics of a body part, particularly the shape of a body part being stimulated. In this case, the characteristic is the position of the sensor in space. The position of the sensor can be the output of the sensor.

[0113] • Multiple emitters, where the emitters are positioned on the carrier element, and the emitter output, here detectable at the detection point, depends on the relative arrangement of the emitters.

[0114] For example, all emitters of a group of emitters can emit signals of a given intensity, and the intensity detected at a detection point depends on the distance between the emitters and the detection point.

[0115] The treatment device may include detection points. Multiple detection points (meaning at least two) may exist.

[0116] The detection point may be an integral part of the treatment device, or it may be included in a separate element such as a handheld device.

[0117] When a camera is used to determine geometric properties, the camera or associated computerized device can be configured to recognize body parts from captured images, for example, by comparing body shapes to a list of body shapes. For each body part that the camera or associated computerized device can recognize, several specific points can be predefined and stored, for example, in the camera or computerized device. The camera or computerized device can be configured to identify predetermined points. The camera or computerized device can be configured to calculate the true dimensions of a body part or to approximate the true shape of a body part from predetermined points. For example, a predetermined point identified on an image can be set in relation to a corresponding point in a pre-registered image of the same body part. The true dimensions or approximation of a body part can be determined, for example, from the difference observed between a predetermined point identified on an image and a corresponding point in a pre-registered image of the same body part.

[0118] However, geometric properties can be determined using equipment other than cameras, such as CT systems, MRI systems, or 3D scanners.

[0119] In the initial step of setting up or manufacturing the treatment device, it is conceivable that more advanced equipment such as a CT system, MRI system, or 3D scanner may be used, and for subsequent steps of setting up and / or verifying the treatment device, other equipment such as a camera, for example, a mobile phone camera, may be used.

[0120] At least one transducer can be securely attached to the carrier element. This means that at least one transducer can be attached to the carrier element in a way that prevents the user from removing it.

[0121] In embodiments including multiple transducers, all transducers, i.e., at least all transducers capable of stimulating a body part with acoustic waves when placed on the body part, can be securely attached to the carrier element.

[0122] In embodiments including multiple transducers, the therapeutic device may include at least one array of transducers containing all or a large number of the multiple transducers.

[0123] Different array designs are possible. For example, the transducers of an array may operate together or separately. Furthermore, an array can be configured to run a first set of transducers or transducers of the array having a first set of operating parameters, and a second set of transducers or transducers of the array having a second set of operating parameters.

[0124] Array design can distinguish between array size and shape. The treatment device may include at least one array of a first design and at least one array of a second design.

[0125] The treatment device may include a single transducer in combination with at least one array.

[0126] Alternatively, at least one transducer can be released from the carrier element and attached to it.

[0127] "Release" means that at least one transducer can be moved relative to the carrier element. This does not necessarily mean that at least one transducer is separated from the carrier element.

[0128] At least one transducer can be mounted, unmounted, and remounted multiple times.

[0129] In particular, at least one transducer can be mounted at a carrier element position different from the position in which it is released.

[0130] In other words, the position of at least one transducer on the carrier element can be changed. This means that the carrier element and at least one transducer are configured such that at least one transducer can be placed in different, ideally all, positions on the carrier element.

[0131] For example, a carrier element may include at least one fixed element to which at least one transducer can be attached.

[0132] The fixed element can be configured to allow a change in the orientation of a transducer attached to the carrier element via the fixed element.

[0133] The mounting elements can be configured to allow mounting of different types of transducers. Transducers may differ, for example, in their size, weight, and / or the output signal they produce.

[0134] The fixing element can be configured to allow fixing of at least one transducer in a selectable orientation.

[0135] For example, the surface of a carrier element, particularly the outer surface when fastened to a body part, may include loops, and at least one transducer may include hooks (and vice versa) of a face-fastener.

[0136] For example, the surface of a carrier element, particularly the outer surface when fastened to a body part, may include pockets in which at least one transducer can be positioned, or may include clamping means, such as an elastic cord, configured to clamp at least one transducer to the carrier element.

[0137] In one embodiment, the treatment device enables the determination of the position of at least one transducer relative to a body part when a carrier element is fastened to a body part and at least one transducer is attached to the carrier element.

[0138] As described above, the embodiment of the therapeutic device according to the first aspect may also include this feature in any embodiment.

[0139] Embodiments of the therapeutic device according to the first embodiment may include any features disclosed with respect to embodiments of the second embodiment, and vice versa.

[0140] For example, a therapeutic device may be configured to determine the position of at least one transducer relative to a body part when the therapeutic device is fastened to the body part. For example, a carrier element may include a conductive track that changes its properties when a transducer is located on or within the carrier element at a track-specific position, and / or the carrier element may include a fixed element configured to detect the presence of a transducer.

[0141] Alternatively, or in addition to the above configuration of the therapeutic device, the therapeutic device may enable the determination of the position of at least one transducer by equipping the transducer with an element that makes its position observable to an instrument for detecting the position. The instrument for detection may be any device mentioned in relation to an instrument for determining the properties of means for determining geometric properties.

[0142] For example, at least one transducer may include a passive detectable element such as a QR code, labeling, or a conspicuous color. Alternatively or additionally, at least one transducer may include an active detectable element such as an emitter or sensor, as disclosed with respect to means for determining the geometric characteristics of a body part, for example.

[0143] In principle, when a carrier element is used to determine the geometric properties, particularly the shape, of a body part, it may be sufficient to determine the position of at least one transducer relative to the carrier element.

[0144] Therefore, the treatment device may include means for determining the shape of the body part to be stimulated, and when the carrier element is fastened to the body part, it may be possible to determine the position of at least one transducer relative to the carrier element. In this embodiment, at least the carrier element should not be moved between determining the shape of the body part and determining the position of at least one transducer. Otherwise, the determined position on the carrier element will not correspond to the position on the body part that can be concluded from the position on the carrier element.

[0145] As described above, at least one transducer may include an element detectable by a detector (sensor). The detector may be, or may be included in, an instrument for determining the properties of means for determining geometric properties.

[0146] The position of at least one transducer relative to a body part (and potentially a carrier element) can be determined by a method disclosed in connection with determining the geometric properties of a body part, namely, a marker, sensor and / or emitter placed on at least one transducer, and associated detection of the output of the marker or sensor or emitter.

[0147] For example, the position of a marker, and therefore at least one transducer, can be determined by taking at least one image including at least one transducer when it is attached to a body part, and by a program configured to calculate the position of at least one transducer.

[0148] A marker can be an identifier or contain an identifier. This allows us to determine which transducer is at which position.

[0149] The treatment device may include a controller. The controller can be configured to control elements of a therapeutic device, such as at least one transducer, sensor, emitter, or instrument for determining the properties of a means for determining a geometric characteristic detector.

[0150] As described above, the therapeutic device receives operating parameters and potentially further parameters of a set of therapeutic parameters from a remote computerized device. Therefore, the therapeutic device does not need to include a computerized device configured to determine the set of therapeutic parameters or any part thereof. Nevertheless, the controller can be configured to run a program for at least one of the following: determining the geometric shape of a body part, determining the position of at least one transducer, determining the type of at least one transducer, verifying the position of at least one transducer, verifying the type of at least one transducer, verifying the set of therapeutic parameters, verifying the geometric shape of a body part, adjusting the set of therapeutic parameters, etc.

[0151] Another element of the treatment device may include a controller, for example, an instrument for determining the properties of a carrier element or a means for determining geometric properties.

[0152] Alternatively, the controller may be a separate element of the therapeutic device capable of establishing data connections to other elements of the therapeutic device, such as at least one transducer, sensor, emitter, instrument for determining the properties of means for determining geometric properties, and detector.

[0153] In one embodiment, the treatment device is a standalone device. This means that it can perform any steps necessary for preparing and applying stimulation to a body part. However, this does not preclude the possibility of connecting the treatment device to a remote device, for example, to download updates and upload information related to the performed stimulation.

[0154] The treatment device may include communication means for transmitting information from the treatment device to a remote computerized device and vice versa.

[0155] The computerized device can be any device owned by the user, such as a mobile phone, tablet, or PC.

[0156] The controller may include means of communication. The computerized device may host and / or access a library, the library containing at least one of the data provided by other users of the therapeutic device and the data provided by the operator of the library. The library may be a library disclosed in relation to any embodiment of the therapeutic device.

[0157] The computerized device can be configured to run a program, for example, one of the programs listed above, or a program for determining a set or part thereof of treatment parameters. In particular, it can be configured to run a program that requires many resources, such as determining a set of treatment parameters.

[0158] In an embodiment of a therapeutic device configured to determine the position of at least one transducer relative to a body part and to transmit the position of at least one transducer relative to a body part to a computerized device, the transmitted position of at least one transducer may be part of a set of therapeutic parameters transmitted to the therapeutic device after its determination, meaning that it is received (acquired) by the therapeutic device.

[0159] In other words, the treatment device can be configured to receive (acquire) a set of treatment parameters, in particular the operating parameters of at least one transducer, via communication means, the set of treatment parameters being determined taking into account a determined position of at least one transducer. The determined position may include information regarding the orientation of the transducer relative to the body part, and information regarding potential contact pressure.

[0160] In this embodiment, the method for determining the set of treatment parameters can be limited to determining the operating parameters.

[0161] This embodiment often includes a transducer that can stimulate a body part with acoustic waves fixedly attached to a carrier element.

[0162] The treatment device can apply a set of treatment parameters, and in particular, it can operate at least one transducer using operating parameters. Specifically, the controller can be configured to operate at least one transducer using operating parameters.

[0163] In one embodiment, the device is configured to receive a set of therapeutic parameters from a computerized device, the set of therapeutic parameters including the target position of at least one transducer. The device includes at least two transducers, and is configured to activate the transducer closest to the target location during stimulation, while the other transducers remain in the off state.

[0164] This feature is further disclosed below with respect to modifications of embodiments that include a device configured to receive a set of therapeutic parameters from a computerized device.

[0165] • The carrier element includes position markers that help position at least one transducer at the target location.

[0166] This feature is further disclosed below with respect to modifications of embodiments that include a device configured to receive a set of therapeutic parameters from a computerized device.

[0167] The device is configured to determine that at least one transducer is at the target position.

[0168] In a modified embodiment including a device configured to receive a set of treatment parameters from a computerized device, the treatment device includes communication means for exchanging data with the computerized device, and the treatment device is configured to transmit the geometric properties of a body part to the computerized device.

[0169] Geometric properties can be used by a computerized device to determine a patient-specific set of treatment parameters, in this embodiment the target position of at least one transducer is determined together with other parameters of the set of treatment parameters, in particular with the operating parameter.

[0170] The target position is the position that at least one transducer should have relative to a body part such that, when other parameters of the parameter set are applied to the therapeutic device, in particular when the operating parameters are applied to at least one transducer, the acoustic field required for a given application is generated in that body part.

[0171] In other words, the treatment device can be configured to receive (acquire) a set of treatment parameters via communication means, which includes, or consists of, the operating parameters of at least one transducer and the target position of at least one transducer, and the set of treatment parameters is determined taking into account the geometric characteristics of the body part.

[0172] Regardless of the specific embodiment, a therapeutic device can operate at least one transducer using operating parameters. In particular, a controller can be configured to operate at least one transducer using operating parameters.

[0173] In many cases, geometric properties refer to the shape of body parts. This embodiment often includes a transducer capable of stimulating a body part with acoustic waves that are detachable from and attachable to a carrier element, the transducer being repositionable on the carrier element.

[0174] The carrier element may include position marks that allow at least one transducer to be positioned at its target location.

[0175] The location marker may be passive, such as a coordinate system, or active, such as a visual impression generated at the target location.

[0176] Alternatively, this embodiment may include a therapeutic device comprising multiple transducers, and the therapeutic device may be configured to select the transducer closest to the target position.

[0177] "Selecting" in this context means that only the selected transducers are activated, while the unselected transducers or sets of transducers remain off. In other words, the operating parameters apply only to the selected transducers, and the unselected transducers do not operate during stimulation. If multiple transducers are selected, the selected transducers cooperate to generate the acoustic waves used for stimulation.

[0178] For example, an array may include transducers, and the acoustic waves generated by the array may be the acoustic waves required for a stimulus.

[0179] The device may include at least two transducers, and the device, in particular its controller, is configured to activate the transducer closest to the target location during stimulation, while the other transducers remain off or are set to off.

[0180] In one embodiment, the device is configured to verify the configuration of the device with respect to a set of therapeutic parameters by comparing at least one measured parameter of the therapeutic device with a relevant parameter of the set of therapeutic parameters.

[0181] The set of therapeutic parameters includes all parameters necessary to configure and operate the therapeutic device so that an acoustic field is generated on a body part, and the acoustic field can stimulate a region of the body part that must be stimulated to achieve the effect expected by the selected application. Examples of therapeutic parameters (see above) include the operating parameters of at least one transducer, the target position of at least one parameter, and further parameters relating to the relative position between at least one transducer and the body part, such as the orientation and contact pressure of the transducer.

[0182] For example, you can compare at least one of the following: • The measurement position of the transducer and the target position of the set of therapeutic parameters.

[0183] When such comparisons are applied, determining the position of at least one transducer relative to a body part can be considered part of the verification process.

[0184] • A related list of selected transducers and treatment parameter sets. • The measured angle between the transducer's vibration axis and the surface normal of the body part at the transducer's position, and the target angle of the set of treatment parameters.

[0185] • Transducer types and a list containing the types of transducers. In this embodiment, the verification is performed immediately before the start of the stimulus.

[0186] Parameters measured for comparison with relevant parameters in a set of therapeutic parameters determine which elements of the therapeutic device are involved. In particular, one of the following elements, namely controllers, sensors, emitters, detectors, and instruments for determining the properties of means for determining geometric properties, can be configured to verify the parameters of the set of therapeutic parameters.

[0187] In one embodiment, the device includes an input element for receiving user feedback related to the effects of ultrasonic stimulation.

[0188] For example, the input elements can be configured to allow evaluation of the generated effects.

[0189] Input elements can include, for example, touchscreens, buttons, and so on. Additionally or alternatively, the input element may be for receiving information related to the effects of ultrasonic stimulation generated in an automated manner.

[0190] For this purpose, the treatment device may include sensors to monitor the effects of ultrasonic stimulation. The sensors may be sensitive to neurons or electrical activity.

[0191] The treatment device may include an electroencephalogram (EEG) sensor. The set of treatment parameters can be adjusted using user feedback and / or information generated in an automated manner.

[0192] In one embodiment, the device includes an input element for receiving (acquiring) information related to the effects of ultrasonic stimulation, and the device includes communication means for transmitting information to a library available to other users.

[0193] Information related to the effects of acoustic wave stimulation can be, for example, user feedback or information generated by automated methods.

[0194] The set of treatment parameters on which the stimulus was based, the measured parameters of the settings used, and further information such as subject-specific information such as sex, age, weight, height, BMI, body fat content, fat percentage, and muscle percentage can be sent to the library along with feedback, as can the geometric characteristics of the determined body parts.

[0195] The measured position of the transducer, the measured operating parameters, the measured orientation of the transducer relative to the body part, and the measured contact pressure are examples of the measured parameters used in the settings.

[0196] The transmitted information can be used to continuously improve the set of treatment parameters transmitted to the treatment device for a specific application by continuously improving the database for determining the set of treatment parameters.

[0197] Information related to the effects of ultrasound stimulation can be stored locally so that it can be used for future treatments of the same type and / or for the same user.

[0198] The information can be stored in elements owned by the user and connectable to the therapeutic device, such as a therapeutic device, a controller, or equipment for determining the properties of means for determining geometric properties.

[0199] In one embodiment, the device includes at least one sensor for generating object-specific information other than the geometric characteristics of body parts.

[0200] At least some object-specific information can be generated by user input. In other words, input elements can be configured to receive (obtain) object-specific information from the user.

[0201] Input elements for receiving target-specific information can be the same elements as input elements for receiving user feedback.

[0202] An input element or another input element that receives target-specific information can be configured for the user to select its purpose.

[0203] In one embodiment, geometric characteristics include the shape of a part of the body, such as the shape of bones like the skull or long bones, or the arrangement of muscles, body fat, etc.

[0204] In such embodiments, the therapeutic device may include a transducer for exciting acoustic waves within a body part and a transducer for detecting acoustic waves transmitted through and / or scattered within the body part.

[0205] A transducer for exciting acoustic waves can also be a transducer for detecting acoustic waves.

[0206] Transducers for exciting acoustic waves and transducers for detecting acoustic waves can differ from transducers that stimulate body parts with acoustic waves in terms of the characteristics of the acoustic waves they generate and the characteristics of the acoustic waves they detect.

[0207] For example, the therapeutic device may include a second type of transducer configured to apply acoustic waves to a body part and measure the transmitted and / or scattered acoustic waves.

[0208] Alternatively, the therapeutic device may include a second type of transducer configured to apply acoustic waves to a body part, and a third type of transducer configured to measure transmitted and / or scattered acoustic waves.

[0209] A second type of transducer and possibly a third type of transducer may differ from at least one transducer capable of stimulating a body part by acoustic waves, wherein the transducer is the same as the first type of transducer in terms of the acoustic waves it generates and the acoustic wave detection characteristics.

[0210] Second and possibly third types of transducers may be located on a carrier element different from the carrier element on which at least one transducer capable of stimulating a body part by acoustic waves (i.e., the "first type of transducer") is located.

[0211] However, the treatment device may include both a carrier element for a first type of transducer and a carrier element for a second type of transducer, and possibly a third type of transducer.

[0212] In embodiments including a carrier element formed according to at least a portion of the body part to be treated, for example, a rigid material formed accordingly, the carrier element may include a per-transducer anchoring element required for a particular application, each anchoring element positioned on the carrier element at a target location for that particular application.

[0213] For example, the anchoring element may be integrated with or securely attached to a carrier element formed according to a part of the body, and the position of the anchoring element on the carrier element corresponds to a selected application (treatment) and a target position for the transducer of the carrier element fixed to the body part, such that the carrier element formed according to the part of the body is adjacent to the part of the body.

[0214] Alternatively, the carrier element includes an arrangement of multiple fixation elements, which are integrated with or securely attached to a portion formed according to a part of the body, for example, and whose number and arrangement allow for the fixation of at least one transducer at a target location for various applications (therapeutic).

[0215] Multiple fixed elements can be optimized for a limited number of predetermined uses. Regardless of a specific embodiment of a therapeutic device including at least one fixing element, the device may include means for detecting the correct fixation of at least one transducer within at least one fixing element. In other words, at least one fixing element and / or at least one transducer may be configured to ensure a predetermined position and orientation of at least one transducer.

[0216] Regardless of the specific embodiment, carrier elements, particularly their rigid parts (if any), can be manufactured by rapid manufacturing processes such as milling, turning, casting, or printing, including additive manufacturing processes such as 3D printing.

[0217] The present invention further relates to a system comprising a carrier element, at least one transducer, communication means (communication unit), and a computer program that, when executed by a remote computerized device, particularly a user-owned computerized device, includes instructions causing the computerized device to exchange data with the communication means.

[0218] When executed by a remote computerized device, the computer program may include any further instructions causing the computerized device to perform any functions disclosed with respect to the treatment device and / or configuration method, such as detecting the shape of the body part being treated and / or the position of at least one transducer by using the computerized device's camera, exchanging data with further remote computerized devices, controlling the treatment device, and providing a user interface.

[0219] In one embodiment, the remote computerized device is not part of the system. The system may include a therapeutic device of any disclosed embodiment, wherein the carrier element, at least one transducer, and communication means are the carrier element, at least one transducer, and communication means of the therapeutic device.

[0220] A computer program (also called an “application” or “app”) is loadable into the internal memory of the computerized device and includes computer executable instructions that cause one or more processors of the computerized device to control the computerized device so that it can perform any functions disclosed with respect to the treatment device and / or methods for setting it up.

[0221] Computer programs can be stored on computer-readable media on which computer-executable instructions are recorded. The computer-readable media is preferably non-temporary, i.e., tangible.

[0222] In particular, in embodiments having a carrier element formed according to a portion of the body part to be treated, at least one object of the present invention can be satisfied by the carrier element, for example, by including a rigid material formed according to the portion of the body part to be treated, and by including at least one fixing element that is integrated with or firmly attached to the carrier element.

[0223] Therefore, the present invention also relates to a carrier element formed according to at least a portion of the body part to be treated, • The carrier element includes at least one fixed element for transducers, and the number and arrangement of the fixed elements are adapted to a specific acoustic wave stimulus, or The carrier element includes an arrangement of multiple fixing elements that allow for the fixation of at least one transducer at the target location of various acoustic wave stimuli.

[0224] In one embodiment, the carrier element is formed according to at least a portion of the body part of an individual subject, the body part being treated. In other words, the carrier element is formed to fit not only at least a portion of the legs, arms, neck, head, back, etc., but also at least a portion of the legs, arms, neck, head, back, etc., of a given patient.

[0225] In one embodiment, the carrier element comprises a rigid material, which is formed according to a portion of the body part to be treated. The body part may be a given patient's body part.

[0226] The carrier element may be part of a kit of components that further includes a number and type of transducers used for a stimulus (application) selected by the user or for multiple stimuli (applications) that the carrier element can perform on a corresponding body part.

[0227] The present invention also relates to a method for manufacturing a therapeutic device, in particular a portable therapeutic device. The method includes the following steps.

[0228] • A step of determining at least part of the shape of the body part to be treated, • Steps to select a body part for treatment, The step of determining the target location of at least one transducer on a body part, wherein the number of transducers and target locations, as well as the target locations, depend on the selected treatment and the determined shape. A step of providing a carrier element and the number of transducers, wherein the carrier element is equipped to position the transducers at target locations.

[0229] In one embodiment, the steps of determining at least a part of the shape of a body part, selecting a treatment for the body part, and determining a target location are performed by a practitioner.

[0230] In one embodiment, the method further includes the step of positioning at least one transducer at at least one target location. This step can be performed by a patient (end-user), a manufacturer, or a practitioner.

[0231] If the placement step is performed by the manufacturer, the therapeutic device provided by the manufacturer may be a fully assembled device.

[0232] In one embodiment, the carrier element is formed according to at least a portion of the shape of the body part to be treated.

[0233] For example, the carrier element can be formed according to at least part of the shape of the body part of the individual subject being treated.

[0234] In one embodiment of a method for manufacturing a carrier element, the provided carrier element is formed according to a (personalized or non-personalized) portion of the body part to be treated and includes at least one anchoring element that is integral with the carrier element or securely attached to the carrier element. For example, the carrier element includes a rigid material formed according to a (personalized or non-personalized) portion of the body part to be treated, and the anchoring element is integral with the rigid material or the anchoring element is attached to the rigid material.

[0235] For example, the step of determining the shape of the body part to be treated includes taking an image of the body part or scanning it, and the step of providing a carrier element includes manufacturing the carrier element using the determined shape of the body part and including a rapid manufacturing process such as milling, turning, casting, or printing, or additive manufacturing such as 3D printing.

[0236] As described above, methods for determining, verifying, and / or adjusting a set of therapeutic parameters for acoustic wave stimulation are described in detail in an application entitled “Therapeutic Parameters for Acoustic Wave Stimulation,” filed on the same date by the same applicant as this application. However, such methods may include the step of generating a digital 3D model including a model of the surface of the body part to be stimulated. In this case, the carrier element can be manufactured using the digital 3D model.

[0237] The present invention further relates to a method for setting up a device for acoustic wave stimulation of a body part. A method for operating a device for acoustic wave stimulation of a body part may include a method for setting up in any embodiment.

[0238] This method is particularly suitable for setting up treatment devices according to any of the above-described embodiments, although this is not exclusive.

[0239] The specific embodiments of the method for setting up the treatment device can vary considerably. For example, In one embodiment, the treatment device may be configured such that improper use could lead to serious consequences. This is often the case when the treatment device is for a medical indication. In this embodiment, the practitioner is typically directly involved in setting up the treatment device.

[0240] Embodiments for setting up this type of therapeutic device may include the steps of receiving a carrier element and at least one transducer from a manufacturer, and placing at least one transducer on the carrier element, the step of placing at least one transducer on the carrier element being performed by a practitioner.

[0241] Optionally, the practitioner may provide reference points (landmarks) to ensure the correct placement of the treatment device on the body part being treated.

[0242] The practitioner can optionally determine the operating parameters. The practitioner can provide these operating parameters so that they can later be received by the treatment device. In other words, the operating parameters are specific to the subject.

[0243] If the therapeutic device is for only one medical indication, the therapeutic device may be fully assembled and accepted. In this case, the step of positioning at least one transducer relative to the carrier element may be omitted.

[0244] In one embodiment, the treatment device may be configured such that improper use could affect the effectiveness of the treatment, but would not result in serious consequences for the user. This is often the case when the treatment device is a well-being device. In this embodiment, the practitioner typically does not need to be directly involved in setting up the treatment device.

[0245] Embodiments for setting up this type of therapeutic device may include the steps of receiving a carrier element and at least one transducer from a manufacturer, and placing at least one transducer on the carrier element, the step of placing at least one transducer on the carrier element being performed by a non-practitioner, such as an end-user or a person providing this type of therapeutic treatment to an end-user.

[0246] The placement step may include receiving information regarding the placement of at least one transducer on a carrier element. In particular, it may include any step disclosed in relation to embodiments in which a set of therapeutic parameters is received. Alternatively or additionally, it may include receiving information from the practitioner regarding the placement of at least one transducer on a carrier element.

[0247] Optionally, the correct placement of the treatment device on the body part being treated can be ensured by reference points (landmarks) provided by the practitioner and / or received from a library.

[0248] The correct placement of at least one transducer and / or treatment device can be ensured by including any steps disclosed relating to determining the geometric characteristics of the body part to be treated and / or determining the position of at least one transducer.

[0249] Optionally, operating parameters may be provided by the practitioner so that they can be subsequently received by the treatment device.

[0250] In embodiments where the carrier element is manufactured based on data generated by a practitioner, the practitioner may be a practitioner who provides operating parameters.

[0251] However, the operating parameters may be determined by a computer implementation configured to select operating parameters from a set of operating parameters stored in a library.

[0252] If the therapeutic device is for only one medical indication, the therapeutic device may be fully assembled and accepted. In this case, the step of positioning at least one transducer relative to the carrier element may be omitted.

[0253] Regardless of any specific embodiment of a method for setting up a therapeutic device, a method for setting up a device for acoustic wave stimulation of a body part, wherein the device includes at least one transducer, a carrier element, and a communication means, includes the step of receiving operating parameters of at least one transducer from a remote computerized device.

[0254] This method may include the step of providing a therapeutic device, in particular a therapeutic device according to any disclosed embodiment.

[0255] The remote computerized device is a remote computerized device according to any of the embodiments described above.

[0256] The received operating parameters may be determined, for example, by the practitioner or by a computer implementation configured to select operating parameters from a set of operating parameters stored in a library. Whether the received operating parameters are determined by the practitioner or by the computer implementation may depend on the application. If the application relates to a medical indication, the operating parameters are preferably determined by the practitioner or at least approved. For example, if the application relates to well-being, the operating parameters are preferably determined by the computer implementation.

[0257] The computer implementation method can be realized as a computer program that, when executed by a computer, includes instructions that cause the computer to select an operating parameter from multiple operating parameters stored in a library.

[0258] The computer implementation method may be the method disclosed in the application entitled “Therapeutic Parameters for Acoustic Wave Stimulation” (Chinese Patent Application Publication No. 00394 / 19), which was filed by the same applicant on the same date as this application.

[0259] In embodiments where the received operating parameters are part of a set of treatment parameters, In the embodiment, the received operating parameters are part of the set of therapeutic parameters in the sense described above. In other words, the data received from the remote computerized device may include information about the placement of at least one transducer, in addition to the operating parameters (pulse duration, pulse length, pulse repetition rate, intensity, etc.).

[0260] The received operating parameters (and in some cases, a set of treatment parameters) are, as described above, the operating parameters (set of treatment parameters) determined by the computerized device.

[0261] Embodiments in which the received operating parameters are part of a set of therapeutic parameters further include at least one of the following:

[0262] The set of received therapeutic parameters includes a target location for at least one transducer on a body part, and the method includes the step of positioning at least one transducer on a carrier element and at the target location.

[0263] In other words, the position of the transducer relative to the body part may be variable during the determination of the set of treatment parameters.

[0264] A therapeutic device operated according to this embodiment of the method requires a transducer that can be released and (re)attached to a carrier element.

[0265] The correct placement of at least one transducer can be supported by the therapeutic device, and in particular, the carrier element may include, for example, the marks disclosed with respect to the therapeutic device.

[0266] The treatment device, particularly the carrier element and optionally at least one transducer, may include a fixing element that allows for the release and (re)attachment of at least one transducer at various positions, as disclosed with respect to the treatment device.

[0267] The step of determining the position of at least one transducer (2) relative to a body part may be an important verification step in an embodiment that includes the steps of receiving a target position and positioning at least one transducer at the target position.

[0268] The device includes multiple transducers, and the received set of therapeutic parameters includes at least one target position of the transducers. The method includes the step of activating the transducer closest to the target position, while the transducers not closest to the target position remain in the off state.

[0269] In other words, the treatment device includes multiple transducers distributed across a carrier element, and the controller is configured to select the transducer closest to the target location of the received set of treatment parameters.

[0270] Optionally, this embodiment of the method may still include the step of repositioning at least one transducer. However, the scope of the repositioning of at least one transducer may be limited. For example, this could be at least one fine adjustment of the position, orientation, and contact pressure of at least one transducer.

[0271] At least one transducer can be fixed to the carrier element to allow for fine adjustment. Optionally, the fixation of the transducer can prevent complete separation of the carrier element and the treatment device.

[0272] - A step to verify the configuration of the treatment device with respect to the received set of treatment parameters by comparing the measured parameters of the treatment device with the relevant parameters of the set of treatment parameters.

[0273] For example, the position and / or orientation of at least one transducer relative to a body part is verified. In this case, the step of determining the position of at least one transducer relative to a body part can be a substep of the verification step.

[0274] The verification step may include the use of the therapeutic device in any embodiment configured for verifying the device configuration.

[0275] Optionally, the validation step may trigger a step to adjust the set of treatment parameters if the results of the validation step are negative.

[0276] The result of the verification step can be negative if the measured parameter is distinguished from the relevant parameter within the set of treatment parameters by exceeding a preset value.

[0277] The verification step can include a sub-step of determining the difference between the measured parameter and the relevant parameter in the set of treatment parameters, and a sub-step of comparing the difference with a preset value.

[0278] The verification step and optionally the adjustment step can be performed before or during the step of applying the set of treatment parameters to the treatment device, depending on the verified parameter.

[0279] As pointed out with respect to the treatment device, there are various ways that can help reduce the parameter space that the user of the treatment device has to handle. As a result, embodiments of the method can vary depending on the specific implementation of the treatment device.

[0280] Embodiments of the method that are particularly suitable for the setting of a treatment device according to or including the first aspect can commonly have the following steps.

[0281] · The step of fastening a carrier element to the body part to be stimulated. · The step of determining the geometric characteristics of the body part.

[0282] The geometric characteristics can be determined in any way disclosed with respect to the treatment device. In particular, the means for determining the geometric characteristics of the body part are used in the step of determining the geometric characteristics of the body part.

[0283] In an embodiment, at least the shape of the body part is determined. · The step of transmitting the geometric characteristics to a computerized device that can determine the operating parameters (possibly a set of treatment parameters) of the treatment device.

[0284] The operating parameters (set of treatment parameters) are the set of treatment parameters described above.

[0285] The computerized device can be, for example, one of the remote devices and devices owned by the user, such as the mobile phone, tablet, PC, etc. disclosed above.

[0286] The computerized device can be configured to determine the operating parameters (in some cases, a set of treatment parameters) for the use given by the selection of the body part and the user.

[0287] The computerized device takes into account the geometric characteristics transmitted when determining the operating parameters (set of treatment parameters).

[0288] Information regarding the desired treatment, the body part to be treated or subject-specific data can be transmitted to the computerized device together with the geometric characteristics.

[0289] Embodiments of a method particularly suitable for the setting of a treatment device according to or including the second aspect can commonly have the following steps.

[0290] · The step of fastening the carrier element to the body part of the stimulation target, and · The step of determining the position of at least one transducer with respect to the body part when at least one transducer is fastened to the carrier element and the carrier element is fastened to the body part.

[0291] · The step of transmitting the position of at least one transducer to the computerized device.

[0292] The computerized device can be, for example, one of the remote devices and devices owned by the user, such as the mobile phone, tablet, PC, etc. disclosed above.

[0293] The computerized device can be configured to determine operating parameters (and possibly a set of therapeutic parameters) for a body part and an application given by the user's selection.

[0294] The computerized device takes into account the position of at least one transducer transmitted when determining the operating parameters (a set of treatment parameters).

[0295] In the embodiment, the method according to the second aspect includes at least one of the following: The step of determining the position of at least one transducer relative to a body part may include any substeps relating to the detection of active or passive elements, as disclosed in relation to therapeutic devices configured to determine the position of at least one transducer relative to a body part.

[0296] In particular, the step of determining the position may include a substep of taking an image. This may also include a substep of acquiring a sequence of images for purposes such as performing a scan.

[0297] Alternatively or additionally, the position determination step may include a substep that determines the presence of at least one transducer within the fixed element of the carrier element.

[0298] The received operating parameters are part of a set of received therapeutic parameters, including the position of at least one transducer as the target position. In other words, the determined position of at least one transducer is assumed to be fixed, and the set of therapeutic parameters is calculated based on the assumption of fixed transducers (and possibly multiple fixed transducers). At least one transducer can be fixed to a body part by a carrier element, for example, in the manner disclosed with respect to the therapeutic device.

[0299] Embodiments according to the first and second embodiments may be part of a method for operating a therapeutic device. In particular, steps common to the first embodiment and / or common to the second embodiment may be characteristic of a method for operating a therapeutic device for acoustic wave stimulation, the device comprising at least one transducer and carrier element.

[0300] Embodiments of this method, particularly embodiments according to the second aspect, may often be a verification step of a more general method for setting up a therapeutic device and / or a method for operating a therapeutic device, or may be part thereof. In such cases, this method can be considered a method for verifying a set of therapeutic parameters or a part thereof.

[0301] One embodiment of the method according to the second embodiment may include the three characteristic steps of the method according to the first embodiment listed above. Additionally or alternatively, any further steps disclosed in connection with the embodiment according to the first embodiment may be included unless otherwise specified.

[0302] Similarly, one embodiment of the method according to the first embodiment may include the step of determining the position of at least one transducer relative to the body part of the second embodiment listed above. Additionally or alternatively, unless otherwise specified, any further steps disclosed in connection with the embodiment according to the second embodiment may be included.

[0303] In one embodiment, the operating parameters (in some cases, a set of treatment parameters) are applied to the treatment device to generate acoustic waves necessary to affect the stimulation that matches the desired application. However, the step of applying the operating parameters (set of treatment parameters) can be performed after at least one of the steps of verifying the operating parameters (set of treatment parameters), verifying the position of at least one transducer, and adjusting the operating parameters (set of treatment parameters). Alternatively or additionally, the step of applying the operating parameters (set of treatment parameters) can include a sub-step of adapting the operating parameters (set of treatment parameters). This means that the operating parameters (set of treatment parameters) are adjusted during the step of applying the operating parameters (set of treatment parameters). The application step can be interrupted for the adjustment of the operating parameters (set of treatment parameters).

[0304] In an embodiment, the method can include at least one of the following steps in addition to any other steps disclosed above or in any combination of the steps disclosed above.

[0305] · The step of receiving user feedback related to the effect of the ultrasonic stimulation. The step of receiving user feedback can include the use of the treatment device in any embodiment that includes an input element for receiving user feedback.

[0306] The step of receiving user feedback can trigger the step of adjusting the set of treatment parameters if the user feedback evaluates that the effect of the ultrasonic stimulation is insufficient.

[0307] · The step of receiving at least one of a start signal and a stop signal from a computerized device. The start signal enables the device to perform the treatment, and the stop signal prevents the start of the treatment.

[0308] Steps of the method in any embodiment may be performed by a therapeutic device, in particular by an element of the therapeutic device configured to perform a specific step of the method, unless otherwise specified.

[0309] Therefore, the treatment device can be configured to perform any step of the disclosed method.

[0310] Further optional steps of this method arise from the description of the treatment device and the claims.

[0311] For example, if a therapeutic device (or its components) is configured to perform an action and / or is capable of performing an action, the method may include the step of performing the action.

[0312] The subject matter of the present invention will be described in more detail below with reference to exemplary embodiments shown in the accompanying drawings. [Brief explanation of the drawing]

[0313] [Figure 1] An exemplary embodiment of the treatment device is shown. [Figure 2] An exemplary embodiment of a carrier element of a therapeutic device is shown. [Figure 3] Further exemplary embodiments of the treatment device are shown. [Figure 4] Further exemplary embodiments of the carrier element are shown. [Figure 5] Further exemplary embodiments of the carrier element are shown. [Figure 6] A flowchart illustrating the method for setting up a therapeutic device for acoustic wave stimulation is shown. [Figure 7] A flowchart illustrating an exemplary embodiment of a method for setting up a therapeutic device for acoustic wave stimulation of a body part is shown. [Figure 8]A flowchart is shown of a method for setting up a therapeutic device for acoustic wave stimulation of a body part, which includes steps relating to a first aspect for reducing the parameter space processed by the user. [Figure 9] A flowchart is shown of a method for setting up a therapeutic device for acoustic wave stimulation of a body part, which includes steps relating to a second aspect for reducing the parameter space processed by the user. [Figure 10] A flowchart illustrating an exemplary embodiment of a method for setting up a therapeutic device for acoustic wave stimulation of a body part is shown. [Figure 11] A flowchart illustrating an exemplary embodiment of a method for setting up a therapeutic device for acoustic wave stimulation of a body part is shown. [Figure 12] A flowchart illustrating an exemplary embodiment of a method for setting up a therapeutic device for acoustic wave stimulation of a body part is shown. [Figure 13] A flowchart illustrating an exemplary embodiment of a method for setting up a therapeutic device for acoustic wave stimulation of a body part is shown. [Figure 14] A flowchart illustrating an exemplary embodiment of a method for setting up a therapeutic device for acoustic wave stimulation of a body part is shown. [Figure 15] A flowchart of an exemplary embodiment of the method for manufacturing a therapeutic device is shown. [Modes for carrying out the invention]

[0314] Figure 1 shows an exemplary embodiment of a therapeutic device. The device shown includes a carrier element 1 made from an essentially flexible material. The carrier element 1 further includes fastening elements 9 positioned and equipped for fastening the carrier element to a body part to be stimulated.

[0315] In the embodiment shown, two transducers 2 configured to generate acoustic waves are attached to a carrier element 1. The transducers include a detectable element 4, namely a QR code, on the surface of the transducer 2, which is visible when the carrier element 2 is fastened to a body part.

[0316] The carrier element 1 includes means for determining the geometric properties of the body part when the carrier element 1 is fastened to the body part. In the shown embodiment, these means are provided by a grid placed on the surface of the carrier element 1, which is visible when the carrier element 2 is fastened to the body part.

[0317] The treatment device shown includes a controller 5 and a communication means 6, i.e., a wireless communication means.

[0318] The communication means 6 is configured to exchange data with a remote computerized device 11. In the shown embodiment, the remote computerized device 11 is a computerized device owned by the user, such as a mobile phone, tablet, or personal computer (as shown).

[0319] The mobile phone can communicate with communication device 6. In the embodiments shown, an application ("App") is provided with the therapeutic device. The App is configured to allow the use of components of a remote computerized device, particularly during the setup and operation of the therapeutic device. This has the advantage that the therapeutic device itself does not require such components, and there is no need to provide such components with the therapeutic device.

[0320] In the embodiment shown, the instrument 18 for determining the properties of means 3 for determining the geometric properties of a body part is not provided by or with the treatment device, and the instrument is a mobile phone camera.

[0321] In the illustrated embodiment, the computerized device 11 can detect and interpret the detectable element 4 via its camera 18. In particular, the computerized device 11 can do this thanks to an application installed on it.

[0322] Furthermore, the user interface 12, which is configured to be controlled by the user and includes input elements for receiving user feedback, is not provided by or with the treatment device, but is provided by a mobile phone.

[0323] In the illustrated embodiment, the mobile phone is a remote computerized device 11 that provides a set of treatment parameters via an application installed on the mobile phone and / or via communication with a further remote computerized device 7.

[0324] Figure 2 shows an exemplary embodiment of carrier element 1 that differs from carrier element 1 shown in Figure 1, by including a plurality of securely attached fixing elements 10 and markings 8 that allow the user to position and fix a number of transducers indicated by the set of treatment parameters on carrier element 1 at positions indicated by the set of treatment parameters.

[0325] A portion of the set of treatment parameters related to the user setting up the treatment device, particularly the number and position of transducers, can be displayed to the user in the user interface 12.

[0326] In alternative embodiments not explicitly shown in Figure 2, the transducer 2 is securely attached to the fixed element 10, and the controller 5 can actuate the transducer 2 as indicated by a set of therapeutic parameters.

[0327] Figure 3 shows an exemplary embodiment of a therapeutic device that differs from the therapeutic device shown in Figure 1 by including means for determining further characteristics of the body part to be stimulated.

[0328] In the embodiments shown, these further means include one or more transducers 14 for exciting acoustic waves within a body part, and one or more transducers 15 for detecting reflected and / or scattered acoustic waves.

[0329] The acoustic waves generated by the transducer 14 for exciting acoustic waves within a body part have properties that allow for the determination of the acoustic properties within the body part, such as propagation speed, attenuation, presence of scattering centers, or location of changes in acoustic properties.

[0330] The controller 5 or any computerized device of the treatment device or a device communicating with it may be configured to analyze the signals observed by the transducer 15 for detecting reflected and / or scattered acoustic waves.

[0331] In the embodiments shown, further means for determining further characteristics of the body part being stimulated include a sensor 13 for recording object-specific information other than the geometric or acoustic characteristics of the body part. Examples of such object-specific information include blood flow, nerve activity, and pulse rate.

[0332] The controller 5 or any computerized device of the treatment device, or a device communicating with it, can be configured to analyze recorded subject-specific information. In particular, subject-specific information may be suitable for observing the effects produced by stimulation. Therefore, subject-specific information may be suitable for use in a feedback loop (control loop) for adjusting treatment parameters.

[0333] Figure 4 shows two different diagrams of an exemplary embodiment of the carrier element 1, which includes a portion 16 of rigid material that forms a negative of the body part to be stimulated, meaning that it includes a surface 17 that forms a negative of the surface of the body part to be stimulated.

[0334] Carrier element 1 is shown in a simplified manner that fits the forearm of a specific user. The carrier element 1 in Figure 4 is not only specific to the subject, but also specific to the treatment, as it includes a surface 17 that forms a nearly complete negative of the forearm of this subject (but not generally another subject). This means that the fixation element 10 and transducer 2 (when attached to the carrier element 1) have positions corresponding to the target location of a particular treatment after the carrier element 1 has been attached to the body part.

[0335] Figure 5 shows a carrier element 1 that differs from the carrier element shown in Figure 4 by including multiple fixed elements 10. This means that the carrier element 1 in Figure 5 is user-specific but not treatment-specific. Rather, the transducer can be mounted in a position and number corresponding to one set of treatment parameters among various possible treatments.

[0336] The transducer can be supported by the marker 8, or the transducer 2 can be securely attached to the fixing element 10, and the controller 5 can be configured to actuate the transducer 2 as indicated by a set of treatment parameters.

[0337] Figure 6 shows a flowchart of the basic steps for setting up the treatment device. The basic steps are as follows:

[0338] Step S1 involves preparing a carrier element 1, at least one transducer 2, and a communication means 6.

[0339] How the carrier element 1, at least one transducer 2, and communication means 5 are prepared may depend on how these components are provided.

[0340] For example, the components may be provided in a fully assembled therapeutic device. In this case, step S2 of preparing the carrier element 1, at least one transducer 2, and communication means 6 may be a step of preparing the therapeutic device. The provided therapeutic device can be a therapeutic device according to any of the disclosed embodiments.

[0341] For example, the components may be provided separately, or some of the components, in particular at least one transducer, may be provided separately from the other components. In this case, step S2 of preparing the carrier element 1, at least one transducer 2, and communication means 6 may be a step of preparing the components as provided by the manufacturer.

[0342] For example, at least one transducer 2 and communication means 6 are provided by the manufacturer, and the carrier element 1 must be manufactured elsewhere, for example, by an end user, practitioner, or medical facility. In this case, step S2 of preparing the carrier element 1, at least one transducer 2, and communication means 6 may be a step of preparing at least one transducer 2 and communication means 6 provided by the manufacturer, and manufacturing the carrier element 1.

[0343] Step S2 connects the communication means 6 to a computerized device 11 owned by the user or another remote computerized device 7, such as a remote computerized device that stores a library containing multiple treatment parameter sets or a portion thereof.

[0344] Step S3: Receiving operating parameters from a remote computerized device. Figure 7 shows a flowchart of an exemplary embodiment of a method for setting up a therapeutic device according to any embodiment disclosed. In the embodiment shown, a number of transducers 2 corresponding to the number of transducers required for a given treatment or a number of given treatments are provided by the manufacturer separately from the carrier element 1 and the communication means 6. In other words, the communication means 6, and other components such as the controller 5 and fixed elements 10, as well as at least one of the following, which may optionally determine geometric properties: means 3, sensors 13 for subject-specific information, transducers 14 for excitation, transducers 15 for detection, etc., are integrated with or attached to the carrier element, but the transducers 2 are separated from the carrier element 1.

[0345] In this embodiment, step S1 of preparing the carrier element 1, at least one transducer 2, and communication means 6 corresponds to the step of preparing the carrier element, which includes the transducer 2 and pre-assembled components of a later therapeutic device.

[0346] With respect to the steps disclosed in the embodiment of Figure 6, the embodiment shown in Figure 7 includes a further step S4 of positioning the transducer 2 on the carrier element 1.

[0347] The placement step S4 includes a substep of positioning and aligning the transducer 2 on the carrier element 1, and a substep of fastening the transducer to the carrier element 1 during that positioning.

[0348] The specific implementation of placement step S4 may depend on the anticipated treatment (use) or multiple anticipated treatments (uses).

[0349] For example, if the treatment is of a type where improper placement of the transducer could have serious consequences for the user, step S4 of positioning the transducer may be performed by the practitioner. In particular in this case, the method may further include a step of providing landmarks for precisely positioning the carrier element 1 on the body part being treated.

[0350] For example, if the treatment is of a type where incorrect placement of the transducer does not have significant consequences for the user, step S4 of positioning the transducer may be performed by the end user. In particular in this case, the method may include a step of receiving information about the position and optionally alignment of the transducer. This information may be provided, for example, by the practitioner via a remote computerized device or by an app.

[0351] Figure 8 shows a flowchart of one embodiment of a method for setting up a treatment device, the embodiment including steps related to a first aspect for reducing the parameter space handled by the user. This embodiment includes the following steps:

[0352] Step S10 involves attaching carrier element 1 to the body part to be stimulated. Step S20: Determine the geometric properties of the body parts.

[0353] Step S30 involves transmitting geometric characteristics to a remote computerized device (7, 11), the remote computerized device which can determine the operating parameters, or optionally, a set of therapeutic parameters for the therapeutic device.

[0354] Step S3, where operational parameters are received, or Step S40, where a set of treatment parameters is received, constitutes a computerized device, and the set of treatment parameters includes operational parameters.

[0355] In principle, the embodiment shown in Figure 8 further includes step S1 of preparing a carrier element 1, at least one transducer 2, and a communication means 6, and step S2 of connecting the communication means 6 to a remote computerized device as disclosed with respect to Figure 6. This may further include the steps disclosed with respect to Figure 7.

[0356] As described above, the therapeutic device, particularly the embodiment of carrier element 1, does not affect the body part when fastening the therapeutic device to the body part, and the necessary geometric properties are determined without using the therapeutic device, thus eliminating the need for step S20 to determine the geometric properties of the body part.

[0357] Figure 9 shows a flowchart of one embodiment of a method for setting up a treatment device, the embodiment including steps related to a second aspect for reducing the parameter space handled by the user. This embodiment includes the following steps:

[0358] Step S10 involves attaching carrier element 1 to the body part to be stimulated. Step S5, which receives the target position of at least one transducer 2, or step S40, which receives a set of treatment parameters, forms a remote computerized device (7, 11), where the set of treatment parameters includes the target position. In particular, between receiving the target position in step S5, or step S40, or receiving the set of treatment parameters, the target position required for the selected treatment can be received for each transducer.

[0359] Step S50: Determine the position of the required transducer 2 relative to the body part. Generally, this step S50 is performed when the required transducer 2 is fastened to the carrier element 1 and the carrier element 1 is fastened to the body part.

[0360] Step S70: Compare the determined position with the target position. Any computerized device of the treatment device, such as the controller 5, or any device associated with the treatment device, can be configured to perform the comparison step S70.

[0361] Depending on the computerized device configured to perform comparison step S70, the method may include a step of transmitting the transducer's location to the computerized device.

[0362] Optionally, the method according to Figure 9 may include a further step of generating a stop signal that prevents the treatment device from performing the treatment, or a further step of generating a start signal that allows the treatment device to initiate the treatment, particularly treatment based on a set of received treatment parameters. The difference between the determined position and the target position of the set of treatment parameters can be used as a criterion for determining whether a stop signal or a start signal is generated.

[0363] Optionally, the computerized device (5, 7, 11) generates an adjusted set of treatment parameters if the difference between the determined position and the target position of the set of treatment parameters is greater than a predetermined value. In this case, the method may include a second step S5 in which the target position of at least one transducer 2 is received, or a second step S40 in which the set of treatment parameters is received from a remote computerized device (7, 11). Again, between receiving the target position in step S5, or step S40, or the set of treatment parameters, the target position required for the selected treatment can be received for each transducer.

[0364] In principle, the embodiment shown in Figure 9 further includes step S1 of preparing a carrier element 1, at least one transducer 2, and a communication means 6, and step S2 of connecting the communication means 6 to a remote computerized device as disclosed with respect to Figure 6. This may further include the steps disclosed with respect to Figures 7 and 8 (if they do not already exist).

[0365] Figure 10 shows an exemplary embodiment of a method for setting up a treatment device, which differs from the embodiment shown in Figure 8 by including an additional step S50 of determining the position of the required transducer 2 relative to the body part, and transmitting not only the determined geometric characteristics but also the position determined in the transmission step S31.

[0366] The embodiment shown in Figure 10 allows for the determination of a set of operating or therapeutic parameters by a computerized device (7, 11) that takes into account both the geometric characteristics of the body part to be stimulated and the available positions of the transducer after the carrier element 1 has been attached to the body part.

[0367] The method in Figure 10 can be used to determine a first set of operating parameters or a first set of therapeutic parameters for a selected application, or it can be used to adjust a set of operating parameters or therapeutic parameters.

[0368] In principle, the embodiment shown in Figure 10 further includes step S1 of preparing a carrier element 1, at least one transducer 2, and communication means 6, and step S2 of connecting the communication means 6 to a remote computerized device as disclosed with respect to Figure 6. This may further include the steps disclosed with respect to Figures 7-9 (if they do not already exist).

[0369] The method shown in Figure 11 is particularly suitable for therapeutic devices that include multiple transducers 2 securely attached to a carrier element 1. Therefore, the exemplary embodiment in Figure 11 includes a step S62 to select the transducer closest to the target location received in the relevant receiving step S41. The received target location is often part of a set of received therapeutic parameters.

[0370] Depending on the realization of the treatment device, particularly the carrier element 1, the steps S20 for determining the geometric characteristics and S30 for transmitting the geometric characteristics can be omitted.

[0371] In principle, the embodiment shown in Figure 11 further includes step S1 of preparing a carrier element 1, at least one transducer 2, and a communication means 6, and step S2 of connecting the communication means 6 to a remote computerized device as disclosed with respect to Figure 6. This may further include the steps disclosed with respect to Figures 7 to 10 (if they do not already exist).

[0372] Figure 12 shows a flowchart of an exemplary embodiment of a method for setting up a therapeutic device, including a set of therapeutic parameters, particularly adjustments to the target location, the adjustments taking into account the effect of the carrier element 1, which is fastened to the body part, on the body part.

[0373] The embodiment in Figure 12 further illustrates step S63, for example, indicating the target position on the carrier element 1 by a small LED, and this step is optional to step S61, which involves positioning the transducer required for the selected treatment at the target position.

[0374] In principle, the embodiment shown in Figure 12 further includes step S1 of preparing a carrier element 1, at least one transducer 2, and a communication means 6, and step S2 of connecting the communication means 6 to a remote computerized device as disclosed with respect to Figure 6. This may further include the steps disclosed with respect to Figures 7 to 11 (if they do not already exist).

[0375] Figure 13 shows a flowchart of an exemplary embodiment of a method for setting up a therapeutic device, which includes an optional step S71 for iteratively verifying the configuration of the therapeutic device. Step S70, which compares the determined position of the transducer with the target position, can be considered as step S71 for verifying the configuration of the therapeutic device. However, other parameters of the therapeutic device can be verified in step S71, for example, the type of transducer 2 installed, the orientation of the installed transducer, etc.

[0376] The embodiment shown in Figure 13 further includes an optional step S80 for determining feedback related to the effect of acoustic wave stimulation. The feedback may depend on user feedback provided by the user via the user interface 12, or on measurements of body parts via sensors 13 for recording object-specific information other than the geometric or acoustic properties of the body parts.

[0377] In step S31, which transmits the required position of transducer 2 and the determined geometric characteristics to a computerized device in accordance with the realization of the treatment device, particularly carrier element 1, step S20, which determines the geometric characteristics and transmits the geometric characteristics to the computerized device, can be omitted.

[0378] In principle, the embodiment shown in Figure 13 further includes step S1 of preparing a carrier element 1, at least one transducer 2, and a communication means 6, and step S2 of connecting the communication means 6 to a remote computerized device as disclosed with respect to Figure 6. This may further include the steps disclosed with respect to Figures 7 to 12 (if they do not already exist).

[0379] Figure 14 shows a flowchart of another exemplary embodiment, which includes step S71 for verifying the configuration of the treatment device and optionally includes step S81 for receiving user feedback related to the effect of acoustic wave stimulation. Step S81 can be considered as one embodiment of the step for determining feedback related to the effect of acoustic wave stimulation.

[0380] In the embodiment shown in Figure 14, a step S71 is required to verify the configuration of the treatment device. This is because the embodiment includes a step S61 in which the required transducers are positioned at the target location given by the set of treatment parameters, or a step S62 in which the transducer closest to the target location is selected. Both steps may result in a position for the required transducer 2 that does not adequately correspond to the target location. Therefore, the configuration of the treatment device must be verified, and the set of treatment parameters may potentially be adjusted based on the differences determined during the configuration verification step S71 and / or based on feedback, which is user feedback in the embodiment shown.

[0381] Depending on the realization of the treatment device, particularly the carrier element 1, the steps S20 for determining the geometric characteristics and S30 for transmitting the geometric characteristics can be omitted.

[0382] Step S71, which verifies the configuration, may include step S50, which determines the position of the required transducer 2 relative to the body part, and step S70, which compares the determined position with the target position received in step S41.

[0383] In principle, the embodiment shown in Figure 14 further includes step S1 of preparing a carrier element 1, at least one transducer 2, and a communication means 6, and step S2 of connecting the communication means 6 to a remote computerized device as disclosed with respect to Figure 6. This may further include the steps disclosed with respect to Figures 7 to 13 (if they do not already exist).

[0384] Figure 15 shows a flowchart of an exemplary embodiment of the method for manufacturing a therapeutic device. This method includes the following steps.

[0385] Step S110: Determine the shape of at least a portion of the body part to be treated. The shape may be determined by any method and / or by any person as disclosed above with respect to the determination of the shape of the body part or part thereof to be treated.

[0386] Step S120: Select at least one treatment for a body part. In other words, a manufactured therapeutic device can be configured for one treatment or multiple treatments.

[0387] Step S130 determines the number of transducers and associated target locations. This means that the minimum number of transducers required for the selected treatment is determined, and the target locations required for the selected treatment are determined.

[0388] Step S140 provides a carrier element 1 equipped to position that number of transducers at the required target locations.

[0389] For example, as pointed out with respect to Figure 6, carrier element 1 can be provided in several ways.

[0390] The carrier elements provided may be provided in any embodiment disclosed above. Step S150: Provide the aforementioned number of transducers.

[0391] For example, as pointed out with respect to Figure 6, transducers can be provided in several ways.

[0392] As noted above, the manufacturing method may include a step of assembling the transducer and carrier element, which is performed by the manufacturer or provider of the carrier element 1 and transducer 2. However, the assembly can be performed by the practitioner or end user.

Claims

1. A therapeutic device for acoustic wave stimulation of a body part, comprising a carrier element (1) and at least one transducer (2), The treatment device is portable and includes communication means (6) configured to receive operating parameters of at least one transducer from a remote computerized device (7, 11), The carrier element (1) comprises a rigid material formed according to a surface that corresponds to at least the shape of at least a portion of the body part to be treated, wherein the rigid material includes or consists of one of rigid plastic and plaster. The carrier element (1) includes fixed elements (10) for each transducer (2) required for a particular application, and each fixed element is positioned on the carrier element (1) at a target position for the particular application received from the computerized device (7, 11).

2. The apparatus according to claim 1, further comprising means (3) for determining the geometric properties of the body part when the carrier element (1) is fastened to the body part, wherein the properties of the means for determining the geometric properties depend on at least one of the shape of the carrier element and the deformation of the carrier element, and the therapeutic apparatus is configured to transmit the geometric properties of the body part to the computerized devices (7, 11).

3. The therapeutic device according to claim 1 or 2, wherein the therapeutic device enables determination of the position of the at least one transducer (2) relative to the body part when the carrier element (1) is fastened to the body part, and the therapeutic device is configured to transmit the position of the at least one transducer relative to the body part to the computerized device (7, 11), wherein at least one of the following applies: the at least one transducer (2) includes a passively detectable element (4), the at least one transducer includes an actively detectable element, and the carrier element (1) includes at least one fixed element (10) configured to detect the presence of the transducer.

4. The device according to any one of claims 1 to 3, wherein the carrier element (1) has a shape specific to the body part of each individual target.

5. The apparatus according to any one of claims 1 to 4, wherein the carrier element (1) includes an arrangement of a plurality of fixing elements (10) that enable the fixing of the at least one transducer (2) at a target location for various applications.

6. The device is configured to receive the target position of at least one transducer (2) from the computerized devices (7, 11), - The device includes at least two transducers (2), and the device is configured to activate the transducer closest to the target position during stimulation, while the other transducers remain in the off state, or - The carrier element (1) includes a position mark (8) that helps to position the at least one transducer at the target position, or The apparatus according to any one of claims 1 to 5, wherein the apparatus is configured to determine that the at least one transducer is in the target position.

7. The apparatus according to any one of claims 1 to 6, further comprising an input element for receiving user feedback related to the effects of ultrasonic stimulation.

8. The apparatus according to any one of claims 1 to 7, wherein the apparatus includes a sensor (13) for generating object-specific information other than the geometric characteristics of the body part.

9. The apparatus according to any one of claims 1 to 8, comprising a transducer (14) for exciting acoustic waves within the body part, and a transducer (15) for detecting acoustic waves transmitted through and / or scattered within the body part.

10. A carrier element (1) for a therapeutic device according to any one of claims 1 to 9, - The carrier element (1) includes fixed elements (10) for at least one transducer (2), the number and arrangement of the fixed elements being adapted to a specific acoustic wave stimulus, or The carrier element (1) includes an arrangement of a plurality of fixing elements (10) that enable the fixation of at least one transducer at a target position for various acoustic wave stimuli.

11. A method for setting up the therapeutic apparatus for acoustic wave stimulation of a body part according to any one of claims 1 to 9, wherein the apparatus comprises at least one transducer (2), a carrier element (1), and communication means (6), the method comprising the step (S3) of receiving the operating parameters of the at least one transducer from a remote computerized device (7, 11), the carrier element (1) comprising fixed elements (10) for each transducer (2) required for the particular application, each fixed element being positioned on the carrier element (1) at a target position for the particular application.

12. - Step (S10) of attaching the carrier element (1) to the body part to be stimulated, - A step (S20) of determining the geometric characteristics of the body part, The method according to claim 11, further comprising the step (S30) of transmitting the geometric characteristics to a computerized device (7, 11) capable of determining the operating parameters of the treatment device.

13. The method according to claim 11 or 12, comprising the steps of: fastening the carrier element (1) to the body part to be stimulated (S10); determining the position of the at least one transducer (2) relative to the body part when the at least one transducer (2) is fastened to the carrier element (1) and the carrier element is fastened to the body part (S50); and transmitting the position of the at least one transducer (2) to the computerized device (7, 11) (S31).

14. The step (S50) of determining the position of the at least one transducer relative to the body part is, - The steps for taking a picture, The method according to claim 13, comprising the step of determining the presence of at least one transducer within a fixed element (10) of the carrier element (1).

15. The apparatus according to claim 5, wherein the fixing element is configured to allow fixing of the at least one transducer in a selectable orientation.

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