Patent Application
20220409403
The invention relates to a stimulator substrate device according to claim 1 and a device for stimulating nerve cells according to claim 9.
On 8 Jun. 2015, in the Science Humanity section of the online daily newspaper derStandard.at, an article was published about the first prosthetic leg that feels sympathetically. The article explained in detail how severed nerves in a patient whose leg had been amputated were reactivated and relocated to a region of the skin on the stump of the leg, causing this area of skin to become particularly sensitive. The nerve endings were rerouted there in such manner that the former foot with six of its foot components, or the nerve area sections typical of the physiognomy these foot components, were mapped to six points in this area of the skin. In other words, a nerve area section typical of the physiognomy is a natural nerve area section that is relocated to the surface of an area of the skin which is actually not typical of it. Consequently, in this relocated foot, or the nerve area sections typical of the physiognomy, the patient felt not the skin (surface) of the leg stump which was normally therefore did not feel the skin (surface) of the leg stump there but as it were the elements of the sole of his foot, of his actually amputated leg.
Now in order to supply this sensed sole with real stimulation below a prosthetic foot—from its prosthetic sole—a total of six pressure sensors were placed in the heel region, the centre region, the forefoot region and the toe region. In these regions, one pressure sensor each was placed along the gait line of a human sole and one of the adapted artificial sole of a prosthetic leg, in six gait line-typical sole sections of the artificial sole. Each pressure sensor is connected to one nerve-stimulating stimulator/(actuator) via a data link and via a controller for the purpose of transmitting information to the corresponding six nerve area sections typical of the physiognomy. As is known from gait analysis, for example, a gait line at least extends from the lateral edge of the heel to the big toe of the sole. Accordingly, gait line-typical sole sections also extend from the edge of the heel to the toes and may be arranged parallel to the gait line, for example.
WO 2019/025838 A1 discloses a device which assigns at least two sensors, that is to say a first sensor and a second sensor also up to an n-th sensor to each gait line-typical sole section. These are connected to one stimulator each via a data connection and via a control. In this way, not just one information source, for example a pressure sensor, but at least two information sources are available for each sole section, and accordingly not just one digitally functioning stimulation source is available for each mapped sole section, but at least two whose mode of action is not digital but analogue. These stimulators can selectively stimulate the nerve area sections typical of the patient's physiognomy.
WO 03/086235 A2 discloses a device for monitoring a patient's state of imbalance. For this purpose, an array of sensors on the sole of the patient's own foot is used to measure whether the patient is in a balanced state. The sensor array is connected to an array of stimulators via a signal evaluator so that if a loss of balance occurs the imbalance signals generated by the signal evaluator are transmitted to the array of stimulators. The array of stimulators is disposed externally on a strap, and in use it is arranged on an extremity so that the patient is informed of the state of imbalance.
A disadvantage of this known solution is that when in use this plurality of stimulators must be arranged precisely and directly on an extremity of the patient in order to be able to transmit an imbalance signal to the patient's extremity that is strong enough to make the patient aware of an imbalance state at all.
In view of the situation as stated, the problem addressed by the present invention is thus to at least partially remedy the disadvantages of the related art, and in particular to create a universally usable stimulator substrate device having a plurality of stimulators for the reproducible transmission of stimulation signals as feedback signals to a user, and to create a universally usable device for the stimulation of nerve cells.
This problem is solved by the features of the independent claims. Advantageous developments thereof are presented in the figures and the dependent claims.
The stimulator substrate device according to the invention for stimulating nerve cells comprises a substrate support, in which a plurality of stimulators for emitting stimulation signals to the nerve cells are provided, wherein the plurality of stimulators is arranged along a line in the substrate support and the substrate support has a tubular structure.
Thus, when the stimulator substrate device is in use by the user, the array of stimulators is positioned at a distance from the user as it is arranged in the substrate support and/or inside the substrate support. In this way, its service life can be prolonged, since the plurality of stimulators can be protected from environmental influences such as dust, moisture, sweat, etc. In the present case, a tubular substrate support is understood to be a receptacle with at least one substrate support opening so that the plurality of stimulators can be protected circumferentially. In contrast to the related art described previously, this stimulator substrate device is not designed simply to capture or process measured signals for forwarding to a user via a feedback device. In a first information channel, this stimulator substrate device enables the reproducible transmission of stimulation signals to a user as feedback signals—regardless of the nature of the measurement signals captured and regardless of the purpose for which the measurement signals are evaluated. Consequently, this stimulator substrate device may be implemented in a wide range of applications and it can be used universally.
In particular, the stimulator substrate device functions to stimulate nerve cells at a user's extremity, so the device can function not only as a bionic prosthesis but also as a bionic orthotic. The stimulator substrate device may be implemented particularly for use as a bionic prosthesis, but also to assist patients/users with polyneuropathy or similar disorders, for sports medical purposes as well as for purely recreational purposes. Polyneuropathy often occurs in diabetic patients, and is characterized by a loss of feeling in the feet. As a result of the condition, pressure points lead to open wounds or sensitive areas on the feet which are difficult to treat.
The plurality of stimulators arranged along a line and in the substrate support are advantageously positioned behind one another or directly side by side. This enables the stimulator substrate device to be constructed in a compact and space-saving manner, so that it can be combined with a variety of items in common use such as a belt or a headband or the like.
In particular, the plurality of stimulators arranged in a line and in the substrate support are positioned in a straight line. Accordingly, the stimulator substrate device is constructed in a compact and space-saving manner, wherein the position of each of the plurality of stimulators can be moved and adjusted with precision.
More preferably, the substrate support surrounds at least a portion of the plurality of stimulators, so that at least a region of said substrate support performs the function of an encapsulation, so that they can be protected extremely effectively.
The substrate support is preferably flexibly movable. This enables the stimulator substrate device and the plurality of stimulators arranged in the substrate support to be applied easily and simply. The flexibly movable substrate support is made from a cloth material for example, so that it is convenient for use by the user.
The plurality of stimulators are preferably tactile stimulators. Tactile stimulators can be actuated easily and incrementally, and especially when they are connected to a controller. In this context, the stimulation frequency, the stimulation intensity, the duration of stimulation or the stimulation channel of the individual stimulators may in particular be controlled variously. Tactile stimulators are safe and practical, and at the same time powerful.
The plurality of stimulators are preferably vibrators. This enables conventional vibration generators, for example a Vibracall element to be used as stimulators for nerve cell ends. Historically, as an aspect of its intended use a Vibracall element typically provides for an emitted sound during the vibration process or produces a buzzing noise as part of the oscillation process. It is commonly known that Vibracall elements serve to cause the mobile phone device to vibrate as a whole, so that the owner can be made aware of an incoming call even when he does not hear a ringtone. In the same way, the user of the stimulator substrate device can also perceive a stimulation, optionally even without hearing a noise.
In particular, the plurality of stimulators each contain at least one eccentric element, by which the stimulation of the nerve cell ends can be effected simply. The respective eccentric element brings the respective stimulator into a vibrating state. The vibration is induced by the alternating centripetal force of the eccentric element. Since the centre of mass of the eccentric element is not located axis-centrally on the drive shaft of the stimulator, an imbalance is created which disturbs the smooth running of the drive and starts the stimulator vibrating. The farther the centre of mass of the eccentric element is from the axis of rotation, and the greater the mass and rotating speed are, the greater the centripetal force becomes and therewith also the amplitude of vibration of the stimulator.
Alternatively or additionally, at least some of the plurality of stimulators each include at least one oscillating element, by which the stimulation of the nerve cell ends can be effected in simple manner. The oscillating element brings the at least one stimulator into an oscillating state. The oscillation is generated by the oscillating element, wherein the respective oscillating element is accelerated via a short electromagnetic pulse and is then moved back to its original position again by the action of a spring mechanism. The mass moment of inertia generated thereby gives rise so a simple harmonic oscillation.
The plurality of stimulators preferably each have a drive motor for driving the respective eccentric element rotationally, so that the eccentric element may be caused to rotate.
Alternatively, the plurality of stimulators include a drive actuator for driving the oscillating element in oscillating manner, so that the respective oscillating element can be made to perform a harmonic oscillation.
More preferably, the substrate support is elastic. This enables the stimulator substrate device and the plurality of stimulators arranged in the substrate support to be placed on the user in a positionally secure and reproducible manner. The elastic substrate support is made for example from a rubber material, so that it can be returned to a dimensionally stable state after a deformation, and consequently the stimulator substrate device is seated firmly on the user's extremity or limb. The substrate support is preferably made from a fabric structure, which conforms easily to the user or his extremity. Thus, the substrate support is comparable to an item of clothing and is very comfortable to wear.
The plurality of stimulators are preferably made from a waterproof material. This renders at least the plurality of stimulators resistant to moisture, and in turn prolongs their useful life.
Alternatively or additionally, the substrate support is made from a waterproof material. In this way, undesirable absorption of moisture by the substrate support can be prevented, as this might cause the stimulators to shift their position in the substrate support.
Alternatively, the plurality of stimulators or the substrate support are coated with a waterproof material. This helps to prevent undesirable absorption of moisture by the plurality of stimulators or the substrate support, thereby further improving the range of uses of the stimulator substrate device.
The substrate support preferably includes a connecting section so that the energy (current/voltage) for the plurality of stimulators can be supplied to a section in the substrate support that is known and defined by the user. This has the effect of simplifying the handling of the stimulator substrate device for the user, so that he is also able to position the stimulator substrate device to best effect even in difficult situations.
The plurality of stimulators are preferably each connected to at least one connecting line, which in turn is connected to a controller for generating control commands for stimulation signals to drive the stimulators, wherein the at least one connecting line exits the substrate support in the area of the connecting section. The plurality of stimulators is actuated by the controller. The controller typically has a processor and a computing unit with several control programs including various control commands, by which the plurality of stimulators may be actuated systematically.
Alternatively or additionally, each of the plurality of stimulators is connected to at least one connecting line, which lines are connected to a supply device for driving the plurality of stimulators, wherein the at least one connecting line exits the substrate support close to the connecting section. The supply device supplies the energy (current/voltage) for the plurality of stimulators, thereby enabling the longest possible operating time of the stimulator substrate device.
An interface unit is preferably present for detaching the at least one connecting line from the controller and/or the supply device. An interface unit may be for example a plug connector, a clip connector or a bayonet lock, which enables a connection of the at least one connecting line to be detached from the controller and/or supply device.
The interface unit is advantageously connectable to various adapters, so that for example plugs conforming to various standards can be connected to the interface unit. For example, a 2-pin or a 3-pin or a multi-pin plug can be connected electrically to the adapter and the interface unit. This enables controllers with different control programs to be connected to the stimulator substrate device.
Advantageously, each of the plurality of stimulators is connected to a connecting line, each of which is connected in turn to the controller for generating control commands for stimulation signals to drive the respective stimulator. In this way, each of the plurality of stimulators can be actuated separately with control commands.
Advantageously, each of the plurality of stimulators is connected to a connecting line which is connected to the supply device for driving the stimulators. In this way, each of the plurality of stimulators can be supplied with energy separately.
Advantageously, the supply lines are bundled and arranged on the connecting section by means of a rigid supply line. The rigid supply line serves as kink protection, to prevent the supply lines from becoming bent in the area of the connecting section.
Each of the plurality of stimulators is advantageously equipped with a feedback unit for generating a feedback signal to the user. The feedback signal from the feedback unit shows the user (at least for training purposes), via another information channel, stimulation signals which are transmitted by the feedback unit to the plurality of stimulators. In particular, these feedback signals are acoustic or visual signals. Unlike the previous display methods, the intention is thus not necessarily to show the patient which signals are received at the sole, but which signals the stimulator is trying to emit to send and communicate to the user. This may be take place for example via Bluetooth®, WLAN, or in particular via mobile phone as the interface.
More preferably, the controller is equipped with a computing unit, wherein the computing unit may be designed to support various control programs, with which control modes may be called with different control commands, individually if necessary, depending on the respective control mode. In this way, the plurality of stimulators can be actuated with control commands according to at least one control program. Moreover, different movement processes, such as a running movement, a walking movement, a hill climbing movement etc. may be activated in the controller, and the control commands associated therewith may be transmitted to the plurality of stimulators and the user may be trained in this respect.
The controller is preferably designed to control the plurality of stimulators using at least one gait line-based sensor signal from at least one sensor in such manner that a stimulation typical of the physiognomy can be transmitted to the user's nerve cells, in particular the nerve cells of a physically existing extremity of the user. In this way, the stimulator substrate device may be used as a training apparatus and/or as a prosthesis and/or in a prosthesis. A gait line-based sensor signal, or a sequence of several gait line-based sensor signals are generated on the basis of information in the area of the gait line-typical sole sections of the human sole or an artificial sole by the sensor located there, in particular by a pressure sensor.
Alternatively or additionally, the controller includes a memory unit. Control programs with various control commands may be stored in the memory unit, and are thus easily retrievable by the controller.
The controller is preferably designed to control the plurality of stimulators using multiple gait line-based sensor signals from at least one sensor or from multiple sensors in such manner that a stimulation typical of the physiognomy may be transmitted to the user's nerve cells, in particular to the nerve cells of an extremity of the user.
The substrate support preferably has a mounting area, on which additional stimulators may be placed. This enables additional stimulators to be positioned in the substrate support, so that the stimulator substrate device can be adapted to individual needs of the user.
The additional stimulators are preferably of exactly the same design as the plurality of stimulators. Accordingly, they can be positioned in the mounting area simply and by the user himself, and maintenance of the stimulator substrate device can be carried out by the user himself.
In particular, the stimulators of the stimulator substrate device are connected to Augmented Reality devices to enable the user to be trained more effectively. For example, by means of a display device an avatar may suggest an ideal motion sequence for the user so that the needs of the user, such as training progress or an improved gait analysis, can be met quickly.
A device according to the invention for stimulating nerve cells comprising a stimulator substrate device such as is described herein and a fastening device for positioning the stimulator substrate device on the nerve cells of a user. In particular, the stimulator substrate device functions to stimulate nerve cells at an extremity of the user, to such effect that said device may serve not only as a bionic prosthesis, but also as a bionic orthotic. In particular, the stimulator substrate device may be implemented particularly for use as a bionic prosthesis, but also to assist patients/users with polyneuropathy or similar disorders, for sports medical purposes as well as for purely recreational purposes.
The fastening device is particularly a cuff or a prosthesis. A cuff allows flexible, elastic positioning of the stimulator substrate device. A prosthesis supports fixed and therefore reproducible positioning of the stimulator substrate device.
The stimulator substrate device is preferably positionable detachably on the fastening device. The stimulator substrate device may thus be separated from the device, for example, and connected electrically to a computer or tablet to back up simulation signal data which may be stored in the memory unit.
Alternatively, the stimulator substrate device is fixedly positionable on the fastening device, so that the stimulator substrate device is arranged immovably in the device, thereby ensuring that secure transmission of the stimulation signals can be guaranteed.
In particular, the stimulator substrate device is positionable on the fastening device in dimensionally stable manner. For example, the stimulator substrate device is bonded or sewn onto the fastening device, thus enabling a limited amount of flexibility despite its dimensional stability.
More preferably, the fastening device is elastic and/or flexible, which has the effect of further expanding the range of application of the device with the stimulator substrate device.
The fastening device is preferably made from another fabric structure, so that the substrate support of the stimulator substrate device described here can be sewn easily and so is mounted securely on the fastening device. For example, the additional fabric structure of the fastening device has a different fabric structure from the substrate support of the stimulator substrate device. Different fabric structures have different functional properties, so for example the fabric structure of the substrate support is designed to allow the plurality of stimulators to be arranged reproducibly on the extremity. For example, the additional fabric structure of the fastening device may be constructed elastically to simplify the arrangement of the device on the user.
In particular, the additional fabric structure is identical to the fabric structure of the substrate support of the stimulator substrate device. In this way, the device can be manufactured inexpensively.
The fastening device preferably has a mounting section for accommodating a controller for the stimulator substrate device. This enables the controller to be positioned close to the device in order to transmit the control commands reliably to multiple stimulators.
Additionally or alternatively thereto, the fastening device has a mounting section for accommodating a supply device for the stimulator substrate device. This enables the supply device to be positioned close to the device to enable an operationally reliable energy supply. The user thus has access to a section where he can arrange the supply device time after time.
The mounting section preferably has a mounting receptacle, in which the controller and/or the supply device can be arranged easily and detachably. User-friendly operation is enhanced thereby.
More preferably, a display device is provided, wherein the display device can be connected to the controller. The display device may be a mobile phone, in particular a smartphone, or a smart tablet sein, or it may also be arranged in the fastening device as a screen, wherein the fastening device comprises at least one touchscreen.
At least an item of information indicative for the stimulation signals of the plurality of stimulators may preferably be set using the display device. Indicative information is would include, but is not limited to the stimulation frequency, the stimulation intensity, the stimulation duration or the stimulation channel in order to adjust the respective plurality of stimulators. For example, maximum values or minimum values for the examples of indicative information given above may be set with the aid of the display device.
The display device is advantageously designed as a gait profile analyser in order to monitor physiognomically typical walking with the human foot or with an artificial foot, allowing a qualitative investigation of a motion sequence of the user, and delivering at least one associated feedback signal to the user. In this context, the gait profile analyser may be permitted to intervene in the emission of the feedback signals to influence the control of the motion sequence. The gait profile analyser may for example be integrated as an in a mobile phone as an application and/or may output an acoustic signal to the user.
The indicative information may advantageously be set in such manner that entire control programs can be created, and existing control programs can also be modified with the aid of the display device.
In particular, an acoustic signal and/or a visual signal that can be displayed on the display device or output from a loudspeaker of the device may be generated on the basis of the indicative information.
The fastening device is preferably a headband or a wristband or a glove or a belt or a garter, or a prosthesis shaft. This makes the stimulator substrate device extremely versatile and usable in a wide range of situations.
Further advantages, features and properties of the invention will be explained in the following description, in which exemplary embodiments of the invention are described with reference to the drawing.
The list of reference numerals is an integral part of the disclosure, as are the technical content of the patent claims and the figures. The figures are described in logical sequence and with regard to their cross-functionality. The same reference numerals denote identical components, reference numerals with different indices indicate functionally equivalent or similar components.
In the drawing:
In the present instance, four stimulators 21, 22, 23, 24 are arranged on a line, positioned one behind the other or directly side by side in the substrate support 20, wherein the substrate support 20 is elastic and/or made from an elastic material, for example rubber or fabric. The substrate support 20 has a fabric structure which readily conforms to the user or an extremity of the user. The plurality of stimulators 21, 22, 23, 24 are coated with a waterproof material. This serves to prevent the plurality of stimulators 21, 22, 23, 24 from absorbing moisture.
Each of the plurality of stimulators 21, 22, 23, 24 is connected electrically with connecting lines 31, 32, 33, 34, which exit the substrate support 20 at a connecting section 27 of the substrate support 20. The supply lines 31, 32, 33, 34 are bundled and are arranged on the connecting section 27 with the aid of a rigid supply line 30. The connecting lines 31, 32, 33, 34 terminate in an interface unit 40 which is constructed as a detachable, 2-part plug connector. The interface unit 40 includes further connecting lines 31a, 32a, 33a, 34a, which connect the interface unit 40 electrically to a controller 50 and to a supply device 60 for driving the stimulators 21, 22, 23, 24, for example a battery or rechargeable battery. Various adapters may be arranged on the interface unit 40, so that for example plugs with different, country-specific standards—e.g., earthed connections—can be connected to the interface unit 40 (not shown). The controller 50 is designed to generate control commands for stimulation signals for driving the stimulators 21, 22, 23, 24. The controller 50 includes a computing unit 51 and a memory unit 52. The computing unit 51 is designed to support various control programs, with which control modes may be called with different control commands, individually if necessary, depending on the respective control mode. In this way, the plurality of stimulators may be actuated with control commands according to at least one control program. The control programs with various control commands are stored in the memory unit 52, so that they are retrievable by the controller 50.
A display device 130 is also provided, wherein the display device 130 is connected to the controller 50 via radio signal 125. In the present case, the display device 130 is a smartphone equipped with a touchscreen.
The display device 130 may be used to set the information that is indicative for the stimulation signals of the plurality of stimulators 21, 22, 23, 24.
The stimulation frequency, simulation intensity, stimulation time or the stimulation channel for example may be changed by user B to adjust the respective plurality of stimulators 21, 22, 23, 24.
The display device 130 is embodied as a gait profile analyser for example, in order to monitor the action of walking with the human foot typical of the physiognomy, so that it allows a qualitative examination of a motion sequence performed by user B and gives user B at least one feedback signal in relation thereto. In this context, the gait profile analyser is permitted to intervene in the feedback signal transmission in order to influence the control of the motion sequence. The gait profile analyser is integrated in the smartphone as an application and outputs an acoustic signal to user B.
The plurality of stimulators 21, 22, 23, 24 of the stimulator substrate device 15 are connected to an Augmented Reality device which is integrated in the display device 130, in order to provide user B with improved training. For example, it may enable an avatar to suggest an ideal motion sequence for user B via a display device 130.
The stimulator substrate device 15 according to
The drive motor 620 is electrically connected to the previously described interface unit 40 via the connecting line 31 and to the controller 50 and the supply device 60 via the connecting line 31a. In this arrangement, the stimulation frequency, simulation intensity, stimulation time or the stimulation channel of the vibrator 610 are controllable.
In the present case, four stimulators 21, 22, 23, 24 inside the substrate support 20a are arranged along a line, positioned one behind the other or directly beside one another, wherein the substrate support 20a is elastic or made from an elastic material, for example from rubber or a cloth. The substrate support 20a has a durable, e.g., fabric structure, which conforms readily to the user or his extremity. As with the other embodiments, the plurality of stimulators 21, 22, 23, 24 are coated with a waterproof material or are embedded in a plastic (or rubber) liner together with their substrate support 20a in waterproof manner (see
In contrast to
As mentioned earlier,
As is known the liner fulfils an important function in connecting the prosthesis to the stump, and its role becomes more critical still, as the invention provides that the stimulation signal transmission has now also been integrated therein.
Accordingly, since a liner is tubular per se, the embodiment according to
Interface unit 40 and controller 50 correspond the components described earlier under these reference numerals.
| Number | Date | Country | Kind |
|---|---|---|---|
| 19206619.9 | Oct 2019 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2020/060227 | 10/30/2020 | WO |
