METHOD FOR CALCULATING A STIMULUS FOR THE CHANGE OF SHAPE OF A MEDICAL AID

Abstract

The invention relates to a method for calculating a stimulus for the change of shape of a medical aid in order to change the position of the medical aid from an actual position to a final target state. In order to achieve optimized treatment for the patient, a method comprising the following steps is provided: Detecting the actual position of the body part to be corrected after a first correction step in a control unit, Comparing the actual position of the body part to be corrected with a target position that is stored in the control unit, If applicable, detecting, by the control unit, the deviation between the actual position and target position of the body part to be corrected, Calculating with the control unit the stimulus that has to act on the medical aid to perform a second correction step, taking into account the deviation between the actual state and target state of the body part to be corrected, wherein the effect of the stimulus on the medical aid is saved in the control unit.

The invention further relates to a control unit.

Claims

1. A method for calculating a stimulus for the change of shape of a medical aid in order to change the shape of the aid from an actual position to a final target state comprising the steps: detecting the actual position of the body part to be corrected after a first correction step in a control unit, comparing the actual position of the body part to be corrected with a target position that is stored in the control unit, wherein the method further comprises the steps if applicable, detecting, by the control unit, the deviation between the actual position and target position of the body part to be corrected, calculating with the control unit the stimulus that has to act on the medical aid to perform a second correction step, taking into account the deviation between the actual state and target state of the body part to be corrected, wherein the effect of the stimulus on the medical aid is saved in the control unit.

2. The method according to claim 1, wherein the stimulus is selected from the group consisting of the parameters time, temperature, pH value, current, radiation, sound, illumination, liquid and combinations of these parameters.

3. The method according to claim 1, wherein the actual position of the body part to be corrected is detected with an impression, by digitally measuring the position of the body part, or by signals from a sensor that detects the position of the body part.

4. The method according to claim 1, wherein the actual position of the body part to be corrected takes place by manual input into the control unit or by an input portal of the manufacturer of the medical aid or by an input portal of the attending physician.

5. The method according to claim 1, wherein the control unit is connected to a treatment device, which is designed to cause the calculated stimulus to act on the medical aid.

6. The method according to claim 1, wherein the control unit stores the temporal progression of the actual state of the body part to be corrected.

7. The method according to claim 1, wherein the control unit takes into account the temporal progression of the actual states of the body part to be corrected when calculating the stimulus for the second correction step.

8. The method according to claim 1, wherein the control unit calculates, emits and stores the duration of the second correction step, the size of the next stimulus, and/or the parameters selected for the stimulation.

9. The method according to claim 1, wherein the duration of the second correction step emitted by the control unit, the size of the next stimulus, and/or the parameters selected for the stimulation are transferred manually to a treatment device or wherein the control unit automatically uses the emitted duration of the second correction step, the size of the next stimulus, and/or the parameters selected for the stimulation to control a treatment device.

10. The method according to claim 1, wherein a separate data set is created for each medical aid, which data set can be edited after entering an editing authorization.

11. A control unit for carrying out a method according to claim 1, connected to an input portal for entering the actual state of the body part to be corrected and with means for calculating a stimulus for the change of shape of a medical aid as well as with a storage device wherein the effect of the stimulus on the medical aid is saved in the control unit, wherein the storage device of control unit is designed to store the temporal progression of the correction steps.

12. The control unit according to claim 11, wherein the control unit and input portal are spatially separated, and wherein the data from the input portal are transferred to the control unit.

13. The control unit according to claim 11, wherein the input portal is opened by means of an access authorization.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Details of the invention are explained below with regard to an exemplary embodiment. In the figures:

[0041] FIG. 1 shows a process diagram of the schematic mapping of the input portal and treatment device;

[0042] FIG. 2a shows a process diagram of the complete calculation of the stimulus;

[0043] FIG. 2b shows a process diagram of the calculation of the difference between the actual position and target position of the tooth to be corrected; and

[0044] FIG. 3 shows carrying out the change of shape.

DETAILED DESCRIPTION

[0045] The following exemplary embodiment refers to a tooth to be corrected. However, it can also be applied to a bone to be corrected (aligning a broken bone, lengthening a bone) or to the correction of a scar or a wound. In a first step of the method according to the invention for calculating a stimulus for triggering a deformation of a medical aid, the actual position of the tooth to be corrected is detected and the final target position of the tooth to be corrected is detected. A treatment plan is created in which the path from the current actual position to the final target position is divided into at least two correction steps, often also multiple correction steps. Corresponding to the treatment plan, the tooth correcting device, in the following “correcting device” for short, is created. The material of the medical aid changes its shape in a precalculated manner under the influence of a stimulus, preferably from an actual position to a target position. The type and intensity of the stimulus influence the magnitude of the change of shape.

[0046] The necessary data of the actual position and the final target position of the tooth to be corrected, the target positions according to the individual correction steps, and the type and intensity of at least one stimulus, preferably multiple stimuli, are saved in a control unit. The control unit comprises a storage device for this purpose. The control unit is further equipped with a processor and with software that, after completion of a first correction step, calculates a stimulus for triggering a change of shape of the medical aid for the second or respectively next following correction step.

[0047] The control unit can be a separate device with an input portal, for example, a keyboard or a touchscreen mask, and advantageously with an output portal, for example, a screen display or a printer.

[0048] Preferably, the control unit is connected—as shown in FIG. 1—to a computer, for example, in the form of a smartphone, a tablet, or a desktop computer. To make the connection to the control unit, a connection to the input portal, for example as a separate application (app), can be downloaded, the input interface of which is connected to the input portal and the output interface of which is connected to the output portal of the control unit. The keyboard of the computer and the screen of the computer can be used for inputs into the input interface and thus into the input portal. Connecting the control unit to a computer has the advantage that the storage device and the software of the control unit can be kept constantly up to date through updates. Alternatively, a stand-alone control unit can be used.

[0049] Starting from a control unit connected to a computer, after switching on and loading any available updates, this control unit is ready for data input, either for creating a new file for a new correcting device or for the evaluation of a correction step that has taken place and the calculation of a stimulus for a following correction step. The control unit or respectively the input portal can be designed for use for the patient, the attending physician, or the manufacturer of the medical aid, depending on who creates a new file for a medical aid or evaluates a correction step and calculates the stimulus for a further correction step. Advantageously, according to FIG. 2a, an access authorization is provided for each user of the control unit to ensure that only authorized persons and, if applicable, users trained to use the control unit make inputs. It is also recommended to create a separate file with a separate access code for each correcting device to ensure that a user who, for example, is overseeing multiple correcting devices as the attending physician always makes inputs for the correct correcting device.

[0050] At the end of a first correction step, the change of shape of the tooth or teeth to be corrected that has been achieved so far is evaluated. The currently achieved actual position of the tooth to be corrected is detected, either manually, for example, through an impression and measuring the impression, or digitally by measuring and determining the actual position of the tooth to be corrected. The data obtained in this way are entered into the input portal of the control unit, either via a keyboard or by means of data transmission, for example, via a cable, Bluetooth, or a wireless network connection (WLAN, Wi-Fi). Optionally, the input portal also asks the patient questions, for example, about the tolerability of the medical aid or the intensity of the correction. Advantageously, standardized responses (for example: good—moderate—poor; high—medium—low) are provided which can be processed in an algorithm that evaluates the first correction step.

[0051] To calculate the stimulus that the change of shape of the medical aid should effect for the following correction step, it is ascertained in accordance with FIG. 2b whether a deviation exists between the current actual position and the target position of the tooth to be corrected that is provided or expected according to the treatment plan. Such a deviation is ascertained, for example, by means of measuring the tooth position with an intraoral scanner or by comparing digital photographs; it can, however, also take place by creating a current impression and comparing it to the previous impression that was taken before beginning the completed correction step.

[0052] If such a deviation exists, this is taken into account for the calculation of the stimulus. Furthermore, in accordance with FIG. 2a, the responses to the questions of the control unit (if such questions have been asked) are taken into account for the calculation of the stimulus. The control unit or respectively the algorithm also takes into account the settings specified in the original treatment plan for the stimulus that should act on the medical aid at the beginning of the following correction step. The specified settings are now recalculated, taking into account any deviations of the actual position from the target position as well as the patients' responses, for example, about tolerability or intensity of the treatment, in order to move the tooth to be corrected into the final target position as quickly as possible with minimal stress to the patient. If applicable, the control unit or respectively the algorithm chooses a different stimulus and/or a different intensity, for example, a switch from heat to liquid or to a combination of stimuli, for example heat and liquid, depending on the extent to which a change of shape of the medical aid is necessary. The method according to the invention thus ensures that correcting the tooth position does not take place according to a rigid treatment plan specified at the beginning of the treatment, but rather that the correction is carried out in an optimized manner, taking into account the actual course of the correction. This results in a short correcting treatment that is gentle for the patient.

[0053] The recalculation of the stimulus for the change of shape of the medical aid is then emitted by the control unit via the output portal. According to a first alternative, the calculation of the stimulus is, for example, printed or displayed by the output portal and is manually transferred to a treatment device. The treatment device can be arranged directly on the medical aid, for example, as a heat source. The treatment device is often configured as a container in which the medical aid can be accommodated. The treatment device is further designed to allow at least one stimulus to act on the medical aid; advantageously, two or more stimuli can act on the medical aid, for example, temperature, liquid and radiation, each individually or in combination.

[0054] According to an alternative embodiment, the control unit is connected to and controls the treatment device. The connection can take place by installation in the housing of the treatment device, but it can also be made by a wired or wireless connection, in that the control unit sends actuation signals to the treatment device.

[0055] When controlling the treatment device in accordance with FIG. 3, the new calculation triggers the activation of one or more stimuli according to the specifications of the previous calculation of the control unit. If applicable, the control unit also causes the display of indicators in advance via the output portal, for example, the indicator to place the medical aid into the treatment apparatus, or the indicator to switch on the treatment apparatus after placing the medical aid and thus trigger the change of shape as a result of the action of the stimulus or the combined stimuli. Further optionally, the output portal displays the course of the action of the stimulus and the resulting change of shape of the medical aid.

[0056] After completion of the application of the stimulus, the output portal optionally displays information about the subsequent correction step, for example, how long the subsequent correction step takes, how long the medical aid is to be worn in each case in order to ensure optimal treatment success.

[0057] Optionally, after the medical aid is inserted by the patient, the output portal then shows the patient some questions that relate in particular to the fit of the correcting device, the shape of which has been changed, in the mouth as well as questions about the sensations (or paresthesia) while the medical aid is worn or questions about the effect of the medical aid on the teeth to be corrected or other teeth. In this manner, it is ensured that any erroneous deformations of the medical aid are discovered early.

[0058] As shown in FIG. 3, the control unit stores the data used to calculate the stimulus so that all information about the treatment is available at the end of the treatment. If applicable, this information is transmitted to the attending physician and/or the manufacturer of the medical aid. If the treatment with the tooth correcting device comprises more than two correction steps, all the information available from previous correction steps can be used to calculate the stimulus for a subsequent correction step.

[0059] Finally, the manner in which the differences between the actual position of the tooth to be corrected and the target position of the tooth to be corrected ascertained in accordance with FIG. 2b are incorporated into the calculation of the stimulus for the change of shape of the medical aid for the respective next correction step will be briefly explained. If it is found after the completion of a first correction step that no deviation between the actual position and the target position exists, the calculation of the stimulus for the change of shape of the medical aid takes place for the following correction step according to the original treatment plan.

[0060] If the tooth to be corrected has moved farther than expected or if the patient reports discomfort, then the treatment plan is changed for the next correction step. A less intense stimulus or a different, less intense stimulus is selected (for example, liquid instead of radiation) by the control unit or respectively by the algorithm.

[0061] If the tooth to be corrected has moved less than expected or if the patient explicitly reports good health, then the treatment plan is changed for the next correction step. A more intense stimulus or a different, more intense stimulus is selected (for example, a longer action of the stimulus) by the control unit or respectively by the algorithm. A combination of stimuli can also be used, always within the scope of the stimuli that the respective treatment device can cause to act on the medical aid.

[0062] It will be explained below how the control unit or respectively the software required to implement the method according to the invention is created. For example, ATMEL chips can be provided with an access code that limit access to the control unit to authorized persons, since the chip can no longer be opened without the correct control code. The access code can be created, for example, with AVR Studio software. As the control unit, for example, an Espressif Systems Wi-Fi/BLESOC microchip (for example, esp8266 WIFI/esp32 WIFI/BLE) can be used that is based on a 32-bit microcontroller that has a sufficient number of digital I/O access points to control all electronic peripheral devices and analog inputs for detecting sensor signals and that also has sufficient storage capacity to store the software codes.

[0063] To create the software or respectively the algorithm, an Arduino IDE platform can be used, that is suitable for creating interactive software. The software is then transferred to a chip by means of a suitable printer. Later, series-produced printed circuit boards (PCBs) can be used, on which the software is stored and which serve as the control unit. If the control unit is installed in a treatment device, this can advantageously connect to a server on its own, for example, of the manufacturer and download updates. It is preferred that an input screen connected to the input portal and, if applicable, a display about the progress or status of the change of shape can be downloaded onto external computers such as smartphones, tablets, or desktop computers as an application (app).

[0064] The chip or respectively the circuit board on which the software is stored can now control numerous processes, including Wi-Fi or Bluetooth connections for transferring data from computers such as smartphones, tablets, or desktop computers, the input and the output portals, which, if applicable, are displayed on these computers, the management of storage devices on which data about the patient and/or about the correcting device or treatment plan is stored, and, if applicable, also the treatment device, by which a stimulus acts on the medical aid to prepare a following correction step. In this case, the chip or respectively the circuit board controls, for example, the switching on and off of the respective stimulus, for example, a heating, a cooling, a radiation source or the addition of liquid, both individually and in combination. Thus, for example, a change of shape of a medical aid can require that first a specified amount of liquid, e.g., water, is let into a container containing the medical aid. It must be indicated beforehand that the medical aid has been correctly inserted into the container. This can be reported optically by a camera or by sensors or switches to the chip or the circuit board. Then, the water must first be heated and then cooled, wherein time specifications for the heating and the cooling must be complied with. Finally, it must be indicated that the change of shape is complete. Then, the data about the change of shape, both the information about the actual and the target positions as well as the inputs of the patient and the calculation of the stimulus, must optionally be stored and, if applicable, transmitted to the physician and manufacturer of the medical aid.

[0065] The control unit or respectively the chip or the circuit board can be brought into connection with a server of the physician or manufacturer, which server can be reached via a static IP address with a domain name. The control unit can retrieve updates or also modifications of the treatment device from the server. A Raspberry Pi server, for example, can be used, on which the operating system Raspbian, an Apache server, and contents programmed in PHP for web applications are installed.

[0066] In a second exemplary embodiment we will explain a possible embodiment of the method according to the invention using the control unit according to the invention. A patient wears a first correcting device for a week. According to the treatment plan, the medical aid should go through two changes of shape, each after one week. After entering the access code, the control unit or respectively software according to the invention is designed to first ask the patient which correcting device he is wearing and since when he has been wearing the medical aid. After entering further data on the actual position of the tooth to be corrected and optionally patient data, the stimulus necessary for the upcoming change of shape of the medical aid is calculated. It is taken into account here that the stimulus for the second correction step, meaning at the beginning of the second week, is to be calculated. The correct stimulus is therefore calculated without error and the treatment device is controlled accordingly by the control unit. After the second week, the same procedure takes place, taking into account the updated timeline. The stimulus is calculated for the third correction step, meaning for the third week. If the patient erroneously attempts to trigger a change of shape of the medical aid between the individual correction steps or after the completion of the correcting treatment, it is provided according to the present embodiment of the invention that the control unit displays that no change of shape is currently provided, or that the shape of the medical aid is up to date. This prevents erroneously undesired changes of shape from being made to the medical aid.

[0067] According to another exemplary embodiment, a single or multi-part orthotic or a plastic bandage is produced as described above from a dynamic synthetic material or in sections from a dynamic synthetic material in conjunction with a static synthetic material by means of a 3D printer. The orthotic or plastic bandage are individually adjusted to a patient to correct the bone position. The bone position, for example, the position of the foot bones, should be corrected in accordance with a multi-step treatment plan, for example, to restore the arch of the foot or the position of the toes.

[0068] A treatment plan is created that provides multiple correction steps. At the end of the first treatment plan, the bone position is detected, for example, by X-ray or another imaging method or by measuring the foot and the bone position. When calculating the following correction step, the actual position of the foot bone or foot bones to be corrected is detected and taken into account when calculating the stimulus necessary to deform the orthotic or the plastic bandage in order to carry out the next correction step. In this exemplary embodiment, more of the previously mentioned, individual parameters related to the patient can of course also be incorporated into the calculation of the stimulus.

[0069] A final exemplary embodiment relates to the care of wounds that takes place using the medical aid. The medical aid is in this case configured, for example, as a staple or as suture material. The changes of shape of the staple or of the suture material taking place in accordance with a multi-step treatment plan help to close wounds such that physiological damage is minimized and at the same time the aesthetic aspect of a scar is optimized. During the deformation of the staple or of the suture material by a stimulus according to the method according to the invention described above, the staples and suture material do not always have to be re-set and their shape can be changed incrementally in very small steps by stimuli calculated according to the invention and thus they can be optimally adjusted to the medical requirements. The shape of the suture material or respectively of the staples can be changed, for example, by heat or by radiation, but also by current.