Medical device for a human joint and method for operating the medical device - Patent application

Abstract

A medical device (9, 9a, 9b, 9c) for a joint (1) of a person (10), comprising at least two parts (11) that are placed on the joint (1) and that are movable relative to each other by the joint (1), and at least one detection device (13) for detecting the relative movement of the parts (11), the medical device (9, 9a, 9b, 9c) comprising: a determination unit (17) for determining, from the detection data of the detection device (13), the range of motion (5) of the joint (1) that is actually used when the medical device (9, 9a, 9b, 9c) is attached; a comparison unit (18) for comparing the range of motion used (5) with the desired range of motion (6); a support unit (19) for determining support information that will guide the person (10) to the widest possible use of the desired range of motion (6), said support information being dependent on the results of the comparison; and The apparatus includes an evaluation device (16) having: The medical instrument (9, 9a, 9b, 9c) further comprises an output device (20) for outputting support information to the person (10).

Description

[Technical Field]

[0001] The present invention relates to a medical instrument for a human joint, the instrument having at least two parts that are placed on the joint and that can be moved relative to each other by the joint, and at least one detection device for detecting the relative movement of the parts. The present invention also relates to a method for operating such a medical instrument. [Background technology]

[0002] Medical devices for a wide variety of human joints have already been proposed in various ways in the prior art, including, for example, bandages, braces, belt systems, stockings, and other garments that act in a particularly compressive manner. Within the scope of this description, "medical" should also be understood to mean sports applications characterized by a desired positive effect on the anatomical structure and / or health and / or performance based on medical considerations. Therefore, this type of medical device for joints also includes, for example, sports bandages. Furthermore, within the scope of this description, the spine should also be considered as a joint or group of joints to which medical devices can be applied.

[0003] A medical device can also exist independently of such a therapeutic device, which may be formed by or comprise the aforementioned components. For example, a medical device can be explicitly designed to detect articulation as relative movement of the components, and thus form an auxiliary or accessory for a therapeutic device, such as a brace, bandage, or stocking. In the case of a medical product, or even more specifically a therapeutic device, the two components can be formed by separate components that are, for example, rigid and articulated together. However, it is also possible to form the components as subregions of a single flexible object, such as a stocking.

[0004] Individuals using medical devices intended for therapeutic treatment and / or joint protection tend to adopt protective postures or perform protective movements that may have adverse effects during treatment with the medical device. When the device includes a brace that limits the range of motion of a joint, such as the knee, individuals typically use a significantly smaller range of motion than the full range permitted by the brace, which may be significantly less than the range of motion desired by the therapist, for example. This can be determined by a detection device in the device that detects the relative movement of the parts.

[0005] For example, WO 2016 / 176544 A1 discloses a sensor and feedback platform for use in orthotic and prosthetic devices. Parameters measured by the sensors that can describe movement are provided to a data processing and / or data representation unit for evaluating and / or implementing actions. Specifically, the proposed sensor mechanism uses an inductive sensor that interacts with conductive material within a belt or strip to generate sensor data indicative of the location of the inductive sensor relative to the belt / strip.

[0006] Unfortunately, however, it may only be determined later through such a platform that the range of motion used did not correspond to the desired or even maximum allowable range of motion, and the person using the prosthesis or brace is then informed. Because there is no intuitive relationship between the assessment and the person's previously performed movements, improvements in range of motion utilization are only limited. However, the use of protective postures or protective exercises can lead to deficiencies in muscle strength and / or motor function when the medical device is worn, which is undesirable. Summary of the Invention [Problem to be solved by the invention]

[0007] It is therefore an object of the present invention to provide an improved method of avoiding a protective posture, in particular without having to dispense with existing protective features of the treatment device. [Means for solving the problem]

[0008] According to the invention, this object is achieved by a medical device according to claim 1 and by a method for operating a medical device according to claim 14. Advantageous embodiments emerge from the dependent claims.

[0009] Thus, according to the invention, a medical device of the type mentioned at the outset comprises: a determination unit for determining a range of motion of a joint that is actually used when the medical device is worn from the detection data of the detection device; a comparison unit for comparing the range of motion used with the desired range of motion; a support unit for determining support information that will guide the person to the widest possible use of the desired range of motion, said support information being dependent on the results of the comparison; an evaluation device comprising: The medical instrument further includes an output device for outputting the support information to a person.

[0010] In the context of the present invention, as mentioned at the beginning, medically oriented sports aids should also be considered medical devices. The device can also be applied to the spine as a group of joints, so in other words, it is a medical device for the joints or spine. Other joints for which such medical devices can be used are, for example, the knee joint and / or the elbow joint. The range of motion also needs to be parameterized in each case for each joint. In the case of a single-axis joint, such as the knee, the range of motion can be defined by the angle at which the movement is or will be performed. For example, the desired range of motion can therefore be defined by a target angle in at least one direction of movement, such as flexion and / or extension of the knee.

[0011] The medical device may be a stand-alone device, but is preferably at least assigned to or comprises a therapeutic device, in particular a therapeutic device formed by or comprising a component. In that case, the therapeutic device may be, for example, a bandage, an orthosis, a garment, in particular a compression garment, a belt system, and / or a splint system. It is therefore particularly conceivable for the device to be assigned to at least one therapeutic device, so to speak, as an auxiliary device, as will be discussed in more detail below.

[0012] The basic idea of the invention is therefore to track the current movement of the joint by means of a detection device, to compare this movement as quickly as possible with a desired range of motion, specified for example via a setting device, and to output, if necessary, support information from this comparison to enable the person to make the most of the desired range of motion. In other words, with the medical device proposed according to the invention, the person not only receives information that he has assumed, for example, an unintentional protective position, but at the same time receives information that he is being guided into a desired, particularly targeted, pre-definable range of motion, so that some kind of positive action is taken.

[0013] Thus, in particular when the supporting information is not always output, at least one information criterion may be provided to the support unit, and the support unit may at least evaluate the comparison result and output a part of the supporting information or the supporting information if the information criterion is met, where different supporting information can be assigned to different information criteria and / or different supporting information can be determined when a particular information criterion is met, in particular by further evaluating the comparison result.

[0014] Specifically, the information criteria can compare at least one degree of utilization to a threshold, for example, to what extent a desired range of motion is utilized and / or for what portion of a joint's motion cycle the range of motion is fully utilized, for which purposes further thresholds may be provided.

[0015] In other words, by evaluating the comparison result, the support unit can provide information to the person when the degree of use is too low, so that the person is guided to use the exercise possibilities, such as to reach the desired range of motion. Preferably, a lack of use information describing the specific nature of the lack of use is determined from the comparison result in this case and can also be taken into account in the parameterization of the support information, particularly in the output time in many cases. For example, a lack of use determined in the case of the knee may be due to too little flexion because the distance from the flexion target angle is too large, limiting the desired range of motion. Parameterization of the support information as a function of the type of lack of use advantageously conveys to the person potential for improvement. Preferred embodiments also enable the current movement state to be taken into account in the parameterization of the support information, particularly for the purpose of temporal adjustment of the support information and / or to instruct the person to change the movement state to better utilize the desired range of motion.

[0016] In summary, based on the comparison results, the support information is generally designed and time-series set to provide information that leads to better utilization of the desired range of motion, particularly intuitively and in the exercise situation itself.

[0017] The desired range of motion, which can preferably be set or adjusted by the setting device, therefore ultimately corresponds to a goal to which a person, for example a patient or an athlete, is guided or directed by the design of the corresponding support information. It is therefore possible to guide the patient from a currently used range of motion, which in particular corresponds to a protective posture or protective movement, to a currently desired therapeutically useful range of motion, which can in particular be individually predefined by the therapist.

[0018] As already mentioned, the medical device can be solely a therapeutic device, but preferably also includes a therapeutic device and thus ultimately provides additional functions. Specifically, the device may include at least one stocking-like enclosure section, designed in particular as a therapeutic device and / or to implement components, pulled over the joint and / or wrapped around the joint as a bandage, and / or as part of a garment and / or as a belt system, and / or as at least one articulated guide element, in particular at least two hinged, rigid, articulated guide elements. Thus, the therapeutic device optionally formed in this way can be or include, in particular, a bandage, a brace, a stocking, a posterior spinal splint, a garment, and / or a belt system.

[0019] At this point, it should also be noted that when assigned to a treatment device, the latter does not have to be permanent or fixed, but it is absolutely conceivable to use, for example, medical instruments that can be removably connected to the treatment device, such as initially using a brace as a treatment device, then using a bandage as a treatment device, then using stockings as a treatment device, and finally using a belt or the like as a treatment device, etc. throughout the treatment.

[0020] In certain cases, the detection device may include at least one sensor integrated into at least one component, or removably or non-removably attached or attachable to at least one component and / or a body region that moves with the component. It should be noted again at this point that the components that are movable relative to each other do not necessarily have to be two separate components of the instrument or treatment device, but it is also entirely conceivable to use a flexible component, in which case the component is formed by a subregion of the component. Such a flexible component may include, for example, the aforementioned stockings, a bandage element made of a compressive material, a flexible splint, a belt, etc. In particular, when a component is implemented as part of an enclosure section, it may be advantageous to already integrate the sensor or sensor component of the detection device into the corresponding component, e.g., the enclosure section, or to intentionally provide a means for removably fastening it to the corresponding component, specifically the respective component. For example, hook-and-loop fasteners can be used for the detachable fastening, but snaps or the like can also be used. This is particularly advantageous when the appropriate position of the sensor of the detection device is already defined by the component, more specifically the treatment device, and the manner in which it is applied, and can ultimately be attached to the corresponding component at a defined position via the fastening means.

[0021] In more specific embodiments, the detection device can be designed to measure the distance between two sensors and / or sensor components, and / or the joint angle and / or at least one dynamic variable of joint movement, particularly angular velocity and / or angular acceleration. For example, in the case of a single-axis joint, the movement of the joint, and therefore the movement of the components relative to each other, occurs as a pivot around this joint axis. Two sensors or two sensor components of a sensor can measure the distance between the sensors or sensor components and thereby infer the joint angle or dynamic variable over time. Of course, this can also be used in joints with multiple joint axes, such as ball joints. For the application of medical instruments to the spine, more complex motion spaces can also be defined, particularly those that jointly map the movement of multiple individual vertebral joints.

[0022] Advantageously, at least one sensor can have a magnetic and / or inductive measurement principle, which is particularly suitable for measuring the movement of parts relative to one another with sufficient accuracy, as described, for example, in the aforementioned WO 2016 / 176544 A1, although other sensor principles, such as capacitive distance measuring sensors, are of course also conceivable.

[0023] It is advantageous to realize at least some of the components of the medical device, particularly the evaluation device, away from the joint, i.e., especially outside the treatment device. In principle, parts of the detection device can also be provided away from the joint or the treatment device. While it is conceivable in principle to realize communication between such spatially separated components of the medical device using wires, within the scope of the present invention, it is preferred to use wireless communication, especially radio communication, in order to minimize human disturbance. For example, proprietary but standardized communication methods, such as Bluetooth®, can be used for wireless communication. Such wireless communication can take place, for example, between the evaluation device and the detection device and / or its subcomponents.

[0024] However, it is of course also possible within the scope of the present invention for the entire medical device, i.e. in particular both the detection and evaluation device and the output device, to be arranged in the joint itself, in particular on or as part of the treatment device. In particular, compact embodiments are also possible, which preferably have tactile and / or acoustic output devices.

[0025] The appliance may preferably have a setting device for setting a desired range of motion of the joint used by the person when wearing the appliance. In principle, within the scope of the present invention, it is preferred to allow manual setting of the desired range of motion, for example by a therapist or other user, optionally by the person themselves, but in many embodiments, it may also be advantageous, preferably additionally or alternatively, to allow automatic setting of the desired range of motion by the setting device. For example, a treatment progress and / or a predetermined treatment plan may be used here, optionally also determinable by the detection device itself.

[0026] In embodiments of the present invention, the setting device can have electronic and / or mechanical setting means, particularly those formed by components that exist independently of the treatment device, particularly the handheld mobile device. This means that the setting device can be designed in many different ways within the scope of the present invention. In particular, when the corresponding setting means of the setting device are provided near the joint, particularly on the treatment device, the setting process can also involve mechanical components, for example, in that at least one joint or at least the setting device can be brought into a position that defines the desired range of motion and the position can be stored accordingly. However, it is also particularly advantageous to provide electronic setting means, particularly for manual and / or automatic setting of the desired range of motion, which setting means can also be at least partially implemented by the handheld mobile device. The handheld mobile device, e.g., a mobile phone, can have a user interface that allows, for example, the desired range of motion and / or criteria for their automatic determination to be entered. For this purpose, in the case of a smartphone and / or tablet, a corresponding computer program, i.e., an application (app), can be provided, for example, on the handheld mobile device.

[0027] Particularly with regard to such embodiments, a particularly preferred development of the present invention allows the mobile device to further comprise a computing device designed as at least part of the evaluation device, on which an application that forms the mobile device as both a setting means and part of the evaluation device is present. In one exemplary embodiment, the handheld mobile device thus communicates, preferably wirelessly, with the detection device, and the computing device evaluates the detection data of the detection device, in particular to compare the range of motion used with the desired range of motion and determine whether to output support information and / or how the support information needs to be parameterized, allowing the person to maximize the desired range of motion. In this context, the output means of the handheld mobile device can also function as an output device; for example, a speaker for acoustic output of support information and / or a display, particularly designed as a touchscreen, can also be used for optical output of support information. Thus, in this way, the equipment and / or computing power of the handheld mobile device are optimally utilized to provide only a few components of the medical instrument to the joint itself. For example, this is advantageous when only the detection device and, optionally, a treatment device are placed in the joint itself.

[0028] Another embodiment, which can optionally be used as a setting means in addition to a handheld mobile device, provides a setting device implemented on or as part of the treatment device and / or designed to evaluate the detection data of the detection device and determine the current joint position as the limit of the desired range of motion, e.g., maximum or minimum, and in particular to include at least one setting button that adopts the current joint position as the limit of the desired range of motion, e.g., maximum or minimum. Thus, in a specific development, for example, the treatment device may have a setting button, e.g., a set button, to define the desired range of motion using the current joint position. In particular, the detection data of the detection device may be used here to enable identification of the current joint position, although other embodiments are of course also conceivable. It should be noted that a control element corresponding to the set button may, of course, also be implemented in the user interface of the handheld mobile device. In both embodiments, i.e. when a setting button is provided on the treatment device or at least one component and / or when a setting button is realized via the user interface of the mobile device, a reset button may also be provided in addition to such a set button, which may be used during repositioning of the medical instrument, in particular at least the components, relative to the patient, e.g. to reset all settings and / or to indicate a basic position for calibrating, e.g., a detection device.

[0029] It should be noted at this point that, in particular with regard to manual setting via the setting device, further adjustments can of course also be made via the setting device of the corresponding embodiment, in particular via setting of support parameters relating to the support information. For example, in addition to specifying the desired range of motion, the described setting device can also be used to define parts of the desired range of motion, such as the range within which support is actually provided (see also the information criteria above), the (relative) time points at which support is provided, the general strength of the possible support information, etc. Furthermore, at least one further range parameter related to the desired range of motion can also be set via the setting device, in particular a time parameter describing the period during which the comparison is evaluated and / or the type of movement for which the desired range of motion is used.

[0030] As already mentioned, the setting device does not have to be (exclusively) suitable for manually setting the desired range of motion, but can also perform at least partially automatic determination of the desired range of motion. Therefore, a preferred development of the present invention provides a setting device designed to at least partially automatically determine the desired range of motion by evaluating user-defined default data and / or historical data detected by the detection device and describing the articulation of the person's joints over a previous period. The user-defined default data can, for example, describe the health status and / or the progress of treatment and / or the desired type and / or speed of treatment. In particular, the default data can also include a treatment plan in which different desired ranges of motion are assigned to different periods. The periods do not need to be defined in absolute terms, as long as the progress of treatment can also be tracked, for example, by evaluating the detection data of the detection device. For example, if the historical data detected by the detection device describing the articulation of the person's joints over a previous period indicates that the desired range of motion provided so far has been fully utilized, the desired range of motion can be extended and moved to a new period. In other words, the currently used desired range of motion can be automatically adapted depending on the person's behavior and / or the progress of their treatment.

[0031] In a preferred embodiment of the present invention, the support unit may be designed to use the current movement state described by the detection data of the detection device and / or the joint's previous movement history when determining the support information to be output. In other words, and more specifically, the movement phase, particularly the approach of the movement state to an extreme position, and / or the joint's movement history may be taken into account by the support unit to determine the support information and / or the time of output of the support information. For support information that should lead to better utilization of the desired range of motion, the time of output or the current movement state at the time of output should be evaluated as relatively important. For example, considering knee movement, if the leg is currently extended, it is advantageous to encourage the person to extend the leg further. Therefore, in the case of flexion, if the support information occurs during deceleration of the flexion process to the corresponding inflection point, a distinct support that can be easily attributed by the person is particularly advantageous.

[0032] Therefore, in the context of the present invention, it is particularly advantageous to evaluate the current motion state and / or the joint's previous motion history to determine or predict the achievement of a motion inflection point and / or stopping point. Finally, it can be said that support is generally tailored to the current motion state, particularly the current motion phase, thereby enabling intuitive understanding. In the case of other single-axis joints, such as knees and / or joints, angular velocity can also be taken into account for this purpose, and thus support information can be determined depending on the angular velocity. Thus, as already explained, the motion slows down just before a change of direction, i.e., just before an inflection point, indicating the approach of the inflection point. This can then provide support information for further pivoting, for example. Of course, other motion phases, such as the swing phase and / or the push-off phase, can also be determined and taken into account within the scope of support, as in the case of a knee joint.

[0033] Support units may be provided that are designed to determine support information by evaluating the comparison results over a predetermined and / or predeterminable period, particularly over a period described by time parameters entered by the setting device, particularly over a period defined as the number of joint movement cycles. Within the scope of the present invention, it is therefore possible to consider a period that can be set by the user to evaluate the utilization of the desired range of motion over such a period and, based on such evaluation, determine which type of support is most advantageous. For example, analysis can be performed over several cycles to determine the average utilization of the desired range of motion and / or recurring "use errors" / usage defects, etc., and thus provide support information on a sound basis. Here, it is particularly advantageous to consider a rolling period, so that the evaluation results can be continuously kept up to date. This allows for a robust and sound determination of the required support and the reliable design of the corresponding support information without prejudice to reasonable timeliness.

[0034] In general, in the context of the present invention, in a particularly preferred embodiment, the evaluation device may be designed to control an output device to output at least one piece of support information during and / or after the evaluated movement. Output of the support information after the evaluated movement is particularly advantageously performed immediately thereafter. The evaluation may relate to the aforementioned period, and therefore it is particularly advantageous to implement the aforementioned "rolling period" to ensure a constant and rapid response to recent changes, particularly progress. In this way, while the person is using the joint, the person receives at least relatively direct feedback regarding the utilization of the desired range of motion and receives directly implementable information during the movement, particularly in the form of support information, regarding how to better utilize the desired range of motion. In the example of knee movement, the evaluation may be performed, for example, over several movement cycles, e.g., one to four movement cycles, while the corresponding results can be output at appropriate times during the ongoing movement, particularly during the movement cycle. For example, if it is found that during the evaluated period the desired range of motion is being utilized significantly less in extension than in flexion, current support information can be output as full knee extension is approached, allowing the person to extend the leg further, but as maximum flexion is approached the strength of the support information may be reduced, indicating that there is still room for improvement here but the deviation is small, allowing the person to intuitively understand that while there is also room for improvement with regard to flexion, extension is, for example, a key issue that the person should particularly focus on at the time the support information is highlighted.

[0035] However, such targeted support can also be performed even when the evaluation does not necessarily take place over a certain period of time. For example, during flexion, it is possible to predict where flexion will occur, for example based on the occurrence of a decrease in angular velocity, and then check how close this predicted angle is to the limit of the desired range of motion, and therefore actively output support information that guides the person to perform further flexion if there is a difference that is particularly relevant to the limit of the desired range of motion. Such an embodiment therefore results in support that is tailored to the movement phase and is more dedicated, but may be less robust or subject to stronger fluctuations than an evaluation over the period of multiple movement cycles of the joint.

[0036] The output device may have tactile and / or acoustic and / or optical output means. However, other output possibilities are also conceivable where appropriate, such as olfactory output means. Preferred embodiments use the output of supporting information as parameterizable optical and / or acoustic output signals and / or also as tactile signals, as will be explained in more detail below.

[0037] Certain particularly advantageous embodiments of the present invention provide a support unit designed to select at least one output parameter, in particular the repetition intensity and / or volume and / or frequency of the sound and / or light signal, and at least one of the support information as a function of the desired range of motion utilization measure and / or the approach to the desired range of motion limit measured from the comparison result. Part of the support information can be output, in particular as a pulsating or essentially periodic signal, with the period and / or intensity adjusted as a function of the comparison result. In the case of an acoustic signal, it is possible to increase the repetition frequency of the sound as the desired range of motion limit is approached, as in a parking assistant, and / or to confirm that the limit has been reached with a continuous sound. The opposite design (reducing the repetition frequency when the desired range of motion limit is approached more closely) is also conceivable within the scope of the present invention, if this has a more intuitive effect for certain groups of people. Additionally or alternatively, the intensity, e.g., volume, can also be increased, resulting in a more underutilized desired range of motion. For example, another particular embodiment of the present invention may also provide a plurality of individual light sources in the form of a scale as optical output means, for example near the joint, in particular at least one of the parts and / or treatment devices. The more the desired range of motion is utilized, the brighter the light sources of the scale can be, for example. In this regard, it is also conceivable to increasingly switch on or off output means on the joint that output support information by vibration.

[0038] A particularly advantageous embodiment, which may be used in addition to or instead of optical and / or acoustic output of support information, provides a medical device that includes, as part of the output device, at least one stimulator controllable by the evaluation device as a function of the comparison result of at least one muscle of the person assigned to the joint, and / or at least one electrical and / or mechanical drive means designed to change the relative position of the components and controllable by the evaluation device as a function of the comparison result. Such a stimulator may, for example, comprise a vibration pad that can be integrated into a therapeutic device. Such a vibration pad is positioned to specifically stimulate the relevant muscle group, and its activation results in improving the utilization of the desired range of motion in the current movement state. For example, if the approach to an extreme position of the movement cycle decelerates too quickly, the continuation of the movement can be achieved or encouraged in a targeted manner by stimulating the muscle. Thus, highly targeted tactile support information can be generated.

[0039] However, selective use of electrical and / or mechanical drive means is also conceivable. In this way, it is also possible to provide clear tactile support signals, for example, to continue a movement phase further than originally planned by, for example, slightly increasing the angular velocity by manipulating the drive means and influencing the relative position of the components accordingly, keeping the movement within limits so that a particularly wide movement is not "imposed" but rather at least primarily serves a reference function. For example, the effect of such tactile support signals can be reduced to a maximum of 1-3° during pivot movements. Furthermore, it is also possible to use purely mechanical drive means to output tactile support signals. In this case, for example, the release of a spring that supports a specific movement direction can be considered, which means that the drive means can have a spring that mechanically supports the movement direction. To output the support signal, the support unit can, for example, release and / or lock the spring.

[0040] At this point, it should be noted that the support information that is preferably output during the joint movement is preferably designed in such a way that the movement sequence is not interrupted and / or disturbed in any case, but is supported in the best possible way.

[0041] A particularly advantageous development of the present invention provides an evaluation device having a classification unit that categorizes current movements into movement type classes based on the detection data of the detection device, and the support information is output only if a movement type class corresponding to the related movement type exists. For example, historical data, particularly of the last movement cycle, can be evaluated to recognize the movement type, for example, related to one or more joints, such as the knee or spine, and whether a person is currently driving a car, climbing stairs, walking on a flat surface, etc. In particular, the support information can be limited to, for example, a specific class of movement type. However, it is of course also possible to distinguish between movement type classes, for example, so that different classes of movement type are associated with different desired ranges of motion and / or different types of support information. For example, if at least one desired range of motion related to a movement type is selected by the setting device, the evaluation device may be configured to use the desired range of motion for comparison only if a movement type class corresponding to the related movement type exists by the classification unit. Thus, particularly when distinguishing between different classes of movement types, the support information can be specifically adapted to a specific type of movement, so as to optimally address therapeutic results, particularly during the therapeutic phase.

[0042] The present invention further provides a medical device having a limiting device for limiting the range of motion of a joint to an allowable range of motion. Therefore, such limiting devices, which are often provided as medical or therapeutic devices, for example in orthotics, allow for defining not only the desired range of motion but also the maximum allowable range of motion, i.e., the allowable range of motion. In this regard, it is particularly advantageous if the setting device is designed to adopt the allowable range of motion set by the limiting device as the desired range of motion. Therefore, the desired range of motion can be particularly easily defined as the allowable range of motion if it is utilized to its fullest extent.

[0043] In addition to the medical instrument, the invention also relates to a method for operating a medical instrument for a human joint, comprising at least two parts attached to the joint and movable relative to each other by the joint, and at least one detection device for detecting the relative movement of the parts, in particular a medical instrument of the type according to the invention, the method comprising: A step of determining the range of motion of the joint that is actually used when the treatment device is attached from the detection data of the detection device; Comparing the range of motion used with the desired range of motion; determining supporting information that will guide the person to the widest possible use of the desired range of motion, said supporting information being dependent on the results of the comparison; outputting the support information to a person; Includes.

[0044] All statements relating to the medical device according to the invention are equally applicable to the method according to the invention for obtaining the aforementioned advantages.

[0045] In particular, the method of the present invention also allows the desired range of motion that a person will use when wearing the appliance to be set in the setting device, particularly based on user input.

[0046] Further advantages and details of the invention emerge from the exemplary embodiments described below and from the drawings. [Brief explanation of the drawings]

[0047] [Figure 1] 1 is a diagram for explaining the underlying problem and approach of the present invention; [Figure 2] 1 is a schematic diagram of components of a medical device according to the present invention; [Figure 3] 1 shows a prosthesis as an exemplary embodiment of a medical device according to the present invention; [Figure 4] FIG. 1 illustrates the application of the medical device of the present invention in a bandage. [Figure 5] FIG. 1 illustrates a handheld mobile device. [Figure 6] FIG. 1 illustrates the application of the present invention in a posterior brace. [Figure 7] 1 is a flowchart of a first exemplary embodiment of a method according to the present invention; [Figure 8] 4 is a flowchart of a second exemplary embodiment of the method according to the present invention. [Figure 9] FIG. 10 is a diagram illustrating the dependence of the signal repetition frequency on the utilization. DETAILED DESCRIPTION OF THE INVENTION

[0048] 1 illustrates the idea underlying the present invention based on the various ranges of motion (ROM) of a human joint 1, such as the knee joint, as indicated by the central point. In this case, the maximum range of motion 2 of the joint 1, indicated by the dashed line, is limited by the limiting devices of the treatment device used, in particular the brace, resulting in an allowable range of motion 4, delimited by the line 3. Due to the protective postures and protective movements during the treatment phase, the patient, or in general the person using the said treatment device, uses only a small part of the allowable range of motion 4, indicated here as the range of motion 5 actually used when wearing the treatment device.

[0049] However, there is also a desired range of motion 6 that is therapeutically useful and that can be described by limits 7. The basic idea of the invention is to design, based on supporting information represented by arrows 8, a medical instrument that can be assigned to or equipped with said treatment device in such a way that the patient is specifically guided to use a larger part of the desired range of motion 6, starting from the currently used range of motion 5.

[0050] FIG. 2 shows a schematic diagram of such a medical device 9 according to the invention for a joint 1 of a person 10, e.g., a knee joint or other single-axis joint. Parts 11 are clearly provided on the body of the person 10 adjacent to the joint 1 and are moved relative to one another by the movement of the joint 1, as indicated by the arrow. The detection device 13, shown here only, may comprise, for example, two sensors 14 or parts of sensors 14 designed to measure their relative position and / or orientation, thereby measuring the actual movement of the joint 1. The detection data can be transferred to an evaluation device 16 via a communication link 15, which is shown here only. The evaluation device 16 includes a determination unit 17 that first determines, from the detection data of the detection device 13, the range of motion 5 of the joint 1 that will actually be used when wearing the medical device 9, in the case of a single-axis joint, for example, as shown here, by tracking the joint angle and determining the maximum angle. It should also be noted that the detection device 13 also describes dynamic parameters in its detection data, i.e., angular velocity in this example.

[0051] A comparison unit 18 of the evaluation device 16 compares the actually used range of motion 5 with the desired range of motion 6. For example, the corresponding, in particular maximum joint angles, describing the used range of motion 5 can be compared with the maximum and minimum joint angles describing the limits 7. Finally, at least one usage measurement result is obtained which indicates the extent to which the desired range of motion 6 is actually used, in particular in relation to each individual limit 7.

[0052] Finally, the evaluation device 16 also has a support unit 19 which determines support information as a function of the comparison result, whereby the support information is determined in such a way as to direct or guide the person 10 towards the widest possible use of the desired range of motion 6, as will be explained in more detail below with respect to specific exemplary embodiments.

[0053] At least one information criterion can be provided in the support unit, and if at least the comparison result is evaluated and the information criterion is met, part of the support information or the support information is output, often after appropriate parameterization, so that the support information does not have to be output at each time or in each situation. Furthermore, when it comes to guiding person 10 to the widest possible use of the desired range of motion 6, it can be said that it is generally advantageous to take into account the current movement state and at least the preceding movement history in the design of the support information, especially during its specific parameterization, so that the support information includes instructions that person 10 can intuitively understand, i.e., how to achieve a wider use of the desired range of motion 6.

[0054] The support information determined by the support unit 19 can be output via a corresponding output device 20, which may comprise, for example, corresponding output means for optical and / or acoustic and / or tactile output of the support information, as will be explained in more detail in specific examples.

[0055] In a preferred exemplary embodiment, the medical device 9 according to the present invention further comprises an input device 21 with at least one input means by which the desired range of motion 6 can be defined manually and / or automatically, preferably based on user input. The input means can be provided in particular in mechanical form in the component 11 and / or the treatment device 22, as shown in FIG. 2 and also in the case of the restriction device already discussed with reference to FIG. 1 as a mechanical input means, via which the desired range of motion 6 can be mechanically defined in the medical device 9. With regard to automatic determination, for example, a dynamic or defined treatment plan can be pre-set for the person 10 by the therapist as user, which, for example, extends the desired range of motion 6 in successive periods for different treatment progressions. While the treatment progression can follow a defined timeline, it is preferred to track the treatment progression via the detection data, especially since the aforementioned usage measurements determined by the comparison unit 18 provide a good indication of the extent to which the desired range of motion 6 has already been used, which can then be taken into account to allow progression to the next treatment level and thus to an extended desired range of motion 6.

[0056] Additionally, such a treatment regimen may also involve the use of different treatment devices 22, for example, first a brace, then a bandage, and finally a belt system, etc. The components and / or at least one sensor are preferably releasably attachable to the treatment device 22, which may include the components 11, for example, via hook-and-loop fasteners that may also be applied to other components of the medical device 9, and thus the medical device 9 may also be used with different treatment devices 22 in certain embodiments.

[0057] In general, it should also be noted at this point that the part 11 can, but does not have to, belong to the treatment device 22. If the treatment device 22 is, for example, a brace, the part 11 can be an articulated rigid articulated guide element, but it is also possible that the part 11 is formed by a sub-region of a flexible component of the treatment device 22 or medical instrument 9, made of a compressible material, for example in the case of a bandage.

[0058] Furthermore, it also generally applies that the evaluation device 16, the output device 20 and the setting device 21 may be implemented at least partially on the treatment device 22, i.e. near the joint, and / or at least partially outside the treatment device 22, in particular away from the joint 1, and the communication link 15 is preferably a wireless communication link. Particular embodiments are described in more detail below.

[0059] As explained, the sensor 14 preferably measures the position and orientation relative to other sensors 14, or in particular to passive sensor components on other components 11. Particularly preferably, magnetic and / or inductive measurement principles can be used, for example by providing one component with a magnetic material and the other component 11 with a corresponding magnetic field sensor. Other possible embodiments include providing one component 11 with a conductive material and the other component 11 with an inductive sensor.

[0060] 3 shows a first particular exemplary embodiment of a medical device 9a according to the invention, comprising a brace 23 as treatment device 22; only the components of the medical device 9a that are provided for a joint 1, here the knee joint, are shown in this case. In this case, the brace has two rigid articulated guide elements 25 connected via a joint 24, which can be held on the upper or lower limb of the person 10 by a belt 26. In this case, the sensor 14 or a sensor component of the sensor 14 is arranged on the belt 26 internal to the knee joint, but may also be provided on the articulated guide element 25. The sensor element 14 forming the detection device 13 can, for example, be integrated into the belt 26.

[0061] 3 also shows various possible embodiments of the output means of the output device 20. On the one hand, scale-like output means 27 is shown, which preferably has a tactile output element, rather than an optical output element, which can be successively switched on to indicate to the person 10, for example, as the approach of full use of the desired range of motion 6 increases. As a further preferred acoustic output means, the output device 20 according to FIG. 3 also has a speaker 28 arranged on the orthosis 23, here on one of the rigid articulated guide elements 25, which can output a sound, possibly also a voice output, as supporting information. An embodiment with a repeated sound is preferred, the repetition frequency and / or volume and / or pitch of which can be varied depending on how well the desired range of motion 6 is actually being used by the person 10.

[0062] A design based on a car parking assistant has proven to be a particularly intuitive embodiment, where, for example, a higher repetition frequency indicates a stronger approach to the limit 7 of the desired range of motion 6. The pitch can be used to inform the person 10, for example, about the limit 7, i.e., for example, about the direction of flexion or extension. In this case, the pitch is already advantageously provided to make the output dependent on the current movement phase or the current movement state, for example, to output supporting information about flexion when approaching an inflection point of the movement during extension, and therefore for flexion.

[0063] Further preferred optional tactile output means are shown in FIG. 3 in the form of vibration pads 29 provided in this case on the upper limbs, which can stimulate the relevant muscle groups, for example as tactile information to maintain the direction of movement longer, and in the form of electrical drive means 30 provided in this case on the joint 24, which can somewhat force movement in one direction (preferably only as information), for example when slowing down, in order to output information to the person 10 that there is still room for the desired movement.

[0064] FIG. 3 further shows a limiting device 31 on the joint 24, via which the allowable range of motion 4 can be set. As already explained, the limiting device 31 can also be understood as a mechanical setting means of the setting device 21, and in this case can be supplemented by a setting button 32, e.g., a SET button. For example, by first using the SET button 32, the desired range of motion 6 can be set via the limiting device 31, and then, by subsequent adjustment of the limiting device 31, it is still possible to extend the allowable range of motion 4 relative to the desired range of motion 6. A RESET button 33 may also be provided, which can be used, for example, when reapplying the brace 23.

[0065] 4 shows the use of a medical device 9b in a bandage 34 as a treatment device 22, although the bandage 34 does not necessarily belong to the medical device 9b here. In this case, and for the sake of clarity, only the fastening means 35 forming the part 11, here the at least one sensor 14 and the sensor-side components of the surface means, are shown. Thus, by means of the fastening means 35, the at least one sensor 14 and the part 11 can be releasably fastened to the bandage 34 at a specific, predetermined position; further components of the device 9b provided outside the joint (evaluation device 16, output device 20, and input device 21) are not shown.

[0066] In this regard, Figure 5 shows a possible embodiment in which a handheld mobile device 36, here a smartphone 37 or a tablet, is at least partly used as evaluation device 16, output device 20 and setting device 21. For this purpose, the mobile device 36 has in particular a computing device 38 with at least one processor, on which an application 39 (app), i.e. a computer program, is provided which implements the corresponding parts or components of the medical instruments 9, 9a, 9b.

[0067] For example, touchscreen 40 may be used as an input means for input device 21 via application 39 to input desired range of motion 6 or default data used to automatically determine same. Additionally, the display of touchscreen 40 may also be used as an output means for output device 20, similar to speaker 41. Computing device 38 may at least partially implement determination unit 17, comparison unit 18, and / or support unit 19.

[0068] Figure 6 shows the use of a medical device 9c in a treatment device 22 designed as a posterior brace 42. The posterior brace 42, which is associated with the spine as a joint or articulated group, has a posterior splint 43 held by a belt system 44. In this case, more sensors 14 are arranged along the posterior splint 43 as articulated guide elements in order to measure the spine's movements as accurately as possible. The ranges of motion 4, 5, and 6 can be described, for example, by local movement limits.

[0069] For clarity, further components of medical instrument 9c are again not shown, and posterior brace 42 may, but need not, be associated with medical instrument 9c as treatment device 22.

[0070] It should also be noted at this point that the belt system 44, the bandage 34, and the belt 26 ultimately form an enclosure section that may function, at least in area, as a component if the treatment device 22 belongs to the corresponding medical instrument 9, 9a, 9b, 9c. It should also be noted that, similar to the bandage 34, stockings or other garments may also be used as part of the treatment device 22 or instrument 9, 9a, 9b, 9c.

[0071] Returning to FIG. 2 , the evaluation device 16 may also further comprise a classification unit 45 that can categorize the current movement into a class of movement type based on the detection data of the detection device 13. In this case, support information may be output only for at least one specific movement type, and different support information or different desired ranges of motion 6 may be defined for different types of movement, etc. For example, it may be desirable to provide different desired ranges of motion 6 or other support information for the knee joint as joint 1 when climbing stairs and walking normally on a flat surface. In this case, the detection data over a particularly defined previous period may be sufficient to clearly indicate which class of movement type is currently being used.

[0072] With reference to Figures 7 and 8, an exemplary embodiment of the method according to the invention that can be implemented by the described medical device 9, 9a, 9b, 9c will now be explained in more detail.

[0073] In the exemplary embodiment according to FIG. 7, the detection data is recorded by the detection device 13 in step S1.

[0074] In step S2, the determination unit 17 of the evaluation device 16 uses the detected data to determine the range of motion 5 of the joint 1 that will actually be used when the treatment device is worn, and further analysis of the detected data is also performed. In the exemplary embodiment of FIG. 7, not only the current movement state but also the previous movement history and / or dynamic parameters, such as angular velocity in the case of a single-axis or multi-axis joint, are taken into account. In this case, the knee should be more accurately considered during cyclical movements. The latter typically consists of a sequence of extension and flexion processes, each of which alternates with an inflection point that represents the limit of the range of motion 5 that will actually be used. When the movement state approaches an inflection point, this is indicated, for example, by a decrease in angular velocity. However, this makes it possible to determine the approach of the inflection point, in particular any inflection point, before the inflection point is reached and to predict the expected location, in particular the joint angle, at which the current movement process will be performed.

[0075] Based on the information determined in step S2, a check is made in step S3 to determine whether a relevant movement stage or movement state exists. This can be intuitively detected and therefore can be considered the first information criterion, since it ultimately checks to what extent reasonable support information is available for the current movement state or current movement stage. If not, the process returns to step S1 or proceeds to step S4. In step S4, the comparison unit 18 of the evaluation device 16 checks to what extent the predicted inflection point reaches the corresponding limit 7 of the desired range of motion 6 in a particular example. In the example of a knee as a single-axis joint, for example, the angular distance between the limit 7 and the predicted inflection point can be determined. Of course, more complex analyses / uses are also conceivable in other exemplary embodiments.

[0076] In step S5, as part of further information criteria, it can be checked whether the deviation from the limit 7 determined in step S4 possibly requires supporting information. If this is not the case, for example because the limit 7 has been reached (or exceeded) in any case, then return to step S1. Note, however, that it is absolutely conceivable to output positive supporting information even if the range of motion 6 has been fully or almost fully used.

[0077] Next, in step S6, supporting information is determined as a function of the comparison results of step S4, for output in step S7.

[0078] In step S6, the support information is parameterized as a function of the information collected from the detection data, in particular the comparison results. For example, the greater the angular distance from limit 7, the greater the strength of the support information that intuitively encourages further movement towards limit 7. For example, if a stimulation device such as vibration pad 29 and / or drive means 30 is used, a stronger stimulation / stronger support information may occur if person 10 is encouraged to continue a current movement process, for example extension or flexion, for a longer period. The same may apply to acoustic and / or optical support information, although it may also be advantageous to intuitively signal the approach of limit 7 by a higher intensity.

[0079] FIG. 8 shows a second exemplary embodiment of a method according to the invention, which can be used alternatively or in combination with FIG.

[0080] Here too, in step S1, the movement is measured by recording the detection data. However, in step S2, the decision unit now takes into account several movement cycles, which means that previous detection data describing the movement history for the period immediately preceding the current point in time is used, resulting in a more robust description of the range of motion 5 actually used. For example, averages (especially weighted averages) can be formed for extreme positions, etc. Here, a continuous update using all new detection data is performed, which means that a rolling period is taken into account in order to be able to react as quickly as possible to changes, in particular improvements or deteriorations regarding the desired range of motion 6.

[0081] In step S4', a comparison is made in the comparison unit 18, since in this exemplary embodiment at least sequential information for guiding or directing a person is desired by the support information.

[0082] Nevertheless, in a next optional step S5', an information criterion may be checked as to how much support information is needed. In particular in the case of an ultimately desired continuous guidance of person 10 to improve the utilization of the desired range of motion 6, it may be desired to no longer output the support information if it has been fully used.

[0083] In step S6', the support information is determined, similar to step S6 in Fig. 7, and output in step S7. In this exemplary embodiment, it is preferred to use a tone sequence, the repetition frequency of which depends on the degree of use, here in particular on the proximity of limit 7.

[0084] FIG. 9 shows such an exemplary dependence of the tone repetition frequency f on the degree of use N. Here, a value of 46 indicates substantially complete use of the desired range of motion 6. Clearly, there is an initial low repetition frequency, which increases significantly as use increases in region 47, thus intuitively conveying the approach to limit 7, similar to the "parking assistant." Above value 46, a region 48, for example, a continuous tone, can be output and / or support information can be deactivated, since the desired range of motion 6 has been used as far as possible.

[0085] 7 and 8, but generally in all embodiments of the present invention, it is advantageous to intuitively output support information, particularly immediately after evaluation, in a manner that can be assigned to movements during the exercise itself. This improves the assignment, particularly when reacting to specific movement phases or predictions, and thus also the guiding and leading effect for improving the utilization of the desired range of motion 6. It is also noted that in general, the support information preferably does not interfere with or interrupt the exercise itself, but intuitively flows into the movement sequence, thus guiding the user to an improved utilization of the desired range of motion 6.

Claims

1. A medical device for a human joint, the medical device comprising at least two parts that are placed on the human body adjacent to said joint and that are movable relative to each other by said joint, and at least one detection device for detecting relative movement of said parts, a determination unit for determining a range of motion of the joint that is actually used when the medical device is worn, from the detection data of the detection device; a comparison unit for comparing the range of motion used with a desired range of motion; a support unit for determining support information depending on the comparison result by the comparison unit, the support information guiding the person to use the desired range of motion as extensively as possible; The evaluation device is characterized by having the medical instrument further comprises an output device for outputting the support information to the person before reaching an inflection point of the movement in a motion state, the output device outputting optical and / or acoustic and / or tactile support information; The medical device is characterized in that the support unit is designed to select the intensity and / or volume and / or frequency of repetition of at least one output parameter of the support information as a function of the desired range of motion usage measurement value determined from the comparison result.

2. a stocking-like enclosure section that is pulled over the joint; an enclosure section that is wrapped around the joint as a bandage; an enclosure section designed as a garment; and an enclosure section designed as a belt system; At least one enclosure section selected from and / or 10. The medical instrument of claim 1, comprising at least one rigid articulating guide element.

3. 3. The medical instrument according to claim 1 or 2, characterized in that the detection device comprises at least one sensor integrated in at least one of the components or attached or attachable removably or non-removably to at least one of the components and / or to a body area moving with the components, and / or is designed to measure angular velocity and / or angular acceleration, which are at least one dynamic variable of the distance and / or joint angle and / or joint movement between two sensors and / or sensor components, and / or the at least one sensor has a measurement principle using magnetism and / or induction.

4. The medical device according to any one of claims 1 to 3, characterized in that the device has a setting device for setting the desired range of motion of the joint used by the person when wearing the device.

5. the setting device has at least one of electronic and mechanical setting means and exists independently of the treatment device formed by the components; And the setting device exists independently of the handheld mobile device, or 5. The medical instrument of claim 4, wherein the setting means of the setting device are at least partly implemented by a handheld mobile device.

6. 6. The medical instrument according to claim 5, characterized in that the independently existing setting device and / or the handheld mobile device further comprises a computing device designed as at least a part of the evaluation device, on which computing device there is present an application that configures the independently existing setting device and / or the handheld mobile device as setting means and as part of the evaluation device.

7. 7. The medical instrument according to claim 4, wherein the setting device is designed to at least partially automatically determine the desired range of motion by evaluating user-defined default data and / or historical data detected by the detection device, describing the articulation movements of the joints of the person during a previous period of time.

8. A medical device according to any one of claims 1 to 7, characterized in that the approach of the movement state to an extreme position in the movement phase and / or the movement history of the joint can be taken into account by the support unit to determine the support information and / or the output time of the support information.

9. 9. The medical instrument according to claim 1, wherein the evaluation device is designed to control the output device for outputting the at least one piece of support information during and after the evaluated movement.

10. 10. The medical instrument according to claim 1, further comprising, as part of the output device, at least one stimulation device controllable by the evaluation device as a function of the result of the comparison of at least one muscle of the person assigned to the joint, and / or at least one electrical and / or mechanical drive means controllable by the evaluation device as a function of the result of the comparison, designed to modify the relative positions of the components.

11. The medical instrument according to any one of claims 1 to 10, characterized in that the evaluation device has a classification unit for categorizing a current movement into a movement type class based on the detection data of the detection device, and the support information is output only if there is a movement type class corresponding to the related movement type.

12. The medical device according to any one of claims 1 to 11, further comprising a limiting device for limiting the range of motion of the joint to an allowable range of motion.

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