Diagnostic device and method for monitoring body tissue of patient

Abstract

A diagnostic device (110) for monitoring at least one body tissue (134) of a patient is disclosed. The diagnostic device (110) comprises: a. At least one bracelet (112) configured to be bound around a body part (132) of the patient; b. At least one electromechanical actuator (114) configured to actively vary the circumference of the bracelet (112); c. At least one measurement unit (126) configured for determining at least one item of information about the electrical power applied to the electromechanical actuator (114) and at least one item of perimeter information about the perimeter of the bracelet (112); and d. At least one evaluation unit (128) configured for determining at least one item of information about a state of the body tissue (134) from the item of information about the electrical power applied to the electromechanical actuator (114) and the item of perimeter information, where the evaluation unit (128) is configured for determining a contact point, the circumference of the bracelet (112) corresponds to a circumference of the body part at the contact point. Further, a method of monitoring at least one body tissue (134) of a patient is disclosed.

Description

Technical Field

[0001] The present invention relates to a diagnostic device for monitoring at least one body tissue of a patient. The present invention further relates to a method for monitoring at least one body tissue of a patient, and certain aspects of a computer implementation of the method. The device and method can be used in particular for monitoring body swelling, such as edema or congestion, particularly ankle edema, of the body tissue of the patient. Additionally or alternatively, other body parts can be monitored, such as body tissue of one or more thighs, calves, wrists, forearms and upper arms of the patient. The present invention can be applied in particular to patient monitoring in the fields of cardiology and internal medicine. However, other application areas are also feasible. Background Art

[0002] In multiple medical fields, monitoring the characteristics of patients' body tissues is an important part of medical care. Specifically, in the fields of cardiology and internal medicine, it is essential to check the characteristics of specific body tissues, for example, in order to detect or monitor swelling or edema. As an example, monitoring ankle edema or other congestion is an important part of cardiac care, because it is well known that ankle edema is an effective indication of the risk of heart failure symptoms. Therefore, in many medical fields, it is necessary to monitor the characteristics of body tissues. As an example, the main challenge of heart failure patient management is to monitor congestion and body tissues, because congestion is one of the most important determinants of heart failure symptoms and is also a major prognostic factor for heart failure. Congestion is mostly treated with diuretics (such as loop diuretics), as recommended, for example, according to major international guidelines.

[0003] Therefore, it is critical to provide devices and methods for adequately determining certain parameters of body tissues, such as the patient's congestion state. Residual congestion at discharge is associated with higher one-year mortality and readmission for heart failure. Although many clinical signs and symptoms of congestion have been well characterized and recognized by published guidelines, no single element in the clinical history or physical examination can accurately detect the underlying hemodynamic changes leading to congestion.

[0004] However, the technical challenge is the availability of robust and reliable clinical tools that can monitor and assess the development of congestion in patients. Professionals use different manual methods, however, these methods are highly dependent on the experience of healthcare professionals. In general, congestion assessment tools can be divided into three groups, but so far, none of these tools alone can provide sufficiently meaningful results to avoid premature discharge of patients or provide appropriate healthcare available to patients at home. Therefore, clinical tools, imaging tools, and pressure and impedance tools for assessing congestion are generally known for monitoring body tissues. Clinical tools typically include monitoring signs and symptoms, such as dyspnea, orthopnea, or other signs and symptoms. In addition, clinical tools can include clinical congestion scores, such as Stevenson scores, Everest scores, Rhode scores, etc. In addition, clinical tools can include the use of circulating biomarkers, such as BNP, NT-proBNP, etc. In addition, certain clinical measurements can be performed, including measurements of plasma volume, hematocrit measurements, serum protein measurements, albumin measurements, etc. Similarly, clinical tools can also include monitoring renal markers, such as potassium, creatinine, etc. Finally, clinical monitoring may include monitoring blood circulation parameters such as central venous pressure, right atrial pressure, etc. The second group (which is the group using imaging tools) may include one or more of chest X-ray, echocardiogram, or others. Finally, the third group of pressure and impedance tools may typically include cardiac catheterization, pressure sensors (such as CardioMEMS TM sensors), bioimpedance vector analysis (BIVA), etc.

[0005] In addition, various sensors are known in the art, which have been described as being useful for monitoring congestion such as ankle edema. As an example, in L. Beker: "Wearable sensors of the elasticity of deeper skin", Nature Biomedical Engineering, Vol. 5, July 2021, pp. 641-642 (www.nature.com / natbiomedeng), a method for dynamically measuring the elasticity modules of the surface and deep layers of the skin by a wearable conformal electromagnetic device consisting of a vibration actuator and a soft strain sensing patch is described.

[0006] Similarly, in R. Fallahzadeh et al.: “Smart-Cuff: A Wearable Bio-Sensing Platform with Activity-Sensitive Information Quality Assessment for Monitoring Ankle Edema”, conference paper, The 7th International Workshop on Information Quality and Quality of Service for Pervasive Computing (IQ2S) in Conjunction with IEEE PerCom, March 2015 (https: / / www.researchgate.net / publication / 307958193_Smart-Cuff_A_Wearable_Bio-Sensing_Platform_with_Activity-Sensitive_Informati on_Quality_Assessment_for_Monitoring_Ankle_Edema), a wearable real-time platform was disclosed that integrates advanced technologies in sensing, computing, signal processing and machine learning for continuous and real-time edema monitoring in remote and home environments.

[0007] In US 8,827,930 B2, a system and method for monitoring a patient are disclosed. An exemplary method includes receiving sensor data related to a patient from multiple sensors of a patient monitoring device, and determining whether the sensor data satisfies one or more trigger conditions. With respect to each satisfied trigger condition, one or more messages are sent to at least one of the patient monitoring device and an external computing device to thereby display to at least one of the patient, a caregiver, and a support staff. The satisfaction of one or more trigger conditions may indicate that the patient suffers from edema and / or tends to decompensate. The sensor data may be collected from a heart rate sensor, an oximeter, an accelerometer, and / or a sensor configured to detect the distance around a patient's limbs. In some embodiments, the trigger condition is provided by the patient, the caregiver, and / or the support staff.

[0008] US10,206,621B2 discloses devices, systems and methods for predicting and preventing acute decompensated heart failure or other patient conditions involving leg or hand effusion. In one example, the wearable device contains a drift-free leg size sensor and a tissue elasticity sensor. These two sensors may be relatively inexpensive and developed using innovative new sensing concepts. Preliminary tests using sensor prototypes showed promising results: the leg size sensor was able to measure a 1 mm change in leg diameter, and the tissue elasticity sensor could detect an elastic difference of 0.15 MPa. In another example, the wearable system includes sensors, processing modules and communication modules for measuring various physiological parameters. Low-top instrumented socks (e.g., wearable devices) with multiple sensors can provide patients with an indication of heart failure status.

[0009] US202110015426 A1 discloses a measuring device capable of measuring the amount of ankle edema. The measuring device includes a sensor having a sheet shape and freely expanding and contracting in a direction intersecting the thickness direction. The measuring device is capable of detecting changes in electrical characteristics associated with expansion or contraction. The measuring device further includes a support member attached to both ends of the sensor in the telescopic direction, and surrounds the ankle joint together with the sensor when the measuring device is mounted on the ankle joint.

[0010] US2010 / 0010406 ​​A1 discloses a self-contained compression device and related methods for periodically compressing a patient's limb to improve blood flow in the limb. In one embodiment, the compression device includes a compression portion whose size and shape are designed to extend around a portion of the limb to apply compression pressure, and a shell operably connected to the compression portion. The shell includes a first shell member and a second shell member, which can move relative to each other between a retracted position and an extended position. A non-pneumatic mechanical actuator is provided in the shell for periodically moving the first shell member and the second shell member from their retracted positions to their extended positions. In one embodiment, the actuator includes a prime mover and at least one cam movable by the prime mover, for achieving relative movement between the first shell member and the second shell member.

[0011] CN 213345640 U discloses an electrical measuring device for postoperative lymphedema of breast cancer, the device comprises a tape measure, a plurality of gear grooves arranged in the middle of the tape measure, and a scale mark arranged on the surface of the tape measure, wherein the scale mark takes one side of the tape measure as a starting point and the other side as an end point. A measuring installation box is fixedly installed on the right side of the tape measure, a fixed installation block is fixedly installed in the measuring installation box, a mounting groove is formed in the fixed installation block, a gear is installed in the mounting groove, a rotating shaft is installed on the gear, one end of the rotating shaft is transmission-connected to the output end of a motor through a coupler, and the other end of the rotating shaft is transmission-connected to the output end of the motor. The gear groove formed on the tape measure meshes with the gear fixedly installed in the measuring installation box, the motor drives the gear to rotate, and thus the tape measure can be automatically tightened by the gear to measure, and the measurement data can be conveniently observed through the scale mark.

[0012] JP 2008096315 A discloses an apparatus for winding a tape around an object to be evaluated for elasticity, the apparatus being configured to pull an end of the wound tape, measure tension generated in the tape, and measure the amount of change in length of the portion of the tape wound around the measurement object.

[0013] Despite the advantages of these technical devices and methods, several technical challenges remain. Therefore, there is still a need for robust and reliable tools that can be used by healthcare professionals or by untrained personnel (such as patients themselves) in clinical settings or at home. In particular, there is a need for devices and methods that are widely independent of environmental conditions (like temperature) and do not require complex in-situ calibration.

[0014] Issues to be resolved

[0015] Therefore, it is desirable to provide devices and methods that at least partially address the above technical challenges.In particular, a device and method for monitoring body tissue should be proposed that is robust and provides reliable results indicative of the state of the body tissue. Summary of the invention

[0016] This problem is solved by a diagnostic device for monitoring at least one body tissue of a patient, and by a method for monitoring at least one body tissue of a patient and certain aspects of a computer implementation of the method, having the features of the independent claims. In the dependent claims and throughout the description, advantageous embodiments are listed which can be realized individually or in any combination.

[0017] As used below, the terms "having", "comprising" or "including" or any grammatical variations thereof are used in a non-exclusive manner. Thus, these terms may refer to the absence of other features in the entity described in this context in addition to the features introduced by these terms, or the presence of one or more other features. As an example, the expressions "A has B", "A includes B" and "A contains B" may refer to the absence of other elements in A in addition to B (i.e., the presence of A solely and exclusively consisting of B); or to the presence of one or more other elements in entity A in addition to B (such as element C, element C and element D, or even other elements).

[0018] Further, it should be noted that the terms "at least one", "one or more" or similar expressions indicating that a feature or element may be present once or more than once are usually used only once when introducing the corresponding feature or element. In the following, in most cases, when referring to the corresponding feature or element, the expression "at least one" or "one or more" is not repeated even though the corresponding feature or element may be present only once or more than once.

[0019] Further, as used hereinafter, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features without limiting the possibilities of alternatives. Therefore, the features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. As the skilled person will recognize, the present invention can be implemented by using alternative features. Similarly, the features introduced by "in one embodiment of the present invention" or similar expressions are intended to be optional features without any limitation on alternative embodiments of the present invention, without any limitation on the scope of the present invention, and without any limitation on the possibility of combining the features introduced in this manner with other optional or non-optional features of the present invention.

[0020] In a first aspect, a diagnostic device for monitoring at least one body tissue of a patient is disclosed. The diagnostic device may be specifically used to monitor body swelling of the body tissue of the patient. The diagnostic device comprises:

[0021] a. At least one bracelet configured to be tied around a body part of the patient, in particular around one or more of the patient's ankle, thigh, calf, wrist, forearm and upper arm;

[0022] b. at least one electromechanical actuator configured to actively change the circumference of the bracelet;

[0023] c. at least one measuring unit configured to determine at least one item of information about the electrical power applied to the electromechanical actuator and at least one item of circumference information about the circumference of the bracelet; and

[0024] d. at least one evaluation unit configured to determine at least one information item about the state of the body tissue from the information item about the electrical power applied to the electromechanical actuator and the circumference information item, in particular wherein the evaluation unit is configured to determine a contact point at which the circumference of the bracelet corresponds to the circumference of the body part.

[0025] As used herein, the term "diagnostic device" is a broad term and is given the ordinary and customary meaning to those of ordinary skill in the art and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, any device or combination of devices capable of determining at least one parameter indicative of a human or animal state, such as at least one physiological or medical parameter.

[0026] Similarly, as used herein, the term "monitoring" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, processes including, such as measuring, recording, and indicating one or more of at least one parameter by electrical means. As an example, the result of monitoring may be or may include at least one information item, such as at least one information item about the electrical power applied to the electromechanical actuator, for example, at least one analog signal and / or at least one digital signal.

[0027] As used herein, the term "bracelet" is a broad term and is given a meaning that is ordinary and customary to a person of ordinary skill in the art and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, any device or combination of devices having at least partially deformable or flexible properties and configured to be tied around at least a portion of a human body. As an example, the bracelet may include a deformable element that can be bent around a body part so as to form at least one loop through which the body part can extend. As an example, the bracelet may be made entirely or partially of a deformable material, such as at least one of the following: a plastic material; a metal material, in particular a metal sheet; a textile material; a paper or cardboard material or any combination thereof.

[0028] As used herein, the term "electromechanical actuator" is a broad term and is given the ordinary and customary meaning to a person of ordinary skill in the art and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, any device or combination of devices that is capable of converting at least one electrical signal or electrical energy into at least one mechanical action, such as into at least one motion, in particular into at least one of linear motion and rotation. Many types of electromechanical actuators are known to those skilled in the art and may also be used in the present invention. In particular, the electromechanical actuator may include at least one electric motor, such as an electric motor selected from the group consisting of: a DC motor; a stepper motor.

[0029] The electric motor may be configured in particular to actively change the circumference of the bracelet, for example by widening or narrowing the loop formed by the bracelet. For this purpose, the electric motor may be configured in particular to move at least one first portion of the bracelet relative to at least one second portion of the bracelet in order to change the circumference of the bracelet. By this, as an example, the loop may be widened or narrowed in a controlled manner by an electromechanical actuator, in particular an electric motor.

[0030] The electromechanical actuator may be completely or partially separate from the bracelet, or alternatively may be completely or partially integrated into or attached to the bracelet. More specifically, the electromechanical actuator may be attached to or in contact with the bracelet in at least two parts of the bracelet. More specifically, the electromechanical actuator may be configured to move a portion of the bracelet relative to another portion of the bracelet in order to narrow and / or widen the loop formed by the bracelet.

[0031] As used herein and as specifically in the context of changing the circumference of the bracelet, the term "actively" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, the characteristics of a process that is controlled, started, and stopped by an external influence. Thus, in contrast to, for example, changing the circumference of the bracelet by internal temperature changes being within the bracelet, the active change of the circumference may include applying an external force and / or using external energy or energy conversion from electrical energy to mechanical energy to change the circumference. Specifically, the process of actively changing the circumference of the bracelet may include controlling the change in the circumference, for example by one or more control signals generated internally or externally, for example by a control unit of the diagnostic device. The control unit may be part of the bracelet, the electromechanical actuator, or may be located externally.

[0032] As used herein, the term "measuring unit" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and should not be limited to a special or custom meaning. The term may specifically refer to, but is not limited to, a device or combination of devices configured to measure at least one characteristic of a system, element or device. As will be further outlined in detail below, the measuring unit may include a single measuring device or multiple measuring devices. The measuring unit may specifically be configured to generate at least one electrical measurement signal, specifically at least one of an analog signal and a digital signal. The measuring unit may be fully or partially embodied as a separate unit, or alternatively, may also be fully or partially integrated into one or more other components of the diagnostic device, such as integrated into at least one of the following items: an electromechanical actuator, a control unit of the diagnostic device, an evaluation unit.

[0033] As used herein, the term "information item about the electric power applied to the electromechanical actuator" is a broad term and is given a common and customary meaning to a person skilled in the art and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, any information item that qualitatively and / or quantitatively measures the electric power applied to the electromechanical actuator, for example, by an external power source and / or by an internal power source (e.g., a battery and / or a battery) integrated into the diagnostic device. The term may further specifically refer to, but is not limited to, any information item that qualitatively and / or quantitatively measures the electric power applied to the electromechanical actuator required to move the electromechanical actuator by a defined distance or angle. By moving the electromechanical actuator by a defined distance or angle, the circumference of the bracelet, in particular the circumference of the ring formed by the bracelet, may be changed (increased or reduced). This change in the circumference of the bracelet (in particular the change in the circumference of the ring formed by the bracelet) may be proportional to the distance or angle by which the electromechanical actuator moves. In particular, the circumference of the bracelet may be reduced from a first circumference to a second circumference. Therefore, the information item about the electric power applied to the electromechanical actuator may include one or more of the current, voltage and electric power.The information item about the electric power applied to the electromechanical actuator may specifically be provided by the measuring unit in an electrical form (such as in the form of an analog electric signal and / or a digital electric signal).

[0034] As used herein, the term "circumference" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, a parameter indicating the length of a loop formed by the bracelet through which a body part of a patient may extend. The circumference may be an inner circumference, particularly an inner circumference of the inner side of the bracelet, which may be configured to contact the body part of the patient when the bracelet is tied around the body part of the patient. Thus, as an example, the diameter of the loop formed by the bracelet may be proportional to the circumference of the loop, and may be determined in particular or by using circumference information. The diameter may be the actual diameter of the ring, or may be related to other parameters (e.g., equivalent diameter) indicating the width of the ring.

[0035] As used herein, the term "circumference information item" or "information item about the circumference of the bracelet" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, any information item that qualitatively and / or quantitatively measures the current circumference, current diameter or equivalent diameter of a bracelet (in particular a ring formed by the bracelet), including the option of providing information about an actual value that allows identification of the circumference and the option of providing information about its time derivative, such as the rate of change of the circumference, diameter or equivalent diameter. The circumference information may include an information item about the inner circumference. This information item may be the inner circumference itself or any value that can be checked to infer the inner circumference. Thus, as an example, the circumference may include information proportional to the actual diameter of the ring, or may also include information about other parameters indicating the width of the ring (e.g., equivalent diameter). As an example, the circumference information item about the circumference of the bracelet may also include information about the absolute position of at least a part of the bracelet, or information about the relative position of two parts of the bracelet relative to each other and / or at least a part of the bracelet relative to a reference point or reference area (e.g. relative to an electromechanical actuator). Specifically, the circumference information item may be provided by the measuring unit in electrical form (e.g. in the form of an analog electrical signal and / or a digital electrical signal, e.g. as a position signal and / or as an angle signal).

[0036] As used herein, the term "evaluation unit" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, any device or combination of devices configured to analyze and / or process data. The evaluation unit may specifically analyze and / or process measurement data, such as measurement results generated by a measurement unit. The evaluation unit may specifically include at least one processor. The processor may specifically be configured to perform one or more evaluation operations on the information item about the electrical power applied to the electromechanical actuator and the circumference information item, for example by software programming.

[0037] Similar to the measuring unit, the evaluation unit can also be implemented as a separate unit or can be fully or partially integrated into one or more other parts of the diagnostic device. Thus, as an example, the evaluation unit can be fully or partially integrated into one or more of the following: an electromechanical actuator, a control unit of the diagnostic device, a measuring unit. However, other options are also feasible.

[0038] As used herein, the term "processor" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, any logic circuit system configured to perform the basic operations of a computer or system; and / or, in general, a device configured to perform calculations or logical operations. In particular, a processor may be configured to process basic instructions that drive a computer or system. As an example, a processor may include at least one arithmetic logic unit (ALU), at least one floating point unit (FPU) (such as a math coprocessor or a numerical coprocessor), a plurality of registers (specifically registers configured to provide operands to the ALU and store operation results) and a memory (such as L1 and L2 cache memories). In particular, the processor may be a multi-core processor. In particular, the processor may be or may include a central processing unit (CPU). Additionally or alternatively, the processor may be or may include a microprocessor, so that, in particular, the elements of the processor may be contained in a single integrated circuit (IC) chip. Additionally or alternatively, the processor may be or may include one or more application specific integrated circuits (ASICs) and / or one or more field programmable gate arrays (FPGAs) and / or one or more tensor processing units (TPUs) and / or one or more chips, such as dedicated machine learning optimized chips, etc. The processor may be specifically configured (such as by software programming) to perform one or more evaluation operations.

[0039] As used herein, the term "information item about the state of body tissue" is a broad term and is given a meaning that is ordinary and customary to a person of ordinary skill in the art and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, any information item that allows qualitative and / or quantitative analysis of the state of body tissue. As an example, the information item about the state of body tissue may be provided by an evaluation unit in the form of at least one electrical signal (such as at least one analog signal and / or at least one digital signal). The information item about the state of body tissue may specifically include at least one information item selected from the group consisting of: a degree of swelling of body tissue, specifically the circumference of body tissue; and an elastic parameter of body tissue, specifically an elastic module of body tissue.

[0040] The information item about the state of the body tissue may include a body part circumference information item of the body part. As an example, the circumference information item of the bracelet at the contact point may be used as the body part circumference information item of the body tissue, or may be used to determine this body part circumference information item. As used herein, the term "contact point" is a broad term and is given a common and customary meaning for a person of ordinary skill in the art, and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, a bracelet attached (particularly fully attached) to a body part in a manner that can determine the circumference of the body part. At the contact point, the circumference of the bracelet (particularly the ring) may correspond to and / or be equal to the circumference of the body part. The contact point may be determined by detecting that the electrical power required to be applied to the actuator begins to rise (e.g., by monitoring the slope of a curve indicating that the electrical power changes with the circumference information); or vice versa.

[0041] By taking into account the contact points, the circumference of the body part can be determined, in particular the absolute value of the circumference of the body part can be determined. The circumference of the body part can be determined in the unstressed state of the body part, in particular when the bracelet does not exert a force on the body part, in particular when the bracelet does not exert any further pressure on the body part in addition to the already applied force caused by the weight of the bracelet.

[0042] In order to determine at least one information item about the state of the body tissue from the information item about the electric power applied to the electromechanical actuator and the circumference information item, the evaluation unit can be configured to use at least one transformation process, in particular at least one programmed transformation algorithm, such as at least one conversion function and / or at least one lookup table. Thereby, as an example, from the electric power required to narrow the circumference of the bracelet against the resistance of the body tissue, the elasticity parameter of the body tissue can be derived, for example, by using an empirical or semi-empirical transformation algorithm. As an example, the diagnostic device can be calibrated, for example, by factory calibration using artificial tissue or prosthesis with known properties (e.g. known elastic properties), and the electric power required to change the circumference of the bracelet against the elasticity of the prosthesis or artificial body tissue can be measured. Thereby, a calibration function or calibration data (such as data for generating a lookup table) can be generated and can be used in subsequent measurements. However, alternatively, the information item about the state of the body tissue can be determined using raw data, such as raw data of the electric power required to change the circumference of the bracelet from a first circumference to a second circumference.

[0043] The diagnostic device may specifically include at least one control unit, which is configured to control at least one measurement routine of the diagnostic device. As used herein, the term "control unit" is a broad term and is given a common and customary meaning to those of ordinary skill in the art, and is not limited to a special or custom meaning. The term may specifically refer to but is not limited to any device or combination of devices configured to control one or more other devices, specifically electrically control one or more other devices by providing one or more control signals (such as electrical control signals). The control unit may include at least one processor. The processor may be specifically configured (such as by software programming) to control one or more measurement routines of the diagnostic device.

[0044] Similar to the measuring unit and the evaluation unit, the control unit can also be implemented as a separate unit or can be fully or partially integrated into one or more other parts of the diagnostic device. Thus, as an example, the control unit can be fully or partially integrated into one or more of the following: an electromechanical actuator, an evaluation unit of the diagnostic device, a measuring unit of the diagnostic device. However, other options are also feasible.

[0045] As used herein, the term "measurement routine" is a broad term and is given a meaning that is ordinary and customary to a person of ordinary skill in the art and should not be limited to a special or customized meaning. The term may specifically refer to, but is not limited to, one or more steps, such as a series of measurement steps, which may be used to obtain at least one information item about the state of body tissue. The one or more steps of the measurement routine may include at least one of the following items: a step of controlling an electromechanical actuator; a measurement step for determining at least one information item about the electrical power applied to the electromechanical actuator; a measurement step for determining at least one circumference information item about the circumference of the bracelet. These steps may also be combined or may also be combined in whole or in part. Examples of measurement routines are given in more detail below.

[0046] Thus, as an example, the measurement routine comprises at least one elasticity measurement step. The elasticity measurement step may specifically comprise the following steps, which may be performed sequentially, specifically in a given order, but which may also be performed in a temporally overlapping manner or in parallel, and wherein one or more of the following steps may also be performed once or repeatedly:

[0047] - adjusting the circumference of the bracelet to at least a first circumference,

[0048] - By using an electromechanical actuator, the circumference of the bracelet is changed from a first circumference to at least one second circumference, in particular to at least one second circumference smaller than the first circumference, wherein at least at the beginning and at the end of this circumference change process, and in particular also during this circumference change process, information items about the electric power applied to the electromechanical actuator and circumference information items are recorded.

[0049] In particular, from recording information about the electrical power applied to the electromechanical actuator as a function of circumference information, valuable information about elasticity can be derived.

[0050] As used herein, the term "elasticity" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art and is not limited to a special or custom meaning. The term may specifically refer to, but is not limited to, the deformability of an object and / or the ability of an object to resist distorting influences or forces. After the distorting influence is removed, the object may be fully or partially restored to its original size and shape. Thus, in particular, at least one elastic information item may be derived, which defines or at least characterizes the elasticity of the object as varying with the applied force. The object may be a body. Therein, as an example, one or more elastic modules known to those skilled in the art may be used. However, additionally or alternatively, other types of elastic information may also be applied in the context of the present invention.

[0051] Therefore, in particular, the information item about the state of the body tissue determined by the evaluation unit from the information item about the electric power applied to the electromechanical actuator and the perimeter information item may include at least one elastic information item about the body tissue. The evaluation unit may be specifically configured to derive the elastic information item from the information item about the electric power applied to the electromechanical actuator and the perimeter information item recorded during the elasticity measurement step. Therefore, as an example, the elastic information item can be derived from one or more of the following items: the quotient of the change of the electric power and the perimeter of the bracelet within a predetermined or determinable measurement range; and the quotient of the change of the electric power and the perimeter of the bracelet within a predetermined or determinable measurement range; the slope of the curve indicating the change of the electric power with the perimeter of the bracelet or the variable corresponding thereto; the slope of the curve indicating the change of the perimeter of the bracelet or the variable corresponding thereto with the electric power or the variable corresponding thereto. However, it should be noted that other types of transformations or other ways of deriving elastic information from the elasticity measurement step are feasible. In order to determine at least one elastic information item, the evaluation unit may use at least one transformation, such as at least one transformation function and / or at least one lookup table. Again, as an example, the transformation can be determined by one or more calibration measurements (e.g., by performing calibration measurements on one or more prostheses and / or on one or more prostheses with known elastic properties), whereby, as an example, a calibration curve or multiple calibration points for generating a lookup table is derived, the calibration curve or multiple calibration points indicating how the elasticity information item varies with the information item about the electrical power applied to the electromechanical actuator and the circumference information item recorded during the elasticity measurement step.

[0052] Thus, as outlined above, the evaluation unit may specifically be configured for deriving the elastic information item from at least one of the following: the slope of a measurement curve indicating the electrical power applied to the electromechanical actuator and the circumference of the bracelet; the slope of a measurement curve indicating the circumference of the bracelet and the electrical power applied to the electromechanical actuator; at least two measurement points, each indicating the circumference of the bracelet and the electrical power applied to the electromechanical actuator. However, other ways of deriving the elastic information item may additionally or alternatively be used.

[0053] In addition to or as an alternative to at least one elasticity measurement step, the above measurement routine may further include at least one body part circumference measurement step. The body part circumference measurement step may specifically include the following steps, which may be performed once or repeatedly:

[0054] - Reducing the circumference of the bracelet by using an electromechanical actuator, wherein an item of information about the electric power applied to the electromechanical actuator and an item of circumference information are recorded.

[0055] As used herein, the term "body part circumference" is a broad term and is given a common and customary meaning to a person of ordinary skill in the art, and is not limited to a special or customized meaning. The term may specifically refer to, but is not limited to, a closed length of the shape and / or size of the body part to which the bracelet is tied, in particular a closed outer length. Specifically, the body part circumference may be quantified by at least one body part circumference information item. The at least one body part circumference information item may provide any quantification of one or both of the size and shape of the body part. As an example, a body part circumference information item may provide information about the circumference of a body part, or may thereby relate to the circumference, diameter and / or equivalent diameter of a body part.

[0056] Thus, in general, the information item about the state of the body tissue may include at least one body part circumference information item about the body tissue, for example in addition to or as an alternative to at least one elastic information item. The evaluation unit may be configured to derive the body part circumference information item from the information item about the electric power applied to the electromechanical actuator and the circumference information item recorded during the body part circumference measurement step. Again, in order to determine at least one body part circumference information item, at least one transformation may be used, such as at least one empirical or semi-empirical transformation determined by one or more calibration measurements. Additionally or alternatively, an analytical solution may be used. Thus, as an example, the evaluation unit may be configured to determine the body part circumference information item about the body tissue from at least one of the following items: the slope of a measurement curve indicating the electric power applied to the electromechanical actuator and the circumference of the bracelet; the slope of a measurement curve indicating the circumference of the bracelet and the electric power applied to the electromechanical actuator; at least two measurement points, each measuring point indicating the circumference of the bracelet and the electric power applied to the electromechanical actuator. As an example, the control unit can be configured to control the electromechanical actuator to reduce the circumference of the bracelet (e.g., gradually or in a stepwise manner). When the bracelet is loosely wrapped around the body part, initially, the electrical power required to be applied to the electromechanical actuator for the reduction of this circumference is relatively low and substantially constant. However, once the circumference of the bracelet matches the circumference of the body part, the body part begins to apply a reaction force and / or begins to resist the twisting influence of the bracelet. Therefore, the electrical power required to be applied to the electromechanical actuator to further reduce the circumference begins to increase. As an example, by monitoring the start of this rise, for example, by monitoring the slope of a curve indicating the change of electrical power with circumference information, a contact point can be determined, and the circumference of the bracelet corresponds to the circumference of the body part at this contact point. As an example, the circumference information item of the bracelet at this contact point can be used as a body part circumference information item about body tissue, or can be used to determine this body part circumference information item. Thus, in general, the at least one body part circumference information item may include at least one information item indicating the circumference of the body part in a rest state, in which the bracelet does not apply any force to the body tissue. The circumference may be proportional to the equivalent diameter of the body part in a rest state, in which the bracelet does not apply any force to the body tissue. The absolute value of the circumference of the body part may be determined.

[0057] At least one elasticity measurement step and at least one body part circumference measurement step may also be combined, for example in one measurement routine and the same measurement routine. Thus, as an example, the control unit may be configured to reduce the circumference of the bracelet by providing a corresponding control signal to the electromechanical actuator. Firstly, from the aforementioned increase in the electric power that needs to be applied to the actuator when the bracelet, which is initially loosely wrapped around the body part, comes into contact with body tissue, at least one body part circumference information item may be derived by the evaluation unit. When the circumference is further reduced, at least one elasticity information item may be derived from the increase in the electric power that needs to be applied to the actuator when the elasticity of the circumference of the bracelet with respect to the body tissue is further reduced (e.g. from the slope of a curve of the electric power varying with the circumference of the bracelet).

[0058] Additionally or alternatively, the absolute value of the circumference of the bracelet can be determined during the body part circumference measurement step. Thereby, the absolute value of the current circumference of the corresponding body part around which the bracelet can be wrapped or tied can be determined. As used herein, the term "length of the bracelet" is a broad term and will be given a common and customary meaning for ordinary technicians in the field, and is not limited to a special or customized meaning. The term can specifically refer to but is not limited to the length of the band used to form the bracelet, especially the ring of the bracelet. The ring can be formed by inserting the free end of the band into the electromechanical actuator so that the free end or the scattered end protrudes from the electromechanical actuator. As used herein, the term "length of the scattered end" is a broad term and will be given a common and customary meaning for ordinary technicians in the field, and is not limited to a special or customized meaning. The term can specifically refer to but is not limited to the length of the free end of the band or the bracelet used to form the bracelet. In particular, the free end or the scattered end may not form the ring of the bracelet. As an example, the free end or the scattered end may protrude from the ring of the bracelet. Thereby, the free end or the flared end can protrude from the electromechanical actuator, in particular when forming a loop of the bracelet by inserting the free end of the strap into the electromechanical actuator.

[0059] The absolute value of the circumference of the wristband, in particular the loop formed by the wristband, can be determined by at least one of the following: taking into account the absolute length of the wristband and the absolute length of the loose ends of the wristband; in particular where the absolute length of the wristband is known and the absolute length of the loose ends can be determined by using a length sensor, more particularly where the length sensor can be an electromechanical actuator; or taking into account at least one position mark on the wristband. In the case where the absolute value of the circumference of the wristband, in particular the loop formed by the wristband, can be determined taking into account the absolute length of the wristband and the absolute length of the loose ends of the wristband, the absolute value of the circumference can be determined by subtracting the absolute length of the loose ends from the absolute length of the wristband. Additionally, a known absolute offset length value can be further taken into account.

[0060] The absolute length of the bracelet can be predetermined and thereby known to the evaluation unit, in particular when the absolute length of the bracelet can be fixed. The length of the loose end may vary, in particular when the bracelet is tied around the body part to form a loop. Before the body part circumference measurement can be performed, the bracelet can be in an initial configuration, wherein the circumference on the loop of the bracelet can have an initial absolute value and the length of the free end can have an initial absolute value. The absolute length of the loose end can be determined by using a length sensor, in particular the absolute length of the loose end in the initial configuration can be determined. As described, the sensor can be the electromechanical actuator itself. Alternatively, the length sensor can be a device different from the electromechanical actuator. As an example, a length sensor, in particular an electromechanical actuator, can be used to determine the number of teeth of a rack inserted into the electromechanical actuator, in particular to form a loop of the bracelet by the patient. In addition, the number of teeth can be determined, which involves actively changing the circumference of the bracelet by the electromechanical actuator. Alternatively or additionally, the absolute value of the circumference can be determined by taking into account at least one or more position marks on the bracelet. In order to take into account at least one position mark, a length sensor can be used. Alternatively or additionally, the patient and / or another person may be asked to indicate at least one value associated with the position marker currently under consideration.

[0061] As outlined above, as an example, the electromechanical actuator may specifically include at least one electric motor. In general, as an example, the electromechanical actuator may specifically be configured for performing a rotational movement, for example for narrowing or widening a loop formed by the bracelet. As an example, the bracelet may include at least one toothed belt or strip configured for interacting with the electromechanical actuator. The diagnostic device may include at least one pinion driven by the electromechanical actuator, the pinion being configured for interacting with the toothed belt or strip. Thereby, as an example, the circumference of the bracelet can be reduced by rotating the electromechanical actuator in one direction, and the circumference of the bracelet can be increased by rotating the electromechanical actuator in the opposite direction.

[0062] As outlined above, the diagnostic device comprises at least one measuring unit. The measuring unit comprises at least one electric measuring device configured to determine at least one information item about the electric power applied to the electromechanical actuator, and at least one position measuring device configured to determine at least one circumference information item about the circumference of the bracelet (in particular the ring formed by the bracelet). As an example, the electric measuring device may include at least one of a voltage measuring device and a current measuring device. Thereby, the electric power applied to the electromechanical actuator can be measured. As outlined above, the measuring unit can also be fully or partially combined with at least one optional control unit (for example by being fully or partially integrated therein), thereby directly obtaining the electric power applied to the electromechanical actuator. However, other ways of determining the electric power are also feasible.

[0063] The position measuring device can be specifically configured to determine at least one of the following: the absolute position of at least one part of the bracelet; the relative position of at least one first part of the bracelet relative to at least one second part of the bracelet; the change of at least one part of the bracelet over time; the change of the relative position of at least one first part of the bracelet relative to at least one second part of the bracelet. For this purpose, various types of position measuring devices can be used alone or in combination. As an example, when using the above-mentioned rotary electromechanical actuator and / or pinion and / or toothed belt or strip, the linear position and / or rotational position can be measured, in particular the linear position and / or rotational position of one part of the bracelet relative to another part. As an example, in general, the electromechanical actuator can be fixed to a part of the bracelet, preferably to a first position of the bracelet, and can be configured to move another part of the bracelet relative to the first part. By measuring the relative position of the first part and the second part, a position measurement can be performed, allowing information about the circumference of the bracelet (in particular the ring formed by the bracelet) to be derived. As an example, the position measuring device can include at least one rotation state that can measure the electromechanical actuator and / or at least one pinion. In the case where the electromechanical actuator comprises at least one stepper motor, the circumference information item can be derived directly or indirectly from at least one signal provided by the stepper motor. Additionally or alternatively, at least one sensor for detecting the rotational state of the motor and / or the pinion can be used, such as a magnetic sensor and / or an optical sensor. Additionally or alternatively, at least one linear position sensor can be used in order to determine, as an example, the position of another part of the bracelet relative to the electromechanical actuator and / or the first part. Again, as an example, an optical sensor can be used. As the skilled person will appreciate, various types of other sensors are feasible.

[0064] In another aspect of the present invention, a method for monitoring at least one body tissue of a patient is disclosed. The method comprises the following steps. These steps can be performed in a given order in particular. However, different orders are also feasible. In addition, two or more method steps can be performed in a temporally overlapping manner or in parallel. In addition, one or more or even all method steps can be performed repeatedly.

[0065] The method comprises the following steps:

[0066] i. at least one diagnostic device according to the invention, for example according to any of the embodiments described above and / or according to any of the embodiments described in further detail below;

[0067] ii. Place the bracelet around the patient's body part;

[0068] iii. actively changing the circumference of the bracelet by using an electromechanical actuator;

[0069] iv. determining, by using the measuring unit, at least one item of information about the electrical power applied to the electromechanical actuator and at least one item of circumference information about the circumference of the bracelet; and

[0070] v. determining, by using at least one evaluation unit, at least one information item about the state of the body tissue from the information item about the electrical power applied to the electromechanical actuator and the circumference information item, in particular and by using at least one evaluation unit determining the contact point at which the circumference of the bracelet corresponds to the circumference of the body part.

[0071] As outlined above, one or more or even all method steps may be performed repeatedly. Thus, as an example, at least method steps iii. to v. may be performed repeatedly (e.g. by forming a routine), wherein, as an example, these method steps are repeated at regular or irregular time intervals and / or whenever triggered by a user or patient. As an example, the measurement routine may be controlled by a control unit.

[0072] The method may also be fully or partially computer-implemented and / or computer-controlled. Thus, as an example, at least step v. is computer-implemented, for example by a corresponding computer program running on an evaluation unit, for example a processor of the evaluation unit. Furthermore, as outlined above, one or more measurement routines may be controlled by at least one control unit. Thus, additionally or alternatively, as an example, steps iii. and / or iv. may be fully or partially computer-controlled, for example by a computer program running on a control unit, for example a processor of the control unit.

[0073] Therefore, in a further aspect, a computer program is disclosed, comprising instructions which, when executed by an evaluation unit of a diagnostic device according to the present invention, for example according to any of the embodiments described above and / or according to any of the embodiments described in further detail below, cause the evaluation unit to perform step v. of the method according to the present invention (for example according to any of the embodiments described above and / or according to any of the embodiments described in further detail below).

[0074] Similarly, in another aspect, a computer-readable storage medium is disclosed, specifically a non-volatile computer-readable storage medium, which includes instructions, which, when executed by an evaluation unit of a diagnostic device according to the present invention, for example, according to any one of the embodiments described above and / or according to any one of the embodiments described in further detail below, cause the evaluation unit to perform step v. of the method according to the present invention (for example, according to any one of the embodiments described above and / or according to any one of the embodiments described in further detail below).

[0075] The present invention according to any of the embodiments described above or according to any of the embodiments described in further detail below provides a number of advantages over known means and methods, in particular over the known methods and devices described above. Thus, in particular, the diagnostic device and method can provide sensing means and methods to quantify at least the swelling of the patient's ankle and / or wrist by means of a bracelet, which can be designed as a band, such as a wristband and / or ankle band, as an example. Thereby, as an example, the circumference of the ankle and / or wrist and / or the elasticity of the body tissue at the ankle and / or wrist can be determined.

[0076] The diagnostic device advantageously provides a simple, durable and cost-effective arrangement, in particular without requiring an additional sensor for measuring the tension generated in the band. Typically, such an additional sensor may be a gauge sensor or a load cell with a short durability. According to the invention, the information required for determining the information item about the state of the body tissue is derived from parameters associated with the electromechanical actuator. Thereby, since no additional sensors associated with measurement errors are required, the accuracy of the measurement is significantly increased and parameters of the electromechanical actuator, such as the electrical power applied to the electromechanical actuator, can typically be determined in a highly precise and accurate manner. Furthermore, since the electromechanical actuator consists of a fastener designed to form a loop of the bracelet, the diagnostic device is particularly compact.

[0077] The results provided by the diagnostic device and / or method as proposed herein may in particular be combined with further sensor signals, parameters or vital signs of the patient (like skin impedance etc.). The at least one further sensor signal may be selected from the group consisting of: temperature signal, electrocardiogram (ECG) signal, pulse signal, oxygen partial pressure (pO 2 ) signals, motion signals (especially generated by accelerometers), breathing signals, pulmonary artery (PA) pressure signals, weight signals. Thereby, a combination of various sensor signals, parameters or vital signs of the patient can be used for diagnosis. Evaluation routines such as self-learning models can be applied to the data provided by the diagnostic device and optionally other devices in order to predict the risk of a patient suffering from heart failure and other diseases.

[0078] Specifically, the diagnostic device can be designed as a wearable device that can be worn by the patient at home and / or in a hospital care environment. The option of quantitative ankle swelling and / or wrist swelling may help improve the monitoring of certain disease exacerbations. Therefore, as an example, the quantification of ankle swelling and / or wrist swelling may help detect congestion in the patient's home, in a hospital environment or in other environments at an early stage. Additionally or alternatively, quantification can be conducive to monitoring the improvement of treatment, such as medical treatment, for example, by associating quantification with treatment and / or monitoring the improvement of treatment by determining trends. In addition, quantification can help health care professionals make decisions, such as making decisions about patient discharge.

[0079] The diagnostic device as proposed herein can be designed in a robust and simple manner. Therefore, the diagnostic device can be designed in whole or in part as a bracelet that can be worn by the patient on the ankle and / or wrist. A mechanically robust design can be selected, for example, by designing the bracelet to be composed of a linear, thin and flexible material, the bracelet containing a functional component at one end thereof, the functional component containing an electromechanical actuator, such as a motor, wherein the other end of the bracelet can be moved along and / or through the electromechanical actuator, thereby increasing and / or reducing the circumference of the ring formed by the bracelet. When the electromechanical actuator, such as a motor, is actuated, for example, when rotating, the circumference of the bracelet is changed, and therefore the diameter and / or equivalent diameter of the bracelet is also changed. Alternatively, the diagnostic device can be designed in whole or in part as or integrated into a wearable device, like a glove, sock or belt that can be worn by the patient.

[0080] As an example, the diagnostic device can be configured to read at least the rotation of an electromechanical actuator (e.g. a motor) to provide a first coordinate or measurement variable, which can be part of at least one circumference information item and / or at least one circumference information item can be derived from the first coordinate or measurement variable. As an example, this circumference information item can simply be the distance x that the electromechanical actuator moves the bracelet, for example by reducing or increasing the circumference of the bracelet by the distance x. In addition, the diagnostic device can be configured to read the electrical power applied to the electromechanical actuator, for example the electrical power applied to the motor. This information item can provide a second coordinate or measurement variable, which can form an information item about the electrical power applied to the electromechanical actuator and / or an information item about the electrical power applied to the electromechanical actuator can be derived from the second coordinate or measurement variable.

[0081] When the bracelet is worn on an ankle, wrist or other body part, the measurement of circumference and elasticity can be performed at predetermined, determinable or even irregular time intervals, such as every 5, 10, 15 minutes, every hour, etc. Thus, in general, as outlined above, the method or parts thereof (such as the measurement routine comprising steps iii. and iv. and optionally step v.) can also be repeated completely or partially.

[0082] As outlined above, the method may include one or more measurement routines. As an example, a typical measurement routine may include the following steps to be performed when the bracelet is worn and loosely wrapped around a body part. As an example, the bracelet may be worn so that its circumference is large enough to add a finger between the bracelet and the body part. This may refer to an initial configuration, in which the circumference on the ring of the bracelet may have an initial absolute value and the length of the free end may have an initial absolute value. The measurement routine may be controlled by a control device. The measurement routine may include a routine start, in which the electromechanical actuator is actuated, for example, by rotating the motor in a known predetermined direction to reduce the circumference of the bracelet. During this step, at least one information item and at least one circumference information item about the electrical power applied to the electromechanical actuator are determined, such as by measuring the electrical power and the rotation and / or distance of the movement. The movement may be stopped at a predetermined point in time and / or under predetermined conditions, for example when a defined amount of electrical power applied to the electromechanical actuator is reached and / or after a predetermined distance. The routine may be controlled to comply with one or more predetermined safety conditions, such as a safety limit on the amount of power applied to the electromechanical actuator and / or a safety limit on the minimum circumference of the bracelet. The electromechanical actuator may then be controlled to move in the opposite direction, thereby increasing the circumference of the bracelet, for example by increasing the circumference of the bracelet by appropriate rotation to the opposite direction, for example in order to restore the original configuration, state or position of the electromechanical actuator and / or the bracelet. This routine or sequence of actions may be repeated. By evaluating at least one information item about the electrical power applied to the electromechanical actuator and at least one circumference information item, at least one information item about the state of the body tissue may be derived, for example, at least one elasticity information item may be derived and / or at least one body part circumference information item of a body part, such as the circumference of an ankle and / or wrist and / or the elasticity of an ankle and / or wrist.

[0083] To summarize and without excluding other possible embodiments, the following embodiments may be envisaged:

[0084] Embodiment 1: A diagnostic device for monitoring at least one body tissue of a patient, specifically for monitoring body swelling of the body tissue of the patient, the diagnostic device comprising:

[0085] a. At least one bracelet configured to be tied around a body part of the patient, in particular around one or more of the patient's ankle, thigh, calf, wrist, forearm and upper arm;

[0086] b. at least one electromechanical actuator configured to actively change the circumference of the bracelet;

[0087] c. at least one measuring unit configured to determine at least one item of information about the electrical power applied to the electromechanical actuator and at least one item of circumference information about the circumference of the bracelet; and

[0088] d. At least one evaluation unit configured for determining at least one information item about the state of the body tissue from the information item about the electrical power applied to the electromechanical actuator and the circumference information item.

[0089] Embodiment 2: The diagnostic device according to the preceding embodiment, wherein the evaluation unit is configured to determine a contact point at which the circumference of the bracelet corresponds to the circumference of the body part.

[0090] Embodiment 3: A diagnostic device according to any one of the preceding embodiments, wherein the electromechanical actuator comprises at least one electric motor.

[0091] Embodiment 4: The diagnostic device according to the preceding embodiment, wherein the electric motor is selected from the group consisting of: a DC motor; a stepper motor.

[0092] Embodiment 5: The diagnostic device according to any one of the two preceding embodiments, wherein the electric motor is configured to move at least one first portion of the bracelet relative to at least one second portion of the bracelet so as to change the circumference of the bracelet.

[0093] Embodiment 6: The diagnostic device according to any of the preceding embodiments, wherein the diagnostic device comprises at least one control unit configured to control at least one measuring routine of the diagnostic device.

[0094] Embodiment 7: The diagnostic device according to the preceding embodiment, wherein the measurement routine comprises at least one elasticity measurement step, the elasticity measurement step comprising:

[0095] - adjusting the circumference of the bracelet to at least a first circumference,

[0096] - changing the circumference of the bracelet from the first circumference to at least one second circumference, in particular to at least one second circumference smaller than the first circumference, wherein the item of information about the electrical power applied to the electromechanical actuator and the item of circumference information are recorded.

[0097] Embodiment 8: A diagnostic device according to the preceding embodiments, wherein the information items about the state of the body tissue include at least one elastic information item about the body tissue, wherein the evaluation unit is configured to derive the elastic information item from the information items about the electric power applied to the electromechanical actuator and the circumference information items recorded during the elasticity measurement step.

[0098] Embodiment 9: A diagnostic device according to the aforementioned embodiments, wherein the evaluation unit is configured to derive the elastic information item from at least one of the following items: a slope of a measurement curve indicating the electric power applied to the electromechanical actuator and the circumference of the bracelet; a slope of a measurement curve indicating the circumference of the bracelet and the electric power applied to the electromechanical actuator; at least two measurement points, each measurement point indicating the circumference of the bracelet and the electric power applied to the electromechanical actuator.

[0099] Embodiment 10: The diagnostic device according to any one of the four preceding embodiments, wherein the measurement routine comprises at least one body part circumference measurement step, the body part circumference measurement step comprising:

[0100] - reducing the circumference of the bracelet, wherein the item of information about the electrical power applied to the electromechanical actuator and the item of circumference information are recorded.

[0101] Embodiment 11: A diagnostic device according to the aforementioned embodiments, wherein the information item about the state of the body tissue includes at least one body part circumference information item about the body tissue, wherein the evaluation unit is configured to derive the body part circumference information item from the information item about the electric power applied to the electromechanical actuator and the circumference information item recorded during the body part circumference measurement step.

[0102] Embodiment 12: The diagnostic device according to the preceding embodiments, wherein the body part circumference information item about the body tissue comprises a value related to the absolute circumference of the body part around which the bracelet is to be tied.

[0103] Embodiment 13: A diagnostic device according to any one of the two preceding embodiments, wherein the evaluation unit is configured to determine an information item about the circumference of the body part of the body tissue from at least one of the following items: a slope of a measurement curve indicating the electric power applied to the electromechanical actuator and the circumference of the bracelet; a slope of a measurement curve indicating the circumference of the bracelet and the electric power applied to the electromechanical actuator; at least two measurement points, each measurement point indicating the circumference of the bracelet and the electric power applied to the electromechanical actuator.

[0104] Embodiment 14: A diagnostic device according to any one of the four preceding embodiments, wherein the absolute value of the circumference of the bracelet is determined during the step of measuring the circumference of the body part, in particular for determining the absolute circumference of the body part around which the bracelet is to be tied.

[0105] Embodiment 15: According to the diagnostic device described in the above embodiment, the absolute value of the circumference of the bracelet is determined by at least one of the following items:

[0106] - taking into account the absolute length of the bracelet and the absolute length of the loose end of the bracelet; in particular wherein the absolute length of the entire bracelet is known, and determining the absolute length of the loose end by using a length sensor, more particularly wherein the length sensor is the electromechanical actuator; or

[0107] - Consider at least one location marker on the bracelet.

[0108] Embodiment 16: The diagnostic device according to any one of the preceding embodiments, wherein the bracelet comprises at least one toothed belt configured to interact with the electromechanical actuator.

[0109] Embodiment 17: The diagnostic device according to the preceding embodiment, wherein the diagnostic device comprises at least one pinion driven by the electromechanical actuator, the pinion being configured for interacting with the toothed belt or strip.

[0110] Embodiment 18: A diagnostic device according to any of the preceding embodiments, wherein the at least one measuring unit comprises at least one electric measuring device configured to determine at least one information item about the electric power applied to the electromechanical actuator, and at least one position measuring device configured to determine at least one circumference information item about the circumference of the bracelet.

[0111] Embodiment 19: The diagnostic device according to the preceding embodiment, wherein the electrical measuring device comprises at least one of a voltage measuring device and a current measuring device.

[0112] Embodiment 20: A diagnostic device according to any one of the two aforementioned embodiments, wherein the position measurement device is configured to determine at least one of the following items: the absolute position of at least a portion of the bracelet; the relative position of at least a first portion of the bracelet relative to at least a second portion of the bracelet; the change in the absolute position of at least a portion of the bracelet over time; or the change in the relative position of at least a first portion of the bracelet relative to at least a second portion of the bracelet.

[0113] Embodiment 21: A method of monitoring at least one body tissue of a patient, the method comprising:

[0114] i. providing at least one diagnostic device according to any one of the preceding embodiments;

[0115] ii. Place the bracelet around the patient's body part;

[0116] iii. actively changing the circumference of the bracelet by using an electromechanical actuator;

[0117] iv. determining, by using the measuring unit, at least one item of information about the electrical power applied to the electromechanical actuator and at least one item of circumference information about the circumference of the bracelet; and

[0118] v. determining at least one item of information about the state of the body tissue from the item of information about the electric power applied to the electromechanical actuator and the item of circumference information by using the at least one evaluation unit.

[0119] Embodiment 22: The method according to the preceding embodiment, wherein step v. further comprises determining a contact point by using the at least one evaluation unit, at which contact point the circumference of the bracelet corresponds to the circumference of the body part.

[0120] Embodiment 23: The method according to any of the two preceding embodiments, wherein at least step v. is computer-implemented.

[0121] Embodiment 24: A computer program comprising instructions, when the program is executed by an evaluation unit of a diagnostic device according to any one of the preceding embodiments relating to the diagnostic device, the program causes the evaluation unit to perform step v. of the method according to any one of the preceding embodiments relating to the method.

[0122] Embodiment 25: A computer-readable storage medium, specifically a non-volatile computer-readable storage medium, comprising instructions which, when executed by an evaluation unit of a diagnostic device according to any one of the aforementioned embodiments relating to the diagnostic device, cause the evaluation unit to perform step v. of the method according to any one of the aforementioned embodiments relating to the method. BRIEF DESCRIPTION OF THE DRAWINGS

[0123] Other optional features and embodiments will be disclosed in more detail in the subsequent description of embodiments, preferably in conjunction with the dependent claims. Wherein, as will be appreciated by those skilled in the art, each optional feature can be implemented in a separate manner and in any arbitrarily feasible combination. The scope of the present invention is not limited by the preferred embodiments. Embodiments are schematically depicted in the accompanying drawings. Wherein, the same reference numerals in these drawings refer to the same or functionally equivalent elements.

[0124] In the attached picture:

[0125] Figure 1 An embodiment of the diagnostic device is shown in a cross-sectional view with the wristband in an open state;

[0126] Figure 2 Shows that the bracelet is closed Figure 1 diagnostic devices;

[0127] Figure 3 Shows Figure 2The interaction of the pinion and electromechanical actuator of the diagnostic device with the toothed belt of the bracelet;

[0128] Figure 4A and Figure 4B Shows the state of the bracelet when it is wrapped around the patient's body, including constriction Figure 2 a measurement routine for the circumference of the wristband; and

[0129] Figure 5 It is shown that from Figure 4A and 4B The measurement routine shown in is used to determine at least one item of information about the state of body tissue. DETAILED DESCRIPTION

[0130] exist Figure 1 and 2 , an embodiment of a diagnostic device 110 for monitoring at least one body tissue of a patient is shown in cross-sectional views in different configurations. In the illustrated embodiment, the diagnostic device 110 includes a bracelet 112 configured to be strapped around a body part of the patient. Figure 1 In FIG. 1 , the bracelet 112 is shown in an open configuration, and in FIG. Figure 2 , the bracelet 112 is shown in a closed configuration.

[0131] The diagnostic device 110 further includes at least one electromechanical actuator 114. In the embodiment shown, the electromechanical actuator 114 may specifically include an electric motor 116. As also shown in the embodiment, the diagnostic device 110 may further include at least one pinion 118 coupled to the electromechanical actuator 114. The pinion 118 may form a gear that interacts with the bracelet 112. As an example, the pinion 118 may interact with a toothed belt 120 coupled to the bracelet 112 and / or integrated into the bracelet 112, wherein the toothed belt 120 may extend along the entire length of the bracelet 112 or along a portion of the length of the bracelet 112.

[0132] The electromechanical actuator 114 can be coupled to or fixed to the first portion 122 of the bracelet 112, such as the end portion. Figure 1 and Figure 2 It can be observed that, in the closed configuration, the bracelet 112 can form a ring with a diameter D, which, in the case of a circular ring, corresponds to the circumference of the ring divided by π. In the case of a non-circular ring, the diameter D can be determined as an equivalent diameter, i.e. the diameter of a circle having the same cross-sectional area as the non-circular ring. The diameter D of the ring can be proportional to the circumference of the ring.

[0133] If you can further Figure 2As observed in , the bracelet 110 may include a fastener 113 designed to form a loop of the bracelet 110, wherein the electromechanical actuator 114 is or includes the fastener 113. The fastener 113 may refer to a unit, in particular a unit separate from the band used to form the bracelet 113, which connects the ends of the band together to form a loop. The fastener 113 may be open and / or closed. The fastener 113 may be a clasp and / or a closure, in particular a clasp and / or a closure required to form a loop of the bracelet 110. The electromechanical actuator 114 may interact with the bracelet 112 in such a way that the second part 124 of the bracelet 112 moves relative to the first part 122. This is in Figure 3 , which shows an enlarged view of the electromechanical actuator 114 and the interaction of the pinion 118 with the toothed belt 120 of the bracelet 112. By rotating the pinion 118, for example Figure 3 In the clockwise direction, the second portion 124 of the bracelet 112 is moved, for example, to Figure 3 This allows you to change Figure 2 The circumference and diameter D of the ring in. As an example, in combination Figure 2 Settings Figure 3 In the direction of movement shown, the diameter D increases and thereby the circumference also increases. By reversing the direction of movement of the pinion 118 to the counterclockwise direction, the diameter D can be reduced and thereby the circumference can also be reduced.

[0134] With regard to monitoring the patient's body tissue and with regard to generating at least one item of information about the state of the body tissue, the diagnostics device 110 comprises further elements, which are Figure 1 and Figure 2. Thus, firstly, the diagnostic device 110 comprises at least one measuring unit 126, which is configured to determine at least one information item about the electric power applied to the electromechanical actuator 114 and at least one circumference information item about the circumference of the bracelet. In addition, the diagnostic device 110 comprises at least one evaluation unit 128, which is configured to determine at least one information item about the state of the body tissue from the information item about the electric power applied to the electromechanical actuator and the circumference information item. In addition, optionally, the diagnostic device 110 may include at least one control unit 130, which is configured to control the diagnostic device 110, for example, configured to control at least one measurement routine of the diagnostic device 110. Although depicted as single and separate components in the figures, the units 126, 128 and 130 may each also be fully or partially integrated into one or more other components, such as into the electromechanical actuator 114 and / or into each other. The units 126 , 128 and 130 may be separate from the bracelet 112 , may be connected to the electromechanical actuator 114 in a wireless or wired combination manner, or alternatively, may be fully or partially integrated into the bracelet 112 and / or the electromechanical actuator 114 .

[0135] As an example, the measuring unit 126 can be fully or partially coupled to an electrical energy supply or power supply of the electromechanical actuator 114, which can be an internal and / or external power supply. Furthermore, the measuring unit 126 can derive at least one circumference information item from the relative position of the first part 122 and the second part 124 and / or from the state of the electromechanical actuator 114, for example from the rotational position of the pinion 118. Various concepts are feasible and can be implemented in the present invention.

[0136] exist Figure 4A and Figure 4B In the figure, a diagnostic device 110 is shown, wherein a bracelet 112 is wrapped around a body part 132 of a patient, the body part 132 having body tissue 134. The sequence of these figures may also provide a measurement routine and / or may be part of a measurement routine, for example controlled by a control unit 130. Thus, first, Figure 4A The wristband 112 in the embodiment is loosely wrapped around a body part 132 (e.g., the patient's ankle and / or wrist). The open end 136 of the wristband 112 protruding from the electromechanical actuator 114 can have a length d 1 . Thereby, the absolute circumference of the loop formed by the bracelet 112 can be determined by taking into account the absolute length of the bracelet 112 and the absolute length of the flared end 136. To this end, the absolute length d of the entire bracelet 112 (in particular the strap of the bracelet 112) can be predetermined or known. In addition, the length d of the flared end 136 lThe length sensor may be predetermined, known, or determined by using a length sensor. The length sensor may be an electromechanical actuator 114. The loop of the wristband 112 may have an initial circumference, particularly an initial circumference when the wristband 112 is just applied to the patient's body part 132. As an example, the electromechanical actuator 114 may count the number of teeth of the toothed belt 120 inserted into the electromechanical actuator 114 during the application of the wristband 112 to the patient's body part 132 to determine the initial absolute length d of the loose end 136. l The absolute length of the initial circumference can be determined by taking into account (particularly subtracting) the initial absolute length d of the divergent end 136 from the known absolute length d of the entire bracelet 112. l Alternatively, the position marks on the bracelet 112 can be used to determine the absolute circumference of the bracelet 112, in particular the absolute circumference of the ring of the bracelet.

[0137] By moving the electromechanical actuator 114, for example by rotating the motor 116, the diameter D of the bracelet changes from Figure 4A D 1 Change to Figure 4B D 2 Thus, the length of the diverging end 136 is increased from Figure 4A The length d 1 Increase to Figure 4B The length d 1 +d 2 As an example, in the case of a ring, the diameter changes from Figure 4A D 1 =(dd 1 ) / π (where d is the length of the entire bracelet 112) is reduced to Figure 4B D 2 =(dd 1 -d 2 ) / π.

[0138] This measurement routine may be used to derive one or more items of information about the state of body tissue 134. An example is shown in Figure 5 , which shows a graph of the electric power p applied to the electromechanical actuator 114 on the vertical axis as a function of the position (denoted by x) of the first portion 122 relative to the second portion 124. In principle, any type of information can be used to provide circumference information, including the position of the pinion 118, a longitudinal coordinate along the bracelet 112, etc.

[0139] If you can Figure 5 As observed in , when the electromechanical actuator 114 is actuated, a low power p must first be applied 0The circumference of the bracelet 112 can be changed as long as the bracelet 112 is loosely wrapped around the body part 132. However, once the circumference of the bracelet 112 matches the circumference of the body part 132 (approximately equivalent to Figure 4B In the case of the wristband 112, the body tissue 134 begins to exert a reaction force to further narrow the wristband 112. Therefore, the electric power p that must be provided to the electromechanical actuator 114 to further reduce the circumference of the wristband 112 begins to rise. Figure 5 Middle position x 0 The rise can be detected, for example, by a measuring unit and / or by an evaluation unit. 0 There is a direct relationship between x and the circumference of the bracelet 112, which can be determined, for example, by geometric considerations and / or by calibration measurements, 0 Body part circumference information about body tissue 134, such as the circumference of body part 132, may be provided.

[0140] When moving further, the reaction force rises, for example according to Hooke's law or other physical relationship between forces exerted in extension or compression of an object (particularly body tissue). As an example, when further increasing x by a distance Δx, the electrical power p applied to the electromechanical actuator 114 can be increased from p 0 Rise to p 1 Thus, for example, the slope can be determined by dividing the rise in power by the change in distance: S = Δp / Δx = (p 1 –p 0 ) / Δx. The slope can provide an item of elastic information.

[0141] As an example, by combining the above options, two different parameters of interest for determining the state of the body tissue 134 can be derived. Thus, at least one body part circumference information item and at least one elasticity information item can be generated. Instead of the variables shown above, other variables can be used, such as the force and / or angle information applied by the electromechanical actuator 114. Various options are feasible.

[0142] Reference numerals list

[0143] 110 Diagnostic Device

[0144] 112 Bracelet

[0145] 113 Fasteners

[0146] 114 Electromechanical Actuator

[0147] 116 Motor

[0148] 118 Small gear

[0149] 120 Toothed belt

[0150] 122 Part 1

[0151] 124 Part 2

[0152] 126 measurement units

[0153] 128 evaluation units

[0154] 130 Control unit

[0155] 132 Body Parts

[0156] 134 Body tissue

[0157] 136 The beginning of the scattered

Claims

1. A diagnostic device (110) for monitoring at least one body tissue (134) of a patient, the diagnostic device (110) comprising: a. at least one bracelet (112) configured to be tied around a body part (132) of the patient; b. at least one electromechanical actuator (114) configured to actively change the circumference of the bracelet (112); c. at least one measuring unit (126) configured to determine at least one item of information about the electrical power applied to the electromechanical actuator (114) and at least one item of circumference information about the circumference of the bracelet (112); as well as d. at least one evaluation unit (128) configured to determine at least one information item about the state of the body tissue (134) from the information item about the electric power applied to the electromechanical actuator (114) and the circumference information item, wherein the evaluation unit (128) is configured to determine a contact point at which the circumference of the bracelet (112) corresponds to the circumference of the body part.

2. The diagnostic device (110) according to the preceding claim, wherein the electromechanical actuator (114) comprises at least one electric motor (116).

3. The diagnostic device (110) according to the preceding claim, wherein the electric motor (116) is selected from the group consisting of: a DC motor; a stepper motor.

4. A diagnostic device (110) according to any one of the two preceding claims, wherein the electric motor (116) is configured to move at least one first portion (122) of the bracelet (112) relative to at least one second portion (124) of the bracelet (112) to change the circumference of the bracelet (112).

5. The diagnostic device (110) according to any of the preceding claims, wherein the diagnostic device (110) comprises at least one control unit (130), which is configured to control at least one measurement routine of the diagnostic device (110).

6. The diagnostic device (110) according to the preceding claim, wherein the measurement routine comprises at least one elasticity measurement step, the elasticity measurement step comprising: - adjusting the circumference of the bracelet (112) to at least a first circumference, - changing the circumference of the bracelet (112) from the first circumference to at least one second circumference, wherein the item of information about the electrical power applied to the electromechanical actuator (114) and the item of circumference information are recorded.

7. A diagnostic device (110) according to the preceding claim, wherein the information items about the state of the body tissue (134) include at least one elastic information item about the body tissue (134), wherein the evaluation unit (128) is configured to derive the elastic information item from the information items about the electric power applied to the electromechanical actuator (114) and the circumference information items recorded during the elasticity measurement step.

8. The diagnostic device (110) according to the preceding claim, wherein the evaluation unit (128) is configured to derive the elastic information item from at least one of the following items: the slope of a measurement curve indicating the electric power applied to the electromechanical actuator (114) and the circumference of the bracelet (112); the slope of a measurement curve indicating the circumference of the bracelet (112) and the electric power applied to the electromechanical actuator (114); at least two measurement points, each measurement point indicating the circumference of the bracelet (112) and the electric power applied to the electromechanical actuator (114).

9. The diagnostic device (110) according to any one of the four preceding claims, wherein the measurement routine comprises at least one step of body part circumference measurement, the step of body part circumference measurement comprising: - reducing the circumference of the bracelet (112), wherein the item of information about the electrical power applied to the electromechanical actuator (114) and the item of circumference information are recorded.

10. A diagnostic device (110) according to the preceding claim, wherein the information items about the state of the body tissue (134) include at least one body part circumference information item about the body tissue (134), and wherein the evaluation unit (128) is configured to derive the body part circumference information item from the information items about the electric power applied to the electromechanical actuator (114) and the circumference information items recorded during the step of measuring the body part circumference.

11. The diagnostic device (110) according to the preceding claim, wherein the body part circumference information item about the body tissue (134) comprises a value associated with the absolute circumference of the body part around which the bracelet (110) is to be tied.

12. A diagnostic device (110) according to any one of the two preceding claims, wherein the evaluation unit (128) is configured to determine an information item about the circumference of the body part of the body tissue (134) from at least one of the following items: a slope of a measurement curve indicating the electric power applied to the electromechanical actuator (114) and the circumference of the bracelet (112); a slope of a measurement curve indicating the circumference of the bracelet (112) and the electric power applied to the electromechanical actuator (114); at least two measurement points, each measuring point indicating the circumference of the bracelet (112) and the electric power applied to the electromechanical actuator (114).

13. The diagnostic device (110) according to any one of the preceding claims, wherein the bracelet (112) comprises at least one toothed belt (120), the at least one toothed belt being configured for interacting with the electromechanical actuator (114).

14. The diagnostic device (110) according to the preceding claim, wherein the diagnostic device (110) comprises at least one pinion (118) driven by the electromechanical actuator (114), the pinion (118) being configured for interaction with the toothed belt (120).

15. The diagnostic device (110) according to any one of the preceding claims, wherein the at least one measuring unit (126) comprises: At least one electrical measuring device configured to determine at least one item of information about the electrical power applied to the electromechanical actuator (114), and at least one position measuring device configured to determine at least one item of circumference information about the circumference of the bracelet (112).

16. A method of monitoring at least one body tissue (134) of a patient, the method comprising: i. Providing at least one diagnostic device (110) according to any one of the preceding claims; ii. Binding the bracelet (112) around the patient's body part (132); iii. actively changing the circumference of the bracelet (112) by using the electromechanical actuator (114); iv. determining, by using the measuring unit (126), at least one item of information about the electrical power applied to the electromechanical actuator (114) and at least one item of circumference information about the circumference of the bracelet (112); and v. determining at least one information item about the state of the body tissue (134) from the information item about the electric power applied to the electromechanical actuator (114) and the circumference information item by using the at least one evaluation unit (128), and determining a contact point by using the at least one evaluation unit (128), the circumference of the bracelet (110) corresponding to the circumference of the body part at the contact point.

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