Diagnostic device and method for monitoring a patient's body tissue

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 wrapped around a body part (132) of said 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 relating to the power applied to the electromechanical actuator (114) and at least one item of circumference information relating to the circumference of the bracelet (112); and d. At least one evaluation unit (128) configured to determine at least one item of information regarding the state of the body tissue (134) from an item of information regarding the power applied to the electromechanical actuator (114) and an item of circumference information, the evaluation unit (128) including at least one evaluation unit (128) configured to determine a contact point where the circumference of the bracelet (112) corresponds to the circumference of the body part. Additionally, 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, as well as certain aspects of the computer implementation of the method. The device and method may be used, in particular, to monitor physical swelling of a patient's body tissue, such as edema or congestion, particularly ankle edema. Additionally or alternatively, other body parts of the patient may be monitored, such as one or more body tissues of the thigh, lower leg, wrist, forearm, and upper arm. The present invention may be particularly applicable to patient monitoring in the fields of cardiology and internal medicine. However, other fields of application are also feasible. [Background technology]

[0002] In several medical fields, monitoring the characteristics of a patient's body tissues is an essential part of medical healthcare. Specifically, in the fields of cardiology and internal medicine, testing certain body tissue characteristics is essential, for example, to detect or monitor swelling or edema. For example, ankle edema is known to provide evidence of risk for heart failure symptoms, so monitoring ankle edema or other congestion is an important part of cardiac healthcare. As a result, monitoring body tissue characteristics is required in many medical fields. For example, because congestion is one of the most important determinants of heart failure symptoms and a major prognostic factor for heart failure, a major challenge in managing heart failure patients is monitoring congestion and body tissues. For example, congestion is primarily treated with diuretics, such as loop diuretics, as recommended by major international guidelines.

[0003] Therefore, it is of paramount importance to provide means and methods for appropriately determining specific parameters of body tissues, such as a patient's hemostatic status. Residual congestion at the time of hospital discharge is associated with higher 1-year mortality and rehospitalization for heart failure. While many clinical signs and symptoms of congestion are well characterized and recognized by published guidelines, no single element from a clinical history or physical examination can accurately detect the underlying hemodynamic changes that result in congestion.

[0004] However, technological challenges remain in the availability of robust and reliable clinical tools capable of monitoring and assessing changes in a patient's hemocongestion. However, various manual approaches, which depend heavily on the healthcare professional's experience, are used by healthcare professionals. Generally, hemocongestion assessment tools can be divided into three groups. However, to date, none of these tools alone have provided meaningful enough results to avoid premature discharge of patients from the hospital or to provide appropriate healthcare that patients can apply at home. Therefore, clinical tools for assessing hemocongestion, including imaging tools and pressure and impedance tools, are commonly known for monitoring body tissues. Clinical tools typically involve monitoring signs and symptoms such as dyspnea, orthopnea, or other signs and symptoms. Clinical tools may also include clinical congestion scores, such as the Stevenson score, Everest score, and Lord score. Clinical tools may also involve the use of circulating biomarkers, such as BNP and NT-proBNP. Furthermore, specific clinical measurements can be performed, including plasma volume measurement, hematocrit measurement, serum protein measurement, and albumin measurement. Similarly, clinical tools may 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 is that using imaging tools, which may include one or more of chest x-ray, echocardiography, etc. Finally, the third group is that of pressure and impedance tools, which may generally include the use of cardiac catheterization, pressure sensors such as CardioMEMS™ Sensors, bioimpedance vector analysis (BIVA), etc.

[0005] Additionally, various sensors are known in the art that have been described as useful for monitoring congestion, such as ankle edema. For example, L. Beker, "Wearable sensors of the elasticity of deeper skin," Nature Biomedical Engineering, vol. 5, July 2021, pp. 641-642 (www.nature.com / natbiomedeng), describes a method for dynamically measuring the elastic modulus of superficial and deep layers of skin via a wearable conformal electromagnetic device consisting of a vibrating actuator and a soft strain-sensing sheet.

[0006] Similarly, 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_Information_Quality_Assessment_for_Monitoring_Ankle_Edema), discloses a wearable real-time platform that integrates advanced technologies in sensing, computing, and signal processing with machine learning for continuous and real-time edema monitoring in remote and home settings.

[0007] U.S. Patent No. 8,827,930 discloses a system and method for monitoring a patient. An exemplary method includes receiving sensor data related to a patient from multiple sensors in a patient monitoring device and determining whether the sensor data satisfies one or more trigger conditions. For each satisfied trigger condition, one or more messages are transmitted to at least one of the patient monitoring device and an external computing device for display, thereby transmitting the messages to at least one of the patient, a caregiver, and a support person. Satisfying one or more trigger conditions may indicate that the patient has edema and / or is heading toward decompensation. The sensor data may be collected from a heart rate sensor, an oximeter, an accelerometer, and / or a sensor configured to detect distance around the patient's limbs. In some embodiments, the trigger condition is provided by the patient, the caregiver, and / or the support person.

[0008] U.S. Patent No. 10,206,621 discloses devices, systems, and methods for predicting and preventing acute decompensated heart failure or other patient conditions involving fluid accumulation in the legs or hands. In one example, a wearable device includes a drift-free leg size sensor and a tissue elasticity sensor. Both sensors are relatively inexpensive and can be developed using innovative new sensing ideas. Preliminary testing with sensor prototypes has shown promising results: the leg size sensor can measure a 1 mm change in leg diameter, and the tissue elasticity sensor can detect a 0.15 MPa difference in elasticity. In another example, a wearable system includes sensors for measuring various physiological parameters, a processing module, and a communications module. A thin instrumented sock with multiple sensors, such as a wearable device, can provide an indication of a patient's heart failure status.

[0009] US Patent No. 202110015426 discloses a measuring device capable of measuring the amount of ankle edema. The measuring device includes a sheet-like sensor that is stretchable in one direction, transverse to the thickness direction. The measuring device is capable of detecting changes in electrical properties associated with stretching. The measuring device further includes support members attached to both ends and in the direction of stretching of the sensor, and which surround the ankle together with the sensor when the measuring device is worn on the ankle.

[0010] U.S. Patent Application Publication No. 2010 / 0010406 ​​discloses a self-contained compression device and related method for cyclically compressing a patient's limb to improve blood flow in the limb. In one embodiment, the compression device includes a compression section sized and shaped to extend around a portion of the limb to apply compressive pressure, and a housing operably connected to the compression section. The housing includes first and second housing members movable relative to each other between retracted and extended positions. A non-pneumatic mechanical actuator is provided on the housing for cyclically moving the first and second housing members 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 to effect relative movement between the first and second housing members.

[0011] Chinese Patent No. 213,345,640 discloses an electrical measurement device for post-breast cancer surgery lymphedema, comprising a tape, a plurality of gear grooves disposed in the center of the tape, and a scale disposed on the surface of the tape, the scale starting from one side of the tape and ending on the other side of the tape. A measurement mounting box is fixedly mounted on the right side of the tape, and a fixed mounting block is fixedly mounted on the measurement mounting box. A mounting groove is formed in the fixed mounting block, a gear is mounted in the mounting groove, and a rotating shaft is mounted on the gear, one end of which is connected to the output end of a motor via a coupler, and the other end of the rotating shaft is connected to the output end of the motor. The gear groove formed in the tape engages with a gear fixedly mounted on the measurement mounting box, and the motor drives the gear to rotate, so that the tape can be automatically tightened via the gear for measurement, and measurement data can be conveniently observed via the scale marks.

[0012] Japanese Patent Application Laid-Open Publication No. 2008-096315 discloses a means for winding a belt around an object whose elasticity is to be evaluated, which is constructed to represent pulling on the end of the wound belt, a means for measuring the tension generated in the belt, and a means for measuring the amount of change in length of the portion of the belt wound around the object to be measured.

[0013] Despite the advantages achieved by these technological devices and methods, several technical challenges remain. Thus, there remains a need for robust and reliable tools to be used either in clinical settings or at home, by medical professionals or by untrained persons, such as patients themselves. Specifically, there is a need for means and methods that are not highly dependent on environmental conditions, such as temperature, and do not require advanced in situ calibration. Summary of the Invention

[0014] It is therefore desirable to provide a device and method that at least partially addresses the above-mentioned 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.

[0015] This problem is addressed by a diagnostic device for monitoring at least one body tissue of a patient, as well as by a method for monitoring at least one body tissue of a patient, and by particular aspects of the computer implementation of the method having the features of the independent claims. Advantageous embodiments, which can be realized alone or in any combination, are set out in the dependent claims as well as in the specification as a whole.

[0016] When used below, the terms "having," "comprising," or "including," or any grammatical variants thereof, are used in a non-exclusive manner. These terms can therefore refer both to a situation in which, besides the features introduced by these terms, no further features are present in the entity described in this context, and to a situation in which one or more further features are present. As an example, the expressions "A has B," "A comprises B," and "A includes B" can both refer to a situation in which, besides B, no other elements are present in A (i.e., a situation in which A consists solely and exclusively of B), and to a situation in which, besides B, one or more further elements are present in entity A, such as element C, elements C and D, or further elements.

[0017] Furthermore, 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 one or more times are typically used only once when introducing each feature or element. In the following, in most cases, when referring to each feature or element, the expressions "at least one" or "one or more" will not be repeated, regardless of the fact that each feature or element may be present one or more times.

[0018] Furthermore, when used hereinafter, the terms "preferably," "more preferably," "particularly," "more particularly," "particularly," "more particularly," or similar terms may be used in conjunction with any feature without limiting its alternative possibilities. Therefore, features introduced by these terms are optional features and are not intended to limit the scope of the claims in any way. The present invention may be implemented by using alternative features, as recognized by those skilled in the art. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features without any limitations regarding alternative embodiments of the invention, without any limitations regarding the scope of the invention, and without any limitations regarding the possibility of combining the feature introduced in this manner with other optional or non-optional features of the invention.

[0019] In a first aspect, a diagnostic device for monitoring at least one bodily tissue of a patient is disclosed. The diagnostic device may be used specifically to monitor physical swelling of the bodily tissue of the patient. The diagnostic device comprises: a. at least one bracelet configured to be wrapped around a body part of the patient, specifically around one or more of the patient's ankle, thigh, lower leg, wrist, forearm, and upper arm; b. at least one electromechanical actuator configured to actively vary the circumference of the bracelet; c. at least one measuring unit configured to determine at least one item of information related to the power applied to the electromechanical actuator and at least one item of circumference information related to the circumference of the bracelet; and d. At least one evaluation unit configured to determine at least one item of information regarding the state of body tissue from an item of information regarding the power applied to the electromechanical actuator and an item of circumference information, in particular the evaluation unit configured to determine a contact point at which the circumference of the bracelet corresponds to the circumference of the body part.

[0020] As used herein, the term "diagnostic device" is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or particular meaning. The term may specifically refer to any device or combination of devices capable of determining at least one parameter indicative of a human or animal condition, such as, but not limited to, at least one physiological or medical parameter.

[0021] The term "monitoring," as used herein, is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or particular meaning. The term may specifically refer to a process that includes, but is not limited to, one or more of measuring, recording, and indicating at least one parameter, such as by electrical means. The result of the monitoring may be or include, by way of example, at least one item of information regarding the power applied to the electromechanical actuator, such as at least one analog and / or at least one digital signal.

[0022] The term "bracelet" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art, and should not be limited to any special or particular meaning. This term may specifically, but not exclusively, refer to any device or combination of devices that has at least partially deformable or flexible properties and is configured to be wrapped around at least a portion of a human body. For example, a bracelet may include a deformable element that can be bent around a body part to form at least one loop through which the body part can pass. For example, a bracelet may be made entirely or partially of at least one of a plastic material; a metal material, particularly a sheet metal material; a textile material; a paper or cardboard material, or any combination thereof.

[0023] The term "electromechanical actuator" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or particular meaning. Specifically, the term may refer, but is not limited to, any device or combination of devices capable of converting at least one electrical signal or electrical energy into at least one mechanical action, e.g., at least one motion, specifically at least one of linear motion and rotation. Many types of electromechanical actuators are known to those skilled in the art and may be used in the present invention. Specifically, the electromechanical actuator may include at least one electric motor, such as an electric motor selected from the group consisting of a DC motor and a stepper motor.

[0024] The electric motor may be specifically configured to actively change the circumference of the bracelet, for example by widening or narrowing the loop formed by the bracelet. To this end, the electric motor may be specifically configured 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. Thereby, for example, the loop may be enlarged or narrowed in a manner controlled by the electromechanical actuator, in particular the electric motor.

[0025] The electromechanical actuator may be completely or partially separate from the bracelet, or 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 at at least two portions of the bracelet. More specifically, the electromechanical actuator may be configured to move one portion of the bracelet relative to another portion of the bracelet to narrow and / or widen the loop formed by the bracelet.

[0026] The term "actively," as used herein, and particularly in the context of changing the circumference of a bracelet, is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or particular meaning. Specifically, the term may refer to, but is not limited to, the nature of a process being controlled, started, and / or stopped by external influences. Thus, for example, in contrast to changing the circumference of a bracelet through internal temperature changes within the bracelet, actively changing the circumference may involve 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 a bracelet may include controlling the change in circumference through one or more control signals generated internally or externally, for example, by a control unit of a diagnostic device. The control unit may be part of the bracelet, an electromechanical actuator, or may be located externally.

[0027] The term "measurement unit" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a specific or special 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. The measurement unit may comprise a single measurement device or multiple measurement devices, as outlined in more detail below. The measurement 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 measurement unit may be embodied as a fully or partially separate unit or may be fully or partially integrated into one or more other components of the diagnostic device, such as an electromechanical actuator, a control unit of the diagnostic device, or an evaluation unit.

[0028] As used herein, the term "item of information regarding the power applied to the electromechanical actuator" is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to any special or particular meaning. This term may specifically, but is not limited to, refer to any item of information qualifying and / or quantifying the power applied to the electromechanical actuator, for example, by an external power source and / or by an internal power source incorporated into the diagnostic device, such as an accumulator and / or battery. This term may also specifically, but is not limited to, refer to any item of information qualifying and / or quantifying the power applied to the electromechanical actuator required to move the electromechanical actuator a specified distance or angle. Moving the electromechanical actuator a specified distance or angle may change, i.e., increase or decrease, the circumference of the bracelet, particularly the circumference of the loop formed by the bracelet. This change in the circumference of the bracelet, particularly the change in the circumference of the loop formed by the bracelet, may be proportional to the movement of the electromechanical actuator a specified distance or angle. In particular, the circumference of the bracelet may decrease from a first circumference to a second circumference. Thus, the item of information regarding the power applied to the electromechanical actuator may include one or more of a current, a voltage, and a power. The item of information regarding the power applied to the electromechanical actuator may be provided by the measurement unit in particular in an electrical format, such as in the form of an analog and / or digital electrical signal.

[0029] As used herein, the term "perimeter" is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a specific or special meaning. This term may specifically, but not exclusively, refer to a parameter indicating the length of a loop formed by a bracelet through which a patient's body part may extend. The circumference may be, in particular, the inner circumference of a bracelet that may be configured to contact a patient's body part when the bracelet is wrapped around the patient's body part. Thus, by way of example, the diameter of a loop formed by a bracelet may be proportional to the circumference of the loop, and may be, in particular, circumference information or may be determined using circumference information. The diameter may be the actual diameter of a circular loop or may be related to another parameter indicating the width of the loop, such as an equivalent diameter.

[0030] As used herein, the term "item of circumference information" or "item of information regarding the circumference of a bracelet" is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a specific or special meaning. This term may specifically refer to, but is not limited to, any item of information that qualifies and / or quantifies the current circumference, the current diameter or equivalent diameter of a bracelet, and in particular the loop formed by a bracelet, including options that provide information about actual values ​​that allow for the identification of the circumference, as well as options that provide information about the time derivative, such as the rate of change of the circumference, diameter, or equivalent diameter. The circumference information may include an item of information regarding the inner circumference. This item of information may be the inner circumference itself or any value that can be examined to determine the inner circumference. Thus, by way of example, the circumference may include information proportional to the actual diameter of a circular loop, or may also include information about other parameters that indicate the width of the loop, such as the equivalent diameter. By way of example, an item of circumference information relating to the circumference of the bracelet may also include information about the absolute position of at least one portion of the bracelet relative to an electromechanical actuator or the like, or the relative position of two portions of the bracelet relative to each other and / or relative to a reference point or area. The item of circumference information may in particular be provided by the measurement unit in an electrical format, such as in the form of an analogue and / or digital electrical signal, for example as a position signal and / or an angle signal.

[0031] The term "evaluation unit" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or particular 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, e.g., measurement results generated by the measurement unit. The evaluation unit may specifically comprise at least one processor. The processor may specifically be configured, e.g., by software programming, to perform one or more evaluation operations on items of information regarding the power applied to the electromechanical actuator and items of circumference information.

[0032] Like the measurement unit, the evaluation unit may also be embodied as a separate unit or may be fully or partially integrated into one or more other parts of the diagnostic device. Thus, by way of example, the evaluation unit may be fully or partially integrated into one or more of the electromechanical actuator, the control unit of the diagnostic device, the measurement unit. However, other options are also feasible.

[0033] As used herein, the term "processor" is a broad term and should be given its ordinary and customary meaning to those skilled in the art, and should not be limited to any specific or special meaning. The term may specifically, but not exclusively, refer to any logic circuitry configured to perform the basic operations of a computer or system, and / or may generally refer to a device configured to perform calculations or logical operations. In particular, a processor may be configured to process the basic instructions that run a computer or system. By way of 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 numeric coprocessor, multiple registers, specifically registers configured to supply operands to the ALU and store calculation results, and memory, such as L1 and L2 cache memories. In particular, a processor may be a multi-core processor. In particular, a processor may be or include a central processing unit (CPU). Additionally or alternatively, a processor may be or include a microprocessor, and thus in particular, the elements of a processor may be included on a single integrated circuit (IC) chip. Additionally or alternatively, the processor may be or include one or more chips, such as 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 dedicated machine learning optimization chips, etc. The processor may be specifically configured, such as by software programming, to perform one or more evaluation operations.

[0034] The term "item of information regarding the state of a body tissue" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a specific or special meaning. This term may specifically refer to, but is not limited to, any item of information that allows qualifying and / or quantifying the state of a body tissue. By way of example, the item of information regarding the state of a body tissue may be provided by the 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 item of information regarding the state of a body tissue may specifically include at least one item of information selected from the group consisting of the degree of swelling of the body tissue, specifically the circumference of the body tissue, and the elasticity parameters of the body tissue, specifically the elasticity module of the body tissue.

[0035] The information item regarding the state of the body tissue may include an item regarding the body part circumference information of the body part. For example, the item regarding the circumference information of the bracelet at the contact point may be used as the item regarding the body part circumference information of the body tissue or may be used to determine this item regarding the body part circumference information. The term "contact point" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or special meaning. This term may specifically, but is not limited to, refer to a bracelet that is particularly fully attached to a body part so that the circumference of the body part can be determined. At the contact point, the circumference of the bracelet, particularly the loop, may correspond to and / or be equal to the circumference of the body part. The contact point may be determined by detecting the onset of the rise in power required to be applied to the actuator, for example, by monitoring the slope of a curve showing power as a function of circumference information, or vice versa.

[0036] 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. The circumference of the body part can be determined in a non-compressed state of the body part, in particular when the bracelet exerts no force on the body part, in particular when the bracelet exerts no further compressive force on the body part in addition to the already applied force caused by the weight of the bracelet.

[0037] To determine at least one item of information regarding the state of the body tissue from the items of information regarding the power applied to the electromechanical actuator and the items of circumference information, the evaluation unit may be configured to use at least one conversion process, specifically at least one programmed conversion algorithm, such as at least one conversion function and / or at least one lookup table. For example, an elasticity parameter of the body tissue may be derived from the power required to reduce the circumference of the bracelet relative to the resistance of the body tissue, for example, by using an empirical or semi-empirical conversion algorithm. For example, the diagnostic device may be calibrated, for example, factory-calibrated, using artificial tissue or a dummy with known properties, for example, known elastic properties, and the power required to change the circumference of the bracelet relative to the elasticity of the dummy or artificial body tissue may be measured. This may generate a calibration function or calibration data, such as data for generating a lookup table, for use in subsequent measurements. However, instead, raw data may be used to determine an item of information regarding the state of the body tissue, for example, raw data regarding the power required to change the circumference of the bracelet from a first circumference to a second circumference.

[0038] The diagnostic device may specifically include at least one control unit configured to control at least one measurement routine of the diagnostic device. The term "control unit," as used herein, is a broad term and should be given its ordinary and customary meaning to those skilled in the art and should not be limited to a special or particular meaning. The term may specifically refer to any device or combination of devices configured to control, 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 specifically be configured to control, such as by software programming, one or more measurement routines of the diagnostic device.

[0039] Like the measurement unit and the evaluation unit, the control unit may be embodied as a separate unit or may be fully or partially integrated into one or more other parts of the diagnostic device. Thus, by way of example, the control unit may be fully or partially integrated into one or more of the electromechanical actuator, the evaluation unit of the diagnostic device, and the measurement unit of the diagnostic device. However, other options are also feasible.

[0040] As used herein, the term "measurement routine" is a broad term and should be given its ordinary and customary meaning to those skilled in the art, without being limited to a specific or special meaning. This term may specifically refer to one or more steps, such as, but not limited to, a series of measurement steps that can be used to obtain at least one item of information regarding the state of bodily tissue. The one or more steps of the measurement routine may include at least one of: controlling an electromechanical actuator; measuring to determine at least one item of information regarding the power applied to the electromechanical actuator; and measuring to determine at least one item of circumference information regarding the circumference of the bracelet. Steps may also be fully or partially combined. Examples of measurement routines are provided in more detail below.

[0041] Thus, by way of example, the measurement routine includes at least one step of elasticity measurement, which may specifically include the following steps, which may be performed in sequence, specifically in a predetermined order, but may also be performed overlappingly or in parallel as appropriate, and one or more of these steps may be performed once or repeatedly: -adjusting the circumference of the bracelet to at least one first circumference; - changing the circumference of the bracelet from a first circumference to at least one second circumference, in particular to at least one second circumference smaller than the first circumference, by using an electromechanical actuator, wherein items of information regarding the power applied to the electromechanical actuator and items of circumference information are recorded at least at the start and end of this circumference change process, in particular also during this circumference change process.

[0042] In particular, useful information regarding elasticity can be derived from recording information regarding the power applied to the electromechanical actuator as a function of circumference information.

[0043] The term "elasticity" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art, and should not be limited to a specific or special meaning. This term may specifically, but not exclusively, refer to the deformability of an object and / or its ability to resist a straining effect or force. After the straining effect is removed, the object may fully or partially return to its original size and shape. Therefore, specifically, at least one item of elasticity information may be derived that quantifies or at least qualifies the deformation of the object as a function of the applied force. The object may be a body. For example, one or more elasticity modules, as known to those skilled in the art, may be used. However, additionally or alternatively, other types of elasticity information may also be applied in the context of the present invention.

[0044] Thus, in particular, the items of information about the power applied to the electromechanical actuator and the items of information about the state of the body tissue determined by the evaluation unit from the items of circumference information may include at least one item of elasticity information about the body tissue. The evaluation unit may be configured to derive the items of elasticity information from the items of information about the power applied to the electromechanical actuator and the items of circumference information recorded during the elasticity measurement step. Thus, by way of example, the items of elasticity information may be derived from one or more of the following: the ratio of power and the change in bracelet circumference over a predetermined or determinable measurement range; the ratio of the change in power and the change in bracelet circumference over a predetermined or determinable measurement range; the slope of a curve showing power as a function of bracelet circumference or a variable correlated therewith; or the slope of a curve showing bracelet circumference or a variable correlated therewith as a function of power or a variable correlated therewith. However, it should be noted that other types of transformations or other methods of deriving elasticity information from the elasticity measurement step are possible. At least one transformation, such as at least one conversion function and / or at least one look-up table, may be used by the evaluation unit to determine the at least one item of elasticity information. Again, by way of example, the transformation may be determined by one or more calibration measurements, for example by way of calibration measurements on one or more dummies and / or one or more dummies with known elasticity properties, whereby by way of example a calibration curve or a plurality of calibration points for generating a look-up table may be derived, the calibration curve or calibration points indicating the item of elasticity information as a function of the item of information on the power applied to the electromechanical actuator and the item of circumference information recorded during the step of elasticity measurement.

[0045] Thus, as outlined above, the evaluation unit may be configured to derive the item of elasticity information from at least one of the following: the slope of a measurement curve indicative of the power applied to the electromechanical actuator and the circumference of the bracelet; the slope of a measurement curve indicative of the circumference of the bracelet and the power applied to the electromechanical actuator; and at least two measurement points, each measurement point indicative of the circumference of the bracelet and the power applied to the electromechanical actuator. However, other methods of deriving the item of elasticity information may additionally or alternatively be used.

[0046] The above-mentioned measurement routine may also include at least one body part circumference measurement step in addition to or as an alternative to at least one step of elasticity measurement. The body part circumference measurement step may specifically include the following steps, which may be performed once or repeatedly: - Decreasing the circumference of the bracelet by using an electromechanical actuator, wherein an item of information about the power applied to the electromechanical actuator and an item of circumference information are recorded.

[0047] As used herein, the term "body part circumference" is a broad term and should be given its ordinary and customary meaning to those skilled in the art, and should not be limited to a special or particular meaning. This term may specifically refer, without limitation, to the closed length, specifically the closed outer length, of the shape and / or size of the body part around which the bracelet is wrapped. Specifically, at least one item of body part circumference information may quantify the body part circumference. At least one item of body part circumference information may provide any quantification of one or both of the size and shape of the body part. For example, the item of body part circumference information may provide information regarding the circumference of the body part, or may thereby relate to the circumference, diameter, and / or equivalent diameter of the body part.

[0048] Thus, in general, the items of information regarding the state of the body tissue may include, for example, at least one item of body part circumference information regarding the body tissue in addition to or as an alternative to at least one item of elasticity information. The evaluation unit may be configured to derive the body part circumference information item from the items of information regarding the power applied to the electromechanical actuator and the items of circumference information recorded during the body part circumference measurement step. Again, for this determination of the at least one item of body part circumference information, 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, analytical solutions may be used. Thus, by way of example, the evaluation unit may be configured to determine the item of body part circumference information regarding the body tissue from at least one of the following: a slope of a measurement curve indicating the 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 power applied to the electromechanical actuator; and at least two measurement points, each measurement point indicating the circumference of the bracelet and the power applied to the electromechanical actuator. For example, the control unit may be configured to control the electromechanical actuator to gradually or stepwise decrease the circumference of the bracelet. When the bracelet is loosely wrapped around a body part, the power required to reduce the circumference is initially relatively low and more or less constant. However, as the circumference of the bracelet engages with the circumference of the body part, the body part begins to exert a counterforce and / or resist the strain caused by the bracelet. As a result, the power required to reduce the circumference begins to increase. For example, by monitoring the onset of this increase, e.g., by monitoring the slope of a curve showing power as a function of circumference information, a contact point at which the circumference of the bracelet corresponds to the circumference of the body part can be determined. The item of bracelet circumference information at this contact point can be used, for example, as a reference for or to determine the body part circumference information of the body tissue.Thus, in general, the at least one item of body part circumference information may include at least one information item indicating the circumference of the body part in a resting state where the bracelet does not exert any force on the body tissue. The circumference may be proportional to the equivalent diameter of the body part in a resting state where the bracelet does not exert any force on the body tissue. The absolute value of the body part circumference may be determined.

[0049] At least one step of elasticity measurement and at least one step of measuring the body part circumference can also be combined, for example, in one and the same measurement routine. Thus, for example, the control unit can be configured to reduce the circumference of the bracelet by providing a corresponding control signal to the electromechanical actuator. At least one item of body part circumference information can be derived by the evaluation unit from the start of the increase in the power that needs to be applied to the actuator when the bracelet, originally loosely wrapped around the body part, comes into contact with body tissue. As the circumference is further reduced, at least one item of elasticity information can be derived from the increase in the power that needs to be applied to the actuator when the circumference of the bracelet is further reduced relative to the elasticity of the body tissue, for example, from the slope of the curve of power as a function of the circumference of the bracelet.

[0050] Additionally or alternatively, the absolute value of the circumference of the bracelet can be determined during the body part circumference measuring step. This allows the absolute value of the current circumference of each body part around which the bracelet can be wrapped to be determined. The term "bracelet length" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art, and should not be limited to a special or particular meaning. This term may specifically, but is not limited to, refer to the length of the band used to form the bracelet, particularly to form the loop of the bracelet. The loop may be formed by inserting the free end of the band into the electromechanical actuator so that the free or loose end protrudes from the electromechanical actuator. The term "loose end length" as used herein is a broad term and should be given its ordinary and customary meaning to those skilled in the art, and should not be limited to a special or particular meaning. This term may specifically, but is not limited to, refer to the length of the free end of the band used to form or for the bracelet. The free or loose end may not particularly form the loop of the bracelet. For example, a free or loose end may protrude from the loop of a bracelet, particularly when the loop of the bracelet is formed by inserting the free end of the band into the electromechanical actuator.

[0051] The absolute value of the circumference of the bracelet, particularly the loop formed by the bracelet, can be determined by at least one of taking into account the absolute length of the bracelet and the absolute length of the loose end of the bracelet, specifically, the absolute length of the bracelet is known and the absolute length of the loose end can be determined using a length sensor, more specifically, the length sensor can be an electromechanical actuator, or by taking into account at least one position marker on the bracelet. If the absolute length of the bracelet and the absolute length of the loose end of the bracelet can be taken into account to determine the absolute value of the circumference of the bracelet, particularly the loop formed by the bracelet, the absolute value of the circumference can be determined by subtracting the absolute length of the loose end from the absolute length of the bracelet. Furthermore, a known absolute offset length value can also be taken into account.

[0052] In particular, the absolute length of the bracelet may be fixed, so that the absolute length of the bracelet is predetermined and thus known to the evaluation unit. The length of the loose end may change, especially when the bracelet is wrapped around a body part to form a loop. Before a body part circumference measurement can be performed, the bracelet may be in an initial configuration in which the circumference of the bracelet loop may have an initial absolute value and the length of the free end may have an initial absolute value. The absolute length of the free end may be determined by using a length sensor, especially the absolute length of the loose end in the initial configuration. As explained, the sensor may be the electromechanical actuator itself. Alternatively, the length sensor may be a device different from the electromechanical actuator. For example, a length sensor, especially an electromechanical actuator, may be used to determine the number of teeth of a toothed rack that is inserted into the electromechanical actuator, especially to form a loop of the bracelet, by the patient. Furthermore, the number of teeth may be determined, which is involved in actively changing the circumference of the bracelet by the electromechanical actuator. Alternatively or additionally, the absolute value of the circumference may be determined by taking into account at least one or more position markers on the bracelet. A length sensor may be used to take into account at least one position marker. Alternatively or additionally, the patient and / or a further person may be asked to indicate at least one value associated with the position marker currently to be taken into account.

[0053] As outlined above, by way of example, the electromechanical actuator may specifically include at least one electric motor. Generally, by way of example, the electromechanical actuator may specifically be configured to perform a rotational movement, for example, to narrow or widen the loop formed by the bracelet. By way of example, the bracelet may include at least one toothed belt or rack configured to interact with the electromechanical actuator. The diagnostic device may include at least one pinion driven by the electromechanical actuator, the pinion configured to interact with the toothed belt or rack. Thus, by way of example, the circumference of the bracelet may be reduced by rotating the electromechanical actuator in one direction and increased by rotating the electromechanical actuator in the opposite direction.

[0054] As outlined above, the diagnostic device includes at least one measurement unit. The at least one measurement unit may include at least one electrical measurement device configured to determine at least one item of information related to the power applied to the electromechanical actuator and at least one position measurement device configured to determine at least one item of circumference information related to the circumference of the bracelet, in particular the loop formed by the bracelet. By way of example, the electrical measurement device may include at least one voltage measurement device and / or current measurement device, thereby measuring the power applied to the electromechanical actuator. As mentioned above, the measurement unit may also be fully or partially combined with at least one optional control unit, for example by being fully or partially integrated into said control unit, thereby providing direct access to the power applied to the electromechanical actuator. However, other methods for determining the power are also possible.

[0055] The position measuring device may be configured to determine at least one of the following: the absolute position of at least one portion of the bracelet; the relative position of at least one first portion of the bracelet with respect to at least one second portion of the bracelet; the change in the absolute position of at least one portion of the bracelet over time; or the change in the relative position of at least one first portion of the bracelet with respect to at least one second portion of the bracelet. For this purpose, various types of position measuring devices may be used alone or in combination. For example, when using the above-mentioned rotary electromechanical actuator and / or pinion and / or toothed belt or rack, the linear and / or rotational position of one portion of the bracelet with respect to another portion may be measured. For example, in general, the electromechanical actuator may be fixed to one portion of the bracelet, preferably a first position, and configured to move another portion of the bracelet with respect to the first portion. By measuring the relative positions of the first and second portions, position measurements may be performed to derive information about the circumference of the bracelet, particularly the loop formed by the bracelet. For example, the position measuring device may include at least one rotational state of the electromechanical actuator and / or may measure at least one rotational state of at least one pinion. If the electromechanical actuator includes at least one stepper motor, the item of circumference information may be derived directly or indirectly from at least one signal provided by the stepper motor. Additionally or alternatively, at least one sensor may be used to detect the rotational state of the motor and / or pinion, such as a magnetic sensor and / or an optical sensor. Additionally or alternatively, for example, at least one linear position sensor may be used to determine the position of the electromechanical actuator and / or the further portion of the bracelet relative to the first portion. Again, for example, an optical sensor may be used. As those skilled in the art will recognize, various types of other sensors are possible.

[0056] In a further aspect of the present invention, a method for monitoring at least one body tissue of a patient is disclosed. The method includes the following steps. The steps may be specifically performed in the specified order. However, different orders are possible. Furthermore, two or more method steps may be performed overlappingly or in parallel as appropriate. Furthermore, one or more or even all of the method steps may be performed repeatedly.

[0057] The method includes the following steps. i. Providing at least one diagnostic device according to the present invention, such as according to any one of the embodiments described above and / or according to any one of the embodiments described in more detail below; ii. wrapping the bracelet around the patient's body part; iii. Actively varying the circumference of the bracelet by using an electromechanical actuator; iv. determining, by using the measurement unit, at least one item of information relating to the power applied to the electromechanical actuator and at least one item of circumference information relating to the circumference of the bracelet; and v. Determining at least one item of information regarding the state of the body tissue from the items of information regarding the power applied to the electromechanical actuator and the items of circumference information, in particular by using at least one evaluation unit, and determining, by using at least one evaluation unit, the contact point at which the circumference of the bracelet corresponds to the circumference of the body part.

[0058] As outlined above, one or more or even all of the method steps may be repeatedly performed. Thus, by way of example, at least method steps iii to v may be repeatedly performed, for example by forming a routine, which may be repeated, for example, at regular or irregular time intervals and / or whenever triggered by a user or patient. The measurement routine may, for example, be controlled by a control unit.

[0059] The method may also be fully or partially computer-implemented and / or computer-controlled. Thus, for example, at least step v. may be computer-implemented, for example, by a corresponding computer program executed on an evaluation unit, for example, a processor of the evaluation unit. Furthermore, as described above, one or more measurement routines may be controlled by at least one control unit. Thus, additionally or alternatively, for example, steps iii. and / or iv. may be fully or partially computer-controlled, for example, by a computer program executed on a control unit, for example, a processor of the control unit.

[0060] Consequently, in a further aspect, a computer program is disclosed comprising instructions which, when the program is executed by an evaluation unit of a diagnostic device according to the invention, such as according to any one of the embodiments described above and / or according to any one of the embodiments disclosed in more detail below, cause the evaluation unit to carry out step v of the method according to the invention, such as according to any one of the embodiments described above and / or according to any one of the embodiments described in more detail below.

[0061] Similarly, in a further aspect, a computer-readable storage medium, in particular a non-volatile computer-readable storage medium, is disclosed which comprises instructions which, when executed by an evaluation unit of a diagnostic device according to the invention, such as according to any one of the embodiments described above and / or according to any one of the embodiments described in more detail below, cause the evaluation unit to perform step v of the method according to the invention, such as according to any one of the embodiments described above and / or according to any one of the embodiments described in more detail below.

[0062] The present invention according to any one of the above-mentioned embodiments or any one of the embodiments described in more detail below provides numerous advantages over known means and methods, particularly over the above-mentioned known methods and devices. Thus, in particular, the diagnostic device and method may provide a detection means and method for quantifying at least swelling of a patient's ankle and / or wrist by means of a bracelet, which may, for example, be generally designed as a band such as a wristband and / or ankle band. This may, for example, determine the circumference of the ankle and / or wrist and / or the elasticity of the body tissue of the ankle and / or wrist.

[0063] The diagnostic device advantageously provides a simple, durable, and cost-effective setup, especially since no additional sensors are required to measure the tension generated in the belt. Typically, such additional sensors may be short-life gauges or load cells. According to the present invention, the information required to determine the items of information regarding the state of the body tissue is derived from parameters related to the electromechanical actuator. This significantly improves the accuracy of the measurements, as no additional sensors related to measurement errors are required, and typically, parameters of the electromechanical actuator, such as the power applied to the electromechanical actuator, can be determined very precisely and accurately. Furthermore, the diagnostic device is particularly compact, because the electromechanical actuator is constituted by a fastener designed to form the loop of the bracelet.

[0064] The results provided by the diagnostic device and / or method proposed herein may be combined with additional sensor signals, patient parameters, or vital signs, such as skin impedance. The at least one additional sensor signal may be selected from the group consisting of a temperature signal, an electrocardiogram (ECG) signal, a pulse signal, a partial oxygen pressure (pO2) signal, a motion signal, particularly a signal generated by an accelerometer, a respiration signal, a pulmonary artery (PA) pressure signal, and a weight signal. Thus, a combination of various sensor signals, patient parameters, or vital signs may be used for diagnosis. For example, an evaluation routine, such as a self-learning model, may be applied to data provided by the diagnostic device and optionally other devices to predict a patient's risk of heart failure and other diseases.

[0065] The diagnostic device may be specifically designed as a wearable device that can be worn by patients in home and / or hospital care settings. The option of quantifying ankle swelling and / or wrist swelling may help improve monitoring of the worsening of certain diseases. Thus, for example, quantifying ankle swelling and / or wrist swelling may help early detection of congestion in a patient's home, hospital, or other environment. Additionally or alternatively, quantification may facilitate monitoring the improvement of a treatment, such as a medical treatment, by, for example, correlating the quantification with the treatment and / or determining trends. Furthermore, quantification may assist healthcare professionals in decision-making, such as when deciding to discharge a patient from hospitalization.

[0066] The diagnostic device proposed herein can be designed in a robust and simple manner. Thus, the diagnostic device can be designed completely or partially as a bracelet that the patient can wear on their ankle and / or wrist. A mechanically robust design can be selected, for example, by designing the bracelet to include a straight, thin, flexible material containing a functional part at one end, including an electromechanical actuator, e.g., a motor, and the other end of the bracelet can move along and / or through the electromechanical actuator, thereby increasing and / or decreasing the circumference of the loop formed by the bracelet. When the electromechanical actuator, e.g., a motor, is actuated, e.g., rotated, the circumference of the bracelet is modified, and therefore the diameter and / or equivalent diameter of the bracelet is also modified. Alternatively, the diagnostic device can be designed completely or partially as, or incorporated into, a wearable device that the patient can wear, e.g., a glove, sock, or belt.

[0067] By way of example, the diagnostic device may be configured to read at least the rotations of an electromechanical actuator, e.g., a motor, to provide a first coordinate or measurement variable that may be part of at least one item of circumference information and / or from which at least one item of circumference information may be derived. By way of example, this item of circumference information may simply be the distance x that the bracelet is moved by the electromechanical actuator, e.g., by decreasing or increasing the circumference of the bracelet by the distance x. Furthermore, the diagnostic device may be configured to read the power applied to the electromechanical actuator, e.g., the power applied to the motor. This item of information may provide a second coordinate or measurement variable that may form an item of information regarding the power applied to the electromechanical actuator and / or from which an item of information regarding the power applied to the electromechanical actuator may be derived.

[0068] If the bracelet is worn on the ankle, wrist, or another body part, circumference and elasticity measurements can be taken at predetermined, determinable time intervals, or can be taken at irregular time intervals such as every 5, 10, 15 minutes, hourly, etc. Thus, in general, the method as outlined above, or parts thereof, such as the measurement routine including steps iii and iv, and optionally also step v, can be carried out in whole or in part repeatedly.

[0069] As outlined above, the method may include one or more measurement routines. For example, a typical measurement routine may include the following steps, which are executed when the bracelet is worn and loosely wrapped around a body part: For example, the bracelet may be worn so that its circumference is large enough to accommodate an additional finger between the bracelet and the body part. This may refer to an initial configuration in which the circumference of the bracelet's loops 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, for example, a routine start in which the electromechanical actuator is activated by rotating a motor in a predetermined direction known to decrease the circumference of the bracelet. During this step, at least one item of information regarding the power applied to the electromechanical actuator and at least one item of circumference information are determined, such as by measuring the power and the distance of rotation and / or movement. The movement may be stopped at a predetermined time and / or under predetermined conditions, for example, when a specified amount of power is applied to the electromechanical actuator 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 regarding the amount of power applied to the electromechanical actuator and / or a safety limit regarding the minimum circumference of the bracelet. The electromechanical actuator may then be controlled to move in the opposite direction, e.g., by an appropriate rotation in the opposite direction, to restore the original configuration, state, or position of the electromechanical actuator and / or bracelet, thereby increasing the circumference of the bracelet. This routine or series of operations may be repeated. By evaluating at least one item of information regarding the power applied to the electromechanical actuator and at least one item of circumference information, at least one item of information regarding the state of the body tissue may be derived, for example, by deriving at least one item of elasticity information and / or at least one item of body part circumference information, e.g., the circumference of the ankle and / or wrist and / or the elasticity of the ankle and / or wrist.

[0070] In summary, without excluding further embodiments, the following embodiments can be envisaged:

[0071] Embodiment 1: A diagnostic device for monitoring at least one body tissue of a patient, in particular for monitoring physical swelling of the body tissue of a patient, the diagnostic device comprising: a. at least one bracelet configured to be wrapped around a body part of the patient, specifically around one or more of the patient's ankle, thigh, lower leg, wrist, forearm, and upper arm; b. at least one electromechanical actuator configured to actively vary the circumference of the bracelet; c. at least one measuring unit configured to determine at least one item of information related to the power applied to the electromechanical actuator and at least one item of circumference information related to the circumference of the bracelet; and d. A diagnostic device comprising at least one evaluation unit configured to determine at least one item of information regarding the state of the body tissue from an item of information regarding the power applied to the electromechanical actuator and an item of circumference information.

[0072] Embodiment 2: The diagnostic device according to the preceding embodiment, wherein the evaluation unit is configured to determine the contact point at which the circumference of the bracelet corresponds to the circumference of the body part.

[0073] Embodiment 3: A diagnostic device according to any one of the preceding embodiments, wherein the electromechanical actuator comprises at least one electric motor.

[0074] Embodiment 4: The diagnostic device of the preceding embodiment, wherein the electric motor is selected from the group consisting of a DC motor and a stepper motor.

[0075] Embodiment 5: A diagnostic device described in any one of the preceding two 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 to vary the circumference of the bracelet.

[0076] Embodiment 6: A diagnostic device according to any one of the preceding embodiments, wherein the diagnostic device comprises at least one control unit configured to control at least one measurement routine of the diagnostic device.

[0077] Embodiment 7: The measurement routine includes at least one elasticity measurement step, wherein the elasticity measurement step: -adjusting the circumference of the bracelet to at least one first circumference; - changing the circumference of the bracelet from a first circumference to at least one second circumference, in particular to at least one second circumference smaller than the first circumference, wherein an item of information regarding the power applied to the electromechanical actuator and an item of circumference information are recorded.

[0078] Embodiment 8: A diagnostic device as described in the preceding embodiment, wherein the items of information regarding the state of the body tissue include at least one item of elasticity information regarding the body tissue, and the evaluation unit is configured to derive the items of elasticity information from the items of circumference information recorded during the elasticity measurement step and the items of information regarding the power applied to the electromechanical actuator.

[0079] Embodiment 9: A diagnostic device as described in the preceding embodiment, wherein the evaluation unit is configured to derive an item of elasticity information from at least one of: a slope of a measurement curve indicative of the power applied to the electromechanical actuator and the circumference of the bracelet; a slope of a measurement curve indicative of the circumference of the bracelet and the power applied to the electromechanical actuator; at least two measurement points, each measurement point indicative of the circumference of the bracelet and the power applied to the electromechanical actuator.

[0080] Embodiment 10: The measurement routine includes at least one body part circumference measurement step, the body part circumference measurement step comprising: The diagnostic device of any one of the four preceding embodiments, comprising: - decreasing the circumference of the bracelet, wherein an item of information regarding the power applied to the electromechanical actuator and an item of circumference information are recorded.

[0081] Embodiment 11: A diagnostic device as described in the preceding embodiment, wherein the items of information regarding the state of the body tissue include at least one item of body part circumference information regarding the body tissue, and the evaluation unit is configured to derive the items of body part circumference information from the items of information regarding the power applied to the electromechanical actuator and the items of circumference information recorded during the body part circumference measurement step.

[0082] Embodiment 12: A diagnostic device as described in the preceding embodiment, wherein the item of body part circumference information relating to the body tissue includes a value relating to the absolute circumference of the body part around which the bracelet should be wrapped.

[0083] Embodiment 13: A diagnostic device described in any one of the preceding two embodiments, wherein the evaluation unit is configured to determine an item of body part circumference information related to the body tissue from at least one of: a slope of a measurement curve indicating the 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 power applied to the electromechanical actuator; and at least two measurement points, each measurement point indicating the circumference of the bracelet and the power applied to the electromechanical actuator.

[0084] Embodiment 14: A diagnostic device described in any one of the four preceding embodiments, wherein the absolute value of the circumference of the bracelet is determined during the body part circumference measuring step, in particular to determine the absolute circumference of the body part around which the bracelet is wrapped.

[0085] Embodiment 15: The absolute value of the circumference of the bracelet is - taking into account the absolute length of the bracelet and the absolute length of the loose ends of the bracelet, in particular the absolute length of the entire bracelet is known and the absolute length of the loose ends is determined by using a length sensor, more particularly the length sensor is an electromechanical actuator, or - taking into account at least one location marker located on the bracelet.

[0086] Embodiment 16: A diagnostic device according to any one of the preceding embodiments, wherein the bracelet comprises at least one toothed belt or rack configured to interact with an electromechanical actuator.

[0087] Embodiment 17: A diagnostic device according to the preceding embodiment, wherein the diagnostic device comprises at least one pinion driven by an electromechanical actuator, the pinion being configured to interact with a toothed belt.

[0088] Embodiment 18: A diagnostic device described in any one of the preceding embodiments, wherein the at least one measuring unit comprises at least one electrical measuring device configured to determine at least one item of information relating to the power applied to the electromechanical actuator, and at least one position measuring device configured to determine at least one item of circumference information relating to the circumference of the bracelet.

[0089] Embodiment 19: A 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.

[0090] Embodiment 20: A diagnostic device described in any one of the preceding two embodiments, wherein the position measuring device is configured to determine at least one of: an absolute position of at least one portion of the bracelet; a relative position of at least one first portion of the bracelet with respect to at least one second portion of the bracelet; a change over time in the absolute position of at least one portion of the bracelet; or a change over time in the relative position of at least one first portion of the bracelet with respect to at least one second portion of the bracelet.

[0091] Embodiment 21: A method of monitoring at least one body tissue of a patient, the method comprising: i. providing at least one diagnostic device according to any one of the preceding embodiments; ii. wrapping the bracelet around the patient's body part; iii. Actively varying the circumference of the bracelet by using an electromechanical actuator; iv. determining, by using the measurement unit, at least one item of information relating to the power applied to the electromechanical actuator and at least one item of circumference information relating to the circumference of the bracelet; and v. A method comprising: determining at least one item of information regarding the state of body tissue from an item of information regarding the power applied to the electromechanical actuator and an item of circumference information by using at least one evaluation unit.

[0092] Embodiment 22: The method according to the preceding embodiment, wherein step v further comprises determining, by using at least one evaluation unit, a contact point at which the circumference of the bracelet corresponds to the circumference of the body part.

[0093] Embodiment 23: The method of any one of the preceding two embodiments, wherein at least step v is computer-implemented.

[0094] 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 referring to a diagnostic device, that cause the evaluation unit to perform step v of the method according to any one of the preceding embodiments referring to a method.

[0095] Embodiment 25: A computer-readable storage medium, a non-volatile computer-readable storage medium comprising instructions, in particular instructions that, when executed by an evaluation unit of a diagnostic device according to any one of the preceding embodiments referring to a diagnostic device, cause the evaluation unit to perform step v of the method according to any one of the preceding embodiments referring to a method.

[0096] Further optional features and embodiments are disclosed in more detail in the following description of the embodiments, preferably in conjunction with the dependent claims. Therein, each optional feature can be realized separately and in any possible combination, as understood by a person skilled in the art. The scope of the present invention is not limited by the preferred embodiments. The embodiments are illustrated schematically in the figures, in which the same reference numerals in these figures refer to the same or functionally equivalent elements. [Brief explanation of the drawings]

[0097] [Figure 1] 1 shows an embodiment of a diagnostic device in a cross-sectional view with the bracelet in an open position. [Figure 2] 2 shows the diagnostic device of FIG. 1 with the bracelet in a closed position. [Figure 3] 3 illustrates the interaction of the pinion and electromechanical actuator of the diagnostic device of FIG. 2 with the toothed belt of the bracelet. [Figure 4A] 3 shows a measurement routine that involves narrowing the circumference of the bracelet of FIG. 2 while the bracelet is wrapped around a patient's body part. [Figure 4B]3 shows a measurement routine that involves narrowing the circumference of the bracelet of FIG. 2 while the bracelet is wrapped around a patient's body part. [Figure 5] 4A and 4B illustrate the determination of at least one item of information relating to the state of a body tissue from a measurement routine, such as that shown in FIGS. 4A and 4B. DETAILED DESCRIPTION OF THE INVENTION

[0098] 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, diagnostic device 110 comprises a bracelet 112 configured to be wrapped around a body part of the patient. In FIG. 1, bracelet 112 is shown in an open configuration, and in FIG. 2, bracelet 112 is shown in a closed configuration.

[0099] The diagnostic device 110 further comprises at least one electromechanical actuator 114. In the illustrated embodiment, the electromechanical actuator 114 may specifically comprise an electric motor 116. The diagnostic device 110 may further comprise at least one pinion 118 coupled to the electromechanical actuator 114, as also shown in the embodiment. The pinion 118 may form a gear that interacts with the bracelet 112. By way of example, the pinion 118 may interact with a toothed belt 120 coupled to and / or integrated into the bracelet 112, which may extend along the entire length of the bracelet 112 or along a portion of the length of the bracelet 112.

[0100] The electromechanical actuator 114 may be coupled or fixed to a first portion 122, such as an end portion, of the bracelet 112. As can be seen by comparing Figures 1 and 2, in a closed configuration, the bracelet 112 may form a loop having a diameter D, which, if the loop is a circular loop, corresponds to the perimeter of the loop divided by π. For non-circular loops, the diameter D may be determined as an equivalent diameter, which is the diameter of a circle having the same cross-sectional area as the non-circular loop. The diameter D of the loop may be proportional to the perimeter of the loop.

[0101] As further seen in FIG. 2 , the bracelet 110 may include a fastener 113 designed to form a loop on the bracelet 110, and the electromechanical actuator 114 is or is configured by the fastener 113. The fastener 113 may refer to a unit that connects the ends of the bands together to form a loop, particularly a unit separate from the bands used to form the bracelet 113. The fastener 113 may be open and / or closed. The fastener 113 may be a clasp and / or closure required to form the loop on the bracelet 110. The electromechanical actuator 114 may interact with the bracelet 112 to move the second portion 124 of the bracelet 112 relative to the first portion 122. This is shown in detail in FIG. 3 , which shows a close-up 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, clockwise in FIG. 3, the second portion 124 of the bracelet 112 is moved, for example, to the left in FIG. 3. This can change the circumference and diameter D of the loop in FIG. 2. By way of example, in the direction of movement shown in FIG. 3 relative to the setting in FIG. 2, the diameter D, and therefore the circumference, increases. By reversing the direction of movement of the pinion 118, counterclockwise, the diameter D, and therefore the circumference, can decrease.

[0102] To monitor the patient's body tissue and generate at least one item of information related to the state of the body tissue, the diagnostic device 110 includes further elements as shown schematically in FIGS. 1 and 2 . Accordingly, the diagnostic device 110 first includes at least one measurement unit 126 configured to determine at least one item of information related to the power applied to the electromechanical actuator 114 and at least one item of circumference information related to the circumference of the bracelet. Furthermore, the diagnostic device 110 includes at least one evaluation unit 128 configured to determine at least one item of information related to the state of the body tissue from the item of information related to the power applied to the electromechanical actuator and the item of circumference information. Optionally, the diagnostic device 110 may further include at least one control unit 130 configured to control the diagnostic device 110, e.g., to control at least one measurement routine of the diagnostic device 110. Although shown as single, separate components in the figures, the units 126, 128, and 130 may each be fully or partially integrated into one or more other components, such as within the electromechanical actuator 114 and / or each other. Units 126, 128, and 130 may be separate from bracelet 112, may be connected to electromechanical actuator 114 in a wireless or wired manner, or may be fully or partially integrated into bracelet 112 and / or electromechanical actuator 114.

[0103] By way of example, the measurement unit 126 may be fully or partially coupled to an electrical energy supply or power source of the electromechanical actuator 114, which may be an internal and / or external source. Additionally, the measurement unit 126 may derive at least one item of circumference information from the relative positions of the first and second portions 122, 124 and / or from the state of the electromechanical actuator 114, e.g., from the rotational position of the pinion 118. Various concepts are possible and may be implemented in the present invention.

[0104] In FIGS. 4A and 4B , the diagnostic device 110 is shown with the bracelet 112 wrapped around a patient's body part 132, which has body tissue 134. The sequence of these figures may also provide a measurement routine and / or be part of a measurement routine controlled, for example, by the control unit 130. Thus, first, the bracelet 112 of FIG. 4A is loosely wrapped around the body part 132, e.g., the patient's ankle and / or wrist. The loose end 136 of the bracelet 112, which protrudes from the electromechanical actuator 114, may have a length d1. Thus, the absolute circumference of the loop formed by the bracelet 112 may be determined by considering the absolute length of the bracelet 112 and the absolute length of the loose end 136. To do so, the absolute length d of the entire bracelet 112, and in particular the band of the bracelet 112, may be predetermined or known. In addition, the length d of the loose end 136 may be determined. l may be predetermined, known, or determined by using a length sensor. The length sensor may be the electromechanical actuator 114. The loop of the bracelet 112 may have an initial circumference, particularly when the bracelet 112 is first attached 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 attachment of the bracelet 112 to the patient's body part 132 to determine the initial absolute length dl of the loose end 136. The initial absolute circumference length may be calculated by subtracting the initial absolute length d of the loose end 136 from the known absolute length d of the entire bracelet 112. l Alternatively, the position markers of the bracelet 112 may be used to determine the absolute circumference of the bracelet 112, and in particular the loops of the bracelet.

[0105] By moving electromechanical actuator 114, for example by rotating motor 116, the diameter D of the bracelet is changed from D1 in Figure 4A to D2 in Figure 4B. This causes the length of loose end 136 to increase from length d1 in Figure 4A to length d1 + d2 in Figure 4B. As an example, for a circular loop, the diameter decreases from D1 = (d - d1) / π in Figure 4A, where d is the overall length of bracelet 112, to D2 = (d - d1 - d2) / π in Figure 4B.

[0106] This measurement routine can be used to derive one or more items of information regarding the condition of the body tissue 134. An example is shown in Figure 5, which shows a graph of the power p applied to the electromechanical actuator 114 on the vertical axis as a function of the position of the first portion 122 relative to the second portion 124, indicated by x. 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.

[0107] As can be seen in FIG. 5 , when the electromechanical actuator 114 is actuated, a low power p0 must initially be applied to change the circumference of the bracelet 112, as long as the bracelet 112 is loosely wrapped around the circumference of the body part 132. However, once the circumference of the bracelet 112 is mated with that of the body part 132, approximately equivalent to the situation in FIG. 4B , the body tissue 134 begins to exert a counterforce against further constriction of the bracelet 112. Therefore, the power p that must be supplied to the electromechanical actuator 114 to further reduce the circumference of the bracelet 112 begins to rise. This is the case at position x0 in FIG. 5 . The rise can be detected, for example, by a measurement unit and / or an evaluation unit. Because there is a direct relationship between position x0 and the circumference of the bracelet 112, which can be determined, for example, by geometric considerations and / or calibration measurements, x0 can provide body part circumference information related to the circumference of the body tissue 134, e.g., the body part 132.

[0108] Going further, the reaction force increases, for example, according to Hooke's law or other physical relationship between applied force and stretching or compressing an object, particularly bodily tissue. As an example, if x is further increased by a distance Δx, the power p applied to the electromechanical actuator 114 may increase from p0 to p1. A slope may then be determined, for example, by dividing the increase in power by the change in distance: S=Δp / Δx=(p1-p0) / Δx. The slope may provide an item of elasticity information.

[0109] By combining the above options, for example, two different parameters of interest may be derived for determining the state of the body tissue 134. Thus, at least one item of body part circumference information and at least one item of elasticity information may be generated. Instead of the above-mentioned variables, other variables may be used, such as information on the force and / or angle applied by the electromechanical actuator 114. Various options are possible. [Explanation of symbols]

[0110] 110 Diagnostic Devices 112 Bracelet 113 Fastener 114 Electromechanical Actuators 116 Motor 118 Pinion 120 Toothed Belt 122 First Part 124 Second Part 126 measurement units 128 evaluation units 130 Control Unit 132 Body parts 134 Body tissues 136 Loose Ends

Claims

1. A diagnostic device (110) for monitoring at least one body tissue (134) of a patient, said diagnostic device (110) comprising: a. at least one bracelet (112) configured to be wrapped around a body part (132) of the patient; b. at least one electromechanical actuator (114) configured to actively vary the circumference of said bracelet (112); c) at least one measuring unit (126) configured to determine at least one item of information relating to the power applied to said electromechanical actuator (114) and at least one item of circumference information relating to the circumference of said bracelet (112); d. a diagnostic device (110) including at least one evaluation unit (128) configured to determine at least one item of information related to the state of the body tissue (134) from the item of information related to the power applied to the electromechanical actuator (114) and the item of circumference information, the evaluation unit (128) configured to determine contact points at which the circumference of the bracelet (112) corresponds to the circumference of a body part.

2. The diagnostic device (110) of claim 1, wherein the electromechanical actuator (114) comprises at least one electric motor (116).

3. The diagnostic device (110) of claim 2, wherein the electric motor (116) is selected from the group consisting of a DC motor and a stepper motor.

4. 4. The diagnostic device (110) of claim 2 or 3, 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. 5. The diagnostic device (110) of claim 1, wherein the diagnostic device (110) comprises at least one control unit (130) configured to control at least one measurement routine of the diagnostic device (110).

6. The measurement routine includes at least one elasticity measurement step, the elasticity measurement step comprising: adjusting the circumference of said bracelet (112) to at least one first circumference; The diagnostic device (110) of claim 5, further comprising changing the circumference of the bracelet (112) from the first circumference to at least one second circumference, wherein an item of information regarding the power applied to the electromechanical actuator (114) and an item of circumference information are recorded.

7. 7. The diagnostic device (110) of claim 6, wherein the items of information regarding the state of the body tissue (134) include at least one item of elasticity information regarding the body tissue (134), and the evaluation unit (128) is configured to derive the items of elasticity information from the items of circumference information recorded during the elasticity measurement step and items of information regarding the power applied to the electromechanical actuator (114).

8. The evaluation unit (128) the slope of a measurement curve indicating the power applied to the electromechanical actuator (114) and the circumference of the bracelet (112); the slope of a measurement curve representing the circumference of the bracelet (112) and the power applied to the electromechanical actuator (114); at least two measurement points, each measurement point indicating the circumference of the bracelet (112) and the power applied to the electromechanical actuator (114); 8. The diagnostic device (110) of claim 7, configured to derive said items of elasticity information from at least one of:

9. The measurement routine includes at least one body part circumference measurement step, the body part circumference measurement step comprising: A diagnostic device (110) according to any one of claims 5 to 8, comprising reducing the circumference of the bracelet (112), wherein an item of information about the power applied to the electromechanical actuator (114) and an item of circumference information are recorded.

10. 10. The diagnostic device (110) of claim 9, wherein the items of information about the state of the body tissue (134) include at least one item of body part circumference information about the body tissue (134), and the evaluation unit (128) is configured to derive the items of body part circumference information from the items of information about the power applied to the electromechanical actuator (114) and the circumference recorded during the body part circumference measurement step.

11. 11. The diagnostic device (110) of claim 10, wherein the item of body part circumference information for the body tissue (134) includes a value for the absolute circumference of the body part around which the bracelet (110) is to be wrapped.

12. The evaluation unit (128) the slope of a measurement curve indicating the power applied to the electromechanical actuator (114) and the circumference of the bracelet (112); the slope of a measurement curve representing the circumference of the bracelet (112) and the power applied to the electromechanical actuator (114); at least two measurement points, each measurement point indicating the circumference of the bracelet (112) and the power applied to the electromechanical actuator (114); 12. The diagnostic device (110) of claim 10 or 11, configured to determine the item of body part circumference information relating to the body tissue (134) from at least one of:

13. 13. The diagnostic device (110) of any one of claims 1 to 12, wherein the bracelet (112) comprises at least one toothed belt (120) configured to interact with the electromechanical actuator (114).

14. 14. The diagnostic device (110) of claim 13, wherein the diagnostic device (110) comprises at least one pinion (118) driven by the electromechanical actuator (114), the pinion (118) configured to interact with the toothed belt (120).

15. 15. A diagnostic device (110) according to any one of claims 1 to 14, wherein the at least one measuring unit (126) comprises at least one electrical measuring device configured to determine the at least one item of information relating to the power applied to the electromechanical actuator (114) and at least one position measuring device configured to determine the at least one item of circumference information relating to the circumference of the bracelet (112).

16. 1. A method for 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 claims 1 to 15; ii. wrapping the bracelet (112) around the patient's body part (132); iii. Actively varying the circumference of the bracelet (112) by using the electromechanical actuator (114); iv. Using said measuring unit (126), determining at least one item of information relating to the power applied to said electromechanical actuator (114) and at least one item of circumference information relating to the circumference of said bracelet (112); v. determining, by using said at least one evaluation unit (128), at least one item of information relating to the state of said body tissue (134) from the item of information relating to the power applied to said electromechanical actuator (114) and from said item of circumference information, and determining, by using said at least one evaluation unit (128), a contact point at which the circumference of said bracelet (110) corresponds to the circumference of said body part.

Images