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WO2006064074A1 - Dispositif orthetique dynamique pour la surveillance, le diagnostic et la suppression du tremblement pathologique - Google Patents

Dispositif orthetique dynamique pour la surveillance, le diagnostic et la suppression du tremblement pathologique Download PDF

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Publication number
WO2006064074A1
WO2006064074A1 PCT/ES2005/070170 ES2005070170W WO2006064074A1 WO 2006064074 A1 WO2006064074 A1 WO 2006064074A1 ES 2005070170 W ES2005070170 W ES 2005070170W WO 2006064074 A1 WO2006064074 A1 WO 2006064074A1
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WO
WIPO (PCT)
Prior art keywords
tremor
orthotic device
orthotic
sensors
electronic device
Prior art date
Application number
PCT/ES2005/070170
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English (en)
Spanish (es)
Inventor
Jose Luis Pons Rovira
Eduardo Rocon De Lima
Andres Felipe Ruiz Olaya
Ramon Ceres Ruiz
Leopoldo Calderon Estevez
Juan Manuel Belda-Lois
Javier Sanchez Lacuesta
Ricard Barbera Guillem
Jaime Prat Pastor
Original Assignee
Consejo Superior De Investigaciones Científicas
Instituto De Biomecanica De Valencia
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Publication date
Application filed by Consejo Superior De Investigaciones Científicas, Instituto De Biomecanica De Valencia filed Critical Consejo Superior De Investigaciones Científicas
Publication of WO2006064074A1 publication Critical patent/WO2006064074A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
    • A61B5/1101—Detecting tremor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6824—Arm or wrist

Definitions

  • the present invention relates to biomechanical or biomedical devices for the monitoring, diagnosis and validation of control strategies, both active and passive, to suppress pathological tremor, specifically in the upper limb. As such, they are applicable in the orthoprosthetic industry and in the rehabilitation and medical treatment.
  • Pathological tremor is a strongly disabling symptom characterized by rhythmic and involuntary contractions of the muscles of the human body. Tremor can affect different parts of the body. These rhythmic oscillations are superimposed on the patient's voluntary movement. The amplitude and frequency characteristics of trembling oscillations depend on the type of tremor, whether at rest, postural or kinetic. In addition, for the same patient these characteristics may be altered depending on the activity or conditions that he develops or that he is subjected to.
  • the frequency of these oscillations varies depending on the type of tremor and the pathology.
  • the commonly accepted range ranges from 2 Hz to 12 Hz.
  • the concept of isolation of the trembling movement task is based on the insertion of a serial device between the human body and the task. This approach can be done electronically or mechanically.
  • a clinically established procedure to reduce the amplitude of the tremor is the application of biomechanical loads to the affected limb and is based on orthotic devices or orthotics (E. Rocon, JM Belda-Lois, JJ. Sanchez-Lacuesta, JLPons, Pathological Tremor management: modeling, compensatory technology and evaluation, Technology and Disability, 16, pp. 3-18, 2004).
  • the application of biomechanical loads can be implemented in both active and passive systems.
  • the actuators In active systems, the actuators generate a movement in the member of equal amplitude but in the opposite direction to the trembling movement, thus subtracting the tremor of the global movement of the member. In passive systems, the actuators apply resistive mechanical loads, whether dissipative or inertial.
  • Non-portable braces can be portable or non-portable.
  • Non-portable braces are subject to the affected limb and to a platform attached to the floor (which may be the floor itself, the wheelchair, a table, etc.).
  • Portable braces are attached only to the patient's arm. The way in which both approaches exert the loads on the arm for the suppression of the tremor is radically opposite.
  • the portable orthoses eliminate the tremor between consecutive elements of the kinematic chain of the arm.
  • Non-portable braces eliminate tremor by applying loads from the floor to the arm.
  • the Neater Eater commercial device we can highlight the Neater Eater commercial device, the MIT damped joystick, the CEDO controlled energy dissipation orthosis and the MED energy dissipation modulated arm.
  • the ideal solution is to apply biomechanical loads only to the trembling movement.
  • these devices apply a dissipative biomechanical load independently of the type of tremor that affects the patient.
  • This load is also independent of the type of movement on which it is applied, be it voluntary, trembling or a combination of both.
  • the upper member has as its main function to allow the hand to perform its functions and can reach any point of space, especially any point on the individual's body surface, so that it is possible to approximate, manipulate and move objects, from the body and / or towards it.
  • the kinematic chain formed by the shoulder, the elbow, the forearm, the wrist and the hand has a high degree of mobility, as well as distal capacity for grip with an infinite number of positions and functions.
  • the upper limb is one of the most anatomically and physiologically complex parts of the body.
  • the upper limb is very important because it is capable of developing cognitive, expression and manipulation activities, and intervenes in the exploratory functions of the environment and in all reflex motor acts.
  • the objectives of the upper limb orthoses should be:
  • An orthotic orthosis or platform is defined as a medical device that acts externally to a segment of the human body in order to establish some type of functional compensation.
  • Postural or passive orthoses represent the common form of action of the orthoses of the upper limb, whose main objective is to preserve the functional position of the hand (E. Viosca and others, Guide to the use and prescription of custom orthopedic products, IBV Publications , 1999).
  • a dynamic orthosis can be defined as a group of articulated splints that, through the use of various dynamic devices, manage to improve the functionality of some member.
  • the dynamic orthoses have independent sections in the forearm, wrist, hand and finger segments, to which various joint components are added to obtain the movement and functionality of the limb.
  • a good fixing effect is required as a prerequisite.
  • two different aspects can be considered:
  • the patent presented refers to an ambulatory orthotic platform for monitoring, diagnosis of tremor and validation of control strategies, both active and passive, for the suppression of pathological tremor while preserving natural movement.
  • the device is developed around an articulated structure that allows to support a set of sensors and actuators necessary for the realization of the tasks of monitoring, diagnosis and application of control strategies.
  • the architecture of the platform is formed by a computer program for the management, configuration and presentation of the information of the system of help to the diagnosis and cancellation of the tremor, a programmable device for the execution of the algorithms of acquisition of the signal of the sensors and control of the orthosis, the algorithms for the acquisition, interpretation of the signal of the sensors and activation of the actuators, electronic circuits for the interface between the sensors and actuators with the programmable device, the structure of the orthosis and power supplies for the actuators, in addition to the actuators themselves.
  • the present invention faces the problem of providing new orthotic devices or dynamic orthoses for the evaluation, diagnosis and treatment of human patients with pathological tremor in limbs or upper limbs.
  • the present patent refers to a dynamic orthotic device with a rigid or elastic structure for fixing actuators and sensors, thus enabling the application of different control strategies for Ia suppression of tremor on three joints of the human upper limb (shoulder, elbow and wrist).
  • the structure of the orthotic device can be flexible (textiles or elastic materials) when used as a tool for objectification, monitoring and / or diagnosis of tremor, in which case it does not include the actuators but the rest of the elements.
  • the application of an external force provides the orthotic with a corrective effect. Secondly, it collaborates in the maintenance of a correct alignment of the different segments involved.
  • This orthosis is based on the application of internal stresses, that is, the force is applied between consecutive segments of the member to suppress the tremor of three joints. Efforts can be resistive, dissipative, inertial or those resulting from active control strategies.
  • This device also allows implementing various control strategies, both active and passive, for the suppression of tremor in the joints responsible for flexion / extension of the wrist, flexion extension of the elbow, in addition to the prone-supination of the forearm, so that independent control strategies can be applied to each of these joints by, for example, the use of the method protected in Spanish patent P200302927 (biomechanical method and device for cancellation of pathological tremor) that protects a control strategy for active cancellation of pathological tremor
  • This method could be programmed in the orthosis controller object of this patent.
  • the sensors would be used to capture user movement.
  • An algorithm would allow the determination of the main frequency of the tremor. This information would be used to generate the counter movement that cancels the tremor.
  • the use of this dynamic orthotic device is related, on the one hand, with an objectification, evaluation and diagnosis tool for patients with pathological tremors under normal conditions or to whom any tremor suppression strategy is applied and, on the other hand, with a tool for the treatment of such patients with tremors.
  • the pathological tremor to which the object of the present invention can be applied (both in its aspect of objectification, evaluation and diagnosis, as in its cancellation slope) is the tremor of rest (characteristic of Parkinson's disease), the postural tremor (characteristic of the essential tremor) and the kinetic or intentional tremor (of multiple etiology).
  • Biomechanical data are obtained from a multiplicity of relative or absolute kinematic and / or kinetic sensors. • It offers direct information on the torque and / or tremor power of each joint of the upper limb, which allows us to estimate the contribution of each joint. on the total movement of the tremor in the entire kinematic chain of the upper limb,
  • the scheme of this group of passive orthoses serves as a basic module on which new components can be added.
  • the orthosis facilitates the interface between the tremor suppression system without external reference and the upper limb. This approach has the following advantages:
  • an object of the present invention constitutes a dynamic orthotic device useful for the monitoring, diagnosis and suppression of pathological tremor in any of its variants of the human upper limb, hereinafter orthotic device or orthosis of the present invention, constituted basically by the following components (Figure 1): a) An orthotic structure with joints (1) for the flexion-extension of the elbow, prone-supination of the forearm and flexo-extension of the wrist that It allows the coupling of a set of actuators for the application of forces (4) and sensors (2, 3), responsible for the interface between the actuators (4) of the orthosis and the upper limb of the patient, consisting of: i.
  • a multiplicity of sensors that allow obtaining the kinematic information of the human arm ii.
  • a multiplicity of rotary actuators that allow acting on the affected organ b)
  • Electric power module (5) connected to the electronic device described in b) and capable of converting the command signal from b) into a power signal for the actuator control
  • An external device connected to the electronic device described in b) capable of providing an interface to access all the functionalities of the orthotic platform that allows: i. The adjustment of the parameters of the control strategies, ii. The definition of the orthosis mode of operation, iii. The presentation of the variables measured by the orthosis, iv. The trembling movement analysis, v. The presentation of diagnoses, vi. Storage of the data acquired by the orthosis, vii. Report generation, and viii. The communication with the orthosis.
  • a particular object of the invention is the orthotic device of the invention in which the sensors used to measure the kinematic variables (angular position, speed and acceleration) of ai) are inertial sensors capable of operating in a minimum frequency range between 0 Y 30 Hz, and among others, by way of illustration and without limiting the scope of the invention, belonging to the following group: goniometers, gyroscopes and accelerometers and force. Tremors have been described up to a maximum frequency of 17-20 Hz, so the range up to 30 Hz is conservative and includes all possible tremors. In the example, a sensor that goes beyond is used.
  • Another particular object of the invention constitutes the orthotic device of the invention in which the sensors used to measure the kinetic variables described in a.ii) are force sensors capable of operating in a minimum frequency range between 0 and 30 Hz, and among others, by way of illustration and without limiting the scope of the invention, belonging to the following group: set of strain gauges mounted on the Wheatstone Bridge configuration.
  • Another particular object of the invention constitutes the orthotic device of the invention in which the rotary actuators of a.iii) are motors for producing the earthquake canceling action, and among others, by way of illustration and without limiting the scope of the invention, belonging to the following group: ultrasonic motors and a set of DC motor and reducer.
  • ultrasonic motors and a set of DC motor and reducer.
  • a flat DC motor has been used as an example of a DC motor and reducer.
  • Another particular object of the invention constitutes the orthotic device of the invention in which the programmable electronic device of b) is capable of acquiring signals from the sensors, processing them, analyzing them and generating a control signal of the actuators and implementing strategies for tremor monitoring and identification based on an algorithm in the domain of frequency or time, among others, by way of illustration and without limiting the scope of the invention, belonging to the following group: IEEE-1057 standard, Kalman filter and the Benedict-Bordner filter (JM Belda-Lois, J. Sanchez-Lacuesta, MJ Vivas-Broseta, E. Rocon, L. Bueno, JL Pons, Tremor movement analysis techniques: an approach towards ambulatory systems, Asistive Technology - Shaping the future , pp. 827-831, 2003).
  • a particular embodiment of the orthotic device of the invention is that in which the programmable electronic device of b) belongs to the next group: a microcontroller, a microprocessor, a DSP or a computer running some real-time operating system.
  • the orthotic device of the present invention can be coupled or adapted by one skilled in the art to other existing embodiments of the market, such as, for example, the method protected by the Spanish patent P200301767 can be used as the tremor cancellation algorithm executed by the programmable electronic device described in point 1.b).
  • Another particular object of the invention constitutes the orthotic device of the invention in which the external device of d) is capable of communicating with the programmable electronic device of b) functioning as a configuration tool capable of: a) adjusting the parameters of the control strategies executed by the electronic device of b), and b) define the mode of operation of the orthosis.
  • Another particular object of the invention constitutes the orthotic device of the invention in which the external device of d) functions as an interface tool between the orthotic device and the observer capable of: a) presenting the variables measured by the orthosis, b ) analyze the trembling movement, c) present diagnoses based on the measured values, d) store the data acquired by the orthosis, and e) generate reports on the experiments performed.
  • Another particular object of the invention constitutes the orthotic device of the invention in which the external device d) can operate in both modes, that is, as a configuration and interface tool.
  • Another particular embodiment of the orthotic device of the invention is that in which the external device d) belongs to the following group: a computer, a PDA and a Pocket PC.
  • Another particular object of the invention constitutes the orthotic device of the invention in which the communication between the programmable electronic device of b) and the external device of d) is carried out, among other means, by way of illustration and without limiting the scope of the invention, belonging to the following group: through cables using TCP / IP communication protocols or serial, wirelessly using Bluetooth technology, Baking technology, Wifi technology and IrDA infrared technology.
  • Another particular object of the present invention is the dynamic orthotic device of the invention in which the structure thereof is not rigid but is flexible (textiles or elastic materials).
  • This alternative of the device would be used as a tool for the objectification, monitoring and / or diagnosis of tremor, in which case it also does not include the actuators although the rest of the elements.
  • the platform object of this patent has three different practical operating modes:
  • the platform acts as a system of measurement and characterization of tremor both qualitatively and quantitatively. In this way it does not offer any kind of opposition to the patient's movement, be it this voluntary or trembling movement. In this mode of operation the platform works in real time, allowing reading, processing the data and recording the tremor for different specific tasks to be performed by the patient. That way it behaves as a tool for acquiring and analyzing tremor signals and can be used as an aid for medical diagnosis (the type and degree of tremor a patient is suffering) and to observe the progress of a treatment.
  • the platform acts as a device capable of mechanically damping the effects caused by the tremor, applying forces on the upper limb to compensate for the vibrations caused by the tremor and stabilize the user's voluntary movement. It is important to highlight that in this mode the platform allows the evaluation of the operation of the control strategy through the reading of the sensor signals. In this way, the reduction, or not, of the effects of the tremor on the upper limb can be seen.
  • another object of the present invention constitutes the use of the orthotic device of the present invention, hereinafter used of the orthotic device, in the monitoring and diagnosis of human patients with pathological tremors in normal conditions or to which any strategy of applying them is applied. suppression of tremor and, in addition, in the treatment of human patients with tremors.
  • the pathological tremor to which the object of the present invention can be applied belongs, among others, for illustrative purposes and without limiting the scope of The present invention, to the following group: resting tremor (characteristic of Parkinson's disease), postural tremor (characteristic of essential tremor) and kinetic or intentional tremor (of multiple etiology).
  • FIG. 1 The figure schematically represents the architecture of the proposed orthotic device.
  • Block 1 represents the rigid structure with joints for the elbow, prono-supination of the forearm and flexion extension.
  • Blocks 2 and 3, respectively, represent the kinematic and kinetic sensors coupled to this rigid structure.
  • Block 4 represents the rotary actuators coupled to the rigid structure that allow acting on the affected organ.
  • the block 5 represents an electric power module connected to the programmable electronic device characterized by converting the command signal into a power signal for the actuator control.
  • Block 6 represents a programmable electronic device characterized by executing different control strategies for the suppression of the tremor and capable of generating control signals for the actuator government and of communicating with an external device.
  • Block 7 represents an external device connected to the electronic device capable of providing an interface to access all the functionalities of the orthotic platform and present the data in an appropriate way to the clinicians.
  • the block 8 represents the communication between block 6 and block 7 that can be implemented both wirelessly (Bluetooth, Oven, Wifi or IrDA) and through cables (TCP / IP, serial cable).
  • FIG. 1 Orthosis for cancellation of tremor at the level of the elbow.
  • the figure schematically illustrates the rigid structure for the elbow joint. Coupled to this rigid structure are a set of kinematic and kinetic sensors in addition to a rotary actuator that allow acting on the elbow joint.
  • Example 1 Development of an orthotic solution for cancellation of tremor at the level of the elbow.
  • an orthosis for the cancellation of the tremor at the elbow level is described.
  • the orthotic is formed by a rigid articulated structure that allows supporting a set of sensors and actuators to implement control strategies for the tremor cancellation (Figure 2).
  • two gyroscopes located on the rigid structure on both sides of each joint and offering information on the absolute angular velocity of the segments (arm and forearm) in the plane of motion of the joint are used as kinematic sensors.
  • the frequency range of measurement is between 0 and 50 Hz, thus covering the entire frequency range of possible tremors.
  • the kinetic sensors used in this example for measuring the interaction force between the orthosis and the member are strain gauges.
  • the gauges are responsible for the measurement of the cancellation torque applied by the motors on the structure of the orthotic platform, therefore, they are mounted on the structure so that they measure only the force perpendicular to the motor axis, in this way their measurements They are not influenced by forces originating in unwanted directions.
  • the strain gauges are connected in a Wheatstone Bridge circuit in a combination of four active gauges (full bridge).
  • As an actuator a flat DC motor and reducer assembly is used to generate the earthquake cancellation torque in the joint of interest.
  • the total torque that can be generated by the geared motor assembly is 8 Nm but is limited through the energy delivered by the power module to the engine at 3 Nm, enough to counteract the average torque of the tremor at this level without the possibility of cause damage to the user.
  • a strategy of identification and monitoring of tremor is implemented according to the method described in Spanish patent P200301767.
  • the sampling frequency selected for the identification loop is 1 KHz. Whenever the selected strategy grants the estimate with a delay of a single sample, the delay of the estimate is reduced to 1 ms, negligible compared to the intrinsic frequency of the tremor that is between 2 and 12 Hz.
  • a dynamic model of the upper limb is able to estimate in real time the torque and power values of the tremor in each joint. With this model it is possible to evaluate the contribution of each arm joint on the tremor in the limb of the arm.
  • the method for obtaining arm kinematics is the method of homogeneous transformation matrices (Fu, KS; González, R. C; Lee, CS G; Robotics: control, sensing, vision, and intelligence. McGraw-Hill, Inc. New York, NY, USA, 1997).
  • the model developed is based on the Denavit-Hartenberg parameterization.
  • the parameters related to the dynamics of the member have been obtained through the corrections of Leva to the biomechanical tables of Zatsiorsky and Selyyanoy (VM Zatsiorsky and VN Seluyanov and LG Chugunova, Methods of determining mass-inertial characteristics of human body segments, in Contemporary problems of biomechanics, CRC Press, pp. 272-291, 1990).
  • VM Zatsiorsky and VN Seluyanov and LG Chugunova Methods of determining mass-inertial characteristics of human body segments, in Contemporary problems of biomechanics, CRC Press, pp. 272-291, 1990.
  • Newton's recursive algorithm has been used so that the implementation of the estimation algorithms is allowed in a modular way.
  • a personal computer is used as an external device responsible for the implementation of the user interface.
  • the user interface is programmed in the object-oriented programming language Visual C ++. Communication between the control computer and the interface computer is done through cables using the TCP / IP communication protocol.

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Abstract

L'invention concerne une plate-forme orthétique ambulatoire qui permet de surveiller et de diagnostiquer le tremblement et de valider des stratégies de contrôle, tant actives que passives, afin de supprimer le tremblement pathologique, tout en préservant le mouvement naturel. Le dispositif selon l'invention est développé autour d'une structure articulée qui permet de supporter un ensemble de capteurs et d'actionneurs nécessaires à Ia réalisation des tâches de surveillance, de diagnostic et d'application de stratégies de contrôle.
PCT/ES2005/070170 2004-12-14 2005-12-05 Dispositif orthetique dynamique pour la surveillance, le diagnostic et la suppression du tremblement pathologique WO2006064074A1 (fr)

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ES200402966A ES2272137B1 (es) 2004-12-14 2004-12-14 Dispositivo ortesico dinamico para la monitorizacion, diagnostico y supresion de temblor patologico.
ESP200402966 2004-12-14

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WO2008096031A1 (fr) * 2007-02-09 2008-08-14 Consejo Superior De Investigaciones Científicas Orthèse destinée à amortir les tremblements
DE102014100460A1 (de) * 2014-01-16 2015-07-16 Tyromotion Gmbh Anordnung zur unterstützenden Beeinflussung einer Bewegung, Rehabilitationssystem und Bewegungsunterstützungssystem
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US10603482B2 (en) 2015-09-23 2020-03-31 Cala Health, Inc. Systems and methods for peripheral nerve stimulation in the finger or hand to treat hand tremors
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WO2018187241A1 (fr) 2017-04-03 2018-10-11 Cala Health, Inc. Systèmes, procédés et dispositifs de neuromodulation périphérique pour le traitement de maladies associées à une hyperactivitévésicale
WO2019143790A1 (fr) 2018-01-17 2019-07-25 Cala Health, Inc. Systèmes et méthodes de traitement d'une maladie intestinale inflammatoire par stimulation du nerf périphérique
US12251560B1 (en) 2019-08-13 2025-03-18 Cala Health, Inc. Connection quality determination for wearable neurostimulation systems
US11890468B1 (en) 2019-10-03 2024-02-06 Cala Health, Inc. Neurostimulation systems with event pattern detection and classification

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WO2008096031A1 (fr) * 2007-02-09 2008-08-14 Consejo Superior De Investigaciones Científicas Orthèse destinée à amortir les tremblements
ES2319022A1 (es) * 2007-02-09 2009-05-01 Consejo Superior Investig. Cientificas Ortesis para amortiguacion de temblor.
ES2319022B1 (es) * 2007-02-09 2010-02-08 Consejo Superior Investig. Cientificas Ortesis para amortiguacion de temblor.
US9107614B2 (en) 2011-07-12 2015-08-18 Xanadu Christina Halkias Systems, methods, and media for finding and matching tremor signals
DE102014100460A1 (de) * 2014-01-16 2015-07-16 Tyromotion Gmbh Anordnung zur unterstützenden Beeinflussung einer Bewegung, Rehabilitationssystem und Bewegungsunterstützungssystem

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