WO2021007619A1 - Méthodes et appareils de caractérisation de tissus corporels - Google Patents

Méthodes et appareils de caractérisation de tissus corporels Download PDF

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Publication number
WO2021007619A1
WO2021007619A1 PCT/AU2020/050731 AU2020050731W WO2021007619A1 WO 2021007619 A1 WO2021007619 A1 WO 2021007619A1 AU 2020050731 W AU2020050731 W AU 2020050731W WO 2021007619 A1 WO2021007619 A1 WO 2021007619A1
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Prior art keywords
joint
electrode
current
electrodes
sensing electrode
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PCT/AU2020/050731
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English (en)
Inventor
Warren Smith
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Ti2 Medical Pty Ltd
Focused Ultrasound Medical Research Foundation Limited
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Priority claimed from AU2019902504A external-priority patent/AU2019902504A0/en
Application filed by Ti2 Medical Pty Ltd, Focused Ultrasound Medical Research Foundation Limited filed Critical Ti2 Medical Pty Ltd
Publication of WO2021007619A1 publication Critical patent/WO2021007619A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
    • A61B5/4528—Joints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
    • A61B5/4538—Evaluating a particular part of the muscoloskeletal system or a particular medical condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4848—Monitoring or testing the effects of treatment, e.g. of medication
    • 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
    • A61B5/6828—Leg
    • 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
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6831—Straps, bands or harnesses
    • 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
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • 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
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/685—Microneedles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/7405—Details of notification to user or communication with user or patient ; user input means using sound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/742—Details of notification to user or communication with user or patient ; user input means using visual displays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/7475—User input or interface means, e.g. keyboard, pointing device, joystick

Definitions

  • the present disclosure relates to methods for characterisation of body tissue at a joint, including methods of bioimpedance analysis, and apparatus for use in such methods.
  • Bioimpedance analysis involves the measurement of the response of body tissue to externally applied electrical waveform. For example, bioimpedance parameters such as resistance, reactance and phase angle can be recorded, for the purposes of determining blood flow and body composition (e.g., water and fat content).
  • bioimpedance parameters such as resistance, reactance and phase angle can be recorded, for the purposes of determining blood flow and body composition (e.g., water and fat content).
  • the present disclosure provides a method for characterization of body tissue at a joint, the method comprising:
  • a first electrical signal between a pair of current electrodes comprising a first current electrode and a second current electrode connected to tissue at a first side and a second side, respectively, of the joint;
  • the first sensing electrode and the second sensing electrode are connected to tissue at the first side and the second side, respectively, of the joint, and wherein the second current electrode is closer to the joint than the second sensing electrode;
  • the present disclosure provides apparatus for characterization of body tissue at a joint, the apparatus comprising:
  • the pair of current electrodes comprising a first current electrode and a second current electrode adapted to connect to tissue at a first side and a second side, respectively, of the joint;
  • a signal generator adapted to apply a first electrical signal between the pair of current electrodes
  • the pair of sensing electrodes comprising a first sensing electrode and a second sensing electrode adapted to be connected to tissue at the first side and the second side, respectively, of the joint, wherein the second current electrode is closer to the joint than the second sensing electrode;
  • a monitoring device adapted to measure one or more voltages between the first sensing electrode and the second sensing electrode resulting from the application of the first electrical signal, and determine, from the one or more voltage measurements, bioimpedance across the joint.
  • the first current electrode may be further from the joint than the first sensing electrode. Accordingly, along the shortest notional path extending through each of the electrodes, the order of the electrodes may be (i) the first current electrode, (ii) the first sensing electrode, (iii) the second current electrode and (iv) the second sensing electrode.
  • the method and apparatus according to the present disclosure contrasts with a standard tetrapolar (four-electrode) method and apparatus by virtue, for example, of the positioning of the pairs of current and sensing electrodes.
  • a standard tetrapolar four-electrode
  • an electrical signal is applied between two outer current electrodes connected to body tissue on opposite sides of a region of interest, and measurement is made of the voltage across two inner sensing electrodes located on opposite sides of the region of interest at positions inside of the outer current electrodes.
  • the standard arrangement does not have any current electrode that is closer to a region of interest, let alone a joint of interest, than the adjacent sensing electrode.
  • the joint of interest may be placed in a bent configuration.
  • the present disclosure provides a method for
  • characterization of body tissue at a joint comprising:
  • a first electrical signal between a pair of current electrodes comprising a first current electrode and a second current electrode connected to tissue at a first side and a second side, respectively, of the joint, the joint being in a bent configuration
  • first sensing electrode and the second sensing electrode are connected to tissue at the first side and the second side, respectively, of the joint;
  • the placing of the joint in a bent configuration may be such that longitudinal axes of limbs immediately either side of the joint are, relative to each other, angled at more than 60°, angled between about 60° and 120°, angled between about 70° and 110°, angled between about 80° and 100°, angled at about 90°, or otherwise.
  • the patient may be placed in a seated position during measurements.
  • placing the joint at an angle such as those described above, e.g. at a 90° angle, may be relatively comfortable for the patient and may allow for accurate and repeatable placement of suitable electrode configurations.
  • the electrodes may be distributed in a row.
  • the electrodes may be distributed across a linear or non-linear path.
  • the electrodes may be distributed in a row but across a non-linear path., e.g. if the joint of interest is in a bent configuration during application of the signal/measuring of the voltage. Whether the joint is bent or otherwise, the electrodes may all be positioned in the same plane of body, e.g. in the same sagittal or parasagittal plane of the body.
  • the first current electrode may be spaced from the first sensing electrode by at least 1 mm, 2 mm, 5 mm, or 10 mm.
  • the first current electrode may be spaced from the first sensing electrode by no more 300 mm, 150 mm, 100 mm, or 50 mm.
  • the second current electrode may be spaced from the closer of the first current and sensing electrodes by at least 40 mm, at least 50 mm, at least 70 mm, or at least 100 mm. This spacing may be dependent on the size of the joint of interest located at least partially therebetween.
  • the second sensing electrode may be spaced from the second current electrode by at least 1 mm, 2 mm, 5 mm, or 10 mm.
  • the second current electrode may be spaced from the second sensing electrode by no more 300 mm, 150 mm, 100 mm, or 50 mm.
  • electrode placement may be made along the anterior surface of the leg along the longitudinal axes of the upper and lower legs.
  • the electrodes may be positioned in a row.
  • the electrodes may all be positioned substantially on the same parasagittal plane of the body, which plane may extend through the knee cap.
  • the first current electrode and the first sensing electrode may be located on the upper leg (which may include the knee cap), to one side of the knee, and the second current electrode and the second sensing electrode may be located on the lower leg, to the opposite side of the knee.
  • the first current electrode and the first sensing electrode may be located on the lower leg, to one side of the knee, and the second current electrode and the second sensing electrode may be located on the upper leg (which may include the knee cap), to the opposite side of the knee.
  • the electrode arrangements and/or the placement of the joint in a bent configuration in methods of the present disclosure may overcome a major challenge with regard to bioimpedance-based characterization of joints, e.g., major joints such as the knee. It may allow the applied electric current to course deeply within the joint, e.g., within the articular cavity of the joint, the primary spatial location of many joint disorders, yet without major and unquantified contributions from other tissues such as surrounding muscles, vasculature etc.
  • the first sensing electrode is placed on the upper leg and fully on, partially on, or slightly proximal to (e.g. 0.1 mm to 30 mm, 1 mm to 20 mm, 1 mm to 10 mm proximal to) to the kneecap (patella).
  • the first current electrode is spaced proximahy apart from the first sensing electrode (i.e. further up the upper leg), e.g. by 1 mm, 2 mm, 5 mm, 10 mm or more from the first sensing electrode.
  • the second current and sensing electrodes are placed on the lower leg, such that second current electrode, which is closest to the knee, is at least 40 to 100 mm distal from the first sensing electrode, and the second sensing electrode is spaced distahy apart (i.e. further down the lower leg), e.g. by 1 mm, 2 mm, 5 mm, 10 mm or more, from the second current electrode.
  • the second current electrode may be placed on the lower leg at least 40 to 100 mm distahy from the first sensing electrode and the second sensing electrode may be placed distahy apart by 1 mm, 2 mm, 5 mm, 10 mm or more from the second current electrode.
  • voltage (V(Si-S2)) is measured between the pair of sensing electrodes (Si, S2) resulting from the application of the first electrical signal and
  • bioimpedance (Z oi) across the joint of interest (JOI) is determined from the voltage measurement (V(Si- S2)).
  • V(Si- S2) the notation“V(Si- S2)” is intended to represent the voltage drop along the path between sensing electrodes Si and S2, and is thus a scalar difference in voltage between these electrodes.
  • impedance Z can be resolved into real (resistive) and imaginary (reactive) components.
  • Characterisation of electrode-to-tissue contact at the first and second current electrodes may be carried out by measuring voltages between different combinations of the four electrodes.
  • Methods and apparatus according to the present disclosure may provide for a low-cost, easy to use setup for tracking changes associated with application of particular therapies such as manual therapy, ultrasound, electrostimulation, EMF, acupuncture, low- level laser stimulation etc.
  • the present bioimpedance apparatus may form part of a broader therapeutic system, which may include therapeutic elements such as focussed ultrasound stimulators or electrostimulators.
  • the bioimpedance apparatus may provide for feedback on therapeutic progress, e.g. as part of a closed loop therapeutic system.
  • the first electrical signal may be a non-therapeutic (non-stimulating) electrical signal. Accordingly, the first electrical signal may be applied for the purposes of
  • the first electrical signal may be a therapeutic (stimulating) electrical signal and/or a second electrical signal may be applied that is a therapeutic (stimulating) electrical signal.
  • the second electrical signal may have different characteristics to the first electrical signal.
  • a second electrical signal may be applied between the pair of current electrodes at a different time from the application of the first electrical signal, wherein the second electrical signal typically has different characteristics to the first electrical signal.
  • the therapeutic electrical signal may provide electrostimulation therapy to the tissue region of interest or otherwise.
  • the methods and apparatuses described herein may have a variety of applications in relation to joints.
  • they may be employed for general bioelectrical impedance analysis applications such as body composition determination, fluid management, wound assessment and monitoring at joints, which may give more accurate impedance
  • the methods and apparatuses may also be used in joint repair or joint wound healing applications, bone and muscle condition assessment and/or recovery applications at joints or otherwise.
  • the joint may be defective.
  • the joint may be wounded, diseased, strained, broken or otherwise.
  • bioimpedance is measured, using the techniques described herein, on corresponding joints.
  • a relative bilateral bioimpedance data comparison may therefore be achieved.
  • bioimpedance measurements at a first joint e.g. the left knee or elbow
  • bioimpedance measurements at a second corresponding joint e.g. the right knee or elbow
  • FIG. 1 provides a representation of electrode positioning in a method and apparatus for characterization of body tissue at a joint according to an embodiment of the present disclosure
  • FIG. 2 provides a representation of electrode positioning in a method and apparatus for characterization of body tissue at a joint according to an embodiment of the present disclosure
  • FIG. 3 provides a representation of electrode positioning in a method and apparatus for characterization of body tissue at a joint according to an embodiment of the present disclosure
  • FIG. 4 provides an anterior view of electrode positioning relative to a knee in a method and apparatus for characterization of body tissue at a knee according to an embodiment of the present disclosure
  • Fig. 5 provides a parasagittal cross-sectional, anatomical, view of the electrode positioning relative to the knee of Fig. 4;
  • Fig. 6 provides a lateral view of the electrode positioning relative to the knee of Fig. 4;
  • Fig. 7 provides a lateral view of electrode positioning relative to a knee in a method and apparatus for characterization of body tissue at a knee according to an embodiment of the present disclosure
  • FIG. 8 provides a schematic representation of apparatus for characterization of body tissue at a joint according to an embodiment of the present disclosure
  • Fig. 9 provides a representation of bilateral electrode positioning in a method and apparatus for characterization of body tissue at a joint according to an embodiment of the present disclosure.
  • Fig. 10 provides a graph of the resistance difference between left and right knees associated with application of an ice pack to the medial surface of the left knee between times 13.7 and 33.0 min. Description of Embodiments
  • electrodes are provided in accordance with the arrangement shown in Fig. 1.
  • at least four electrodes are provided, including a pair of current electrodes Ii, h and a pair of sensing electrodes Si, S2 which electrodes Ii, I 3 ⁇ 4 Si, S2 are all in electrical contact with a surface 11 of tissue 10 of a patient at or adjacent a joint of interest 12.
  • the joint of interest may be any joint, e.g. a synovial joint such as a knee joint, elbow joint, wrist joint, ankle joint, shoulder joint, finger joint, toe joint, joint of the pelvic girdle, or otherwise.
  • the pair of current electrodes Ii, I2 include a first current electrode Ii, and a second current electrode I2, which are adapted to apply an electrical signal from a signal generator 20 to the tissue 10 including the joint of interest 12.
  • the pair of sensing electrodes Si, S2 include a first sensing electrode Si, and a second sensing electrode S2 and are provided for the purpose of sensing voltages. Nonetheless, the current electrodes Ii, I2 can also provide a voltage sensing function in some embodiments, e.g. for the purpose of measuring contact impedances at different electrodes.
  • the joint of interest 12 is positioned at and directly underneath the tissue surface 11.
  • the first current electrode Ii and the second current electrode I2 are connected to tissue at a first side and a second side, respectively, of the joint of interest 12.
  • the first sensing electrode Si and the second sensing electrode S2 are connected to tissue at the first side and the second side, respectively, of the joint of interest 12, and such that the second current electrode Eis closer to the joint than the second sensing electrode S2.
  • the order of the electrodes in this embodiment is (i) the first current electrode Ii, (ii) the first sensing electrode Si, (iii) the second current electrode I2 and (iv) the second sensing electrode S2.
  • the electrodes Ii , I2, Si, S2 are illustrated in a substantially linear configuration. In some embodiments, however, as represented in Fig. 2, the electrodes Ii , I2, Si, S2 may be distributed across a partially non-linear path, e.g. if the joint of interest is in a bent configuration during application of the signal/measuring of the voltage. Nonetheless, in some embodiments, whether the joint is bent or otherwise, the electrodes T, I2, Si, S2 may all be positioned in a row and/or in the same plane of body, e.g. in the same sagittal or parasagittal plane of the body. As shown in Fig. 2, despite the bending of the joint, along the shortest notional path 13’ extending through each of the electrodes, the order of the electrodes remains the same as in Fig. 1.
  • the electrodes are all positioned on the same surface 11 of the body, e.g. the same anterior, posterior, medial, lateral, superior or posterior surface of the body. In some embodiments, however, as illustrated in Fig. 3, the electrodes may be positioned on opposing surfaces of the body, e.g. such that the first current electrode Ii and first sensing electrode Si are on a first (e.g. anterior) surface 11 of the body and the second current electrode F and the second sending electrode S2 are located on a second (e.g.
  • FIG. 4 A more detailed illustration of example positioning of the electrodes F , I2, Si, S2 relative to a knee is provided in Figures 4 and 5.
  • the electrodes Ii , I2, Si, S2 are placed along the anterior surface along the longitudinal axes of the upper leg 41 and lower leg 42.
  • the electrodes Ii , I2, Si, S2 are positioned substantially on the same parasagittal plane 40 of the body, extending through the knee cap (patella) 43.
  • the first current electrode Ii and the first sensing electrode Si are located on the upper leg 41 (including the knee cap 43), and the second current electrode I2 and the second sensing electrode S2 are located on the lower leg 42, to the opposite side of the knee.
  • the first sensing electrode Si is placed on the upper leg 41 and fully on, partially on, or slightly proximal to (e.g. 0.1mm to 30 mm, 1 mm to 20 mm, 1 mm to 10 mm proximal to) to the kneecap 43.
  • the first current electrode may be spaced proximally apart from the first sensing electrode (i.e. further up the upper leg), e.g. by 1 mm,
  • the second current electrode I2 and second sensing electrode S2 may be placed on the lower leg 42, such that the second current electrode I2 is at least 40 to 100 mm distal from the first sensing electrode Si, and the second sensing electrode S2 is spaced distally apart (i.e. further down the lower leg 41), e.g. by 1mm, 2 mm, 5 mm, 10 mm or more, from the second current electrode I2.
  • One or more parts of the anatomy may be used as anatomical references for location of one or more of the electrodes. For example, in one embodiment, with reference to Fig. 5, a depression 44 may be readily located, e.g. by sliding a finger down the centre of the quadriceps muscle 45 of the upper leg 31.
  • the depression 45 may be superficial to the connection between the quadriceps tendon 46 and the patella 43, i.e. the depression may be just proximal to the patella 43.
  • the depression 45 may be used to align one of the electrodes such as the most proximal electrode (T in this embodiment).
  • the joint of interest may be placed in a bent configuration, e.g. such that longitudinal axes of limbs immediately either side of the joint are, relative to each other, angled at more than 60°, angled between about 60° and 120°, angled between about 70° and 110°, angled between about 80° and 100°, angled at about 90°, or otherwise.
  • the patient may be placed in a seated position during measurements.
  • An illustration of the bending of a knee joint, specifically to a 90° angle, is provided in Fig. 6
  • placing the joint at an angle such as those described above, e.g. a 90° angle, may be relatively comfortable for the patient and may allow for accurate and repeatable placement of suitable electrode configurations.
  • the order and positioning of electrodes may be substantially maintained as per the embodiment of Figs. 1 to 6, the direction may be reversed.
  • the first current electrode Ii and the first sensing electrode Si are located on the lower leg 42
  • the second current electrode F and the second sensing electrode S2 are located on the upper leg 41 (including the knee cap 43), to the opposite side of the knee.
  • the electrode arrangement of the present disclosure may overcome a major challenge with regard to bioimpedance-based characterization of joints, e.g., major joints such as the knee. It may allow the applied electric current to course more deeply within the joint, e.g., within the articular cavity of the joint (see e.g. the articular cavity 47 of the knee between the femur 48 and tibia 49 as illustrated in Fig. 5), the primary spatial location of many joint disorders, yet without major and unquantified contributions from other tissues such as surrounding muscles, vasculature etc.
  • the voltage V(Si-S2) is measured between the pair of sensing electrodes Si, S2 during application of the electrical signal. Since substantially only the current applied between the current electrodes Ii, h that is coursing through the joint of interest 12 is monitored between the sensing electrodes Si, S2, the voltage measurement between the sensing electrodes Si, S2 is dictated by the impedance of the tissue 10 at the joint of interest 12, substantially independent of the impedance of the tissue 10 outside of the joint of interest 12.
  • the bioimpedance Z oi may be determined using Equation 1 :
  • FIG. 8 Apparatus employing an electrode configuration in accordance with Figs. 1 , 2 and 3 is shown schematically in Fig. 8.
  • the apparatus comprises integrated drive and voltage sensing circuitry 31, the circuitry 31 being connected to the pair of current electrodes Ii, I2 to deliver electrical signal current from a power supply 32 across a joint region of interest 12 of a patient 1 and to sense voltages between the pair of sensing electrodes Si, S2 while the signal is delivered.
  • the drive and voltage circuitry 31 is connected to a processor 33, which provides a monitoring device and is configured to control the delivery of the electrical signal, determine the voltage measurements, and process the measurements to determine one or more bioimpedance measurement ZJOI, across the joint of interest in accordance with e.g. Equation 1.
  • Measurements may also be made to determine the quality of electrode contacts, e.g. by determining transverse impedances between different electrode combinations.
  • a user interface 34 (e.g. keyboard, touch screen, etc.) is connected to the processer 33 to allow the user to start and stop the process and/or control other characteristics of the process.
  • the processor 33 is also connected to a display 35 to display at least the determined bioimpedance(s) and/or other indicators about the configuration of the apparatus. Particularly where a touch screen is employed, the display and user interface may be provided by substantially the same element.
  • the processor 33 may also be connected to a loudspeaker 36 to provide an alert signal, e.g. if the apparatus senses an issue, e.g. based on quality of electrode contact. An alert may additionally, or alternatively, be issued on the display 35.
  • the circuitry 31, power supply 32, processor 33, user interface 34, display, 35, and loud-speaker 36 are integrated into a single bioimpedance analysis unit 3, manufactured to carry out the process described above
  • any one or more of these components may be located separately and connected by wires and/or other appropriate communication links including wireless communication links.
  • the processor 33, user interface 34, loud-speaker 36 and display 35 may be provided by more standard personal computing apparatus configured to run bespoke software in order to implement the process described above, which computing apparatus is connected to the integrated drive and voltage sensing circuitry 31 and power supply.
  • a wide variety of apparatus configurations may be used in order to carry out the process described above, including configuring the apparatus as wearable apparatus and/or use of inductive charging for example.
  • the electrical signal is applied for non-therapeutic effect.
  • the electrical signal is applied for the purpose of analysing bioimpedance.
  • the apparatus may be adapted such that the same or additional electrical signals are applied by the current electrodes for therapeutic purposes. These signals may have very different characteristics to those required for bioimpedance analysis, in order to provide therapeutically relevant electrostimulation of the tissue.
  • the techniques to characterise tissue of a joint as describe above are carried out bilaterally, e.g. on both a right arm 51 and a left arm 52 of a body 5.
  • the right arm has a damaged elbow joint 53, the damaged joint 53 being a first joint of interest.
  • the left arm has a healthy elbow joint 54, the healthy joint 54 being a second region of interest.
  • the configuration of the electrodes Ii, Si, Ii, S2 on the left arm is essentially a mirror image of the configuration on the right arm. Accordingly, bioimpedance measurements at a joint of interest, in particular the elbow joint 53, of the right arm can be compared with bioimpedance measurements at the corresponding healthy joint of interest 54 of the left arm 52.
  • one or more of the current and sensing electrodes may use a wet-type contact (e.g. using a conductive paste or hydrogel etc.).
  • the contact may be adhesive or non-adhesive.
  • any one or more of the current and sensing electrodes may use a dry-type contact (e.g. using metal, metal oxide, conductive textile, conformal“tattoo-like” thin-film, microstructured carbon or ultrafine microneedle arrays etc.).
  • Any one of more of the electrodes can be active electrodes which have small or unit amplification close to the electrode. This may allow the electrodes to be used without electrode gel, for example.
  • any one or more of the electrodes may rely on an adhesive contact with the patient, and/or tattoo-like van der Waal’s contact and/or may be held in position using straps, bands, gloves, socks or belts or patient pressure (e.g. through a patient gripping or standing or resting on the electrodes).
  • any one more of the electrodes may be fixed to the patient or be moveable. Any one or more of the electrodes may be provided by the same or different moveable probes, which are brought into contact with the patient.
  • any one or more of the electrodes may take the form of metal plates, discs, strips, ellipses, heart-shapes, squares, rectangles or otherwise. Arrays of such electrodes may also be employed.
  • the electrodes may have a width or diameter of between 0.1 and 15 mm, between 2 mm and 10 mm, between 10 mm and 20 mm, between 10 mm and 100 mm, or otherwise.
  • the electrodes may be comprised in electrode devices that include anisotropically conductive material, e.g. as described in PCT Application No.
  • insulative template or mask layers may be used to define one or more electrodes across larger conductive substrates.
  • Electrodes can be independently mounted, or two or more electrodes can be fabricated onto/into a single carrier material such as a dressing. All or part of any one of the electrodes may be disposable, and discarded following testing to reduce the likelihood of cross-contamination between patients. Alternatively, any one or more of the electrodes may be disinfected after use, and suitably dried.
  • Standard medically-approved leads and cables may be used to connect the electrodes to the control apparatus.
  • the leads may be directly connected to the control apparatus or connected to a wireless transmission unit for wireless transfer of data and/or electrical signals.
  • the electrical signals for the non-therapeutic electrical characterisation of the body tissue may have a variety of different waveforms (frequencies, current levels) etc.
  • the electrical signals may be a continuous AC waveform or pulsed.
  • the electrical signals may have a frequency range of 1 kHz to 100 MHz, preferably 3 kHz to 1MHz. Signals may be in the form of a single frequency, a set of frequencies (i.e. multi-frequency) or a continuous sweep (spectrum) of frequencies.
  • applied current may be between 0.2 mA and 2 mA, e.g., between 5 mA and 250 mA or between 5 mA and 500 mA, or otherwise.
  • the applied voltage may be between 0.05V to 5.0 V, e.g. between 0.2 V to 2.0 V, or otherwise.
  • a constant current drive may be preferable to counteract slight variations in the surface profile / quality of electrode contact at the connection positions.
  • the electrical signals for the therapeutic (stimulating) treatment of the body tissue can be direct current (DC) and/or alternating current (AC).
  • the therapeutic schemes include constant DCs, DC pulses, and ACs.
  • a significant number of choices of different amplitudes, frequencies (AC and pulsed DC), duty cycles, durations, current strengths, etc. can be used.
  • Current is typically very small for DC stimulation (hundreds of mA).
  • Low- voltage pulsed currents can be pulses with durations up to 1 s and voltages up to 150 V, for example.
  • Monophasic and biphasic pulsed currents can be low voltage and high voltage up to several hundred volts with short duration (ps), for example.
  • Bioimpedance measurements were made using electrodes configured in relation to a normal knee, in accordance with the arrangement shown in Figs. 4 to 6, also referred to herein as a“hybrid” arrangement.
  • An electrical signal was applied between current electrodes Ii, . at a frequency of 50 kHz with the subject in seated position and with leg bent at 90°. Biompedance was calculated based on voltage measurements between the sensing electrodes Si, S2.
  • electrodes were positioned outside of the adjacent sensing electrodes, rather than one of the current electrodes being located inside of the adjacent sensing electrode, as per the hybrid arrangement.
  • the hybrid arrangement can provide for greater sensitivity when sensing resistance changes that may be indicative of knee abnormalities.
  • the hybrid electrode arrangement was also found to result in lower resistance values for a patient with diagnosed bilateral osteoarthritis in both knees.
  • Table 2 below shows comparative data between the patient (Subject #1) and a subject with normal knees (Subject#2).
  • Fig. 8 presents the findings as left-right difference in resistance measured with a 2-minute time offset using two bioimpedance devices.
  • the expected increase in knee resistance associated with the application of the ice pack can be seen to be about 1.6 W relative to the baseline during which time the ice pack was not applied to the left knee. Resistance difference can be seen to continue to increase slightly even after the ice pack was removed.

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Abstract

La présente invention concerne des méthodes et appareils de caractérisation de tissus corporels au niveau d'une articulation. Un premier signal électrique est appliqué entre une paire d'électrodes de courant, la paire d'électrodes de courant comprenant une première électrode de courant et une seconde électrode de courant connectées au tissu au niveau d'un premier côté et d'un second côté, respectivement, d'une articulation d'intérêt. Une ou plusieurs tensions sont mesurées entre une paire d'électrodes de détection comprenant une première électrode de détection et une seconde électrode de détection, les tensions résultant de l'application du premier signal électrique. La première électrode de détection et la seconde électrode de détection sont reliées au tissu au niveau du premier côté et du second côté, respectivement, de l'articulation, et la seconde électrode de courant est plus proche de l'articulation que la seconde électrode de détection. La bioimpédance à travers l'articulation est déterminée à partir de la mesure ou des mesures de tension.
PCT/AU2020/050731 2019-07-16 2020-07-16 Méthodes et appareils de caractérisation de tissus corporels WO2021007619A1 (fr)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040167420A1 (en) * 2003-02-22 2004-08-26 Song Chul Gyu Apparatus and method for analyzing motions using bio-impedance
WO2009105895A1 (fr) * 2008-02-29 2009-09-03 Corporation De L'École Polytechnique De Montréal Mesure non invasive de potentiels électriques induits par la charge dans des diarthroses
WO2014201522A1 (fr) * 2013-06-19 2014-12-24 Ti2 Pty Ltd Méthodes et appareils de caractérisation de tissus corporels
US20180289313A1 (en) * 2015-05-27 2018-10-11 Georgia Tech Research Corporation Wearable Technologies For Joint Health Assessment

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040167420A1 (en) * 2003-02-22 2004-08-26 Song Chul Gyu Apparatus and method for analyzing motions using bio-impedance
WO2009105895A1 (fr) * 2008-02-29 2009-09-03 Corporation De L'École Polytechnique De Montréal Mesure non invasive de potentiels électriques induits par la charge dans des diarthroses
WO2014201522A1 (fr) * 2013-06-19 2014-12-24 Ti2 Pty Ltd Méthodes et appareils de caractérisation de tissus corporels
US20180289313A1 (en) * 2015-05-27 2018-10-11 Georgia Tech Research Corporation Wearable Technologies For Joint Health Assessment

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