WO2011143071A2 - Sem scanner sensing apparatus, system and methodology for early detection of ulcers - Google Patents

Sem scanner sensing apparatus, system and methodology for early detection of ulcers Download PDF

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Publication number
WO2011143071A2
WO2011143071A2 PCT/US2011/035618 US2011035618W WO2011143071A2 WO 2011143071 A2 WO2011143071 A2 WO 2011143071A2 US 2011035618 W US2011035618 W US 2011035618W WO 2011143071 A2 WO2011143071 A2 WO 2011143071A2
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WIPO (PCT)
Prior art keywords
substrate
skin
recited
sensors
sensor
Prior art date
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Ceased
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PCT/US2011/035618
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English (en)
French (fr)
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WO2011143071A3 (en
Inventor
Majid Sarrafzadeh
William Kaiser
Alireza Mehrnia
Barbara Bates-Jensen
Frank Wang
Yeung Lam
Michael Flesch
Joseph Boystak
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Bruin Biometrics LLC
University of California Berkeley
University of California San Diego UCSD
Original Assignee
Bruin Biometrics LLC
University of California Berkeley
University of California San Diego UCSD
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Priority to SG2012081691A priority Critical patent/SG185131A1/en
Priority to HK13109075.4A priority patent/HK1181847B/xx
Priority to CA2811609A priority patent/CA2811609C/en
Priority to BR112012028408A priority patent/BR112012028408B8/pt
Priority to BR122021016044-9A priority patent/BR122021016044B1/pt
Priority to ES11781061.4T priority patent/ES2626143T3/es
Priority to KR1020127031008A priority patent/KR101688918B1/ko
Priority to JP2013509311A priority patent/JP5763751B2/ja
Priority to EP11781061.4A priority patent/EP2569618B1/en
Priority to KR1020167033760A priority patent/KR101809623B1/ko
Priority to BR122021014110-0A priority patent/BR122021014110B1/pt
Priority to EP16196899.5A priority patent/EP3155965B1/en
Priority to AU2011253253A priority patent/AU2011253253B2/en
Priority to CN201180027702.3A priority patent/CN102933958B/zh
Priority to EP22172497.4A priority patent/EP4122383B1/en
Priority to EP19190000.0A priority patent/EP3581105B1/en
Priority to EP23207316.3A priority patent/EP4335362A1/en
Application filed by Bruin Biometrics LLC, University of California Berkeley, University of California San Diego UCSD filed Critical Bruin Biometrics LLC
Publication of WO2011143071A2 publication Critical patent/WO2011143071A2/en
Publication of WO2011143071A3 publication Critical patent/WO2011143071A3/en
Priority to US13/668,047 priority patent/US20130123587A1/en
Anticipated expiration legal-status Critical
Priority to US14/297,977 priority patent/US9220455B2/en
Priority to US14/827,375 priority patent/US9398879B2/en
Priority to AU2015275343A priority patent/AU2015275343C1/en
Priority to US15/058,964 priority patent/US9980673B2/en
Priority to US15/095,046 priority patent/US10188340B2/en
Priority to AU2018204664A priority patent/AU2018204664B2/en
Priority to US16/210,911 priority patent/US11253192B2/en
Priority to US16/440,687 priority patent/US11779265B2/en
Priority to US18/346,103 priority patent/US20230337966A1/en
Priority to US19/028,224 priority patent/US20250152090A1/en
Ceased legal-status Critical Current

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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
    • A61B5/68—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
    • A61B5/6843—Monitoring or controlling sensor contact pressure
    • 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
    • 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
    • A61B5/0531—Measuring skin impedance
    • A61B5/0533—Measuring galvanic skin response
    • 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
    • A61B5/0537—Measuring body composition by impedance, e.g. tissue hydration or fat content
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/44—Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
    • A61B5/441—Skin evaluation, e.g. for skin disorder diagnosis
    • A61B5/443—Evaluating skin constituents, e.g. elastin, melanin, water
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/44—Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
    • A61B5/441—Skin evaluation, e.g. for skin disorder diagnosis
    • A61B5/445—Evaluating skin irritation or skin trauma, e.g. rash, eczema, wound, bed sore
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/44—Detecting, measuring or recording for evaluating the integumentary system, e.g. skin, hair or nails
    • A61B5/441—Skin evaluation, e.g. for skin disorder diagnosis
    • A61B5/447—Skin evaluation, e.g. for skin disorder diagnosis specially adapted for aiding the prevention of ulcer or pressure sore development, i.e. before the ulcer or sore has developed
    • 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
    • A61B5/6844—Monitoring or controlling distance between sensor and tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271—Specific aspects of physiological measurement analysis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271—Specific aspects of physiological measurement analysis
    • A61B5/7285—Specific aspects of physiological measurement analysis for synchronizing or triggering a physiological measurement or image acquisition with a physiological event or waveform, e.g. an ECG signal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
    • A61B2562/0214—Capacitive electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0247—Pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/046—Arrangements of multiple sensors of the same type in a matrix array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/06—Arrangements of multiple sensors of different types
    • A61B2562/066—Arrangements of multiple sensors of different types in a matrix array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/164—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted in or on a conformable substrate or carrier

Definitions

  • This invention pertains generally to monitoring skin pressure ulcers and more particularly to skin ulcer monitoring via measurement of Sub-epidermal Moisture (SEM).
  • SEM Sub-epidermal Moisture
  • An aspect of the present invention is a smart compact capacitive
  • the device incorporates an array of electrodes which are excited to measure and scan SEM in a programmable and multiplexed manner by a battery-less RF-powered chip.
  • the scanning operation is initiated by an interrogator which excites a coil embedded in the apparatus and provides the needed energy burst to support the scanning/reading operation.
  • Each embedded electrode measures the equivalent sub-epidermal capacitance corresponding and representing the moisture content of the target surface.
  • An aspect of this invention is the in situ sensing and monitoring of skin or wound or ulcer development status using a wireless, biocompatible RF powered capacitive sensing system referred to as smart SEM imager.
  • the present invention enables the realization of smart preventive measures by enabling early detection of ulcer formation or inflammatory pressure which would otherwise have not been detected for an extended period with increased risk of infection and higher stage ulcer development.
  • the handheld capacitive sensing imager apparatus incorporates pressure sensing components in conjunction with the sensing electrodes to monitor the level of applied pressure on each electrode in order to guarantee precise wound or skin electrical capacitance
  • embodiment would enable new capabilities including but not limited to: 1 ) measurement capabilities such as SEM imaging and SEM depth imaging determined by electrode geometry and dielectrics, and 2) signal processing and pattern recognition having automatic and assured registration exploiting pressure imaging and automatic assurance of usage exploiting software systems providing usage tracking.
  • One aspect is apparatus for sensing sub-epidermal moisture (SEM) from a location external to a patient's skin.
  • the apparatus includes a bipolar RF sensor embedded on a flexible substrate, and a conformal pressure pad disposed adjacent and underneath the substrate, wherein the conformal pressure pad is configured to support the flexible substrate while allowing the flexible substrate to conform to a non-planar sensing surface of the patient's skin.
  • the apparatus further includes interface electronics coupled to the sensor; wherein the interface electronics are configured to control emission and reception of RF energy to interrogate the patient's skin.
  • Another aspect is a method for monitoring the formation of pressure ulcers at a target location of a patient's skin.
  • the method includes the steps of positioning a flexible substrate adjacent the target location of the patient's skin; the flexible substrate comprising one or more bipolar RF sensors; conforming the flexible substrate to the patient's skin at the target location; exciting the one or more bipolar RF sensor to emit RF energy into the patient's skin; and measuring the capacitance of the skin at the target location as an indicator of the Sub-Epidermal Moisture (SEM) at the target location.
  • SEM Sub-Epidermal Moisture
  • FIG. 1 illustrates an assembled perspective component view of the
  • FIG. 2 illustrates a perspective view of a Kapton-based conforming
  • FIG. 3 shows a top view of an exemplary concentric sensing electrode in accordance with the present invention.
  • FIG. 4 illustrates a side view of a flex stack-up for the Kapton-based conforming sensing substrate shown in FIG. 2.
  • FIG. 5 illustrates a side view of an alternative flex stack-up for a
  • FIG. 6 shows a top view of two-electrode sensing Kapton-based flex sensor substrates for three alternative types of capacitive sensing concentric electrodes.
  • FIG. 7 illustrates an exploded perspective component view of the SEM scanner of FIG. 1 .
  • FIG. 8 illustrates a schematic side view of the SEM scanner of FIG. 1 .
  • FIG. 9 illustrates a schematic side view of the SEM scanner of FIG. 8 in contact with subject skin.
  • FIG. 10 illustrates a perspective view of an assembled SEM scanner with an alternative array of sensors in accordance with the present invention.
  • FIG. 1 1 is a plot of normalized responses of the tested electrodes of the present invention.
  • FIG. 12 is a graph of measured equivalent capacitance for dry volar arm for three different concentric sensor electrodes.
  • FIG. 13 is a plot of time dependent fractional change in capacitance relative to dry skin for three different concentric sensor electrodes (after 30 minutes of applying lotion).
  • FIG. 14 is a plot of time dependent fractional change in capacitance relative to dry skin for three different concentric sensor electrodes (after 15 minutes of applying lotion).
  • FIG. 15 is a plot of fractional change vs. time.
  • FIG. 16 shows a SEM scanner electrode system and electrode layering providing proper shielding from interference.
  • FIG. 17 shows an SEM scanner mechanical compliance for electrodes developed to enable probing of bony prominence.
  • a smart handheld capacitive sensing device employs a programmable sensing electrode array. This is based on methods that use an interrogator to excite the embedded electrodes.
  • FIG. 1 illustrates an SEM scanning/sensing apparatus 10 according to the present invention.
  • the scanner 10 comprises five main components, including a top silicone edge sealing gasket 18 encircling a Kapton-based sensing substrate 16, which rests on a conformal silicone pressure pad 12.
  • a thick annular silicone spacer 20 is disposed under pressure pad to provide free space for the pressure pad to deform.
  • the bottom layer comprises an interface electronics package enclosure 22 that houses interface circuitry for interrogating and transmitting data for evaluation.
  • Electrode sensors 24 and 26 is embedded on a flexible biocompatible substrate 16.
  • Substrate 16 may comprise a laminated Kapton (Polyimide) chip-on-flex.
  • FIG. 2 illustrates one embodiment of a Kapton sensor substrate 16a that comprises an array 14 of differing sized concentric sensing electrodes.
  • a flexible biocompatible Polyimide or Kapton substrate 32 comprises a layer of sensing pads 14 and 15 coated on one side with an ultra thin cover layer 30 of Polyimide (e.g. CA335) to isolate pads electrodes 14,15 from direct moisture contact and also to provide a uniform contact surface.
  • Polyimide e.g. CA335
  • sample capacitive sensing electrodes 14 are shown in FIG. 1.
  • Sensing electrodes 14 may comprise any number of different shape and configurations, such as the concentric circles of array 14, or the interdigitating fingers of sensor 15.
  • FIG. 3 illustrates a close-up top view of a concentric sensing pad 26 in accordance with the present invention.
  • Pad 26 comprises a bipolar configuration having a first electrode 36 comprising an outer annular ring disposed around a second inner circular electrode 38.
  • Outer ring electrode 36 has an outer diameter D 0 and an inner diameter D, that is larger than the diameter D c of the circular inner electrode 38 to form annular gap 40.
  • Inner circular electrode 38 and outer ring electrode 36 are coupled electrically to interface electronics in the interface electronics package 22. As shown in greater detail in FIGS. 4 and 5, electrodes 36 and 38 are disposed on separate layers within the substrate assembly 16.
  • the dimensions of the sensor pads 24, 26 generally correspond to the depth of interrogation into the derma of the patient. Accordingly, a larger diameter pad (e.g. pad 26 or 29) will penetrate deeper into the skin than a smaller pad. The desired depth may vary depending on the region of the body being scanned, or the age, skin anatomy or other characteristic of the patient.
  • SEM scanner 10 may comprise an array of different sized pads (e.g. small pads 24 and medium sized pads 26 shown in FIG. 1 ) each individually coupled to the interface electronics package 22.
  • FIG. 4 illustrates side view of a flex stack-up for a Kapton based
  • a stiffener 50 is disposed under lower coverlay 48, being positioned directly under copper layer 46 of the sensing pads.
  • the stiffener 50 forms a rigid portion of the substrate where sensing pad array 14, connectors (e.g. connectors 66, 76, or 86 shown in FIG. 6) and interfacing (e.g. lead wires 34) are located, so that these areas do not deform, whereas the rest of the substrate is free to deform.
  • the top copper layer 44 is used to etch out electrode array 14 and corresponding copper routing 34 to the connectors.
  • the bottom copper layer 46 preferably comprises a crisscross ground plane to shield electrode array 14 from unwanted electromagnetic interference.
  • the flex substrate 16 assembly comprises Pyralux FR material from Dupont.
  • Pyralux FR material from Dupont.
  • approximately 5mil thick FR9150R double-sided Pyralux FR copper clad laminate is used as the Kapton substrate.
  • Top coverlay 30 comprises Pyralux 5mil FR0150 and the bottom coverlay 48 comprises 1 mil FR01 10 Pyralux.
  • the thickness of the top FR0150 coverlay 30 is an important parameter as it affects the sensitivity of sensing electrodes in measuring skin moisture content.
  • Copper layers 44, 46 are generally 1 .4mil thick, while adhesive layers 42 are generally 1 mil thick.
  • the stiffener 50 is shown in FIG. 4 is approximately 31 mil thick.
  • FIG. 5 shows a side view of a preferred alternative flex stack-up for a Kapton based substrate 120, where thin adhesive layers 42 (1 mil) are used to attach an 18 mil Kapton layer 122 in between 1 .4 mil copper layers 44 and 46, all of which are disposed between 2 mil upper coverlay 30 and 1 mil lower coverlay 48.
  • a stiffener 50 is disposed under lower coverlay 48, being positioned directly under copper layer 46 of the sensing pad.
  • the 31 mil FR4 stiffener 126 forms a rigid portion of the substrate under the array 14 of sensing pads, connectors 66 and interfacing 34.
  • a 2 mil layer of PSA adhesive 124 is used between the bottom coverlay 48 and stiffener 126.
  • the layering of assembly 120 is configured to provide proper shielding from interference.
  • FIG. 6 shows a top view of three separate and adjacently arranged concentric bipolar electrode sensing Kapton-based flex pads 60, 70 and 80 having different sized capacitive sensing concentric electrodes.
  • Pad 60 comprises a substrate having two large concentric electrodes 62 wired through substrate 64 via connectors 34 to lead line inputs 66.
  • Pad 70 comprises a substrate having two medium concentric electrodes 72 wired through substrate 74 to lead line inputs 76.
  • Pad 80 comprises a substrate having two small concentric electrodes 82 wired through substrate 84 to lead line inputs 86.
  • the configuration shown in FIG. 6 is optimized for cutting/manufacturing and also to avoid interference between data lines and sensors.
  • Each of the bipolar electrode pads is individually wired to the electronics package 22 to allow for independent interrogation, excitation, and data retrieval.
  • FIG. 7 illustrates an exploded perspective component view of the SEM scanner 10.
  • the silicone edge sealing gasket 18 is applied over the Kapton sensor substrate assembly 16 to seal and shield the edge interface connectors through which interface electronics package 22 excite and controls the sensing electrode array 14.
  • the Kapton sensor substrate assembly 16 rests on a conformal silicone pressure pad 12 that provides both support and conformity to enable measurements over body curvature and bony
  • pressure sensor 1 1 may be embedded under each sensing electrode 24, 26 (e.g. in an identical array not shown), sandwiched between Kapton sensor substrate 26 and the conformal silicone pressure pad 28 to measure applied pressure at each electrode, thus ensuring a uniform pressure and precise capacitance sensing.
  • Lead access apertures 28 provide passage for routing the connector wires (not shown) from the substrate connectors (e.g. 66, 76, 86) through the pressure pad 12, annular spacer 20 to the interface electronics 22.
  • the annular silicone spacer 20 comprises a central opening 27 that provides needed spacing between the conformal silicone pressure pad 12 and the interface electronics package 22 to allow the pressure pad 12 and flexible substrate to conform in a non-planar fashion to conduct measurements over body curvatures or bony prominences.
  • the interface electronics package 22 is connected to a logging unit or other electronics (not shown) through wire-line USB connector 56.
  • the interface electronics package 22 preferably comprises an
  • FIG. 8 is a schematic side view of the SEM scanner 10 in the nominal configuration, showing the edge gasket 18 over Kapton substrate 16, and lead access apertures 28, which provide access through annular spacer 20 and conformal pad 12 to electronics 22.
  • FIG. 9 illustrates a schematic side view of the SEM scanner 10 in
  • Electrode array 14 which is embedded in substrate16, is shown interrogating into the derma of tissue 25 by directing emission of an RF signal or energy into the skin and receiving the signal and correspondingly reading the reflected signal.
  • the interrogator or electronics package 22 excites electrode coil 14 by providing the needed energy burst to support the scanning/reading of the tissue.
  • Each embedded electrode 14 measures the equivalent sub-epidermal capacitance corresponding to the moisture content of the target skin 25.
  • RF is generally preferred for its resolution in SEM scanning.
  • FIG. 10 illustrates a perspective view of an assembled SEM scanner 10 with an alternative substrate 16b having an array 14 of ten sensors dispersed within the substrate 16b.
  • This larger array 14 provides for a larger scanning area of the subject anatomy, thus providing a complete picture of the target anatomy in one image without having to generate a scanning motion. It is appreciated that array 14 may comprise any number of individual sensors, in be disposed in a variety of patterns.
  • the SEM scanner 10 was evaluated using a number of different sized and types of sensors 26.
  • Table 1 illustrates electrode geometries are used throughout the following measurements.
  • the outer ring electrode diameter D 0 varied from 5 mm for the XXS pad, to 55 mm for the large pad.
  • the outer ring electrode inner diameter D varied from 4 mm for the XXS pad, to 40 mm for the large pad.
  • the inner electrode diameter D c varied from 2 mm for the XXS pad, to 7 mm for the large pad. It is appreciated that the actual dimensions of the electrodes may vary from ranges shown in these experiments.
  • the contact diameter may range from 5 mm to 30 mm, and preferably ranges from 10 mm to 20 mm.
  • FIG. 1 1 is a plot of normalized responses of the tested electrodes of the present invention.
  • the four sensors' (XXS, XS, S, M) normalized responses are compared in FIG. 1 1 and Table 2.
  • the S electrode appears to be most responsive overall to the presence of moisture. Both the M and S electrodes seem to exhibit a peak. This suggests a depth dependency of the moisture being absorbed into the skin, as the roll-off from the M electrode occurs about 5 minutes after the peak for S electrode.
  • the SEM scanner 10 was also tested on the inner arm.
  • a resistive pressure sensor e.g. sensor 1 1 shown in FIG. 7 was also used to measure pressure applied on sensor to the arm. This way, constant pressure is applied across measurements.
  • the dry inner arm was measured using the XS, S and M electrodes. Then, the same area was masked off with tape, and moisturizer lotion was applied for 30 minutes. Subsequent measurements were made on the same location after cleaning the surface.
  • FIG. 12 is a graph of measured equivalent capacitance for dry Volar arm for three different sized (M, S, XS) concentric sensor electrodes before applying the commercial lotion moisturizer.
  • FIG. 13 is a plot of time dependent fractional change in capacitance relative to dry skin for three different concentric sensor electrodes (after 30 minutes of applying lotion).
  • FIG. 14 is a plot of time dependent fractional change in capacitance relative to dry skin for three different concentric sensor electrodes (after 15 minutes of applying lotion) on two subjects. This experiment was performed with faster sampling intervals and with lotion applied for 15 minutes only on forearms of two test subjects. Again, a resistive pressure sensor was used to measure pressure applied on sensor to the arm. This way, constant pressure is applied across measurements. First the dry inner arm was measured using the XS, S and M electrodes. Then the same area was masked off with tape, and lotion was applied for 15 minutes. Subsequent measurements were made on the same location every 5 minutes. Pressure was maintained at 50k Ohms, and the forearm was tested again. We noticed an interesting observation for the case “F” in comparison to case "A” and also compared to previous measurements. Case "F” took a shower right before running the
  • FIG. 15 is a plot of results for fractional change vs. time for M, S and XS electrodes.
  • FIG. 16 shows a preferred embodiment of a layered SEM scanner
  • Pad 104 is connected to lead line inputs 1 16 via wiring 34 along curved path 1 12.
  • Pad 102 is connected to lead line inputs 1 10 via wiring 34 along curved path 106.
  • a stiffener layer e.g. layer 126 in FIG. 5 is provided directly under lead inputs 1 10 and 1 16 (see footprint 108 and 1 14 respectively) and under pads 102 and 104 (see footprint 122 and 120 respectively).
  • the electrode size is approximately 2300 in width by 3910 mil in height.
  • FIG. 17 illustrates the SEM Scanner mechanical compliance (force- displacement relationship) for electrodes of system 100, developed to enable probing of bony prominence.
  • the diamond symbols show the upper electrode 104 response, square symbols show the lower electrode 102 response.
  • the SEM scanner device 10 may also include other instruments, such as a camera (not shown), which can be used to take pictures of the wound, or develop a scanning system to scan barcodes as a login mechanism or an interrogator.
  • a camera not shown
  • a scanning system to scan barcodes as a login mechanism or an interrogator.
  • Patients using the SEM scanner device 10 may wear a bracelet (not shown) that contains data relating to their patient ID. This ID can be scanned by the camera embedded in the SEM scanner 10 to confirm correct patient ID correspondence. Alternatively, a separate RF scanner (not shown) may be used for interrogating the bracelet (in addition to the camera).
  • the SEM scanner device 10 is preferably ergonomically shaped to encourage correct placement of the device on desired body location.
  • the SEM Scanner device 10 of the present invention is capable of generating physical, absolute measurement values, and can produce measurements at multiple depths.
  • An apparatus for sensing sub-epidermal moisture from a location external to a patient's skin comprising: a bipolar RF sensor embedded on a flexible substrate; a conformal pressure pad disposed adjacent and
  • the conformal pressure pad is configured to support the flexible substrate while allowing the flexible substrate to conform to a non-planar sensing surface of the patient's skin; and interface electronics coupled to the sensor; wherein said interface electronics is configured to control emission and reception of RF energy to interrogate the patient's skin.
  • each of the sensors is configured to measure an equivalent sub-epidermal capacitance of a target region of skin; said sub-epidermal capacitance corresponding to the moisture content of the target region of skin.
  • first and second sensors interrogate the skin at different depths.
  • the substrate comprises a substrate assembly comprising a substrate layer; and wherein the sensor comprises a sensing pad having a first electrode embedded on a first side of the substrate and a second electrode embedded on a second side of the substrate.
  • invention 4 further comprising: a pressure sensor positioned in line with said RF sensor; said pressure sensor configured to measure an applied pressure of the substrate at a location on the patient's skin.
  • an array of bipolar RF sensors embedded on a flexible substrate comprising: an array of bipolar RF sensors embedded on a flexible substrate; and a conformal pressure pad disposed adjacent and underneath the substrate; wherein the conformal pressure pad is configured to support the flexible substrate while allowing the flexible substrate to conform to a non-planar sensing surface of the patient's skin; wherein said sensor array is configured to emit and receive RF energy to interrogate the patient's skin; and wherein each of the sensors are independently are individually wired to independently interrogate the patient's skin.
  • each of the sensors is configured to measure an equivalent sub-epidermal capacitance of a target region of skin; said sub-epidermal capacitance corresponding to the moisture content of the target region of skin.
  • first and second sensors interrogate the skin at different depths.
  • each sensor comprises a first electrode in the form of an annular ring having an inner radius and an outer radius and a second electrode comprising an outer radius having a smaller diameter than the first electrode; and wherein said second electrode is concentric with said first radius.
  • the substrate comprises a substrate assembly comprising a substrate layer; and wherein the first electrode is embedded on a first side of the substrate and the second electrode embedded on a second side of the substrate.
  • biocompatible cover layer disposed over said first side of said substrate layer and a lower cover layer disposed under said second side of said substrate layer.
  • a method for monitoring the formation of pressure ulcers at a target location of a patient's skin comprising: positioning a flexible substrate adjacent the target location of the patient's skin; the flexible substrate comprising one or more bipolar RF sensors; conforming the flexible substrate to the patient's skin at the target location; exciting the one or more bipolar RF sensor to emit RF energy into the patient's skin; and measuring the

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PCT/US2011/035618 2010-05-08 2011-05-06 Sem scanner sensing apparatus, system and methodology for early detection of ulcers Ceased WO2011143071A2 (en)

Priority Applications (28)

Application Number Priority Date Filing Date Title
EP23207316.3A EP4335362A1 (en) 2010-05-08 2011-05-06 Method and apparatus for early detection of ulcers by scanning of subepidermal moisture
CA2811609A CA2811609C (en) 2010-05-08 2011-05-06 Sem scanner sensing apparatus, system and methodology for early detection of ulcers
BR112012028408A BR112012028408B8 (pt) 2010-05-08 2011-05-06 Scanner e aparelho para detecção de umidade subepidérmica a partir de local externo à pele do paciente
BR122021016044-9A BR122021016044B1 (pt) 2010-05-08 2011-05-06 Aparelho para detecção de umidade subepidérmica (sem)
ES11781061.4T ES2626143T3 (es) 2010-05-08 2011-05-06 Aparato, sistema y metodología de detección de SEM con escáner, para la detección temprana de úlceras
KR1020127031008A KR101688918B1 (ko) 2010-05-08 2011-05-06 궤양의 조기 발견을 위한 sem 스캐너 감지 장치, 시스템 및 방법
JP2013509311A JP5763751B2 (ja) 2010-05-08 2011-05-06 潰瘍の早期発見のためのｓｅｍスキャナ検出装置、システムおよび方法
EP11781061.4A EP2569618B1 (en) 2010-05-08 2011-05-06 Sem scanner sensing apparatus, system and methodology for early detection of ulcers
KR1020167033760A KR101809623B1 (ko) 2010-05-08 2011-05-06 궤양의 조기 발견을 위한 sem 스캐너 감지 장치, 시스템 및 방법
BR122021014110-0A BR122021014110B1 (pt) 2010-05-08 2011-05-06 Aparelho e scanner para detecção de umidade subepidérmica (sem) a partir de local externo à pele de paciente e método para monitorar a formação de úlceras de pressão em local alvo na pele de paciente
EP16196899.5A EP3155965B1 (en) 2010-05-08 2011-05-06 Radiofrequency sensing method and apparatus for early detection of pressure ulcers
AU2011253253A AU2011253253B2 (en) 2010-05-08 2011-05-06 SEM scanner sensing apparatus, system and methodology for early detection of ulcers
CN201180027702.3A CN102933958B (zh) 2010-05-08 2011-05-06 用于早期溃疡检测的sem扫描器感测设备、系统和方法
EP22172497.4A EP4122383B1 (en) 2010-05-08 2011-05-06 Sem scanner sensing apparatus for early detection of ulcers
EP19190000.0A EP3581105B1 (en) 2010-05-08 2011-05-06 Apparatus for early detection of ulcers by scanning of subepidermal moisture
SG2012081691A SG185131A1 (en) 2010-05-08 2011-05-06 Sem scanner sensing apparatus, system and methodology for early detection of ulcers
HK13109075.4A HK1181847B (en) 2010-05-08 2011-05-06 Sem scanner sensing apparatus, system and methodology for early detection of ulcers
US13/668,047 US20130123587A1 (en) 2010-05-08 2012-11-02 Sem scanner sensing apparatus, system and methodology for early detection of ulcers
US14/297,977 US9220455B2 (en) 2010-05-08 2014-06-06 SEM scanner sensing apparatus, system and methodology for early detection of ulcers
US14/827,375 US9398879B2 (en) 2010-05-08 2015-08-17 SEM scanner sensing apparatus, system and methodology for early detection of ulcers
AU2015275343A AU2015275343C1 (en) 2010-05-08 2015-12-24 SEM scanner sensing apparatus, system and methodology for early detection of ulcers
US15/058,964 US9980673B2 (en) 2010-05-08 2016-03-02 SEM scanner sensing apparatus, system and methodology for early detection of ulcers
US15/095,046 US10188340B2 (en) 2010-05-08 2016-04-09 SEM scanner sensing apparatus, system and methodology for early detection of ulcers
AU2018204664A AU2018204664B2 (en) 2010-05-08 2018-06-27 SEM scanner sensing apparatus, system and methodology for early detection of ulcers
US16/210,911 US11253192B2 (en) 2010-05-08 2018-12-05 SEM scanner sensing apparatus, system and methodology for early detection of ulcers
US16/440,687 US11779265B2 (en) 2010-05-08 2019-06-13 SEM scanner sensing apparatus, system and methodology for early detection of ulcers
US18/346,103 US20230337966A1 (en) 2010-05-08 2023-06-30 SEM Scanner Sensing Apparatus, System and Methodology for Early Detection of Ulcers
US19/028,224 US20250152090A1 (en) 2010-05-08 2025-01-17 SEM Scanner Sensing Apparatus, System and Methodology for Early Detection of Ulcers

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