WEARABLE ULTRASOUND DEVICE FOR SIGNALLING CHANGES IN A HUMAN OR ANIMAL BODY

Abstract

A wearable ultrasound device for signalling changes in human or animal body, and use of such a wearable device for signalling over a prolonged period of time. In an example the changes occur in a bladder. Such is especially relevant for elderly persons, women after delivery of a baby, lesion patients, demented people, children, and others, have a difficulty to control functioning of the bladder, and to be at the toilet on time to urinate.

Claims

1. A wireless ultrasound device for continuously or semi-continuously signalling a change in a body tissue over a prolonged period of time, body vessel or body cavity, comprising: (i) at least one first electrical-acoustical element, wherein the first element is capable of generating an ultrasound frequency pulse of 20 kHz-50 MHz, and at least one second electrical acoustical element, wherein the second element is capable of detecting a reflected ultrasound frequency pulse of 20 kHz-50 MHz, (ii) at least one processor for controlling the device, (iii) an electrical power provider in connection with the transducer, and processor, (iv) a positioner for maintaining the device in a position, (v) a voltage controller for applying a voltage to the transducer, wherein (vi) at least one sensor for determining posture of a body of a user in a continuous or semi-continuous mode, such as a tilt sensor, and one or more of a direction means for directing the generating and/or detecting means, a contacting means for contacting the device to a skin of the body, and an energy scavenger, and wherein the device is wearable and is substantially flat, and wherein the device configures itself automatically to an optimal setting, and wherein the wearable device consists of one integrated package.

2. The device according to claim 1, wherein the at least one first element is a transducer, and wherein the at least one second element is a transducer.

3. The device according to claim 1, comprising at least one array of first elements, and comprising at least one array of second elements.

4. The device according to claim 2, wherein the transducers are capable of operating separately, sequentially, in phase-shift mode, in parallel mode, in frequency scan mode, in spatial scan mode, in intensity mode, in pulsed mode, variations thereof, and combinations thereof.

5. The device according to claim 1, comprising a transceiver for wireless communication between the device and an external supporting device, and comprising stored on the device and/or stored on the external supporting device software and/or gathered data.

6. The device according to claim 1, wherein the contacting means comprises an acoustical matcher between the skin and the transducer/device, and a package for containing a gel, wherein the contacting means are preferably removable from the device, and wherein the positioner is an adhesive, a strap, a belt, a blister, and combinations thereof, and wherein the positioning means and contacting means may be one and the same.

7. The device according to claim 1, comprising a movement sensor.

8. The device according to claim 1, further comprising at least one of an alarm generator, a false signal detector, a false contact detector, a touch sensor, a pressure sensor, a clock, a timer, a multiplexer, an activator, an electric stimuli generator, a vibrator, an ADC, a DAC, an amplifier, an LED for signalling, a sound generator, a GPS-sensor, and an on-off button, and at least one of a transceiver, an RFID, a unique identification code, and at least one threshold, the threshold for determining a pre-set unique identity, and wherein the device is integrated.

9. The device according to claim 1, wherein the device is one or more of an IC, a MEMS, a piezoelectric element, and a printed circuit board (PCB).

10. The device according to claim 1, wherein the voltage source and the at least one transducer are in electrical contact.

11. A use of a device according to claim 1 for determining or monitoring a liquid volume in a cavity, wherein the cavity is selected from a bladder, a uterus (amniotic fluid), a sinus, a pleural cavity, a pericardial sac, and a vessel for detecting or monitoring at least one of aneurism, infection, tumour, dehydration, pleural effusion, urine influx rate from at least one kidney, hydrocephalus, a size of a human or animal cavity, for determining a liquid volume in a lung, for training, for ultrasound image forming, as a flow sensor, for (semi)continuous monitoring over longer periods of time, for monitoring during normal life, and for monitoring outside a hospital or caretaking environment.

12. A method of operating an ultrasound device according to claim 1, comprising the steps of: determining or deducing posture of a user, using the posture of a user in determining an amount of liquid in a bladder, based on the amount determined, performing a further act, or refraining from further action.

13. The method according to claim 12, wherein the ultrasound device provides a signal if a pre-set unique minimum amount of liquid is exceeded, and a location of said person or device, and wherein the at least one first transducer provides at least one pulse at one or more of a given time-interval, a given time, a pre-determined time, and upon error-detection for generating a warning.

14. The method according to claim 12, wherein the at least one first transducer has a centre frequency of 20 kHz-50 MHz, an active area of 4*10.sup.−4-2000 mm.sup.2, a near field length of 0.1-50 mm, is positioned at an angle of 0-45 degrees relative to the skin, and wherein the at least one second transducer is positioned at an angle of 5-50 degrees relative to the skin.

15. The method according to claim 14, wherein a MEMS is used having an active area of 4*10.sup.−4-10.sup.2 mm.sup.2.

Description

SUMMARY OF FIGURES

[0090] FIG. 1 is a schematic set-up of part of the present device.

[0091] FIG. 2 is a schematic set-up of the present device.

[0092] FIGS. 3-4 show a schematic set-up of the present device.

DETAILED DESCRIPTION OF FIGURES

[0093] In FIG. 1 a schematic set-up of part of the present device is given. Therein a number of (6) transducers (n) is attached to the device comprising electronics (p). The transducers (n) are connected to the electronics (p) via a cable.

[0094] In the electronics a multiplexer (f) selects one of the transducers (n). A high-voltage driver (d) generates a pulse that excites the transducer such that it generates an ultrasound wave. The transducer converts the reflected ultrasound wave into an electrical signal which is amplified by a Low Noise Amplifier (m). A signal dependent attenuation is compensated for by an optional Time Gain Amplifier (l) which can be configured digitally by using a digital-to-analogue converter (h). After digitization of the signal by the analogue-to-digital-converter (k), the data can be stored in a volatile memory (a) and non-volatile memory (g), such as an SD Card. Signal processing can be performed on the device using the digital configurable logic, such as an FPGA (j), possibly combined with information from a posture sensor (b). The information obtained can be send wirelessly to a computer, phone or tablet by a wireless transceiver (c). Further a power supply (i) and a T/R switch (e) are shown.

[0095] In FIG. 2 a schematical set-up of the present device is given. Therein a positioner 1 in the form of a ribbon is shown. The device is connected to electronics by a wire 4. The present ultrasound transducer(s) and optional further components are in a casing 2. The positioner 1 comprises a recess which fits an optional positioning knob 3 for further precisely positioning the device.

[0096] Further details of the figures are given throughout the description.

Examples

Measurement Procedure

[0097] Measured ultrasound signals are processed using specifically made software. Before interpretation of the data, the received signals will first be pre-processed by filtering and/or amplifying the signal. This step reduces the influences of high and/or low frequency noise in the signal. A time-gain amplifier and/or a band pass frequency filter may be used. Furthermore, the signals will be analysed by a custom-made algorithm, which will determines the time between the echo pulses, which is used to calculate a distance between the front wall and back wall of the bladder (bladder depth) by multiplication of this time lapse with the speed of ultrasound in the body.

[0098] Using a bench-top setting several measurements were made in healthy adults proofing that the distance between an anterior wall and posterior wall can be measured and that the distance measured varies based on the degree of filling of the bladder. An algorithm is used to make the above visible and enable the setting of an alarm, if relevant. A technical design (attached) has been made for a clinical prototype which encompasses all elements currently thought to be necessary to be effective. This clinical prototype may be worn semi-permanently. Using the transducer to be used in the clinical prototype in combination with a time-gain amplifier and the bench-top set used earlier, measurements have been made in healthy adults and these have been compared to measurements made by an expert using standard ultrasound.

[0099] The bladder depth measured is compared with earlier measurements and possibly with the predicted course of the increase of the bladder depth, and the algorithm determines if the measurement is in line with expectations.

[0100] Unexpected outliers are discarded and new measurements may be made. Repeated unexpected results may cause an alarm being set off to warn the wearer and/or his caretaker(s) that the device may not be working properly.

[0101] The present algorithm also determines if the alarm should be activated by using one or more of the rules set out below:

1. If the measured bladder depth exceeds a predetermined limit, the alarm is set off. This limit may be based on: age, and/or length, and/weigh, and/or gender/sex of the wearer; or maybe be determined individually (see below)
2. By comparing the new measured bladder depth with the previous measurements, the algorithm determines the increase in bladder depth. When the bladder becomes completely full the increase in bladder depth will slow down, or even stop completely, and an alarm is set off.
3. If the time since a last urination exceeds a predetermined time the alarm is set of. This predetermined time limit may be set individually or be based on age, weight, length and or gender/sex of the wearer.

[0102] Parameters used by the algorithm to determine the moment that the alarm is set off may be tuned individually to adjust for the individual situation. This may be done manually and/or automatically: the algorithm may be self-learning, in a way all the relevant data of a user are saved and by using a built-in algorithm the system will calculate the best individual limit for setting off the alarm. Relevant parameters and indicators may be status of a pregnancy, age, weight, sex, medical history, post-operative situation, medication, and anaesthetic.

[0103] The algorithms used for determining bladder depth, the moment for setting of the alarm and regulating individual limits, may also use data on posture and movement as generated by a accelerometer of other movement and/or posture sensor either as part of the device or separate.

[0104] An algorithm is used to determine an optimal position of the device, such as by searching an echo of a signal. The amplitude and characteristics are required to fall within pre-set boundary conditions.

[0105] An algorithm is used to establish a quality of a signal; if required a measurement can be repeated, improved, such as by phase-shift, etc.

[0106] Algorithms may be present for detecting aneurism, amount of rest urine, dehydration, etc. Additional transducers may be present for said purpose.

[0107] An algorithm may be present for providing bio-feedback, e.g. in order to train a user, such as a child.

[0108] An algorithm may be present to minimize energy consumption, e.g. by taking into account a learning curve.

[0109] An algorithm may be present to set an alarm when the bladder is 80% filled, and when it is fully filled.

[0110] An algorithm is used to measure a thickness of the belly wall and of belly fat. This measurement is used to further optimise functioning of the present device.

[0111] An error detection algorithm is present, e.g. for detecting “absence” of a bladder.

[0112] An algorithm may be present for forecasting and prediction.

Example of Pulse Generation

[0113] Initially a first transducer is excited with a voltage pulse and an echo is detected by a second transducer if an echo signal is sensed within a pre-set time interval for the echoes from the front and back of the cavity with liquid. For instance in case of a bladder a pre-set time is close to the time interval of 20 microseconds and 200 microseconds, for a front and back wall respectively. The echo signals are recorded by the second transducer. After repeating this for several first and second transducers and recording the strength of the echo signals, those transducers are selected having a suitably strong echo signal for further use. In an alternative the first and second transducer are one and the same.

[0114] Using these selected transducers a measurement is executed as a sequence of, for instance, 5 pulses and detection of the echo after each pulse. The time difference between de first and second echo's within the interval is used to calculate the distance between front and back wall of the cavity, in this example the bladder. With an algorithm, depending on the angular viewing angles of the transducers along all directions, the size of the cavity is calculated.

[0115] The use of the present device may involve an initiation procedure when the device is positioned, such as on the body of a human being for detection of a liquid filled cavity, such as a bladder. During the initiation voltage pulses are applied at a set of one or more first transducers, and after detection of echo signals on second transducers during a pre-set time window, an algorithm determines which transducers give a favourable signal, which leads to a selection of a set of transducers for an optimized operation with more (further) pulse excitations.

[0116] At installation of the present device on a person, the tuning may be done with the help of a doctor or professional help for optimized viewing angles and time intervals for having a good signal.

[0117] In an example of an application, the present device can be used to determine the rest urine after letting out urine naturally, as rest urine is considered a main cause for infections. An advantage over existing rest urine equipment is that with the present device the patient is free to move around while waiting to urinate without a required presence of a health care professional who will use a handheld non-wearable device for measurement of the rest urine.

Examples of Contacting Means

1. Addition of a Self-Adhesive (Silicone) Tape or Pad

[0118] By adding a self-adhesive tape or pad, the present bladder monitor can be properly positioned against a patient's abdomen without irritation to the skin. The material of the tape or pad is preferably water based, for example a silicone gel. Examples of current clinical applications using these kind of materials are wound dressings, bandages, and scar management. Another clear example of using medical-grade, self-adhesive silicone is the NuBra®, a strapless, backless adhesive bra. An advantage of using self-adhesive silicone is that it can be used multiple times and also allows proper acoustic coupling for ultrasound applications. E.g. without a use of an ultrasound gel.

2. Ultrasound Coupling (Conductor)

[0119] An important aspect in ultrasound imaging is found to be the ultrasound coupling. Currently, liquid ultrasound gel is used to minimize the acoustic interference of air. However, by using this method, the ultrasound will eventually dry out. In this respect a patch is considered consisting of a chamber which holds an ultrasound transducer. The transducer faces outward towards the opening of the chamber. Inside the chamber, a quantity of ultrasound conductive medium is placed to keep contact with the surface.

3. Semi-Permeable Membrane

[0120] To minimize a loss of ultrasound medium, it is possible to introduce a semi-permeable membrane. Such may include a semi-permeable membrane that is configured to be “leaky”, thereby allowing the contact surface to become slight wet, and allowing efficient ultrasound transmission. The semi-permeable membrane can be thin for efficient ultrasound energy transfer, and to allow liquid to wet the contact surface of the body of ultrasound transmission (e.g. a human).

4. Prototype Example

[0121] The prototype comprises an non-slip strap fixed on the inside of an elastic belt, to increase stability and reduce movement; A self-adhesive silicone tape 21 to position the bladder monitor assembly against the abdomen of a patient; Optionally the bladder monitor can be integrated into a special developed undergarment/pant; in addition a silicone barrier (ring) 22 may be provided.

[0122] Considering the conductive ultrasound medium, experiments are performed to determine if the self-adhesive silicone tape 21 resulted in accurate enough measurements of the bladder diameter (by ultrasound). If the transmission of ultrasound is reduced, a liquid coupling may be used. The liquid coupling gel 23 may be in the middle in front of the transducer. The self-adhesive tape will secure the position of the sensor against the abdomen.

Examples of Positioning Means

1. Addition of a Non-Slip Straps on the Elastic Band/Pants

[0123] When an elastic band (or pants) is used to position the present device, a non-slip strap can be made on the inside of a belt. The non-slip strap is found to increase the friction with the skin, keeping the belt (properly) more in place.

2. Integration of the Casing in a Pants.

[0124] Another possibility is an integration of the present bladder monitor into the undergarment of the patient. In 2008, Phillips published a patent application (WO 2008/004159 A2) for an integrated wireless module into the undergarment of the patient. The patent points out that “it is particularly suitable for implementation in a continuously wearable undergarment with integrated measuring sensors or electrodes, so as to be directly in contact with the subject's skin.”

[0125] A pants prohibits the upwards movement of the present bladder monitor, as result of the strap between the legs. However, without a direct/airless connection to the skin, the bladder monitor will not be able to measure accurate data. For this reason, an undergarments is only useful, when the transducer assembly is in addition stuck to the skin (for example by a silicone adhesive tape).

Example of a Sensor for Determining Posture of a Body of a User

[0126] An example of a suitable tilt sensor is an Adafruit learning system tilt sensor. The sensor has a sensitivity in a range of ±15 degrees, requires a power supply of 24 V and 5 mA.

[0127] The tilt sensor can be integrated with microcontroller, such as a Texas Instrument MSP430F2012. In addition further integration is possible, such as into a circuit board layout or IC. See for example document SLAA309 of June 2006 in this respect.

[0128] The invention although described in detailed explanatory context may be best understood in conjunction with the accompanying examples and figures.