Method, system and apparatus for using electromagnetic radiation for monitoring a tissue of a user

• US 10,758,150 B2
• Filed: 06/20/2013
• Issued: 09/01/2020
• Est. Priority Date: 09/05/2007
• Status: Active Grant

• Current Assignee: Sensible Medical Innovations Ltd.
• Original Assignee: Sensible Medical Innovations Ltd.
• Inventors: Saroka, Amir, Bergida, Shlomi, Mizrahi, Nadav, Rappaport, Dan, Ronen, Amir, Almog, Benyamin
• Primary Examiner(s): Fernandez, Katherine L
• Application Number:
  US13/922,299
• Publication Number:
  US 20130281800A1
• Time in Patent Office: 2,630 Days
• CPC Class Codes: A61B 5/00 Measuring for diagnostic purposes radiation diagnosis A61B6/00; diagnosis by ultrasonic, sonic or infrasonic waves A61B8/00; Identification of persons
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61B 5/726 using Wavelet transforms
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor

Abstract

A wearable monitoring apparatus for monitoring at least one biological parameter of an internal tissue of an ambulatory user. Said wearable monitoring apparatus comprises at least one transducer configured for delivering electromagnetic (EM) radiation to said internal tissue and intercepting a reflection of said EM radiation said reform in a plurality of transmission sessions during at least 24 hours, a processing unit configured for analyzing respective said reflection and identifying a change in said at least one biological parameter accordingly, a reporting unit configured for generating a report according to said change, and a housing for containing said at least one transducer, said reporting unit, and said processing unit, said housing being configured for being disposed on said body of said ambulatory user.

Claims

1. A wearable monitoring apparatus for monitoring at least one biological parameter of an internal tissue of an ambulatory user, comprising:

at least one transducer having at least one antenna configured for delivering radio frequency radiation having a plurality of different frequencies between 900 MHz and 2.5 GHz to the internal tissue and intercepting said radio frequency radiation from said internal tissue, in a plurality of transmission sessions during a period of at least 24 hours;

a memory storing code; and

at least one processor coupled to the at least one transducer and the memory for executing the stored code, the code comprising;

code instructions for computing a differential signal from a plurality of signals of the intercepted radio frequency radiation obtained over at least one of a breathing cycle and a heart beat cycle using a tissue model of a chest that maps at least one parameter for each of a plurality of tissue layers comprising at least some of a skin tissue layer, a fat tissue layer, a muscle tissue layer, a bone layer and a pulmonary tissue, the at least one parameter that is mapped by the tissue model being time dependent wherein the tissue model is dynamically changed in a circulatory manner having a pattern according to the at least one of the breathing cycle and the heart beat cycle, wherein the differential signal is computed as at least one of;

(i) the differences between the intercepted radio frequency radiation received during inspiratory phase and the intercepted radio frequency radiation received during expiratory phase of the breathing cycle, and (ii) the differences between the intercepted radio frequency radiation received during a systolic phase and the intercepted radio frequency radiation received during a diastolic phase of the heart beat cycle, wherein known changes in internal organs over the at least one of the breathing cycle and the heart beat cycle are used for the computing of the differential signal, wherein said at least one parameter defines for a respective layer of said plurality of tissue layers a member selected from a group consisting of;

a tissue layer dielectric coefficient,

a tissue layer thickness, and

an effect imposed on an RF signal that is propagating in a respective said tissue layer;

code instructions for identifying a change in the at least one biological parameter, according to the differential signal, to detect a medical condition of the ambulatory user; and

code instructions for generating an output for a treatment of the medical condition of the ambulatory user;

wherein said at least one antenna is configured for being disposed on the body of the ambulatory user and adapted to be fixed to at least one location on the body of the ambulatory user.

2. The wearable monitoring apparatus of claim 1, wherein said at least one processor is adapted to cause a remote server to perform at least one of said computing and said identifying.

3. The wearable monitoring apparatus of claim 1, wherein said identifying said change comprises detecting at least one of a trend, a biological process, and a pattern according to said intercepted radio frequency radiation of said plurality of transmission sessions.

4. The wearable monitoring apparatus of claim 1, wherein said at least one processor is adapted to execute code instructions for evaluating a property change in a dielectric related property of the internal tissue in at least one of said plurality of transmission sessions and performing said identification according to said property change.

5. The wearable monitoring apparatus of claim 1, wherein said plurality of transmission sessions are performed in an adaptive rate.

6. The wearable monitoring apparatus of claim 5, wherein said adaptive rate is determined according to a clinical state of the user, said at least one processor being configured for calculating said clinical state according to at least one output of a non radio frequency radiation sensor and said intercepted radio frequency radiation.

7. The wearable monitoring apparatus of claim 5, wherein said at least one processor is adapted to execute code instructions for detecting a posture of the user, said adaptive rate being determined according to said posture.

8. The wearable monitoring apparatus of claim 1, wherein said at least one processor is adapted to execute code instructions for generating a report in real time.

9. The wearable monitoring apparatus of claim 1, wherein said change is indicative of a fluid content change in the internal tissue during said period.

10. The wearable monitoring apparatus of claim 9, wherein said at least one processor is adapted to execute code instructions for detecting a pattern of at least one physiological activity of the user and calculating a clinical state of said user with respect to said fluid content change and to said pattern;

wherein said intercepted radio frequency radiation is being changed as an outcome of at least one thoracic movement during said period.

11. The wearable monitoring apparatus of claim 1, wherein said change is indicative of a member of a group consisting of:

a trauma a degenerative process, atelectasis, a post-operative atelectasis, an acute respiratory deficiency syndrome (ARDS), an infectious cause, an inhaled toxins, a circulating exogenous toxins, a vasoactive substance, a disseminated intravascular coagulopathy (DIC), a burn, an emphysema, a immunologic processes reaction, a uremia, a post drowning lung water level, a pulmonary venous thrombosis, a stenosis, a veno-occlusive disease, a hypoalbuminemia, a lymphatic insufficiency, a high altitude pulmonary edema (HAPE), a neurogenic pulmonary edema, a drug overdose, a pulmonary embolism, an eclampsia, a postcardioversion, a postanesthetic, a postextubation, a post-cardiopulmonary bypass an inflammation progress of ARDS users, and postoperative atelectasis.

12. The wearable monitoring apparatus of claim 1, further comprising a repository configured for storing information pertaining to said user, said at least one processor being configured for performing a signal analysis with respect to said information, wherein said information comprises at least one of physiological, anatomical, and clinical data related to said user.

13. The wearable monitoring apparatus of claim 1, further comprising a non radio frequency radiation sensor configured for evaluating an indicator of a physical condition of said user, said at least one processor identifying said change by a combination of said indicator and said intercepted radio frequency radiation.

14. The wearable monitoring apparatus of claim 1, further comprising a non EM radiation sensor configured for evaluating an indicator to allow performing a signal analysis with respect to said evaluated indicator, said non EM radiation sensor being a member of a group consisting of electromyogram (EMG), an ultrasound transducer, a blood pressure sensor, an optical blood saturation detector, a pulse oximeter, electrocardiogram (ECG), tiltmeter, accelerometer, an activity sensor, and a coagulometer.

15. The wearable monitoring apparatus of claim 1, wherein said at least one processor is adapted to execute code instructions for detecting a physiological activity of the user by signal analysis of said intercepted radio frequency radiation and performing said identifying with respect to said physiological activity.

16. The wearable monitoring apparatus of claim 1, wherein said at least one processor is adapted to execute code instructions for detecting a posture of the user and analyzing said intercepted radio frequency radiation with respect to said posture.

17. The wearable monitoring apparatus of claim 1, wherein said change is indicative of a change in concentration of a solute in the internal tissue.

18. The wearable monitoring apparatus of claim 17, wherein said solute is a member of a group consisting of a salt, glucose, and inflammatory indicative fluid.

19. The wearable monitoring apparatus of claim 1, wherein said radio frequency radiation comprises a narrowband signal of less than 50 Mega Hertz (MHz) bandwidth and a pulse signal of at least 0.5 gigahertz (GHz) bandwidth.

20. The wearable monitoring apparatus of claim 1, wherein said radio frequency radiation is transmitted in a swept frequency mode.

21. The wearable monitoring apparatus of claim 1, wherein said at least one processor is adapted to execute code instructions for providing a position of said at least one antenna in relation to a reference internal tissue of the user, said delivering being performed with respect to said position.

22. The wearable monitoring apparatus of claim 21, wherein said providing a position of said at least one antenna comprises at least one of:

monitoring and guiding the positioning of said wearable monitoring apparatus,

monitoring and guiding the repositioning of said wearable monitoring apparatus, and

identifying at least one of a misplacement and a disengagement of said wearable monitoring apparatus.

23. The wearable monitoring apparatus of claim 21, wherein said providing a position of said at least one antenna comprises causing a mechanical element to change the positioning of said wearable monitoring apparatus.

24. The wearable monitoring apparatus of claim 1, wherein said at least one antenna comprises a planar wide band antenna.

25. The wearable monitoring apparatus of claim 1, wherein said at least one transducer and said at least one processor are configured to be integrated into a garment.

26. The wearable monitoring apparatus of claim 1, wherein said at least one processor is adapted to execute code instructions for providing treatment instructions.

27. The wearable monitoring apparatus of claim 1, wherein said at least one transducer comprises a plurality of transducers configured for delivering radio frequency radiation to the internal tissue and intercepting said intercepted radio frequency radiation therefrom.

28. The wearable monitoring apparatus of claim 27, wherein said plurality of transducers comprises at least one transmitter configured for performing said delivering and at least one receiver configured for performing said intercepting.

29. The wearable monitoring apparatus of claim 1, wherein said at least one transducer being configured for intercepting said intercepted radio frequency radiation from a plurality of sub-areas of said internal tissue for improving the resolution of said intercepted radio frequency radiation.

30. The wearable monitoring apparatus of claim 29, wherein said at least one processor is adapted to execute code instructions for reducing at least one of a noise, a disturbance, a posture movement effect and/or an interference intercepted by said at least one transducer by comparing segments of said intercepted radio frequency radiation from a first and second of said sub-areas.

31. The wearable monitoring apparatus of claim 1, wherein said at least one processor is adapted to execute code instructions for computing a misplacement of said at least one antenna in relation to the internal tissue of said ambulatory user and outputting a notification about said misplacement.

32. The wearable monitoring apparatus of claim 1, wherein at least one of said at least one processor is disposed on the body of the ambulatory user.

33. The wearable monitoring apparatus of claim 1, wherein said plurality of transmission sessions are intermittent.

34. The wearable monitoring apparatus of claim 1, wherein during said period, said at least one processor is adapted to execute code instructions for performing at least one of the following:

detecting at least one of a misplacement and disengagement of the wearable monitoring apparatus,

identifying a data acquisition period suitable for performing a data acquisition session, and

identifying said change by at least one of calculating a baseline and identifying a normal range which are adjusted according to the monitored user.

35. The wearable monitoring apparatus of claim 1, the code instructions further comprising code instructions for reducing an effect of a movement on said change identification, said movement comprises a member of a group consisting of:

a thoracic movement, an internal physiological activity, and an external physiological activity irregularity.

36. The wearable monitoring apparatus of claim 1, the code instructions further comprising code instructions for reducing an effect of a movement on said change identification, said movement comprises a member of a group consisting of:

an organ movement, an antenna movement, a change of posture movement, a bodily movement, an activity related movement.

37. The wearable monitoring apparatus of claim 1, wherein said identifying said change comprises an analysis of differential physiological activities signals.

38. The wearable monitoring apparatus of claim 1, wherein during said period, said at least one processor is adapted to execute code instructions for performing at least one of the following:

computing a reduction to at least one movement effect, and

generating guidance instructions for at least one of repositioning the wearable monitoring apparatus and guiding the monitored user to a posture.

39. The wearable monitoring apparatus of claim 1, wherein said identifying said change comprises detecting a trend that reflect a fluid content change in the fluid content of said internal tissue in said intercepted radio frequency radiation among said plurality of transmission sessions during said period.

40. The wearable monitoring apparatus of claim 1, wherein said at least one processor is adapted to execute code instructions for detecting when a patient wearing said wearable monitoring apparatus is at rest and instructs said at least one transducer to perform at least some of said plurality of transmission sessions in response to said rest detection.

41. The wearable monitoring apparatus of claim 1, wherein said tissue model defines a range of normal dielectric related properties of the internal tissue.

42. The wearable monitoring apparatus of claim 1, wherein said tissue model defines a range of abnormal dielectric related properties of the internal tissue.

43. The wearable monitoring apparatus of claim 1, wherein said tissue model is estimated based on data acquired from said internal tissue by an electromagnetic (EM) sensor.

44. The wearable monitoring apparatus of claim 1, wherein said tissue model is estimated based on data acquired from said internal tissue by a non electromagnetic (EM) sensor.

45. The wearable monitoring apparatus of claim 1, wherein the differential signal is computed as a difference between two or more signals measured during a short period of time.

46. The wearable monitoring apparatus of claim 1, wherein the differential signal is computed based on a reflection from an interface between a lung and a heart during the systolic phase and the diastolic phase of the heart beat cycle.

47. The wearable monitoring apparatus of claim 1, further comprising code for computing a concentration of fluid in the lungs of the ambulatory user according to at least one of amplitude and phase of the differential signal.

48. The wearable monitoring apparatus of claim 1, further comprising code for classifying posture of the ambulatory user according to a position of a highest peak of the differential signal.

49. The wearable monitoring apparatus of claim 1, further comprising code for detecting the at least one of the breathing cycle and the heart beat cycle of the patient according to an analysis of a plurality of signals of the intercepted radio frequency radiation.