Classifications

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  • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
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  • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
  • A61B5/0006—ECG or EEG signals
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  • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
  • A61B5/0008—Temperature signals
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  • A61B5/0013—Medical image data
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  • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
  • A61B5/02055—Simultaneously evaluating both cardiovascular condition and temperature
• • A—HUMAN NECESSITIES
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  • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
  • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
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  • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue
  • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
  • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value ; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
• • A—HUMAN NECESSITIES
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  • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
  • A61B5/25—Bioelectric electrodes therefor
  • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
  • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
  • A61B5/282—Holders for multiple electrodes
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  • A61B5/316—Modalities, i.e. specific diagnostic methods
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  • A61B5/339—Displays specially adapted therefor
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  • A61B5/7405—Details of notification to user or communication with user or patient; User input means using sound
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• • A—HUMAN NECESSITIES
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  • A61B8/4427—Device being portable or laptop-like
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  • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
  • A61B8/4455—Features of the external shape of the probe, e.g. ergonomic aspects
• • A—HUMAN NECESSITIES
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• • A—HUMAN NECESSITIES
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• • A—HUMAN NECESSITIES
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  • A61B8/52—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves
• • A—HUMAN NECESSITIES
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• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
  • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
  • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
• • H—ELECTRICITY
  • H04—ELECTRIC COMMUNICATION TECHNIQUE
  • H04B—TRANSMISSION
  • H04B7/00—Radio transmission systems, i.e. using radiation field
  • H04B7/24—Radio transmission systems, i.e. using radiation field for communication between two or more posts
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  • A61B6/46—Arrangements for interfacing with the operator or the patient
  • A61B6/467—Arrangements for interfacing with the operator or the patient characterised by special input means
  • A61B6/468—Arrangements for interfacing with the operator or the patient characterised by special input means allowing annotation or message recording
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  • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
  • A61B8/4433—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device involving a docking unit

Definitions

• This invention relates to medical apparatus and methods in general, and more particularly to medical apparatus and methods for acquiring diagnostic and prognostic information from a patient at the bedside or at some other patient location.
• a healthcare professional e.g., doctor, nurse, etc. must frequently acquire diagnostic and
• this diagnostic and prognostic information may be acquired by interviewing the patient (or an
• this diagnostic and prognostic information may be acquired by the visual and tactile examination of the patient, e.g., by observing the appearance of the patient, sensing tissue tone and texture, etc. And in some cases this diagnostic and prognostic information may be acquired through the use of medical apparatus, e.g., a stethoscope may be used to acquire sounds from the patient's body (heart, vasculature, lungs, abdomen, etc.), an ultrasound machine may be used to acquire images of internal anatomy (organs,
• an electrocardiogram (ECG) machine may be used to acquire electrical signals from the patient's body, etc.
• the present invention is directed to situations where a medical apparatus is used to acquire
• stethoscopes are commonly utilized to acquire realtime sound information from the patient.
• this real-time sound information is subject to the immediate, on-the-fly, individualized interpretation of the healthcare professional who is using the stethoscope and is not stored for subsequent
• Comparison engine or “auto- interpretation engine” which can compare the current sound information against a library of sound information and its
• ultrasound machines are typically relatively large, cart -mounted devices which must be pre-positioned at the patient's bedside (or at some other patient location) or moved to the patient's bedside (or to some other patient location) prior to use.
• One portable hand-held ultrasound-only device has recently become available in the marketplace, but this device is not normally carried by most healthcare
• ultrasound machines are typically not used as frequently as would be desirable to acquire diagnostic and prognostic information from the patient at the bedside or at some other patient location .
• ECG machines tend to share the same size and logistical limitations as ultrasound machines, i.e., even where they are made smaller or portable, they are still an ECG-only device which is not normally carried by most healthcare professionals as part of their routine equipment due to cost and convenience considerations. Hence ECG machines are also not used as frequently as would be desirable to acquire diagnostic and prognostic information from the patient at the bedside or at some other patient location. Furthermore, the standard 12 -lead ECG machine generally takes some time and skill to set up, further limiting its use at the bedside or at some other patient location.
• each of the foregoing devices i.e., stethoscope, ultrasound machine and ECG
• healthcare professional at the bedside or some other patient location would be extremely useful in properly diagnosing and identifying fluid build-ups in the body (e.g., in the chest, limbs or abdomen) such as by palpation in conjunction with sound information and/or image data, determining appropriate biopsy sites and obtaining desired biopsy specimens, identifying and accessing (e.g., via instrument guidance) desired interventional sites, accurately locating blood vessels, etc.
• the use of sound e.g., the use of sound
• diagnostic and prognostic functions e.g., sound information and image data
• the healthcare professional could be better able to localize a problem (e.g., the healthcare professional could hear an issue via auscultation, and could then immediately run an ultrasound to visualize the problem, instead of having to wait for the results of a separate
• a novel apparatus for acquiring diagnostic and prognostic information from a patient at the bedside or at some other patient location
• the novel apparatus comprises an integrated, hand-held device which is intended to be conveniently carried by the healthcare professional on their person (e.g., in the manner of a conventional stethoscope) and which can be used to acquire sound, image and preferably also electrical and other (e.g., patient history, blood pressure, blood oximetry, patient temperature, etc.) information from the patient, so as to enable the healthcare professional to carry out a rapid, accurate and comprehensive objective physical
• cardiovascular diagnostics and prognostics regardless of any other equipment that may be available at that location, and/or to aid/guide the healthcare professional in therapeutic interventions (e.g., localization of pericardial or pleural effusions and guiding a needle/catheter to drain the fluid) , and to store the diagnostic and prognostic information acquired from the patient, either locally on the device or
• the novel integrated, hand-held apparatus of the present invention facilitates the acquisition of objective diagnostic and prognostic information from the patient
• the present invention facilitates a more accurate and prompt diagnosis and prognosis of patient conditions by the clinician and also allows a broader set of healthcare professionals (e.g., technicians and others who will not actually render a diagnosis) to be involved in the acquisition of diagnostic and prognostic information from the patient .
• an integrated, hand-held apparatus for acquiring diagnostic and prognostic information from a patient at the bedside or at some other patient location, the apparatus comprising:
• a wand comprising:
• a microphone for acquiring sound information from the patient
• an ultrasound emitter/receiver for acquiring image data from the patient
• a base unit comprising: a speaker for presenting sound information to a user;
• a display for presenting image information to a user
• transferring means for transferring the sound information acquired by the microphone, and the image information acquired by the ultrasound
• a wand comprising:
• a microphone for acquiring sound information from the patient
• an ultrasound emitter/receiver for acquiring image data from the patient.
• an integrated, hand-held apparatus for acquiring diagnostic and prognostic information from a patient at the bedside or at some other patient location, the apparatus comprising:
• a wand comprising: a microphone for acquiring sound information from the patient; and
• an ultrasound emitter/receiver for acquiring image data from the patient
• a base unit comprising:
• a speaker for presenting sound information to a user
• a display for presenting image information to a user
• transferring means for transferring the sound information acquired by the microphone, and the image information acquired by the ultrasound
• a pulse oximeter for acquiring pulse rate and Sp0 2 information from the patient, means for transferring the pulse rate and Sp0 2 information from the blood pulse oximeter to the base unit, and means for
• a temperature sensor for acquiring temperature information from the patient, means for transferring the temperature information from the temperature sensor to the base unit, and means for displaying temperature information on at least one of the display and the speaker;
• communication means for permitting the apparatus to communicate with an external network.
• a wand comprising:
• a microphone for acquiring sound information from the patient
• an ultrasound emitter/receiver for acquiring image data from the patient
• a base unit comprising:
• transferring means for transferring the sound information acquired by the microphone, and the image information acquired by the ultrasound
• Fig. 1 is a schematic view showing the front side of a novel integrated, hand-held apparatus for acquiring diagnostic and prognostic information from a patient at the bedside or at some other patient location, wherein the novel apparatus comprises a base unit and a wand;
• Fig. 2 is a schematic view showing the rear side of the novel integrated, hand-held apparatus shown in Fig. 1;
• Fig. 3 is a schematic view showing the internal system components of the base unit of the novel integrated, hand-held apparatus shown in Fig. 1;
• Fig. 4 is a schematic view showing the internal system components of the wand of the novel integrated, hand-held apparatus shown in Fig. 1 ;
• Figs. 4A-4C are schematic views showing
• Fig. 5 is a schematic view showing the novel integrated, hand-held apparatus of Fig. 1 being used to acquire sound information from the body of a patient ;
• Figs. 6 and 7 are schematic views showing the novel integrated, hand-held apparatus of Fig. 1 being used to acquire image information from the body of a patient ;
• Fig. 8 is a schematic view showing integration of the novel integrated, hand-held apparatus of Fig. 1 with an external network;
• FIG. 9 and 10 show alternative constructions for the wand of the novel integrated, hand-held apparatus shown in Fig . 1 ;
• FIG. 11 is a schematic view showing the novel integrated, hand-held apparatus of Fig. 1 being used to acquire electrical information from the body of a patient ;
• Fig. 12 is a schematic view showing a novel pressure cuff which may be used with the novel
• Fig. 13 is a schematic view showing a novel pulse oximeter which may be used with the novel integrated, hand-held apparatus of Fig. 1 to acquire pulse rate information and Sp0 2 information from the body of a patient ;
• Fig. 14 is a schematic view showing a novel temperature monitor which may be used with the novel integrated, hand-held apparatus of Fig. 1 to acquire temperature information from the body of a patient;
• Fig. 15 is a schematic view showing how a docking station may be used with the novel integrated, handheld apparatus of Fig. 1, and also showing further aspects of the present invention
• Fig. 16 is a schematic view showing one exemplary architecture which may be employed in the construction of the novel integrated, hand-held apparatus of Fig. 1;
• Figs. 17-33 are schematic views showing
• Fig. 34 is a schematic view showing an
• Figs. 35-37 are schematic views showing one approach for the "unibody" construction of Fig. 34.
• Figs. 38 and 39 are schematic views showing another approach for the "unibody" construction of Detailed Description Of the Preferred Embodiments
• FIGs. 1 and 2 there is shown novel apparatus 5 for acquiring diagnostic and
• Novel apparatus 5 comprises an integrated, hand-held device which is intended to be conveniently carried by a healthcare professional on their person (e.g., in the manner of a conventional stethoscope) and which can be used to acquire sound, image and preferably also electrical and other (e.g., patient history, blood pressure, blood oximetry, patient temperature, etc.) information from the patient, so as to enable the healthcare professional to carry out a rapid, accurate and comprehensive objective physical examination of the patient at the bedside or at some other patient location, including cardiovascular diagnostics and prognostics, regardless of any other equipment that may be available at that location, and/or to aid/guide the healthcare professional in therapeutic
• a healthcare professional e.g., in the manner of a conventional stethoscope
• electrical and other e.g., patient history, blood pressure, blood oximetry, patient temperature, etc.
• interventions e.g., localization of pericardial or pleural effusions and guiding a needle/catheter to drain the fluid
• to store the diagnostic and prognostic information acquired from the patient either locally on the device or externally on an external network, for later review by that same healthcare professional and/or by others.
• Novel integrated, hand-held apparatus 5 generally comprises a base unit 10 and a wand 15 which is preferably releasably mounted to the base unit.
• Base unit 10 comprises a body 20 generally characterized by a front side 25, a rear side 30, a top end 35, a bottom end 40, a right side 45 and a left side 50.
• a touchscreen display 55 is mounted to front side 25 of body 20.
• Body 20 of base unit 10 is sized so as to be conveniently hand-held by a
• novel apparatus 5 generally comprises a central processing unit (CPU) 60, a local data storage unit 65 (e.g., non-volatile semiconductor memory) , a wireless transceiver 70 (e.g., a Bluetooth device, etc.) for communicating with wand 15 (and/or with other devices.
• CPU central processing unit
• local data storage unit 65 e.g., non-volatile semiconductor memory
• wireless transceiver 70 e.g., a Bluetooth device, etc.
• an input/output interface 75 for driving touchscreen display 55 a wireless transceiver 80 (e.g., a WiFi device) for communicating with an external network (e.g., a wireless computer network operated by a healthcare facility such as a hospital) , a speaker 82 for presenting sound information to the healthcare professional, and a power source (e.g., battery) 85 for powering the aforementioned electrical components, as well as any other electrical components that might be provided in base unit 10.
• a wireless transceiver 80 e.g., a WiFi device
• an external network e.g., a wireless computer network operated by a healthcare facility such as a hospital
• a speaker 82 for presenting sound information to the healthcare professional
• a power source 85 e.g., battery
• wand 15 comprises a body 90 for carrying the various electrical components which provide the wand with its functional
• Body 90 of wand 15 is sized to be conveniently hand-held by a healthcare professional . More particularly, in one preferred form of the invention, wand 15 has an elongated, generally
• cylindrical body 90, and wand 15 comprises a
• an ultrasound emitter/receiver 100 for acquiring image data from the patient
• a wireless transceiver 105 e.g., a Bluetooth device
• a power source e.g., battery
• emitter/receiver 100 used to acquire image data from the patient may be of the sort well known in the art of ultrasound imaging, e.g., it may comprise
• Ultrasound emitter/receiver 100 is preferably also configured to perform Doppler ultrasound (color Doppler and
• spectral e.g., for analyzing blood flow.
• base unit 10 includes one or more retainers 115 (Figs. 1-3) for releasably holding wand 15 to base unit 10.
• base unit 10 may include a recess for receiving wand 15 therein, so that wand 15 may be stored within base unit 10 while the wand is not in use (thereby providing a more integrated form factor which may facilitate
• wand 15 may be releasably stored in a recess 116 formed in base unit 10
• Fig. 4B where wand 15 may selectively project out of a recess 116 formed in base unit 10
• Fig. 4C where wand 15 may be hinged to base unit 10 at a hinge 117 such that wand 15 may fold into a recess 116 formed in base unit 10.
• the healthcare professional is intended to carry novel integrated, hand-held apparatus 5 on their person as they move throughout a healthcare facility (e.g., a hospital) .
• a healthcare facility e.g., a hospital
• the healthcare professional may use a healthcare professional to acquire diagnostic and prognostic information from a patient at the bedside or at some other patient location.
• touchscreen display 55 (Fig. 1) to navigate between the different functional capabilities of novel
• touchscreen display 55 may use touchscreen display 55 to store text information about the patient (e.g., text information acquired by interviewing the patient or an accompanying individual) .
• This information may be stored locally on base unit 10 in local data storage unit 65 and/or uploaded to an external network via wireless transceiver 80 in base unit 10 (e.g., to be added to an Electronic Health Record (EHR) ) .
• EHR Electronic Health Record
• the healthcare professional may also use
• microphone 95 on wand 15 to acquire sound information from the patient, e.g., sounds from the heart, vasculature, lungs, abdomen, etc. See Fig. 5.
• the sound information acquired by microphone 95 on wand 15 is transmitted to base unit 10 via wireless
• Base unit 10 may then present this sound information to the healthcare professional, e.g., audibly via speaker 82 and/or visually via touchscreen display 55. Preferably this sound
• EHR Electronic Health Record
• the healthcare professional may also use
• ultrasound emitter/receiver 100 on wand 15 to acquire image information from the patient, e.g., images of the heart, vasculature, lungs, abdomen, etc. See Figs. 6 and 7.
• image information acquired by ultrasound emitter/receiver 100 on wand 15 is
• Base unit 10 may then present this image information to the healthcare professional visually via touchscreen display 55.
• this image information is also simultaneously stored on base unit 10 in local data storage unit 65 and/or uploaded to an external network via wireless transceiver 80 in base unit 10 (e.g., to be added to an Electronic Health Record (EHR) ) .
• EHR Electronic Health Record
• the sound information acquired from the patient by novel apparatus 5, and/or the image data acquired from the patient by novel apparatus 5, may be used directly by the healthcare professional to make a diagnosis and prognosis. Additionally and/or
• the sound information and/or image data may be used by a computerized “comparison engine” or “auto- interpretation” engine (which can be
• the sound information acquired from the patient by novel apparatus 5, and/or the image data acquired from the patient by novel apparatus 5, may be used by the healthcare professional to
• novel integrated, hand-held apparatus 5 may also acquire data (e.g., text, sounds, images, etc.) from an external network (e.g., a wireless computer network operated by a healthcare facility such as a hospital) via wireless transceiver 80 in base unit 10 (e.g., to access information from an Electronic Health Record (EHR) ) and present that data to the healthcare professional via touchscreen display 55 and/or speaker 82.
• EHR Electronic Health Record
• novel integrated, hand-held apparatus 5 also provides the healthcare professional with access to patient records which may be available from the external network, whereby to further assist the healthcare professional in the diagnosis of the patient.
• access to patient records allows the current diagnostic and prognostic information acquired by novel integrated, hand-held apparatus 5 to be compared with the historic
• diagnostic and prognostic information against a library of diagnostic and prognostic information and its anatomical meaning (e.g., heart murmur, valve issues, etc.) so as to provide further assistance to the healthcare professional.
• anatomical meaning e.g., heart murmur, valve issues, etc.
• wand 15 comprises a microphone 95 for acquiring sound information from the patient, and an ultrasound emitter/receiver 100 for acquiring image data from the patient.
• wand 15 may be constructed so that microphone 95 and ultrasound emitter/receiver 100 are both presented at an end of the elongated, generally cylindrical body 90 of wand 15. See, for example, Figs. 5-7.
• microphone 95 and ultrasound emitter/receiver 100 may be disposed adjacent to one another at one end of wand 15 (e.g., longitudinally adjacent to one another or laterally adjacent to one another), and/or share common components.
• ultrasound emitter/receiver 100 may be disposed at opposite ends of wand 15.
• wand 15 may be constructed so that one component
• body 90 of wand 15 with something other than a generally cylindrical configuration. See, for
• FIG. 9 which show body 90 of wand 15 having a more complex configuration
• microphone 95 intermediate the length of wand 15 and ultrasound emitter/receiver 100 at one end of the wand .
• base unit 10 of novel integrated, hand-held apparatus 5 also comprises a plurality of electrodes 120 for acquiring electrical information from the patient.
• base unit 10 also comprises signal processing circuitry 125 (Fig. 3) for converting the analog electrical signals detected by electrodes 120 into the digital electrical signals required by CPU 60.
• electrodes 120 are disposed adjacent the four corners of rear side 30 of base unit 10, in the manner shown in Fig. 2. In another preferred form of the
• electrodes 120, and the electrodes 120 are arranged in a predetermined pattern on the rear side 30 of base unit 10, with this predetermined pattern being
• the predetermined pattern may be configured so as to optimize the acquisition of particular types of cardiac signals from the body of the patient.
• electrodes 120 be configured in the specific electrode pattern used in a standard 12 -lead ECG procedure; however, it should also be appreciated that important electrical information can be acquired from the patient's body without using a standard 12-lead ECG electrode array, and the plurality of electrodes 120 provided on base unit 10 allow the healthcare professional to acquire some of this important
• the electrical information acquired by the plurality of electrodes 120 can be highly useful to a healthcare professional diagnosing the patient even though electrodes 120 are not configured in a standard 12-lead ECG electrode array.
• the provision of electrodes 120 on novel apparatus 5 allows the healthcare professional to get a quick insight into any heart rhythm abnormalities of the patient almost immediately, without waiting for a traditional 12-lead ECG
• Electrodes 120 is processed by signal processing circuitry 125 and then passed to CPU 60. As a result, the electrical information acquired by
• electrodes 120 may then be presented to the healthcare professional, e.g., visually via touchscreen display 55 and/or audibly via speaker 82. See Fig. 11.
• this electrical information is also
• base unit 10 in local data storage unit 65 and/or uploaded to an external network (e.g., a wireless computer network operated by a healthcare facility such as a hospital) via wireless transceiver 80 in base unit 10 (e.g., to be added to an Electronic Health Record (EHR) ) .
• EHR Electronic Health Record
• base unit 10 preferably includes a connector 130
• FIGs. 2 and 3 for connecting a standard 12-lead ECG electrode array to base unit 10 of novel integrated, hand-held apparatus 5.
• the electrical information acquired by the standard 12-lead ECG electrode array may be processed by signal processing circuitry 125 and CPU 60, and then presented to the healthcare professional, e.g., visually via touchscreen display 55 and/or audibly via speaker 82.
• the electrical information acquired from the standard 12- lead ECG electrode array connected to connector 130 is also simultaneously stored locally on base unit 10 in local data storage unit 65 and/or uploaded to an external network (e.g., a wireless computer network operated by a healthcare facility such as a hospital) via wireless transceiver 80 in base unit 10 (e.g., to be added to an Electronic Health Record (EHR) ) .
• an external network e.g., a wireless computer network operated by a healthcare facility such as a hospital
• wireless transceiver 80 in base unit 10 e.g., to be added to an Electronic Health Record (EHR)
• the electrical information acquired from the patient by novel apparatus 5 may be used directly by the healthcare professional to make a diagnosis and prognosis. Additionally and/or alternatively, the electrical information may be used by a computerized “comparison engine” or “auto- interpretation” engine (which can be incorporated in novel integrated, handheld apparatus 5) to provide additional diagnostic and prognostic information to the healthcare professional .
• the electrical information acquired from the patient by novel apparatus 5 may be used by the healthcare professional to aid/guide the
• novel integrated, hand-held apparatus 5 also provides the healthcare professional with access to patient records (e.g., an Electronic Health Record (EHR) ) which may be available from an external network (e.g., a wireless computer network operated by a healthcare facility such as a hospital) .
• patient records e.g., an Electronic Health Record (EHR)
• EHR Electronic Health Record
• external network e.g., a wireless computer network operated by a healthcare facility such as a hospital
• Such access to patient records allows the current diagnostic and prognostic information acquired by novel integrated, hand-held apparatus 5 (e.g., a current ECG waveform) to be compared with the historic diagnostic and prognostic information in the patient records (e.g., an historic ECG waveform) which can assist the healthcare professional in the diagnosis of the patient. This comparison of current vs.
• historic diagnostic and prognostic information can be effected by the healthcare professional themselves or by a computerized “comparison engine” or “auto- interpretation engine” which can be incorporated in novel integrated, hand-held apparatus 5 or provided by the external network.
• the "auto- interpretation engine” can compare the current diagnostic and prognostic information against a library of diagnostic and prognostic information and its anatomical meaning (e.g., heart murmur, valve issues, etc.) so as to provide further assistance to the heathcare provider.
• blood pressure cuff 135 for acquiring blood pressure information from the patient.
• blood pressure cuff 135 generally comprises an inflatable cuff 140, inflated by a manual or electrical air pump 145, for positioning a blood pressure sensor 150 against an artery of the patient.
• Blood pressure cuff 135 also comprises a wireless transceiver 155 (e.g., a Bluetooth device) for transmitting blood pressure information from blood pressure cuff 135 to base unit 10 (i.e., via the wireless transceiver 70 provided on base unit 10) .
• a wireless transceiver 155 e.g., a Bluetooth device
• the healthcare professional when the healthcare professional wishes to acquire blood pressure data from a patient at the bedside or at some other patient location, the healthcare professional positions blood pressure cuff 135 over an artery of the patient (e.g., around an arm of a patient), and then inflates inflatable cuff 140 using air pump 145.
• the blood pressure information acquired by blood pressure sensor 150 is then transmitted to base unit 10 via wireless transceiver 155 on blood pressure cuff 135 and wireless transceiver 70 on base unit 10.
• This blood pressure information may then be presented to the healthcare professional, e.g., visually via touchscreen display 55 and/or audibly via speaker 82.
• this blood pressure information is also simultaneously stored locally on base unit 10 in local data storage unit 65 and/or uploaded to an external network (e.g., a wireless computer network operated by a healthcare facility such as a hospital) via wireless transceiver 80 in base unit 10 (e.g., to be added to an Electronic Health Record (EHR) ) .
• an external network e.g., a wireless computer network operated by a healthcare facility such as a hospital
• wireless transceiver 80 in base unit 10 e.g., to be added to an Electronic Health Record (EHR)
• the blood pressure information acquired from the patient by novel apparatus 5 may be used directly by the healthcare professional to make a diagnosis and prognosis. Additionally and/or alternatively, the blood pressure information may be used by a
• the blood pressure information acquired from the patient by novel apparatus 5 may be used by the healthcare professional to aid/guide the healthcare professional in therapeutic interventions.
• novel integrated, hand-held apparatus 5 may also acquire data (e.g., text, sounds, images, etc.) from an external network (e.g., a wireless computer network operated by a healthcare facility such as a hospital) via wireless transceiver 80 in base unit 10 (e.g., to access information from an Electronic Health Record (EHR) ) and present that data to the healthcare
• EHR Electronic Health Record
• novel integrated, hand- held apparatus 5 also provides the healthcare
• diagnostic and prognostic information in the patient records which can assist the healthcare professional in the diagnosis of the patient.
• This comparison of current vs. historic diagnostic and prognostic information can be effected by the healthcare
• “comparison engine” or “auto- interpretation engine” which can be incorporated in novel integrated, handheld apparatus 5 or provided by the external network.
• the “auto- interpretation engine” can compare the current diagnostic and prognostic information against a library of diagnostic and prognostic information and its anatomical meaning (e.g., heart murmur, valve issues, etc.) so as to provide further assistance to the healthcare professional.
• integrated, hand-held apparatus 5 may also comprise a pulse oximeter 160 for acquiring pulse rate
• pulse oximeter 160 comprises an appropriate pulse oximeter sensor 165 for positioning against the tissue of the patient (e.g., against a fingertip of a patient) , and a wireless transceiver 170 (e.g., a Bluetooth device) for transmitting pulse oximeter information from pulse oximeter 160 to base unit 10 (i.e., via wireless transceiver 70 provided on base unit 10) .
• a wireless transceiver 170 e.g., a Bluetooth device
• the healthcare professional when the healthcare professional wishes to acquire pulse oximeter data from a patient at the bedside or at some other patient location, the healthcare professional positions pulse oximeter 160 against the tissue of the patient, i.e., so that pulse oximeter sensor 165 is positioned against the tissue of the patient.
• the pulse oximeter information acquired by pulse oximeter sensor 165 is then transmitted to base unit 10 via wireless transceiver 170 on pulse oximeter 160 and wireless transceiver 70 on base unit 10. This pulse oximeter information may then be presented to the healthcare professional, e.g., visually via
• this pulse oximeter information is also simultaneously stored locally on base unit 10 in local data storage unit 65 and/or uploaded to an external network (e.g., a wireless computer network operated by a healthcare facility such as a hospital) via wireless transceiver 80 in base unit 10 (e.g., to be added to an Electronic Health Record (EHR) ) .
• EHR Electronic Health Record
• the pulse rate information and Sp0 2 information acquired from the patient by novel apparatus 5 may be used directly by the healthcare professional to make a diagnosis and prognosis. Additionally and/or
• the pulse rate information and Sp0 2 information may be used by a computerized “comparison engine” or “auto- interpretation” engine (which can be incorporated in novel integrated, hand-held apparatus 5) to provide additional diagnostic and prognostic information to the healthcare professional .
• apparatus 5 may be used by the healthcare professional to aid/guide the healthcare professional in
• novel integrated, hand-held apparatus 5 may also acquire data (e.g., text, sounds, images, etc.) from an external network (e.g., a wireless computer network operated by a healthcare facility such as a hospital) via wireless transceiver 80 in base unit 10 (e.g., to access information from an Electronic Health Record (EHR) ) and present that data to the healthcare
• EHR Electronic Health Record
• novel integrated, hand held apparatus 5 also provides the healthcare
• diagnostic and prognostic information in the patient records which can assist the healthcare professional in the diagnosis of the patient.
• This comparison of current vs. historic diagnostic and prognostic information can be effected by the healthcare
• “comparison engine” or “auto- interpretation engine” which can be incorporated in novel integrated, handheld apparatus 5 or provided by the external network.
• the “auto- interpretation engine” can compare the current diagnostic and prognostic information against a library of diagnostic and prognostic information and its anatomical meaning (e.g., heart murmur, valve issues, etc.) so as to provide further assistance to the healthcare professional.
• integrated, hand-held apparatus 5 may also comprise a temperature monitor 175 for acquiring temperature information from the body of the patient.
• temperature monitor 175 comprises an appropriate temperature sensor 180 for positioning against the tissue of the patient, and a wireless transceiver 185 (e.g., a Bluetooth device) for transmitting
• temperature information acquired by temperature sensor 180 to base unit 10 i.e., via wireless transceiver 70 provided on base unit 10.
• temperature sensor 180 information acquired by temperature sensor 180 is then transmitted to base unit 10 via wireless transceiver 185 on temperature monitor 175 and wireless
• transceiver 70 on base unit 10 This temperature information may then be presented to the healthcare professional, e.g., visually via touchscreen display 55 and/or audibly via speaker 82. Preferably this temperature information is also simultaneously stored locally on base unit 10 in local data storage unit 65 and/or uploaded to an external network (e.g., a wireless computer network operated by a healthcare facility such as a hospital) via wireless transceiver 80 in base unit 10 (e.g., to be added to an Electronic Health Record (EHR) ) .
• EHR Electronic Health Record
• the temperature information acquired from the patient by novel apparatus 5 may be used directly by the healthcare professional to make a diagnosis and prognosis. Additionally and/or alternatively, the temperature information may be used by a computerized “comparison engine” or “auto- interpretation” engine (which can be incorporated in novel integrated, handheld apparatus 5) to provide additional diagnostic and prognostic information to the healthcare professional .
• acquired from the patient by novel apparatus 5 may be used by the healthcare professional to aid/guide the healthcare professional in therapeutic interventions.
• novel integrated, hand-held apparatus 5 may also acquire data (e.g., text, sounds, images, etc.) from an external network (e.g., a wireless computer network operated by a healthcare facility such as a hospital) via wireless transceiver 80 in base unit 10 (e.g., to access information from an Electronic Health Record (EHR) ) and present that data to the healthcare
• EHR Electronic Health Record
• novel integrated, handheld apparatus 5 also provides the healthcare
• prognostic information in the patient records which can assist the healthcare professional in the
• This comparison of current vs. historic diagnostic and prognostic information can be effected by the healthcare professional themselves or by a computerized “comparison engine” or “auto- interpretation engine” which can be incorporated in novel integrated, hand-held apparatus 5 or provided by the external network.
• the "auto- interpretation engine” can compare the current diagnostic and prognostic information against a library of diagnostic and prognostic information and its anatomical meaning (e.g., heart murmur, valve issues, etc.) so as to provide further assistance to the healthcare professional.
• novel integrated, hand-held apparatus 5 may be included in novel integrated, hand-held apparatus 5 so as to provide the device with additional functionality.
• novel apparatus 5 may also be provided with a voice
• microphone 190 for audio recording, e.g., to record the voice of the healthcare
• the voice data acquired by voice microphone 190 is preferably stored locally on base unit 10 in local data storage unit 65 and/or uploaded to an external data network (e.g., a wireless computer network operated by a healthcare facility such as a hospital) via wireless transceiver 80 in base unit 10 (e.g., to be added to an Electronic
• voice microphone 190 may be disposed on base unit 10 (Figs. 2 and 3) . In another preferred form of the invention, voice microphone 190 may be disposed on wand 15, and the information acquired by voice microphone 190 may be relayed to base unit 10 via wireless transceiver 105 in wand 15 and wireless transceiver 70 in base unit 10. If voice microphone 190 is disposed on wand 15, voice microphone 190 may be combined with the microphone 95 previously
• novel integrated, hand-held apparatus 5 may also be provided with a camera 195 for taking pictures, e.g., to visually record the appearance of patient anatomy.
• camera 195 is also provided with
• the image data acquired by camera 195 is preferably stored locally on base unit 10 in local data storage unit 65 and/or uploaded to an external data network (e.g., a wireless computer network operated by a healthcare facility such as a hospital) via wireless transceiver 80 in base unit 10 (e.g., to be added to an Electronic Health Record (EHR) ) .
• EHR Electronic Health Record
• speaker 82 on base unit 10 may be supplemented by providing an earphone jack 200 (Figs. 2 and 3) for receiving the input of an earphone.
• Earphone jack 200 can be very helpful for the healthcare professional where there is a substantial amount of ambient noise about the patient, or where there is a need for quiet about the patient.
• associated earphone may replaced by a corresponding headphone jack/headphone arrangement which provides a microphone for dictation by the healthcare
• dictation by the healthcare professional is preferably stored locally on base unit 10 in local data storage unit 65 and/or uploaded to an external data network (e.g., a wireless computer network operated by a healthcare facility such as a hospital) via wireless transceiver 80 in base unit 10 (e.g., to be added to an Electronic Health Record (EHR) ) .
• EHR Electronic Health Record
• base unit 10 of novel integrated, handheld apparatus 5 may incorporate appropriate
• base unit 10 accessing the Internet via the wireless transceiver 80 which communicates with an external network (e.g., a wireless computer network operated by a healthcare facility such as a hospital) .
• an external network e.g., a wireless computer network operated by a healthcare facility such as a hospital
• This arrangement can provide the healthcare professional with access to information and services available on the Internet, e.g., publications, E-mail, telephone, text-paging, text messages (including sms) , etc.
• base unit 10 may be configured to provide additional helpful information to the healthcare professional so as to improve patient care and/or healthcare professional efficiency, e.g., base unit 10 may provide the healthcare professional with a list of the patients who are to be seen by that healthcare professional, etc. Wired Vs. Wireless Communications
• connections associated with novel integrated, handheld apparatus 5 may be replaced by a hard-wired link.
• the wireless connection between base unit 10 and wand 15 i.e., the wireless transceiver 70 in base unit 10 and the wireless transceiver 105 in wand 15
• the wireless connection between base unit 10 and an external network i.e., the wireless transceiver 80 in base unit 10 and a corresponding wireless transceiver in the external network
• the wireless connection between base unit 10 and blood pressure cuff 135 i.e., the wireless transceiver 70 in base unit 10 and the wireless transceiver 155 in blood pressure cuff 135) may be replaced by a hard-wired link
• the wireless connection between base unit 10 and pulse oximeter 160 i.e., the wireless transceiver 70 in base unit 10 and the wireless transceiver 170 in blood oximeter 160
• the wireless connection between base unit 10 and pulse oximeter 160 i.e., the wireless transceiver 70 in base unit 10 and the wireless
• associated earphone may be replaced by a wireless earphone, and/or the headphone jack/headphone
• arrangement may be replaced by a wireless headphone, etc .
• a docking station 205 may be provided for base unit 10 of novel integrated, hand-held apparatus 5.
• This docking station can provide battery recharging functions, as well as data download and upload functions, for base unit 10.
• FIG. 16 shows one exemplary system block diagram for novel integrated, hand-held apparatus 5.
• Other system architectures will be apparent to those skilled in the art in view of the present disclosure.
• wand 15 may be formed with an elongated, generally cylindrical configuration (Figs.
• Figs. 17-32 show still other possible configurations for wand 15.
• the wands 15 shown in Figs. 17-32 are provided with a wire 210 for connecting wand 15 to base unit 10 via a hard-wired connection .
• wand 15 can be provided with earpieces 215 (see Fig. 33), whereby to provide an ergonomic construction (the wand and earpieces are formed as a single unit) having a familiar feel and appearance to the healthcare professional and the patient (the healthcare professional manipulates the wand in a manner somewhat analogous to the head of a conventional stethoscope) .
• base unit 10 and wand 15 may be combined together in a "unibody" construction, such that body 90 of wand 15 is mounted to, and extends from, body 20 of base unit 10 and, if desired, can be retracted into base unit 10.
• apparatus 5 may be provided with a multi -directional hinge 220 (or a gooseneck mechanism, etc.) at the intersection of wand 15 and base unit 10 so that touchscreen display 55 can be appropriately angled for easy reading by the heathcare professional when wand 15 is appropriately contacting the patient. See Figs. 35-37.
• touchscreen display 55 may be mounted to body 20 of base unit 10 by an internal pivoting hinge mechanism (not shown) so that
• touchscreen display 55 can be appropriately angled for easy reading by the healthcare professional when wand 15 is appropriately contacting the patient. See Figs. 38 and 39.
• the audio transducer of wand 15 is capable of measuring input signal amplitudes of 20 dB minimum, the frequency response of the audio transducer has an accuracy of +/- 2 dB in the 50 Hz to 10 kHz range, the auscultation circuitry has a dynamic range of 40 dB minimum, the auscultation circuitry has an SNR of 40 dB minimum and the sampling frequency of the audio input signal is no less than 48 kSPS;
• the ultrasound transducer of wand 15 produces ultrasonic energy waves in the range of 2 MHz to 7 MHz
• the ultrasound system is capable of detecting echos from depths of 1 cm to 20 cm from the face of the wand
• the ultrasound system is capable of steering the focused energy in a plane of up to 90 degrees centered around the parallel axis of the wand
• the ultrasound system includes a band-pass filter with corner frequencies of 2 and 7 MHz
• the ultrasound system digitizes each ultrasound reading with a resolution of no less than 10 bits
• the ultrasound system has a spatial resolution of no more than 1 mm
• the ultrasound system has a temporal resolution of no more than 300 ⁇ is per transmitted pulse
• the ultrasound system digitizes the ultrasound reading with a sampling frequency of no less than 20 MSPS
• the ultrasound system is capable of processing and
• the ultrasound system is capable of processing and displaying color Doppler ultrasound images
• the ultrasound system is capable of processing and displaying pulsed-wave Doppler ultrasound images
• the ultrasound system includes 256 shades of gray in the output amplitude image
• the ultrasound system includes 256 shades of color in the color/pulsed-wave Doppler images
• the color/pulsed-wave Doppler image shading displays a red-yellow color at a step value of -128 corresponding to a positive frequency shift
• the color/pulsed-wave Doppler image shading displays a blue-green color at a step value of 128 corresponding to a negative
• the color/pulsed-wave Doppler images display black when no Doppler shift has occurred (step value of 0) , the ultrasound image is updated at a minimum rate of 30 Hz for B-mode imaging and 15 Hz for color/pulsed-wave Doppler image;
• the touchscreen display is an LCD device with a contrast ratio of no less than 5:1 and has a
• the ECG inputs have an input impedance of no less than 10 ⁇ when a DC voltage is applied, the ECG inputs have ESD protection for voltage spikes of up to 10 kV, the ECG valid signal input range is a minimum of +/- 3 mVAC, the ECG system has a CMRR of 60 dB minimum at 60 Hz and 45 dB minimum at 120 Hz, the ECG system meets all requirements with up to +/- 300 mVDC applied to the electrodes, the ECG system includes a band-pass filter with corner frequencies of 0.1 Hz and 100 Hz, the signal gain of the ECG system in the range of 0.5 Hz to 30 Hz does not vary by more than +/- 15% of the gain at 5 Hz, the ECG system digitizes the input signals at a sampling rate of no less than 200 SPS;
• the blood pressure cuff is capable of
• the pulse oximeter reports the Sp0 2 as a
• the pulse oximeter reports Sp0 2 with an accuracy of +/- 0.1 % Sp0 2 ;
• the voice microphone is capable of measuring sound amplitudes of up to 70 dB, the voice microphone is capable of measuring sound amplitudes down to 20 dB with an SNR of 40 dB minimum, the voice microphone includes a band-pass filter with corner frequencies of 20 Hz and 20 kHz, the system digitizes the input of the voice microphone at a sampling frequency of no less than 48 kSPS; the system is capable of outputting up to 70 dB of audio sound from 100 Hz to 10 kHz measured at 12 inches from the front face of the system unit; and
• the camera has image resolutions of up to 5 megapixels, the camera is capable of focusing an object in the range of 0.5 feet to 3 feet from the camera face, and the camera is ready to capture a new image within 5 seconds of capturing a previous image.
• novel apparatus 5 comprises an integrated, hand-held device which is intended to be conveniently carried by a healthcare professional on their person (e.g., in the manner of a conventional stethoscope) and which can be used to acquire sound, image and preferably also electrical and other (e.g., patient history, blood pressure, blood oximetry, patient temperature, etc.) information from the patient, so as to enable the healthcare professional to carry out a rapid, accurate and comprehensive objective physical examination of the patient at the bedside or at some other patient location, including cardiovascular diagnostics and prognostics, regardless of any other equipment that may be available at that location, and/or to aid/guide the healthcare professional in therapeutic
• a healthcare professional e.g., in the manner of a conventional stethoscope
• electrical and other e.g., patient history, blood pressure, blood oximetry, patient temperature, etc.
• interventions e.g., localization of pericardial or pleural effusions and guiding a needle/catheter to drain the fluid
• to store the diagnostic and prognostic information acquired from the patient either locally on the device or externally on an external network, for later review by that same healthcare professional and/or by others.
• the novel integrated, hand-held apparatus of the present invention facilitates the acquisition of objective diagnostic and prognostic information from the patient
• the present invention facilitates a more accurate and prompt diagnosis and prognosis of patient conditions by the clinician and also allows a broader set of healthcare professionals (e.g., technicians and others who will not actually render a diagnosis) to be involved in the acquisition of diagnostic and prognostic information from the patient .
• healthcare professional at the bedside or some other patient location may be extremely useful in properly diagnosing and identifying fluid build-ups in the body (e.g., in the chest, limbs and abdomen) such as by palpation in conjunction with sound information and/or image data, determining appropriate biopsy sites and obtaining desired biopsy specimens, identifying and accessing (e.g., via instrument guidance) desired interventional sites, accurately locating blood vessels, etc.
• the use of sound e.g., the use of sound
• the healthcare professional could be better able to localize a problem (e.g., the healthcare professional could hear an issue via auscultation, and could then immediately run an ultrasound to visualize the problem, instead of having to wait for the results of a separate
• the healthcare professional could be better able to isolate/detect a problem while the patient is actually experiencing the problem (e.g., the healthcare professional could hear, see and correlate the problem with other key

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