Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • 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
  • A61B5/1459—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 invasive, e.g. introduced into the body by a catheter
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
  • A61B5/02007—Evaluating blood vessel condition, e.g. elasticity, compliance
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • 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
  • A61B5/14542—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 for measuring blood gases
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/48—Other medical applications
  • A61B5/4887—Locating particular structures in or on the body
  • A61B5/489—Blood vessels
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/04—Measuring blood pressure
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/06—Measuring blood flow
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
  • A61B8/4483—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device characterised by features of the ultrasound transducer
  • A61B8/4494—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device characterised by features of the ultrasound transducer characterised by the arrangement of the transducer elements

Definitions

• Heart arrhythmias are changes in the normal sequence of electrical impulses that cause the heart to pump blood through the body. Continuous monitoring may be required to detect arrhythmias because abnormal heart impulse changes might only occur sporadically. With continuous monitoring, medical personnel can characterize cardiac conditions and establish a proper course of treatment.
• One prior art device that measures heart rate is the "Reveal" monitor by Medtronic (Minneapolis, MN, USA).
• This device comprises an implantable heart monitor used, for example, in determining if syncope (fainting) in a patient is related to a heart rhythm problem.
• the Reveal monitor continuously monitors the rate and rhythm of the heart for up to 14 months. After waking from a fainting episode, the patient places a recording device external to the skin over the implanted Reveal monitor and presses a button to transfer data from the monitor to the recording device.
• the recording device is provided to a physician who analyzes the information stored therein to determine whether abnormal heart rhythm has been recorded.
• the use of the recording device is neither automatic nor autonomic, and therefore requires either the patient to be conscious or another person's intervention to transfer the information from the monitor to the recording device.
• transponder-type device in which a transponder is implanted in a patient and is subsequently accessed with a hand-held electromagnetic reader in a non-invasive manner.
• a hand-held electromagnetic reader in a non-invasive manner.
• the sensing device comprises a sensor assembly and a computing device.
• the sensor assembly includes a plurality of emitters and a plurality of detectors for generating a plurality of signals.
• the emitters and detectors face one side of a vessel.
• a computing device operates the plurality of emitters and detectors and processes the plurality of signals to obtain measurement values.
• the sensor assembly and the computing device are enclosed in a housing.
• One embodiment of a method according to the invention includes the steps of providing a sensor device such as the one described in the paragraph above, operating the plurality of emitters and detectors to obtain a plurality of signals, processing the signals to obtain measurement values, and analyzing the measurement values to obtain parameter values indicative of a characteristic of at least one of the vessel and the fluid.
• Another embodiment according to the invention discloses a device for optically measuring a characteristic of at least one of a blood vessel and blood flowing through the blood vessel.
• the device includes a housing, a sensor assembly, and a computing device.
• the sensor assembly is mounted to the housing and includes a plurality of emitters for emitting photons through a first side of the housing and a plurality of detectors for receiving at least a portion of the emitted photons through the first side of the housing.
• Each emitter is operationally paired with a separate detector and oriented such that a beam of photons emitted from the emitter that impinges upon a vessel adjacent the sensor assembly will partially reflect toward the paired detector, each detector being configured to produce a signal representing the emitted photons received by the detector.
• the computing device is configured to activate the plurality of emitters and interpret the signals from the detectors to determine the characteristic
• Figures 1 A is a schematic side view of a sensing device according to one embodiment of the invention.
• Figures 1 B is an outwardly-facing view of the sensing device of Figure 1 .
• Figures 1 C is a perspective view of the sensing device of Figure 1
• FIG. 1 A illustrates a sensing device 1 according to one embodiment of the invention.
• Sensing device 1 generally includes a plurality of components including a sensor assembly 2, a computing device 20, a communication device 30, and an energy storage device 40, each of the components mounted on a board 80 and being in electronic communication with computing device 20.
• the components are enclosed in a housing 90.
• Sensor assembly 2 includes an emitter array 100 having a plurality of emitters and a detector array 200 having a plurality of detectors.
• sensing device 1 senses parameters of the patient's blood conveyed in a vessel such as a vein or an artery.
• sensing device 1 emits beams of electromagnetic energy in the infrared (IR) range of the electromagnetic spectrum and detects IR signals reflected from blood circulating in the vessel.
• IR infrared
• Sensing device 1 may emit IR beams at one or more frequencies selected for their ability to pass through the patient's body with minimal interference or absorption by the body and to reflect from specific blood components selected for their ability to convey the desired blood parameters values.
• sensing device 1 emits infrared beams selected to reflect from haemoglobin, which is the iron-containing oxygen-transport metalloprotein in red blood cells.
• Photocell arrays may be utilized to emit and detect the IR beams. As disclosed in detail below, each array is displayed as having sixteen photocells arranged in a grid of four rows with four cells each. Under certain operating conditions described below, all of the photocells in emitter array 100 emit beams simultaneously, while under other operating conditions each photocell emits a beam at a selected time to obtain specific information and/or to conserve energy. In yet another embodiment, photocells are dispersed over the surface of the sensing device in any manner, including in arrangements where emitters and detectors are interspersed and/or dispersed in alternating rows or columns of emitters and detectors.
• the beam travels through tissue at a known constant velocity
• the distance from the midpoint between photocells 101 and 201 on centerline 8 to vessel 3, shown as arrow 9, may be calculated from the travel time between emission and detection and the geometrical relationship between photocells 101 and 201 .
• one or more lenses may be included to focus, at least partially, the beams emitted by emitter 101 such that the cross-sectional dimensions of the beams remain constant to within a small percentage of their original dimension over the distance of travel of the beams.
• a collimator may be included to focus beams created by each emitter. Emitter beams may then be correlated to signals produced by detectors to provide additional information about the vessel.
• Figs. 3 and 4 illustrate one embodiment of a sensor assembly 2 comprising transmitters and receivers positioned in emitter array 100 and detector array 200, respectively.
• Emitter array 100 includes sixteen emitters 101 -1 16 disposed in a matrix and may emit sixteen beams as directed by computing device 20 For simplicity, in Fig 3 only emitted beam 10 from emitter 104 is shown. A portion of beam 10 is reflected from vessel 3 as reflected beam 11 .
• Numeral 7 represents a portion of beam 10 that was not reflected by haemoglobin
• Detector array 200 includes sixteen detectors 201 -216 disposed in a matrix. Detector array 200 receives the photons in reflected beam 11 . More specifically, in this example detector 204 receives photons in reflected beam 1 1.
• the angle between an emitter and its paired detector is the same for each pair.
• emitted beam 113E is directed toward vessel 3 and, if it impinges vessel 3, reflected beam 113R is received by detector 213.
• the angle formed by emitted beam 113E and reflected beam 113R is the same as the angle formed by the emitted and reflected beams of the other emitter cell / detector cell pairs. This angle is referred to herein as the common angle.
• sensor assemblies 2 may be constructed having different common angles between their respective emitter and detector pairs.
• the common angle between the cells of emitter array 100 and the paired cells of detector array 200 of Fig. 4 may be 45 degrees.
• the common angle between the pairs may be 30 degrees.
• the anatomy of the patient may determine the appropriate sensor assembly 2 to use. For example, when sensing device 1 is implanted subcutaneously in a very thin or very small patient, the distance between sensor assembly 2 and vessel 3 of interest may be small compared to the corresponding distance in a very heavy or very large patient.
• emitter array 100 and detector array 200 may be mounted in sensing device 1 at an angle relative to one another.
• emitter array 100 and detector array 200 are coplanar (i.e., at an angle of zero relative to one another).
• the arrays may be tilted toward one another as shown in dotted lines in the figure.
• a portion of the photons that impinge upon vessel 3 are reflected and detected at detector 205 as reflected beam 105R.
• the portion of the photons of emitted beam 109E that are reflected by the haemoglobin in vessel 3 are detected at detector 209 as reflected beam 109R.
• emitted beam 101 E only a portion of emitted beam 113E impinges upon vessel 3 to yield reflected beam 1 13R at detector 213.
• Fig. 5C is a view even farther into the page essentially of a plane through the third column of emitters 103, 107, 11 1 , 1 15 and the third column of detectors 203, 207, 21 1 , 213.
• vessel 12 is again shown in phantom because it does not occupy the area illuminated by emitted beams 103E, 107E, 1 11 E, 1 15E. As vessel 12 does not interfere with the emitted beams and the location of vessel 3 is the same as shown in Fig.
• a value of 1 equals the power expected to be received by a detector cell if the corresponding emitter cell emits a wave that encounters maximum interference with (and therefore reflection by) a vessel 3 of interest
• an electronic circuit (not shown) is used to filter, scale, and conditioning the signals received from detector array 200 and the output of the electronic circuit is provided to computing device 20 for processing
• computing device 20 evaluates and maps the measurement values to determine the location and diameter of vessel 3, as is further described below.
• a full power signal is scaled to equate to a vessel portion having a width of 0 7 centimeters Each fraction of full power represents linearly a fraction of 0.7 centimeters width.
• the width, or diameter, of the vessel is calculated by adding measured values in a row or in a column of detector cells, as the case might be.
• the vessel's diameter is identified when measured values in two or more rows, or columns when values in columns are added, differ by less than 10% In another embodiment, the vessel's diameter is identified when measured values in two or more rows, or columns, differ by less than 5%.
• Table 2 shows a conceptual representation of processed values similar to Table 1 but corresponding to the depiction of vessels 3 and 12 shown in Figs. 5A-C.
• the decreased values in column 2 corresponding to detectors 206, 210, and 214 represent the interference caused by vessel 12 as depicted in Fig. 5B.
• Values in columns 1 , 3 and 4 differ by less than 5% (indeed, as shown they are identical).
• computing device 20 may disregard the signals in column 2 and compute the diameter of vessel 2 using the signals in any of columns 1 , 3 or 4 in the manner described above.
• measurement values indicating the presence of vessels having diameters smaller than a predetermined size are deleted, or filtered out, to obtain a clearer representation of vessels of interest.
• measurement values corresponding to vessel diameters smaller than 1 centimeter are deleted.
• the vessel of interest is the aorta, which has a known approximate diameter (depending upon the physical characteristics of the patient) that is substantially larger than nearly any other vessel in the vicinity of the mounting location of sensing device 1.
• sensing device 1 computes the position and diameter of a vessel of interest, such as the aorta, by the scanning method already described. Based upon the dimensions of the vessel, the geometrical relation between the emitter and detector arrays and the vessel, and physical characteristics of the emitter and detector arrays, e.g., size of array, width of emitter beams, disposition of emitters and transmitters, sensing device 1 calculates a maximum potential oxygen saturation value according to known photon diffusion equations. Since the physiological characteristics of each patient differ, sensing device 1 may calibrate the maximum potential value for each patient using reference values stored in the memory of computing device 20.
• sensing device 1 also calculates cardiac pulse.
• detectors produce power signals representative of iron content in blood.
• the power signals fluctuate.
• a plurality of power signals may be obtained in rapid succession to capture the power measurement fluctuation. More specifically, by performing many oxygen saturation measurements (e.g., ten times per second), over a period of time (e.g., fifteen seconds), the saturation measurements will exhibit a pattern or periodicity that represents the beating of the heart.
• Computing device 20 may determine a curve to fit the saturation measurements, such as a sinusoidal curve, which corresponds directly to the cardiac cycle.
• Computing device 20 may determine the frequency of peak values of the curve to determine its period. Each period represents a cardiac cycle.
• computing device 20 may determine pulse rate in terms of cardiac cycles per minute.
• computing device 20 stores cardiac pulse values as normal reference values and detects an abnormal or irregular cardiac rhythm by comparing cardiac pulse values to reference values.
• the program represents computer instructions directing the processor to perform tasks responsive to data
• the program resides in the memory.
• Data including reference data and measurement data, also resides in the memory
• Reference data may be stored in ROM or it may be stored in RAM so that it may be modified over time, either in response to external inputs or in response to characteristics of measurement data collected over time.
• Protocols for responding to measurement values may also be provided. Protocols may be stored in permanent memory or may be stored in non-permanent memory such as RAM.
• Computing device 20 controls sensor assembly 2 and communication device 30 through inputs and outputs. Computing device 20 may control the number, frequency, power level and emission sequence of the plurality of beams emitted by emitters 101 -1 16 to obtain the desired measurements using the least amount of energy.
• Fig 6A discloses a system 300 for exchanging information with sensing device 1 .
• System 300 includes sensing device 1 having communication device 30 and, optionally, connector 85.
• System 300 may also include a computer 302, a docking station 304 operably coupled to computer 302 via cable 303, a telephone 306
• system 300 transmits and receives communication signals 312 wirelessly to/from sensing device 1 based on processing performed by computing device 20
• Connector 85 is adapted to plug into docking station 304.
• Sensing device 1 is shown docked on docking station 304. While docked, sensing device 1 may charge energy storage device 40.
• Fig 7 is a flowchart illustrating one routine of the program performed by computing device 20 according to one embodiment of the invention.
• computing device 20 activates sensor assembly 2 such that all emitters 101 -1 16 emit beams or the emitters sequentially emit individual beams, depending upon the measurement being performed as described above.
• Step 400 also represents the procedure of generating signals at detectors 201 -216 representing reflected beams.
• computing device 20 processes the signals to obtain measurement values.
• Processing may involve removing inherent signal noise, converting signals from analog to digital form, optical to digital form, scaling, and otherwise conditioning the detected signals. Alternatively, some processing functions may be performed by circuits such as A/D converters After processing, measured values may be stored in memory or may be analyzed to determine whether the values should be stored. Steps 400 and 402 may be repeated as necessary to obtain sufficient measurement values to calculate the desired parameters in accordance with the disclosure provided above. Steps 400 and 402 may be performed concurrently.
• computing device 20 transmits an alert if an abnormal condition is detected, particularly a condition determined to be a serious or dangerous condition according to a prescribed protocol.
• the alert may be used to actuate an alarm or to alert the patient to take remedial action.
• a remedial action may be terminating or reducing physical activity.
• the alert may also provide global positioning (GPS) information to an emergency service.
• GPS global positioning
• the abnormal condition when found to be present, may also be displayed on a computer 302 and/or transmitted via communication device 30 (e.g., Nokia modem KNL 1147-V) to a caregiver.
• the alert may comprise a text message or a code corresponding to the condition.
• Computing device 20 may also initiate a new measurement cycle and measure on a continuous basis in response to the detection of an abnormal condition.
• the parameter values or other information are communicated to an external device. Step 410 may be performed concurrently with any of the above steps.
• the parameter values may be stored in memory and transmitted wirelessly by communication device 30.
• the communication signal from communication device 30 may be activated on a periodic basis, in response to an abnormal condition, in response to an externally received command, whenever memory usage exceeds a predetermined amount, or whenever the energy storage level is determined to be low, the latter two conditions established to prevent data loss as a result of memory overflow or energy loss.
• sensing device 1 may include communication devices in addition to communication device 30 For example, where communication device 30 is a cellular modem, sensing device 1 may also include a backup Bluetooth or RF communication device.
• the relay unit may include a receiver for receiving the transmissions from communication device 30, and a transmitter for re-transmitting the communication signal to another external communication device.
• the relay unit may also be stationary and hardwired for connection to the internet or direct connection to a healthcare provider's computer. Likewise, the relay unit may receive a communication signal from a healthcare provider and transmit the signal to communication device 30
• the communication signal from communication device 30 may include a voice message, a text message, and/or measured data.
• the communication received by communication device 30 may include data, such as updated reference data, or commands.
• a command may include, for example, instructions to computing device 20 for performing a task such as providing a treatment to the patient, collecting and transmitting additional data, or updating the reference data. Additional embodiments of methods of communicating information according to the invention are disclosed in the above-referenced related U.S. Utility Patent Application titled "METHOD AND SYSTEM FOR MONITORING A HEALTH CONDITION"
• an energy coupler is an electromagnetic device, such as induction coils 308, for receiving external electromagnetic signals 310 and converting such signals into electrical energy for recharging the energy storage component.
• An external electromagnetic device 308 generates electromagnetic signal 310 which is received and converted into electrical energy by energy storage device 40.
• Energy storage device 40 may provide a charge signal to computing device 20.
• Computing device 20 may compare the charge signal to a reference charge signal and initiate a low charge communication signal for alerting the patient and/or healthcare providers Alternatively, a detector, such as a voltage sensor, may be used to monitor the charge of energy storage device 40 and provide a signal to computing device 20 when the charge falls below a threshold
• Electromagnetic device 308 may be placed near sensing device 1 to charge energy storage device 40.
• Energy may instead, or additionally, be provided in the form of ultrasonic vibrations.
• a piezoelectric transducer may be included in sensing device 1.
• An ultrasonic vibration may be provided externally.
• the transducer generates electricity when driven by ultrasonic vibrations.
• a sensing device for acquiring signals and computing measurements comprising a sensor assembly including a plurality of emitters and a plurality of detectors for generating a plurality of signals, the emitters and detectors facing one side of a vessel; a computing device operating the plurality of emitters and detectors and processing the plurality of signals to obtain measurement values; and a housing enclosing the sensor assembly and the computing device.
• the sensing device of claim 1 wherein the computing device includes an algorithm for computing parameter values.
• the parameter values include a distance from the sensor assembly to a vessel and a diameter of the vessel.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Physics & Mathematics (AREA)
• Animal Behavior & Ethology (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Biophysics (AREA)
• Pathology (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Surgery (AREA)
• General Health & Medical Sciences (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Radiology & Medical Imaging (AREA)
• Optics & Photonics (AREA)
• Vascular Medicine (AREA)
• Hematology (AREA)
• Gynecology & Obstetrics (AREA)
• Cardiology (AREA)
• Spectroscopy & Molecular Physics (AREA)
• Physiology (AREA)
• Measuring Pulse, Heart Rate, Blood Pressure Or Blood Flow (AREA)
• Measuring And Recording Apparatus For Diagnosis (AREA)
• Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
• Ultra Sonic Daignosis Equipment (AREA)
• Investigating Or Analysing Materials By Optical Means (AREA)
• Investigating Or Analyzing Materials By The Use Of Ultrasonic Waves (AREA)
• Optical Measuring Cells (AREA)

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• 2009
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