JP5497008B2 - Sensing device - Google Patents

Description

Disclosure details

[Priority claim]
This application is a US patent application No. 12 / 119,315 with the name “OPTICAL SENSOR APPARATUS AND METHOD OF USING SAME”, and US Patent Application No. 12/119 with the name “DOPPLER MOTION SENSOR APPARATUS AND METHOD OF USING SAME”. No. 119,339, US Patent Application No. 12 / 119,325 with the name “INTEGRATED HEART MONITORING DEVICE AND METHOD OF USING SAME”, US Patent Application No. 12 with the name “METHOD AND SYSTEM FOR MONITORING A HEALTH CONDITION” No. 119,462 (all filed on May 12, 2008) and US Patent Application No. 12 / 206,885 (filed September 9, 2008) with the name “DOPPLER MOTION SENSOR APPARATUS AND METHOD OF USING SAME” ) Claim priority. These are all due to the same inventor as the present application, and all applications are incorporated herein by reference in their entirety.

(Field of the Invention)
The present invention relates to a sensing device, and more particularly to a sensing device for locating an object and / or measuring an object.

BACKGROUND AND SUMMARY OF THE INVENTION
For medical reasons, the patient's in vivo parameters may need to be monitored over a period of time. Cardiac arrhythmias are changes in the normal sequence of electrical impulses that cause the heart to pump blood systemically. Continuous monitoring may be required to detect arrhythmias. This is because abnormal heart impulse changes may only occur sporadically. With continuous monitoring, medical personnel can characterize the condition of the heart and establish an appropriate course of treatment.

  One prior art device for measuring heart rate is the “Reveal” monitor by Medtronic (Minneapolis, MN, USA). This device includes, for example, an implantable heart monitor that is used in determining whether a patient's fainting (falling) is associated with a heartbeat problem. The Reveal monitor continuously monitors heart rate and heartbeat for up to 14 months. After waking up from the onset of symptoms, the patient places the recording device outside the skin on the implanted Reveal monitor and pushes a button to transfer data from the monitor to the recording device. A recording device is provided to the doctor, who analyzes the information stored in the recording device to determine if an abnormal heartbeat is recorded. The use of the recording device is neither automatic nor autonomic and therefore requires patient awareness or another human intervention to transfer information from the monitor to the recording device.

  Another known type of implantable monitoring device is a transponder-type device in which the transponder is implanted in a patient and subsequently accessed non-invasively with a handheld electromagnetic reader. An example of the latter type of device is described in US Pat. No. 5,833,603.

  In a first exemplary embodiment, a sensing device is provided for acquiring a signal and calculating a measurement, the sensing device including a plurality of emitters and a plurality of detectors to generate a plurality of signals. An emitter and a detector that face one side of a blood vessel, operate a plurality of emitters and detectors, process a plurality of signals to obtain measured values, and a sensor assembly. And a housing surrounding the solid and the calculation device.

  In one variation of the sensing device, the calculation device includes an algorithm that calculates a parameter value. In one example, the parameter value includes the distance from the sensor assembly to the blood vessel and the diameter of the blood vessel. In another example thereof, the parameter value includes a parameter of fluid carried by the blood vessel. Exemplary fluids include blood. In another example, the parameter value includes at least one of aortic location, aortic diameter, oxygen saturation, and heartbeat.

  In another variation of the sensing device, the housing is configured to be implanted subcutaneously.

  In a further variation of the sensing device, the plurality of emitters are arranged in a matrix. In one example, the plurality of detectors are arranged in a matrix. In one example, the emitter matrix includes 4 rows of 4 emitters, and the detector matrix includes 4 rows of 4 detectors.

  In yet another variation of the sensing device, each detector is operably paired with a different emitter.

  In a further variation of the sensing device, the number of emitters in the plurality of emitters is different from the number of detectors in the plurality of detectors.

  In yet a further variation of the sensing device, the sensing device is approximately the same size as a stack of two 25 cent coins.

  In another variation of the sensing device, the sensor assembly and the computing device are integrated in a single piece.

  In yet a further variation of the sensing device, the sensing device further includes one or more communication devices that transmit and receive communication signals. In one example, the communication device transmits and receives a wireless communication signal. In another example, the communication device includes a connector configured to operably couple to one or more of the docking station and the second sensing device. In one example, the sensor assembly, the computing device, and the one or more communication devices are integrated into one part.

  In another variation of the sensing device, the sensing device further includes an energy storage device that stores energy and powers the computing device and the sensor. In one example, the energy storage device includes an energy coupler that receives energy to recharge the energy storage device.

  In a second exemplary embodiment, a method is provided for acquiring a signal and calculating a measurement. The method provides a sensing device, wherein the sensing device is a plurality of photon emitters and detectors, where the emitter emits a beam, the detector detects the beam, and detects the detected beam. Providing a corresponding plurality of signals, the emitter and detector comprising a plurality of photon emitters and detectors facing one side of the blood vessel, and a computing device for operating the plurality of emitters and detectors; Manipulating multiple emitters and detectors to obtain multiple signals, processing multiple signals to obtain measured values, and parameter values indicating characteristics of at least one of blood vessels and fluids Analyzing the measurements to obtain.

  In a variation of the second exemplary embodiment, the sensing device further includes a communication device, the method diagnosing a condition using at least one of the parameter values, and functioning in response to the diagnostic step. And a step of executing. In one example, the state is an abnormal state. In another example, the function is to communicate an alarm. In a further example, the function is to initiate treatment. An exemplary treatment is electric shock. Another exemplary treatment is delivering a drug. Another exemplary function is to communicate information periodically.

  In another variation of the second exemplary embodiment, the step of manipulating includes manipulating the paired emitter and detector to obtain measurements. In one example, the emitter and detector pair is operated sequentially. In another example, the emitter and detector pair are operated simultaneously. In yet another example thereof, the step of manipulating includes sequentially manipulating the emitter and detector pair to obtain a first plurality of signals corresponding to the first parameter value; Obtaining a value; selecting a plurality of emitter and detector pairs based on the first parameter value; and obtaining a second plurality of signals corresponding to the second parameter value. Simultaneously operating a pair of emitters and detectors. An exemplary second parameter value is an oxygen saturation value.

  In a third exemplary embodiment, an apparatus is provided for optically measuring the characteristics of at least one of a blood vessel and blood flowing through the blood vessel. The apparatus includes a housing having a first side and a second side, and a sensor assembly attached to the housing, wherein the sensor assembly emits photons through the first side of the housing; and A plurality of detectors that receive at least a portion of the emitted photons through the first side of the housing, each emitter being operably paired with a separate detector, and a blood vessel adjacent to the sensor assembly The beam of photons emitted from the emitter is directed to partially reflect towards the paired detectors, each detector generating a signal representative of the emitted photons received by the detector A calculation assembly configured to activate a sensor assembly and a plurality of emitters and to interpret the signal from the detector to determine characteristics. And, including the.

  In a variation of the third exemplary embodiment, the characteristic is the diameter of the blood vessel.

  In another variation of the third exemplary embodiment, the characteristic is blood oxygen saturation.

  In a further variation of the third exemplary embodiment, each pair of emitter and detector is positioned at an angle relative to each other. The angle is the same for all emitter and detector pairs.

  In yet another variation of the third exemplary embodiment, the computing device activates each of the plurality of emitters individually and sequentially to determine the diameter of the blood vessel. In that example, the calculation device activates all of the plurality of emitters simultaneously to determine the oxygen saturation of the blood.

  The features of the present invention and the manner of obtaining those features will become more apparent and the invention itself will be better understood by reference to the following description of embodiments of the invention understood in conjunction with the accompanying drawings. .

  Corresponding reference characters indicate corresponding parts throughout the several views. Although the drawings represent embodiments of the present invention, the drawings are not necessarily to scale and certain features may be emphasized in order to better illustrate and explain the present invention. The illustrations set forth in this specification illustrate embodiments of the invention in several forms, and such illustration is not to be construed as limiting the scope of the invention in any way. .

Detailed Description of Embodiments of the Invention
The embodiments discussed below are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments have been chosen and described so that others skilled in the art can utilize their teachings.

  FIG. 1A shows a sensing device 1 according to one embodiment of the present invention. The sensing device 1 generally includes a plurality of components including a sensor assembly 2, a calculation device 20, a communication device 30, and an energy storage device 40, each of which is attached to a board 80 and is Is in electronic communication. The component is surrounded by a housing 90. The sensor assembly 2 includes an emitter array 100 having a plurality of emitters and a detector array 200 having a plurality of detectors.

  In one embodiment according to the invention, the sensing device 1 is configured to determine the physiological state of the patient. “Patient” means a human or animal whose physiological state is measured by the sensing device 1. Although the invention disclosed herein is described in a medical context, the teachings disclosed herein are equally applicable in other situations where a small data acquisition assembly is desirable for taking measurements over time. Is possible. For example, sensor assemblies according to the present invention may be desirable in submerged or difficult to reach applications, hazardous environments, applications with weight and size restrictions, fieldwork activities, etc. .

  In one embodiment according to the present invention, the sensing device 1 is implanted subcutaneously in the patient's body. However, it should be understood that the sensing device 1 can be implanted at different locations using various implantation techniques. For example, the sensing device 1 may be implanted in the thoracic cavity under the thorax. The housing 90 may be formed in the shape of a circular or elliptical disc, and the dimensions are approximately the same as two 25 cent coins stacked. Of course, the housing 90 may be configured in a variety of other shapes, depending on the application. The housing can include four outwardly projecting loops 92, shown in FIGS. 1B and 1C, for receiving sutures to secure the assembly subcutaneously within the patient's body. More or fewer loops 92 may be provided depending on the shape of the housing 90. When so secured, the sensor assembly 2 is positioned facing inward, while the energy coupler described in detail below faces outward.

  In another embodiment, the sensing device 1 is positioned outside the patient's body. A support member is provided for supporting the sensing device 1 outside the body. The support member can be permanently or temporarily connected to the sensing device 1. In one embodiment, the support member includes an adhesive layer that adhesively connects the support member to the patient's body. In another embodiment, the support member includes a belt that may be elastic to hold the sensing device 1 against the patient's body.

  The sensing device 1 can be implanted subcutaneously or positioned on a patient with the aid of an external mapping system such as an ultrasound device. By appropriately installing, the target blood vessel is surely positioned within the sensing range of the sensing device 1. If the blood vessel of interest is the aorta, the sensing device 1 is positioned on the patient's chest or back at a location that reduces the interference caused by the ribs of the measurements obtained by the methods described herein. Good.

  In one embodiment according to the present invention, the sensing device 1 has a communication port for connecting to and exchanging information with other devices. A connector 85 is shown. The operation of the connector 85 connected to the other components of the sensing device 1 through the board 80 will be described in more detail below with reference to FIGS. 6A and 6B.

1. Blood vessel detector In one embodiment according to the present invention, the sensing device 1 senses parameters of a patient's blood carried in a blood vessel such as a vein or artery. In an exemplary embodiment, sensing device 1 emits a beam of electromagnetic energy in the infrared (IR) region of the electromagnetic spectrum and detects an IR signal reflected from blood circulating in the blood vessel. However, it should be understood that other types of electromagnetic energy consistent with the teachings of the present invention may be utilized. The sensing device 1 has the ability to pass through the body with minimal interference or absorption by the patient's body and to reflect from a particular blood component selected for the ability to transmit a desired blood parameter value. The IR beam can be emitted at one or more frequencies selected together. In an exemplary embodiment, sensing device 1 emits an infrared beam selected to reflect from hemoglobin, a metallic protein that contains iron and carries oxygen in red blood cells.

  An optical cell array can be used to emit and detect IR beams. As disclosed in detail below, each array is displayed as having 16 light cells arranged in a grid of 4 columns, each with 4 cells. Under certain operating conditions described below, all of the light cells of the emitter array 100 emit a beam simultaneously, but under other operating conditions, each light cell emits a beam at a selected time, Get specific information and / or save energy. In yet another embodiment, the light cell comprises emitters and detectors spaced apart and / or distributed in alternating rows or columns of emitters and detectors. Distributed on the surface of the sensing device in any way, including

  FIG. 2 shows the relationship between a blood vessel 3 carrying blood 4 with hemoglobin in red blood cells 5 and a pair of light cells, emitter 101 and detector 201, ie sensor assembly 2. The sensor assembly 2 may be selected from 8572 series optical sensors manufactured by Motorola. Emitter 101 emits a beam of photons including photon 101 '. As will be described in more detail below with reference to FIG. 3, some of the photons in the beam pass through the blood vessel 3 and some are reflected as a reflected beam, including photons 101 ′ in this example. . Receiver 201 receives the reflected beam. The calculation device 20 directs the emitter 101 to emit a beam and measures the time required for the cell 201 to detect the reflected beam. The beam travels through the tissue at a known constant velocity. The distance from the intermediate point between the light cell 101 and the light cell 201 on the center line 8 indicated by the arrow 9 to the blood vessel 3 is the travel time between emission and detection, and the light cell 101 and the light cell 201 Can be calculated from the geometric relationship between.

  In one embodiment, one or more lenses may be included to at least partially focus the beam emitted by the emitter 101, the beam cross-sectional dimension over the distance traveled by the beam. It remains constant within a small fraction of the original dimensions of. A collimator may be included to focus the beam produced by each emitter at the focal point. The emitter beam can then be correlated with the signal generated by the detector to provide additional information about the blood vessel.

  3 and 4 illustrate one embodiment of a sensor assembly 2 that includes a transmitter and a receiver positioned in the emitter array 100 and the detector array 200, respectively. The emitter array 100 includes 16 emitters 101 to 116 arranged in a matrix, and can emit 16 beams directed by the calculation device 20. For simplicity, only the radiation beam 10 from the emitter 104 is shown in FIG. A part of the beam 10 is reflected from the blood vessel 3 as a reflected beam 11. The number 7 represents a portion of the beam 10 that was not reflected by hemoglobin. The detector array 200 includes 16 detectors 201 to 216 arranged in a matrix. The detector array 200 receives photons in the reflected beam 11. More specifically, in this example, detector 204 receives photons in reflected beam 11.

  An exemplary square matrix comprising four rows of four cells each is illustrated, depending on the cell size, the desired measurement accuracy, and the distance between the sensor assembly 2 and the target vessel. More or fewer cells may be disposed in the sensor assembly 2. Sufficient photons must be emitted in order to provide a reflected beam suitable for its intended purpose. In another embodiment, each array includes 25 cells. In yet another embodiment, each array includes 12 cells. The number of cells in the emitter and detector arrays and the size of each cell need not be equal. Additional detectors can be added to the detector array to increase the resolution of blood vessel mapping, as further described below. In one embodiment, the detectors in detector array 200 are square and the length of each side is 1 mm. In another embodiment, each side is 2.5 mm. The width of the radiation beam can be slightly wider with distance. For example, a 2.5 mm beam may be widened to about 3.5 mm when it hits a blood vessel located at a distance of 10 cm.

  FIG. 4 shows a side view of a schematic representation of the sensor assembly 2 shown in FIG. It should be understood that each emitter of emitter array 100 is paired with a corresponding detector in detector array 200. More specifically, emitter 101 is paired with detector 201, emitter 105 is paired with detector 205, emitter 109 is paired with detector 209, and emitter 113 is paired with detector 213. . The remaining emitters and detectors (not shown) are similarly paired. In one embodiment of the invention, the angle between the emitter and its paired detector is the same for each pair. As shown, the radiation beam 113E is directed toward the blood vessel 3, and when the beam hits the blood vessel 3, the reflected beam 113R is received by the detector 213. For each sensor assembly 2, the angle formed by the radiation beam 113E and the reflected beam 113R is the same as the angle formed by the radiation and reflected beams of the other emitter / detector cell pairs. This angle is referred to herein as a common angle.

  However, it should be understood that a variety of different sensor assemblies 2 can be constructed having different common angles between each emitter and detector pair. For example, the common angle between the cells of the emitter array 100 of FIG. 4 and the detector array 200 pairs may be 45 °. In another sensor assembly 2 configured to further penetrate into the patient's body, the common angle between the pairs may be 30 °. The patient's anatomy may determine the appropriate sensor assembly 2 to use. For example, if the sensing device 1 is implanted subcutaneously in a very thin patient or a very small patient, the distance between the sensor assembly 2 and the target vessel 3 may be very fat or very large. It can be smaller than the corresponding distance in the patient. Thus, a sensor assembly 2 having a larger common angle between the emitter and the paired detectors is appropriate for lean patients, while a sensor assembly 2 having a smaller common angle is appropriate for fat patients. Will.

  It should be further understood that in some embodiments, emitter array 100 and detector array 200 may be attached to sensing device 1 at an angle relative to each other. In FIG. 4, emitter array 100 and detector array 200 are coplanar (ie, at a zero angle relative to each other). As a result of size constraints or desired mounting locations for emitter array 100 and detector array 200, these arrays may be tilted toward each other, as shown by the dotted lines in this drawing.

  5A-5C are schematic representations of the sensor assembly 2 shown in FIG. 4 with the addition of a small blood vessel 12 oriented perpendicular to the blood vessel 3. In FIG. 5A, only the cells along the outer edges of the emitter array 100 and detector array 200 are shown. Each emitter cell 101, 105, 109, 113 emits an IR beam 101E, 105E, 109E, 113E, respectively. The blood vessel 12 is shown in a perspective view because it is further away in the drawing and none of the radiation beams 101E, 105E, 109E, 113E hits the blood vessel 12. As shown, the radiation beam 101E fails to completely reach blood vessels 3 and 12. Thus, no reflected beam is detected by the detector 201. A part of the radiation beam 105E hits the blood vessel 3. A part of the photons that hit the blood vessel 3 are reflected and detected by the detector 205 as a reflected beam 105R. The radiation beam 109E all hits the blood vessel 3. The photon portion of the radiation beam 109E reflected by hemoglobin in the blood vessel 3 is detected by the detector 209 as a reflected beam 109R. Similar to the radiation beam 101E, only a portion of the radiation beam 113E hits the blood vessel 3 and provides a reflected beam 113R at the detector 213.

  Compared to FIG. 5A, FIG. 5B shows that the plane through the second column of emitters 102, 106, 110, 114 and the second column of detectors 202, 206, 210, 214 is essentially further in the page. It is a view farther into the page. In this figure, blood vessel 12 is shown in solid lines because it is located in the area illuminated by the beams emitted from emitters 102, 106, 110 and 114. When activated, the emitter 102 emits a radiation beam 102E that fails to completely reach the blood vessel 3. However, a portion of the radiation beam 102E strikes the blood vessel 12 and a portion of the impinging photon is reflected as a reflected beam 102R '. In this example, none of the reflected beam 102 </ b> R ′ is detected by detector 202 due to the location of blood vessel 12. Similar to the radiation beam 105E of FIG. 5A, a part of the radiation beam 106E hits the blood vessel 3. Here, however, another part of the radiation beam 106E hits the blood vessel 12 before reaching the blood vessel 3. Some of the photons impinging on the blood vessel 12 are reflected as a reflected beam 106R ', which is not detected by the detector 206. Therefore, the portion of the radiation beam 106E that strikes the blood vessel 3 is smaller than the portion of the radiation beam 105E that strikes the blood vessel 3 due to interference of the blood vessel 12. Accordingly, the reflected beam 106R detected by the detector 206 has a lower intensity than the reflected beam 105R detected by the detector 205. Similarly, interference in vessel 12 results in reflected beam 110R 'and reflected beam 114R', which reduces the number of photons in reflected beams 110R and 114R detected by detectors 210 and 214, respectively.

  FIG. 5C shows a plane that passes through the third column emitters 103, 107, 111, 115 and the third column detectors 203, 207, 211, 213, essentially further into the page. . In FIG. 5C, the blood vessel 12 does not occupy the area illuminated by the radiation beams 103E, 107E, 111E, 115E and is again shown in perspective. Since the blood vessel 12 does not interfere with the radiation beam and the location of the blood vessel 3 is the same as shown in FIG. 5A, the travel path of the radiation beams 103E, 107E, 111E, 115E and the resulting reflected beams 107R, 111R 115R is the same as the corresponding beam described with respect to FIG. 5A.

  According to one embodiment of the present invention, the computing device 20 processes the signals by filtering, scaling, and adjusting the signals received from the detector array 200, and the beam received by the detector array 200. Calculate the measurement corresponding to the strength or power. In one embodiment, the computing device 20 digitizes the analog signal generated by the detector array 200. In Tables 1 and 2 below, a value of 1 indicates 100% of the total power. In other words, a value of 1 is equal to the power expected to be received by the detector cell when the corresponding emitter cell emits a wave that encounters the maximum interference of the blood vessel 3 of interest (and thus the reflection by the blood vessel 3). In an alternative embodiment, electronic circuitry (not shown) is used to filter, scale, and adjust the signal received from detector array 200 and the output of the electronic circuitry is provided to computing device 20 for processing. It is done. In another step, the calculation device 20 evaluates and maps the measured values to determine the location and diameter of the blood vessel 3, as further described below.

  In one embodiment according to the invention, the full power signal is scaled to be equal to a vessel portion having a width of 0.7 cm. Each piece of total power represents a 0.7 cm wide piece linearly. The width or diameter of the vessel is optionally calculated by adding measurements in the detector cell row or column. A vessel diameter is identified if the measured values in two or more rows or columns when adding column values differ by less than 10%. In another embodiment, the vessel diameter is identified if the measurements in two or more rows or columns differ by less than 5%.

Table 1 shows a conceptual representation of the measured values corresponding to the depiction of the blood vessel 3 shown in FIG. These values indicate that none of the photons in the beams emitted from the emitters 101-104 were reflected by the paired detectors 201-204 of the array 200 and were not subsequently detected. More photons are detected by the cells in the second row (detectors 205-208) and the fourth row (detectors 213-216), and more by the cells in the third row (detectors 209-212). Many photons were detected. As is apparent from Table 1, the signal detected in each column of the detector is the same. According to the embodiment disclosed above, where the total power signal is equal to 0.7 cm, the width or diameter of the vessel 3 is obtained by multiplying the signal of each detector in the column by 0.7 cm and adding the resulting product. Can be calculated. More specifically, the diameter of the blood vessel 3 in this example is 0.0 * 0.7 + 0.8 * 0.7 + 1.0 * 0.7 + 0.8 * 0.7, that is, 1.82 cm.

Table 2 is similar to FIG. 1 but shows a conceptual representation of the process values corresponding to the depiction of blood vessels 3 and 12 shown in FIGS. 5A-5C. The reduced value in column 2 corresponding to detectors 206, 210 and 214 represents the interference caused by vessel 12 as shown in FIG. 5B. The values in columns 1, 3 and 4 differ by less than 5% (in fact they are identical as shown). Therefore, the calculation device 20 can ignore the signal of the column 2 and calculate the diameter of the blood vessel 2 using any one of the signals of the column 1, 3 or 4 as described above.

  In one embodiment according to the present invention, measurements indicative of the presence of blood vessels having a diameter smaller than a predetermined size are deleted or removed to obtain a clearer indication of the target blood vessel. In one embodiment, measurements corresponding to vessel diameters less than 1 cm are deleted. In such embodiments, the vessel of interest is an aorta having a known approximate diameter (depending on the patient's physical characteristics) that is substantially larger than almost any other vessel near the attachment location of the sensing device 1. .

  It should be understood that in determining the vessel diameter and mapping its location as described above, each emitter 101-116 is actuated individually in a row. Although several radiation beams are shown simultaneously in the various drawings, only one beam is emitted at a time, avoiding beam superposition and generating signals that are not confused by such superposition. By emitting one beam and receiving one reflected beam at a pair of detectors, each signal provides un-confounded information about the blood vessel. Each signal represents the interference and spread experienced by a single beam. In one embodiment of the invention, the beams were emitted individually starting from emitter 101 and scanning row by row, which was followed continuously until emitter 116 was activated. In other embodiments, other sequences were followed.

  As the array detectors are scanned, the signal produced by each detector represents the interference and spread experienced by each beam. In general, a scan provides information about the location and diameter mapping of a blood vessel. If the blood in the blood vessel is sufficiently oxygenated, the blood will contain more iron and the detector will generate a signal that represents full power. If the blood is not fully oxygenated, the detector generates a signal indicating less than total power. However, since the scan is performed quickly, the oxygenation level is constant during each scan cycle, and therefore the beam power difference received by each detector is independent of the oxygenation level, regardless of the oxygenation level. Can be used to map.

  The diameter of the pulmonary artery in the vicinity of the aorta is similar to the diameter of the aorta. Therefore, in order to identify and measure the diameter of the aorta, the sensing device 1 must distinguish between the pulmonary artery and the aorta. This is because both the pulmonary artery and the aorta have a diameter that exceeds a predetermined diameter threshold. The sensing device 1 measures each oxygen saturation and selects the blood vessel with the highest oxygen saturation (this is always the aorta because the pulmonary artery carries deoxygenated blood from the heart to the lung) Differentiate the two blood vessels.

  When measuring oxygen saturation, the sensing device 1 operates all the emitters 101 to 116 of the emitter array 100 simultaneously. First, the sensing device 1 calculates the position and diameter of a target blood vessel such as the aorta by the scanning method already described. Vascular dimensions, the geometric relationship between the emitter and detector arrays and the vessel, and the physical properties of the emitter and detector arrays, eg, array size, emitter beam width, emitter and transmitter placement , The sensing device 1 calculates a potential maximum oxygen saturation value according to a known photon diffusion equation. Since the physiological characteristics of each patient are different, the sensing device 1 can calibrate the potential maximum value for each patient using the reference values stored in the memory of the computing device 20. The sensing device 1 then emits a beam simultaneously from the emitter array, detects the reflected beam at the detector array, and converts the reflected beam into a power signal. In one embodiment, the sensing device 1 combines signals generated from a detector that receives photons reflected by a blood vessel and divides the total value by the potential maximum value to obtain a saturation ratio. The saturation ratio represents the degree of saturation in the blood flowing through the blood vessels. In another embodiment, the sensing device 1 only activates an emitter that is expected to produce a beam that will hit the blood vessel, and does not activate an emitter that the beam will not hit the blood vessel to save energy. To do. In another embodiment, sensing device 1 saves energy and simplifies photon diffusion calculations simply by activating an emitter that is expected to produce a beam that hits the vessel and will not hit other vessels. To do. In a further embodiment, the sensing device 1 can selectively activate emitter and detector pairs to minimize the number of activated pairs and save power.

  Under normal operating conditions, the sensing device 1 can perform oxygen saturation measurements once or twice per day. When an abnormal state is detected, or when functioning as a heartbeat detector as described below, the sensing device 1 can perform a plurality of oxygen saturation measurements during a short period. While taking very frequent measurements consumes considerable power, the data acquired can be important to the patient's health.

  In one embodiment, the sensing device 1 also calculates the heartbeat. As discussed above, the detector generates power signals that represent iron content in the blood. As the heart pumps oxygenated blood through the aorta, the power signal fluctuates. Multiple power signals can be obtained in quick succession to capture power measurement variations. More specifically, by performing a number of oxygen saturation measurements (eg, 10 times per second) over a period of time (eg, 15 seconds), the saturation measurement exhibits a pattern or periodicity that represents the heartbeat. The computing device 20 can define a curve that fits the saturation measurement, for example a sinusoid, which directly corresponds to the cardiac cycle. The calculation device 20 can determine the frequency of the peak value of the curve and determine the period. Each period represents a cardiac cycle. By multiplying the number of cardiac cycles in a sample period (eg, 15 seconds) by an appropriate factor, the computing device 20 can determine the pulse rate in terms of cardiac cycles per minute. In one embodiment, the calculation device 20 stores a heart beat value as a normal reference value and detects an abnormal or irregular heart rhythm by comparing the heart beat value with a reference value.

  In another embodiment of the sensing device 1 according to the present invention, the sensor assembly 2 and other features of the sensing device 1 are pacemakers, cardiac resynchronization therapy (CRT) devices, implantable cardioverter defibrillators (ICDs), etc. Integrated with an implantable heart device.

2. Calculation device The calculation device 20 includes a plurality of components. Although the components are described herein as if they were independent components, these components may be combined into a single device, such as an application specific integrated circuit. The calculation device 20 includes a processor, a memory, a program, an input, and an output. The memory may include, but is not limited to, RAM, ROM, EEPROM, flash memory or other memory technology. The processor and memory may be built in an integrated circuit. The integrated circuit can include an emitter array 100, a detector array 200, and a communication device 30. Furthermore, the calculation device 20 may include an A / D and / or D / A converter on the integrated circuit. Alternatively, an A / D and / or D / A converter may be provided separately.

  A program represents computer instructions that instruct a processor to perform a task in response to data. The program exists in memory. Data including reference data and measurement data is also present in the memory. The reference data may be stored in ROM in response to external input or in response to characteristics of measurement data collected over time, or may be stored in RAM so that it can be changed over time. A protocol that responds to the measurement may also be provided. The protocol may be stored in persistent memory or may be stored in non-persistent memory such as RAM.

  The calculation device 20 controls the sensor assembly 2 and the communication device 30 through input and output. The calculation device 20 controls the number, frequency, power level, and emission sequence of the plurality of beams emitted by the emitters 101-116 to obtain a desired measurement value using a minimum amount of energy. Can do.

  FIG. 6A discloses a system 300 for exchanging information with the sensing device 1. System 300 includes a sensing device 1 having a communication device 30 and optionally a connector 85. System 300 may also include a computer 302, a docking station 304 operably connected to computer 302 by cable 303, and a telephone 306. In one embodiment of the present invention, the system 300 transmits and receives a communication signal 312 wirelessly to / from the sensing device 1 based on processing performed by the computing device 20.

  Connector 85 is configured to be plugged into docking station 304. A sensing device 1 docked on a docking station 304 is shown. While docked, the sensing device 1 can charge the energy storage device 40. The docking station is operably coupled to the computer 302 to update programs and reference values stored in the memory of the computing device 20 prior to placing the sensing device 1 on or in the patient. In another embodiment, the sensing device 2 is positioned external to the patient and the connector 85 is operatively connected to the energy source to power the sensing device 2 and prevent the energy storage device 40 from being depleted.

  In a further embodiment according to the present invention, additional sensors and devices can be coupled to the sensing device 1 through the connector 85. Other sensors and devices may include, but are not limited to, additional sensor assemblies 2, temperature sensors, pressure sensors, and accelerometers. Other devices may or may not include a calculation device. Other devices may also be combined with the sensing device 1 within the housing 90. An integrated sensing device is disclosed in the above-referenced related US utility model application, named “INTEGRATED HEART MONITORING DEVICE AND METHOD OF USING SAME”. The function of the sensing device 1 may be configured to operate the additional sensors and devices by downloading a modification program configured to operate the additional sensors and devices to the memory of the computing device 20. The download may be performed while the calculation device 20 is docked in the docking station. Alternatively, a new program may be downloaded wirelessly through the calculation device 40.

  FIG. 7 is a flowchart showing one routine of a program executed by the calculation device 20 according to an embodiment of the present invention. At step 400, the computing device 20 activates the sensor assembly 2 and, depending on the measurements being performed as described above, either all emitters 101-116 emit a beam, or the emitters are individually beamed individually. Radiate. Step 400 also represents a procedure for generating signals at detectors 201-216 that represent the reflected beam.

  In step 402, the calculation device 20 processes the signal to obtain a measurement value. Processing includes removing inherent signal noise, converting the signal from analog form to digital form, optical to digital form, scaling the detected signal, and adjusting otherwise May include. Alternatively, some processing functions may be performed by a circuit such as an A / D converter. After processing, the measured value may be stored in memory or analyzed to determine whether the value should be stored. Steps 400 and 402 may be repeated as necessary to obtain sufficient measurements to calculate the desired parameters in accordance with the above disclosure. Steps 400 and 402 may be performed simultaneously.

  In step 404, the calculation device 20 analyzes the measured value. The analysis can include calculation of parameter data and / or diagnosis. Parameter data refers to calculated values such as vessel diameter and location, oxygen saturation, cardiac rhythm, and the like. Diagnosis refers to comparing parameter values with reference values to detect abnormal patient conditions. The reference data corresponds to the normal state of the patient. If abnormal conditions are detected, the calculation device 20 communicates (consumes unnecessary power) when the measurement values are collected, or the memory is full or at a predetermined transmission time. Rather than waiting to send measurements until they are reached (exposing the patient to unnecessary risks during the waiting period), an alarm can be communicated.

  The reference value can include a target value and an acceptable variation range or limit. Parameter values can indicate an anomaly if they are outside the target reference value or range. In some embodiments, the parameter value can generate a statistical value, such as a moving average, for example, and an anomaly is detected when the statistical value of the parameter exceeds the predicted amount and differs from the baseline statistical value.

  If the parameter data exceeds the predetermined amount and is different from the predicted value, the calculation device 20 can start the new measurement cycle and check the parameter data before diagnosing the abnormality. In one embodiment, the computing device 20 remaps the location and diameter of the aorta when the measured value differs by more than 10% from the predicted value. In another embodiment, the computing device 20 remaps the position and diameter of the aorta when the measured value differs from the predicted value by more than 5%.

  One abnormal medical condition is hypoxia saturation. The calculation device 20 may be configured to perform an analysis of the measured value, for example to determine whether the oxygen saturation value is too low. “Normal” oxygen saturation values vary from patient to patient and depend on the patient's condition, but generally oxygen saturation measurements below 90% are considered low. Another abnormal medical condition is an irregular heart rhythm that can be detected in the manner described above.

  Further abnormal medical conditions can be detected externally or using values obtained from additional sensors. Additional sensors that can be included in the sensing device 1 are related US utility models referred to above, named “DOPPLER MOTION SENSOR APPARATUS AND METHOD OF USING SAME” and “INTEGRATED HEART MONITORING DEVICE AND METHOD OF USING SAME”. Disclosed in the application.

  In embodiments where the sensing device 1 includes a Doppler sensor, the vessel diameter and location may be used to calculate fluid velocity and pumping rate. If the blood vessel is an aorta, these parameters may be used to calculate and diagnose abnormal conditions related to cardiac output. Aortic parameters can be combined with systolic and diastolic blood velocity values obtained with a Doppler sensor to calculate systolic and diastolic blood pressure. Other sensors can include ECG sensors and temperature sensors.

  In step 406, the computing device 20 transmits an alarm when an abnormal condition is detected, particularly a condition that is determined to be a serious or dangerous condition according to a defined protocol. The alarm can be used to trigger an alarm device or alert the patient to perform a therapeutic action. The therapeutic action may terminate or reduce physical activity. The alert can also provide global positioning (GPS) information to an emergency service. Referring to FIG. 6A, if an abnormal condition is found to exist, it is displayed on computer 302 and / or transmitted to the caregiver by communication device 30 (eg, Nokia modem KNL 1147-V). You can also The alert can include a text message or code corresponding to the condition. The computing device 20 can also initiate new measurement cycles and measurements continuously in response to detecting an abnormal condition.

  In step 408, the calculation device 20 can start treatment. The sensing device 1 can receive an external command to execute treatment in response to the alarm through the communication device 30. Optionally, based on the protocol, an abnormal condition may be used to instruct a device configured to deliver a treatment to deliver such a treatment. Treatment can include, for example, electric shock or drug delivery.

  In step 410, parameter values or other information is communicated to an external device. Step 410 may be performed simultaneously with any of the above steps. The parameter value can be stored in a memory and transmitted wirelessly by the communication device 30. The communication signal from the communication device 30 is in response to an abnormal state, in response to an externally received command, each time the use of the memory exceeds a predetermined amount, or whenever it is determined that the energy storage level is low. The latter two states can be activated periodically, established to prevent data loss or energy loss as a result of memory overflow. It should also be understood that the sensing device 1 may include a communication device in addition to the communication device 30. For example, if the communication device 30 is a cellular modem, the sensing device 1 can also include a backup Bluetooth or RF communication device. Such a backup device is an alternative in situations where the cellular modem is unable to transmit information (eg due to poor power available, poor reception of cellular or other communication signals, poor network coverage, etc.). It may be desirable to provide a communication means. In such a situation, the computing device 20 can activate the backup communication device to send information or alerts to an alternative external receiving device.

  Step 410 can be performed, for example, once an abnormal condition is detected, so as to provide the caregiver with up-to-date information in substantially real time. Step 410 may be performed at regular intervals, such as once a day, once a week, once a month, or the like. Alternatively, or in addition to these transmissions, the computing device 20 causes the communication device 30 to transmit the requested data or information representing the requested data to the communication device 30 (eg, from a healthcare provider). Can be programmed to respond to a request for data received by.

  The communication signal may be received by equipment near the patient, to alert the patient to the condition, or remotely (e.g., networked by a healthcare provider, relative, or other predetermined recipient) Can be received).

3. Communication Device Referring again to FIG. 6B, a system configured to send and receive communication signals according to one embodiment of the present invention is shown. The communication device 30 is a two-way communication device via, for example, a mobile phone system and / or a GPS satellite system. The communication device 30 includes an antenna 32 that transmits and receives communication signals. The communication signal identified by numeral 312 moves wirelessly to and from one of a plurality of optional external communication devices.

  The external communication device may be a computer 302, or any electronic device, such as a telephone 306, that is embodied herein as a mobile phone and that can receive communication signals wirelessly. The telephone 306 may be an emergency facility switchboard or a hospital or medical center switchboard. By communication signal is meant a signal having one or more of its characteristics set or changed to encode signal information. By way of example, and not limitation, communication signals include acoustic media, RF media, infrared media, other wireless media, and combinations of any of the foregoing. The external communication device may also be a relay unit located outside the patient's body, for example clipped to the patient's belt. The relay unit can include a receiver that receives a transmission from the communication device 30 and a transmitter that retransmits the communication signal to another external communication device. The relay unit may also be fixed and wired so that it is connected to the Internet or directly connected to the healthcare provider's computer. Similarly, the relay unit can receive a communication signal from the healthcare provider and transmit the signal to the communication device 30.

  The communication signal from the communication device 30 can include a voice message, a text message, and / or measurement data. The communication received by the communication device 30 can include data such as updated reference data, or commands. The commands can include instructions to the computing device 20 to perform tasks such as, for example, treating a patient, collecting and transmitting additional data, or updating reference data. A further embodiment of the method for communicating information according to the invention is disclosed in the above referenced US utility model application, referred to above as “METHOD AND SYSTEM FOR MONITORING A HEALTH CONDITION”.

4). Energy Storage Device Referring again to FIGS. 1B, 1C, and 6, a system for recharging the energy storage device 40 may be provided in one embodiment according to the present invention. The calculation device 20 receives energy from the energy storage device 40. The energy storage device 40 includes energy storage components such as a battery. Optionally, the sensing device 1 may also include an energy coupler that receives energy from an external source to charge the energy storage device 40.

  An example of an energy coupler is an electromagnetic device, such as an induction coil 308, that receives an external electromagnetic signal 310 and converts such signal to electrical energy to recharge the energy storage component. An external electromagnetic device 308 generates an electromagnetic signal 310 that is received by the energy storage device 40 and converted into an electrical signal. The energy storage device 40 can provide a charge signal to the calculation device 20. The computing device 20 can compare the charge signal with a reference charge signal, initiate a low charge communication signal, and alert the patient and / or health care provider. Alternatively, a detector such as a voltage sensor may be used to monitor the charging of the energy storage device 40 and provide a signal to the computing device 20 when the charging falls below a threshold. The electromagnetic device 308 can be placed near the sensing device 1 to charge the energy storage device 40.

  Alternatively or additionally, energy may be provided in the form of ultrasonic vibrations. For example, a piezoelectric transducer may be included in the sensing device 1. Ultrasonic vibration may be applied from the outside. The transducer generates electricity when driven by ultrasonic vibration.

  While this invention has been described as having an exemplary design, the present invention may be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the invention using its general principles. Furthermore, this application is intended to cover departures from the present disclosure that fall within known or customary practice in the art to which this invention belongs.

Embodiment
(1) In a sensing device that acquires a signal and calculates a measured value,
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 blood vessel, each emitter emitting a photon from the emitter impinging on a blood vessel Are directed to partially reflect toward the plurality of detectors, each detector configured to generate each of the plurality of signals representative of the emitted photons received by the detector. A sensor assembly;
A calculator for operating the plurality of emitters and detectors and processing the plurality of signals generated by the plurality of detectors to obtain a measurement of at least one characteristic of the blood vessel;
A housing surrounding the sensor assembly and the calculation device;
A sensing device.
(2) In a sensing device that optically measures at least one characteristic of a blood vessel and blood flowing through the blood vessel,
A housing having a first side and a second side;
A sensor assembly attached to the housing, the sensor assembly including a plurality of emitters that emit photons through the first side of the housing, and the emitted photons through the first side of the housing. A plurality of detectors for receiving at least a portion, each emitter operatively paired with a separate detector, and a beam of photons emitted from the emitter impinging on a blood vessel adjacent to the sensor assembly; A sensor assembly that is directed to partially reflect toward a detector comprising: each detector configured to generate a signal representative of the emitted photons received by the detector;
A computing device attached to the housing and configured to activate the plurality of emitters and interpret the signal from the detector to determine the characteristic;
A sensing device.
(3) In a method of acquiring a signal and calculating a measurement value,
Providing a sensing device, the sensing device comprising:
A plurality of photon emitters and detectors, wherein the emitters emit a beam, the detector detects the beam and generates a plurality of signals corresponding to the detected beams, the emitter and detector A plurality of photon emitters and detectors facing one side of the blood vessel, and
A calculation device for operating the plurality of emitters and detectors;
Including, providing,
Operating the plurality of emitters and detectors to obtain a plurality of signals;
Processing the plurality of signals to obtain measured values;
Analyzing the measured value to obtain a parameter value indicative of a characteristic of at least one of the blood vessel and the fluid;
Including a method.

1 is a schematic side view of a sensing device according to an embodiment of the present invention. FIG. 2 is a view of the sensing device of FIG. 1 facing outward. It is a perspective view of the sensing device of FIG. FIG. 2 is a schematic side view of the sensing device and blood vessel of FIG. 1. 1 is a schematic perspective view of a sensor assembly and a blood vessel according to one embodiment of the present invention. FIG. 1 is a schematic side view of a sensor assembly, blood vessel, radiation beam, and reflected beam according to an embodiment of the present invention. FIG. 2 is a schematic side view of a sensor assembly, large blood vessel, small blood vessel, radiation beam, and reflected beam according to an embodiment of the present invention. FIG. 2 is a schematic side view of a sensor assembly, large blood vessel, small blood vessel, radiation beam, and reflected beam according to an embodiment of the present invention. FIG. 2 is a schematic side view of a sensor assembly, large blood vessel, small blood vessel, radiation beam, and reflected beam according to an embodiment of the present invention. 2 is a schematic front view of a system configured to communicate with the sensing device of FIG. FIG. 2 is a schematic side view of a system configured to communicate with the sensing device of FIG. 1. 4 is a flowchart of a method according to the present invention.

Claims (12)

In the sensing device that acquires the signal and calculates the measured value,
A sensor assembly including a plurality of detectors and a plurality of emitters for generating a plurality of signals, each emitter having a beam of photons emitted from the emitter impinging on a blood vessel partially directed toward the plurality of detectors A sensor assembly, wherein each detector is configured to generate each of the plurality of signals representative of photons of the reflected beam received by the detector;
A computing device for manipulating the emitter such that the emitter emits a beam of photons and processing the plurality of signals generated by the plurality of detectors;
An energy storage device for storing energy and supplying power to the calculating device and the sensor assembly;
A housing surrounding the sensor assembly, the energy storage device, and the computing device;
Including
The sensing device is configured to be implanted in a patient;
The emitter and the detector are arranged in the housing to face one side of a blood vessel when implanted,
Each of the plurality of detectors is paired with each of the corresponding plurality of emitters to receive the beam of photons emitted from the corresponding emitter and reflected from the blood vessel ,
The process includes calculating a distance from the sensor assembly to the blood vessel, a diameter of the blood vessel, and an oxygen saturation value of blood flowing through the blood vessel after implantation. The sensing device according to claim 1.
The computing device selectively activates emitter and detector pairs to minimize the number of activated pairs and save energy. The sensing device according to claim 1 or 2,
The sensing device calculates the position and diameter of the blood vessel by a scanning method, and then simultaneously activates an emitter that is predicted to generate a beam that will hit the blood vessel. The sensing device according to any one of claims 1 to 3,
The sensing device calculates at least one of aortic location, aortic diameter, oxygen saturation, and cardiac rhythm. The sensing device according to any one of claims 1 to 4,
The sensing device, wherein the plurality of emitters are arranged in an emitter matrix, and the plurality of detectors are arranged in a detector matrix. The sensing device according to any one of claims 1 to 5,
The sensor assembly and the calculation device are integrated into one part,
The device is the same size as the overlapped two sheets of 25 cent coins, the sensing device. The sensing device according to any one of claims 1 to 6,
A sensing device further comprising one or more communication devices for wirelessly transmitting and receiving communication signals. The sensing device according to claim 4 .
The calculating device, based on said at least one of oxygen saturation and said heart rhythm to determine whether or abnormal patient's condition is normal, the sensing device. The sensing device according to claim 8.
In response to the determination that the condition is abnormal, the computing device transmits an alarm, initiates treatment, delivers a medication, communicates information periodically, and an electric shock. A sensing device that performs a function selected from causing. The sensing device according to claim 9 ,
The calculation device calculates a first parameter value based on the signal generated by the detector;
An emitter and detector pair is selected based on the first parameter value;
A sensing device, wherein the selected emitter and detector pair is used to measure the oxygen saturation value . The sensing device according to claim 10 .
The sensing device, wherein the first parameter value includes a diameter of the blood vessel. The sensing device according to any one of claims 1 to 11 ,
The sensing device, wherein the energy storage device includes an energy coupler that receives energy to recharge the energy storage device.

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