Ergonomic Handheld Oximeter Device
20170303836 · 2017-10-26
Inventors
- Kate LeeAnn BECHTEL (Pleasant Hill, CA, US)
- Sophia Elizabeth Berger (Palo Alto, CA, US)
- Audrey Steever (Fremont, CA, US)
Cpc classification
A61B2562/0238
HUMAN NECESSITIES
A61B5/7221
HUMAN NECESSITIES
A61B2562/0242
HUMAN NECESSITIES
A61B2560/0475
HUMAN NECESSITIES
International classification
Abstract
An oximeter device has an ergonomically shaped enclosure that allows a user to comfortably grip and use the device during handheld operation. A sensor tip can be easily placed evenly on the tissue surface, so that all sources and detectors are directly on the tissue with even pressure. This allows for more consistent and accurate results. The user can easily move the device from one position to another and take numerous measurements. The user will have a wide, unobstructed view of the tissue because of the tip's small size, angle of display, and the grip and fingers are positioned away from the tip. Components housed by the enclosure are arranged to give the device a balanced weighting while in the hand. The device can be used for long periods at a time without fatigue.
Claims
1. A device comprising: a body portion comprising: a rectangular tubular portion comprising a front side surface and a back side surface, coupled together by first and second side surfaces; and a tip portion comprising: a first finger rest surface, coupled to the front side surface, wherein the first finger rest surface is a convex surface that extends at a first angle in a first turn direction relative to the front side surface; a front tip surface, coupled to the first finger rest surface, wherein the front tip surface extends at a second angle in a second turn direction relative to the first finger rest surface; a bottom face surface, coupled to the front tip surface, wherein the bottom face surface extends at a third angle in the second turn direction relative to the first finger rest surface, and the bottom face surface comprises an opening which will retain a sensor head of the device; a second finger rest finger, coupled to the back side surface, wherein the second finger rest surface is a concave surface that extends at a fourth angle in the first turn direction relative to the back side surface; and a back tip surface, coupled between the second finger rest surface and the bottom face surface, wherein the back tip surface is a convex surface that extends at a fifth angle in the first turn direction relative to the second finger rest surface.
2. The device of claim 1 wherein the back side and bottom face surfaces are relatively flat surfaces that are angled relative to each other in a range from 90 degrees to about 150 degrees.
3. The device of claim 1 wherein a first height of the first finger position above the bottom face surface is greater than a second height of the second finger position above the bottom face surface.
4. The device of claim 1 wherein the first angle is angled relative to the front side surface in a range from 90 degrees to about 60 degrees.
5. The device of claim 1 wherein batteries are enclosed within the rectangular tubular portion, and the batteries are closer to the back side surface than the front side surface.
6. The device of claim 1 wherein the rectangular tubular portion comprises rounded corners.
7. The device of claim 1 wherein the first finger rest surface is adapted for a thumb of a user.
8. The device of claim 1 wherein the second finger rest surface is adapted for a middle finger of a user.
9. The device of claim 1 wherein when the device is gripped by a hand of a user, a thumb of the user will be against the first finger rest surface, a middle finger of the user will be against the first finger rest surface, and a webbing between the thumb and a index finger of the user will be against the back side surface.
10. The device of claim 1 wherein the sensor head comprise: a plurality of sources, the sources are arranged along a line; and a plurality of detectors, wherein there are an equal number of detectors on either side of this line, and a position of a detector on a first side of the line will have point symmetry with another detector on a second of the line about a selected point on the line.
11. The device of claim 10 wherein the selected point is a middle between two sources.
12. The device of claim 1 wherein a first distance between the first and second side surfaces is greater than a second distance between the front and back side surfaces.
13. An oximeter system comprising the device of claim 1.
14. The device of claim 1 comprising: batteries, enclosed within the rectangular tubular portion, wherein the batteries are closer to the back side surface than the front side surface; sensor head, comprising an arrangement of source structures and detector structures; a display; and electronics, coupled to the battery, sensor head, and display, wherein the electronics cause light to be transmitted through the source structures of the sensor head, and based on light received through the detector structures, the electronics determines an oxygen saturation value and causes the display to show the oxygen saturation value.
15. The device of claim 1 comprising: a sensor head assembly comprising the sensor head, wherein the sensor head assembly is enclosed by a space between the convex surface of the first finger rest surface and the concave surface of the second finger rest surface.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE INVENTION
[0051]
[0052] In a specific implementation, Intra.Ox is a sterile, cordless, battery-powered device that noninvasively estimates percent oxygen saturation (StO2) in a volume of tissue. The device uses spatially resolved optical measurements at four wavelengths. The device performs measurements on the patient by direct physical contact to the patient's tissue and displays the StO2 estimate on the device's built-in screen. Intra.Ox is a single-use disposable constructed from biocompatible materials that can tolerate bodily fluids and other liquids such as disinfectants and marking materials.
[0053] Intra.Ox can be used in medical environments including doctor or physician offices, hospitals, ambulatory case, and emergency medical services. The device provides medical parameters including tissue oxygen saturation (e.g., percent StO2) and can include a trend graph. The device uses spectrophotometric oximetry. For operation, the device uses near-infrared light, generated by light emitting diode semiconductor integrated circuits at wavelengths of 760, 810, 850, and 900 nanometers. Other wavelengths may be used, such as 690 and 830 nanometers, and many others.
[0054] The sensor and a control unit, which controls operation of the sensor, are integrated into a single unit and the entire unit is disposable after use. The device is powered by four lithium AA-size batteries, which have a total battery voltage of 6 volts.
[0055] The following U.S. patent applications are incorporated by reference along with all other references cited in this application: Ser. Nos. 15/493,132, 15/493,111, 15/493,121, filed Apr. 20, 2017, Ser. No. 15/494,444, filed Apr. 21, 2017, Ser. Nos. 15/495,194 and 15/495,212, filed Apr. 24, 2017, 62/363,562, filed Jul. 18, 2016; 62/326,673 and 62/326,630, filed Apr. 22, 2016; 62/325,919, filed Apr. 21, 2016; 62/325,403, 62/325,413, 62/325,416, filed Apr. 20, 2016; Ser. No. 29/561,749, filed Apr. 19, 2016; Ser. No. 13/887,130, 13/887,220, 13/887,213, 13/887,178, 13/965,156, and 13/887,152, filed May 3, 2013; and 61/642,389, 61/642,393, 61/642,395, 61/642,399, 61/682,146, filed May 5, 2012. The above applications describe various oximeter devices and oximetry techniques, and the discussion in the above applications can be combined with aspects of the invention described in this application, in any combination.
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[0057] The device has a thumb rest 207 and a middle finger rest 409. The thumb rest is a portion of the device against which the thumb will be placed against. The middle finger rest is a portion of the device against which the middle finger will be placed against.
[0058]
[0059] Referring to
[0060] With the thumb positioned on the thumb rest, pressure from the thumb is applied from above the sensor tip to provide even pressure for the sensor head to contact the tissue being measured. All sources and detectors of the sensor will be against the tissue surface, so the sensor will have full contact with the tissue surface. This allows for more consistent and accurate sensor readings.
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[0062] A display head upon which the built-in screen is positions is angled with respect to the tubular portion of the body and tip portion, so the user can easily view the screen and the tissue being measured at the same time from a variety of viewing angles during use. The angle of the tubular portion of the device (e.g., which slopes in the hand on the webbing between the thumb and index finger) is also selected to allow for ease in viewing by the user.
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[0064] Referring to
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[0066] The source structures and detector structures can be arranged at various positions on the sensor surface to give the distances desired. For example, the two sources form a line, and there are equal number of detectors above and below this line. And the position of a detector (on one side, e.g., above, of the line) will have point symmetry with another detector (on the other side, e.g., below, of the line) about a selected point on the line of the two sources. As an example, the selected point may be the middle between the two sources, but not necessarily. In other implementations, the positioning can be arranged based on a shape, such as a circle, an ellipse, an ovoid, randomly, triangular, rectangular, square, or other shape.
[0067] An enclosure of the oximeter has a number of panels, which are attached together at various seam lines shown in the drawings. In an implementation, the enclosure has four panels (e.g., four plastic shells). The panels are made of a plastic material, thermoplastic, resin, acetal homopolymer resin, acetal copolymer, or other polymer.
[0068] A back panel 423 is removable so a user can access the batteries, such as to replace the batteries. In an implementation, the batteries are not replaceable. Further, the back panel can be removed to access a data port, which is underneath the batteries. This data port may have a proprietary connector, or can be serial port, universal serial port, or other standard port interface. The user can connect a cable to the data port and download data stored by the oximeter, such as oxygen saturation or other measurements. Also, the port can be used to update the software or firmware of the device.
[0069] This application describes some examples of implementations with specific dimensions, measurements, and values. These are not intended to be exhaustive or to limit the invention to the precise form described.
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[0071] For the specific implementations described, some specific values, ranges of values, and numbers are provided. These values indicate, for example, dimension, angles, ranges, frequencies, wavelengths, numbers, and other quantities (e.g., numbers of sensors, sources, detectors, diodes, fiber optic cables, domes, and so forth). Some measurements are for a specific implementation of the device, and other implementations can have different values, such as certain dimensions made larger for a larger-sized product, or smaller for a smaller-sized product. The device may be made proportionally larger or smaller by adjusting relative measurements proportionally (e.g., maintaining the same or about the same ratio between different measurements). In various implementations, the values (or numbers or quantities) can be the same as the value given, about the same of the value given, at least or greater than the value given, or can be at most or less than the value given, or any combination of these. The values (or numbers or quantities) can also be within a range of any two values given or a range including the two values given.
[0072] The oximeter has a body portion and a tip portion. The tip portion is distal to the body. The body as a back panel or back spine surface, which is relatively flat surface. Opposite the back spine is a relatively flat front surface which is attached to the back spine via to two relatively flat side surfaces. A cross section of this body portion has a generally rectangular shape (with dimensions of about 32.63 millimeters by 41.17 millimeters) with rounded corners. In other implementations, the cross section may be circular, elliptical, triangular, square, pentagonal, hexagonal, octagonal, or any other polygonal shape with any number of sides or facets (e.g., 7, 9, 10, 11, 12, or more).
[0073] The thumb rest position extends from the body at an angle of about 32.6 degrees and provides a surface against which the thumb can rest. A length of the thumb rest is about 15 millimeters (x direction), and gradually curves downward toward the tip (which extends a total length from the body about 31.23 millimeters). The thumb rest is about 37.27 millimeters (z direction) above a bottom face of oximeter. The bottom face of the oximeter is relatively flat and has the sensor head, that is formed relatively flush with the bottom face. An angle between the bottom face and back spine of the oximeter is about 120 degrees. Referring to
[0074] The middle finger rest is below the body and thumb rest. The middle finger rest has a surface about 23.29 millimeters (z direction) above the bottom face. The thumb and middle finger rests may also be referred to as edges, shelves, ridges, grips, holds, landings, and others.
[0075] The display head is angled to allow the user to view the built-in screen from a wide range of viewing angles. In an implementation, the display head is angled from about 30 degrees relative to the back spine surface. In other implementations, the angle can vary from about 10 to about 60 degrees.
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[0077] To access the various modes, the oximeter is operated by way of its single button. The button is used to turn on the device. Table A lists some types of button click operations.
TABLE-US-00001 TABLE A Type of Button Operation User Action Short Click User presses button for <2 seconds Double Click Two short clicks within 750 milliseconds Long Click User presses button for >2 seconds and < than 12 seconds Hardware Long Click User presses and holds button for >12 seconds Inactivity No valid StO2 numbers, no user clicks
[0078] The system modes of
TABLE-US-00002 TABLE B Mode Description LCD Logging Startup The system enters Test Pattern Data Log Startup mode when Improper shutdown Revision numbers the system is off message if appropriate with timestamp and the user clicks Splash screen with Error Log the power button. warm-up countdown Revision numbers The system powers timer that persists until with timestamp up and operations LED ambient temperature Errors begin. is in valid range or for 5 minutes, whichever is shorter. Measurement After Startup mode Operating time Data Log activities are StO2 numeric value Data values and StO2 complete, the or dashes results per separate list system starts StO2 Low battery icon if Error Log measurements if appropriate (Note, no Errors possible. If not battery icon appears possible a warning until the low battery is displayed. condition exists, battery <5.3 V) Warnings if appropriate- see separate table Standby The system enters Same as Measurement Data Log Standby mode mode, but LCD None from Measurement backlight is off, and Error Log mode either dashes are always Errors manually if the displayed since StO2 user short-clicks calculations are not once or performed. automatically after 2 minutes of inactivity (no valid StO2 values and no user clicks). StO2 calculations cease, but LEDs remain powered to maintain temperature. Data logging is not performed. A short click returns the system to Measurement mode. Revision If the user double SW and FW Revision Data Log Display clicks in Standby Numbers None mode, SW and FW Error Log revision numbers Errors are displayed on LCD. A short click returns the user to Measurement mode. Unrecoverable If an unrecoverable Unrecoverable error Data Log Error error occurs in any message (see table) Log is flushed to flash other mode, a Error Log partial SW- Unrecoverable error mediated shutdown Log is flushed to flash occurs and ends with an appropriate error message displayed on the LCD. The user must press and hold the power button to power down. See separate table of unrecoverable errors. Shutdown From any other Shutting down Data Log mode except message: Log is flushed Unrecoverable Line 1: >“Shutting to flash Error, pressing and down. . .” Error Log holding the power Line 3: Release button” Errors button more than 2 Log is flushed to seconds (long flash click) initiates a SW-mediated graceful shutdown and power down. If the SW-mediated shutdown is unsuccessful, the user can press and hold the power button for at least 12 seconds to force a hard shut down. It is likely that this action will corrupt operating time, data log data and error log data, and will cause an Improper Shutdown message at the next power- up.
[0079] Table C describes mode modifiers that change or supplement system behavior in the various system modes listed earlier.
TABLE-US-00003 TABLE C Modifier Description LCD Logging Communications If commanded to do so Same as current Date Log Modifier by an external PC, the mode. If in None system enters Measurement mode, Error Log communications mode, the Communications None where all loggings ceases mode indicator text No logging is done and no StO2 calculations “COMM MODE” so a new unit can be are performed. This added to the LCD. initialized during allows data to be manufacturing transferred to and from without consuming the system and the flash log space. external PC. This type of operation is intended for manufacturing calibration and for downloading data and error logs from the device. Engineering/ If commanded to do so Same as current Lab Modifier by an external PC, the mode. If in system enters Engineering mode, Engineering/Lab mode. the Communications Supplemental mode indicator text information may be “ENG MODE” displayed on the LCD, added to the LCD. data logging may Supplemental increase and warning information may be precedence may be displayed. modified. This type of operation is intended for lab testing and for manufacturing calibration.
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[0085] For a specific implementation, table D lists some logging frequencies for data logged in measurement mode.
TABLE-US-00004 TABLE D Optical detector magnitude Per interrupt, data and StO2 result 1 to 3 hertz Temp1 and Temp2 thermistor data About 1 hertz CPU internal temperature About 1/3 hertz ADC Maximums About 1/3 hertz or if saturated ADC Minimums About 1/3 hertz or if saturated Battery Voltage About 1/5 hertz
[0086] A clinical data log capacity is approximately 4.8 hours assuming 3 hertz interrupts and no saturation. If saturated, then log analog to digital converter (ADC) maximums and minimums at 1-3 hertz.
[0087] Table E lists some warning messages.
TABLE-US-00005 TABLE E Condition LCD Message Impact Corrective Action Flash data log is Data Full No further data For clinical study, users full (for clinicals logging. StO2 should stop collecting data only, not in measurements and get another device. product) continue. Shut down the device LEDs >45 MAX TEMP LED powers set to degrees zero and StO2 Celsius invalid, dashes displayed until condition no longer exists. LED power levels restored when condition no longer exists. LEDs >37.5 High Temp StO2 invalid, dashes Move the device to a cooler degrees Celsius displayed until area until condition no longer condition no longer exists exists LEDs <36.5 Low Temp StO2 invalid, dashes Move the device to a cooler degrees Celsius displayed until area until condition no longer condition no longer exists exists Detector Saturated StO2 invalid, dashes Correct sensor head saturation displayed until placement to improve condition no longer tissue contact exists Too much Ambient StO2 invalid, dashes Shield the sensor head from ambient light displayed until ambient light. condition no longer exists
[0088] In an implementation, only one warning message can be displayed at a time, so the following warning order of precedence applies.
[0089] Clinical Operation Warning Precedence
[0090] 1. LEDs greater than 45 degrees Celsius
[0091] 2. Flash data log full (will be removed for product)
[0092] 3. High Temp or Low Temp (36.5 degrees Celsius to 37.5 degrees Celsius)
[0093] 4. Detector saturation
[0094] 5. Too much ambient light
[0095] Table F lists some other error messages.
TABLE-US-00006 TABLE F Condition LCD Message Description Improper shutdown Improper Shutdown Message seen at power-up after a Logs/Time Corrupted hard shut down. Device still measures StO2, but logged data and operating time are corrupted. Algorithm data could not be Missing Calibration (Hex A read error or checksum error read from flash successfully code) occurred when attempting to read algorithm data from flash. The hex code indicates the offending item.
[0096] In an implementation, a device includes a body portion and tip portion. The body portion includes a rectangular tubular portion including a front side surface and a back side surface, connected together by first and second side surfaces. The tip portion includes: A first finger rest surface is connected to the front side surface, where the first finger rest surface is a convex surface that extends at a first angle in a first turn direction relative to the front side surface. A front tip surface is connected to the first finger rest surface, where the front tip surface extends at a second angle in a second turn direction relative to the first finger rest surface.
[0097] A bottom face surface is connected to the front tip surface, where the bottom face surface extends at a third angle in the second turn direction relative to the first finger rest surface. The bottom face surface includes an opening which will retain a sensor head of the device. A second finger rest finger is connected to the back side surface, where the second finger rest surface is a concave surface that extends at a fourth angle in the first turn direction relative to the back side surface. A back tip surface is connected between the second finger rest surface and the bottom face surface, where the back tip surface is a convex surface that extends at a fifth angle in the first turn direction relative to the second finger rest surface.
[0098] The back side and bottom face surfaces are relatively flat surfaces that are angled relative to each other in a range from 90 degrees to about 150 degrees. A first height of the first finger position above the bottom face surface is greater than a second height of the second finger position above the bottom face surface. The first angle is angled relative to the front side surface in a range from 90 degrees to about 60 degrees.
[0099] Batteries are enclosed within the rectangular tubular portion, and the batteries are closer to the back side surface than the front side surface. The rectangular tubular portion includes rounded corners. The first finger rest surface is adapted for a thumb of a user. The second finger rest surface is adapted for a middle finger of a user. When the device is gripped by a hand of a user, a thumb of the user will be against the first finger rest surface, a middle finger of the user will be against the first finger rest surface, and a webbing between the thumb and a index finger of the user will be against the back side surface.
[0100] The sensor head includes a number of sources and a number of detectors. The sources are arranged along a line. There are an equal number of detectors on either side of this line. A position of a detector on a first side of the line will have point symmetry with another detector on a second of the line about a selected point on the line. The selected point is a middle or midpoint between two sources. A first distance between the first and second side surfaces is greater than a second distance between the front and back side surfaces.
[0101] An oximeter system can include or incorporate the device described. In an implementation, the oximeter system is a pulse oximeter system. In an implementation, the oximeter system is a tissue oximeter system or reflective oximeter system.
[0102] For a pulse oximetry: At the measuring site there are constant light absorbers and scatterers that are always present. They are skin, tissue, venous blood, and the arterial blood. There is also a time varying component of the light signal that is primarily due to absorption that is a result of an increase in arterial blood volume across the measuring site. This results in more light absorption during the surge. A pulse oximeter measures the absorption at the peak of the pulse and subtracts out the baseline to isolate the absorption of the pulse itself and which is due to the arterial blood absorption and calculation the pulsatile arterial saturation.
[0103] For tissue oximetry: the Intra.Ox looks at the constant light absorbers and scatterers, measuring the tissue saturation trend which is primarily due to a combination of both the arterial and venous saturations changes over time scales longer than the pulsatile part.
[0104] The device can include: batteries, enclosed within the rectangular tubular portion, where the batteries are closer to the back side surface than the front side surface; sensor head including an arrangement of source structures and detector structures; a display; and electronics, connected to the battery, sensor head, and display. The electronics cause light to be transmitted through the source structures of the sensor head, and based on light received through the detector structures, the electronics determines an oxygen saturation value and causes the display to show the oxygen saturation value.
[0105] The device can include a sensor head assembly including or incorporating the sensor head. The sensor head assembly is enclosed by a space between the convex surface of the first finger rest surface and the concave surface of the second finger rest surface.
[0106] This description of the invention has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form described, and many modifications and variations are possible in light of the teaching above. The embodiments were chosen and described in order to best explain the principles of the invention and its practical applications. This description will enable others skilled in the art to best utilize and practice the invention in various embodiments and with various modifications as are suited to a particular use. The scope of the invention is defined by the following claims.