Coil system and method for obtaining volumetric physiological measurements
09986936 ยท 2018-06-05
Assignee
Inventors
Cpc classification
A61B5/091
HUMAN NECESSITIES
A61B2562/08
HUMAN NECESSITIES
A61B5/7214
HUMAN NECESSITIES
International classification
A61B5/103
HUMAN NECESSITIES
A61B5/107
HUMAN NECESSITIES
A61B5/091
HUMAN NECESSITIES
A61B5/08
HUMAN NECESSITIES
A61B5/11
HUMAN NECESSITIES
Abstract
A coil device is provided having a member adapted to extend around and conform to an outer surface of a subject and a conductor adapted to extend only once around a first portion of the subject. The coil device can be positioned about the subject in order to measure a volume of the subject. When placed about the subject in the presence of a relatively homogeneous magnetic field, the conductor can generate a signal indicative of a volume of the first portion of the subject. The coil device may also include two or more conductors separately generating signals indicating volumes of two or more corresponding portions of the subject. In some cases the coil device includes associated authorization data that can limit use of the coil device. Systems and methods incorporating the coil device are also provided.
Claims
1. A system for measuring volume, the system comprising: an electromagnet configured to produce a magnetic field; a single winding of a conductor configured to cover a portion of a subject for which a volumetric measurement is desired, the conductor, having a plurality of angled segments, configured to wrap around the subject only once in a first direction and extending non-linearly along a width generally perpendicular to the first direction, wherein upon placement of the conductor in the magnetic field the conductor is configured to produce a signal representing an average cross-sectional area, averaged over the width of the conductor, of the portion of the subject, wherein the plurality of angled segments have at least one of varying lengths and varying angles such that the width of the conductor varies along a length of the conductor; and a control system configured to determine a volume of the portion of the subject based on the signal produced by the conductor, wherein a strength of a correlation between the signal and the volume of the portion of the subject depends on a number of and configuration of the angled segments, wherein the signal is proportional to the volume of the portion by a proportionality constant determined based on the width of the conductor corresponding to a distance between a first edge of the conductor and a second edge of the conductor.
2. The system of claim 1, wherein the magnetic field is a time-varying magnetic field.
3. The system of claim 2, wherein the magnetic field has a coefficient of variation of less than five percent throughout a spatial volume that encompasses the conductor when the conductor is placed in the magnetic field.
4. The system of claim 1, wherein the electromagnet is configured to be positioned entirely above the conductor when the conductor is placed in the magnetic field.
5. The system of claim 1, wherein the electromagnet is generally planar.
6. The system of claim 1, wherein the conductor is configured to produce a voltage signal upon placement of the conductor in the magnetic field.
7. The system of claim 1, wherein the conductor is electrically coupled to an electrical lead and wherein the electrical lead is electrically coupled to the control system.
8. The system of claim 1, wherein the conductor comprises triangularly-shaped segments forming a zigzag pattern extending in the first direction, and wherein the width of the conductor is delineated by a top and a bottom of the triangularly-shaped segments.
9. The system of claim 1, wherein the control system is configured to determine the volume by multiplying the signal produced by the conductor by a multiplier.
10. The system of claim 9, wherein the multiplier corresponds to the width of the conductor.
11. The system of claim 9, wherein the multiplier is determined without the use of a spirometer.
12. The system of claim 9, further comprising electronic memory configured to store the multiplier for use by the control system to determine the volume.
13. The system of claim 12, further comprising a connector electrically coupled to the conductor, wherein the connector comprises the electronic memory.
14. The system of claim 1, wherein the control system comprises at least one of an amplifier, a rectifier, and a low-pass filter configured to produce an amplified, rectified, and/or low-pass filtered version of the signal and wherein the control system is configured to determine the volume of the portion of the subject based on the amplified, rectified, and/or low-pass filtered version of the signal.
15. The system of claim 1, further comprising a coil device, wherein the coil device comprises: a substrate; the conductor fastened to the substrate; and electronic memory.
16. The system of claim 15, wherein the electronic memory is physically coupled to the substrate.
17. The system of claim 15, wherein the coil device further comprises a connector electrically coupled to the conductor, and wherein the connector comprises the electronic memory.
18. The system of claim 15, wherein the electronic memory is configured to store data for determining whether use of the coil device is authorized.
19. The system of claim 18, wherein the data comprises at least one of a count corresponding to a maximum number of uses allowed for the coil device, a count corresponding to a number of actual uses of the coil device, and an identifier for identifying a user for which use of the coil device is authorized.
20. The system of claim 18, wherein the control system is configured to determine whether use of the coil device is authorized based on the data stored in the electronic memory.
21. The system of claim 20, further comprising a display, wherein the control system is configured to cause a message to be displayed on the display indicating that use of the coil device is not authorized.
22. The system of claim 15, wherein: the substrate has a length, and a top and a bottom separated by a width, wherein the substrate is configured to extend, along the length of the substrate, around the subject; and the substrate comprises a first end and a second end separated by the length, wherein the substrate is configured to assume (i) an open position in which the first end and the second end of the substrate are not joined such that the portion of the subject around which the substrate is to be placed can pass between the first and second ends of the substrate, and (ii) a closed position in which the first end and the second end are joined and the substrate extends around the portion of the subject.
23. The system of claim 15, wherein the substrate comprises an elastic material that is configured to expand or retract in response to volumetric changes in the portion of the subject around which the substrate is placed.
24. The system of claim 15, wherein the coil device further comprises: a second conductor fastened to the substrate and configured to cover a second portion of the subject for which a volumetric measurement is desired, the second conductor configured to extend only once around the subject in the first direction and having a second width generally perpendicular to the first direction, wherein upon placement of the second conductor in the magnetic field the second conductor is configured to produce a signal representing an average cross-sectional area, averaged over the width of the second conductor, of the second portion of the subject; wherein the control system is further configured to determine a volume of the second portion of the subject based on the signal produced by the second conductor.
25. The system of claim 24, wherein the coil device is configured such that the portion of the subject corresponds to the subject's thorax and the second portion of the subject corresponds to the subject's abdomen.
26. The system of claim 25, wherein the control system is configured to determine, based on the signal produced by the conductor and the signal produced by the second conductor, whether the subject's abdomen moves in asynchrony with the subject's thorax thereby indicating an asynchronous breathing pattern.
27. The system of claim 15, wherein the coil device further comprises: a second conductor fastened to the substrate and providing for the conductor a return electrical path along the substrate in a direction opposite to the conductor, the second conductor extending only once along the substrate and configured to cover a second portion of the subject, wherein the second conductor is configured to pick up a noise signal having an opposite polarity to a noise signal picked up by the conductor.
28. The system of claim 27, wherein the coil device is configured such that the second portion of the subject corresponds to the subject's hips.
29. The system of claim 27, wherein the coil device is configured such that the second portion of the subject corresponds to a portion of the subject that does not change its volume during respiration of the subject.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The following drawings are illustrative of particular embodiments of the present invention and therefore do not limit the scope of the invention. The drawings are not to scale (unless so stated) and are intended for use in conjunction with the explanations in the following detailed description. Embodiments of the present invention will hereinafter be described in conjunction with the appended drawings, wherein like numerals denote like elements.
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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
(15) The following detailed description is exemplary in nature and is not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the following description provides practical illustrations for implementing exemplary embodiments of the present invention. Examples of constructions, materials, dimensions, and manufacturing processes are provided for selected elements, and all other elements employ that which is known to those of skill in the field of the invention. Those skilled in the art will recognize that many of the examples provided have suitable alternatives that can be utilized.
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(17) The coil device 10 can be useful for measuring volumes of a variety of objects, including those with irregularly-shaped volumes and/or volumes that change over time. In some cases, the coil device 10 can be useful for measuring changes in volume. For example, as shown in
(18) Embodiments of the coil device 10 can be especially useful for measuring breathing volumes of human subjects, including fully grown adults, adolescents, and, as shown in
(19) Returning to
(20) In some embodiments, the configuration of the first conductor 14 also defines a first end section 22 and an opposed second end section 24 of the first member 12. Referring to
(21) In some embodiments, the first member 12 (and any optional substrate 15) can have a planar configuration that is wrapped about the subject 16 to measure volume.
(22) In one embodiment, the first conductor 14 includes at least thirty angled segments 26. In some such embodiments, the first conductor 14 crosses back and forth at least fifteen times from the first end section 22 to the second opposed end section 24. The number of angled segments 26 may vary depending upon a variety of factors including the size of the subject and the measurement accuracy desired. For example, the number of angled segments 26 may be less or more than thirty. In some cases, the strength of the correlation between the induced signal and the volume of the subject 16 to be measured increases as the number of angled segments 26 between the first and second opposed end sections 22, 24 increases.
(23) Returning to
(24) The first member 12 can conform to the outer surface of the first portion despite changes in the contour of the outer surface. Such contour changes can result in a varying cross-sectional area of the first portion 30 between the first and second edges of the first member. For example, the outer surface of the first portion 30 may be formed in a somewhat variable and irregular shape, and include the natural contours of the subject's torso, e.g., widening at the hips and chest. In addition, the contour of the subject's outer surface may change while the subject 16 breathes and the subject's chest and/or abdomen rise and fall. Accordingly, in some embodiments movement of the first member is representative of movement of the underlying portion of the subject 16.
(25) According to some embodiments of the invention, when the subject 16 and the coil device 10 are placed within a relatively homogeneous, time-varying magnetic field, the first conductor 14 generates a signal indicative of a volume of the first portion 30 of the subject 16. The first conductor 14 can in some cases be considered the magnetic equivalent of a single, planar loop having a cross-sectional area equal to the average cross-sectional area of the first portion 30. In this embodiment the first conductor 14 generates a signal corresponding to the average cross-sectional area of the first portion 30. This signal can then in turn be used to measure the volume of the first portion 30 of the subject 16.
(26) In some cases the induced signal (e.g., a voltage) is related to the volume of the first portion 30 by a proportionality constant. For example, the signal generated by the first conductor 14 may be proportional to the volume of the first portion 30 by an approximate proportionality constant equal to the width W of the first member 12 (i.e., the distance between the first and second opposed edges 18, 20 of the first member). Thus, in some embodiments, the induced signal is related to the configuration of the first conductor's angled segments 26.
(27) As will be appreciated from the discussion and figures herein, embodiments of the invention are useful for measuring volumes with a single turn or winding of a single conductor. Referring to
(28) As shown in
(29) For example, the first member 12 can itself have stretchable properties that provide a close, conforming fit around the subject 16 without the use of a separate substrate. In some cases the first member 12 may be manufactured from a material with an inherent spring constant or other elastic properties. In another embodiment, the angled segments 26 of the first member 12 may stretch apart at their common joints, thus increasing the angles between adjacent segments 26 and stretching the first member 12 to the necessary degree to extend around and conform to the outer surface of the first portion 30 of the subject 16.
(30) Referring to
(31) In some embodiments, the substrate 15 can take the form of a planar sheet that can be wrapped about the first portion 30 of the subject 16. For example, referring to
(32) Once positioned, the first and second end sections can be secured to conform the substrate to the outer surface of the first portion 30. For example, in some cases the first and second end sections 38, 40 of the substrate may be secured directly to the subject 16 with e.g., an adhesive tape. In another embodiment, the substrate 15 includes a fastener 42 for fastening the first end section 38 to the second end section 40. For example, the fastener 42 may include a variety of fasteners, such as hook-and-loop, adhesive, snaps, zippers, buttons, and for staples.
(33) Referring to
(34) While the substrate 15 is shown in
(35) The substrate 15 comprises a stretchable material such as spandex or rubber, and in some embodiments can be formed from an elastic medical bandage material. In some embodiments, an electrically insulating layer of material is preferably positioned over the substrate 15 and the first conductor 14. The first conductor 14 may comprise any electrically conducting material known in the art. For example, the first conductor may comprise copper. In another embodiment, the first conductor 14 may be stamped or cut from a thin metal foil sheet (e.g., aluminum). In some cases this can provide an easily constructed and disposable coil device.
(36) As will be appreciated from the discussion and figures herein, embodiments of the invention are useful for measuring volumes with a single turn or winding of a single conductor. Thus the coil device 10 includes a less complex configuration for measuring a volume of the first portion 30 of the subject 16 when compared to devices with multiple windings of a single conductor, or with single turns of multiple conductors. For example, with only a single conductor rather than multiple conductors, the coil device 10 requires fewer electrical connections that in past designs. Fewer electrical connections can simplify the measurement process by, for example, making the coil device 10 easier to place around and remove from a subject. In addition, the single turn of the first conductor 14 allows a simpler and less expensive production process for manufacturing the coil device 10, especially when compared with devices including multiple conductors for measuring volume.
(37) Turning now to
(38) The first member 102, first conductor 104, second member 122 and second conductor 124 have features similar and generally corresponding to the first member 12 and first conductor 14 of the coil device 10 depicted in
(39) According to some embodiments of the invention, when the subject 16 and the coil device 100 are placed within a relatively homogeneous, time-varying magnetic field, the first conductor 104 generates a signal indicative of a volume of the first portion 106 of the subject 16 and the second conductor 124 generates a signal indicative of a volume of the second portion 126 of the subject 16. Each conductor can in some cases be considered the magnetic equivalent of a single, planar loop having a cross-sectional area equal to the average cross-sectional area of the first portion 106 and the second portion 126, respectively. The signals generated correspond to the average cross-sectional areas and can then in turn be used to measure the volumes of the first and second portions 106, 126 of the subject 16.
(40) In some cases the induced signal (e.g., a voltage) in each conductor is related to the measured volume by a proportionality constant. For example, referring to
(41) The coil device 100 can be coupled with a control system as desired by leads extending from the end sections of the first and second conductors. In some cases each of the first and second conductors 104, 124 may be coupled individually to the larger system or possibly by a shared common return conductor. For example, referring to
(42) As with the coil device 10 of
(43) For example, the first and second members 102, 122 can themselves have stretchable properties that provide a close, conforming fit around the subject 16 without the use of a separate substrate. In some cases the first and second members may be manufactured from a material with an inherent spring constant or other elastic properties. In another embodiment, the angled segments 116, 136 may stretch apart at their common joints, thus increasing the angles between adjacent segments and stretching the first and second members to the necessary degree to extend around and conform to the outer surface of the first and second portions 106, 126 of the subject 16, respectively.
(44) Referring to
(45) As shown in
(46) In addition, while the substrate 135 is shown as a planar body that may be wrapped about the subject 16, other configurations are possible and the invention is not limited to any single configuration. For example, in some embodiments, the substrate 135 may be configured in the shape of a continuous sleeve or other similar shape that can be positioned about the subject 16 by pulling it over the subject's head or legs.
(47) As will be appreciated, a wide variety of configurations of the first and second members 102, 122 are possible. For example, in some embodiments of the invention, the first and second members 102, 122 may share the same substrate 135, while in other cases the first member 102 may be carried by a first substrate and the second member 122 may be carried by a second substrate. Also, the first and second members 102, 122 may be positioned adjacent one another, as in
(48) Referring to
(49) As shown in
(50) As shown in
(51) In addition, in some cases the third conductor 150 provides an additional advantage for noise cancellation. As will be appreciated, noise from external sources induces noise signals in the first, second, and third conductors of the coil device 100. Because the third conductor 150 extends around the subject 16 in the opposite direction from the first and second conductors, noise signals originating from external magnetic fields induced in the third conductor 150 will have a polarity opposite of noise signals induced in the first and second conductors. These signals of opposite polarity will have a tendency to cancel each other, and thus some embodiments of the coil device provide enhanced noise performance.
(52) In additional embodiments, any of the coil devices 10, 100 can include an electronic memory storing authorization data for determining whether use of the coil device is authorized. Referring now to
(53) The connector 32 can be provided in any number of the wide variety of forms available in the art. In one embodiment, the connector 32 is provided as a 6P6C plug, which conveniently provides three lines for the three leads 117, 118, 127, and three dedicated lines for the electronic memory 160. The memory 160 can be provided in a wide variety of formats and sizes. In some cases the memory 160 is configured as TO-92 package with three leads and with 1024 bits. In at least one embodiment the electronic memory 160 is a programmable read-only memory, which allows the connected control system to write to the memory 160 once and then read it many times.
(54) The authorization data within the electronic memory 160 can comprise a variety of information. In some embodiments the authorization data limits the number of uses of the coil device. For example, the authorization data may include a maximum count corresponding to the maximum number of authorized uses allowed for the coil device. The authorization data may also include a current count that can be compared to the maximum count to determine if use of the coil device is authorized. The authorization data may also include a stored identifier corresponding to a particular subject that may be authorized to use the coil device.
(55) As will be discussed in further detail, the authorization data can be implemented into volume measurement procedures in a variety of ways. For example, when an operator, such as a laboratory technician connects a particular coil device to a control system, the control system can retrieve the authorization data from the coil device and determine if use of the device is authorized. If use is authorized, the operator can then place the coil device around a subject and measure the desired volume. Alternatively, if use is not authorized, the control system can, for example, display an error message and stop the measurement process.
(56) Accordingly, the authorization data can limit use of a particular coil device when desirable. For example, in some embodiments a coil device may be provided in a disposable, single-use form. In this case, it may be desirable to limit the coil device to a single use in accordance with, for example, sanitation policies or business practices, and/or because of ordinary wear and tear on the coil device. The number of authorized uses can be adjusted to any suitable number as desired. Also, it may be desirable to limit use of a reusable coil device to a single subject, again due to, for example, sanitation and/or a particular business model.
(57) In addition to or instead of authorization data, the electronic memory 160 may include a wide variety of other information. For example, in some embodiments the electronic memory 160 stores one or more proportionality constants corresponding to one or more members of the coil device as previously explained. A control system coupled to the coil device can retrieve the proportionality constant(s) from the memory and use them with the induced signal(s) measured from the conductor(s) to estimate the one or more volumes of the subject.
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(59) The control system 200 may include a variety of elements similar in many respects to the systems described in U.S. Pat. Nos. 6,374,667; 6,945,941; and 7,390,307, which are hereby incorporated by reference herein in their respective entireties. For example, in some embodiments, the system integrates into a single system both the current source that powers the electromagnet 202 and the circuits needed to amplify and rectify the signals measured from the coil device 100. In some cases the components of the control system 200 may be implemented in hardware, firmware, and/or software depending upon the particular application and operating environment. For example, in some cases portions of the control system 200 may be implemented in hardware, such as on a dedicated circuit board, and other portions may be implemented in executable software instructions, either on the dedicated circuit board, or within a computer (e.g., a personal laptop computer) coupled with the dedicated board. Those skilled in the art will appreciate a variety of implementations other than these particular examples are possible.
(60) The current source includes an alternating current signal generator 204 and power amplifier 206 that feed the electromagnet 202. The electromagnet 202 can take a variety of forms. For example, the electromagnet 202 can include one of the electromagnets described in U.S. Pat. Nos. 6,374,667; 6,945,941; and 7,390,307. Once energized, the electromagnet 202 generates a relatively homogeneous, time-varying field within a predefined spatial volume 208. For example, the field may have a coefficient of variation of less than five percent throughout the spatial volume 208. The electromagnet 202 is typically configured and positioned such that the predefined spatial volume 208 is positioned proximate to a subject support surface for measuring a volume of the subject 16 resting upon the support surface. For example, the electromagnet 202 may be positioned to generate the magnetic field within the spatial volume 208 proximate a crib, an incubator, a bed, or another suitable platform supporting the subject 16.
(61) The signals induced in the members of the coil device 100 are fed into parallel processing paths in one embodiment. For example, as shown in
(62) In some embodiments, the signals exiting the low-pass filters 218, 220 generally correspond to the average cross-sectional areas of the first and second members of the coil device 100, respectively. The control system 200 may retrieve one or more proportionality constants stored in electronic memory associated with the coil device 100 (e.g., located within connector 32) and use these to estimate the volumes of the subject 16 in multipliers 222, 224. The multipliers 222, 224 may be implemented in hardware, firmware, and/or software depending upon the particular environment and operating environment. The resulting signals, in this case indicating a volume of the subject's chest (thorax) and abdomen, are then available for output or further processing if desired.
(63) In some embodiments, the control system 200 further includes an authorization module 230 that may communicate with the optional electronic memory of the coil device 100. The authorization module 230 retrieves authorization data from the electronic memory and is adapted to determine whether use or the coil device 100 is authorized. For example, the authorization module 230 may compare a current count of authorized uses with a maximum count of authorized uses allowed for the coil device stored within the electronic memory. The authorization module 230 may further compare a subject identifier with a stored identifier to determine if use of the coil device 100 is authorized for a particular subject.
(64) Of course, a variety of other elements can be included within the control system 200 to, e.g., further condition and process the signals measured in the coil device 100. Just a few examples include additional amplifying or filtering elements and means for subtracting out a substantial DC or constant component (corresponding to the total volume of the body inside the coils) in the signals so that only changes in volume are detected. The volume signal can also be processed to detect respiratory cycles, and determine the frequency of respiration, tidal volume and a range of variables used in clinical spirometry. In addition, the rate of air flow in and out of the lungs can be calculated by differentiating the volume signal as a function of time.
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(66) Either before or after providing the coil device and extending it around the subject, the method includes generating (174) with an electromagnet a relatively homogeneous magnetic field throughout a predefined spatial volume. For example, an alternating current may be fed to an electromagnet to generate a time-varying, relatively homogeneous magnetic field throughout the spatial volume. In some cases this means that the magnetic field has a coefficient of variation throughout the spatial volume of less than five percent variation. After generating the field, the patient and coil device are positioned (176) within the magnetic field to induce a signal in the coil device. The induced signal is measured (178) by a connected control system, which can then estimate (180) a volume of the subject's abdomen and/or chest using the induced and measured signal.
(67) In some embodiments, a second member having a second conductor may also be extended around an outer surface of a second portion of the subject's abdomen and/or chest. After positioning the second portion of the subject's abdomen and/or chest within the spatial volume and magnetic field, a signal induced in the second conductor can be measured and used to estimate a volume of the second portion. As indicated above, the coil device may be used to measure the volume of a variety of areas of the subject. In one case, the first portion is at least part of the subject's abdomen and not part of the subject's chest. Corresponding to this arrangement, the second portion may be at least part of the subject's chest and not part of the subject's abdomen.
(68) As previously discussed with reference to the figures, in some cases the signal measured in the first and/or second conductors corresponds to an average cross-sectional area of the first and second portions of the subject, respectively. In some embodiments, methods of the invention further include estimating the volume of the first and/or second portions by multiplying the average cross-sectional area (as represented by the measured signals) by a proportionality constant, such as the width of the first or second members, as explained with reference to
(69) In some embodiments of the invention, the authorization data stored in the electronic memory 160 (see
(70) Of course, a number of variations related to the authorization data arc possible. One or more steps in the process may be preconditioned upon authorization of the coil device. As just one example, in some cases the signal induced in the conductor(s) of the coil device may only be measured if use of the coil device is authorized.
(71) In some embodiments, authorizing the coil device may include determining whether the coil device has exceeded a predetermined maximum number of authorized uses. For example, the authorization data may include a maximum count corresponding to the maximum number of authorized uses and a current count corresponding to an actual number of uses of the coil device. The current count can be compared with the maximum count to determine if the device is authorized for use. In further embodiments, the current count may be incremented after a use of the coil device by writing to the electronic memory to change the current count. This can allow the coil device to track the number of times it has been used.
(72) In additional embodiments, a stored identifier within the electronic memory can associate a particular coil device with a particular subject. For example, a subject identifier can be assigned to the subject being monitored with the coil device and then stored in the electronic memory to associate the subject with the coil device. Upon later using the coil device, the device may first be authorized by comparing a subject identifier for the current subject with the stored identifier within the electronic memory. Use of the coil device may only be authorized if the two identifiers match.
(73) Thus, embodiments of the Coil System And Method For Obtaining Volumetric Physiological Measurements are disclosed. Although the present invention has been described in considerable detail with reference to certain disclosed embodiments, the disclosed embodiments are presented for purposes of illustration and not limitation and other embodiments of the invention are possible. One skilled in the art will appreciate that various changes, adaptations, and modifications may be made without departing from the spirit of the invention and the scope of the appended claims.