Patient Monitoring Apparatus
20210153762 · 2021-05-27
Inventors
- Edward C. Bremer (Victor, NY)
- Thaddeus J. Wawro (Auburn, NY, US)
- Carlos A. Suarez (Syacuse, NY, US)
- Brian L. Jovanovski (Syracuse, NY)
- Shelby M. Reed (Phoenix, NY, US)
- Analia Briceno-Gutierrez (Cameron, NC, US)
- Jennifer M. Grant (Syracuse, NY, US)
Cpc classification
A61B2562/0219
HUMAN NECESSITIES
A61B5/01
HUMAN NECESSITIES
International classification
Abstract
A suite of components for monitoring a subject includes one or more ECG electrodes, a securement component adapted to hold the one or more electrodes to the subject's body, and a host removably connected to or adapted to be removably connected to the one or more electrodes. The host includes a sensor, a processor, and an energy source.
Claims
1. A suite of components for monitoring a subject, comprising: one or more ECG electrodes; a securement component adapted to hold the one or more electrodes to the subject's body; and a host removably connected to or adapted to be removably connected to the one or more electrodes, the host including a sensor, a processor and an energy source.
2. (canceled)
3. The suite of components of claim 1 wherein the host comprises a power module which includes the energy source and a processor module which includes the processor.
4. The suite of components of claim 3 wherein the processor module also includes the sensor.
5. The suite of components of claim 1 wherein the energy source is a battery and the power module includes a charging receiver.
6-7. (canceled)
8. The suite of components of claim 1 wherein the host comprises: a power module which includes a first housing comprised of a first housing base and a first housing cover, the first base and the first cover defining an interior of the first housing, and wherein the energy source is a battery residing in the interior space; and a processor module which includes a second housing comprised of a second housing base and a second housing cover, the second base and the second cover defining an interior of the second housing, the interior of the second housing containing: a) a main circuit assembly, b) an ON/OFF switch, c) an accelerometer, and d) a temperature sensing assembly.
9. The suite of components of claim 8 in which the power module and the processor module each include an electrode coupler whereby the power module can be coupled to at least one first ECG electrode by way of the power module electrode coupler(s) and the processor module can be coupled to at least one second ECG electrode by way of the processor module electrode coupler(s).
10. The suite of components of claim 9 wherein the power module electrode couplers include a first IPG drive electrode and a first IPG sense electrode, and the processor module electrode couplers include a second IPG drive electrode and a second IPG sense electrode.
11. The suite of components of claim 8 comprising a conduit having wiring extending therethrough for conveying electrical energy from the battery to the processor module to power components of the processor module.
12-14. (canceled)
15. The suite of components of claim 1 wherein: a) each electrode includes a snap assembly; and b) the securement component is a pad having a bottom side and a top side, the bottom side including an adhesive, the pad also including a hole through which the snap assembly projects when the suite of components is being employed to monitor the subject.
16. The suite of components of claim 15 wherein the adhesive is one that adheres strongly enough to the subject's skin to resist detachment for approximately seven days and weakly enough to be intentionally removed from the subject's skin without damaging the subject's skin.
17. The suite of components of claim 1 wherein: a) each electrode includes a contact portion and a snap assembly extending from the contact portion; b) the securement component is a pad having a bottom side and a top side, the bottom side including an adhesive, the pad also including a hole therethrough; c) the host includes a base; and d) when the suite of components is arranged to monitor the subject, the securement component resides between the base and the subject, a first portion of the securement component overlies the contact portion of the electrode, a second portion of the securement component sticks to the subject's skin, and the snap assembly projects into the host.
18. (canceled)
19. The suite of components of claim 1 wherein, as initially encountered by an end user thereof, the host is separate from the one or more ECG electrodes.
20. The suite of components of claim 19 wherein: the host includes exactly two modules as set forth below: a first module adapted to be removably connected to M ECG electrodes, the first module including exactly N connection sites spatially distributed in a first connection site pattern and a second module adapted to be removably connected to N ECG electrodes, the second module including exactly N connection sites spatially distributed in a second connection site pattern; and the one or more ECG electrodes includes exactly N+N electrodes.
21. The suite of components of claim 19 wherein the one or more electrodes includes: a first set of N electrodes which are spatially distributed or spatially distributable in a first electrode pattern which matches the first connection site pattern; and a second set of N electrodes which are spatially distributed or spatially distributable in a second electrode pattern which matches the second connection site pattern.
22. The suite of components of claim 21 wherein N=N=2 and the second connection site pattern is a replica of the first connection site pattern.
23. The suite of components of claim 19 wherein: the host includes exactly two modules as set forth below: a first module which includes exactly two connection sites spaced apart by a first site spacing S.sub.S1; and a second module which includes exactly two connection sites spaced apart by a second site spacing S.sub.S2; and the one or more electrodes comprise: a first set of exactly two electrodes which are spaced from each other by a first electrode spacing S.sub.E1 or are constrained to be spaceable from each other by no more than the first electrode spacing S.sub.E1 wherein S.sub.E1=S.sub.S1; and a second set of exactly two electrodes which are spaced from each other by a second electrode spacing S.sub.E2 or are constrained to be spaceable from each other by no more than the second electrode spacing S.sub.E2 wherein S.sub.E2=S.sub.S2.
24-28. (canceled)
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] The foregoing and other features of the various embodiments of the component suite and method will become more apparent from the following detailed description and the accompanying drawings in which:
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DETAILED DESCRIPTION
[0038] The present invention may comprise one or more of the features recited in the appended claims and/or one or more of the following features or combinations thereof.
[0039] In this specification and drawings, features similar to or the same as features already described may be identified by reference characters or numerals which are the same as or similar to those previously used. Similar elements may be identified by a common reference character or numeral, with suffixes being used to refer to specific occurrences of the element.
[0040] Referring to
[0041] Each electrode 50 includes a patch of comfort gel 54 and a ring of hydrocolloid adhesive 56 whose outer and inner diameters both exceed the diameter of gel patch 54. As a result, dismounting of the electrode from the release liner exposes an annular adhesive surface. Adhesive 56 adheres the electrode to the patient's skin however, as described below, is not the exclusive means for maintaining the electrode at a fixed position on the patient. The comfort gel makes the electrode more comfortable to the patient.
[0042] Each electrode also includes a lower pressure sensitive adhesive layer 62, a polyethelene layer 64, an upper foam pressure sensitive adhesive layer 66, and a foam layer 68. Taken collectively, components 54, 56, 62, 64, 66, 68, are referred to as the contact portion 72 of the electrode. Each electrode also includes a snap assembly 74 comprising an electrode magnetic snap 76 and an electrode eyelet 78. When the electrode is in its assembled state, eyelet 78 nests inside magnetic snap 76, and the snap assembly projects above electrode contact portion 72. Despite the nomenclature, magnetic snap 76 of the illustrated embodiment is ferrous, but is not magnetic. As explained in more detail below, the snap assembly and a host component of the component suite are removably connected to each other. However despite the nomenclature “snap”, the connection is a magnetic connection, not a mechanical snap connection.
[0043]
[0044] The adhesive 104 employed on the bottom of the securement component is one that adheres strongly enough to the patient's skin to resist detachment for a specified period of time, for example approximately seven days, and weakly enough to be intentionally removed from the patient's skin without damaging the patient's skin. One benchmark for skin damage is breaking the skin.
[0045] One material which may be useful for the securement component is Tegader™ transparent film dressing, a 3M™ product. Tegaderm is said to provide a waterproof, sterile barrier to external contaminants, has an adhesive which is gentle to the skin, and flexes with the skin to enhance patient comfort.
[0046]
[0047] The illustrated host 130 includes a first module 132 which is referred to herein as a power module 132. The power module includes a first housing 136 comprised of a first housing base 138 and a first housing cover 140. The first base and the first cover define an interior 142 of the first housing. Housing base 138 has two coupler openings, 146. The housing cover includes a perimeter flange 152 and an archway 154. A housing adhesive, not shown, on at least the top of the perimeter flange is provided to connect the cover to the base.
[0048] The power module also includes a chassis adhesive 156 and a chassis 158. The chassis includes internally threaded posts 166 at each corner thereof, a central opening 168, and an archway seat 170 shaped similarly to archway 154 except for a longitudinally projecting tube segment 172. The bottom of the chassis also includes recesses 174.
[0049] The power module also includes a Qi charging receiver 180, a Qi receiver adhesive 182 which holds charging receiver 180 to chassis 158, a battery 184, and a foam battery spacer 186 between the battery and the Qi receiver. The battery is the energy source for the host. Qi charging works by transferring energy from a nearby charger, which is external to the host, to the receiver by way of electromagnetic induction. The charger uses an induction coil to create an alternating electromagnetic field, which the receiver converts back into electricity to be fed into the battery. Wireless charging arrangements other than Qi charging may be used. Wired charging arrangements may also be used.
[0050] The power module also includes a battery cover 190. Screws 192 threaded into posts 166 secure the battery cover to the chassis so that battery 184, spacer 186, Qi receiver 180, and Qi receiver adhesive 182 are contained with a space defined by the battery cover and chassis. When cover 140 and base 138 are sealed to each other at cover flange 152, the battery cover 190, battery 184, spacer 186, Qi receiver 180, Qi receiver adhesive 182, chassis 158 and chassis adhesive 156 are all contained in the interior space defined by the base and cover. A band of adhesive 194 between archway 154 and archway seat 170, in combination with the housing adhesive along perimeter flange 152, helps seal against ingress of water and other contaminants into the housing interior.
[0051] Magnetic electrode couplers 210S.sup.−, 210D.sup.− reside in chassis recesses 174. “Magnetic”, as used in the phrase “magnetic electrode coupler” indicates that the coupler is magnetic. This is in contrast to magnetic snaps 76 of electrodes 50 which, as previously noted, are ferrous but not magnetic. The locations of the couplers are referred to as connection sites and are identified with reference numeral 212. As described in more detail below, when the component suite is being employed to monitor the patient, magnetic attraction between the magnetic couplers 210S.sup.−, 210D.sup.− and snaps 76 of electrode snap assembly 74 cause power module 132 to be removably engaged with the ECG electrodes. The couplers also serve as impedance plethysmography (IPG) negative drive and sense electrodes, hence the D.sup.− and S.sup.− suffixes. The unsuffixed reference numeral 210 may be used herein when the text is referring to the coupling function of the couplers but not to their plethysmography function.
[0052] The illustrated host also includes a second module 232 which is referred to herein as a processor module 232. Features of the processor module which are the same as or analogous to features of the power module are or may be identified with the reference numerals of the power module incremented by 100. The processor module chassis adhesive 256, chassis 258, magnetic couplers 310S.sup.+, 310D.sup.+ (analogous to couplers 210S.sup.−, 210D.sup.− of power module 132), and adhesive band 294 are the same as their counterpart elements of the power module. (Unsuffixed reference numeral 310 may be used herein when the text is referring to the coupling function of the couplers but not to their plethysmography function.) The processor module housing cover 240 is the same as the power module housing cover 140 except that the processor module has a heart shaped emblem 320, and the power module is either plain as in
[0053] The processor module also includes a temperature sensing assembly 330 comprised of a sensor housing 332, a temperature sensor 334 and temperature sensor circuitry 336. The illustrated temperature sensor is an infrared sensor, i.e. it is responsive to infrared wavelengths. The illustrated sensor circuitry is a printed circuit assembly (PCA). As seen best in
[0054] The processor module also includes a foam spacer layer 340 with a center hole 342, and a main circuit board or main PCA 346. Wires, not shown, pass through center hole 342. A foam plug 344 also occupies the hole. Together, foam layer 340 and plug 344 provide thermal and electrical insulation between main PCA 346 and temperature sensor 334.
[0055] Referring additionally to
[0056] Processor module 232 also includes a PCA cover 360 with a heart shaped opening 362. When the module is assembled as seen in
[0057] In summary, the processor module includes at least one sensor. These may include IPG sensors for estimating the patient's respiratory rate, temperature sensor 334 for estimating the patient's skin temperature, and an acceleration sensor 352. Readings from the accelerometer may be used to monitor for accelerations that might indicate a health related problem (e.g. tremors, shivering, coughing) or might indicate that the patient in moving in an undesirable way (e.g. attempting to make an unauthorized exit from his bed). The accelerometer readings may also be integrated or double integrated over time to establish an estimate of the speed of patient movement and the patient's present position.
[0058] Host 130 also includes a conduit 370. Each end of the conduit circumscribes one of the tube segments 172, 272 that extend from the chassis of the power and processor modules. An adhesive, not shown is applied to the outside surface of the tube segments to help secure the connection. The tubes may also be barbed to resist separation of the conduit. The conduit has a length such that when the ECG electrodes are correctly positioned on the patient and engaged with modules 132, 232, the conduit will accommodate a patient size range from a 5th percentile female to a 95th percentile male. Wiring, not shown, extends through the conduit. The wiring includes two wires from the battery, two wires connecting the Qi charger to the Qi charger circuitry, one wire from the IPG sense electrode and one wire from the IPG drive electrode.
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[0060] Host 130, represented in
[0061] Continuing to refer to
[0062] The magnetic attraction between electrode snaps 76 and housing magnetic couplers 210, 310 is strong enough to hold the module and its sensors in a fixed position relative to the ECG electrodes, and therefore in a fixed position relative to the patient's anatomical features. The magnetic attraction is strong enough to achieve this state of securement even if the module is bumped or otherwise exposed to actions or conditions that might dislodge it from the electrodes. However the magnetic attraction is weak enough that if the module needs to temporarily removed, such removal can be easily accomplished without special tools and with a force well within the capabilities of a human caregiver. As already explained such temporary removal might be required to avoid subjecting the module, or the components contained within it, to a degrading influence such as radiation. Moreover, the required separation force is also small enough that its application will break the magnetic bond at the snap/coupler interface rather than separating the securement component from the patient's skin.
[0063] In view of the foregoing, certain variations and generalizations can now be better appreciated.
[0064] In general, the host can be a single module or can be comprised of three or more modules, rather than the two modules described so far. Each module may include fewer or more than the two connection sites described above. Moreover the quantity of connection sites need not be the same on all the modules. If the quantity of connection sites is the same on two or more modules, is it not necessary for the spatial distribution pattern of those connection sites to be the same.
[0065] In a more specific example in which the host is comprised of exactly two modules, a first of the two modules is adapted to be removably connected to M ECG electrodes. The first module includes exactly N electrode connection sites, one for each of the N ECG electrodes. The N electrode connection sites are spatially distributed in a first connection site pattern. “Connection site pattern” means the spatial relationships amongst the N connection sites, A second module is adapted to be removably connected to N ECG electrodes. The second module includes exactly N electrode connection sites, one for each of the N ECG electrodes. The N electrode connection sites are spatially distributed in a second connection site pattern. The set of electrodes includes exactly N+N electrodes. In one specific embodiment N=N.
[0066] Referring to
[0067] The set of N electrodes may be packaged similarly to the way just described in connection with the set of N electrodes so that they are spatially distributed in a second electrode pattern which matches the second connection site pattern. The above example of the N electrode arrangement suffices for the reader to understand the N electrode arrangement. The first and second connection site patterns may be replicas of each other or may differ from each other. N may be equal to N or N may differ from N. In one embodiment N=N=2.
[0068] As seen in
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[0070]
[0071] The method includes the step, at block 400, of installing the electrodes 50 in the module 132 thereby forming an electrode/module subassembly 394.
[0072] The method also includes the step, at block 408, of placing subassembly 394 at a monitoring site on a patient. The adhesiveness of the adhesive surface causes the electrodes to adhere to the patient, e.g. to his skin.
[0073] The method also includes the step, at block 410, of disconnecting the module from the adhered electrodes. In other words a caregiver lifts up the module, breaking the magnetic connection between the snap assemblies of the electrodes and the magnetic coupler of the host. The adhesiveness of the adhesive surface causes the electrodes to remain adhered to the patient.
[0074] The method also includes the step, at block 412, of adhering the securement component to the patient so that each snap assembly 74 projects through one of holes 96 in the securement component.
[0075] The method also includes the step, at block 414, of reconnecting the module to the adhered electrodes. In other words the caregiver places the module over the electrodes so that the magnetic connection between each electrode and its companion magnetic coupler is re-established.
[0076] At the conclusion of reconnecting step 414 the monitor is secured to the patient, with the module removably secured to the electrodes. Securement of the electrodes to the patient is enhanced by the presence of securement layer 90. The caregiver may then press the ON/OFF switch on the module to commence patient monitoring.
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[0081] The method shown in
[0082] As noted in the Background section of this application, certain of the monitor's sensors must be accurately positioned on the patient in order to achieve the best possible readings. In other words the caregiver needs to identify a location on the patient's body that will be clinically satisfactory for the monitor. To do so the caregiver can position the monitor on or near the patient's body with patient side release liner 100 still covering the adhesive layer 56 of the electrodes. However when the caregiver lifts the monitor away from the patient in order to peel off the protective liner, he may lose track of the identified satisfactory location.
[0083] Therefore, the monitor may include one or more features to address the above described difficulty. Examples of such features are the progressive release feature illustrated in FIGS. 25-26 of U.S. patent application Ser. No. 16/150,572, and registration notches illustrated in FIGS. 27-28 of that application.
[0084]
[0085] In the foregoing description, securement component 90 is described as a component separate from the host component 130 (power module 132 and processor module 232) and from EKG electrodes 50. In another embodiment the securement component is part of an assembly that includes an electrode or a set of electrodes.
[0086] Although this disclosure refers to specific embodiments, it will be understood by those skilled in the art that various changes in form and detail may be made without departing from the subject matter set forth in the accompanying claims.