WO2012015759A2

WO2012015759A2 - Vital-signs patch having a strain relief

Info

Publication number: WO2012015759A2
Application number: PCT/US2011/045240
Authority: WO
Inventors: Pierre Paquet; Mark Raptis
Original assignee: CareFusion 303 Inc
Current assignee: CareFusion 303 Inc
Priority date: 2010-07-27
Filing date: 2011-07-25
Publication date: 2012-02-02
Anticipated expiration: 2013-01-27
Also published as: US20120029309A1; US20170143264A1; WO2012015759A3; US11083415B2; US9585620B2

Abstract

A vital-signs monitor patch containing at least two electrodes, a circuit assembly, and a patch body having a chamber in which the circuit assembly is housed. The patch body also contains at least one flexible portion adjacent to the circuit assembly chamber, with at least one electrode attached to the flexible portion. The electrodes are configured for attaching the patch to the skin of a patient.

Description

VITAL-SIGNS PATCH HAVING A STRAIN RELIEF

BACKGROUND

Cross-References to Related Applications

[0001] The following applications disclose certain common subject matter with the present application: A Vital-Signs Monitor with Encapsulation Arrangement, docket number 080624-0612; A Vital-Signs Monitor with Spaced Electrodes, docket number 080624-0623; A Temperature Probe Suitable for Axillary Reading, docket number 080624-0625; System and Method for Monitoring Body Temperature of a Person, docket number 080624-0626; A System and Method for Storing and Forwarding Data from a Vital-Signs Monitor, docket number 080624-0627; System and Method for Saving Battery Power in a Vital Signs Monitor, docket number 080624-0628; A System and Method for Conserving Battery Power in a Patient Monitoring System, docket number 080624-0629; A System and Method for Saving Battery Power in a Patient Monitoring System, docket number 080624-0630; A System And Method for Tracking Vital-Signs Monitor Patches, Docket Number 080624-0631 ; A System And Method for Reducing False Alarms Associated with Vital-Signs Monitoring, docket number 080624-0632; A System And Method for Location Tracking of Patients in a Vital-Signs Monitoring System, docket number 080624-0633; A System And Method for Reducing False Alarms Based on Motion and Location Sensing, docket number 080624-0634; all of the listed applications filed on July 27, 2010.

Field

[0002] The present disclosure generally relates to systems and methods of physiological monitoring, and, in particular, relates to monitoring of vital signs of patients.

Description of the Related Art

[0003] Some of the most basic indicators of a person's health are those physiological measurements that reflect basic body functions and are commonly referred to as a person's "vital signs." The four measurements commonly considered to be vital signs are body temperature, pulse rate, blood pressure, and respiratory rate. Some clinicians consider oxygen saturation (S₀₂) to be a "fifth vital sign" particularly for pediatric or geriatric cases. Some or all of these measurements may be performed routinely upon a patient when they arrive at a healthcare facility, whether it is a routine visit to their doctor or arrival at an Emergency Room (ER).

[0004] Vital signs are frequently taken by a nurse using basic tools including a thermometer to measure body temperature, a sphygmomanometer to measure blood pressure, and a watch to count the number of breaths or the number of heart beats in a defined period of time which is then converted to a "per minute" rate. If a patient's pulse is weak, it may not be possible to detect a pulse by hand and the nurse may use a stethoscope to amplify the sound of the patient's heart beat so that she can count the beats. Oxygen saturation of the blood is most easily measured with a pulse oximeter.

[0005] When a patient is admitted to a hospital, it is common for vital signs to be measured and recorded at regular intervals during the patient's stay to monitor their condition. A typical interval is 4 hours, which leads to the undesirable requirement for a nurse to awaken a patient in the middle of the night to take vital sign measurements.

[0006] When a patient is admitted to an ER, it is common for a nurse to do a "triage" assessment of the patient's condition that will determine how quickly the patient receives treatment. During busy times in an ER, a patient who does not appear to have a life-threatening injury may wait for hours until more-serious cases have been treated. While the patient may be reassessed at intervals while awaiting treatment, the patient may not be under observation between these reassessments.

[0007] Measuring certain vital signs is normally intrusive at best and difficult to do on a continuous basis. Measurement of body temperature, for example, is commonly done by placing an oral thermometer under the tongue or placing an infrared thermometer in the ear canal such that the tympanic membrane, which shared blood circulation with the brain, is in the sensor's field of view. Another method of taking a body temperature is by placing a thermometer under the arm, referred to as an "axillary" measurement as axilla is the Latin word for armpit. Skin temperature can be measured using a stick-on strip that may contain panels that change color to indicate the temperature of the skin below the strip. [0008] Measurement of respiration is easy for a nurse to do, but relatively complicated for equipment to achieve. A method of automatically measuring respiration is to encircle the upper torso with a flexible band that can detect the physical expansion of the rib cage when a patient inhales. An alternate technique is to measure a high-frequency electrical impedance between two electrodes placed on the torso and detect the change in impedance created when the lungs fill with air. The electrodes are typically placed on opposite sides of one or both lungs, resulting in placement on the front and back or on the left and right sides of the torso, commonly done with adhesive electrodes connected by wires or by using a torso band with multiple electrodes in the strap.

[0009] Measurement of pulse is also relatively easy for a nurse to do and intrusive for equipment to achieve. A common automatic method of measuring a pulse is to use an electrocardiograph (ECG or EKG) to detect the electrical activity of the heart. An EK.G machine may use 12 electrodes placed at defined points on the body to detect various signals associated with the heart function. Another common piece of equipment is simply called a "heart rate monitor.¹* Widely sold for use in exercise and training, heart rate monitors commonly consist of a torso band, in which are embedded two electrodes held against the skin and a small electronics package. Such heart rate monitors can communicate wirelessly to other equipment such as a small device that is worn like a wristwatch and that can transfer data wirelessly to a PC.

[00i0] Nurses are expected to provide complete care to an assigned number of patients. The workload of a typical nurse is increasing, driven by a combination of a continuing shortage of nurses, an increase in the number of formal procedures that must be followed, and an expectation of increased documentation. Replacing the manual measurement and logging of vital signs with a system that measures and records vital signs would enable a nurse to spend more time on other activities and avoid the potential for error that is inherent in any manual procedure.

SUMMARY

[0011] For some or all of the reasons listed above, there is a need to be able to continuously monitor patients in different settings. In addition, it is desirable for this monitoring to be done with limited interference with a patient's mobility or interfering with their other activities. [0012] Embodiments of the patient monitoring system disclosed herein measure certain vital signs of a patient, which include respiratory rate, pulse rate, blood pressure, body temperature, and, in some cases, oxygen saturation (S₀₂), on a regular basis and compare these measurements to defined limits.

[0013] In certain aspects of the present disclosure, a vital-signs patch is provided that includes at least two electrodes and a circuit assembly that periodically take at least one measurement from the electrodes. The patch is a unitized device that contains the circuit assembly with the electrodes on the underside of the patch. The patch can be attached to a patient with the electrodes in electrical contact with the patient's skin. The segments of the patch that connect the electrodes to the circuit assembly are flexible, which reduces the noise induced in the measurement by stress on the contact between the electrodes and the patient.

[0014] In certain aspects of the present disclosure, a vital-signs patch is provided that includes a patch housing having a circuit housing portion and at least one flexible electrode portion, a circuit assembly, and at least one electrode. The electrode is attached to the electrode portion of the patch housing and configured for attaching the patch housing to the skin of the patient.

[0015] It is understood that other configurations of the subject technology will become readily apparent to those skilled in the art from the following detailed description, wherein various configurations of the subject technology are shown and described by way of illustration. As will be realized, the subject technology is capable of other and different configurations and its several details are capable of modification in various other respects, all without departing from the scope of the subject technology. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The accompanying drawings, which are included to provide further understanding and are incorporated in and constitute a part of this specification, illustrate disclosed embodiments and together with the description serve to explain the principles of the disclosed embodiments. In the drawings: [0017] FIG. 1 is a diagram illustrating an exemplary embodiment of a patient monitoring system according to certain aspects of the present disclosure.

[0018] FIG. 2A is a perspective view of the vital-signs monitor patch of FIG. 1 according to certain aspects of the present disclosure.

[0019] FIG. 2B is a cross-section of the vital-signs monitor patch of FIG. 1 according to certain aspects of the present disclosure.

[0020] FIG. 2C is a functional block diagram illustrating exemplary electronic and sensor components of the vital-signs monitor patch of FIG. I according to certain aspects of the present disclosure.

|0021] FIG. 3A is a perspective view of an exemplary embodiment of a patient monitoring system according to certain aspects of the present disclosure.

[0022] FIG. 3B, 3C, and 3D are side views of the embodiment of FIG. 3A in various displaced configurations.

[0023] FIG. 4A is a perspective view of another embodiment of a patient monitoring system according to certain aspects of the present disclosure.

[0024] FIG. 4B, 4C, and 4D are side views of the embodiment of FIG. 4A in various displaced configurations.

[0025] FIG. 5A and 5B are perspective views of additional embodiments of a patient monitoring system according to certain aspects of the present disclosure.

DETAILED DESCRIPTION

[0026] Periodic monitoring of patients in a hospital is desirable at least to ensure that patients do not suffer an un-noticed sudden deterioration in their condition or a secondary injury during their stay in the hospital. It is impractical to provide continuous monitoring by a clinician and cumbersome to connect sensors to a patient, which are then connected to a fixed monitoring instrument by wires. Furthermore, systems that sound an alarm when the measured value exceeds a threshold value may sound alarms so often and in situations that are not truly serious that such alarms are ignored by clinicians. [0027] Measuring vital signs is difficult to do on a continuous basis. Accurate measurement of cardiac pulse, for example, can be done using an electrocardiograph (ECG or EK.G) to detect the electrical activity of the heart. An EKG machine may use up to 12 electrodes placed at various points on the body to detect various signals associated with the cardiac function. Another common piece of equipment is termed a "heart rate monitor." Widely sold for use in exercise and physical training, heart rate monitors may comprise a torso band in which are embedded two electrodes held against the skin and a small electronics package. Such heart rate monitors can communicate wirelessly to other equipment such as a small device that is worn like a wristwatch and that can transfer data wirelessly to a personal computer (PC).

[0028] Monitoring of patients that is referred to as "continuous" is frequently periodic, in that measurements are taken at intervals. In many cases, the process to make a single measurement takes a certain amount of time, such that even back-to-back measurements produce values at an interval equal to the time that it takes to make the measurement. For the purpose of vital sign measurement, a sequence of repeated measurements can be considered to be "continuous" when the vital sign is not likely to change an amount that is of clinical significance within the interval between measurements. For example, a measurement of blood pressure every 10 minutes may be considered "continuous" if it is considered unlikely that a patient's blood pressure can change by a clinically significant amount within 10 minutes. The interval appropriate for measurements to be considered continuous may depend on a variety of factors including the type of injury or treatment and the patient's medical history. Compared to intervals of 4-8 hours for manual vital sign measurement in a hospital, measurement intervals of 30 minutes to several hours may still be considered "continuous."

[0029] Certain exemplary embodiments of the present disclosure include a system that comprises a vital-signs monitor patch that is attached to the patient, and a bridge that communicates with monitor patches and links them to a central server that processes the data, where the server can send data and alarms to a hospital system according to algorithms and protocols defined by the hospital.

[0030] The construction of the vital-signs monitor patch is described according to certain aspects of the present disclosure. As the patch may be worn continuously for a period of time that may be several days, as is described in the following disclosure, it is desirable to encapsulate the components of the patch such that the patient can bathe or shower and engage in their normal activities without degradation of the patch function. An exemplary configuration of the construction of the patch to provide a hermetically sealed enclosure about the electronics is disclosed.

[0031] In the following detailed description, numerous specific details are set forth to provide a full understanding of the present disclosure. It will be apparent, however, to one ordinarily skilled in the art that embodiments of the present disclosure may be practiced without some of the specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the disclosure.

[0032] FIG. 1 discloses a vital sign monitoring system according to certain embodiments of the present disclosure. The vital sign monitoring system 12 includes vital-signs monitor patch 20, bridge 40, and surveillance server 60 that can send messages or interact with peripheral devices exemplified by mobile device 90 and workstation 100.

[0033] Monitor patch 20 resembles a large adhesive bandage and is applied to a patient 10 when in use. It is preferable to apply the monitor patch 20 to the upper chest of the patient 10 although other locations may be appropriate in some circumstances. Monitor patch 20 incorporates one or more electrodes (not shown) that are in contact with the skin of patient 10 to measure vital signs such as cardiac pulse rate and respiration rate. Monitor patch 20 also may include other sensors such as an accelerometer, temperature sensor, or oxygen saturation sensor to measure other characteristics associated with the patient. These other sensors may be internal to the monitor patch 20 or external sensors that are operably connected to the monitor patch 20 via a cable or wireless connection. Monitor patch 20 also includes a wireless transmitter that can both transmit and receive signals. This transmitter is preferably a short-range, low-power radio frequency (RF) device operating in one of the unlicensed radio bands. One band in the United States (US) is, for example, centered at 915 MHz and designated for industrial, scientific and medical (ISM) purposes. An example of an equivalent band in the European Union (EU) is centered at 868 MHz. Other frequencies of operation may be possible dependent upon the International Telecommunication Union (ITU), local regulations and interference from other wireless devices. [0034] Surveillance server 60 may be a standard computer server connected to the hospital communication network and preferably located in the hospital data center or computer room, although other locations may be employed. The server 60 stores and processes signals related to the operation of the patient monitoring system 12 disclosed herein including the association of individual monitor patches 20 with patients 10 and measurement signals received from multiple monitor patches 20. Hence, although only a single patient 10 and monitor patch 20 are depicted in FIG. I , the server 60 is able to monitor the monitor patches 20 for multiple patients 10.

[0035] Bridge 40 is a device that connects, or "bridges", between monitor patch 20 and server 60. Bridge 40 communicates with monitor patch 20 over communication link 30 operating, in these exemplary embodiments, at approximately 915 MHz and at a power level that enables communication link 30 to function up to a distance of approximately 10 meters. It is preferable to place a bridge 40 in each room and at regular intervals along hallways of the healthcare facility where it is desired to provide the ability to communicate with monitor patches 20. Bridge 40 also is able to communicate with server 60 over network link 50 using any of a variety of computer communication systems including hardwired and wireless Ethernet using protocols such as 802.1 la/b/g or 802.3af. As the communication protocols of communication link 30 and network link 50 may be very different, bridge 40 provides data buffering and protocol conversion to enable bidirectional signal transmission between monitor patch 20 and server 60.

[0036] While the embodiments illustrated by FIG. 1 employ a bridge 20 to provide communication link between the monitor patch 20 and the server 60, in certain alternative embodiments, the monitor patch 20 may engage in direct wireless communication with the server 60. In such alternative embodiments, the server 60 itself or a wireless modem connected to the server 60 may include a wireless communication system to receive data from the monitor patch 20.

[0037] In use, a monitor patch 20 is applied to a patient 10 by a clinician when it is desirable to continuously monitor basic vital signs of patient 10 while patient 10 is, in this embodiment, in a hospital. Monitor patch 20 is intended to remain attached to patient 10 for an extended period of time, for example, up to 5 days in certain embodiments, limited by the battery life of monitor patch 20. In some embodiments, monitor patch 20 is disposable when removed from patient 10.

[0038] Server 60 executes analytical protocols on the measurement data that it receives from monitor patch 20 and provides this information to clinicians through external workstations 100, preferably personal computers (PCs), laptops, or smart phones, over the hospital network 70. Server 60 may also send messages to mobile devices 90, such as cell phones or pagers, over a mobile device link 80 if a measurement signal exceeds specified parameters. Mobile device link 80 may include the hospital network 70 and internal or external wireless communication systems that are capable of sending messages that can be received by mobile devices 90.

[0039] FIG. 2A is a perspective view of the vital-signs monitor patch 20 shown in FIG. 1 according to certain aspects of the present disclosure. In the illustrated embodiment, the monitor patch 20 includes component carrier 23 comprising a central segment 21 and side segments 22 on opposing sides of the central segment 21 . In certain embodiments, the central segment 21 is substantially rigid and includes a circuit assembly (24, FIG. 2B) having electronic components and battery mounted to a rigid printed circuit board (PCB). The side segments 22 are flexible and include a flexible conductive circuit (26, FIG. 2B) that connect the circuit assembly 24 to electrodes 28 disposed at each end of the monitor patch 20, with side segment 22 on the right shown as being bent upwards for purposes of illustration to make one of the electrodes 28 visible in this view.

[0040] FIG. 2B is a cross-sectional view of the vital-signs patch 20 shown in Figures 1 and 2A according to certain aspects of the present disclosure. The circuit assembly 24 and flexible conductive circuit 26 described above can be seen herein. The flexible conductive circuit 26 operably connects the circuit assembly 24 to the electrodes 28. Top and bottom layers 23 and 27 form a housing 25 that encapsulate circuit assembly 28 to provide a water and particulate barrier as well as mechanical protection. There are sealing areas on layers 23 and 27 that encircles circuit assembly 28 and is visible in the cross-section view of FIG. 2B as areas 29. Layers 23 and 27 arc sealed to each other in this area to form a substantially hermetic seal. Within the context of certain aspects of the present disclosure, the term 'hermetic' implies that the rate of transmission of moisture through the seal is substantially the same as through the material of the layers that are sealed to each other, and further implies that the size of particulates that can pass through the seal are below the size that can have a significant effect on circuit assembly 24. Flexible conductive circuit 26 passes through portions of sealing areas 29 and the seal between layers 23 and 27 is maintained by sealing of layers 23 and 27 to flexible circuit assembly 28. The layers 23 and 27 are thin and flexible, as is the flexible conductive circuit 26, allowing the side segment 22 of the monitor patch 20 between the electrodes 28 and the circuit assembly 24 to bend as shown in FIG. 2A.

[0041] FIG. 2C is a functional block diagram 200 illustrating exemplary electronic and sensor components of the monitor patch 20 of FIG. I according to certain aspects of the present disclosure. The block diagram 200 shows a processing and sensor interface module 201 and external sensors 232, 234 connected to the module 201 . In the illustrated example, the module 201 includes a processor 202, a wireless transceiver 207 having a receiver 206 and a transmitter 209, a memory 210, a first sensor interface 212, a second sensor interface 214, a third sensor interface 216, and an internal sensor 236 connected to the third sensor interface 216. The first and second sensor interfaces 212 and 214 are connected to the first and second external sensors 232, 234 via first and second connection ports 222, 224, respectively. In certain embodiments, some or all of the aforementioned components of the module 201 and other components are mounted on a PCB.

[0042] Each of the sensor interfaces 212, 214, 216 can include one or more electronic components that are configured to generate an excitation signal or provide DC power for the sensor that the interface is connected to and/or to condition and digitize a sensor signal from the sensor. For example, the sensor interface can include a signal generator for generating an excitation signal or a voltage regulator for providing power to the sensor. The sensor interface can further include an amplifier for amplifying a sensor signal from the sensor and an analog-to-digital converter for digitizing the amplified sensor signal. The sensor interface can further include a filter (e.g., a low-pass or bandpass filter) for filtering out spurious noises (e.g., a 60Hz noise pickup).

[0043] The processor 202 is configured to send and receive data (e.g., digitized signal or control data) to and from the sensor interfaces 212, 214, 216 via a bus 204, which can be one or more wire traces on the PCB. Although a bus communication topology is used in this embodiment, some or all communication between discrete components can also be implemented as direct links without departing from the scope of the present disclosure. For example, the processor 202 may send data representative of an excitation signal to the sensor excitation signal generator inside the sensor interface and receive data representative of the sensor signal from the sensor interface, over either a bus or direct data links between processor 202 and each of sensor interface 212, 214, and 216.

[0044] The processor 202 is also capable of communication with the receiver 206 and the transmitter 209 of the wireless transceiver 207 via the bus 204. For example, the processor 202 using the transmitter and receiver 209, 206 can transmit and receive data to and from the bridge 40. In certain embodiments, the transmitter 209 includes one or more of a RF signal generator (e.g., an oscillator), a modulator (a mixer), and a transmitting antenna; and the receiver 206 includes a demodulator (a mixer) and a receiving antenna which may or may not be the saine as the transmitting antenna. In some embodiments, the transmitter 209 may include a digital-to-analog converter configured to receive data from the processor 202 and to generate a base signal; and/or the receiver 206 may include an analog-to-digital converter configured to digitize a demodulated base signal and output a stream of digitized data to the processor 202. In other embodiments, the radio may comprise a direct sequence radio, a software-defined radio, or an impulse spread spectrum radio.

[0045] The processor 202 may include a general-purpose processor or a specific- purpose processor for executing instructions and may further include a memory 21 , such as a volatile or non-volatile memory, for storing data and/or instructions for software programs. The instructions, which may be stored in a memory 219 and/or 210, may be executed by the processor 202 to control and manage the wireless transceiver 207, the sensor interfaces 212, 214, 216, as well as provide other communication and processing functions.

[0046] The processor 202 may be a general-purpose microprocessor, a microcontroller, a Digital Signal Processor (DSP), an Application Specific Integrated Circuit (ASIC), a Field Programmable Gate Array (FPGA), a Programmable Logic Device (PLD), a controller, a state machine, gated logic, discrete hardware components, or any other suitable device or a combination of devices that can perform calculations or other manipulations of information. [0047] Information, such as program instructions, data representative of sensor readings, preset alarm conditions, threshold limits, may be stored in a computer or processor readable medium such as a memory internal to the processor 202 (e.g., the memory 219) or a memory external to the processor 202 (e.g., the memory 210), such as a Random Access Memory (RAM), a flash memory, a Read Only Memory (ROM), a Programmable Read-Only Memory (PROM), an Erasable PROM (EPROM), registers, a hard disk, a removable disk, or any other suitable storage device.

[0048] In certain embodiments, the internal sensor 236 can be one or more sensors configured to measure certain properties of the processing and sensor interface module 201 , such as a board temperature sensor thermally coupled to a PCB. In other embodiments, the internal sensor 236 can be one or more sensors configured to measure certain properties of the patient 10, such as a motion sensor (e.g., an accelerometer) for measuring the patient's motion or position with respect to gravity.

[0049] The external sensors 232, 234 can include sensors and sensing arrangements that are configured to produce a signal representative of one or more vital signs of the patient to which the monitor patch 20 is attached. For example, the first external sensor 232 can be a set of sensing electrodes that are affixed to an exterior surface of the monitor patch 20 and configured to be in contact with the patient for measuring the patient's respiratory rate, and the second external sensor 234 can include a temperature sensing element (e.g., a thermocouple or a thermistor or resistive thermal device (RTD)) affixed, either directly or via an interposing layer, to skin of the patient 10 for measuring the patient's body temperature. In other embodiments, one or more of the external sensors 232, 234 or one or more additional exlernal sensors can measure other vital signs of the patient, such as blood pressure, pulse rate, or oxygen saturation.

[0050] FIG. 3A is a perspective view of an exemplary embodiment of a patient monitoring system according to certain aspects of the subject disclosure. The unitized patch 300 has a central section 305 that contains the electronics of the patch. Electrodes 320 are shown attached to flaps 315 on opposite sides of section 305.

[0051] FIG. 3B is a side view of patch 300 of FIG. 3A in a configuration in which it is attached to a patient's body 301. Electrodes 320 are adhered to the patient's skin 302 and are coupled to flaps 315 of patch 300 by a snap fitting 330 that is electrically conductive and disconnectable. The central section 305 is rigid, in these embodiments, as the circuit assembly incorporates a rigid printed circuit board (PCB). Flaps 315 have segments 310 that are flexible between the snap fitting 330 and the central section 305. Each electrode 330 comprises a layer of adhesive 325 on the surface that is in contact with the patient's skin 302.

[0052] One definition of 'flexible' is "capable of bending easily without breaking." The term 'flexible' is applied to various degrees of this capability to bend without breaking. Items that are sometimes described as 'flexible' include a thin sheet of rubber, which can be folded tightly upon itself without breaking, and a thin cantilevered steel rod, which will bend a perceptible amount when a transverse load is applied at its tip and return to its original position when the load is removed. In the context of the disclosed vital-signs monitor patch 20, the segments 310 of the patch 20 that are considered flexible are able to be bent by hand with very little effort into shapes that have one or more curves. The flexible patch segments 310 need not be bendable into sharp corners or folded flat against themselves. In the configuration where a compressive force is applied in the plane of the flexible segment 310 of the patch 20, the segment 310 will assume a wavy shape that is shorter in the direction of the applied force than prior to the application of the force, and the amount of force required to compress the segment 310 a small amount, on the order of a few percent, is negligible. Thus, application of term 'flexible' to a segment 310 of the patch 20 that has an electrode 320 attached at one end implies an ability of the patch segment 310 to assume a shape with a reduced length with the load applied by the electrode 320 below the level that would ci'eate noise artifacts.

[0053] It has been observed that the quality of the electrical connection of electrodes to a patient's body is strongly affected by mechanical stress on the connection between the electrode and the skin. This shows up as noise artifacts in the measurement signal as the impedance of the connection changes with stress on the connection. For example, the skin across the chest contracts as a patient reaches forward with both hands. When this happens, a pair of rigidly connected electrodes that were adhered to the chest of a patient while the patient's hands were at their sides will experience significant shear force on each connector when the patient reaches forward with both hands. The noise artifacts induced in this situation in the signal from these electrodes are referred to as "motion induced noise." Even something as minor as sitting up or walking around, both of which involve simple arm motions, are enough to produce significant noise in the measurement of respiration or pulse.

[0054] FIGS. 3C and 3D show displaced configurations of patch 300 when the patient 10 bends or moves such that the portion of the patient's body 301 under patch 300 is no longer of the same shape as it was when the patch was initially applied, as would be typified by the configuration of FIG. 3B. In FIG. 3C, the patient is pulling on something such that the chest muscles 303 are contracting and the distance between the adhered electrodes 320 is reduced. As the electrodes 320 move towards each other, the flexible segments 310 will bend and deform to accommodate this motion. As a result, there is very little shear stress placed on the adhesive 325 of electrodes 320. FIG. 3D shows a similar configuration where the patient 330 has bent over or moved such that the area under the patch 300 is now curved. The flexible segments 310 have changed shape to accommodate the motion and avoid applying stress to the adhesive 325 of electrodes 320. In addition, the swivel capability of connectors 330 permits rotary motion of the patch flaps 315 relative to the electrodes 320 and avoided tension and compression stresses on the adhesive 325.

[0055] The disclosed embodiments of patch 300 provide a significant reduction in noise in the measurements of vital signs as the patient moves about during normal activities. As an advantage of a vital-signs monitor 20 is its continuous monitoring during normal activity, reduced motion-induced noise artifacts enables electrodes 320 to be closer together, which further enables the entire patch 20 to be smaller and less intrusive in the patient's activities.

[0056] The flexible connection between the electrodes 320 and the circuit assembly package 305 can be accomplished in a variety of configurations without departing from the scope of the present disclosure. FIG. 4A shows an alternate embodiment of patch 350, wherein the electrodes 355 are configured such that the surface of the electrode 355 is approximately flush with the surface of the patch body. This could be implemented as either a coating or film applied to the surface of the patch body or an electrode embedded in the material of the body. In this embodiment, conductive adhesive 360 is applied around electrode 355 allowing a conductive gel (not shown) to be utilized between electrode 355 and the skin 302 to improve electrical contact. The patch 20 has flexible segments 310 between the central section 305 and the electrodes 355. FIGS. 4C and 4D illustrate the behavior of the flexible segments 310 in accommodating movement of the patient 10 without inducing stress in the adhesive 360 of the path so as to avoid inducing noise artifacts in the signal.

[0057] FIGS. 5A and 5B illustrate additional configurations of a vital-signs patch that are within the scope of the claims. Patch 500 of FIG. 5 A shows the two electrodes 320 positioned on a common side of central section 305. Adhesive (not shown) may be applied to the underside of central section 305 to provide mechanical attachment to the patient. FIG. 5B shows patch 550 where the electrodes 320 are on opposite sides of central section 305 in one direction and on a common side of central section 305 in the perpendicular direction. Patch 500 and 550 may be suitable for use in specific care situations or in conjunction with certain medical procedures.

[0058] It can be seen that the disclosed embodiments of the vital-signs monitor patch provide a mobile solution to monitoring the vilal signs of a patient. The design of the vital-signs monitor patch frees nurses, or other caregivers, from the task of repetitively measuring the vital signs of their patients, allowing the caregivers to spend more time on other duties. The ability to continuously monitor a patient's vital signs using a monitor patch, together with the rest of the patient monitoring system, increases the ability of the nurse to respond quickly to a sudden change in a patient's condition, resulting in improved care for the patient.

[0059] The strain relief capability of the patch body in the area between the electrodes reduces the magnitude of noise-induced noise artifacts in the measurement signals taken by the vital-signs monitoring patch. As noise is one of the limiting factors in reducing the size of the monitor patch, a lower level of noise enables the patch to be smaller. A smaller patch is less intrusive to the patient and easier for the nurse or other caregiver to apply.

[0060] The previous description is provided to enable any person skilled in the art to practice the various aspects described herein. While the foregoing has described what are considered to be the best mode and/or other examples, it is understood that various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects. Thus, the claims are not intended to be limited to the aspects shown herein, but is to be accorded the full scope consistent with the language claims, wherein reference to an element in the singular is not intended to mean "one and only one" unless specifically so stated, but rather "one or more." Unless specifically stated otherwise, the term "some" refers to one or more. Pronouns in the masculine (e.g., his) include the feminine and neuter gender (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the invention.

[0061] It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the processes may be rearranged. Some of the steps may be performed simultaneously. The accompanying method claims present elements of the various steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0062] Terms such as "top," "bottom," "front," "rear" and the like as used in this disclosure should be understood as referring to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, a top surface, a bottom surface, a front surface, and a rear surface may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference.

[0063] A phrase such as an "aspect" does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. A disclosure relating to an aspect may apply to all configurations, or one or more configurations. A phrase such as an aspect may refer to one or more aspects and vice versa. A phrase such as an "embodiment" does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. A disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. A phrase such an embodiment may refer to one or more embodiments and vice versa.

|0064| The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs.

[0065] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. §1 12, sixth paragraph, unless the element is expressly recited using the phrase "means for" or, in the case of a method claim, the element is recited using the phrase "step for." Furthermore, to the extent that the term "include," "have," or the like is used in the description or the claims, such term is intended to be inclusive in a manner similar to the term "comprise" as "comprise" is interpreted when employed as a transitional word in a claim.

[0066] All elements, parts and steps described herein are preferably included. It is to be understood that any of these elements, parts and steps may be replaced by other elements, parts and steps or deleted altogether as will be obvious to those skilled in the art.

[0068] Broadly, this writing has presented at least a vital-signs monitor patch containing at least two electrodes, a circuit assembly, and a patch body having a chamber in which the circuit assembly is housed. The patch body also contains at least one flexible portion adjacent to the circuit assembly chamber, with at least one electrode attached to the flexible portion. The electrodes are configured for attaching the patch to the skin of a patient.

CONCEPTS

[0068] This writing has disclosed at least the following concepts.

Concept 1. A vital-signs monitor patch comprising:

at least two electrodes;

a circuit assembly operably attached to the electrodes and configured to periodically take at least one measurement from at least one of the electrodes; and

a patch body having;

a circuit assembly chamber in which the circuit assembly is housed;

at least one flexible portion adjacent to the circuit assembly chamber, and to which at least one of the electrodes is attached, the at least one electrode configured for attaching the patch to the skin of a patient.

Concept 2. The vital-signs patch of Concept 1 wherein there are two flexible portions with at least one electrode attached to each portion, and wherein the two portions are on opposite sides of the circuit assembly chamber.

Concept 3. The vital-signs patch of Concept 1 wherein the measurement is related to at least one vital sign of the set of body temperature, cardiac pulse rate, respiration rate, blood pressure, and oxygen saturation.

Concept 4. The vital-signs patch of Concept 1 wherein the electrodes are connectors to which separate electrodes can be attached.

Concept 5. The vital-signs patch of Concept 1 wherein the electrodes comprise a layer of adhesive covering at least a portion of the electrodes, wherein the adhesive of the electrodes provide the attachment of the patch to the patient.

Concept 6. A vital-signs monitor patch for wearing on the skin of a patient, comprising:

a patch housing having a circuit housing portion and at least one electrode portion connected to the circuit housing portion, the at least one electrode portion being flexible;

a circuit assembly in the circuit housing portion; and at least one electrode on the at least one electrode portion and electrically connected to the circuit assembly, the at least one electrode configured for attaching the patch housing to the skin of the patient.

Concept 7. The vital-signs patch of Concept 6 wherein the measurement is related to at least one vital sign of the set of body temperature, cardiac pulse rate, respiration rate, blood pressure, and oxygen saturation.

Concept 8. The vital-signs patch of Concept 6 wherein the electrodes are connectors to which separate electrodes can be attached.

Concept 9. The vital-signs patch of Concept 6 wherein the at least one electrode comprises a layer of adhesive covering at least a portion of the at least one electrode, wherein the adhesive provides the attachment of the patch to the patient.

Concept 10. The vital-signs patch of Concept 6 wherein the patch housing is configured with two electrode portions, each of which is configured with at least one electrode, wherein the two electrode portions are on substantially opposite sides of the circuit housing portion.

Concept 1 1. The vital-signs patch of Concept 6 wherein the patch housing is configured with two electrode portions, each of which is configured with at least one electrode, wherein the two electrode portions are attached to opposite sides of the circuit housing portion and extend to a common side of the circuit housing portion.

Concept 12. The vital-signs patch of Concept 6 wherein the patch housing is configured with one electrode portion and comprises at least two electrodes, the first electrode being attached to the electrode portion of the patch housing, and a seoond electrode being attached to either the circuit housing portion or the electrode portion of the patch housing.

Claims

CLAIMS WHAT IS CLAIMED IS:

1 . A vital-signs monitor patch comprising:

at least two electrodes;

a patch body having:

a circuit assembly chamber in which the circu it assembly is housed;

2. The vital-signs patch of claim 1 wherein there are two flexible portions with at least one electrode attached to each portion, and wherein the two portions are on opposite sides of the circuit assembly chamber.

3. The vital-signs patch of claim 1 wherein the measurement is related to at least one vital sign of the set of body temperature, cardiac pulse rate, respiration rate, blood pressure, and oxygen saturation.

4. The vital-signs patch of claim 1 wherein the electrodes are connectors to which separate electrodes can be attached.

5. The vital-signs patch of claim 1 wherein the electrodes comprise a layer of adhesive covering at least a portion of the electrodes, wherein the adhesive of the electrodes provide the attachment of the patch to the patient.

6. A vital-signs monitor patch for wearing on the skin of a patient, comprising:

a patch housing having a circuit housing portion and at least one electrode portion connected to the circuit housing portion, the at least one electrode portion being flexible; a circuit assembly in the circuit housing portion; and

at least one electrode on the at least one electrode portion and electrically connected to the circuit assembly, the at least one electrode configured for attaching the patch housing to the skin of the patient.

7. The vital-signs patch of claim 6 wherein the measurement is related to at least one vital sign of the set of body temperature, cardiac pulse rate, respiration rate, blood pressure, and oxygen saturation.

8. The vital-signs patch of claim 6 wherein the electrodes are connectors to which separate electrodes can be attached.

9. The vital-signs patch of claim 6 wherein the at least one electrode comprises a layer of adhesive covering at least a portion of the at least one electrode, wherein the adhesive provides the attachment of the patch to the patient.

1 0. The vital-signs patch of claim 6 wherein the patch housing is configured with two electrode portions, each of which is configured with at least one electrode, wherein the two electrode portions are on substantially opposite sides of the circuit housing portion.

1 1 . The vital-signs patch of claim 6 wherein the patch housing is configured with two electrode portions, each of which is configured with at least one electrode, wherein the two electrode portions are attached to opposite sides of the circuit housing portion and extend to a common side of the circuit housing portion.

12. The vital-signs patch of claim 6 wherein the patch housing is configured with one electrode portion and comprises at least two electrodes, the first electrode being attached to the electrode portion of the patch housing, and a second electrode being attached to either the circuit housing portion or the electrode portion of the patch housing.