Patent Application
20150238107
The present invention relates to one or more wireless sensors, and a network of wireless sensors, for monitoring, in real time (or quasi real time), a patient's vital signs, such as various hemodynamic parameters of the patient. In addition, the present invention relates to using wireless surface-attached sensors with implantable heart monitoring devices for providing improved diagnosis, monitoring, and treatment of medical conditions. Further, the present invention relates to integration of such wireless sensors with an electronic medical record storage and management system for managing patient healthcare, such as providing clinical decision support, facilitating diagnosis and validating treatment options.
Monitoring various vital signs of a patient has been an important aspect of hospital patient care, especially for patients with diseases at advanced stages, suffering from severe trauma, or in other emergency settings. Additionally, outpatient monitoring of various physiological conditions are being increasingly used for evaluation of patient health conditions as well as early detection and treatment of heart diseases, diabetes, and other diseases. For example, an electrocardiogram (ECG or EKG) can be used to evaluate the heart condition of a patient, where electrodes are placed at certain locations on the chest, arms, and/or legs. These electrodes can be connected to an ECG machine by lead wires, and the electric signals received by the ECG machine can be analyzed and displayed for the physician's information and further interpretation.
Attempts have also been made to develop systems to improve a patient's comfort, freedom and privacy by decreasing the number and volume of devices directly or indirectly attached to the patient. For example, U.S. Pat. No. 7,979,111 discloses a wireless electrode arrangement and method for patient monitoring, where a plurality of wireless electrodes suitable for attachment to the surface of the body of a patient are capable of continuously monitoring of a subject wirelessly. Copending U.S. patent application Ser. No. 13/835,049 (published as U.S. Patent Application Publication No. 20130204100) further describes a network of wireless sensors for monitoring hemodynamic parameters of a subject. The disclosures of both of these documents are incorporated in its entirety by reference herein.
Implantable devices such as implantable cardioverter defibrillators (ICDs) or pacemakers are often indicated for patients who have or are at increased risk for various heart conditions related to the heart's electrical system, such as ventricular and atrial arrhythmias including but not limited to ventricular fibrillation, ventricular tachycardia, atrial fibrillation, and bradycardia, etc. These implantable devices can monitor and/or manage certain heart conditions of the patients and prevent or control heart episodes that would otherwise interfere with daily life or be life threatening, and can therefore allow patients with certain heart conditions to carry on their normal lives with relatively few restrictions and generally low level of discomfort.
However, there can be limiting factors for these implantable devices such as inaccuracy in detecting the relevant heart condition episodes and administering appropriate therapies. For example, the positioning and contact of the leads of the ICDs with the heart muscle can be affected by the patient's movement, and the problem is more acute for young and more active patients. ICDs can also have lead failures after being worn by a patient for an extended period of time, e.g., a number of years. Lead positioning errors and failures can cause inaccurate or distorted electrograms, and thereby may lead to insufficient, overly aggressive, or otherwise inappropriate cardiac intervention, such as excessive number of unwarranted shocks or shocks with unnecessarily large magnitude, which can cause discomfort, pain, and other undesirable effects on the quality of life of the patients.
Since the last decade, and especially after the enactment of the American Recovery and Reinvestment Act of 2009, healthcare providers are facing more regulations regarding electronic record management (EMR) and electronic health records (EHR) (or personal health record (PHR)). Meanwhile, medical software providers have been developing a plethora of systems that facilitate electronic data storage and management to enable healthcare providers to be in compliance with such increased regulations. For example, a patient's EHR can provide a longitudinal electronic record of patient health information gathered during one or more encounters in a care delivery setting, which can include information such as patient demographics, medications, vital signs, medical history, laboratory test results, and radiology reports, etc. The EHR can also be used to provide decision support, quality management, and outcomes reporting.
There is a need for a system that integrates the real time monitoring capability of wireless sensors worn by a patient with the data storage and processing capabilities afforded by electronic health records management systems for personalized monitoring and clinical decision support, improving accuracy in diagnosis and validating treatment options proposed by physicians.
According to some embodiments of the present invention, a system for detecting an electrocardiogram (ECG) signal of a subject is provided. In various embodiments, the system includes a first substrate that is configured to be placed on and adhere to the skin over the sternum of the subject. A first electrode, a second electrode, and a third electrode are disposed on the first substrate, and each of the electrodes has an end for contacting a respective area of the skin of the subject. On the first substrate, the directional positioning from the second electrode to the first electrode is substantially perpendicular to directional positioning from the third electrode to the first electrode. A first circuit is disposed on the first substrate and is connected to one or more of the first electrode, the second electrode and the third electrode. The first circuit generates at least two channels of ECG data, including a first channel measuring a difference in electric signals between the first electrode and the second electrode, and a second channel measuring a difference in electric signals between the first electrode and the third electrode. Finally, a first communication component is also disposed on the substrate and is configured to wirelessly transmit information from the first circuit to an external device. The first substrate may also include a first power source, such as a battery.
In preferred embodiments, the first substrate is sized to fit a region of the chest below the clavicle and over the sternum. More preferably still, the first substrate is star-shaped and the first, second and third electrodes are each positioned near respective distal ends of the first substrate.
In one aspect, the first circuit uses the at least two channels of ECG data to generate a third channel of ECG data using vector characteristics of ECG data.
In preferred embodiments, the first circuit also has a memory to store ECG data generated or recorded by the first circuit. Preferably, the information transmitted from the first communication component comprises ECG data. In other preferred embodiment, a ground electrode is also disposed on the first substrate and is connected to the first circuit.
In some embodiments, the system further includes another sensor that is configured to obtain data from the subject. This sensor includes a second communication component that is configured to wirelessly communicate with the first circuit to synchronize signal acquisition. In preferred embodiments the sensor includes a second substrate; a fourth electrode, a fifth electrode, and a sixth electrode disposed on the second substrate, each of which has an end for contacting a respective area of skin of the subject and arranged on the second substrate so that directional positioning from the fifth electrode to the fourth electrode is substantially perpendicular to directional positioning from the sixth electrode to the fourth electrode. A second circuit is in communication with one or more of the fourth electrode, the fifth electrode and the sixth electrode and is configured to generate at least two channels of ECG data, including a third channel measuring a difference in electric signals between the fourth electrode and the fifth electrode, and a third channel measuring a difference in electric signals between the fourth electrode and the sixth electrode. A second power source, such as a battery, is disposed on the second substrate. The second communication component is configured to wirelessly transmit ECG data to one or more of the first circuit and the external device, so that at least one of the external device and the first circuit can generate at least five-lead ECG data from ECG data generated by the first circuit and the ECG data generated by the second circuit.
In preferred embodiments, the external device is a mobile telephone configured to communicate with a remote server to provide ECG data obtained from the first sensor to the remote server. Additionally, the mobile telephone may be configured to receive information from the remote server and forward such information to the first circuit.
In another aspect, a method is disclosed for obtaining electrocardiogram (ECG) data from a subject. The method includes applying a first sensor onto skin over a sternum of the subject. The first sensor includes a first substrate configured to be placed on and adhere to the skin; a first electrode, a second electrode, and a third electrode disposed on the first substrate, each of which has an end for contacting a respective area of the skin. Directional positioning from the second electrode to the first electrode is substantially perpendicular to directional positioning from the third electrode to the first electrode. A first circuit is in communication with one or more of the first electrode, the second electrode and the third electrode and configured to generate at least two channels of ECG data, including a first channel measuring a difference in electric signals between the first electrode and the second electrode, and a second channel measuring a difference in electric signals between the first electrode and the third electrode. A first power source, such as a battery, is disposed on the first substrate, along with a first communication component that is configured to wirelessly transmit information from the circuit to an external device. The method then further includes utilizing the external device to obtain ECG data from the first sensor.
In preferred embodiments, the external device is a mobile telephone that communicates with a remote server to provide the ECG data obtained from the first sensor to the remote server. The mobile telephone may also be configured to receive information from the remote server and forward the information to the first sensor.
The method may further include applying a second sensor, similar to the first sensor, onto the skin of the subject. In such embodiments, at least one of the external device and the first circuit is configured to generate at least five-lead ECG data from ECG data obtained from the first sensor and ECG data obtained from the second sensor. The first sensor and the second sensor may form a cluster to enable enhanced generation of ECG data.
In yet another aspect, a method of managing a heart condition for a subject is disclosed. The method includes: (a) detecting intrathoracic electrogram signals of the subject over a first defined period of time by at least one implantable cardiac device having a sensor component implanted in the heart of the subject; (b) determining whether the subject is experiencing a heart condition based on the intrathoracic electrogram signals; (c) detecting electrocardiogram (ECG) signals of the subject over the first defined period of time by at least one surface sensor attached to skin of the subject; (d) determining whether the subject is experiencing the heart condition based on the ECG signals; (e) based upon the results of each of steps (b) and (d), determining whether to perform an action by the implantable cardiac device of a therapy to influence the electrical system of the heart of the subject in order to address the heart condition; (f) performing, by the implantable cardiac device, the action if indicated according to the determination result in step (e); (g) wirelessly sending, by the at least one implantable cardiac device, selected information relating to at least one of the electrogram signals in step (a), the determination result in step (b), and the determination result in step (e), to the at least one surface sensor; and (h) wirelessly sending, by the at least one surface sensor, the information received from the at least one implantable cardiac device, as well as selected information relating to at least one of the ECG signals in step (c) and the determination result in step (d), to an external computing device for storage or further analysis. The method may also include sending, by the external computing device, an alert to a medical personnel based on information received by the computing device.
The various aspects and embodiments disclosed herein will be better understood when read in conjunction with the appended drawings, wherein like reference numerals refer to like components. For the purposes of illustrating aspects of the present application, there are shown in the drawings certain preferred embodiments. It should be understood, however, that the application is not limited to the precise arrangement, structures, features, embodiments, aspects, and devices shown, and the arrangements, structures, features, embodiments, aspects and devices shown may be used singularly or in combination with other arrangements, structures, features, embodiments, aspects and devices. The drawings are not necessarily drawn to scale and are not in any way intended to limit the scope of this invention, but are merely presented to clarify illustrated embodiments of the invention. In these drawings:
Certain embodiments of the present invention will now be discussed with reference to the aforementioned figures. In one embodiment, the present invention provides a system for managing healthcare for a subject (which used interchangeably herein with a “patient”). The system includes a plurality of wireless sensors suitable for attachment to the skin of a subject or implantable in the body of the subject. The plurality of wireless sensors can form a network. The type of network may utilize a routing topology include: star, mesh, pseudo-mesh network, or any other routing topology. Each of the sensors can include a sensing component configured to detect a signal corresponding to at least one physiological condition of the subject, and a communication component configured to wirelessly transmit the detected signal to either another wireless sensor or an external monitoring unit. The communication component of selected sensors can also be configured to receive and/or relay signals transmitted from other wireless sensors.
As described herein, a wireless sensor includes a sensing component configured to detect a signal corresponding to a physiological condition, such as vital signs including hemodynamic parameters of a patient. Hemodynamics, as known in the art, relates to the study of blood flow. The circulatory system, including the heart, the arteries, the microcirculation, and the vein, functions to transport the blood to deliver O2, nutrients and chemicals to the cells of the body, and to remove the cellular waste products. The heart is the driver of the circulatory system generating cardiac output (CO) by rhythmically contracting and relaxing. This creates changes in regional pressures, and, combined with a complex valvular system in the heart and the veins, ensures that the blood moves around the circulatory system in one direction. Hemodynamic parameters (or properties), as described herein, include the physiological conditions associated with the blood flow, which includes not only the physical characteristics of the blood flow itself, e.g., blood flow rate, blood flow pressure, and pulse rate, but also those parameters relating to the blood components such as cells, proteins, chemicals, etc.
The vital signs to be monitored as contemplated in the disclosed embodiments can include, but are not limited to, ECG (electrocardiogram), EEG (electroencephalogram), EMG (electromyogram), EOG (electrooculogram), ERG (electroretinogram), temperature, pulse oximetry, oxygen saturation, oxyhemoglobin saturation, blood component concentration (e.g., glucose level, lipid level, cholesterol level, triglyceride level, levels of different salts, concentration of different types of cells, concentration of blood proteins such as thrombin, cancer markers, heart failure markers), renal function test components (e.g., concentration of albumin, urea, and creatinine in the urine), liver function test components, organ functions, blood pressure (such as atrial pressure, ventricular pressure, pulmonary artery pressure, systolic pressure, diastolic pressure, etc.), blood velocity, respiration rate, pulse rate, (end tidal) CO2 level, blood drug concentration, organic or inorganic substance concentration in the blood (e.g. uric acid, vitamins, heavy metals, carbon monoxide, bacterial toxin), cardiac output, heart rate, heart rhythm, heart rate variability, pH, pathogens, motion, weight, etc. Additionally, the system can be used to monitor migraines, a patient's galvanic skin response, and responses to electrical nerve and muscle stimulation, etc. Depending on the types of underlying physiological conditions to be monitored, the sensing component can include, but is not limited to, an electrochemical detector (such as an needle electrode galvanic electrode or a band electrode for detecting a surface potential or current), an electromagnetic detector (e.g., an optical detector such as an infrared detector and visible light detector, as well as an x-ray detector, gamma-ray detector, etc.), a thermal detector, a pressure detector, an ultrasonic detector, a chemical detector, a magnetic detector, an x-ray detector, an accelerometer, a gyrometer, a motion detector, etc. Other detectors in emerging sensor technology, such as laser Doppler, paper sensors, sensor tattoos, etc., can also be used.
Further, each wireless sensor includes a communication component configured for wireless communication with other sensors. For example, the wireless electrodes described in U.S. Pat. No. 7,979,111 (including the transmitting circuit, such as the remote telemeter 52), can be such a wireless sensor. A wireless sensor can include a mote as described in the above patent, or can include a fully integrated and functional communication circuit that includes an amplifier, a processor, a memory, a battery, and an RF module. Each or selected ones of the wireless sensors can further include a memory of suitable size (for example, 4 GB or 8 GB, to store a large volume or size of relevant medical records of a patient), a data processor, power supply, etc.
In some embodiments, the wireless sensors form a mesh network, where each sensor (also referred to as a “node”, “sensor node” or “regular node” hereinafter) not only captures and disseminates its own data, but also serve as a relay for other nodes, that is, the nodes in the mesh network collaborate with each other to propagate the data in the network. In certain embodiments, the mesh network further includes one or more control nodes (or master nodes), which communicate with selected or all of the regular nodes. The master nodes can serve as a data acquisition, processing, and command center, and will be further described below. In other embodiments, the wireless sensors communicate only with each other, e.g., for purpose of synchronizing signal acquisition. In further embodiments, the wireless sensors communicate only with an external control node, but do not communicate with each other or form a mesh network.
The wireless sensors or the network of the wireless sensors can continuously monitor selected vital signs of the subject, and communicates the signals acquired from the sensing components via the communicating components of the sensors to a control or master node. Each of the wireless sensors can be programmed such that signals detected by the sensor falling into a predetermined (e.g., an acceptable or normal) range are not transmitted, or transmitted at a lower frequency. The acceptable range for signals for different patients and for each wireless sensor can be set individually, for example, based on the type of the sensor, the patient's condition, the therapy being used by the patient, etc. As described herein, the control or master node includes a communication component configured to wireless receive signals from each of the plurality of wireless sensors, and send data and/or command to each of the plurality of wireless sensors. The control or master node can further include a monitoring unit coupled with the communication component. For example, the monitoring unit can include a readable medium and a processor coupled to the computer readable medium. The computer readable medium can store coded instructions for execution by the computer processor, which, upon the execution of the instructions, carries out pre-designed tasks.
In some embodiments, the master node of a mesh network can be a PC or workstation computer equipped with a communication component, such as a dongle, for communicating with the wireless sensors. The master node can also include a portable device having a processor, a memory, a display and/or other audiovisual output capabilities to present information to a user, and capabilities of wirelessly communicating with the wireless sensors. In other examples, the master node can include a commercial portable computing device, such as a smart phone (e.g., an iPhone, an Android-based phone, a Windows Mobile-based phone, etc.), a tablet (such as an iPad, a Samsung Galaxy Tab, Google Nexus 7 or 10, etc.), or other similar devices. In further examples, the control and communication capabilities of a master node can also be implemented on one or more regular nodes to “upgrade” such regular nodes into “super nodes” that include both sensing capabilities and the functionalities of the master node as discussed herein.
In the following, wireless sensors including ECG electrodes suitable for acquiring electrophysiological signals related to cardiac function are used for illustrating the operating principles of the sensors and the network formed therefrom. In these sensors, each of the sensors include one or more electrodes which can acquire data related to the quality of the ECG signal, such as the amplitude of a detected voltage, a detected current, and/or electrical skin resistance, and transmit such data to other sensors or the master nodes. The ECG electrodes may be incorporated into a single unit, or they can utilize off-the-shelf snap connector ECG electrodes to adhere to the thorax and to electrically connect to the skin.
In ECG applications, multiple wireless sensors are typically required, which are placed on the patient's body in predetermined locations. As will be further discussed below, these wireless sensors can further self-configure into a set or group which wirelessly sends diagnostic quality ECG signals in a synchronous fashion to a master node, which can derive or synthesize ECG spectrum for display or other forms usable by a physician (or other users) based on the transmitted ECG signals. These sensors can also be configured to send and/or receive signals to/from the master node when a proximity criterion is satisfied, e.g., when the master node is within a predetermined distance from the wireless sensor, e.g., within 3 feet.
For illustration purposes and not limitation, a mesh or pseudo-mesh network formed by a plurality of sensors can be represented by a schematic block diagram as shown in
For wireless sensors that are configured to detect ECG signals, examples of which are described herein, the sensors can be attached to the skin of a patient for ECG signals recordation in a manner that is similar to the configuration of traditional 3-lead, 5-lead, or 12-lead ECG leads. In certain embodiments, the wireless sensors can be arranged in one or more groups of electrodes each arranged in an orthogonal configuration, such as those illustrated in
As shown in
An example block diagram of the structure of such a tripole sensor is illustrated in
The configuration of the tripole sensor as shown in
The signals acquired from the two orthogonal channels can be combined using vector mathematics to obtain a signal corresponding to any desired vector angle. This can be used to optimize the measurement of any particular waveform signals of interest, thereby assist in detecting various heart conditions. For example, the absence of P wave can be an important characteristic for diagnosis of atrial fibrillation. As P waves are typically very small, improving signal to noise ratio can be crucial. For example, the presence of p waves can be confirmed by adjusting the vector angle to coincide with the axis of depolarization of the atrium, which coincides with maximum amplitude of the p wave. This can overcome the problem known to those skilled in the art that some patients exhibit very small p waves in the standard ECG vectors.
Adjusting the vector angle of the combined channel can also be used to confirm the absence of p waves in certain conditions such as atrial fibrillation. For example, the vector angles can be incremented in in an attempt to detect the presence of p waves, which are seen as a deflection in the ECO typically 0.12 to 0.20 seconds prior to the R wave. If the deflections are not seen in multiple beats of all angles then the absence of the p wave can be confirmed. The vector angle can also be adjusted to find maximum R wave amplitude, which can improve the accuracy of detecting the time of the R wave peak, leading to improvement in the measurement of R to R interval, which is a feature important to the detection of atrial fibrillation because in atrial fibrillation the R to R interval varies chaotically. It is important to distinguish true R to R variability due to noisy measurement of the interval. As another example, S-T segment of a patient's ECG waveform can also be optimized, which is relevant to myocardial infarction (MI) and myocardial ischemia. Those skilled in the art will appreciate that other ECG features and cardiac conditions can be optimized with this technique.
In some embodiments, multiple surface nodes can be placed on the skin of the patient. As shown in
In a system where there are more than one wireless sensors (as shown the three tripole sensors shown in
Further, the wireless sensors according to one embodiment of the present invention can include different sensing components for monitoring a plurality of different vital signs. For example, one sensor can include a pressure detector for monitoring the pulse rate, and another sensor can include an electrochemical detector for blood glucose level measurement (the glucose level can also be measured by an infrared detector or eye scanner). For another example, one wireless sensor can include a surface-attached sensing component, such as one or more ECG electrodes, and another sensor can include an implantable sensing component, such as an implanted intracardiac pressure transducer coupled to a heart chamber (e.g., the right ventricle). Thus, wireless sensors of different types for monitoring different vital signs can be conveniently worn by or implanted in the patient depending on the needs of care for the patient. For purpose of illustration and not limitation,
The use of hybrid sensors can also provide a caregiver with more comprehensive information regarding the patient's condition in a more efficient and/or more reliable manner. For example, monitoring different vital signs simultaneously using different types of wireless sensors can provide redundancy and improved robustness of monitoring quality as well as facilitate reconciliation of inconsistencies among the data gathered from different types of sensors (for different vital signs), reduce false alarm rates, etc. Certain vital signs can also be considered as having higher priorities (e.g., because the sensors for monitoring these vital signs have higher reliability or accuracy), and as such, the data gathered for these vital signs can be given more weight when data gathered for other vital signs may suggest a different condition the patient is in. In addition, when implanted wireless sensors are used, especially those implanted relatively deep within the patient's body (e.g., in the patient's heart), one or more surface-attached sensors, e.g., those located near the implanted sensors, can be used to relay the signals acquired from the implanted sensors, e.g., to a master node, thereby providing potentially better quality signals for further processing and analysis. For example, for a wireless sensor implanted in a patient's heart chamber, another wireless sensor can be attached at the patient's chest to receive and re-broadcast the signals obtained by the implanted sensor. The wireless sensors can be further used in conjunction with certain medical devices worn by the patient (e.g., rehabilitating devices, robotics, prostheses, etc.), for collecting and transmitting sensed signals as a feedback or input for these devices so as to further enhance their functionalities.
The data collected from different types of sensors can be weighted, ranked, processed, validated, transmitted to an EMR server, and utilized with other data in the EMR of a patient. The ECG and other vitals can be prioritized by the patient disease conditions and health status. For example, an otherwise health patient having AF surgery has a limited set of parameters, whereas a patient just discharged with Congestive Heart Failure (CHF) with co-morbidities of diabetes, and obesity, and multiple medications can be monitored for those vital sign signals relevant to disease specific algorithms based on ECG, blood glucose levels and weight.
For example, the system can store “diagnostic templates” containing threshold levels of specific vital signs, which can trigger a diagnosis when the threshold levels for the vital signs are reached by a patient undergoing monitoring. In response to information patient-specific information, the system can adjust the “diagnostic templates” based on disease-specific risk factors (e.g. heart rate variability in patients having atrial fibrillation) as well as patient-specific risk factors (e.g. fluctuation in blood pressure in patients with hypertension). The system can also differentially weigh different vital signs according to the indication and patient's existing conditions, measure the patient's vital sign variability, trends over time, and deviations from previous states using predetermined statistical models, for example, statistical models that use measurements such as average, standard deviation, and covariance. The data processing and analysis can be performed on the sensor nodes, a monitoring device that is configured to receive the sensor data from the various sensors (or from the gateway sensor node as shown in
In an example embodiment, the configuration of different types of wireless sensors as depicted in
In certain embodiments, the present invention provides a system for monitoring a heart condition for a subject (or a patient) using an implantable cardiac device in combination with one or more wireless sensors suitable for attachment to the skin of a subject for monitoring the patient's ECG. In such a manner, the electrograms (EGM) obtained by the internal electrodes of the implantable cardiac device (which are subject to positioning errors or failure and difficult to adjust or replace) can be cross-checked with the ECG signals collected from skin-attached wireless sensors or nodes (which are more robust in positioning stability and easier to adjust/manipulate), thereby improving the confidence and accuracy of detection and management of certain heart conditions by implantable devices.
In some embodiments of the invention, the implantable cardiac device can include an ICD, a single or multi-chamber pacemaker, a cardiac resynchronization therapy device, and other implantable electronic devices that are capable of monitoring, intervening, or influencing the electrical system of the patient's heart. It is understood that modern-day ICD can be designed to perform functions of conventional pacemakers, and therefore ICD can represent a broader category of implantable cardiac devices.
In some embodiments of the invention, the one or more wireless sensors (e.g., surface sensor(s), surface node(s)) can each include a sensing component configured to detect ECG signals. Additionally, the wireless sensors can include a communication component configured to wirelessly transmit the detected signal or other information to other surface nodes, as well as wirelessly receive detected signal or other information from other surface nodes. Selected surface nodes can also wirelessly communicate with the implantable device. In some embodiments, selected surface nodes can also receive signals transmitted from the implantable device. For example, the wireless sensors can be used to detect one or more of heart conditions based on ECG signals, such as ventricular and atrial arrhythmias including but not limited to ventricular fibrillation, ventricular tachycardia, atrial fibrillation, and bradycardia. The implantable device and the surface nodes can interact with each other on a number of different ways, such as: (1) the surface nodes provide diagnostic information to the implantable device which can use such information to make adjustments in its operation; (2) the surface nodes and the implantable device exchanges information such that the operations of both the implantable device and the surface nodes can be affected by each other; and/or (3) the surface nodes actively participates in the monitoring/treatment decision making, e.g., in determining whether and when to administer a therapy to the patient (such as shock or pacing) to influence the electrical system of the heart so as to address the detected condition. The implantable device can include a communication component to wirelessly transmit information to, and/or receive information from one or more of the surface nodes, as will be further described below, where the communication can be conducted through RF, magnetic, acoustic, electrical, optical, and other transmission means as appropriate. The implantable device can also include software configured to process information received from the sensor of the implantable device and the information received from the surface nodes, as well as components for administering the therapies appropriate to address the heart conditions detected.
In certain embodiments, additional components, such as a remote or central server, can be used to make such a diagnostic/treatment decision based on information received from the implantable device and the surface nodes. Again, the implantable device can be used to execute the action corresponding to the decision made with the information provided by the surface nodes.
In some embodiments, the surface-attached wireless sensors include ECG electrodes suitable for acquiring electrophysiological signals related to cardiac function are used for illustrating the operating principles of the sensors and the network formed therefrom. In other embodiments, the surface-attached wireless sensors can include one or more tripole sensors, as illustrated in
In some embodiments where a plurality of wireless sensors are employed, the wireless sensors can be configured to form a network which can be use a routing strategy such as star, mesh, pseudo-mesh, or any other routing topology. The network can include one or more master nodes or other devices which can receive signals from the wireless sensors and have additional signal processing, decision making, and other supervising or coordinating functionalities. The master node(s) or other devices do not need to be attached to the patient's body. For example, the master code can be a desktop or laptop PC, a tablet, a smartphone, etc., as discussed above.
In some embodiments, one or more surface-attached sensors, e.g., those located near an implanted cardiac device, can be used to relay the signals acquired from the implanted sensors, e.g., to an external monitoring device, thereby providing potentially better quality signals for further processing and analysis. For example, for an ICD, a wireless sensor can be attached at the patient's chest to receive and resend the signals obtained by the implanted sensor of the ICD.
As shown in
Control then flows to step 1110 and the ICD cross-references diagnoses with the SN(s). If ICD detects VF in all five diagnoses in decision block 1120, control flows to step 1130 in which the ICD ignores the diagnoses by SN(s) and deploys a predetermined defibrillation therapy. If the ICD diagnoses is less than 100% for VF in decision block 1120, the ICD can incorporate diagnoses by the SN(s) in the decision-making For example, in decision block 1140, if the SN(s) detects any episode of VF, control flows to step 1080 and the ICD deploys defibrillation current. If the SN(s) does not detect any VF in all five episodes, control then flows to step 1150 and the ICD can decide not to administer defibrillation, or administering a defibrillation current with modified parameters (e.g., with a modified waveform, reduced energy, or reduced duration, as desired or needed).
Independent of the final decision, the ICD can further transmit relevant electrogram data and decision of the episode to the SN(s), using, but not limited to, RF, electric, magnetic, acoustic, or optical communication protocol(s) with proper encryption as in step 1160. The control then flows to step 1170 where the SN(s) (or selected SNs from a plurality of SNs) further packages the data from both ICD and SN(s) for the episode and transmits to a remote server using, but not limited to, RF, electric, magnetic, acoustic, or optical communication protocol(s). The transfer of data to the server may route through secured relay station(s). The data package can also contain an alert to the server (in-house or third-party) such that the server can generate a notification for, but not limited to, medical professional(s), caregiver(s) and/or care providers(s). The server also generates an entry documenting the episode to an EMR system.
After the pacing episode, the PM can transmit relevant electrogram data and pacing current parameters to the SN(s), using, but not limited to, RF, electric, magnetic, acoustic, or optical communication protocol(s) with proper encryption as in step 2090. The control then flows to step 2100 where the SN(s) further packages the data from both PM and SN(s) for the episode and transmits to a remote server using, but not limited to, RF, electric, magnetic, acoustic, or optical communication protocol(s). The transfer of data to the server may route through secured relay station(s). The data package also contains an alert to the platform (in-house or third-party) such that the server will generate a notification for, but not limited to, medical professional(s), caregiver(s) and/or care providers(s). The server can also generate an entry documenting the episode to an EMR system.
It is understood that in the voting algorithm illustrated above with respect to
According to another embodiment of the present invention, an integrated system is provided for acquiring, transmitting, analyzing, and utilizing vital signs (e.g., hemodynamic parameters, organ functions, blood test results) monitored in real time by wireless sensors worn by the patient together with the patient's medical records for clinical decision support and other patient health care objectives. Such an integrated system includes the wireless sensors and a monitoring unit, and can further include a remote server(s) that stores the patient's EMR data.
As discussed herein, the monitoring unit or device (and/or a remote server connected to the monitoring unit or device) can include a computer program that manages the transmission of the real time data from the wireless sensors, as well as perform certain specified tasks based on the real time monitoring data as well as the patient's EMR, e.g., diagnosing a condition of the patient, alerting the patient or a physician of a diagnosed condition of the patient, making a suggestion for the diagnosis or treatment of the subject, and/or validating a diagnosis or treatment proposed by a physician, etc. The monitoring unit (or a remote server coupled thereto) can further integrate such received real time monitoring data from the wireless sensors with the patient's past medical history and/or other relevant data (e.g., stored demographics, vital signs history, previous diagnosis, medications, allergies, etc.).
The EMR and other relevant data of a patient can be stored in a permanent storage medium (e.g., a hard drive, a solid state drive, a flash drive, or other types of memories) of the monitoring unit, or transmitted from a physician computer or a remote server (such as a remotely located server operated by a healthcare provider, or a cloud server) accessible by the monitoring unit by wired and/or wireless communications. Also, the data acquired and stored by one or more of the wireless sensors can also be asynchronously or simultaneously uploaded to the monitoring unit and/or further to the remote server for long term storage and/or further analysis. In other words, the patient's EMR can be updated continuously or from time to time by incorporating the data gathered by the wireless sensors. Without departing from the scope of the invention, this data can be stored either locally on the sensor or remotely anywhere on the network. For example, selected portion of a patient's medical history in the patients EMR can be retrieved from a remote server or computer to be stored on selected wireless sensors having a storage medium having a sufficient storage capacity such that relevant patient data can be carried around on the wireless sensors worn by the patient and readily accessible in a clinical setting or another setting where the patient medical records are not otherwise available.
The real-time monitoring data gathered and transmitted by the wireless sensors can be processed if necessary to extract clinically relevant information (e.g., as a diagnosis) and formatted for specific EMR systems, and entered into EMR database located on a computer or data server as individual entries and/or file attachments in a format that complies with current regulatory standards. The data transmission frequency, data format, security and other settings can be preset before the wireless sensors are activated, but can made adjustable according to a patient's current conditions detected by the monitoring system and/or clinical information obtained from other sources (e.g., medications, allergies, lab results, past/present diagnoses). For example, the parameters of the monitoring by the wireless sensors can be adjusted in response to updated patient EMR. When the patient's EMR information is updated (including a change in patient conditions or detection of a “health event,” updated lab results, changes in/initiation of medications, imaging results, or new diagnosis), the monitoring system can change the protocol of the monitoring, e.g., data transmission frequencies of uploading the wireless data to the monitoring unit, threshold levels for alerts and alarms, etc. As an example, if a patient's EMR is updated to include a new medication (e.g., a beta blocker) that the patient starts to take, the monitoring program installed at the monitoring unit or the remote server can decide if the patient monitoring protocol needs to be altered. If the patient having a low heart rate, a beta blocker can make the patient prone to develop bradycardia. In this case, the monitoring system can adjust the transmission frequencies of the heart rate appropriate to monitor signs of bradycardia.
In addition, a list of the medications (and their dosages) that have been prescribed to the patient may be stored in the patient EMR with the schedule for taking them. The monitoring system can also access the patient EMR and download the medications, their dosages, and schedule in order to provide alerts (e.g., sound or vibration alarm, text message, or other types of notification) to healthcare professionals or the patient. If the medications or schedule are changed in the patient EMR, then notifications can be sent to the monitoring system and the alert schedule can be updated accordingly. Additionally, the monitoring unit can also make determination, based on the data received from the wireless sensors, whether the patient has been taking the medications, and/or the correct dosages of medications as prescribed by physicians. The monitoring program can be configured such that a detected noncompliance by the patient can trigger alerts or notification to the patient, as well to the responsible physicians. In this way, the monitoring system could also act as a “compliance monitor.”
It is noted that the diagnosis may be based on both the transmitted data from the wireless sensors and the patient's existing EMR (i.e., before the EMR is updated to incorporate the new diagnosis).
Additionally, after the patient EMR is updated, the monitoring program can reevaluate the patient's condition and decides if additional actions to be performed (e.g., if certain alerts are be sent to appropriate recipients or if the monitoring protocol has to be adjusted.
Further, the diagnostic algorithm cross-references patient's EMR and determines what may be associated or a cause for the detected condition (e.g., a haloperidol medication being taken by the patient). Accordingly, the medical personnel is notified or alerted with the appropriate message at 870, and the diagnostic event is entered into the patient's EMR at 880. Also, the monitoring protocol or settings can be updated at 860 based on the determined cause of the condition (e.g., the frequency of transmitting ECG data is updated to be 30 minutes), and the new settings are sent to the wireless sensors or relay sensor(s) at 860.
As additional examples, the integrated monitoring system can allow a physician to provide a correct diagnosis of symptoms exhibited by a patient and detected by the wireless sensors. For example, although oxygen saturation for a healthy person is 90-100%, for a patient having a chronic obstructive pulmonary disease, the “normal” oxygen saturation is much lower. Thus, if the patient has an oxygen saturation level of lower than 90% (e.g., 86%) detected by the sensor network, the monitoring unit will not produce an alarm condition, and can remind the physician if the physician makes a treatment recommendation under a mistaken belief regarding the “normal” oxygen saturation of this patient. In another example, if a patient who has been taking beta-blockers has a low heart rate, e.g., lower than 40/min, as sensed by the wireless sensor and reported to a physician either remotely or in the physician's office, the system can make that determination and alert the physician that the patient should no longer be prescribed beta-blockers, but should consider other medicine or therapies. As a further example, if a patient is taking an antibiotic, the appropriate dosage of the antibiotic can depend on the weight of the patient such that the patient's kidney function and liver function are not compromised. If the patient's weight has been mistaken when a prescription is given by the physician, the dosage can be incorrect as well, which can lead to ineffective treatment or undesired side effects. In this scenario, the system can validate the dosage prescribed by the physician based on a weight sensor worn by the patient, or by the patient's EMR information stored on a physician computer or downloaded from a server, and alert the physician if the dosage prescribed is not within a predetermined range appropriate for such a patient. As a further example, if a patient visiting a healthcare provider complains about a fever and chest pains, the physician can check the patient's past medical records, which can be stored in the wireless sensors worn by the patient, including the patient's X-ray test result, and determine that the patient is suffering from a pneumonia. If the patient also has a history of alcohol (or other substance) dependence or abuse as indicated by the patient's past medical history, an antibiotic can be prescribed for the patient with an appropriate dosage based on this information as well as the patient's weight and other relevant information, or another therapy can be prescribed for the patient. The prescription can be entered into the monitoring unit of the system or a computer in the physician's office that is wirelessly coupled to the monitoring unit for sending and receiving information. Further, the system can further notify a pharmacy of the entered prescription, and direct the patient to fill the prescription at such a pharmacy. The physiological conditions of a patient of interest, including the effects of a prescribed therapy (including drug treatment, surgical procedures, etc.) on a patient can also be monitored by the patient or the physician by wireless sensors monitoring the vital signs relevant to the prescribed therapy, either in real time (e.g., the data acquired by the sensors can be transmitted in real time or intermittently to a monitoring device accessible by the physician (intermittent transmission refers to transmission of acquired data at a lower interval than the data acquisition or sampling rate by the sensor)), or at each visit to the physician's office by the patient.
The present invention is not to be limited in scope by the specific embodiments described herein. Various modifications of the invention in addition to those described herein will become apparent to those skilled in the art from the foregoing description and the accompanying figures.
One having ordinary skill in the art will recognize that the various mechanisms described for the preferred embodiments of the device may be adapted and interchanged between the preferred embodiments, without significantly impacting the structure and operation of the device. Use of the words “preferred embodiment” or “preferably” is not intended to imply that any other embodiment is less preferred or is not encompassed in the scope of the invention. Those skilled in the art will recognize that the present invention has many applications, may be implemented in many manners and, as such is not to be limited by the foregoing embodiments and examples.
Any number of the features of the different embodiments described herein may be combined into one single embodiment, the locations of particular elements can be altered and alternate embodiments having fewer than or more than all of the features herein described are possible. Functionality may also be, in whole or in part, distributed among multiple components, in manners now known or to become known.
It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention. While there had been shown and described fundamental features of the invention as applied to being exemplary embodiments thereof, it will be understood that omissions and substitutions and changes in the form and details of the disclosed invention may be made by those skilled in the art without departing from the spirit of the invention. Therefore, the appended claims are intended to cover conventionally known, future developed variations and modifications to the components described herein as would be understood by those skilled in the art.
This application is a continuation of U.S. application Ser. No. 14/216,174, filed Mar. 17, 2014, which claims priority to U.S. provisional application No. 61/787,772, filed on Mar. 15, 2013, and U.S. provisional application No. 61/924,986, filed Jan. 8, 2014, the disclosure of each of which is incorporated herein by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 61787772 | Mar 2013 | US | |
| 61924986 | Jan 2014 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14216174 | Mar 2014 | US |
| Child | 14699566 | US |
