Patent Grant
11213237
This application relates in general to electrocardiography and, in particular, to a system and method for secure cloud-based physiological data processing and delivery.
The first electrocardiogram (ECG) was invented by a Dutch physiologist, Willem Einthoven, in 1903, who used a string galvanometer to measure the electrical activity of the heart. Generations of physicians around the world have since used ECGs, in various forms, to diagnose heart problems and other potential medical concerns. Although the basic principles underlying Dr. Einthoven's original work, including his naming of various waveform deflections (Einthoven's triangle), are still applicable today, ECG machines have evolved from his original three-lead ECG, to ECGs with unipolar leads connected to a central reference terminal starting in 1934, to augmented unipolar leads beginning in 1942, and finally to the 12-lead ECG standardized by the American Heart Association in 1954 and still in use today. Further advances in portability and computerized interpretation have been made, yet the electronic design of the ECG recording apparatuses has remained fundamentally the same for much of the past 40 years.
Essentially, an ECG measures the electrical signals emitted by the heart as generated by the propagation of the action potentials that trigger depolarization of heart fibers. Physiologically, transmembrane ionic currents are generated within the heart during cardiac activation and recovery sequences. Cardiac depolarization originates high in the right atrium in the sinoatrial (SA) node before spreading leftward towards the left atrium and inferiorly towards the atrioventricular (AV) node. After a delay occasioned by the AV node, the depolarization impulse transits the Bundle of His and moves into the right and left bundle branches and Purkinje fibers to activate the right and left ventricles.
During each cardiac cycle, the ionic currents create an electrical field in and around the heart that can be detected by ECG electrodes placed on the skin. Cardiac electrical activity is then visually represented in an ECG trace by PQRSTU-waveforms. The P-wave represents atrial electrical activity, and the QRSTU components represent ventricular electrical activity. Specifically, a P-wave represents atrial depolarization, which causes atrial contraction.
P-wave analysis based on ECG monitoring is critical to accurate cardiac rhythm diagnosis and focuses on localizing the sites of origin and pathways of arrhythmic conditions. P-wave analysis is also used in the diagnosis of other medical disorders, including imbalance of blood chemistry. Cardiac arrhythmias are defined by the morphology of P-waves and their relationship to QRS intervals. For instance, atrial fibrillation (AF), an abnormally rapid heart rhythm, can be confirmed by the presence of erratic atrial activity or the absence of distinct P-waves and an irregular ventricular rate. Atrial flutter can be diagnosed with characteristic “sawtooth” P-waves often occurring twice for each QRS wave. Some congenital supraventricular tachycardias, like AV node re-entry and atrioventricular reentrant tachycardia using a concealed bypass tract, are characterized by an inverted P-wave occurring shortly after the QRS wave. Similarly, sinoatrial block is characterized by a delay in the onset of P-waves, while junctional rhythm, an abnormal heart rhythm resulting from impulses coming from a locus of tissue in the area of the AV node, usually presents without P-waves or with inverted P-waves within or shortly before or after the QRS wave. Also, the amplitudes of P-waves are valuable for diagnosis. The presence of broad, notched P-waves can indicate left atrial enlargement or disease. Conversely, the presence of tall, peaked P-waves, especially in the initial half, can indicate right atrial enlargement. Finally, P-waves with increased amplitude can indicate hypokalemia, caused by low blood potassium, whereas P-waves with decreased amplitude can indicate hyperkalemia, caused by elevated blood potassium.
Cardiac rhythm disorders may present with lightheadedness, fainting, chest pain, hypoxia, syncope, palpitations, and congestive heart failure (CHF), yet rhythm disorders are often sporadic in occurrence and may not show up in-clinic during a conventional 12-second ECG. Some atrial rhythm disorders, like atrial fibrillation, are known to cause stroke, even when intermittent. Continuous ECG monitoring with P-wave-centric action potential acquisition over an extended period is more apt to capture sporadic cardiac events that can be specifically identified and diagnosed. However, recording sufficient ECG and related physiological data over an extended period remains a significant challenge, despite an over 40-year history of ambulatory ECG monitoring efforts combined with no appreciable improvement in P-wave acquisition techniques since Dr. Einthoven's original pioneering work over a 110 years ago.
Electrocardiographic monitoring over an extended period provides a physician with the kinds of data essential to identifying the underlying cause of sporadic cardiac conditions, especially rhythm disorders, and other physiological events of potential concern. A 30-day observation period is considered the “gold standard” of monitoring by some, yet a 14-day observation period is currently deemed more achievable by conventional ECG monitoring approaches. Realizing a 30-day observation period has proven unworkable with existing ECG monitoring systems, which are arduous to employ; cumbersome, uncomfortable and not user-friendly to the patient; and costly to manufacture and deploy. An intractable problem is the inability to have the monitoring electrodes adhere to the skin for periods of time exceeding 5-14 days, let alone 30 days. Still, if a patient's ECG could be recorded in an ambulatory setting over a prolonged time periods, particularly for more than 14 days, the chances of acquiring meaningful medical information and capturing an abnormal event while the patient is engaged in normal activities are greatly improved.
The location of the atria and their low amplitude, low frequency content electrical signals make P-waves difficult to sense, particularly through ambulatory ECG monitoring. The atria are located either immediately behind the mid sternum (upper anterior right atrium) or posteriorly within the chest (left atrium), and their physical distance from the skin surface, especially when standard ECG monitoring locations are used, adversely affects current strength and signal fidelity. Cardiac electrical potentials measured from the classical dermal locations have an amplitude of only one-percent of the amplitude of transmembrane electrical potentials. The distance between the heart and ECG electrodes reduces the magnitude of electrical potentials in proportion to the square of change in distance, which compounds the problem of sensing low amplitude P-waves. Moreover, the tissues and structures that lie between the activation regions within the heart and the body's surface further attenuate the cardiac electrical field due to changes in the electrical resistivity of adjacent tissues. Thus, surface electrical potentials, when even capable of being accurately detected, are smoothed over in aspect and bear only a general spatial relationship to actual underlying cardiac events, thereby complicating diagnosis. Conventional 12-lead ECGs attempt to compensate for weak P-wave signals by monitoring the heart from multiple perspectives and angles, while conventional ambulatory ECGs primarily focus on monitoring higher amplitude ventricular activity, i.e., the R-wave that, comparatively, can be readily sensed. Both approaches are relatively unsatisfactory with respect to the P-wave and related need for the accurate acquisition of the P and R-wave medically actionable data of the myriad cardiac rhythm disorders that exist.
Additionally, maintaining continual contact between ECG electrodes and the skin after a day or two of ambulatory ECG monitoring has been a problem. Time, dirt, moisture, and other environmental contaminants, as well as perspiration, skin oil, and dead skin cells from the patient's body, can get between an ECG electrode's non-conductive adhesive and the skin's surface. These factors adversely affect electrode adhesion which in turn adversely affects the quality of cardiac signal recordings. Furthermore, the physical movements of the patient and their clothing impart various compressional, tensile, bending, and torsional forces on the contact point of an ECG electrode, especially over long recording times, and an inflexibly fastened ECG electrode will be prone to becoming dislodged or unattached. Moreover, subtle dislodgment may occur and be unbeknownst to the patient, making the ECG recordings worthless. Further, some patients may have skin that is susceptible to itching or irritation, and the wearing of ECG electrodes can aggravate such skin conditions. Thus, a patient may want or need to periodically remove or replace ECG electrodes during a long-term ECG monitoring period, whether to replace a dislodged electrode, reestablish better adhesion, alleviate itching or irritation, allow for cleansing of the skin, allow for showering and exercise, or for other purpose. Such replacement or slight alteration in electrode location actually facilitates the goal of recording the ECG signal for long periods of time.
Conventionally, multi-week or multi-month monitoring can be performed by implantable ECG monitors, such as the Reveal LINQ insertable cardiac monitor, manufactured by Medtronic, Inc., Minneapolis, Minn. This monitor can detect and record paroxysmal or asymptomatic arrhythmias for up to three years. However, like all forms of implantable medical device (IMD), use of this monitor requires invasive surgical implantation, which significantly increases costs; requires ongoing follow up by a physician throughout the period of implantation; requires specialized equipment to retrieve monitoring data; and carries complications attendant to all surgery, including risks of infection, injury or death. Finally, such devices do not necessarily avoid the problem of signal noise and recording high quality signals.
Holter monitors are widely used for ambulatory ECG monitoring. Typically, they are used for only 24-48 hours. A typical Holter monitor is a wearable and portable version of an ECG that includes cables for each electrode placed on the skin and a separate battery-powered ECG recorder. The leads are placed in the anterior thoracic region in a manner similar to what is done with an in-clinic standard ECG machine using electrode locations that are not specifically intended for optimal P-wave capture but more to identify events in the ventricles by capturing the R-wave. The duration of monitoring depends on the sensing and storage capabilities of the monitor. A “looping” Holter (or event) monitor can operate for a longer period of time by overwriting older ECG tracings, thence “recycling” storage in favor of extended operation, yet at the risk of losing event data. Although capable of extended ECG monitoring, Holter monitors are cumbersome, expensive and typically only available by medical prescription, which limits their usability. Further, the skill required to properly place the electrodes on the patient's chest precludes a patient from replacing or removing the sensing leads and usually involves moving the patient from the physician office to a specialized center within the hospital or clinic.
Further, in addition to ECG signal acquisition and processing, significant challenges exist in regards to the storage of the results of acquisition, processing of such results, and making such results quickly available to only authorized parties, such as the patient's physician. Multiple laws govern the safeguarding of electronic patient records. For example, in the United States, the governing law includes Health Insurance Portability and Accountability Act (HIPAA) while in the European Union the law includes the European Union's Data Protection Directive. In particular, such laws, and HIPAA in particular, focus protection on individually identifiable health information, information that can be tied to a particular patient. Such patient identifying information can include information on the patient's physical or mental health, provision of care to the patient, payment for provision of health care, and identifying information such as name, address, birth date, and social security number. Disclosure of such information in breach of the applicable laws can incur significant penalties. Considering that the disclosure can happen through ways as diverse as a hack of a database containing the records, personnel error, and loss of access information for the database, significant potential for an illegal disclosure exists with conventional record storage techniques.
The potential for an unauthorized disclosure of patient health information increases as the information is transmitted between multiple parties during the course of processing, storage, and use of the results of a cardiac monitoring. For example, the protected health information may be exchanged between computing devices of the patient, the physician who ordered the cardiac monitoring for the patient, and the personnel that set up the patient's electronic medical records, and the protected health information may be vulnerable to theft both during storage (such as due to presence of malware) on these devices and the transmission between the devices. In addition, the protected health information is commonly shared with at least one third party, such as an Independent Diagnostic Testing Facilities (“IDTF”). IDTFs are routinely used in cardiology, as well as other branches of medicine, to evaluate monitoring results, allowing to decrease the time necessary for the evaluation and allowing the physician to other tasks. By providing the monitoring results to an IDTF for interpretation, any protected health information in the monitoring results becomes can be vulnerable to interception during both transmission to the IDTF and storage on the IDTF computer system. Thus, currently, the increase in the processing time of monitoring results is offset by the decrease in security of patient's data. Further, as the number of users authorized to access the patient's health information grows, the burden to authenticate the identity of these users similarly increases.
Finally, as the number of parties contributing to a patient's medical records increases, the potential for the contributed information to be misplaced or misattributed to a different patient also increases. Thus, if the patient's medical records are identified by the patient's name, a misspelling of the patient's name in data intended for the patient's medical records can prevent matching patient-related information to the patient's medical records or even result in the data being stored for a different patient with a similar name. Likewise, if a different identifier is used for the medical records, a misspelling of the identifier can still result in a misattribution of data intended for a patient's medical records.
Accordingly, there is a need for a convenient way to securely upload and exchange ECG monitoring results between the multiple parties involved in data acquisition, processing and use.
A further need remains for a low cost extended wear continuously recording ECG monitor attuned to capturing low amplitude cardiac action potential propagation for arrhythmia diagnosis, particularly atrial activation P-waves, and practicably capable of being worn for a long period of time, especially in patient's whose breast anatomy or size can interfere with signal quality in both women and men.
Physiological monitoring can be provided through a lightweight wearable monitor that includes two components, a flexible extended wear electrode patch and a reusable monitor recorder that removably snaps into a receptacle on the electrode patch. The wearable monitor sits centrally (in the midline) on the patient's chest along the sternum oriented top-to-bottom. The ECG electrodes on the electrode patch are tailored to be positioned axially along the midline of the sternum for capturing action potential propagation in an orientation that corresponds to the aVF lead used in a conventional 12-lead ECG that is used to sense positive or upright P-waves. The placement of the wearable monitor in a location at the sternal midline (or immediately to either side of the sternum), with its unique narrow “hourglass”-like shape, significantly improves the ability of the wearable monitor to cutaneously sense cardiac electrical potential signals, particularly the P-wave (or atrial activity) and, to a lesser extent, the QRS interval signals indicating ventricular activity in the ECG waveforms.
Moreover, the electrocardiography monitor offers superior patient comfort, convenience and user-friendliness. The electrode patch is specifically designed for ease of use by a patient (or caregiver); assistance by professional medical personnel is not required. The patient is free to replace the electrode patch at any time and need not wait for a doctor's appointment to have a new electrode patch placed. Patients can easily be taught to find the familiar physical landmarks on the body necessary for proper placement of the electrode patch. Empowering patients with the knowledge to place the electrode patch in the right place ensures that the ECG electrodes will be correctly positioned on the skin, no matter the number of times that the electrode patch is replaced. In addition, the monitor recorder operates automatically and the patient only need snap the monitor recorder into place on the electrode patch to initiate ECG monitoring. Thus, the synergistic combination of the electrode patch and monitor recorder makes the use of the electrocardiography monitor a reliable and virtually foolproof way to monitor a patient's ECG and physiology for an extended, or even open-ended, period of time.
The foregoing aspects enhance ECG monitoring performance and quality by facilitating long-term ECG recording, which is critical to accurate arrhythmia and cardiac rhythm disorder diagnoses.
The monitoring patch is especially suited to the female anatomy, although also easily used over the male sternum. The narrow longitudinal midsection can fit nicely within the inter-mammary cleft of the breasts without inducing discomfort, whereas conventional patch electrodes are wide and, if adhered between the breasts, would cause chafing, irritation, discomfort, and annoyance, leading to low patient compliance.
In addition, the foregoing aspects enhance comfort in women (and certain men), but not irritation of the breasts, by placing the monitoring patch in the best location possible for optimizing the recording of cardiac signals from the atrium, particularly P-waves, which is another feature critical to proper arrhythmia and cardiac rhythm disorder diagnoses.
Electronic medical records (EMRs) with the results of the monitoring can be stored in a cloud-computing environment. All communications with the cloud-computing environment are performed via a secure connection to protect the data, including communications with any IDTFs that perform an over-read of the results of the monitoring. Each of the EMRs can be associated with an identifier that is provided with the results of the monitoring data and that is also associated with a monitoring patch used for the monitoring. The EMRs can be created, viewed, and modified using a mobile application that provides a quick, secure, and convenient access to the EMRs. The mobile application can use a scanner in the mobile device on which the application executes to obtain the identifier associated from with a particular monitoring patch, such as from a barcode on a label that is issued with the patch or included as part of the patch, and uses the identifier to direct actions of the user towards the appropriate EMR, thus reducing a possibility of error that can occur if the identifier is misspelled when manually input. The mobile application can further provide additional user access authentication, such as by acquiring a biometric feature of the user through the mobile device on which the application executes, and using the biometric feature to confirm the user identity. Alerts can further be provided through the mobile application, helping to speed up the actions of the parties involved in the monitoring interpretation and patient treatment. The mobile application deletes from the mobile device on which the application executes any information that has been transmitted or received from the cloud-computing environment once the information is no longer used, thus reducing the risk that an unauthorized disclosure of such information occurs.
In one embodiment, a system and method for secure cloud-based physiological data processing and delivery is provided. A secure database is maintained in a cloud-computing environment storing a plurality of electronic medical records (EMRs). One of the EMRs is created by at least one server, the at least one server is interconnected to a data communications network and coupled to the secure database, based on an input from a user one of the EMRs, the EMR associated with an identifier of a physiological monitoring device used for conducting a physiological monitoring of a patient and a physician associated with the patient. Results of the physiological monitoring performed by the monitoring device associated with the patient are received by the at least one server together with the identifier and the results are stored using the identifier in the EMR. The results of the physiological monitoring are provided by the at least one server over a secure connection via the data communication network to a processing console. A report comprising an interpretation of the physiological monitoring is received by the at least one server over a further secure connection from the processing console, and the report is stored in the EMR by the at least one server. The physician is alerted by the at least one server upon the receipt of the report via a mobile application executing on a mobile device associated with the physician over the data communication network.
Still other embodiments of the present invention will become readily apparent to those skilled in the art from the following detailed description, wherein are described embodiments by way of illustrating the best mode contemplated for carrying out the invention. As will be realized, the invention is capable of other and different embodiments and its several details are capable of modifications in various obvious respects, all without departing from the spirit and the scope of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.
Physiological monitoring can be provided through a wearable monitor that includes two components, a flexible extended wear electrode patch and a removable reusable monitor recorder. Both the electrode patch and the monitor recorder are optimized to capture electrical signals from the propagation of low amplitude, relatively low frequency content cardiac action potentials, particularly the P-waves generated during atrial activation.
During ECG monitoring, the amplitude and strength of action potentials sensed on the body's surface are affected to varying degrees by cardiac, cellular, extracellular, vector of current flow, and physical factors, like obesity, dermatitis, large breasts, and high impedance skin, as can occur in dark-skinned individuals. Sensing along the sternal midline 16 (or immediately to either side of the sternum 13) significantly improves the ability of the wearable monitor 12 to cutaneously sense cardiac electric signals, particularly the P-wave (or atrial activity) and, to a lesser extent, the QRS interval signals in the ECG waveforms that indicate ventricular activity by countering some of the effects of these factors.
The ability to sense low amplitude, low frequency content body surface potentials is directly related to the location of ECG electrodes on the skin's surface and the ability of the sensing circuitry to capture these electrical signals.
Internal tissues and body structures can adversely affect the current strength and signal fidelity of all body surface potentials, yet low amplitude cardiac action potentials, particularly the P-wave with a normative amplitude of less than 0.25 microvolts (mV) and a normative duration of less than 120 milliseconds (ms), are most apt to be negatively impacted. The atria 6 are generally located posteriorly within the thoracic cavity (with the exception of the anterior right atrium and right atrial appendage), and, physically, the left atrium constitutes the portion of the heart 4 furthest away from the surface of the skin on the anterior chest. Conversely, the ventricles 7, which generate larger amplitude signals, generally are located anteriorly with the anterior right ventricle and most of the left ventricle situated relatively close to the skin surface on the anterior chest, which contributes to the relatively stronger amplitudes of ventricular waveforms. Thus, the quality of P-waves (and other already-low amplitude action potential signals) is more susceptible to weakening from intervening tissues and structures than the waveforms associated with ventricular activation.
The importance of the positioning of ECG electrodes along the sternal midline 15 has largely been overlooked by conventional approaches to ECG monitoring, in part due to the inability of their sensing circuitry to reliably detect low amplitude, low frequency content electrical signals, particularly in P-waves. In turn, that inability to keenly sense P-waves has motivated ECG electrode placement in other non-sternal midline thoracic locations, where the QRSTU components of the ECG that represent ventricular electrical activity are more readily detectable by their sensing circuitry than P-waves. In addition, ECG electrode placement along the sternal midline 15 presents major patient wearability challenges, such as fitting a monitoring ensemble within the narrow confines of the inter-mammary cleft between the breasts, that to large extent drive physical packaging concerns, which can be incompatible with ECG monitors intended for placement, say, in the upper pectoral region or other non-sternal midline thoracic locations. In contrast, the wearable monitor 12 uses an electrode patch 15 that is specifically intended for extended wear placement in a location at the sternal midline 16 (or immediately to either side of the sternum 13). When combined with a monitor recorder 14 that uses sensing circuitry optimized to preserve the characteristics of low amplitude cardiac action potentials, especially those signals from the atria, as further described infra with reference to
Referring back to
Moreover, cardiac action potential propagation travels simultaneously along a north-to-south and right-to-left vector, beginning high in the right atrium and ultimately ending in the posterior and lateral region of the left ventricle. Cardiac depolarization originates high in the right atrium in the SA node before concurrently spreading leftward towards the left atrium and inferiorly towards the AV node. The ECG electrodes of the electrode patch 15 are placed with the upper or superior pole (ECG electrode) along the sternal midline 13 beneath the manubrium and the lower or inferior pole (ECG electrode) along the sternal midline 13 in the region of the Xiphoid process 9 and lower sternum. The ECG electrodes are placed primarily in a head-to-foot orientation along the sternum 13 that corresponds to the head-to-foot waveform vector exhibited during atrial activation. This orientation corresponds to the aVF lead used in a conventional 12-lead ECG that is used to sense positive or upright P-waves.
Furthermore, the thoracic region underlying the sternum 13 along the midline 16 between the manubrium 8 and Xiphoid process 9 is relatively free of lung tissue, musculature, and other internal body structures that could occlude the electrical signal path between the heart 4, particularly the atria, and ECG electrodes placed on the surface of the skin. Fewer obstructions means that cardiac electrical potentials encounter fewer boundaries between different tissues. As a result, when compared to other thoracic ECG sensing locations, the cardiac electrical field is less altered when sensed dermally along the sternal midline 13. As well, the proximity of the sternal midline 16 to the ventricles 7 facilitates sensing of right ventricular activity and provides superior recordation of the QRS interval, again, in part due to the relatively clear electrical path between the heart 4 and the skin surface.
Finally, non-spatial factors can affect transmembrane action potential shape and conductivity. For instance, myocardial ischemia, an acute cardiac condition, can cause a transient increase in blood perfusion in the lungs 5. The perfused blood can significantly increase electrical resistance across the lungs 5 and therefore degrade transmission of the cardiac electrical field to the skin's surface. However, the placement of the wearable monitor 12 along the sternal midline 16 in the inter-mammary cleft between the breasts is relatively resilient to the adverse effects to cardiac action potential degradation caused by ischemic conditions as the body surface potentials from a location relatively clear of underlying lung tissue and fat help compensate for the loss of signal amplitude and content. The monitor recorder 14 is thus able to record the P-wave morphology that may be compromised by myocardial ischemia and therefore make diagnosis of the specific arrhythmias that can be associated with myocardial ischemia more difficult.
The placement of the wearable monitor 12 in a location at the sternal midline 16 (or immediately to either side of the sternum 13) significantly improves the ability of the wearable monitor 12 to cutaneously sense cardiac electric signals, particularly the P-wave (or atrial activity) and, to a lesser extent, the QRS interval signals in the ECG waveforms that indicate ventricular activity, while simultaneously facilitating comfortable long-term wear for many weeks. The sternum 13 overlies the right atrium of the heart and the placement of the wearable monitor 12 in the region of the sternal midline 13 puts the ECG electrodes of the electrode patch 15 in a location better adapted to sensing and recording P-wave signals than other placement locations, say, the upper left pectoral region or lateral thoracic region or the limb leads. In addition, placing the lower or inferior pole (ECG electrode) of the electrode patch 15 over (or near) the Xiphoid process facilitates sensing of ventricular activity and provides excellent recordation of the QRS interval as the Xiphoid process overlies the apical region of the ventricles.
At least one component of the monitor 12 can be associated with at an identifier, such as a serial number, though other kinds of numerical, alphabetical, and alphanumerical identifiers are also possible. Still other kinds of identifiers are also possible. As described below, the identifiers of the patch are associated with results of the monitoring performed using that patch 15 and are used to store and access the results.
The label 200 includes the identifier 201 associated with at least one component of the monitor 12. In a further embodiment, the identifier 201 can be located on the patch 15 used in the monitoring, such as on a sticker. For example, as described further below, the identifier 201 can be encoded on the patch 15 and combined with the data collected by the monitor recorder 14 through the patch 15. Thus, if multiple patches 15 are dispensed to the patient, multiple labels 200 with multiple identifiers 201 will be issued to the patient 10, 11 and other authorized parties. As the patches 15 do not get reused after a monitoring, the monitoring results of different patients will have different identifiers 201 associated with them even if they were obtained using the same monitor recorder 14. While the identifier 201 is shown to have eight components with reference to
The label 200 further includes a password 202, also referred to as an access token 202 in the description below that is also necessary to access the monitoring results. The password 202 can be based on the identifier 202 associated with the patch 15. For example, the password 202 can include a cryptographic hash of at least a portion of the identifier 201 combined with other digits or numbers. The encryption of the identifier 201 can be performed using any suitable encryption hashing function, such as MDS, though other kinds of functions can also be used. In one embodiment, only a portion of the identifier 201, such as 2-3 bytes, are used to create the hash. In a further embodiment, the entire identifier 201 is used to create the hash. The numbers with which the hash can be combined to generate the password can be pseudorandomly generated numbers, though other kinds of numbers are possible. Other kinds of passwords 202 are possible. In one embodiment, the password 202 can be composed of 10 digits; other numbers of digits are possible. Still other kinds of the passwords 202 are possible.
In one embodiment, the label 200 can further include a website address 203, such as a url, that the party in possession of the label 200 can use to access the Electronic Medical Records (EMR) that include the monitoring results and other data related to the results, as further described below. With all three pieces of information on the label 201, the patient 10, 11 or another authorized party could visit the website identified by the address 203, and after entering the identifier 201 and the password 202, access the website EMRs, as further described below with reference to
Similarly, as further described below, medical personnel can use a mobile application executable on a mobile device to scan the identifier 201 and the password 202 from the label 202 and access an interface that allows to set-up the EMRs in which the results of the monitoring will be stored. Likewise, a physician of the patient can access the EMRs 51 via scanning the label 205 with the clinician's mobile device 301, and optionally provide additional authentication, such as a scan of the clinician's fingerprint obtained through the mobile device. Other uses of the label 201 are possible.
The label 200 can include the identifier 201 and the password 202 in multiple forms, including more than one form at the same time. In one embodiment, the label 201 can include a barcode 204(?) that has encoded the identifier 201, the password 202, and optionally, the website address 203. In one embodiment, the barcode 204 can be a QR code, though other kinds of barcodes are possible, with the mobile application including applicable barcode recognition software. In a further embodiment, the mobile application can extract the identifier 201 and the password 202 from the label 200 when the identifier 201 and the password 202 are in plain text on the label 200. Regardless of the kind of representation of the identifier 201 and the password 202 on the label 200, the label 200 can be scanned by a mobile application of a party authorized to create, modify, or view the patient's 10, 11 medical records, with the mobile application extracts the identifier 201 and the password 202 from the scanned representation and uses the identifier 201 and the password 202 with any action taken towards the electronic medical records, thus preventing a misspelling of the identifier 201 that could lead to an action on a medical record of a different patient.
The identifier 201 and the password 202 are also included with the data collected by the monitor 12. During use, the electrode patch 15 is first adhesed to the skin along the sternal midline 16 (or immediately to either side of the sternum 13). A monitor recorder 14 is then snapped into place on the electrode patch 15 to initiate ECG monitoring.
The electrode patch 15 incorporates features that significantly improve wearability, performance, and patient comfort throughout an extended monitoring period. During wear, the electrode patch 15 is susceptible to pushing, pulling, and torqueing movements, including compressional and torsional forces when the patient bends forward, and tensile and torsional forces when the patient leans backwards. To counter these stress forces, the electrode patch 15 incorporates strain and crimp reliefs, such as described in commonly-assigned U.S. Pat. No. 9,545,204, issued Jan. 17, 2017, the disclosure of which is incorporated by reference. In addition, the cut-outs 222 and longitudinal midsection 223 help minimize interference with and discomfort to breast tissue, particularly in women (and gynecomastic men). The cut-outs 222 and longitudinal midsection 223 further allow better conformity of the electrode patch 15 to sternal bowing and to the narrow isthmus of flat skin that can occur along the bottom of the intermammary cleft between the breasts, especially in buxom women. The cut-outs 222 and longitudinal midsection 223 help the electrode patch 15 fit nicely between a pair of female breasts in the intermammary cleft. Still other shapes, cut-outs and conformities to the electrode patch 15 are possible.
The monitor recorder 14 removably and reusably snaps into an electrically non-conductive receptacle 225 during use. The monitor recorder 14 contains electronic circuitry for recording and storing the patient's electrocardiography as sensed via a pair of ECG electrodes provided on the electrode patch 15, such as described in commonly-assigned U.S. Pat. No. 9,730,593, issued Aug. 15, 2017, the disclosure which is incorporated by reference. The non-conductive receptacle 225 is provided on the top surface of the flexible backing 220 with a retention catch 226 and tension clip 227 molded into the non-conductive receptacle 225 to conformably receive and securely hold the monitor recorder 14 in place.
The monitor recorder 14 includes a sealed housing that snaps into place in the non-conductive receptacle 225.
As mentioned above, the electrode patch 15 is intended to be disposable. The monitor recorder 14, however, is reusable and can be transferred to successive electrode patches 15 to ensure continuity of monitoring. The placement of the wearable monitor 12 in a location at the sternal midline 16 (or immediately to either side of the sternum 13) benefits long-term extended wear by removing the requirement that ECG electrodes be continually placed in the same spots on the skin throughout the monitoring period. Instead, the patient is free to place an electrode patch 15 anywhere within the general region of the sternum 13.
As a result, at any point during ECG monitoring, the patient's skin is able to recover from the wearing of an electrode patch 15, which increases patient comfort and satisfaction, while the monitor recorder 14 ensures ECG monitoring continuity with minimal effort. A monitor recorder 14 is merely unsnapped from a worn out electrode patch 15, the worn out electrode patch 15 is removed from the skin, a new electrode patch 15 is adhered to the skin, possibly in a new spot immediately adjacent to the earlier location, and the same monitor recorder 14 is snapped into the new electrode patch 15 to reinitiate and continue the ECG monitoring.
During use, the electrode patch 15 is first adhered to the skin in the sternal region.
In addition, a battery compartment 236 is formed on the bottom surface of the non-conductive receptacle 225, and a pair of battery leads (not shown) electrically interface the battery to another pair of the electrical pads 234. The battery contained within the battery compartment 235 can be replaceable, rechargeable or disposable.
The monitor recorder 14 draws power externally from the battery provided in the non-conductive receptacle 225, thereby uniquely obviating the need for the monitor recorder 14 to carry a dedicated power source.
The placement of the flexible backing 220 on the sternal midline 16 (or immediately to either side of the sternum 13) also helps to minimize the side-to-side movement of the wearable monitor 12 in the left- and right-handed directions during wear. To counter the dislodgment of the flexible backing 220 due to compressional and torsional forces, a layer of non-irritating adhesive, such as hydrocolloid, is provided at least partially on the underside, or contact, surface of the flexible backing 20, but only on the distal end 230 and the proximal end 231. As a result, the underside, or contact surface of the longitudinal midsection 223 does not have an adhesive layer and remains free to move relative to the skin. Thus, the longitudinal midsection 223 forms a crimp relief that respectively facilitates compression and twisting of the flexible backing 220 in response to compressional and torsional forces. Other forms of flexible backing crimp reliefs are possible.
Unlike the flexible backing 20, the flexible circuit 232 is only able to bend and cannot stretch in a planar direction. The flexible circuit 232 can be provided either above or below the flexible backing 20.
ECG monitoring and other functions performed by the monitor recorder 14 are provided through a micro controlled architecture.
Operation of the circuitry 260 of the monitor recorder 14 is managed by a microcontroller 261. The microcontroller 261 includes a program memory unit containing internal flash memory that is readable and writeable. The internal flash memory can also be programmed externally. The microcontroller 261 draws power externally from the battery provided on the electrode patch 15 via a pair of the electrical contacts 256. The microcontroller 261 connects to the ECG front end circuit 263 that measures raw cutaneous electrical signals and generates an analog ECG signal representative of the electrical activity of the patient's heart over time.
The microcontroller 261 operates under modular micro program control as specified in firmware, and the program control includes processing of the analog ECG signal output by the ECG front end circuit 263.
The ECG front end circuit 263 first outputs an analog ECG signal, which the ADC 171 acquires, samples and converts into an uncompressed digital representation. The microcontroller 261 includes one or more firmware modules 173 that perform filtering. In one embodiment, a high pass smoothing filter is used for the filtering; other filters and combinations of high pass and low pass filters are possible in a further embodiment. Following filtering, the digital representation of the cardiac activation wave front amplitudes are compressed by a compression module 174 before being written out to storage 175.
The circuitry 260 of the monitor recorder 14 also includes a flash memory 262, which the microcontroller 261 uses for storing ECG monitoring data and other physiology and information. The data is stored in the memory 262 together with the identifier 201 associated with the patch 15 and the password 202, which are obtained from the patch 15 as further described below. The flash memory 262 also draws power externally from the battery provided on the electrode patch 15 via a pair of the electrical contacts 256. Data is stored in a serial flash memory circuit, which supports read, erase and program operations over a communications bus. The flash memory 262 enables the microcontroller 261 to store digitized ECG data. The communications bus further enables the flash memory 262 to be directly accessed externally over the external connector 265 when the monitor recorder 14 is interfaced to a download station.
The circuitry 260 of the monitor recorder 14 further includes an actigraphy sensor 264 implemented as a 3-axis accelerometer. The accelerometer may be configured to generate interrupt signals to the microcontroller 261 by independent initial wake up and free fall events, as well as by device position. In addition, the actigraphy provided by the accelerometer can be used during post-monitoring analysis to correct the orientation of the monitor recorder 14 if, for instance, the monitor recorder 14 has been inadvertently installed upside down, that is, with the monitor recorder 14 oriented on the electrode patch 15 towards the patient's feet, as well as for other event occurrence analyses, such as described in commonly-assigned U.S. Pat. No. 9,737,224, issued Aug. 22, 2017, the disclosure of which is incorporated by reference.
The circuitry 260 of the monitor recorder 14 includes a wireless transceiver 269 that can provides wireless interfacing capabilities. The wireless transceiver 269 also draws power externally from the battery provided on the electrode patch 15 via a pair of the electrical contacts 256. The wireless transceiver 269 can be implemented using one or more forms of wireless communications, including the IEEE 280 2.11 computer communications standard, that is Wi-Fi; the 4G mobile phone mobile standard; the Bluetooth® data exchange standard; or other wireless communications or data exchange standards and protocols. For example, the wireless transceiver 69 can be implemented using the Bluetooth® 4.0 standard, allowing to conserve power, or Bluetooth® 4.2 standards, allowing the transceiver 69 to have at least some capabilities of a cellular phone, as further described in the commonly-assigned U.S. patent application entitled “Contact-Activated Extended Wear Electrocardiography and Physiological Sensor Monitor Recorder,” Ser. No. 14/656,615, filed Mar. 12, 2015, pending, the disclosure of which is incorporated by reference.
The microcontroller 261 includes an expansion port that also utilizes the communications bus. External devices, separately drawing power externally from the battery provided on the electrode patch 15 or other source, can interface to the microcontroller 261 over the expansion port in half duplex mode. For instance, an external physiology sensor can be provided as part of the circuitry 260 of the monitor recorder 14, or can be provided on the electrode patch 15 with communication with the microcontroller 261 provided over one of the electrical contacts 256. The physiology sensor can include an SpO2 sensor, blood pressure sensor, temperature sensor, respiratory rate sensor, glucose sensor, airflow sensor, volumetric pressure sensing, or other types of sensor or telemetric input sources. For instance, the integration of an airflow sensor is described in commonly-assigned U.S. Pat. No. 9,364,155, issued Jun. 14, 2016, the disclosure which is incorporated by reference.
Finally, the circuitry 260 of the monitor recorder 14 includes patient-interfaceable components, including a tactile feedback button 266, which a patient can press to mark events or to perform other functions, and a buzzer 267, such as a speaker, magnetic resonator or piezoelectric buzzer. The buzzer 267 can be used by the microcontroller 261 to output feedback to a patient such as to confirm power up and initiation of ECG monitoring. Still other components as part of the circuitry 260 of the monitor recorder 14 are possible.
While the monitor recorder 14 operates under micro control, most of the electrical components of the electrode patch 15 operate passively.
The circuitry 270 of the electrode patch 15 performs three primary functions. First, a battery 271 is provided in a battery compartment formed on the bottom surface of the non-conductive receptacle 225. The battery 271 is electrically interfaced to the circuitry 260 of the monitor recorder 14 as a source of external power. The unique provisioning of the battery 271 on the electrode patch 15 provides several advantages. First, the locating of the battery 271 physically on the electrode patch 15 lowers the center of gravity of the overall wearable monitor 12 and thereby helps to minimize shear forces and the effects of movements of the patient and clothing. Moreover, the housing 250 of the monitor recorder 14 is sealed against moisture and providing power externally avoids having to either periodically open the housing 250 for the battery replacement, which also creates the potential for moisture intrusion and human error, or to recharge the battery, which can potentially take the monitor recorder 14 off line for hours at a time. In addition, the electrode patch 15 is intended to be disposable, while the monitor recorder 14 is a reusable component. Each time that the electrode patch 15 is replaced, a fresh battery is provided for the use of the monitor recorder 14, which enhances ECG monitoring performance quality and duration of use. Finally, the architecture of the monitor recorder 14 is open, in that other physiology sensors or components can be added by virtue of the expansion port of the microcontroller 261. Requiring those additional sensors or components to draw power from a source external to the monitor recorder 14 keeps power considerations independent of the monitor recorder 14. Thus, a battery of higher capacity could be introduced when needed to support the additional sensors or components without effecting the monitor recorders circuitry 260.
Second, the pair of ECG electrodes 238, 239 respectively provided on the distal and proximal ends of the flexible circuit 232 are electrically coupled to the set of pads 234 provided on the bottom of the non-conductive receptacle 225 by way of their respective circuit traces 233, 237. The signal ECG electrode 239 includes a protection circuit 272, which is an inline resistor that protects the patient from excessive leakage current.
Last, the circuitry 270 of the electrode patch 15 includes a cryptographic circuit 273 that stores an encoded password 202 for accessing data collecting using this patch 15. The password 202 is encrypted using the secret key 203 to prevent an unauthorized party from obtaining the password 202 once the patch 15 is discarded by the patient. The password 202 is encrypted using a secret key of which the micro-controller 261 has a copy. Thus, only the micro-controller 261 can interface with the cryptographic circuit 273 to obtain the password 202 and decode the password 202 using the secret key, which can be stored in the memory 262. The cryptographic circuit can further store the identifier 201 associated with that patch and the identifier 201 can also be retrieved by the micro-controller 261. In one embodiment, the identifier 201 can be encrypted; in a further embodiment, the identifier 201 can be unencrypted.
In a further embodiment, the cryptographic circuit 73 could be used to authenticate an electrode patch 15 for use with a monitor recorder 14. The cryptographic circuit 273 includes a device capable of secure authentication and validation. The cryptographic device 273 ensures that only genuine, non-expired, safe, and authenticated electrode patches 15 are permitted to provide monitoring data to a monitor recorder 14, such as described in commonly-assigned U.S. Pat. No. 9,655,538, issued May 23, 2017, the disclosure which is incorporated by reference.
The ECG front end circuit 263 measures raw cutaneous electrical signals using a driven reference that effectively reduces common mode noise, power supply noise and system noise, which is critical to preserving the characteristics of low amplitude cardiac action potentials, especially those signals from the atria.
The ECG front end circuit 263 is organized into five stages, a passive input filter stage 281, a unity gain voltage follower stage 282, a passive high pass filtering stage 283, a voltage amplification and active filtering stage 284, and an anti-aliasing passive filter stage 285, plus a reference generator. Each of these stages and the reference generator will now be described.
The passive input filter stage 281 includes the parasitic impedance of the ECG electrodes 238, 239 (shown in
The unity gain voltage follower stage 282 provides a unity voltage gain that allows current amplification by an Operational Amplifier (“Op Amp”) 290. In this stage, the voltage stays the same as the input, but more current is available to feed additional stages. This configuration allows a very high input impedance, so as not to disrupt the body surface potentials or the filtering effect of the previous stage.
The passive high pass filtering stage 283 is a high pass filter that removes baseline wander and any offset generated from the previous stage. Adding an AC coupling capacitor 291 after the Op Amp 290 allows the use of lower cost components, while increasing signal fidelity.
The voltage amplification and active filtering stage 284 amplifies the voltage of the input signal through Op Amp 291, while applying a low pass filter. The DC bias of the input signal is automatically centered in the highest performance input region of the Op Amp 291 because of the AC coupling capacitor 291.
The anti-aliasing passive filter stage 285 provides an anti-aliasing low pass filter. When the microcontroller 261 acquires a sample of the analog input signal, a disruption in the signal occurs as a sample and hold capacitor that is internal to the microcontroller 261 is charged to supply signal for acquisition.
The reference generator in subcircuit 286 drives a driven reference containing power supply noise and system noise to the reference lead REF. A coupling capacitor 287 is included on the signal lead S1 and a pair of resistors 293a, 293b inject system noise into the reference lead REF. The reference generator is connected directly to the patient, thereby avoiding the thermal noise of the protection resistor that is included as part of the protection circuit 272.
In contrast, conventional ECG lead configurations try to balance signal and reference lead connections. The conventional approach suffers from the introduction of differential thermal noise, lower input common mode rejection, increased power supply noise, increased system noise, and differential voltages between the patient reference and the reference used on the device that can obscure, at times, extremely, low amplitude body surface potentials.
Here, the parasitic impedance of the ECG electrodes 238, 239, the protection resistor that is included as part of the protection circuit 272 and the coupling capacitor 287 allow the reference lead REF to be connected directly to the skin's surface without any further components. As a result, the differential thermal noise problem caused by pairing protection resistors to signal and reference leads, as used in conventional approaches, is avoided.
In a further embodiment, the circuitry 270 of the electrode patch 15 includes a wireless transceiver 275, in lieu the including of the wireless transceiver 269 in the circuitry 260 of the monitor recorder 14, which interfaces with the microcontroller 261 over the microcontroller's expansion port via the external connector 274. Similarly to the wireless transceiver 269, the wireless transceiver 275 can be implemented using a standard that allows to conserve battery power, such as the Bluetooth® 4.0 standard, though other standards are possible. Further, similarly to the wireless transceiver 269, the wireless transceiver 275 can be implemented using a standard that allows the transceiver 275 to act have cellular phone capabilities, such as the Bluetooth® 4.2 standard.
The monitor recorder 14 continuously monitors the patient's heart rate and physiology.
The micro-controller 61 retrieves and, as necessary, decodes the password 202 and the identifier 201 associated with the electrode patch 15 (step 102). Subsequent physiological data obtained using the patch 15 is stored in the memory 262 with the password 202 and the identifier in plaintext, unencrypted, form.
Following satisfactory completion of the power up sequence and the decoding, an iterative processing loop (steps 103-112) is continually executed by the microcontroller 261. During each iteration (step 103) of the processing loop, the ECG front end 263 (shown in
Sampling of the R-to-R interval enables heart rate information derivation. For instance, the R-to-R interval represents the ventricular rate and rhythm, while the P-to-P interval represents the atrial rate and rhythm. Importantly, the PR interval is indicative of atrioventricular (AV) conduction time and abnormalities in the PR interval can reveal underlying heart disorders, thus representing another reason why the P-wave quality achievable by the extended wear ambulatory electrocardiography and physiological sensor monitor described herein is medically unique and important. The long-term observation of these ECG indicia, as provided through extended wear of the wearable monitor 12, provides valuable insights to the patient's cardiac function and overall well-being.
Returning to
Each sampled ECG signal, in quantized and digitized form, is temporarily staged in buffer (step 108), pending compression preparatory to storage in the flash memory 262 (step 109). If wireless data sample was read in step 106, the wireless data sample, in quantized and digitized form, is temporarily staged in the buffer (step 108), pending compression preparatory to storage in the flash memory 62 (step 109). Following compression, the compressed ECG digitized sample, and if present, the wireless data sample, is again buffered (step 110), then written to the flash memory 262 (step 111) using the communications bus. Processing continues (step 112), so long as the monitoring recorder 14 remains connected to the electrode patch 15 (and storage space remains available in the flash memory 262), after which the processing loop is exited and execution terminates. Still other operations and steps are possible. In a further embodiment, the reading and storage of the wireless data takes place, in a conceptually-separate execution thread, such as described in commonly-assigned U.S. Pat. No. 10,165,946, issued Jan. 1, 2019, to Bardy et al., the disclosure of which is incorporated by reference.
Once ECG data is collected by the monitor 12, the data can undergo various kinds of processing. In particular, the ECG data can undergo additional filtering to further remove noise. For the example, the data can optionally be filtered under a guidance
The data obtained from the monitor 12, and optionally, pre-processed, can be securely retrieved, stored, and accessed by multiple authorized parties in a cloud-computing environment.
The system 40 includes the monitor 12, which can offload data in a number of ways. Prior to being used to perform physiological monitoring, the recorder 14 and the patch 15 can be programmed using a programming wand 207. In particular, the wand 207 can generate the password 202 for an identifier 201 and load the identifier 201 and the password into the patch 15. In one embodiment, the wand can generate the identifier 201; in a further embodiment, the identifier 201 can be preloaded into the patch 15. The wand 207 also loads the secret key used to decode the password 202 into the monitor recorder 14. The wand 207 can interface with the recorder 14 and the patch 15 wirelessly, such as through the wireless transceivers 269 and 275. In a further embodiment, the wand 207 can interface with the recorder 14 and the patch 15 through wired connections. The wand 207 can include a wireless transceiver and can wirelessly interface with the servers 54. For example, after loading an identifier 201 and the password 201 into the patch 15, the wand 207 can wirelessly send a report to the servers 54 of what identifier 201 has been used and the password 202 generated for that identifier 201. The servers 54 can keep track of whether data for the identifier has been received.
In one embodiment, the wand 207 can be used to program any number of patches 15 and recorders 14. In a further embodiment, the wand 207 can be configured to need recalibration after a preset number of uses.
As mentioned above, one of the options for offloading data from the monitor 12 can offload data to a download station 44, as further described below with reference to
In a further embodiment, prior to being uploaded to the EMRs 51, additional processing can be applied to results of the monitoring. For example, the download station can execute a filtering software that allows a user to select a portion of an ECG trace created based on the results, select particular filters for application to digital signals corresponding to the selecting trace, and apply the selected filters only to that portion of the ECG trace, as further described in U.S. patent application Ser. No. 14/341,698, filed Jul. 25, 2014, abandoned, the disclosure of which is incorporated by reference.
A client-server model could be used to employ one or more servers 54 to remotely interface with the download station 44 over the network 53 and retrieve the formatted data or other information. The one or more servers 54 can be implemented in the cloud-computing environment 304. The servers 54 execute a patient management program 55 (“Mgt”) or similar application that stores the retrieved formatted data 301 and other information cataloged in that patient's EMRs 51 in the secure database 52. The secure database 52 can also be located in the cloud-computing environment 304. The EMRs 51 in the secure database 52 can be encrypted, and whenever any information from the EMR 51 is transmitted to another device, the information is transmitted in an encrypted form, with the receiving device having the keys necessary for decryption. In a further embodiment, the servers 54 and the database 52 can be dedicated servers and database.
In a further embodiment, the download station 44 could be used to transfer data from the monitor 12 to the servers 54 without involvement of the network 53. For example, following a completion of the monitoring, the patient 11 can use an envelope 206 to mail the monitor to a processing center (not shown), where information is extracted from the monitor 12 using the download station 44 directly connected to the servers 54. In a still further embodiment, the servers 54 could receive the data collected by the monitor 12 directly from the monitor 12 over a wireless connection.
The cloud-computing environment 304 can be a part of Microsoft Azure® offered by Microsoft Corporation of Redmond, Wash., though other kinds of cloud-computing environments 304 are possible. In addition, the patient management program 55 could manage a subscription service that authorizes a monitor recorder 12 to operate for a set period of time or under pre-defined operational parameters.
Modern ECG analysis tends to occur in a distributed setting, and the medical personnel interpreting the ECG trace that results from the monitoring are not in the same location as the medical personnel who make the decision regarding patient treatment. Accordingly, the servers 54 are capable of remotely interacting with one or more remote ECG processing consoles 305 over the network 53. For example, the remote console 305 can be a computing device, such as a desktop computer, a laptop computer, or a tablet, though other kinds of computing devices are also possible. The remote console 305 executes an ECG trace processing program 306, such as NorthEast Monitoring Holter LX Analysis software distributed by NorthEast Monitoring Inc. of Maynard, Mass., though other kinds of processing programs 306 are also possible. The processing console 305 can be physically located in an IDTF (not shown), and multiple IDTFs can provide the interpretation services for the EMRs 51, with each IDTF having one or more consoles 305. For example, geographically distributed IDTFs can provide around-the-clock interpretation of the monitoring results.
The servers 54 provide data 301 accumulated from the monitoring to the remote console over a secure connection via the network 53, such as via the https protocol, though other kinds of protocols are possible. In particular, the patient management program 55 can include an application programming interface (API) that securely communicates with the processing console 305. In one embodiment, the provided data 301 includes only the data retrieved from the memory of the monitor recorder 14 after undergoing on the download station described with reference to
The servers 54 can provide the data 301 as soon as the data 301 becomes available. Alternatively, clinicians interpreting the data 301 can view contents of a particular EMR 51 over the secure connection and request the data 301 from the EMR 51 to be sent over the secure connection.
The clinician can perform an interpretation of the results 301 of the monitoring using the processing console 305 and prepare a report 307, which can include the clinician's interpretation of the monitoring data 301, including a summary of the patient's supraventricular ectopy, ventricular ectopy, ST episodes, a summary of critical events encountered during the monitoring, as well as an ECG trace representing the cardiac activity of the patient during an entirety or a portion of the monitoring. Other information can further be included into the report 307. The report 307 is prepared in a PDF format, though other formats are also possible. Once the report 307 is completed, the report 307 is provided to the servers 54 via the secure connection, and stored in the secure database 52 as part of the EMRs of the patient whose records were analyzed. Once the report 307 is stored as part of the EMRs 51, the physician responsible for treating the patient based on the monitoring can be notified of the report being uploaded, such as via the mobile application 302 running on the mobile device 301 of that physician.
Once the servers 54 receives the data 301 collected by the monitor along with the identifier 201, the server 54 stores the received data using the identifier 201 and the password 202 included with the data as part of the received medical records. If the upload happens using the download station and the servers 54 does not recognize the identifier included with the data as being associated with any of the medical records, the servers 54 can provide the user uploading the data an option to search the EMRs 51 and to find the EMR 51 associated with the patient.
The patient management program 55, or other trusted application executed by the servers 54, also maintains and safeguards the secure database 52 to limit access to patient EMRs 51 to only authorized parties for appropriate medical or other uses, such as mandated by state or federal law, such as under the HIPAA or per the European Union's Data Protection Directive. The patient management program 55 maintains several levels of access for different kinds of users with needs to create, access, and modify the EMRs. Thus, users denoted as “administrators” (though other identifications are possible) have access to create profiles of new users and groups and subgroups of users, such as groups of clinicians of a particular IDTF that can interpret a particular EMR 51, as well as subgroups within those groups based on particular traits of the physicians. Another category of users, denoted as “technicians” (though other identifications are possible, have a read-only access to the EMRs 51, and can interpret the monitoring results and provide a preliminary interpretation of the results prior to a physician providing an official medical interpretation of the results. The third category of users, “clinicians,” includes medical personnel that need to set-up EMRs 51 for a particular patient, the physician of the patient ordering the monitoring, and medical personnel at an IDTF that interpret monitoring results. Clinicians can both view, create, and modify the medical records once they are set-up. Finally, the fourth category of users are patients, who can add specific kind of data, such as entries to the patient's diary 303 associated with the monitoring, to the EMRs 51. Such diary entries 303 can include the subjective feelings of the patient experienced during the monitoring period, such as whether the patient felt dizzy or panicked at a particular time. Other kinds of users are also possible.
Each clinician may further be associated with an EMR 51 of a particular patient and be notified upon changes happening to the EMRs. For example, a physician that ordered the monitoring of a particular patient can be notified of the receipt of the report 307 by the servers 54, such as via a mobile application 302 running on the mobile device 132 of the physician. Other notifications for a physician as well as other types of users are also possible. Similarly, a clinician or a group of clinician in an IDTF responsible for performing an over-read of monitoring results 301 stored as part of a particular EMR 51 can also be associated with that EMR 51, and can be provided an alert, such as via e-mail that the monitoring results 301 have been uploaded to the EMR 51.
In a further embodiment, each user can further be associated with additional data that can be used to verify the user's identity. For example, each user can be associated with biometric data, such as a scan of the user's fingerprint, as further described below, though other kind of biometric data is also possible. The biometric data can be stored either under the control of the patient management program 55, such as in the secure database 52, or by a third party service (not shown) that performs the verification of the user's identity using the biometric data and confirms the result to the servers 54.
For ease of access to the servers 54, the users of the system 40 can employ a mobile application 302 running on the mobile devices 132 of the users to create, view, or modify an EMR 51. To prevent misspellings of the identifier 201 when trying to create, access, or modify a particular EMR, the mobile application 302 can utilize a scanner included in the mobile devices 302 to scan a label 205 with a representation of the identifier, such as the barcode 205, and extract the identifier 201 from the barcode. Any other information encoded in the barcode 205 and necessary for creation or accessing of an EMR 51, such as the password 202 associated with the identifier 202 can, further be extracted from the barcode 205. The mobile application 302 can also receive additional input from the user, either for verification of the user's identity or for creation or modification of an EMR 301. In a further embodiment, the mobile application 301 can obtain the identifier 201 and other information from other sources.
For example, a version of the application 302 running on the mobile device 301 of the patient 10, 11 allows the patient to scan the label 204 to obtain the identifier 201 and the password 202. The mobile application 302 further provides a user interface where the user can enter a diary entry 303, describing the subjective feelings the patient experienced at a particular time. The application provides the information obtained from the scan, such as the identifier 201 and the password 202, together with the diary entry 303 to the servers 54 using a secure connection over the network 53, with the patient management program 55 storing the received diary as part of one of the EMRs 51 by comparing the identifier 201 received with the diary entry 303 to the identifiers associated with each of the EMRs 51.
Similarly, the use of the mobile application 302 simplifies setting up an EMR 51 for a particular patient by medical personnel, such as a nurse issuing the monitor 12 to the patient, at the beginning of the monitoring. The version of the mobile application 302 running on the mobile device 133 of the nurse can be specifically tailored for the registration of the patient. Thus, the version of the mobile application 302 can include a user interface that allows the nurse to enter any information associated with the patient that goes into the EMRs 51, such as patient's age or health information, and the information regarding the physician ordering the monitoring. Still other information can be entered by the nurse (or other medical personnel registering the patient into the mobile application). The entry of the identifier 201 and the password 202 can either be performed by scanning the label 204 showing the barcode 205 with a scanner included in the mobile device 301 to avoid the misspelling of the information, though other ways to enter the identifier 201 and the password 202 (such as through manual entry) are also possible. Once the servers 54 receives the information, the servers 54 set up the EMRs 51 that are associated with the received identifier 201, include the entered health information and the physician information, and can be accessed using information that includes at least the identifier 201 and the password 202.
The mobile application 302 further allows a physician to review and make the change to the EMRs 51 stored in the database 52. For example, the physician can access the EMRs 51 by scanning the label 204 with the barcode 205 (or another representation of the identifier 201 and the password 202), and for additional verification, by providing biometric data, such as by scanning his or her fingerprint with the mobile phone scanner. The application 302 provides the identifier 201 and the password 202 obtained through the scan to the servers 54, and the scan of the physician's fingerprint either to the servers 54 or to a third party service that would confirm the physician's identity to the servers 54. Once his or her identity is confirmed, the physician would be able to access and modify the EMR 51 of the patient 10, 11 using the application 302.
All versions of the mobile application 302 communicate with the servers 54 via a secure connection, protecting the data being exchanged between the mobile device 132 of the user and the servers 54. In one embodiment, the secure connection can be established using the https protocol, though other kinds of secure connection protocols are also possible.
While multiple versions of the mobile application 302 exist for multiple kinds of users, no version of the mobile application 302 stores any information relating to either a patient or the patient's monitoring that is entered into application 302 once that information is either provided to the servers 54 or is not used by the user (such as when the user closes the application 302), deleting the information from the memory of the mobile device 133 on which that application executes. The deletion of the data from the mobile device 133 protects patient health information entered provided to the device from becoming compromised during storage on the device.
In one embodiment, the EMRs 51 are not associated with and the database 52 does not store any patient identifying information, such as patient's name, social security number, or date of birth, but instead uses the identifier 201 of the patch 15 used to collect data in the EMRs as the only piece of information tying the patient to the EMR 51. By excluding the patient identifying information and organizing the EMRs 51 exclusively based on the identifiers 201, the database 52 eliminates the risk of violating particular laws regarding disclosure of patient identifying information since such information is not stored. In a further embodiment, an EMR 51 can store patient identifying information 308, such as a patient name, patient birth date and hospital ID number. In that embodiment, monitoring data 301 collected using multiple patches 15 can be stored in the same EMR 51.
The database can further store a log 58 of identifiers 201 of the patches 15 that have been issued using the wand 207 and the passwords 202 that are associated with the patches 15 with the identifiers. Once the program 55 receives the directions to set-up an EMR 51 with one of the identifiers from appropriate medical personnel, such as via the mobile application 302, the program 55 can compare the identifiers 201 received from the wand 207 to the identifier 201 provided by the medical personnel as an additional check that the identifier entered by medical personnel is in fact associated with the patient prior to setting up the EMR 51 with that number.
As mentioned above, the monitor 12 can collect multiple kinds of physiological data and thus the EMRs 51 can include diverse physiological data such as samples of the electrocardiographic data, and data from other sensors of the monitor 12, such as air-flow data, actigraphy data, temperature data, though other kinds of data is possible. Further, the servers 54 can receive a filtered ECG trace processed using the application 30 on a user device and store the trace with the EMR 51 associated with the identifier 201 of the patch used to collect the ECG samples on which the trace is based.
In one embodiment, while the patient 10, 11 can enter the diary entries 303 into the data 301, the patient cannot access results of the EMR 51 directly and has to learn the outcome of the monitoring from the patient's physician or other medical personnel. In a further embodiment, the servers 54 further maintain a website where the patient 10, 11 or another authorized party can access the patient's EMRs 51. For example, the patient can use the mobile device 133 to scan the QR code 204, with the EMRs corresponding to the supplied identifier being presented on a webpage that is a part of the website through the mobile device. As mentioned above, the QR code 205 could be scanned using a separate scanner, such as a scanner (not shown) attached to the computer 50, with the website being presented through the computer 50. Other devices can also be used to access the website 133 in other ways. In a still further embodiment, the servers 54, under the control of the patient, can post some of the information on a social networking or personal medical record site (not shown) after receiving a command from the patient through a user interface provided through the website 133.
Further, the servers 54 can also implement an automated over-read program 59 that conducts an automated over-read of the ECG trace generated based on the data obtained by the monitor 12 and that stores the results of the automated over-read as part of the EMR 51. The automated over-read can be performed following the processing of the monitoring results 301 using the download station 44 described above and below as well as optionally, the ECG trace filtering software described in detail in the U.S. patent application Ser. No. 14/341,698, filed Jul. 25, 2014, abandoned, the disclosure of which is incorporated by reference. During the over-read, the program 59 compares features of the ECG trace resulting from the monitoring data 51, such as shape and position of the waves, to an ECG trace features known to be indicative of one or more conditions. For example, irregular distances between successive R waves (“R-to-R intervals”) in an ECG can be indicative of atrial fibrillation, one of the most common cardiac arrhythmias that is caused by seemingly disorganized atrial depolarizations without effective atrial contractions. By analyzing the R-to-R intervals in the ECG trace created based on the electrocardiographic signals collected by the monitor, the program 59 can detect a presence of a condition indicative of atrial fibrillation. Further, in addition to detecting of ECG characteristics indicative of the condition, the program 59 can generate a recommendation based on the detected condition. The recommendation and other results of the over-read can be stored as part of the EMRs 51 associated with the identifier 201 for the patch 15 that was used to collect the physiological data used in the over-read. In a further embodiment, the recommendation can be provided to the patient 10, 11 or another authorized party, such as the physician who ordered the monitored, as an alert.
The recommendation can depend on the duration of the detected condition. For example, if the analysis of the R-R waves indicates that the patient 10, 11 has been experiencing atrial fibrillation for more than an hour, the recommendation can be for the patient to take a dose of an appropriate medication, such as aspirin. Similarly, as prolonged atrial fibrillation can increase a risk of stroke, if the analysis of the R-R waves indicates that the patient has been experiencing atrial fibrillation for more a day or more, the recommendation can include visiting a physician for elective cardioversion prior to the likely development of an atrial clot. Other kinds of indications are possible. Still other data can be part of the EMRs 51.
The mobile application 302 can be a downloadable application, though other ways to obtain the application are also possible. The mobile device 132 can be a smartphone, a tablet, or another kind of computing device capable of executing the mobile application 302. The mobile devices 132, the console 305, and the servers 54 can include components conventionally found in programmable computing devices, such as a central processing unit, memory, input/output ports, network interfaces, and non-volatile storage, although other components are possible, and can each include one or more modules for carrying out the embodiments disclosed herein. The modules can be implemented as a computer program or procedure written as source code in a conventional programming language and that is presented for execution by the central processing unit as object or byte code. Alternatively, the modules could also be implemented in hardware, either as integrated circuitry or burned into read-only memory components, and each of the mobile devices 132, the console 305, and the servers 54 can act as a specialized computer. For instance, when the modules are implemented as hardware, that particular hardware is specialized to perform the functions described above and below and the computers without the hardware cannot be used for that purpose. The various implementations of the source code and object and byte codes can be held on a computer-readable storage medium, such as a floppy disk, hard drive, digital video disk (DVD), random access memory (RAM), read-only memory (ROM) and similar storage mediums. Other types of modules and module functions are possible, as well as other physical hardware components.
Optionally, one or more patient diary entries 303 are received by the patient management program 54 over the network 53 and stored in the EMR 51 for the monitoring (step 312). The one or more of the diary entries 303 can be received during the duration of the monitoring, such as via the patient using the mobile application 302. Alternatively, the one or more of the diary entries 303 can be made by the patient in a journal that is mailed to a processing center (not shown) along with the monitor recorder, as described above, and uploaded by the processing center to the EMR 51 associated with the monitoring via the network 53.
Upon a completion of the monitoring, physiological data 301 collected from the monitor and optionally processed by the download station, as described below with reference to
Optionally, the patient management program 55 performs an automated over-read of an ECG trace resulting from the monitoring data stored in the EMR 51, as further described above with reference to
Optionally, the clinician responsible for performing an over-read of the results of the monitoring, is provided an alert that the data has been stored as part of the EMR 51 upon a completion of step 314 (step 315). The alert can be delivered via the mobile application 302 executing on the mobile device 301 of the clinician, or through another technique, such as by sending an e-mail or an SMS message, though other ways to deliver the alert are also possible.
An over-read is performed by the interpreting clinician and the report 307 including results of the over-read are stored in the EMR 51 associated with the monitoring, as further described with reference to
The secure communication between the processing console 305 and the servers 54 allows for remote processing of results of the monitoring, which saves the doctor while at the same time protecting patient privacy.
The download station 44 can include an array of filtering modules that can perform processing of collected data instead of or in addition to any user-guided processing.
An automatic gain control (AGC) module 145 can also be provided to adjust the digital signals to a usable level based on peak or average signal level or other metric. AGC is particularly critical to single-lead ECG monitors, where physical factors, such as the tilt of the heart, can affect the electrical field generated. On three-lead Holter monitors, the leads are oriented in vertical, horizontal and diagonal directions. As a result, the horizontal and diagonal leads may be higher amplitude and ECG interpretation will be based on one or both of the higher amplitude leads. In contrast, the electrocardiography monitor 12 has only a single lead that is oriented in the vertical direction, so variations in amplitude will be wider than available with multi-lead monitors, which have alternate leads to fall back upon.
In addition, AGC may be necessary to maintain compatibility with existing ECG interpretation software, which is typically calibrated for multi-lead ECG monitors for viewing signals over a narrow range of amplitudes. Through the AGC module 145, the gain of signals recorded by the monitor recorder 14 of the electrocardiography monitor 12 can be attenuated up (or down) to work with FDA-approved commercially available ECG interpretation.
AGC can be implemented in a fixed fashion that is uniformly applied to all signals in an ECG recording, adjusted as appropriate on a recording-by-recording basis. Typically, a fixed AGC value is calculated based on how an ECG recording is received to preserve the amplitude relationship between the signals. Alternatively, AGC can be varied dynamically throughout an ECG recording, where signals in different segments of an ECG recording are amplified up (or down) by differing amounts of gain.
Typically, the monitor recorder 14 will record a high resolution, low frequency signal for the P-wave segment. However, for some patients, the result may still be a visually small signal. Although high resolution is present, the unaided eye will normally be unable to discern the P-wave segment. Therefore, gaining the signal is critical to visually depicting P-wave detail. This technique works most efficaciously with a raw signal with low noise and high resolution, as generated by the monitor recorder 14. Automatic gain control applied to a high noise signal will only exacerbate noise content and be self-defeating.
Finally, the download station 44 can include filtering modules specifically intended to enhance P-wave content. For instance, a P-wave enhancement filter 146, which is a form of pre-emphasis filter, can be applied to the signal to restore missing frequency content or to correct phase distortion. Still other filters and types of signal processing are possible.
In addition to the processing described above, the download station 44 can also convert retrieved data into a format suitable for use by third party post-monitoring analysis software, such as the processing software 306 running on a ECG trace processing console 305 employed at an IDTF, as further described below with reference to
The monitor recorder 14 stores ECG data and other information in the flash memory 262 (shown in
Initially, the download station 44 is connected to the monitor recorder 14 (step 151), such as by physically interfacing to a set of terminals 45 on a paired receptacle 127 or by wireless connection, if available. The data stored on the monitor recorder 14, including ECG and physiological monitoring data, other recorded data, and other information are retrieved (step 152) over a hard link 48 using a control program 49 (“Ctl”) or analogous application executing on a personal computer 50 or other connectable computing device.
The data retrieved from the monitor recorder 14 is in a proprietary storage format and each datum of recorded ECG monitoring data, as well as any other physiological data or other information, must be converted, so that the data can be used by a third-party post-monitoring analysis program. Each datum of ECG monitoring data is converted by the middleware (steps 153-159) in an iterative processing loop. During each iteration (step 153), the ECG datum is read (step 154) and, if necessary, the gain of the ECG signal is adjusted (step 155) to compensate, for instance, for relocation or replacement of the electrode patch 15 during the monitoring period. Filtering described above with reference to
In addition, depending upon the configuration of the wearable monitor 12, other physiological data (or other information), including patient events, such as a fall, peak activity level, sleep detection, detection of patient activity levels and states, and so on, may be recorded along with the ECG monitoring data. For instance, actigraphy data may have been sampled by the actigraphy sensor 264 based on a sensed event occurrence, such as a sudden change in orientation due to the patient taking a fall. In response, the monitor recorder 14 will embed the actigraphy data samples into the stream of data, including ECG monitoring data, that is recorded to the flash memory 262 by the microcontroller 261. Post-monitoring, the actigraphy data is temporally matched to the ECG data to provide the proper physiological context to the sensed event occurrence. As a result, the three-axis actigraphy signal is turned into an actionable event occurrence that is provided, through conversion by the middleware, to third party post-monitoring analysis programs, along with the ECG recordings contemporaneous to the event occurrence. Other types of processing of the other physiological data (or other information) are possible.
Thus, during execution of the middleware, any other physiological data (or other information) that has been embedded into the recorded ECG monitoring data is read (step 156) and time-correlated to the time frame of the ECG signals that occurred at the time that the other physiological data (or other information) was noted (step 157). Finally, the ECG datum, signal gain adjusted, if appropriate, and other physiological data, if applicable and as time-correlated, are stored in a format suitable to the backend software (step 158) used in post-monitoring analysis.
In a further embodiment, the other physiological data, if apropos, is embedded within an unused ECG track. For example, the SCP-ENG standard allows multiple ECG channels to be recorded into a single ECG record. The monitor recorder 14, though, only senses one ECG channel. The other physiological data can be stored into an additional ECG channel, which would otherwise be zero-padded or altogether omitted. The backend software would then be able to read the other physiological data in context with the single channel of ECG monitoring data recorded by the monitor recorder 14, provided the backend software implemented changes necessary to interpret the other physiological data. Still other forms of embedding of the other physiological data with formatted ECG monitoring data, or of providing the other physiological data in a separate manner, are possible.
Processing continues (step 159) for each remaining ECG datum, after which the processing loop is exited and execution terminates. Still other operations and steps are possible.
While the invention has been particularly shown and described as referenced to the embodiments thereof, those skilled in the art will understand that the foregoing and other changes in form and detail may be made therein without departing from the spirit and scope.
This present non-provisional patent application is a continuation-in-part of U.S. Pat. No. 10,278,603, issued May 7, 2019, which is a continuation of U.S. Pat. No. 9,955,885, issued May 1, 2018; which is a continuation of U.S. Pat. No. 9,619,660, issued Apr. 11, 2017; which is a continuation-in-part of Ser. No. 14/341,698, filed Jul. 25, 2014, abandoned; which is a continuation-in-part of U.S. Pat. No. 9,433,367, issued Sep. 6, 2016; which is a continuation-in-part of U.S. Pat. No. 9,545,204, issued Jan. 17, 2017, and a continuation-in-part of U.S. Pat. No. 9,730,593, issued Aug. 15, 2017; and which further claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent application Ser. No. 61/882,403, filed Sep. 25, 2013, the disclosures of which are incorporated by reference; the U.S. Pat. No. 9,619,660, issued Apr. 11, 2017, is also a continuation-in-part of U.S. Pat. No. 9,700,227, issued Jul. 11, 2017, which is a continuation-in-part of U.S. Pat. No. 9,730,593, issued Aug. 15, 2017, and further claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent application Ser. No. 61/882,403, filed Sep. 25, 2013, the disclosures of which are incorporated by reference.
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