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WO2018001389A1 - Implantable monitor - Google Patents

Implantable monitor Download PDF

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Publication number
WO2018001389A1
WO2018001389A1 PCT/CN2017/097625 CN2017097625W WO2018001389A1 WO 2018001389 A1 WO2018001389 A1 WO 2018001389A1 CN 2017097625 W CN2017097625 W CN 2017097625W WO 2018001389 A1 WO2018001389 A1 WO 2018001389A1
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WIPO (PCT)
Prior art keywords
implantable monitor
monitor
implantable
patient
information
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Ceased
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PCT/CN2017/097625
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French (fr)
Inventor
Dongping Lin
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Individual
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Individual
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • A61B5/0006—ECG or EEG signals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/686—Permanently implanted devices, e.g. pacemakers, other stimulators, biochips

Definitions

  • the present invention relates generally to medical instrumentation systems and methods, which is suitable for long-term monitoring and diagnoses. It may also provide information regarding the effectiveness of a therapy to a patient.
  • the invention also has wireless communication capabilities and a remote data transmission function.
  • the system and method include an implantable monitor, which records, detects, stores, and transmits physiological signals; a programming station, which can be used by a physician to set up and program the implantable monitor; a handheld controller, which communicates with the implantable monitor; an optional receiver, which receives the recorded physiological signals and transmit the signals to a storage device that can save the physiological signals.
  • the storage device can be local, remote, or cloud-based.
  • the physiological signal can be analyzed by the implantable monitor and/or by any other part of the system; the analysis can also be divided and be performed by different parts of the system. Big data analysis can also be preformed on the collected signal.
  • U.S. patents 4,172,459 and 4,281,664 disclosed such devices. The purpose of such devices is to record patients’ conditions for physicians to review and to help physicians make diagnoses so that they can better take care of their patients.
  • minimally invasive techniques, diagnostic methods and equipment, wireless capabilities, and patient care means over the past decades major disadvantages still exist for identifying and treating major cardiac diseases. Diagnostic methods are still limited to non-invasive monitoring and in-vitro diagnoses.
  • U.S. patent 6,699,200 disclosed another implantable medical device with multiple sensing electrodes. The sensing electrodes are complicated and are not conventional electrode, or lead, configurations.
  • US patent 6,699,200 has not been implemented.
  • US patent 5,404,877 disclosed a lead-less implantable using a different frequency to measure impedance changes to derive arrhythmias. This is a non-traditional sensing technique for detecting arrhythmias.
  • a product for that disclosure has not been seen on the market either. Those systems and methods are inefficient and cumbersome to use, hard to be implemented as a product, and cannot provide sufficient information for physicians to make definitive decisions. More importantly, they do not provide timely and real-time information.
  • Reveal LINQ is an insertable cardiac monitor, which is surgically implanted in a patient’s chest area under the skin and records electrocardiogram (ECG) .
  • ECG electrocardiogram
  • the recorded ECG signal can be transmitted wirelessly to a signal repeater, which than can re-transmit the signal to a clinical facility for a physician to review.
  • Reveal LINQ records only one channel of ECG signal and this channel is not a part of any standard ECG systems. Certain cardiac arrhythmias may not be easily detected by one channel. Physicians are trained to read ECG tracings from standard ECG systems. ECG databases for testing ECG analysis algorithm are also recorded with standard ECG systems. Using only one non-standard ECG channel may lead to wrong interpretation, which can result in providing the wrong therapy to a patient.
  • Reveal LINQ records only ECG signals. It does not record other physiological signals, such as blood pressure and glucose signals. This drawback limits the applications of LINQ.
  • Reveal LINQ is also limited by its physical characteristics. The size and the shape of Reveal LINQ is not the best for being surgically implanted into human body and may not be the best for recording ECG signals. The material and the shape of Reveal LINQ make it very hard to be removed after it is implanted.
  • Reveal LINQ Reveal LINQ is not easy to use and increases the risk of human error.
  • the present invention responds to the needs of recording more than one channel of ECG.
  • a further objective of the present invention is to provide a better shape such that the surgically procedure be much more easily performed.
  • a further object of the present invention is to use better material, better device design, and modern surface processing technologies to make the device easy to be removed after it is implanted.
  • a further objective is to significantly reduce the number of programmable parameters to improve user experience and provide more accurate and timely information.
  • a further objective is to ensure patient connectivity through system design with better user interface and multiple transmission devices.
  • a further objective is to ensure the signal quality before an implantable monitor is surgically implanted in a patient.
  • a further objective is to use artifact reduction and elimination technologies to enhance signal quality.
  • a final objective is to create new business models using the implantable monitor.
  • This invention offers a considerable improvement over current systems and methods; it employs a new philosophy of designing the system and method for users so that cardiac arrhythmias and other conditions can be accurately and timely detected.
  • the present invention proposes for the first time the concepts of using better material, better design, multi-channel and multi-signal mobile and internet technologies, reduced programmable parameters, and better user experience; the present invention is also the first to realize these concepts in a novel implantable system and method.
  • FIG. 1 is a diagram of a preferred and complete system embodiment.
  • FIG. 2 is a diagram of a preferred implantable monitor, which is surgically inserted into a human body.
  • FIG. 3 is a diagram of another preferred implantable monitor, which is surgically inserted into a human body.
  • FIG. 4 is a diagram of an insertion package.
  • FIG. 5 is a diagram of removable package.
  • FIG. 6 is a flowchart of an algorithm to detect arrhythmia and syncope.
  • FIG. 7 is a drawing of preferred embodiments for device removal
  • FIG. 8 is a preferred system configuration.
  • FIG. 9 is a diagram with some connectivity devices.
  • FIG. 10 is a diagram of signal probe for finding a position for better signal.
  • FIG. 11 is a list of types of events, which can be generated by an implantable monitor system.
  • FIG 1 is a preferred system embodiment that consists of an implantable monitor 120, a handheld device 160, a transmission station 112, a programmer 130, a technician 135, a insertion package 150, a removal tool package 155, an information storage device 110, a review station 190, a handheld review device 195, a caregiver 193 who uses the review station 190 to review the patient data, and a caregiver 198 who uses a handheld device to review the patient data.
  • a patient can use the handheld device 160 to mark an event.
  • a technician 135 can use the programmer.
  • Caregivers 193 and 198 can use the review station 190 and the handheld review device 195 to check patient information.
  • the information storage device 110 receives data sent by implantable monitors via either a patient’s handheld device or transmission station 112.
  • the information storage device 110 can be implemented as a single device, a group of devices in one location, or a group of distributed devices in different physical locations.
  • the data stored in the information storage device 110 can be retrieved by authorized individuals.
  • the information storage device 110 has computation capacity to receive, analyze, store, and share data from and to authorized people.
  • the storage device 110 has privacy protection capabilities, such as password protection or data encryption.
  • An implantable monitor 120, patient’s handheld device 160, a transmission station 112, and a programmer 130 have their own unique device identification code, which is used to identify themselves when sending and retrieving data in the implantable monitor system. The use of a unique device identification code ensures data integrity across the entire implantable monitor system and eliminates potential data-cross, which can result in misdiagnosis of a patient’s condition.
  • the implantable monitor 120 collects physiological signals, stores and examines the collected signals, and transmits the signals and examination results to a patient’s handheld device 160.
  • the implantable monitor 120 also is capable of communicating to a programmer 130.
  • a clinician or a technician can use the programmer 130 to configure the implantable monitor 120.
  • the communication technology employs a wireless technology 180, such as Bluetooth.
  • Other wireless technologies such as Radio Frequency (RF) or ZigBee, can also be implemented.
  • RF Radio Frequency
  • ZigBee ZigBee
  • an implantable monitor 120 constructs a basic implantable monitor system.
  • the implantable monitor 120 acquires a patient’s physiologic signals, stores and analyzes the signals, transmits the signals. Signal analysis can be performed through the entire system.
  • an implantable monitor 120 only acquires signals and signal analysis is performed at the review station 190.
  • the implantable monitor 120 acquires signals and performs analysis. Analysis can also be divided and be performed in different parts of the system.
  • the system can download the data; the review station 190 can download new configuration settings, analysis algorithms, and other information to the implantable monitor.
  • the distribution of the analysis and other tasks is configurable. Being able to configure the distribution of tasks and of downloading the analysis algorithm and other information enable the system to have future enhancements.
  • the review station 190 does not only receive signals and analyze results, but also fetches stored and/or real time data from the implantable monitor. When a clinical event is reviewed, information before and after the event and the patient’s current status are very important. The review station allows the operator to fetch previous and current data from the implantable monitor; this can be performed in real time or be processed later.
  • the review station 190 can have an option to communicate with an implantable monitor 120 directly.
  • the implantable monitor can have multiple configurations, such as manufacturer’s configuration, which is set and modified by the manufacturer.
  • the implantable monitor 120 is surgically implanted into a human body.
  • a set of the insertion tools 150 by a physician to perform the surgery.
  • the tools are packaged into a sealed box and the package contains a knife, an implantable monitor 120, insertion tool 150, instructions for use, and a barcode that can be scanned by the programmer 130 to identify the implantable monitor 120.
  • FIG 4 illustrates such a package.
  • the barcode can be printed directly on the package or be a label glued on the package.
  • the implantable monitor 120 in a package is pre-programmed to pair with a patient’s handheld device 160 in the same package.
  • the handheld device communicates with the implantable monitor 120 in the same package only and cannot communicate with other implantable monitors, which prevents cross-talk of patient data and ensures patient data integrity.
  • the implantable monitor 120 is an “L” shaped device 200; while in another preferred embodiment, the implantable monitor is a “T” shaped device 300. Other physical shape can be used to design the implantable monitor.
  • FIG 2 illustrates a preferred embodiment of the implantable monitor.
  • “L” shaped device 200 is one preferred embodiment of the implantable monitor 120.
  • the physical components of an implantable monitor are a horizontal bar 240, a vertical bar 280, and three electrodes 220, 260, and 290.
  • the three electrodes 220, 260, 290 are made of a conductive material and can be formed in any shape and can be on flexible wires.
  • one electrode 220 is placed at the outer end of the horizontal bar 240
  • the second electrode 260 is placed at one end of the vertical bar 280
  • the third electrode 290 is placed at the other end of the vertical bar 280.
  • the “L” shape When it is implanted, the “L” shape is placed in an upside-down position and is a mirror image, shown in FIG 2, of a letter “L” to provide a lead configuration that is familiar to physicians.
  • the three electrodes 220, 260, 290 form a triangle shape that is identical to the triangle shape of the standard Einthoven limb lead (three electrocardiogram lead) system I 230, II 233, and III 237 shown in FIG 2.
  • the triangle shape of the standard three ECG lead system I, II, and III is formed by three ECG electrodes RA 210, LA 213, and LL 217.
  • the ECG tracings generated by this embodiment are easier for physicians to review and interpret and for a microprocessor to analyze because they are tracings from the standard ECG leads I, II, and III.
  • the “L” shaped device 200 can be manufactured as one piece or as a horizontal piece 240 and a vertical piece 280 attached together.
  • FIG 2 demonstrates a way that a horizontal piece 240 is attached to vertical piece 280.
  • a vertical bar can be attached to the horizontal bar.
  • FIG 3 illustrates another preferred embodiment of the implantable monitor, a “T” shaped device 300.
  • the physical components are a horizontal bar 340, a vertical bar 380, and three electrodes 320, 360, and 390.
  • the three electrodes 320, 360, 390 are integral part of the device 300. They are made of a conductive material and can be formed in any shape.
  • one electrode 320 is placed at one outer end of the horizontal bar 340
  • the second electrode 360 is placed at the other outer end of the horizontal bar 340
  • the third electrode 390 is placed at the outer end of the vertical bar 380.
  • Those three electrodes 320, 360, 390 form a triangle shape that is similar to the triangle shape of the standard three ECG lead system I 230, II 233, and III 237, shown in FIG 2.
  • the triangle formed by three electrodes 320, 340, and 390 is identical to the triangle shape of the standard three ECG lead system I, II, and III.
  • the “T” shaped device 300 can be manufactured as one piece or as a horizontal piece 340 and a vertical piece 380 attached together.
  • FIG 3 demonstrates a way that a vertical piece 380 is attached to horizontal piece 340.
  • a horizontal bar can be attached to the vertical bar.
  • the “L” shaped and “T” shaped embodiments of the implantable monitors have the following significant advantages over the conventional Implantable Loop Recorders and Insertable Cardiac Monitor:
  • the first advantage is the ECG tracings provided by the disclosed embodiments above can help physicians much more easily and more accurately review and make interpretations of the data and, thus, provide timely and effective treatment to patients. Because the ECG signals are collected by the same triangle as the one in the standard three ECG lead system I, II, and III, physicians will be familiar with those ECG tracings. Physicians can apply the knowledge and experience they have accumulated through many years of education and practice to review and interpret those tracings.
  • the second advantage is that the multi-lead systems of the above embodiments provide more information for physicians to make interpretations and diagnoses. It provides physicians more choices for collecting information. Not all abnormal electrical activities can be seen on all ECG leads. Some abnormal activities may only be seen on certain leads. A single-lead system may capture some abnormal activities late or may even miss some abnormal activities. As such, a multi-lead system is superior to a single-lead system for discovering abnormal electrical activities of heart or arrhythmias.
  • the multi-lead systems in the disclosed invention have the advantage of reducing or eliminating artifacts normally seen on ECG tracings.
  • Artifact is a major issue for ECG interpretation by physicians or analysis by microprocessors. Artifact can distort signals, hide real information, and create false information. As a result, artifact can cause misdiagnoses. In the disclosed embodiments, artifact can be reduced and even eliminated.
  • a lead with a high signal-to-noise ratio can be used as the primary lead for signal analysis by the microprocessor.
  • the multi-lead systems in the disclosed embodiment above make it possible to perform superior artifact identification or artifact cancellation for more accurate analysis results.
  • the disclosed embodiments have the advantage of preventing an implanted monitor from moving or changing positions once implanted. After implantation, a physician typically will check to ensure the ECG signal is suitable for the microprocessor to analyze and for him/her to review and interpret later. A technician will typically print and save an ECG tracing in the patient’s log. If the position of an implanted monitor moves, the ECG signal will be changed. This change will definitely make ECG tracing different from the one saved in the patient’s log and will potentially render the ECG signal useless by physicians. The ECG signal changes created by the position change can lead to wrong diagnoses. Position changes will also make review and interpretation much harder because the previous ECG tracing saved in the patient’s log become useless.
  • Reveal LINQ has more resistance in the horizontal direction but less resistance in the vertical direction.
  • the resistance in the vertical direction is much more needed to overcome the effects of gravity.
  • the disclosed embodiments of “L” and “T” shaped monitors have much more resistance than Reveal LINQ in the vertical direction; therefore, the implantable monitor in the disclosed embodiments is less likely to move than Revel LINQ.
  • the disclosed embodiments are also easier to remove after the goal of the implantable monitor is achieved or when the battery in the implantable monitor runs out. With proper tools provided in the removal package, the horizontal bar of the disclosed embodiments can function as a handle to hold and pull out an implanted monitor.
  • Artifact such as motion artifact, is a real issue in physiologic signal analysis and it can cause misinterpretation of the signals, resulting in misdiagnoses.
  • An implantable monitor in a preferred embodiment contains internal lead wires connected to electrodes, electronic circuits, and at least one battery.
  • Other sensors such as a temperature sensor, accelerometer, blood pressure sensor, pulse oximetry (SpO2) sensor, glucose sensor etc., can also be in the implantable monitor. Since it is not visible after it is implanted, a preferred implantable monitor can have a built-in locator to disclose its physical location in a patient.
  • the built-in location can be an optical device, such as an LED, which can be visible externally on a body when turned on.
  • the locator makes it easy to identify the physical location of an implanted monitor so that if it moves, the patient or clinician can be alerted. It can also accurately identify the location of an implantable monitor to avoid radiation for locating it for removal.
  • FIG 4 is a diagram for the insertion package 400, which contains a sealed box 410 with a knife 420 and an implantable monitor loaded into a syringe like insertion tool 430.
  • the package also contains a patient handheld device 440, which is paired to the implantable monitor in the sealed box and an instruction manual 450.
  • FIG 5 is a diagram of the removal package 500, which contains a sealed package 510 with a surgical knife 520 and a removal tool 530 and an envelop 540 addressed to a processing center for returning the implantable monitors and the patient’s handheld devices.
  • the processing center receives the returned devices, the processing center retires the implantable monitor and patient’s handheld device from service to terminate the device lifecycle and complete the device tracing activities required by regulatory agencies.
  • the processing center also processes hazardous materials.
  • the removal tool 530 is designed so an operator can use it to hold the horizontal bar to pull the implanted monitor out.
  • One embodiment is to make a removal tool an “L” -shaped hook, which can be slide under the horizontal bar, then be turned 90 degrees. This moves the bottom of the “L”-shaped hook under the horizontal bar so the operator can pull the removal tool to bring the implantable monitor out.
  • FIG 6 is a flowchart of a preferred syncope detection algorithm.
  • the algorithm acquires a new signal sample 610. This sample contains a set of newly acquired data. By using position data, the algorithm checks if the patient falls 620. If the answer is “No” 623, the algorithm checks if an arrhythmia is detected 630. If the answer is “No” 633, the algorithm goes back to acquire a new signal sample. If the answer is Yes 637, the algorithm marks an arrhythmia event 650 and saves the event 680. If the answer to the question of “if the patient falls 620” is Yes 627, the algorithm checks if an arrhythmia is detected 640.
  • the algorithm marks “Syncope detected” 660 and saves the event 680. If the answer is “Yes” 647, the algorithm marks an arrhythmia related syncope 670 is detected and saves the event. After an event is saved, the algorithm goes back 690 to acquire a new signal sample.
  • the programmer automatically turns this detection algorithm on if the patient has unexplainable syncope. An operator can turn this detection on or off manually. The programmer is not allowed to automatically turn this detection on after it is turned off by an operator.
  • an operator can use a programmer to turn this detection off when the detection is no longer needed. This can happen when an arrhythmia-related syncope is detected or the purpose of the detection has been achieved. The detection can be turned on again later.
  • the algorithm checks patient falls (syncope) first before detecting an arrhythmia.
  • the algorithm can check for arrhythmias first. The importance is to detect arrhythmia-related syncope. It is not important whether syncope or arrhythmias gets detected first. The detection can also be distributed in the system, meaning one part of the system detects syncope and another part detects arrhythmias.
  • FIG 7 is a drawing of three preferred embodiments for device removal. After an implantable monitor is implanted, it needs to be removed from a patient’s body when one or more of the following conditions occur:
  • FIG 7 shows an embodiment with two connectors 723 and 727 on the horizontal bar 720 with a hole in each of the connector.
  • the two connectors can be opposite of the vertical bar 730, as shown in FIG 7 or can be on the left and right end of the horizontal bar.
  • a removal tool has a long handle 710, two arms 712 and 714, and two hooks 716 and 718. Those two hooks 716 and 718 can hook on to the two connectors 723 and 727 by going through the holes of the connectors.
  • the connectors and the removal tool allow a physican to grab an implantable monitor and apply force to remove it from a patient’s body by pulling it out.
  • the vertical bar 730 is a part of the implantable monitor in this embodiment.
  • the center diagram in FIG 7 shows another embodiment with a tunnel on the horizontal bar 750 and two exit ports 752 and 754.
  • the tunnel is implemented as two holds and those two holds are not connected.
  • a removal tool has a long handle 740 and two arms 745 and 747. The two arms 745 and 747 are attached to the handle 740 at one end and other ends can go into the tunnel through the exits 752 and 754. After the two arms are inserted into the tunnel, a ring 742 or a holding part can slide along the handle 740 to lock two arms 745 and 747 in the position so that a physician can remove the implantable monitor by pulling the handle.
  • the two exits are covered to prevent tissues from growing into them; the cover is broken by a physician during the removal of the implantable monitor.
  • the two exits are two holds at the left and right end 756 and 758 of the horizontal bar 750. The two holds do not necessarily need to be connected as a tunnel.
  • the vertical bar 760 is a part of the implantable monitor in this embodiment.
  • FIG 7 shows another embodiment with one arch 785 on the horizontal bar 780.
  • a removal tool has a long handle 770 with a hook 775, which is hooked to the arch during the removal procedure of the implantable monitor.
  • the vertical bar 790 is a part of the implantable monitor in this embodiment.
  • FIG 8 shows a preferred system embodiment of an implantable monitor where at least one device with display, such as the patient’s handheld device, programmer, review station, and physician’s handheld device have the capability to configure the implantable monitor.
  • the implantable monitor has at least two levels of the following configurations:
  • a factory configuration 810 is the configuration set at the factory or set by a technician authorized by the factory. This configuration is in the implantable monitor 120 and controls how the implantable monitor functions.
  • One example is the low battery alarm. When the battery power of the implantable monitor is lower than a preconfigured level, the implantable monitor set off a battery low alarm.
  • Patient configuration 820 is the configuration set by the patient 100.
  • An example is that a patient may want the system to notify him/her to log an activity at certain time of the day; to do so, the patient can configure a reminder in patient’s handheld device.
  • An institutional configuration 830 is the configuration set by an institute.
  • An institute can determine and set a standard configuration for the institute.
  • a simple example is that an institute can set the institute name, address, and phone number for the report.
  • This configuration can be set by a technician 135 using the programmer 130 with configuration instructions provided by the institute.
  • Physician configuration 840 is the configuration set by an individual physician. An example is that a physician can set the system to detect atrial fibrillation only if he/she only is only interested in managing atrial fibrillation. This configuration is set by a technician 135 using the programmer under the direction of the physician.
  • Clinician configuration 850 is the configuration set by a clinician 193. This configuration can be set at a review station 190. If the configuration is in the implantable monitor or patient handheld device, the system will transmit the configuration to the implantable monitor and patient’s handheld device to ensure the implantable monitor and the patient handheld device implement the new configuration. For example, when a clinician notices artifacts, he/she can change an artifact rejection configuration to apply more and enhanced artifact filters.
  • Caregiver configuration 860 can also be set by a caregiver 198 using a caregiver’s handheld device 195. What can be configured by configuration 850 and by configuration 860 can be the same in one embodiment and can be different in another embodiment.
  • the configurable settings can be grouped, which reduces the time to set up an implantable.
  • some configurable settings are grouped by the indication for use.
  • the settings in each group are also configurable to provide caregivers or institutions more flexibility.
  • Connectivity is a major issue for some current implantable monitors. The issue can reduce the utility of the monitor and may even weaken the purpose of using implantable monitors.
  • a novel solution is to use wearable devices as transceiver. To enhance the capability of connection, multiple wearable devices can be used. The connectivity is enhanced due to repetitiveness. FIG 9 shows some of those devices. When using multiple connection devices, it is important to have only one device transmit received information from an implantable to the storage device to reduce the burden on the storage device, communication cost, and power consumption of the connection devices for longevity. Therefore, when multiple wearable devices are present, it is required to have a strategy to select one device to serve as the transceiver for connection.
  • Two preferred approaches or embodiments can be implemented. One is to select a transceiver that is the most likely one to be carried or worn by the patient; the other one is to select a device that consumes less battery power so it can last longer. For example, a necklace can be selected because it is likely to be the one that is the closest to the implantable monitor.
  • a modern communication technology such as Bluetooth 4.0, the power consumption of both the implantable monitor and the transceiver can be significantly reduced.
  • a necklace is selected as transceiver.
  • the implantable monitor can detect the loss of connectivity and increases power to search for another transceiver. If the patient also wears a wristband as a backup, the wristband can detect the search signal and activate the wristband’s receiving and transmission functions. The communication between the implantable and the storage device is reestablished.
  • Devices for connectivity in FIG 9 are a cell phone 910, a watch 920, a wristband 930, a pair of glasses 940, a necklace 950, and a belt 960.
  • Other wearable devices such as a keychain, a hat etc. can also be used.
  • an alarm or warning function can be implemented to ensure the connectivity.
  • the wearable device sounds an alarm when it losses connection with the implantable monitor to alert the patient that he/she is leaving the connection device.
  • the alarm function can be implemented as a standalone device to attach to a keychain or put in a purse of wallet.
  • this standalone alarm device detects a loss of connection between the implantable monitor and a transceiver, it sounds an alarm to inform the patient of the connection loss.
  • a transceiver can have two types of charging mechanisms.
  • the two changing methods are wireless charging and USB port charging. Again, two methods are employed to ensure a transceiver is charged to prevent connectivity loss. Other charge methods, such as solar and motion can also be used.
  • the two charging methods are wireless charge and solar charge. Wireless charge can be used at night using a charger at bedside and solar charge can be used during the day.
  • FIG 10 is a signal probe.
  • the signal probe is an ECG patch where the electrode’s position on the patch is identical to the ones on the implantable monitor. A caregiver can put this probe on a patient to find out where is the best place to surgically insert an implantable monitor.
  • the signal is a handheld device.
  • RA 1010 is the right arm electrode
  • LA 1030 is the left arm electrode
  • LL 1060 is the left leg electrode.
  • Those three electrodes are the ones in an implantable monitor and they forms ECG lead I 1020, II 1040, and III 1050.
  • the electrode and lead configuration 1065 represents those of an implantable monitor.
  • RA 1060, LA 1070, and LL 1080 on a patch 1090 have identical electrode positions and configuration as those 1060 in an implantable monitor.
  • the side view of the patch 1095 is shown at the bottom right-hand side of FIG 10.
  • the patch or the handheld signal probe can be applied to a patient to transmit the ECG signals to the programmer so that a caregiver can check the ECG signals before the surgery to ensure the signal quality and signal-to-noise ratio.
  • the patch and the handheld signal probe are used to guide the selection of the position where an implantable monitor is surgically inserted.
  • FIG 11 shows an implantable monitor with at least five types of events: such as 1) patient-initiated events; 2) automatically generated events by the implantable monitor; and 3) automatically generated events by the storage device, including the cloud through cloud computing; and 4) automatically generated events by changing configuration settings, and 5) caregiver marked events.
  • events such as 1) patient-initiated events; 2) automatically generated events by the implantable monitor; and 3) automatically generated events by the storage device, including the cloud through cloud computing; and 4) automatically generated events by changing configuration settings, and 5) caregiver marked events.
  • Patient-initiated events are generated by patients pressing an event button on his or her handheld device.
  • the patient can initiate an event when he/she does not feel comfortable, feels a condition, or wants to record an activity.
  • Either the hardware or the software of an implantable monitor can trigger and record an automatic event, which can be an alert, an alarm, a device malfunction, or a condition detected by the analysis algorithm in the device.
  • Cloud storage can have computing capability, which may include analysis algorithm for a physiological signal.
  • the analysis algorithm generates an automatic event when the algorithm detects an abnormal condition.
  • An analysis algorithm in the cloud can perform analysis on a specific patient with the patient’s configuration settings.
  • a caregiver-marked event is generated by the caregiver.
  • a caregiver can discover a condition, which he/she wants to record. The caregiver can also change or detect an event.
  • At least three types of events will be presented to caregivers to review. Those types of events are patient-activated events, automatically-detected events by an implantable monitor, and post-analysis generated events.
  • a patient-activated event or a patient-marked event is recorded when the patient informs the implantable monitor system of the event using his/her handheld.
  • An-automatically detected event is generated by the analysis software in the implantable monitor system.
  • a post-analysis event is generated by analysis by the storage device, such as cloud computing or analysis performed in the review station.
  • An implantable monitor can also be customized to have specific purpose, such as to monitor a particular disease, to monitor the effectiveness of a therapy, e.g., drug or ablation, to monitor overall well-being or physical condition, to locate a patient’s position, or to check patient compliance.
  • a therapy e.g., drug or ablation
  • an implantable monitor is implanted into a patient’s body long-term, i.e., from months to years, the surface of the monitor needs to be easy to remove after duration of use.
  • Special material, special coding, nano-technologies, and/or absorbable materials can be employed to achieve the goal of easy removal.
  • Special material, special coding, and nano-technologies for surface processing are to ensure separation of the human tissues and an implantable.
  • Special solution can also be used to separate an implantable monitor and tissues to help a removal.
  • an implantable monitor acquires signals to monitor one or more physiological conditions of a patient; the review stations are organized such that machines automatically analyze the signals and present the results to a caregiver when necessary.
  • a caregiver provides instructions to the patient to help correct the condition.
  • the caregiver sends someone to the patient to correct the condition.
  • Another business model is that patients with an implantable monitor can send the recorded information to a storage device, which can be reviewed by a clinician who then ranks the recorded information by severity or risk to the patient.
  • a service organization can use the information to form a team to provide consultation and life-saving rescue effort when necessary.
  • healthcare resources can be used more efficiently and effectively.

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Abstract

An implantable monitor system and method for recording and/or analyzing physiological signals and related information. It is user-centric, easier to use, and contains more information. It is innovative for the following reasons: first, it is small and is designed for physicians to easily perform implantation and removal of the device; secondly, it uses cloud technology, which allows universal access to the information by physicians, patients, and other authorized individuals; thirdly, it tracks and records long-term data; the fourth innovative aspect is the intelligent part of the monitor, including analysis algorithm, smart power management, efficient information transmission, etc.; fifthly, it has the capacity to request and receive specific (time, type, etc.) information from the monitor; finally, it enables immediate access to health care by a patient. It is easy to use, despite being a complex implantable device. The device has an interface that is user-friendly for both clinicians and patients, a better method of implantation and removal, a tool to identify where to insert an implantable, a design to reduce or eliminate artifact, a programming device, a storage device, and a data review station.

Description

无标题 FIELD OF THE INVENTION
The present invention relates generally to medical instrumentation systems and methods, which is suitable for long-term monitoring and diagnoses. It may also provide information regarding the effectiveness of a therapy to a patient. The invention also has wireless communication capabilities and a remote data transmission function. The system and method include an implantable monitor, which records, detects, stores, and transmits physiological signals； a programming station, which can be used by a physician to set up and program the implantable monitor； a handheld controller, which communicates with the implantable monitor； an optional receiver, which receives the recorded physiological signals and transmit the signals to a storage device that can save the physiological signals. The storage device can be local, remote, or cloud-based. The physiological signal can be analyzed by the implantable monitor and/or by any other part of the system； the analysis can also be divided and be performed by different parts of the system. Big data analysis can also be preformed on the collected signal.
BACKGROUND OF THE INVENTION
Since 1970’s , implantable loop recorders and insertable cardiac monitors were created to record and monitor patients’ physiological signals. U.S. patents 4,172,459 and 4,281,664 disclosed such devices. The purpose of such devices is to record patients’ conditions for physicians to review and to help physicians make diagnoses so that they can better take care of their patients. Despite major advances in medical instrumentation technologies, minimally invasive techniques, diagnostic methods and equipment, wireless capabilities, and patient care means over the past decades, major disadvantages still exist for identifying and treating major cardiac diseases. Diagnostic methods are still limited to non-invasive monitoring and in-vitro diagnoses. U.S. patent 6,699,200 disclosed another implantable medical device with multiple sensing electrodes. The sensing electrodes are complicated and are not conventional electrode, or lead, configurations. For implantable devices, leads have been major safety issues, resulting in many recalls. Removal of leads is very difficult and can cause injuries. That may be the reason that US patent 6,699,200 has not been implemented. US patent 5,404,877 disclosed a lead-less implantable using a different frequency to measure impedance changes to derive arrhythmias. This is a non-traditional sensing technique for detecting arrhythmias. A product for that disclosure has not been seen on the market either. Those systems and methods are inefficient and cumbersome to use, hard to be implemented as a product, and cannot provide sufficient information for physicians to make definitive decisions. More importantly, they do not provide timely and real-time information.
The FDA recently cleared device Reveal LINQ, made by Medtronic, which has made significant advances to overcome the above-mentioned issues. Reveal LINQ is an insertable cardiac monitor, which is surgically implanted in a patient’s chest area under the skin and records  electrocardiogram (ECG) . The recorded ECG signal can be transmitted wirelessly to a signal repeater, which than can re-transmit the signal to a clinical facility for a physician to review.
One drawback of Reveal LINQ is that it records only one channel of ECG signal and this channel is not a part of any standard ECG systems. Certain cardiac arrhythmias may not be easily detected by one channel. Physicians are trained to read ECG tracings from standard ECG systems. ECG databases for testing ECG analysis algorithm are also recorded with standard ECG systems. Using only one non-standard ECG channel may lead to wrong interpretation, which can result in providing the wrong therapy to a patient. Another drawback is Reveal LINQ records only ECG signals. It does not record other physiological signals, such as blood pressure and glucose signals. This drawback limits the applications of LINQ.
Reveal LINQ is also limited by its physical characteristics. The size and the shape of Reveal LINQ is not the best for being surgically implanted into human body and may not be the best for recording ECG signals. The material and the shape of Reveal LINQ make it very hard to be removed after it is implanted.
More importantly, the clinical utility of LINQ can be seriously affected due to its connectivity issues. A recent report on LINQ ICM (Implantable Cardiac Monitor) by Dr. Mittal, et al. concluded that “daily connectivity could be established in only 30％of patients. In a significant number of patients, there was either extended loss of connectivity or no connectivity at all. Use of the LinQ in clinical practice will be negatively impacted unless reliable connectivity is ensured. ”
Artifact and other unusable signal are also issues for LINQ. The current practice is that a physician surgically implants a LINQ Implantable Cardiac Monitor into a patient’s chest subcutaneously. Then, the implanted monitor is activated and its recorded electrocardiogram is transmitted to a display device for a technician or a physician to verify the signal quality. By this time, even the signal quality is not good and the signal-to-noise ratio is very poor； it may be too late to do anything unless a removal and re-implantation are performed. With only one channel of electrocardiogram, this product can have serious artifact or noise problems.
With a total of over 50 programmable parameters, Reveal LINQ is not easy to use and increases the risk of human error. Many studies conclude that human error is most common error in health care. Reduction of programmable parameters can not only lead to reduction of human errors so that much more accurate results and better health care can be provided, but also lead to better user experience.
OBJECTIVES AND SUMMARY OF THE INVENTION
The present invention responds to the needs of recording more than one channel of ECG.
It is accordingly an objective of the present invention to provide an improved system and method for multi-signal monitoring.
A further objective of the present invention is to provide a better shape such that the surgically procedure be much more easily performed.
A further object of the present invention is to use better material, better device design, and modern surface processing technologies to make the device easy to be removed after it is implanted.
A further objective to provide real-time programmable capability by employing mobile communication and/or internet technology.
A further objective is to significantly reduce the number of programmable parameters to improve user experience and provide more accurate and timely information.
A further objective is to ensure patient connectivity through system design with better user interface and multiple transmission devices.
A further objective is to ensure the signal quality before an implantable monitor is surgically implanted in a patient.
A further objective is to use artifact reduction and elimination technologies to enhance signal quality.
A final objective is to create new business models using the implantable monitor.
These and other objectives of the invention are realized by providing a novel implantable monitor.
This invention offers a considerable improvement over current systems and methods； it employs a new philosophy of designing the system and method for users so that cardiac arrhythmias and other conditions can be accurately and timely detected.
In comparison with known methods, the present invention proposes for the first time the concepts of using better material, better design, multi-channel and multi-signal mobile and internet technologies, reduced programmable parameters, and better user experience； the present invention is also the first to realize these concepts in a novel implantable system and method.
Other objectives will be demonstrated with the description of this novel invention.
BRIEF DESCRIPTION OF THE DRAWINGS
The above and other objectives and advantages of the present invention will be more fully understood with reference to the following detailed descriptions, taken in conjunction with the accompanying drawings, in which:
FIG. 1 is a diagram of a preferred and complete system embodiment.
FIG. 2 is a diagram of a preferred implantable monitor, which is surgically inserted into a human body.
FIG. 3 is a diagram of another preferred implantable monitor, which is surgically inserted into a human body.
FIG. 4 is a diagram of an insertion package.
FIG. 5 is a diagram of removable package.
FIG. 6 is a flowchart of an algorithm to detect arrhythmia and syncope.
FIG. 7 is a drawing of preferred embodiments for device removal
FIG. 8 is a preferred system configuration.
FIG. 9 is a diagram with some connectivity devices.
FIG. 10 is a diagram of signal probe for finding a position for better signal.
FIG. 11 is a list of types of events, which can be generated by an implantable monitor system.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
FIG 1 is a preferred system embodiment that consists of an implantable monitor 120, a handheld device 160, a transmission station 112, a programmer 130, a technician 135, a insertion package 150, a removal tool package 155, an information storage device 110, a review station 190, a handheld review device 195, a caregiver 193 who uses the review station 190 to review the patient data, and a caregiver 198 who uses a handheld device to review the patient data.
A patient can use the handheld device 160 to mark an event. A technician 135 can use the programmer.  Caregivers  193 and 198 can use the review station 190 and the handheld review device 195 to check patient information.
The information storage device 110 receives data sent by implantable monitors via either a patient’s handheld device or transmission station 112. The information storage device 110 can be implemented as a single device, a group of devices in one location, or a group of distributed devices in different physical locations. The data stored in the information storage device 110 can be retrieved by authorized individuals. The information storage device 110 has computation capacity to receive, analyze, store, and share data from and to authorized people. The storage device 110 has privacy protection capabilities, such as password protection or data encryption. An implantable monitor 120, patient’s handheld device 160, a transmission station 112, and a programmer 130 have their own unique device identification code, which is used to identify themselves when sending and retrieving data in the implantable monitor system. The use of a unique device identification code ensures data integrity across the entire implantable monitor system and eliminates potential data-cross, which can result in misdiagnosis of a patient’s condition.
The implantable monitor 120 collects physiological signals, stores and examines the collected signals, and transmits the signals and examination results to a patient’s handheld device 160. The implantable monitor 120 also is capable of communicating to a programmer 130. A clinician or a technician can use the programmer 130 to configure the implantable monitor 120. In a preferred implementation, the communication technology employs a wireless technology 180, such as Bluetooth. Other wireless technologies, such as Radio Frequency (RF) or ZigBee, can also be implemented. The implantable monitor 120 communicates with the patient’s handheld device 160 and the programmer 130 wirelessly 180 and 185.
In a preferred embodiment, an implantable monitor 120, patient’s handheld device 160, a transmission station 112, programmer 130, storage device 110, review station 190, and handheld  review device 195 construct a basic implantable monitor system. The implantable monitor 120 acquires a patient’s physiologic signals, stores and analyzes the signals, transmits the signals. Signal analysis can be performed through the entire system. In one embodiment, an implantable monitor 120 only acquires signals and signal analysis is performed at the review station 190. In the same embodiment, the implantable monitor 120 acquires signals and performs analysis. Analysis can also be divided and be performed in different parts of the system.
The system can download the data； the review station 190 can download new configuration settings, analysis algorithms, and other information to the implantable monitor. The distribution of the analysis and other tasks is configurable. Being able to configure the distribution of tasks and of downloading the analysis algorithm and other information enable the system to have future enhancements.
All communications are bidirectional. The review station 190 does not only receive signals and analyze results, but also fetches stored and/or real time data from the implantable monitor. When a clinical event is reviewed, information before and after the event and the patient’s current status are very important. The review station allows the operator to fetch previous and current data from the implantable monitor； this can be performed in real time or be processed later.
Although it is not shown in FIG 1, the review station 190 can have an option to communicate with an implantable monitor 120 directly.
The implantable monitor can have multiple configurations, such as manufacturer’s configuration, which is set and modified by the manufacturer.
The implantable monitor 120 is surgically implanted into a human body. A set of the insertion tools 150 by a physician to perform the surgery. In a preferred embodiment, the tools are packaged into a sealed box and the package contains a knife, an implantable monitor 120, insertion tool 150, instructions for use, and a barcode that can be scanned by the programmer 130 to identify the implantable monitor 120. FIG 4 illustrates such a package. The barcode can be printed directly on the package or be a label glued on the package. The implantable monitor 120 in a package is pre-programmed to pair with a patient’s handheld device 160 in the same package. The handheld device communicates with the implantable monitor 120 in the same package only and cannot communicate with other implantable monitors, which prevents cross-talk of patient data and ensures patient data integrity.
In one preferred embodiment, the implantable monitor 120 is an “L” shaped device 200； while in another preferred embodiment, the implantable monitor is a “T” shaped device 300. Other physical shape can be used to design the implantable monitor.
FIG 2 illustrates a preferred embodiment of the implantable monitor. In FIG 2, “L” shaped device 200 is one preferred embodiment of the implantable monitor 120. The physical components of an implantable monitor are a horizontal bar 240, a vertical bar 280, and three  electrodes  220, 260, and 290. The three  electrodes  220, 260, 290 are made of a conductive material and can be formed in any shape and can be on flexible wires. In a preferred embodiment, one electrode 220 is placed at the outer end of the horizontal bar 240, the second electrode 260 is placed at one end of the vertical bar 280, and the third electrode 290 is placed at the other end of the vertical bar 280. When it is implanted, the “L” shape is placed in an upside-down position and is a  mirror image, shown in FIG 2, of a letter “L” to provide a lead configuration that is familiar to physicians. In this implantation, the three  electrodes  220, 260, 290 form a triangle shape that is identical to the triangle shape of the standard Einthoven limb lead (three electrocardiogram lead) system I 230, II 233, and III 237 shown in FIG 2. The triangle shape of the standard three ECG lead system I, II, and III is formed by three ECG electrodes RA 210, LA 213, and LL 217. The ECG tracings generated by this embodiment are easier for physicians to review and interpret and for a microprocessor to analyze because they are tracings from the standard ECG leads I, II, and III.
The “L” shaped device 200 can be manufactured as one piece or as a horizontal piece 240 and a vertical piece 280 attached together. FIG 2 demonstrates a way that a horizontal piece 240 is attached to vertical piece 280. In another embodiment, a vertical bar can be attached to the horizontal bar.
FIG 3 illustrates another preferred embodiment of the implantable monitor, a “T” shaped device 300. The physical components are a horizontal bar 340, a vertical bar 380, and three  electrodes  320, 360, and 390. The three  electrodes  320, 360, 390 are integral part of the device 300. They are made of a conductive material and can be formed in any shape. In this preferred embodiment, one electrode 320 is placed at one outer end of the horizontal bar 340, the second electrode 360 is placed at the other outer end of the horizontal bar 340, and the third electrode 390 is placed at the outer end of the vertical bar 380. Those three  electrodes  320, 360, 390 form a triangle shape that is similar to the triangle shape of the standard three ECG lead system I 230, II 233, and III 237, shown in FIG 2. When the second electrode 360 is placed in the middle of the horizontal bar 340, the triangle formed by three  electrodes  320, 340, and 390 is identical to the triangle shape of the standard three ECG lead system I, II, and III.
The “T” shaped device 300 can be manufactured as one piece or as a horizontal piece 340 and a vertical piece 380 attached together. FIG 3 demonstrates a way that a vertical piece 380 is attached to horizontal piece 340. In another embodiment, a horizontal bar can be attached to the vertical bar.
The “L” shaped and “T” shaped embodiments of the implantable monitors have the following significant advantages over the conventional Implantable Loop Recorders and Insertable Cardiac Monitor:
1. The first advantage is the ECG tracings provided by the disclosed embodiments above can help physicians much more easily and more accurately review and make interpretations of the data and, thus, provide timely and effective treatment to patients. Because the ECG signals are collected by the same triangle as the one in the standard three ECG lead system I, II, and III, physicians will be familiar with those ECG tracings. Physicians can apply the knowledge and experience they have accumulated through many years of education and practice to review and interpret those tracings.
2. The second advantage is that the multi-lead systems of the above embodiments provide more information for physicians to make interpretations and diagnoses. It provides physicians more choices for collecting information. Not all abnormal electrical activities can be seen on all ECG leads. Some abnormal activities may only be seen on certain leads. A single-lead system may capture some abnormal activities late or may even miss some abnormal activities. As such, a multi-lead system is superior to a single-lead system for discovering abnormal  electrical activities of heart or arrhythmias.
3. The multi-lead systems in the disclosed invention have the advantage of reducing or eliminating artifacts normally seen on ECG tracings. Artifact is a major issue for ECG interpretation by physicians or analysis by microprocessors. Artifact can distort signals, hide real information, and create false information. As a result, artifact can cause misdiagnoses. In the disclosed embodiments, artifact can be reduced and even eliminated. Depending on the physician’s selection, a lead with a high signal-to-noise ratio can be used as the primary lead for signal analysis by the microprocessor. The multi-lead systems in the disclosed embodiment above make it possible to perform superior artifact identification or artifact cancellation for more accurate analysis results.
4. The disclosed embodiments have the advantage of preventing an implanted monitor from moving or changing positions once implanted. After implantation, a physician typically will check to ensure the ECG signal is suitable for the microprocessor to analyze and for him/her to review and interpret later. A technician will typically print and save an ECG tracing in the patient’s log. If the position of an implanted monitor moves, the ECG signal will be changed. This change will definitely make ECG tracing different from the one saved in the patient’s log and will potentially render the ECG signal useless by physicians. The ECG signal changes created by the position change can lead to wrong diagnoses. Position changes will also make review and interpretation much harder because the previous ECG tracing saved in the patient’s log become useless. In the insertion position recommended by the manufacturer, Reveal LINQ has more resistance in the horizontal direction but less resistance in the vertical direction. To prevent an implanted device from moving, the resistance in the vertical direction is much more needed to overcome the effects of gravity. The disclosed embodiments of “L” and “T” shaped monitors have much more resistance than Reveal LINQ in the vertical direction； therefore, the implantable monitor in the disclosed embodiments is less likely to move than Revel LINQ.
5. The disclosed embodiments are also easier to remove after the goal of the implantable monitor is achieved or when the battery in the implantable monitor runs out. With proper tools provided in the removal package, the horizontal bar of the disclosed embodiments can function as a handle to hold and pull out an implanted monitor.
6. The disclosed embodiments and multi-lead system provide better artifact reduction and elimination. Artifact, such as motion artifact, is a real issue in physiologic signal analysis and it can cause misinterpretation of the signals, resulting in misdiagnoses.
An implantable monitor in a preferred embodiment contains internal lead wires connected to electrodes, electronic circuits, and at least one battery. Other sensors, such as a temperature sensor, accelerometer, blood pressure sensor, pulse oximetry (SpO2) sensor, glucose sensor etc., can also be in the implantable monitor. Since it is not visible after it is implanted, a preferred implantable monitor can have a built-in locator to disclose its physical location in a patient. The built-in location can be an optical device, such as an LED, which can be visible externally on a body when turned on. The locator makes it easy to identify the physical location of an implanted monitor so that if it moves, the patient or clinician can be alerted. It can also accurately identify the location of an implantable monitor to avoid radiation for locating it for removal.
FIG 4 is a diagram for the insertion package 400, which contains a sealed box 410 with a knife 420 and an implantable monitor loaded into a syringe like insertion tool 430. The package also  contains a patient handheld device 440, which is paired to the implantable monitor in the sealed box and an instruction manual 450.
FIG 5 is a diagram of the removal package 500, which contains a sealed package 510 with a surgical knife 520 and a removal tool 530 and an envelop 540 addressed to a processing center for returning the implantable monitors and the patient’s handheld devices. When the processing center receives the returned devices, the processing center retires the implantable monitor and patient’s handheld device from service to terminate the device lifecycle and complete the device tracing activities required by regulatory agencies. The processing center also processes hazardous materials.
The removal tool 530 is designed so an operator can use it to hold the horizontal bar to pull the implanted monitor out. One embodiment is to make a removal tool an “L” -shaped hook, which can be slide under the horizontal bar, then be turned 90 degrees. This moves the bottom of the “L”-shaped hook under the horizontal bar so the operator can pull the removal tool to bring the implantable monitor out.
Returning the devices to the manufacturer has the following advantages:
1. Ensures the proper disposal of hazardous materials, such as batteries in the implantable monitor and in patient’s handheld device.
2. Relieves the burden of processing medical waste from physicians.
3. Properly terminates the lifecycle of the implantable monitor and completes tracing requirements by regulatory agencies.
FIG 6 is a flowchart of a preferred syncope detection algorithm. After initialization 600, the algorithm acquires a new signal sample 610. This sample contains a set of newly acquired data. By using position data, the algorithm checks if the patient falls 620. If the answer is “No” 623, the algorithm checks if an arrhythmia is detected 630. If the answer is “No” 633, the algorithm goes back to acquire a new signal sample. If the answer is Yes 637, the algorithm marks an arrhythmia event 650 and saves the event 680. If the answer to the question of “if the patient falls 620” is Yes 627, the algorithm checks if an arrhythmia is detected 640. If the answer is “No” , 643 the algorithm marks “Syncope detected” 660 and saves the event 680. If the answer is “Yes” 647, the algorithm marks an arrhythmia related syncope 670 is detected and saves the event. After an event is saved, the algorithm goes back 690 to acquire a new signal sample. The programmer automatically turns this detection algorithm on if the patient has unexplainable syncope. An operator can turn this detection on or off manually. The programmer is not allowed to automatically turn this detection on after it is turned off by an operator.
During an office visit, an operator can use a programmer to turn this detection off when the detection is no longer needed. This can happen when an arrhythmia-related syncope is detected or the purpose of the detection has been achieved. The detection can be turned on again later.
In this preferred embodiment, the algorithm checks patient falls (syncope) first before detecting an arrhythmia. In another embodiment, the algorithm can check for arrhythmias first. The importance is to detect arrhythmia-related syncope. It is not important whether syncope or arrhythmias gets detected first. The detection can also be distributed in the system, meaning one part of the system detects syncope and another part detects arrhythmias.
FIG 7 is a drawing of three preferred embodiments for device removal. After an implantable monitor is implanted, it needs to be removed from a patient’s body when one or more of the following conditions occur:
1. The goal of the implantation is achieved；
2. The battery in the monitor runs out；
3. On a physician’s order；
4. On patient’s demand.
The left part of FIG 7 shows an embodiment with two  connectors  723 and 727 on the horizontal bar 720 with a hole in each of the connector. The two connectors can be opposite of the vertical bar 730, as shown in FIG 7 or can be on the left and right end of the horizontal bar. A removal tool has a long handle 710, two  arms  712 and 714, and two  hooks  716 and 718. Those two  hooks  716 and 718 can hook on to the two  connectors  723 and 727 by going through the holes of the connectors. The connectors and the removal tool allow a physican to grab an implantable monitor and apply force to remove it from a patient’s body by pulling it out. The vertical bar 730 is a part of the implantable monitor in this embodiment.
The center diagram in FIG 7 shows another embodiment with a tunnel on the horizontal bar 750 and two exit ports 752 and 754. In one embodiment, the tunnel is implemented as two holds and those two holds are not connected. A removal tool has a long handle 740 and two  arms  745 and 747. The two  arms  745 and 747 are attached to the handle 740 at one end and other ends can go into the tunnel through the exits 752 and 754. After the two arms are inserted into the tunnel, a ring 742 or a holding part can slide along the handle 740 to lock two  arms  745 and 747 in the position so that a physician can remove the implantable monitor by pulling the handle. The two exits are covered to prevent tissues from growing into them； the cover is broken by a physician during the removal of the implantable monitor. In another embodiment, the two exits are two holds at the left and right end 756 and 758 of the horizontal bar 750. The two holds do not necessarily need to be connected as a tunnel. The vertical bar 760 is a part of the implantable monitor in this embodiment.
The right part of FIG 7 shows another embodiment with one arch 785 on the horizontal bar 780. A removal tool has a long handle 770 with a hook 775, which is hooked to the arch during the removal procedure of the implantable monitor. The vertical bar 790 is a part of the implantable monitor in this embodiment.
FIG 8 shows a preferred system embodiment of an implantable monitor where at least one device with display, such as the patient’s handheld device, programmer, review station, and physician’s handheld device have the capability to configure the implantable monitor. The implantable monitor has at least two levels of the following configurations:
1. Factory configuration；
2. Institutional configuration；
3. Physician configuration；
4. Patient configuration； and
5. Caregiver configuration.
A factory configuration 810 is the configuration set at the factory or set by a technician authorized by the factory. This configuration is in the implantable monitor 120 and controls how the  implantable monitor functions. One example is the low battery alarm. When the battery power of the implantable monitor is lower than a preconfigured level, the implantable monitor set off a battery low alarm.
Patient configuration 820 is the configuration set by the patient 100. An example is that a patient may want the system to notify him/her to log an activity at certain time of the day； to do so, the patient can configure a reminder in patient’s handheld device.
An institutional configuration 830 is the configuration set by an institute. An institute can determine and set a standard configuration for the institute. A simple example is that an institute can set the institute name, address, and phone number for the report. This configuration can be set by a technician 135 using the programmer 130 with configuration instructions provided by the institute.
Physician configuration 840 is the configuration set by an individual physician. An example is that a physician can set the system to detect atrial fibrillation only if he/she only is only interested in managing atrial fibrillation. This configuration is set by a technician 135 using the programmer under the direction of the physician.
Clinician configuration 850 is the configuration set by a clinician 193. This configuration can be set at a review station 190. If the configuration is in the implantable monitor or patient handheld device, the system will transmit the configuration to the implantable monitor and patient’s handheld device to ensure the implantable monitor and the patient handheld device implement the new configuration. For example, when a clinician notices artifacts, he/she can change an artifact rejection configuration to apply more and enhanced artifact filters.
Caregiver configuration 860 can also be set by a caregiver 198 using a caregiver’s handheld device 195. What can be configured by configuration 850 and by configuration 860 can be the same in one embodiment and can be different in another embodiment.
To simplify the configuration, the configurable settings can be grouped, which reduces the time to set up an implantable. In one embodiment, some configurable settings are grouped by the indication for use. The settings in each group are also configurable to provide caregivers or institutions more flexibility.
Connectivity is a major issue for some current implantable monitors. The issue can reduce the utility of the monitor and may even weaken the purpose of using implantable monitors. A novel solution is to use wearable devices as transceiver. To enhance the capability of connection, multiple wearable devices can be used. The connectivity is enhanced due to repetitiveness. FIG 9 shows some of those devices. When using multiple connection devices, it is important to have only one device transmit received information from an implantable to the storage device to reduce the burden on the storage device, communication cost, and power consumption of the connection devices for longevity. Therefore, when multiple wearable devices are present, it is required to have a strategy to select one device to serve as the transceiver for connection.
Two preferred approaches or embodiments can be implemented. One is to select a transceiver that is the most likely one to be carried or worn by the patient； the other one is to select a device that consumes less battery power so it can last longer. For example, a necklace can be selected because it is likely to be the one that is the closest to the implantable monitor. By using a modern  communication technology, such as Bluetooth 4.0, the power consumption of both the implantable monitor and the transceiver can be significantly reduced.
If for some reasons, the connectivity of one transceiver is lost, another transceiver can be automatically activated. In one preferred embodiment, a necklace is selected as transceiver. When the necklace runs out of battery, the implantable monitor can detect the loss of connectivity and increases power to search for another transceiver. If the patient also wears a wristband as a backup, the wristband can detect the search signal and activate the wristband’s receiving and transmission functions. The communication between the implantable and the storage device is reestablished.
Devices for connectivity in FIG 9 are a cell phone 910, a watch 920, a wristband 930, a pair of glasses 940, a necklace 950, and a belt 960. Other wearable devices, such as a keychain, a hat etc. can also be used.
An alarm or warning function can be implemented to ensure the connectivity. In one preferred embodiment, the wearable device sounds an alarm when it losses connection with the implantable monitor to alert the patient that he/she is leaving the connection device.
The alarm function can be implemented as a standalone device to attach to a keychain or put in a purse of wallet. When this standalone alarm device detects a loss of connection between the implantable monitor and a transceiver, it sounds an alarm to inform the patient of the connection loss.
Since its size is not as critical as that of an implantable, a transceiver can have two types of charging mechanisms. In one embodiment, the two changing methods are wireless charging and USB port charging. Again, two methods are employed to ensure a transceiver is charged to prevent connectivity loss. Other charge methods, such as solar and motion can also be used. In a preferred embodiment, the two charging methods are wireless charge and solar charge. Wireless charge can be used at night using a charger at bedside and solar charge can be used during the day.
FIG 10 is a signal probe. In one preferred embodiment, the signal probe is an ECG patch where the electrode’s position on the patch is identical to the ones on the implantable monitor. A caregiver can put this probe on a patient to find out where is the best place to surgically insert an implantable monitor. In another embodiment, the signal is a handheld device.
In FIG 10, RA 1010 is the right arm electrode, LA 1030 is the left arm electrode, and LL 1060 is the left leg electrode. Those three electrodes are the ones in an implantable monitor and they forms ECG lead I 1020, II 1040, and III 1050. The electrode and lead configuration 1065 represents those of an implantable monitor. On the top right hand side of FIG 10, RA 1060, LA 1070, and LL 1080 on a patch 1090 have identical electrode positions and configuration as those 1060 in an implantable monitor. The side view of the patch 1095 is shown at the bottom right-hand side of FIG 10.
The patch or the handheld signal probe can be applied to a patient to transmit the ECG signals to the programmer so that a caregiver can check the ECG signals before the surgery to ensure the signal quality and signal-to-noise ratio. The patch and the handheld signal probe are used to guide the selection of the position where an implantable monitor is surgically inserted.
FIG 11 shows an implantable monitor with at least five types of events: such as 1) patient-initiated events； 2) automatically generated events by the implantable monitor； and 3) automatically generated events by the storage device, including the cloud through cloud computing； and 4) automatically generated events by changing configuration settings, and 5) caregiver marked events.
Patient-initiated events are generated by patients pressing an event button on his or her handheld device. The patient can initiate an event when he/she does not feel comfortable, feels a condition, or wants to record an activity.
Either the hardware or the software of an implantable monitor can trigger and record an automatic event, which can be an alert, an alarm, a device malfunction, or a condition detected by the analysis algorithm in the device.
Cloud storage can have computing capability, which may include analysis algorithm for a physiological signal. The analysis algorithm generates an automatic event when the algorithm detects an abnormal condition. An analysis algorithm in the cloud can perform analysis on a specific patient with the patient’s configuration settings.
A caregiver-marked event is generated by the caregiver. When reviewing a patient’s data recorded by an implantable monitor, a caregiver can discover a condition, which he/she wants to record. The caregiver can also change or detect an event.
At least three types of events will be presented to caregivers to review. Those types of events are patient-activated events, automatically-detected events by an implantable monitor, and post-analysis generated events. A patient-activated event or a patient-marked event is recorded when the patient informs the implantable monitor system of the event using his/her handheld. An-automatically detected event is generated by the analysis software in the implantable monitor system. A post-analysis event is generated by analysis by the storage device, such as cloud computing or analysis performed in the review station.
An implantable monitor can also be customized to have specific purpose, such as to monitor a particular disease, to monitor the effectiveness of a therapy, e.g., drug or ablation, to monitor overall well-being or physical condition, to locate a patient’s position, or to check patient compliance.
Since an implantable monitor is implanted into a patient’s body long-term, i.e., from months to years, the surface of the monitor needs to be easy to remove after duration of use. Special material, special coding, nano-technologies, and/or absorbable materials can be employed to achieve the goal of easy removal. Special material, special coding, and nano-technologies for surface processing are to ensure separation of the human tissues and an implantable. Special solution can also be used to separate an implantable monitor and tissues to help a removal.
Monitoring the body position, body temperature, weight, impedance, and other physiologic signals for diseases, such as heart failure, stroke, diabetes, cardiac arrhythmias, high or low blood pressures, respiratory problems, are in the scope of this invention.
With the disclosed invention, new business models can be created. In one business model, an implantable monitor acquires signals to monitor one or more physiological conditions of a patient； the review stations are organized such that machines automatically analyze the signals and present  the results to a caregiver when necessary. When the condition is confirmed, a caregiver provides instructions to the patient to help correct the condition. When that failed, the caregiver sends someone to the patient to correct the condition.
Another business model is that patients with an implantable monitor can send the recorded information to a storage device, which can be reviewed by a clinician who then ranks the recorded information by severity or risk to the patient. A service organization can use the information to form a team to provide consultation and life-saving rescue effort when necessary. In this business model, healthcare resources can be used more efficiently and effectively.

Claims (48)

  1. An implantable monitor system comprising:
    (a) an implantable monitor that is either in a “L” or “T” shape with at least two ECG leads；
    (b) a patient handheld device；
    (c) a programmer； and
    (d) an external storage device.
  2. The system of claim 1, wherein said system has a station that receives information from the implantable monitor and has communication capability to said external storage device.
  3. The system of claim 1, wherein said external storage is a device with computing capability.
  4. The system of claim 1, wherein the said external storage has a privacy protection capability.
  5. An implantable monitor system comprising:
    (a) an implantable monitor with a built-in locator.
  6. An implantable monitor system comprising:
    (a) an implantable monitor with an unique device identification code； and
    (b) a patient handheld device with an unique device identification code.
  7. An implantable monitor method where a unique device identification code is used to distinguish each device for accurate, reliable, and private data transmission.
  8. An implantable monitor system comprising:
    (a) an implantable monitor with a physical shape of “L” or “T” ； and
    (b) a removal tool for using the horizontal bar of said implantable monitor to remove said implantable monitor.
  9. An implantable monitor system comprising:
    (a) an implantable monitor with a physical shape of “L” or “T” ；
    (b) an horizontal bar with at least one connector with a hole on it； and
    (c) a removal tool with a handle for a caregiver to hold and a hook to grab the monitor.
  10. An implantable monitor system comprising:
    (a) an implantable monitor with a physical shape of “L” or “T” ； and
    (b) an horizontal bar with a tunnel with two exits for a removal tool to attach to.
  11. The system of claim 10, in which the said two exits are:
    (a) sealed to prevent human tissues from growing into them.
  12. An implantable monitor system comprising:
    (a) an implantable monitor with a physical shape of “L” or “T” ；
    (b) an horizontal bar with at least two holes on the horizontal bar.
  13. The system of claim 12, in which the said two holes are:
    (a) sealed to prevent human tissues from growing into them.
  14. An implantable monitor system comprising:
    (a) an implantable monitor with a physical shape of “L” or “T” ； and
    (b) an arch connected to the horizontal bar.
  15. The review station of the implantable monitor system comprising:
    (a) a bi-directional communication capability；
    (b) a display screen to show information received from the implantable monitor and analysis results；
    (c) the capability to print the information and analysis results；
    (d) data fetch capability to allow an operator to send requests to the implantable monitor and to receive the requested information.
  16. The programmer of an implantable monitor system comprising:
    (a) a portable computer；
    (b) a program running in the computer； and
    (c) a communication module that wirelessly communicates with said implantable monitor.
  17. The system of claim 16, which said programmer configures
    (a) a bar code reader to read bar code of the implantable monitor and/or the patient.
  18. The system of claim 16 which said programmer configures
    (a) a transmitter that receives patient information.
  19. The system of claim16, which said programmer configures
    (a) a dropdown menu for patient conditions.
  20. The system of claim 16, which said programmer configures
    (a) a dropdown menu for names of the operators.
  21. The system of claim 16, which said programmer comprising:
    (a) a dropdown menu for medication for the patient.
  22. The system of claim 16, which said programmer comprising:
    (a) a dropdown menu for the names of physicians in the organization.
  23. An implantable monitor system comprising:
    (a) capability to configure what type of information needs to be recorded and/or transmitted.
  24. The system of claim 23, in which the said system further comprises:
    (a) configuration capability to enable and disable analysis algorithms；
    (b) configuration capability of setting analysis parameters； and
    (c) configuration capability of setting a patient’s specific condition.
  25. The system of claim 23, in which the said system further comprises:
    (a) at least two levels of configuration capability.
  26. An implantable monitor system comprising
    (a) a multi-lead ECG system for monitoring and arrhythmia analysis；
    (b) an artifact reduction algorithm to reduce artifact in the ECG signal.
  27. The system of claim 26, in which said artifact reduction algorithm further comprises:
    (a) a cross checking function to reduce artifact.
  28. An implantable monitor system comprising:
    (a) the monitor using a material that prevents tissues from growing onto it； and
    (b) a surface processing technology to prevent tissues from growing onto the monitor.
  29. An implantable monitor system comprising:
    (a) a solution that helps to separate the implantable monitor from tissues for easy removal of the monitor.
  30. An implantable monitor system comprising:
    (a) an implantable monitor；
    (b) a storage device,
    (c) at least two transceivers, one of which is a wearable device；
    (d) capability for transceivers to receive information from said implantable monitor and transmit the information to a storage device.
  31. A method of implantable monitor transmission comprising:
    (a) an implantable monitor；
    (b) a storage device,
    (c) at least two transceivers, one of which is a wearable device；
    (d) only one transceiver receives information from said implantable monitor and transmits the information to a storage device；
    (e) a transceiver that uses the least battery power is selected to receive and transmit the information.；
  32. A method of implantable monitor transmission comprising:
    (a) an implantable monitor；
    (b) a storage device,
    (c) at least two transceivers, one of which is a wearable device；
    (d) only one transceiver receives information from said implantable monitor and transmits the information to a storage device；
    (e) a transceiver closest to the implantable monitor is selected to receive and transmit the information.
  33. An implantable monitor system comprising:
    (a) an implantable monitor；
    (b) a storage device,
    (c) a transceiver with a recharge battery and the battery is wirelessly charged；
  34. An implantable monitor system comprising:
    (a) an implantable monitor；
    (b) a storage device,
    (c) a transceiver with a rechargeable battery that can be charged in two ways.
  35. An implantable monitor system comprising:
    (a) an implantable monitor；
    (b) a programmer
    (c) a signal probe where the position configuration of sensors on the probe is identical to that on the implantable monitor.
  36. The system claim 35, which said signal probe comprises:
    (a) a display device；
    (b) a communication module to transmit a sensed signal to the said programmer where the  signal can be displayed；
  37. The system claim 35, which said signal probe comprises:
    (a) a display device where the sensed signal is displayed；
  38. An implantable monitor system comprising:
    (a) a sensor to monitor and detect cardiac output.
  39. An implantable monitor system comprising:
    (a) a sensor to monitor and detect diabetes.
  40. An implantable monitor system comprising:
    (a) a sensor to monitor and detect heart failure.
  41. An implantable monitor system comprising:
    (a) a sensor to monitor and detect high and low blood pressure.
  42. An implantable monitor system comprising:
    (a) a sensor to monitor and detect stroke.
  43. An implantable monitor system comprising:
    (a) a sensor to monitor and detect a medical condition.
  44. An implantable monitor system comprising:
    (a) at least two sensors to perform crosscheck for monitoring and detecting a medical condition.
  45. An implantable monitor system comprising:
    (a) a method to establish a business model；
    (b) the implantable monitor system that serves as data collection and provides patient conditions in the business model.
  46. The system of claim 45, in which said business model comprises:
    (a) a means to collect patient’s physiologic signal changes during a clinical study.
  47. The system of claim 46, in which said physiologic signal changes comprises:
    (a) the QT interval changes over a period time or before and after taking a medication.
  48. A method of an implantable monitor comprising:
    (a) an acquisition means to obtain patient’s physiological information；
    (b) a programming means to configure said implantable monitor；
    (c) a means for a patient to initiate an event；
    (d) a transmission means to send obtained physiological information to a caregiver； and
    (e) a mean to easily remove the monitor from patient’s body.
PCT/CN2017/097625 2016-06-27 2017-08-16 Implantable monitor Ceased WO2018001389A1 (en)

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