Medical System Comprising an Active Implantable Medical Device and Method for Operation of the Same

Abstract

Medical system and method for operation of an active implantable medical device (IMD) and an extracorporeal device attached to a patient's skin, comprising: determining data regarding a bodily parameter of the patient by the IMD, processing the determined data and detecting a condition from a plurality of predefined conditions based on the determined data, periodically sending an intra-body communication signal representing the detected condition by the IMD to the extracorporeal device, receiving the intra-body communication signal by the extracorporeal device, providing a predefined notification signal by the extracorporeal device to the patient to motivate the patient to perform a predefined action based on the received intra-body communication signal, sending a termination signal by the extracorporeal device to the IMD, and receiving the termination signal by the IMD and subsequently terminating sending the intra-body communication signal which was initiated by the previously detected condition.

Claims

1. A medical system comprising an active implantable medical device (IMD) and an extracorporeal device attached to a patient's skin, wherein the IMD comprises: a measurement unit adapted to determining data regarding at least one bodily parameter of the patient when the IMD is implanted within a body of the patient, a processor adapted to process data regarding the at least one bodily parameter and to detect at least one condition associated with a plurality of predefined conditions based on the data, and a communication unit adapted to periodically send an intra-body communication signal representing the at least one detected condition to the extracorporeal device, wherein the extracorporeal device comprises: a transceiver unit adapted to receive the intra-body communication signal, and a notification unit adapted to provide at least one predefined notification signal to the patient to motivate the patient to perform a predefined action based on the received intra-body communication signal, wherein the transceiver unit of the extracorporeal device is further adapted to send a termination signal to the communication unit of the IMD, and wherein the communication unit of the IMD is further adapted to receive the termination signal and to subsequently terminate sending the intra-body communication signal which was initiated by the previously at least one detected condition.

2. The medical system according to claim 1, wherein, the transceiver unit of the extracorporeal device is configured to send the termination signal automatically to the communication unit of the IMD when the transceiver unit of the extracorporeal device receives the intra-body communication signal, or wherein, the transceiver unit of the extracorporeal device is configured to send the termination signal to the communication unit of the IMD when the notification signal is acknowledged by the patient.

3. The medical system according to claim 1, wherein the intra-body communication signal is an acoustic signal, an electrical signal and/or an impedance-based signal.

4. The medical system according to claim 1, wherein the notification signal comprises a visual signal, haptic/tactile signal, and/or an acoustic signal.

5. The medical system according to claim 1, wherein the extracorporeal device is a smart watch, a wrist band, a mobile phone worn in direct physical contact with the patient's skin and/or a patch device.

6. The medical system according to claim 1, wherein the notification signal comprises: a reporting to an user of the condition observed by the IMD, an invitation of the patient to establish a data communication connection to the IMD (10) using a patient device, and/or an invitation of the patient to take a medication, and/or an invitation of the patient to visit a healthcare professional.

7. The medical system according to claim 6, wherein in case a data communication connection to the IMD is established, the patient device is configured to send the data collected by the IMD to a remote services infrastructure, and/or the patient device is configured to provide access to the IMD to a user by means of the patient device or by means of the remote services infrastructure via the patient device.

8. The medical system according to claim 7, wherein the data collected by the IMD comprises: specific information related to the detected condition recognized by the IMD, and/or data collected by or associated with the IMD for a follow-up examination,

9. The medical system according to claim 1, wherein the notification signal provided by the extracorporeal device comprises information. from a remote service infrastructure, wherein the information is sent: from the remote service infrastructure to the extracorporeal device, or from the remote service infrastructure via the patient device to the extracorporeal device.

10. A method for operation of a medical system comprising an active implantable medical device (IMD) and an extracorporeal device attached to a patient's skin, comprising the following steps: determining data regarding at least one bodily parameter of the patient by a measurement unit of the IMD when the IMD is implanted within a body of the patient, processing the data regarding the at least one bodily parameter and detecting at least one condition of a plurality of predefined condition based on the data by a processor of the IMD, periodically sending an intra-body communication signal representing the at least one detected condition by a communication unit of the IMD to the extracorporeal device, receiving the intra-body communication signal by a transceiver unit of the extracorporeal device, providing at least one predefined notification signal by the extracorporeal device to the patient to motivate the patient to perform a predefined action based on the received intra-body communication signal, sending a termination signal by the transceiver unit of the extracorporeal device: to the communication unit of the IMD, and receiving the termination signal by the communication unit of the IMD and subsequently terminating sending the intra-body communication signal which was initiated by the previously at least one detected condition.

11. The method according to claim 10, wherein, the termination signal is sent automatically by the transceiver unit of the extracorporeal device to the communication unit of the IMD when the transceiver unit of the extracorporeal device receives the intra-body communication signal, or wherein, the termination signal is sent by the transceiver unit of the extracorporeal device to the communication unit of the IMD when the notification signal is acknowledged by the patient.

12. The method according to claim 10, wherein the notification signal comprises: a reporting to an user of the condition observed by the IMD, an invitation for the patient to establish a data communication connection to the IMD using a patient device, and/or an invitation of the patient to take a medication, and/or an invitation of the patient to visit a healthcare professional,

13. The method according to claim 12, wherein in case a data communication connection to the IMD is established, the patient device enables sending the data collected by the IMD to a remote services infrastructure, and/or access to the IMD is provided to a user by means of the patient device or by means of a remote services infrastructure via the patient device.

14. The method according to claim 13, wherein sending the data collected by the IMD to the remote services infrastructure comprises providing either: specific information related to the detected condition recognized by the IMD, and/or information/data for a follow-up examination.

15. The method according to claim 10, wherein the notification signal provided by the extracorporeal device comprises information from a remote service infrastructure, wherein the information is sent: from the remote service infrastructure to the extracorporeal device, or from the remote service infrastructure via the patient device to the extracorporeal device.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0083] The present invention will now be described in further detail with reference to the accompanying schematic drawings, wherein:

[0084] FIG. 1A shows an exemplary inventive medical system with an active implantable medical device (IMD) implanted within a patient's body, more specific within a patient's heart,

[0085] FIG. 1B shows the IMD and an extracorporeal device in more detail,

[0086] FIG. 2 depicts a flow chart of an embodiment of an inventive method for operation of such medical system, and

[0087] FIG. 3 depicts a flow chart of an embodiment of an inventive method for operation of such medical system.

DETAILED DESCRIPTION

[0088] FIG. 1A shows an exemplary embodiment of the inventive medical system for a patient 1 comprising an active implantable medical device (IMD) in the form of an implantable leadless pacemaker (ILP) 10 implanted within the heart 5 of the patient 1. Further, the patient wears an extracorporeal device 12 realized, for example, as a smart watch or wrist band at his/her wrist and is attached to the skin in the wrist region. Further, the system comprises another patient device 15 being equipped with a processing and data storage capability, a coil-based inductive transceiver unit for communication with the IMD 10 and CMDA, VOIP, or otherwise enabled transceiver unit for connecting to a remote services infrastructure (16)—said infrastructure serving as a data access portal for the patient's healthcare provider.

[0089] FIG. 1B shows the IMD 10 and the extracorporeal device 12 in more detail. The IMD 10 comprises a measurement unit 7, a processor 8 and a communication unit 9 which are electrically connected. The extracorporeal device 12 comprises a transceiver unit 13 and a notification unit 14 which are electrically connected. The IMD 10 is in communication (preferably wireless communication) with the extracorporeal device 12.

[0090] The steps of an exemplary embodiment of the inventive method are depicted in FIG. 2 to which the following explanation of the method refers.

[0091] The measurement unit 7 of the IMD 10 determines continuously at least one bodily parameter of the patient's body, for example electric signals of the heart 5, e.g. an electrocardiogram, and sends the determined data of the bodily parameter to the processor 8 of the IMD 10 (see step 30) which is connected to the measurement unit 7. The processor 8 then, in step 31, analyses the received data of the bodily parameter and determines whether the data correspond to a predefined patient/device condition, for example an atrial fibrillation (AF). The at least one predefined condition and their criteria (for example threshold values) are stored in the storage unit of the IMD 10 in order to compare the received data of the at least one bodily parameter with them. In case detection of one of the predefined conditions is confirmed (step 32), the method continues with step 33 and the processor 8 activates the communication unit 9 of the IMD 10 and the communication unit 9 sends repeatedly, for example each ½ hour for the next 24 hours, a predefined intra-body communication signal through the body of the patient (depicted by arrow 20 of FIG. 1A) to the extracorporeal device 12 which is attached to the skin of the patient 1. In case no predefined condition is detected, the method continues with step 30.

[0092] The intra-body communication signal 20 may be realized as a short encoded beacon travelling through the body of the patient as explained above, for example an acoustic signal, an electrical measure or an impedance-modulated signal. In step 34 the transceiver unit 13 of the extracorporeal device 12 receives the intra-body communication signal 20 and the extracorporeal device provides a notification signal using its notification unit 14, i.e. it displays, for example, a respective icon and provides a beep showing the patient 1 that an atrial fibrillation condition has occurred and that the data associated with the detected atrial fibrillation needs to be collected by the patient device 15 for subsequent relay to the remote services infrastructure. The notification signal is depicted in FIG. 1A by the wave-symbol 22. As soon as, in step 35, the patient recognizes the notification signal 22 and confirms its receipt, e.g. by pressing a respective button of the extracorporeal device 12. the transceiver unit 13 sends a predefined intra-body communication signal 20 comprising a termination information to the communication unit 9 of the IMD 10.

[0093] Alternatively or in combination, the extracorporeal device 12 sends a termination signal to IMD 10 via intra-body communication upon receiving the notification signal 22. Alternatively or in combination, if the intra-body communication signal 20 received by the transceiver unit 13 of the extracorporeal device 12 in step 34 requires the interrogation of IMD 10 via patient device 15, the extracorporeal device 12 displays said request to the patient 1. Patient 1 needs to perform the steps for said interrogation first before the receipt of notification signal 22 can be confirmed and before the termination information is sent to the communication unit 9 of the IMD 10. After successful interrogation, the patient device 15 may automatically inform the IMD 10 (directly or via extracorporeal device 12) that the intra-body communication signal. 20 may be terminated. Alternatively or in combination, all notifications on the extracorporeal device 12 associated with the notification signal 22 are cleared upon successful interrogation of IMD 10. In the next step 36 the communication unit 9 receives the termination information and subsequently terminates sending the intra-body communication signal 20 by which the condition (e.g., “AF”) is communicated to the extracorporeal device 12 reducing the power demands on the primary cell battery within the IMD 10.

[0094] The steps of an exemplary embodiment of the inventive method are depicted in FIG. 3 to which the following explanation of the method refers.

[0095] Notifications to the patient 1 can be transmitted from the remote services infrastructure 16 via patient device 15 to the extracorporeal device 12. In step 40, a request for such a notification is recognized in the remote services infrastructure 16. This can be initiated by a user, e.g. a physician, or automatically triggered by a periodical request (e.g. in the framework of a regular notification for a remote follow-up examination). In step 41, said request data is sent by from the remote services infrastructure 16 to the patient device 15. In step 42, patient device 15 forwards the request to extracorporeal device 12 where it is displayed as notification signal 22 to the patient. In step 43, the patient recognizes the notification signal 22 and confirms its receipt, e.g. by pressing a respective button of the extracorporeal device 12. Upon said confirmation, extracorporeal device 12 stops displaying notification signal 22 in step 44. Alternatively or in combination, after said confirmation a message is sent back via the patient device 15 to the remote services infrastructure 16 to inform the latter that the patient had acknowledged the request. Alternatively, if the notification signal 22 received the extracorporeal device 12 in step 43 requires the interrogation of IMD 10 via patient device 15, the extracorporeal device 12 displays said request to the patient 1. Patient 1 needs to perform the steps for said interrogation first before the receipt of notification signal 22 can be confirmed and before the notification signal 22 is stopped from being displayed by the extracorporeal device 12. After successful interrogation, the patient device 15 may automatically inform the extracorporeal device 12 (directly or via IMD 10) that displaying the notification signal 22 can be stopped. The patient device 15 may furthermore transport the collected information to the remote services center.

[0096] The above disclosure outlines a means for leveraging short, encoded messages from a deeply-implanted IMD 10 to inform the user of IMD/patient status through notifications emergent from an extracorporeal device 12 and request further patient interactions. This relaying of short, encoded messages (i.e. beacons) informs the recipient extracorporeal device 12 that the implanted IMD 10 has detected a patient or device condition that merits further survey or suggested needs for the administration of more proactive patient care measures. Additionally, it offers a means for tracking the system and/or patient with prescriptive measures outlined by the patient's clinical care team to either remind the patient to administer medications or that they should interact with their separate patient device to collect and relay data to remote, monitored resources. Within this framework, the extracorporeal device 12 directly informs the patient 1 of such needs as part of its capacity for communicating with:

[0097] 1.) a remote services infrastructure (either directly or indirectly via relay through a separate patient device), and potentially also

[0098] 2.) the IMD 10.

[0099] The data relay approaches that support the notification capabilities described in the present invention (whether beaconing from the IMD 10 to the extracorporeal device 12 or messaging from the remote services infrastructure—either directly or indirectly, by way of the patient device 15 to the extracorporeal device 12) generally contain minimal information, but passes sufficient content to the extracorporeal device 12 to inform the user that the active IMD 10 has witnessed a condition that merits further scrutiny or is reflective of indicators (potentially asymptomatic in nature) requiring patient actions to align with a co-prescribed medication regimen or, furthermore, pairs with a scheduled time point that merits “poking” the patient to remotely enhance care compliance.

[0100] The extracorporeal device 12 would, in a preferred embodiment, present either iconography or legible messaging to the patient/wearer that:

[0101] 1.) encourages the application of the wand-based patient device 15, to inductively communicate further with the IMD 10 (in cases where added data could assist with clinical oversight), and/or

[0102] 2.) calls attention to the patient regarding potential non-compliance with co-prescribed medication regimens (in cases where the implant alone recognizes key diagnostic signals or a time point prescribed by scheduling relayed from the remote monitoring infrastructure 16 has been reached), and/or

[0103] 3.) comprises information/data for a follow-up examination, e.g. baseline follow-up data in support of a (nominally prescribed) device/patient monitoring regimen.

[0104] In case 2.), there is a data transmission first to the patient device 15 from the remote service center and a second data transmission form the. patient device 15 to the extracorporeal device 12, for example in order to notify the patient of an activity based on assistance of a healthcare practitioner.

[0105] In the case where added data collection is driven by the implanted IMD 10 based upon algorithmic observations of key patient conditions, following the placement of the wand-enabled patient device 15 on the patient's body (over or near the IMD 10), the patient device 15 would perform an implant interrogation procedures to pull statistics, program/device settings, and potentially other log data from the IMD 10. This collected device information would, be re-transmitted to the remote service center by the patient device 15 to enable remote monitoring support. For cases where the extracorporeal device 12 indicated possible non-compliance with co-prescribed drug regimens, the patient would, confirm, through the device 12, that they had, in turn, responded by taking their medications or indicate that the reminder was unwarranted (potentially training the indicator algorithm as a result, whether it resides within the device or the remote services infrastructure). For cases where the extracorporeal device 12 indicates non-compliance to a prescription from the remote monitoring infrastructure 16 regarding the routine of follow-up examinations, the patient would confirm the message through device 12, wherein the message would reappear after a predetermined time period, relayed by the remote monitoring infrastructure 16 if the patient has still not undergone a follow-up examination.

[0106] It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range, including the end points.