Systems and methods for managing and analyzing data generated by an implantable device

• US 10,769,244 B2
• Filed: 08/23/2017
• Issued: 09/08/2020
• Est. Priority Date: 08/26/2016
• Status: Active Grant

• Current Assignee: Sequana Medical NV
• Original Assignee: Sequana Medical NV
• Inventors: Degen, Thomas Werner, Tschumper, Stefan
• Primary Examiner(s): Flory, Christopher A
• Application Number:
  US15/684,479
• Publication Number:
  US 20180060520A1
• Time in Patent Office: 1,112 Days
• Field of Search: 600300, 600301
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/02444 Details of sensor A61B5/02427 takes precedence
• CPC Class Codes: A61B 5/07 Endoradiosondes
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/6847 mounted on an invasive device
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3365 Rotational speed
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 80/00 : ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring

Abstract

A system is provided including an implantable device configured to be implanted subcutaneously within a patient, a clinician monitoring and control device, an optional patient mobile device, a remote server and/or at least one data analyst device used by a data analyst. The implantable device may communicate with any or all of the monitoring and control device, the mobile device and/or the remote server through the charging device or by establishing a direct wireless connection with each such device. The data analyst device may establish a direct connection with the remote server and also may establish a connection with the monitoring and control device and the mobile device. By analyzing and reviewing the data generated by the implantable device, the data analyst may diagnose a medical condition or indicate a heightened risk of a condition.

Claims

1. A system for managing and reviewing data obtained from an implantable device at a data analyst device, the system comprising:

an outlet catheter configured to be implanted in a patient so as to be in fluidic communication with a patient'"'"'s bladder;

an implantable device comprising a housing containing a first inductive charging circuit, a first microprocessor, a battery, a first communication unit, a pump coupled to the outlet catheter and configured to move fluid from a peritoneal cavity to the bladder via the outlet catheter, and a plurality of sensors, the implantable device configured to generate operational data and physiological data, the physiological data corresponding to the patient;

a charging device comprising a second inductive charging circuit, a second microprocessor, and a second communication unit, the charging device configured to wirelessly transfer energy transcutaneously from the second inductive circuit to the first inductive circuit to charge the battery, the charging device programmed to communicate with the implantable device to receive the operational data and the physiological data from the implantable device and to store the operational data and the physiological data on the charging device;

first instructions stored on a first non-transitory computer readable medium of the charging device configured to cause transmission of the operational data associated with the pump and the physiological data based on measurements from at least one sensor of the plurality of sensors associated with the pump stored on the charging device to a remote server so that the operational data and the physiological data are accessible from the remote server by a data analyst device; and

second instructions stored on a second non-transitory computer readable medium of the data analyst device configured to cause the data analyst device to access the physiological data based on the measurements from the at least one sensor associated with the pump from the remote server, automatically compare the physiological data to other physiological data corresponding to at least one patient different from the patient, determine whether the physiological data exceeds one or more preprogrammed thresholds, and automatically generate an alert for transmission if the physiological data exceeds the one or more preprogrammed thresholds.

2. The system of claim 1, wherein the first instructions stored on the first non-transitory computer readable medium of the charging device are configured to cause the charging device to communicate with the remoter server via the Internet.

3. The system of claim 1, wherein the first instructions stored on the first non-transitory computer readable medium of the charging device are configured to cause the charging device to communicate with the remoter server via a wireless telephony regime.

4. The system of claim 1, wherein the first instructions stored on the first non-transitory computer readable medium of the charging device are also configured to cause transmission of operational instructions, including at least operational parameters, to the implantable device.

5. The system of claim 1, wherein the first instructions stored on the first non-transitory computer readable medium of the charging device are configured to encrypt communications between the charging device and the remote server such that transmission of the operational data and the physiological data is encrypted.

6. The system of claim 1, further comprising third instructions stored on a third non-transitory computer readable medium of a clinician computer configured to cause the clinician computer to communicate with the remote server and to receive from the remote server the operational data associated with the pump and the physiological data based on the measurements from at least one sensor of the plurality of sensors associated with the pump.

7. The system of claim 1, further comprising third instructions stored on a third non-transitory computer readable medium of a patient mobile communication device configured to cause the patient mobile communication device to communicate with the remote server and to receive from the remote server the operational data associated with the pump and the physiological data based on measurements from at the least one sensor of the plurality of sensors associated with the pump.

8. The system of claim 1, further comprising third instructions stored on a third non-transitory computer readable medium of a clinician computer configured to cause transmission of operational instructions, including at least operational parameters, from the clinician computer to the charging device.

9. The system of claim 1, wherein the second instructions stored on the second non-transitory computer readable medium of the data analyst device are further configured to cause the data analyst device to compile the operational data and the physiological data, generate analyst data and transmit the analyst data to the remote server.

10. The system of claim 1, wherein the second instructions stored on the second non-transitory computer readable medium of the data analyst device will cause the data analyst device to generate a warning message when the operational data exceeds one or more preprogrammed thresholds and communicate the warning message to at least one or more of a patient mobile communication device and a clinician computer.

11. The system of claim 1, wherein the plurality of sensors comprises at least one or more of a heart rate sensor, an ECG sensor, a temperature sensor, or a respiratory sensor and the physiological data comprises at least one of a heart rate, ECG data, a temperature or a respiratory rate.

12. A method of managing an implantable device comprising:

establishing a wireless connection between a clinician computer and an implantable device, the implantable device comprising a housing containing an inductive charging circuit, a microprocessor, a battery, a communication unit, a pump and one or more sensors;

receiving operational parameters at the implantable device from the clinician computer;

adjusting operation of the implantable device according to received operational parameters at the implantable device;

pumping fluid from a peritoneal cavity to a bladder of a patient via the pump coupled to an outlet catheter;

generating operational data and physiological data from the one or more sensors in the implantable device, the physiological data corresponding to the patient;

transmitting the operational data associated with the pump and physiological data based on measurements from the one or more sensors associated with the pump to a remote server so that the operational data and physiological data are accessible for review on a data analyst device;

automatically comparing, on the data analyst device, the physiological data based on the measurements from the one or more sensors associated with the pump to other physiological data corresponding to at least one patient different from the patient;

determining whether the physiological data exceeds one or more predetermined thresholds; and

automatically generating a warning for transmission if the physiological data exceeds the one or more predetermined thresholds.

13. The method of claim 12, further comprising:

automatically comparing, at the data analyst device, the operational data to one or more predetermined threshold ranges; and

automatically generating, at the data analyst device, an alert if the operational data is outside one or more of the predetermined threshold ranges.

14. The method of claim 13, further comprising transmitting the alert from the data analyst device to at least one or more of the remote server, a patient mobile communication device and the clinician computer.

15. The method of claim 12, further comprising:

analyzing on the data analyst device, at least one of the operational data and physiological data accessed from the remote server;

generating analyst data on the data analyst device based on the at least one of the operational data and physiological data; and

transmitting the analyst data from the data analyst device to the remote server.

16. The method of claim 15, wherein the generating the analyst data on the data analyst device further comprises generating at least one of a diagnosis of a medical condition, actionable insight and an indication of a heightened risk of a medical condition.

17. The method of claim 15, further comprising accessing, using a clinician computer, the analyst data stored on the remote server.

18. The method of claim 16, further comprising periodically interrogating, by the clinician computer, the remote server to determine whether the analyst data comprises at least one of a diagnosis of a medical condition or an indication of high risk of a medical condition.

19. The method of claim 18, further comprising transmitting an alert to a patient mobile communication device, from the clinician computer, upon confirmation that the analyst data comprises at least one of a diagnosis of a medical condition, an indication of high risk of a medical condition or other actionable insight.