System and method for collecting clinical data associated with a medical apparatus including an implantable device

• US 9,839,373 B2
• Filed: 06/23/2015
• Issued: 12/12/2017
• Est. Priority Date: 05/14/2015
• Status: Active Grant

• Current Assignee: Vesiflo Co., Vesiflo, Inc.
• Original Assignee: Vesiflo Co.
• Inventors: Connolly, Kevin M., Moore, Terence M., Gery, Jean-Marc
• Primary Examiner(s): Hoekstra, Jeffrey G
• Assistant Examiner(s): ABOUELELA, MAY A
• Application Number:
  US14/747,479
• Publication Number:
  US 20160331311A1
• Time in Patent Office: 903 Days
• Field of Search: 600573, 600574, 600578, 600579, 600581
• CPC Class Codes: A61B 2560/0456 Apparatus provided with a docking unit
• CPC Class Codes: A61B 2560/0481 in implanted apparatus
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/202 Assessing bladder functions, e.g. incontinence assessment
• CPC Class Codes: A61B 5/208 adapted to determine urine quantity, e.g. flow, volume
• CPC Class Codes: A61B 5/4851 Prosthesis assessment or monitoring
• CPC Class Codes: A61B 5/72 Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• 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: A61B 5/7465 Arrangements for interactive communication between patient and care services, e.g. by using a telephone network telemetry of measured physiological signal A61B5/0002
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2/48 Operating or control means, e.g. from outside the body, control of sphincters
• CPC Class Codes: A61F 2/488 Means for detecting or monitoring wear
• CPC Class Codes: A61F 2210/009 magnetic
• CPC Class Codes: A61F 2250/0002 for data transfer

Abstract

A system and method for collecting operation data associated with a medical apparatus including an internal device implanted in a subject and an external device that is magnetically-coupled to and drives the internal device. The medical apparatus may be monitored to obtain raw data associated with the operation of the medical apparatus and one or more calculations may be performed on the raw data, wherein the raw data and/or calculated values may be associated with voiding frequency and voiding volume of the subject. A report may be generated from the raw data and/or calculated values. In addition, one or more signals may be sent to the external device and/or a docking station, or communicated by other means, to indicate to the subject that the operation of the medical apparatus should be altered.

Claims

1. A medical apparatus to assist with voiding, the medical apparatus comprising:

an internal device configured to be implanted within a subject and including a driven magnet; and

an external device including a drive magnet, a processor, and a memory, the drive magnet of the external device configured to be magnetically coupled to the driven magnet of the internal device, wherein the memory is coupled to the processor and wherein the processor is configured to;

determine that the drive magnet of the external device is activated to magnetically rotate the driven magnet of the internal device,

collect clinical data based on the operation and magnetic coupling of the internal device and the external device of the medical apparatus, wherein the clinical data includes (1) a duration of a voiding session and how long the driven magnet of the internal device is magnetically coupled to the drive magnet of the external device during the voiding session, and (2) how many times the driven magnet of the internal device is magnetically coupled to the drive magnet of the external device,

transmit, over a network, the collected clinical data to a computing device that compares the collected clinical data to one or more predefined threshold values; and

receive, over the network and from the computing device, one or more signals when the collected clinical data meets the one or more predefined threshold values, where the one or more signals are utilized to indicate to the subject via the external device that voiding behavior should be altered.

2. The medical apparatus of claim 1 wherein the processor is further configured to perform one or more calculations on the collected clinical data.

3. The medical apparatus of claim 1 wherein the drive magnet is activated based on a button on the external device being pressed.

4. The medical apparatus of claim 1 wherein the collected clinical data is associated with the voiding behavior of the subject.

5. The medical apparatus of claim 4 wherein the collected clinical data further includes at least a voiding frequency, a voiding volume, an estimated real-time flow rate, and an estimated average flow rate.

6. The medical apparatus of claim 1 wherein the computing device includes a computing processor configured to perform one or more calculations on the collected clinical data to produce calculated values.

7. The medical apparatus of claim 6 wherein the computing processor is further configured to generate one or more reports based on at least one of the collected clinical data and the calculated values.

8. The medical apparatus of claim 7 wherein the computing processor is further configured to generate one or more alerts indicating that the one or more reports are available for viewing by a medical professional, wherein the one or more alerts are transmitted to a mobile phone application executing on a mobile phone used by the medical professional.

9. The medical apparatus of claim 1 wherein the processor is further configured to transmit the collected clinical data to a docking station over a computer network, wherein the docking station includes a docking station processor configured to perform one or more calculations on the collected clinical data.

10. A method, comprising:

determining, by a processor of an external device of a medical apparatus, that a drive magnet of the external device is activated to rotate a driven magnet of an internal device, wherein the medical apparatus assists in voiding, and wherein the drive magnet is configured to be magnetically coupled to the driven magnet of an internal device of the medical apparatus and the internal device is configured to be implanted within a subject;

in response to determining that the drive magnet is activated, collecting, by the processor of the external device, clinical data based on the operation and interaction of the internal device and the external device of the medical apparatus, wherein the clinical data includes (1) a duration of a voiding session and how long the driven magnet of the internal device is magnetically coupled to the drive magnet of the external device during the voiding, and (2) how many times the driven magnet of the internal device is magnetically coupled to the drive magnet of the external device; and

transmitting, over a computer network, the collected clinical data to a computing device; and

receiving one or more signals at one or more of the external device, a mobile device, and a different computing device based on a determination that the collected clinical data meets one or more threshold values, wherein the one or more signals are utilized to indicate to the subject that voiding behavior should be altered via the one or more of the external device, the mobile device, and the different computing device.

11. The method of claim 10 wherein the processor is further configured to perform one or more calculations on the collected clinical data.

12. The method of claim 10 wherein the drive magnet is activated based on a button on the external device being pressed.

13. The method of claim 10 wherein the collected clinical data is associated with the voiding behavior of the subject.

14. The method of claim 10 wherein the collected clinical data further includes at least one of a voiding frequency, a voiding volume, an estimated real-time flow rate, and an estimated average flow rate.

15. The method of claim 10 wherein the computing device includes a computing processor that performs one or more calculations on the collected clinical data to produce calculated values.

16. The method of claim 15 wherein the computing processor generates one or more reports based on at least one of the collected clinical data and the calculated values.

17. The method of claim 16 wherein the computing processor generates one or more alerts indicating that the one or more reports are available for viewing by a medical professional, wherein the one or more alerts are transmitted to a mobile phone application executing on a selected mobile phone used by the medical professional.

18. The method of claim 10 further comprising transmitting the collected clinical data to a docking station over the computer network, wherein the docking station includes a docking station processor configured to perform one or more calculations on the collected clinical data.

19. A system to assist with voiding, the system comprising:

an external device including a drive magnet, a processor, and a memory, the drive magnet of the external device configured to be magnetically coupled to a driven magnet of an internal device, wherein the memory is coupled to the processor and wherein the processor is configured to;

determine that the drive magnet of the external device is activated to magnetically rotate the driven magnet of the internal device, and

collect clinical data based on the operation and magnetic coupling of the internal device and external device of the system, wherein the clinical data includes at least one of (1) a duration of a voiding session and how long the driven magnet of the internal device is magnetically coupled to the drive magnet of the external device during the voiding session, and (2) how many times the driven magnet of the internal device is magnetically coupled to the drive magnet of the external device, and

transmit the collected clinical data to a computing device over a computer network; and

at least one of the external device, a mobile device, and a different computing device configured to receive from the computing device, based on a determination that the collected clinical data meets one or more predefined threshold values, one or more signals utilized to indicate to a subject of the system that voiding behavior should be altered via the at least one of the external device, the mobile device, and the different computing device.