Regulatory compliant transmission of medical data employing a patient implantable medical device and a generic network access device

• US 8,265,757 B2
• Filed: 01/24/2012
• Issued: 09/11/2012
• Est. Priority Date: 05/22/2008
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Mass, William, Carpenter, Greg P., Kollmann, Daniel, Lai, Arthur, Dion, Philip G., Phillips, Thomas, Eash, Aaron
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): Wieland, Robert N
• Application Number:
  US13/357,399
• Publication Number:
  US 20120124210A1
• Time in Patent Office: 231 Days
• Field of Search: 607/30, 607/32, 600/300, 705/2, 709/205
• US Class Current: 607/32
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: H04L 65/1069 Session establishment or de-establishment

Abstract

Various embodiments concern a method which may include communicating medical information between a PIMD and an interface module via a first channel in compliance with a predetermined medical information regulatory standard, preventing access to the PIMD via the interface module other than through the first channel, detecting a communication protocol used by an available generic network access device, selecting a communication protocol rule set from a plurality of communication protocol rule sets to effect communication between the interface device and an available generic network access device of a plurality of generic network access devices, and transferring at least some of the medical information to the remote network via a second channel established between the interface module and the available generic network access device using the selected communication protocol rule set.

Claims

1. An interface device for facilitating transfer of medical information between a patient implantable medical device (PIMD) and a remote network server via a public network using any one of a plurality of network access devices having disparate communication protocols, the interface device comprising:

first communication circuitry configured to effect communication between the PIMD and the interface device in compliance with a predetermined medical information regulatory standard governing implantable medical devices including the PIMD;

second communication circuitry configured to effect communication between the interface device and any one of the plurality of network access devices;

the PIMD accessible using any of the plurality of network access devices only if such access is in compliance with the predetermined medical information regulatory standard; and

a processor coupled to the first communication circuitry and the second communication circuitry, the processor configured to detect an available network access device of the plurality of network access devices and cooperate with the second communication circuitry to effect communication between the interface device and the available network device.

2. The device of claim 1, wherein the first communication circuitry is configured to implement medical firmware to effect communication between the PIMD and the interface device in compliance with the predetermined medical information regulatory standard.

3. The device of claim 2, wherein the second communication circuitry is configured to implement communication firmware to effect communication between the interface device and any one of the plurality of generic network access devices.

4. The device of claim 1, wherein the first circuitry comprises a regulatory compliance module having an input coupled to the first communications interface, an output, and a regulatory memory for storing compliance rules consistent with the predetermined medical information regulatory standard, the regulatory compliance module configured to moderate communicative interaction between the PIMD and the first circuitry and to process PIMD data in accordance with the compliance rules.

5. The device of claim 1, wherein the second communication circuitry comprises:

a protocol library comprising sets of communication protocol rules, each communication protocol rule set associated with one of the plurality of disparate communication protocols; and

a second communications interface coupled to the protocol library and configurable to implement any one of the communication protocol rule sets.

6. The device of claim 1, wherein the processor is configured to facilitate remote access to the PIMD via the first communication circuitry, the second communication circuitry, and at least one of the plurality of network access devices, and the first communication circuitry is further configured to limit non-authenticated remote access to the PIMD.

7. The device of claim 1, wherein at least some of the plurality of network access devices, including the available network access device, comprise off-the-shelf cellular devices that have not been configured for compliance with the predetermined medical information regulatory standard.

8. The device of claim 1, wherein the processor is configured to cause the issuance of commands using the second communication circuitry to the available network access device for controlling a subset of available network access device functions.

9. The device of claim 8, wherein the processor is configured to requisition one or more functions of the subset of available network access device functions to communicate with, and collect data from, a sensor-based patient data collection device.

10. An interface device for facilitating transfer of medical information between a patient implantable medical device (PIMD) and a remote network server via a public network using any one of a plurality of network access devices having disparate communication protocols, the interface device comprising:

first communication circuitry configured to effect communication between the PIMD and the interface device in compliance with a predetermined medical information regulatory standard governing implantable medical devices including the PIMD;

second communication circuitry configured to effect communication between the interface device and any one of the plurality of network access devices;

the PIMD accessible for purposes of medical information transfer and remote programming using any of the plurality of network access devices only if such access is in compliance with the predetermined medical information regulatory standard; and

a processor coupled to the first communication circuitry and the second communication circuitry, the processor configured to detect an available network access device of the plurality of network access devices and cooperate with the second communication circuitry to effect communication between the interface device and the available network device.

11. The device of claim 10, wherein the processor is configured to authorize establishment of a programming communication link between the interface device and a remote network server via the available network access device in compliance with the predetermined medical information regulatory standard.

12. The device of claim 11, wherein the processor is configured to authenticate the remote network server.

13. The device of claim 11, wherein the PIMD is configured to authenticate the interface device.

14. The device of claim 11, wherein the processor is configured to verify programming commands received from the programming communication link for one or both of authenticity and integrity.

15. The device of claim 11, wherein the processor is configured to restore a previous version of programming in response to interruption or unintended termination of a programming session between the remote network server and the PIMD.

16. The device of claim 10, wherein:

the first communication circuitry is configured to implement medical firmware to effect communication between the PIMD and the interface device in compliance with the predetermined medical information regulatory standard; and

the second communication circuitry is configured to implement communication firmware to effect communication between the interface device and any one of the plurality of generic network access devices.

17. The device of claim 10, wherein the first circuitry comprises a regulatory compliance module having an input coupled to the first communications interface, an output, and a regulatory memory for storing compliance rules consistent with the predetermined medical information regulatory standard, the regulatory compliance module configured to moderate communicative interaction between the PIMD and the first circuitry and to process PIMD data in accordance with the compliance rules.

18. The device of claim 10, wherein the second communication circuitry comprises:

a protocol library comprising sets of communication protocol rules, each communication protocol rule set associated with one of the plurality of disparate communication protocols; and

a second communications interface coupled to the protocol library and configurable to implement any one of the communication protocol rule sets.

19. A method, implemented by use of a portable interface device, for facilitating transfer of medical information between a patient implantable medical device (PIMD) and a remote network server, the method comprising:

communicating medical information between the PIMD and the interface device via a communication channel and in compliance with a predetermined medical information regulatory standard governing implantable medical devices including the PIMD;

preventing access to the PIMD via the interface device other than access in compliance with the predetermined medical information regulatory standard;

detecting a communication protocol used by an available network access device of a plurality of network access devices;

selecting a communication protocol rule set from a plurality of communication protocol rule sets in response to detection of the communication protocol used by the available network access device;

establishing a communication link between the interface device and the available network access device using the selected communication protocol rule set; and

transferring at least some of the medical information to the available network access device for communication to a remote network server via the established communication link in compliance with the predetermined medical information regulatory standard.

20. The method of claim 19, further comprising:

establishing a programming communication link between the remote network server and the PIMD in compliance with the predetermined medical information regulatory standard; and

programming or re-programming the PIMD via the established programming communication link.