Implantable blood flow system with secure remote control

• US 9,302,035 B2
• Filed: 08/01/2014
• Issued: 04/05/2016
• Est. Priority Date: 08/02/2013
• Status: Active Grant

• Current Assignee: Circulite Inc. (Medtronic Plc)
• Original Assignee: Circulite Inc. (Medtronic Plc)
• Inventors: Marseille, Oliver, Lehmann, Kirk A., Schleicher, Tobias, Flaherty, J. Christopher
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US14/449,423
• Publication Number:
  US 20150038771A1
• Time in Patent Office: 613 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/165 implantable in, on, or around the heart
• CPC Class Codes: A61M 60/216 including a rotating member acting on the blood, e.g. impeller
• CPC Class Codes: A61M 60/538 Regulation using real-time blood pump operational parameter data, e.g. motor current
• CPC Class Codes: A61M 60/546 of blood flow, e.g. by adapting rotor speed
• CPC Class Codes: A61M 60/585 User interfaces
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A fluid flow system for a patient comprises a controller and an implantable pump assembly. The controller comprises a processing unit and a battery. The processing unit includes a signal generator and one or more pump operational parameters. The signal generator provides a drive signal. The battery provides power to the processing unit. The implantable pump assembly receives the drive signal from the processing unit and propels fluid based on the drive signal. The system includes a local communication device and a remote communication device that each include a unique identifier produced by a security key generator. The remote communication device includes a code generator that produces encrypted commands. The local communication device receives the encrypted commands and modifies a pump operational parameter of the processing unit based on the received encrypted command.

Claims

1. A blood flow system for a patient comprising:

a controller comprising;

a processing unit comprising a signal generator and one or more blood pump operational parameters, wherein the signal generator is constructed and arranged to deliver a drive signal; and

a battery constructed and arranged to provide power to the processing unit;

an implantable blood pump assembly constructed and arranged to receive the drive signal from the processing unit and propel blood based on the drive signal;

a security key generator constructed and arranged to produce a unique identifier;

a remote communication device comprising a code generator and the unique identifier produced by the security key generator, wherein the code generator is constructed and arranged to produce encrypted commands based on the unique identifier; and

a local communication device comprising the unique identifier;

wherein the local communication device is constructed and arranged to receive the encrypted commands from the remote communication device, decrypt the encrypted commands using the unique identifier, and modify a blood pump operational parameter of the processing unit based on the decrypted commands.

2. The system of claim 1 wherein the processing unit is constructed and arranged to deliver the drive signal to the implantable blood pump assembly based on the one or more pump operational parameters.

3. The system of claim 1 further comprising a programmer including a first connector, wherein the processing unit includes a second connector constructed and arranged to operably connect to the first connector, wherein the programmer communicates with the processing unit via the first connector.

4. The system of claim 3 wherein the programmer is constructed and arranged to be maintained at a location remote from the patient.

5. The system of claim 3 wherein the programmer is constructed and arranged to modify at least one blood pump operational parameter of the processing unit.

6. The system of claim 5 wherein the programmer is constructed and arranged to prevent the patient from changing the at least one blood pump operational parameter.

7. The system of claim 3 wherein the programmer is constructed and arranged to transfer power to the controller.

8. The system of claim 1 wherein the processing unit comprises a wireless transmitter.

9. The system of claim 1 wherein the one or more blood pump operational parameters comprise a parameter selected from the group consisting of:

blood pump flow rate;

blood pump maximum flow rate;

blood pump minimum flow rate;

blood pump fluid drive element speed;

blood pump maximum fluid drive element speed;

blood pump minimum fluid drive element speed;

speed alternations and/or waveforms;

alarm status;

alarm level;

alarm sensitivity;

alarm type;

temperature level;

battery status; and

combinations thereof.

10. The system of claim 1 wherein the processing unit comprises an alarm algorithm, and the one or more blood pump operational parameters comprise an alarm algorithm parameter.

11. The system of claim 1 wherein the security key generator is further constructed and arranged to produce a second unique identifier for a second blood flow system.

12. The system of claim 1 further comprising a second local communication device and wherein the security key generator is further constructed and arranged to produce a second unique identifier for the second local communication device.

13. The system of claim 1 further comprising a second remote communication device and wherein the security key generator is further constructed and arranged to produce a second unique identifier for the second remote communication device.

14. The system of claim 1 wherein the code generator is constructed and arranged to produce a first encrypted command by encrypting blood pump operational parameter change information with the unique identifier.

15. The system of claim 14 wherein the remote communication device comprises a user interface constructed and arranged to allow an operator to input the blood pump operational parameter change information.

16. The system of claim 14 wherein the first encrypted command comprises a command received by the local communication device.

17. The system of claim 16 wherein the local communication device is constructed and arranged to decrypt the first encrypted command and transmit the blood pump operational parameter change information to the processing unit if the first encrypted command is based on a proper unique identifier.

18. The system of claim 16 wherein the local communication device is constructed and arranged to decrypt the first encrypted command and not transmit the blood pump operational parameter change information to the processing unit if the first encrypted command is not based on a proper unique identifier.

19. The system of claim 1 wherein the local communication device comprises a first local communication device, wherein the system further comprises a second local communication device comprising a second unique identifier produced by the security key generator, wherein the remote communication device further comprises the second unique identifier, and wherein the remote communication device is constructed and arranged to communicate with the first local communication device and the second local communication device.

20. The system of claim 19 wherein the remote communication device comprises a lookup table comprising the first unique identifier and the second unique identifier.

21. The system of claim 1 wherein the local communication device further comprises a user interface constructed and arranged to receive the encrypted commands from a first human operator.

22. The system of claim 1 wherein the local communication device is constructed and arranged to receive a message and to alert a user if the message is determined to be invalid.

23. The system of claim 22 wherein the local communication device is constructed and arranged to enter an alarm state if multiple invalid messages are received.

24. The system of claim 23 wherein the local communication device is constructed and arranged to enter alarm state if the multiple invalid messages are received within a pre-determined time period.

25. The system of claim 1 wherein the remote communication device comprises a first remote communication device, wherein the system further comprises a second remote communication device comprising a second unique identifier produced by the security key generator, wherein the local communication device further comprises the second unique identifier, and wherein the local communication device is constructed and arranged to communicate with the first remote communication device and the second remote communication device.

26. The system of claim 25 wherein the local communication device comprises a lookup table comprising the first unique identifier and the second unique identifier.

27. The system of claim 1 further comprising an error correction algorithm constructed and arranged to correct errors in communication between the local communication device and the remote communication device.

28. A method of modifying an operational parameter of a blood flow system comprising:

providing a blood flow system comprising;

a controller comprising;

a processing unit comprising a signal generator and one or more blood pump operational parameters, wherein the signal generator is constructed and arranged to deliver a drive signal; and

a battery constructed and arranged to provide power to the processing unit;

an implantable blood pump assembly constructed and arranged to receive the drive signal from the processing unit and propel blood based on the drive signal;

a security key generator constructed and arranged to produce a unique identifier;

a remote communication device comprising the unique identifier produced by the security key generator and a code generator, wherein the code generator is constructed and arranged to produce encrypted commands based on the unique identifier; and

a local communication device comprising the unique identifier;

wherein the local communication device is constructed and arranged to receive the encrypted commands from the remote communication device and modify a blood pump operational parameter of the processing unit based on the received encrypted command;

having the security key generator produce the unique identifier;

incorporating the unique identifier into the remote communication device and the local communication device;

generating an encrypted command with the remote communication device that includes a proposed modification to one or more blood pump operational parameters;

receiving the encrypted command with the local communication device and confirming the acceptability of the encrypted command; and

modifying the one or more blood pump operational parameters of the processing unit if the encrypted command acceptability is confirmed.

29. The method according to claim 28 wherein modifying the one or more blood pump operational parameters modifies a blood pump alarm state.

30. The method according to claim 28 wherein modifying the one or more blood pump operational parameters modifies a blood pump flow rate.