Patient programmer for implantable drug delivery device

• US 10,010,670 B2
• Filed: 06/26/2017
• Issued: 07/03/2018
• Est. Priority Date: 04/16/2015
• Status: Active Grant

• Current Assignee: FLO, LLC
• Original Assignee: Flowonix Medical, Inc.
• Inventors: Burke, Paul, Adler, Steve
• Primary Examiner(s): Garcia, Santiago
• Application Number:
  US15/632,988
• Publication Number:
  US 20180001018A1
• Time in Patent Office: 372 Days
• Field of Search: 34087007
• CPC Class Codes: A61B 5/0026 characterised by the transmission medium
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

Methods for programming an implantable drug delivery device using a mobile computing device that include establishing a connection with a telemetry unit configured for wireless communication with the implantable drug delivery device, displaying user-selectable drug delivery settings for the implantable drug delivery device, receiving at least one selection of a drug delivery setting, translating the received selection into a signal format readable by the telemetry unit, and sending the translated signal to the telemetry unit to program the implantable drug delivery device. Further embodiments include telemetry units for communication with an implantable drug delivery device, and patient programmers and a method for patient modification to a programmed drug delivery regimen.

Claims

1. A system, comprising:

an implantable drug delivery device configured to deliver infusate according to a drug delivery regimen;

a telemetry unit configured to communicate with the implantable drug delivery device;

a mobile computing device configured to communicate with the telemetry unit and with a communication network; and

a remote computing device configured to communicate with the mobile computing device via the communication network,

wherein the mobile computing device is configured to communicate with the remote computing device via the communication network, and

wherein the telemetry unit is configured to communicate with the implantable drug delivery device using a first communication interface and with the mobile computing device using a second communication interface different from the first communication interface, and

wherein the remote computing device is configured to transmit information associated with the drug delivery regimen to the mobile computing device which is configured to transmit the information associated with the drug delivery regime to the telemetry unit which is configured to transmit the information associated with the drug delivery regime to the implantable drug delivery device.

2. The system of claim 1, wherein:

the implantable drug delivery device is further configured to;

store information associated with at least one of the drug delivery regimen, a status of the implantable drug delivery device, and physiological data of a patient associated with the implantable drug delivery device; and

transmit the stored information to the telemetry unit;

the telemetry unit is further configured to transmit the information received from the implantable drug delivery device to the mobile computing device; and

the mobile computing device is further configured to transmit the information received from the telemetry unit to the remote computing device.

3. The system of claim 2, wherein the stored information includes at least one of a dosage history during the drug delivery regimen, an amount of drug delivered by the implantable drug delivery device during the drug delivery regimen, an amount of infusate remaining in a drug reservoir of the implantable drug delivery device, an indication of an amount of remaining power associated with the implantable drug delivery device, and information associated with malfunctions of the implantable drug delivery device.

4. The system of claim 1, wherein the telemetry unit is further configured to:

receive a patient request to modify the drug delivery regimen;

determine whether the requested modification to the drug delivery regimen is permissible; and

communicate a command to the implantable drug delivery device in response to determining that the requested modification to the drug delivery regimen is permissible.

5. The system of claim 4, wherein the telemetry unit is further configured to transmit to the mobile computing device for relay to the remote computing device information related to requested modifications to the drug delivery regimen including one or more of information associated with at least one of a number of bolus doses requested within a predetermined time period of the drug delivery regimen, a volume of drug administered per each requested bolus dose, information associated with a time period between administered bolus doses, information associated with a time in which each bolus dose is administered, and information associated with a modification of a basal rate of delivery during the drug delivery regimen.

6. The system of claim 1, wherein the mobile computing device is further configured to:

receive a patient request to modify the drug delivery regimen;

determine whether the requested modification to the drug delivery regimen is permissible; and

communicate a command to the implantable drug delivery device via the telemetry unit in response to determining that the requested modification to the drug delivery regimen is permissible.

7. The system of claim 6, wherein the mobile computing device is further configured to transmit to the remote computing device information related to requested modifications to the drug delivery regimen including one or more of information associated with at least one of a number of bolus doses requested within a predetermined time period of the drug delivery regimen, a volume of drug administered per each requested bolus dose, information associated with a time period between administered bolus doses, information associated with a time in which each bolus dose is administered, and information associated with a modification of a basal rate of delivery during the drug delivery regimen.

8. The system of claim 7, wherein the mobile computing device is further configured to receive a modification to the drug delivery regimen from the remote computer in response to transmitting the information related to requested modifications to the drug delivery regimen and communicate the modification to the drug delivery regimen received from the remote computer to the implantable drug delivery device via the telemetry unit.

9. The system of claim 1, further comprising a patient programmer configured to:

receive requests from a patient to modify the drug delivery regimen for the patient;

communicate instructions for modifying the drug delivery regime to the telemetry unit via a third communication link for relaying to the implantable drug delivery device; and

transmit information to and received information from the mobile computing device via a fourth communication link different from the third communication link.

10. The system of claim 1, further comprising a server configured to:

receive information associated with the implantable drug delivery device from the mobile computing device over the communication network;

store the information associated with the implantable drug delivery device; and

communicate with the remote computing device,

wherein the remote computing device is configured to receive the information associated with the implantable drug delivery device by retrieving the information associated with the implantable drug delivery device stored at the server.

11. The system of claim 1, wherein the remote computing device is associated with a medical clinician.

12. The system of claim 1, wherein the remote computing device is further configured to diagnose, reprogram, or manage the implantable drug delivery device, the telemetry unit, or the mobile computing device from a location remote from a location of the implantable drug delivery device, the telemetry unit, or the mobile computing device.

13. A method of programming an implantable drug delivery device, comprising:

receiving from the implantable drug delivery device by a first telemetry unit via a first communication link information related to a patient in which the implantable drug delivery device is implanted, wherein the implantable drug delivery device is configured to administer an infusate according to a first drug delivery regimen;

relaying the information from the first telemetry unit to a mobile computing device via a second communication link different from the first communication link;

relaying the information from the mobile computing device to a remote computing device via a third communication link different from the first and second communication links;

receiving by the mobile computing device from the remote computing device via the third communication link a second drug delivery regimen to be implemented by the implantable drug delivery device;

relaying the second drug delivery regimen from the mobile computing device to the telemetry unit via the second communication link;

relaying the second drug delivery regimen from the telemetry unit to the implantable drug delivery device via the first communication link; and

implementing the second drug delivery regimen by the implantable drug delivery device.

14. The method of claim 13, wherein the information related to the patient comprises one or more of a dosage history during the first drug delivery regimen, an amount of drug delivered by the implantable drug delivery device during the first drug delivery regimen, a number of times the patient requested a modification of the first drug delivery regimen, an amount of infusate remaining in a drug reservoir of the implantable drug delivery device, an indication of an amount of remaining power associated with the implantable drug delivery device, and information associated with malfunctions of the implantable drug delivery device.

15. The method of claim 13, further comprising:

transmitting from a second telemetry unit to the implantable drug delivery device the first drug delivery regimen, wherein the second telemetry unit is different from the first telemetry unit;

implementing the first drug delivery regimen by the implantable drug delivery device; and

monitoring by a processor within the implantable drug delivery device operations of the implantable drug delivery device administering the infusate according to the first drug delivery regimen,

wherein the information related to the patient comprises information obtained by the processor while monitoring operations of the implantable drug delivery device.

16. The method of claim 13, further comprising:

receiving an input from the patient at the mobile computing device, wherein the input requests a modification of the first drug delivery regimen;

determining whether the patient requested modification of the first drug delivery regimen is permissible;

transmitting from the mobile computing device to the first telemetry unit an instruction to implement the patient requested modification of the first drug delivery regimen in response to determining that the patient requested modification of the first drug delivery regimen is permissible;

transmitting from the first telemetry unit to the implantable drug delivery device the instruction to implement the patient requested modification of the first drug delivery regimen; and

implementing the patient requested modification of the first drug delivery regimen by the implantable drug delivery device.

17. The method of claim 16, wherein:

the patient requested modification of the first drug delivery regimen comprises a request for an additional administration of the infusate; and

implementing the patient requested modification of the first drug delivery regimen by the implantable drug delivery device comprises administering an additional bolus of infusate to the patient.

18. The method of claim 16, wherein determining whether the patient requested modification of the first drug delivery regimen is permissible comprises determining whether the patient requested modification is within a threshold of a parameter associated with the first drug delivery regimen.

19. The method of claim 13, further comprising:

displaying the information by the remote computing device in a format suitable for viewing by a physician; and

receiving parameters defining the second drug delivery regimen as inputs from the physician; and

transmitting the second drug delivery regimen from the remote computing device to the mobile computing device.