Implantable drug pumps and refill devices therefor

• US 10,286,146 B2
• Filed: 10/01/2012
• Issued: 05/14/2019
• Est. Priority Date: 03/14/2011
• Status: Active Grant

• Current Assignee: MiniPumps, LLC
• Original Assignee: MiniPumps, LLC
• Inventors: Shih, Jason, Caffey, Sean
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Zamory, Justin L
• Application Number:
  US13/632,722
• Publication Number:
  US 20130116666A1
• Time in Patent Office: 2,416 Days
• Field of Search: 604141, 60428801, 60428802, 6048911
• CPC Class Codes: A61M 2205/3507 with implanted devices, e.g. external control
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14

Abstract

A system for refilling the drug reservoir of an implanted drug pump device may facilitate wireless data exchange between the refill system and the implanted device, e.g., to verify proper drug selection prior to commencement of the refill process. Via the wireless link, the drug pump device and refill system can exchange data such as, for example, refill information (including, e.g., a type of drug), a drug pump device history, a drug dosage log, and/or a drug-delivery protocol. Further, the refill system can facilitate reprogramming the implanted device wirelessly.

Claims

1. A combination comprising an implanted, refillable drug pump device and an external system for filling the implanted, refillable drug pump device, the combination comprising:

an implanted, refillable drug pump device comprising a memory and a drug reservoir with a fill port;

a needle for insertion into the fill port of the implanted drug pump device; and

an external refill system for refilling the implanted pump device via the needle, the refill system comprising;

at least one fluid container fluidly connectable to the needle and to the drug reservoir therethrough;

at least one pump for causing fluid flow through the needle between the at least one fluid container and the drug reservoir;

electronic circuitry including a processor for controlling operation of the at least one pump to perform a refill operation; and

a wireless communication module facilitating wireless data exchange between the electronic circuitry of the external refill system and the implanted drug pump device for wirelessly obtaining sensor data from sensors in the implanted drug pump and transmitting the obtained sensor data to the electronic circuitry, wherein the electronic circuitry is configured to (i) determine refill information based on the sensor data and (ii) cause the wireless communication module to send the determined refill information to the implanted, refillable drug pump device for storage in the memory thereof,

wherein the refill information comprises at least one of a volume injected into the reservoir, a type of drug, a drug dosing schedule, or a date of refill, and the electronic circuitry is configured to perform the refill operation by controlling the at least one pump based at least in part on the obtained sensor data, the refill information sent from the wireless communication module and stored in the memory, and a current fill level of the drug reservoir.

2. The combination of claim 1, further comprising:

tubing for fluidically connecting the at least one fluid container to the needle.

3. The combination of claim 1, wherein the wireless communication module is integrated in the electronic circuitry.

4. The combination of claim 1, wherein the wireless communication module is integrated in a handheld telemetry wand in communication with the electronic circuitry.

5. The combination of claim 1, wherein the wireless communication module is integrated in patient-worn eyeglasses in communication with the electronic circuitry.

6. The combination of claim 1, wherein the sensor data comprises sensor readings of sensors disposed in the drug reservoir.

7. The combination of claim 1, wherein the wireless data comprises information indicative of a type of drug to be administered.

8. The combination of claim 1, wherein the wireless data comprises information indicative of an error condition that has occurred in the drug pump device since a previous communication between the electronic circuitry and the drug pump device.

9. The combination of claim 1, wherein the electronic circuitry is configured to control pump operation based, at least in part, on sensor readings of at least one of flow sensors or pressure sensors disposed in at least one of the needle, the at least one pump, or a fluidic connection between the needle and the at least one fluid container.

10. The combination of claim 1, wherein the wireless communication module is configured to retrieve refill information previously sent from the external refill system and stored in the implanted drug pump device, the electronic circuitry being configured to perform the refill operation by controlling the at least one pump based at least in part on the retrieved refill information.

11. The combination of claim 9, wherein the refill information comprises at least one of a type of drug, an amount of drug, a dosing schedule, or a refill date.

12. The combination of claim 1, wherein the at least one fluid container comprises a drug-containing cartridge.

13. The combination of claim 12, wherein the at least one fluid container further comprises at least one of a waste-fluid receptacle or a rinsing-fluid-containing cartridge.

14. The combination of claim 12, wherein the drug-containing cartridge comprises a label indicative of a type of drug contained in the cartridge.

15. The combination of claim 14, wherein the label comprises at least one of a barcode, an RFID, an optical ID, or an EPROM.

16. The combination of claim 14, further comprising a reader for reading the label.

17. The combination of claim 14, wherein the electronic circuitry activates the at least one pump so as to cause fluid flow from the drug-containing cartridge to the drug reservoir only if the type of drug indicated by the label matches a type of drug to be administered as determined based on data received from the implanted drug pump device via the wireless communication module.

18. The combination of claim 12, wherein the drug-containing cartridge has a shape indicative of a type of drug contained in the cartridge.

19. The combination of claim 1, wherein the electronic circuitry further facilitates data exchange with an external server.

20. The combination of claim 19, wherein the data exchanged with the external server comprises a serial number of the implanted drug pump device and data associated therewith, the serial number being received by the system from the implanted drug pump device via the wireless communication module.

21. The combination of claim 20, wherein the data associated with the serial number of the implanted drug pump device comprises at least one of patient data, a drug dosage log, or a drug pump device history.

26. The combination of claim 1, wherein the drug reservoir is collapsible.

27. The combination of claim 1, wherein the refill information further comprises at least one of a drug dosing log or an operating history comprising information about an error condition that has occurred in the implanted, refillable drug pump device.

22. A combination comprising an implanted, refillable drug pump device and a system for filling the implanted, refillable drug pump device, the combination comprising:

an implanted, refillable drug pump device comprising a memory and a drug reservoir with a fill port;

a base unit comprising (i) a pump for causing fluid flow through a fluidic connection between a drug-containing cartridge and the drug reservoir, and (ii) electronic circuitry including a processor for controlling operation of the pump; and

in communication with the base unit, a wireless communication module facilitating wireless data exchange with the implanted, refillable drug pump device and configured to send drug delivery protocols for storage in the memory of the implanted, refillable drug pump, the data including an identification of the drug in the cartridge, wherein the electronic circuitry of the base unit is configured to provide new programming to the implanted drug pump device based on the identification, if the identification does not match a drug that the implanted, refillable drug pump device was previously programmed to accept, the new programming causing the implanted, refillable drug pump device to accept the drug in the cartridge, retrieve a new drug delivery protocol associated with the identification from the drug delivery protocols sent from the wireless communication module and stored in the memory, and execute the retrieved drug delivery protocol.

24. The combination of claim 22, wherein the wireless communication module is configured to send the new drug-delivery protocol to the implanted drug pump device for storage therein.

23. A method of verifying proper selection of a drug prior to injection thereof by a refill system into a drug reservoir of an implanted drug pump device, the method comprising the steps of:

receiving a drug cartridge in a well of the refill system, the drug cartridge having an electronically readable label indicative of a drug contained in the cartridge;

causing the refill system to electronically read the label,

causing the refill system to (i) receive, from the implanted drug pump device via a wireless communication module of the refill system, data indicative of a drug to be administered and (ii) send drug delivery protocols to the implanted drug pump device, via the wireless communication module, for storage in a memory associated with the implanted drug pump device, the data including an identification of the drug in the cartridge; and

causing the refill system to determine whether the drug indicated by the label matches the drug to be administered, and

in accordance with a determination that the drug indicated by the label does not match the drug to be administered, upon operator command providing new programming to the implanted drug pump device to cause the implanted drug device to accept the drug in the cartridge, retrieve a new drug delivery protocol associated with the drug from the drug delivery protocols sent from the wireless communication module and stored in the memory, and execute the retrieved drug delivery protocol, and

in accordance with a determination that the drug indicated by the label matches the drug to be administered, injecting the drug into the reservoir.

25. The combination of claim 23, wherein the wireless communication module is configured to send the new drug-delivery protocol to the implanted drug pump device for storage therein.