Closed loop medicament pump

• US 7,429,255 B2
• Filed: 12/29/2003
• Issued: 09/30/2008
• Est. Priority Date: 04/30/1999
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Thompson, David L.
• Primary Examiner(s): Mendez; Manuel A
• Application Number:
  US10/747,832
• Publication Number:
  US 20040147872A1
• Time in Patent Office: 1,737 Days
• Field of Search: 604/30, 604/31, 604/65, 604/66, 604/67, 604/70, 604/93.01, 604/890.1, 604/891.1, 128/DIG.12, 128/DIG.13
• US Class Current: 604/67
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0028 Body tissue as transmission medium, i.e. transmission systems where the medium is the human body
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery

Abstract

A device to determine the level of a substance of interest in a patient'"'"'s body and provide a therapeutic amount of medicament is disclosed. The level of a substance of interest in the patient'"'"'s body is determined by iontopheretically sampling the patient'"'"'s blood and then analyzing the resulting sample to determine the level of the substance of interest. The information about the level of a substance of interest is transmitted to an implanted drug pump in the patient'"'"'s body. In the preferred embodiment, the substance of interest sensor is an external sensor applied to the user'"'"'s skin.;: In an alternate embodiment, the sensor may be implanted. The preferred method of transmitting information about the level of a substance of interest determined by the sensor is transmitted to an implanted drug pump in the patient'"'"'s body is via a so called “body bus”. The “body bus” is a telemetry system where the patient'"'"'s own body provides the interconnection between the iontopheretic device and the implanted drug pump.

Claims

1. A closed loop medicament pump system for a patient for sampling and determining the concentration of a substance of interest through the patient'"'"'s skin and for determining and delivering a responsive dose of an appropriate medicament to the patient comprising:

an iontopheretic sensor module for sampling and detecting a concentration of a substance of interest through skin, wherein the sensor module comprises a sampling system and a concentration determining system;

a control system, responsive to the iontopheretic sensor module, for determining a response to the sampled and determined concentration of a substance of interest;

a sensor telemetry system for transmitting information regarding the response determined by the control system through the patient'"'"'s body;

a pump telemetry system for receiving information regarding the response determined by the control system through the patient'"'"'s body and for communicating the information to an implantable drug pump; and

an implantable drug pump, acting in response to the information communicated to the implantable drug pump from the pump telemetry system, to deliver a responsive dose of an appropriate medicament to the patient.

2. A closed loop medicament pump system according to claim 1 wherein the sensor module is an external sensor.

3. A closed loop medicament pump system according to claim 1 wherein the sensor module is disposable.

4. A closed loop medicament pump system according to claim 1 wherein the sensor module is reusable.

5. A closed loop medicament pump system according to claim 1 wherein the sensor module is attached to a flexible substrate.

6. A closed loop medicament pump system according to claim 5 wherein the flexible substrate includes an adhesive to adhere the sensor module to skin of a patient.

7. A closed loop medicament pump system according to claim 1 wherein the control system is a microprocessor.

8. A closed loop medicament pump system as in claim 7, in which the microprocessor further includes a memory with a look-up table for the responsive dose of the appropriate medicament, and the step of determining the responsive dose includes retrieving a value from the look-up table.

9. A closed loop medicament pump system as in claim 7, in which the microprocessor further includes a memory with a formula for the responsive dose of the appropriate medicament, and the step of determining the responsive dose includes determining the dose according to the formula.

10. A closed loop medicament pump system as in claim 9, in which the formula includes the variables of the determined concentration of the substance of interest and the patient'"'"'s weight.

11. A closed loop medicament pump system as in claim 7, in which the drug pump includes memory, and the information communicated to the pump to cause the drug pump to deliver the responsive dose of the appropriate medicament is stored in the memory.

12. A closed loop medicament pump system as in claim 11, in which the information is stored in the memory with related time of the delivery of the responsive dose.

13. A closed loop medicament pump system as in claim 11, in which the information is stored in the memory with related time of the delivery of the responsive dose and the memory keeps the information and time available for later uplink telemetry.

14. A closed loop medicament pump system as in claim 13, further comprising uplink telemetry equipment.

15. A closed loop medicament pump system as in claim 7, wherein the microprocessor operates a program including the steps of receiving information related to the concentration of the substance of interest, comparing the information related to the concentration to information related to a predetermined limit, and then, if the comparing step indicates the concentration exceeds the predetermined limit, determining the appropriate response to the determined concentration.

16. A closed loop madicament pump system as in claim 15, in which the operation of the program steps of receiving information related to the concentration of the substance of interest and comparing the information related to the concentration to information related to the predetermined limit may be accomplished on command.

17. A closed loop medicament pump system as in claim 15, in which the system, pump or medical device includes a patient command means and the operation of the program steps of receiving information related to the concentration to substance of interest and comparing the information related to the concentration to information related to the predetermined limit may be accomplished on patient command through the patient command means.

18. A closed loop medicament pump system as in claim 15, wherein the program further includes the step of generating information to cause the drug pump to deliver the responsive dose of the appropriate medicament.

19. A closed loop medicament pump system as in claim 15, wherein the program further includes the step, if the comparing step indicates the concentration does not exceed the predetermined limit, waiting for a period of time to expire before again operating the program steps of receiving information related to the concentration of the substance of interest and comparing the information related to the concentration to information related to the predetermined limit.

20. A closed loop medicament pump system as in claim 19, in which the periodicity of the operation of the program, including the period of time for waiting, may be present in the program.

21. A closed loop medicament pump system as in claim 19, in which the periodicity of the operation of the program, including the period of time for waiting, is programmable.

22. A closed loop medicament pump system as in claim 1, the drug pump acting in response to communication to the drug pump by body bus.

23. A closed loop medicament pump system as in claim 1, the drug pump acting in response to communication to the drug pump by radio telemetry.

24. A closed loop medicament pump system as in claim 1, further comprising an operatively connected antenna which receives downlinked telemetry programming data transmitted by an external programmer.

25. A closed loop medicament pump system as in claim 1, further comprising an operatively connected battery.

26. A closed loop medicament pump system, pump or medical device as in claim 25 wherein the battery is a flexible battery.

27. A closed loop medicament pump system as in claim 1, in which the control system is located with the drug pump.

28. A closed loop medicament pump system as in claim 1, in which the control system is located with the sensor module.

29. A closed loop medicament pump system according to claim 1 wherein the substance of interest includes glucose and the sensor module samples and detects a concentration of the substance of interest including glucose.

30. A closed loop medicament pump system according to claim 1 wherein the appropriate medicament is insulin, and the drug pump delivers insulin.