Closed loop medicament pump

• US 6,669,663 B1
• Filed: 04/30/1999
• Issued: 12/30/2003
• 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:
  US09/302,593
• Time in Patent Office: 1,705 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, 128/13
• 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;

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 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:

a sensor module for sampling and determining the concentration of a substance of interest in the patient;

a control system for determining an appropriate response to the determined concentration of the substance of interest;

an implantable drug pump for dispensing an appropriate amount of a medicament to the patient;

means for communicating information from the sensor module to the control system; and

,

means for communicating information from the control system to the implantable drug pump.

3. A closed loop medicament pump according to claim 2 wherein the sensor module comprises a sampling system and a concentration determining system.

4. A closed loop medicament pump according to claim 3 wherein the sampling system is an iontopheretic system.

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

6. A closed loop medicament pump according to claim 2 wherein the sensor module is disposable.

7. A closed loop medicament pump according to claim 2 wherein the sensor module is reusable.

8. A closed loop medicament pump according to claim 2 wherein the sensor module is attached to a flexible substrate.

9. A closed loop medicament pump according to claim 8 wherein the flexible substrate includes an adhesive to adhere the sensor module to skin of a patient.

10. A closed loop medicament pump according to claim 2 wherein the control system is a microprocessor.

11. A method of treating a medical condition in a patient comprising the steps of:

providing;

a sensor module for sampling and determining the concentration of a substance of interest in the patient;

a control system for determining an appropriate response the determined concentration of the substance of interest;

an implantable drug pump for dispensing an appropriate amount of a medicament to the patient;

means for communicating information from the sensor module to the control system; and

,

means for communicating information from the control system to the implantable drug pump;

determining the concentration of a substance of interest;

comparing the determined concentration of the substance of interest to a predetermined limit;

determining an appropriate response to the determined concentration of the substance of interest;

communicating the determined appropriate response to the medicament pump.

12. The method of claim 11 further comprising the step of infusing, if an appropriate response is determined to be to infuse medicament to a patient, medicament to the patient.

13. A closed loop medicament pump for a patient for sampling and determining the concentration of a substance of interest and for determining and delivering a responsive dose of an appropriate medicament to the patient comprising:

a sensor for sampling and determining the concentration of a substance of interest in the patient;

a control system for determining an appropriate response to the determined concentration of the substance of interest;

an implantable drug pump for dispensing an appropriate amount of a medicament to the patient;

a first communications system capable of communicating information, regarding the sensed concentration of a substance of interest in the patient, from the sensor to the control system; and

,

a second communications system capable of communicating information, regarding the determined response to the determined concentration of the substance of interest, from the control system to the implantable drug pump.

14. A method of treating a medical condition in a patient comprising the steps of:

providing;

a sensor module for determining the concentration of a substance of interest in the patient;

a control system for determining an appropriate response the determined concentration of the substance of interest;

an implantable drug pump for dispensing an appropriate amount of a medicament to the patient;

means for communicating information from the sensor module to the control system; and

,

means for communicating information from the control system to the implantable drug pump;

determining the concentration of a substance of interest;

comparing the determined concentration of the substance of interest to a predetermined limit;

determining an appropriate response to the determined concentration of the substance of interest;

taking the appropriate response by action by the drug pump.

15. A method of treating a medical condition in a patient comprising the steps of:

providing;

a sensor module for determining the concentration of a substance of interest in the patient;

a control system for determining an appropriate response the determined concentration of the substance of interest;

a medical device for taking an action appropriate to a concentration of interest in a patient;

means for communicating information from the sensor module to the control system; and

, means for communicating information from the control system to the medical device;

determining the concentration of a substance of interest;

comparing the determined concentration of the substance of interest to a predetermined limit;

determining an appropriate response by the medical device to the determined concentration of the substance of interest;

taking the appropriate response by action by the medical device.

16. A closed loop medicament pump for a patient for sampling and determining the concentration of a substance of interest and for determining and delivering a responsive dose of an appropriate medicament to the patient comprising:

a sensor module for sampling and determining the concentration of a substance of interest in the patient;

a control system for determining an appropriate response to the determined concentration of the substance of interest, the control system being integrally connected to the sensor module;

an implantable drug pump for dispensing an appropriate amount of a medicament to the patient; and

a telemetry system for communicating information from the control system to the implantable drug pump.

17. A closed loop medicament pump for a patient for sampling and determining the concentration of a substance of interest and for determining and delivering a responsive dose of an appropriate medicament to the patient comprising:

a sensor module for sampling and determining the concentration of a substance of interest in the patient;

a control system for determining an appropriate response to the determined concentration of the substance of interest, the control system being connected to the sensor module by a wire;

an implantable drug pump for dispensing an appropriate amount of a medicament to the patient; and

a telemetry system for communicating information from the control system to the implantable drug pump.

18. A closed loop medical device for a patient for sampling and determining the concentration of a substance of interest in the patient and for taking an appropriate action in response thereto comprising:

a sensor module for sampling and determining the concentration of a substance of interest in the patient;

a control system for determining an appropriate response to the determined concentration of the substance of interest, the control system being integrally connected to the sensor module;

a medical device for taking an action appropriate to a concentration of interest in a patient; and

a telemetry system for communicating information from the control system to the medical device.

19. A closed loop medical device for a patient for sampling and determining the concentration of a substance of interest in the patient and for taking an appropriate action in response thereto comprising:

a sensor module for sampling and determining the concentration of a substance of interest in the patient;

a control system for determining an appropriate response to the determined concentration of the substance of interest, the control system being connected to the sensor module by a wire;

a medical device for taking an action appropriate to a concentration of interest in a patient; and

a telemetry system for communicating information from the control system to the medical device.

20. A closed loop medical device for a patient for determining the concentration of a substance of interest in the patient and for taking an appropriate action in response thereto comprising:

means for determining the concentration of a substance of interest in the patient;

means for determining an appropriate response to the determined concentration of the substance of interest;

a medical device for taking an action appropriate to a concentration of interest in a patient;

means for communicating information from the means for determining the concentration to the means for determining an appropriate response; and

,

means for communicating information from the means for determining an appropriate response to the medical device.