Systems and methods for monitoring gastrointestinal system

• US 7,141,016 B2
• Filed: 04/25/2003
• Issued: 11/28/2006
• Est. Priority Date: 04/25/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Madsen, Michael, Lykke, Michael, Starkebaum, Warren L., Gerber, Martin T.
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): MALLARI, PATRICIA C
• Application Number:
  US10/423,594
• Publication Number:
  US 20040215068A1
• Time in Patent Office: 1,313 Days
• Field of Search: 600/593, 600/300, 600/361, 600/365
• US Class Current: 600/300
• CPC Class Codes: A61B 5/062 using magnetic field
• CPC Class Codes: A61B 5/07 Endoradiosondes
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/4238 stomach

Abstract

In general, the invention is directed to systems and methods for monitoring the gastrointestinal system of a patient. In one embodiment, the invention includes techniques for monitoring the emptying of the patient'"'"'s stomach. The techniques may employ glucose monitoring, pH monitoring with a consumable sensor, of monitoring the position of a consumable sensor as it exits the stomach. Consumable sensors may be employed to sense conditions, such as temperature or bile concentration, in other segments of the gastrointestinal system. The invention also includes systems for tracking the position of one or more consumable sensors as the sensors transit the gastrointestinal system, and monitoring the conditions sensed by the sensors.

Claims

1. A method comprising:

monitoring a blood glucose concentration in a patient following consumption of a meal by the patient; and

estimating the time that gastric emptying occurs in the patient as a function of the blood glucose concentration.

2. The method of claim 1, further comprising recording the time of consumption of the meal.

3. The method of claim 1, wherein estimating the time that gastric emptying occurs comprises:

recording a baseline blood glucose concentration;

recording the time that the monitored blood glucose concentration substantially changes from the baseline concentration; and

estimating the time that gastric emptying occurs as the time when the blood glucose concentration substantially changes from the baseline concentration.

4. The method of claim 1, further comprising:

monitoring a position of a device in the gastrointestinal system, the device consumed by the patient with the meal; and

estimating the time that gastric emptying occurs as a function of the position.

5. The method of claim 1, further comprising:

monitoring a pH signal from a device in a gastrointestinal system, the device consumed by the patient with the meal; and

estimating the time that gastric emptying occurs as a function of the pH signal.

6. The method of claim 1, wherein the meal includes a known amount of glucose.

7. A method comprising:

monitoring a first pH signal from a first device in a gastrointestinal system of a patient;

monitoring a second pH signal from a second device in the gastrointestinal system of the patient; and

estimating the time that gastric emptying occurs in the patient as a function of the first and second pH signals.

8. The method of claim 7, wherein estimating the time that gastric emptying occurs comprises estimating the time that at least one of the first or second pH signals indicates a substantial pH increase from a range of approximately 1 to 2 pH.

9. The method of claim 8, wherein estimating the time that gastric emptying occurs comprises estimating the time that at least one of the first or second pH signals indicates a pH increase from a range of approximately 1 to 2 pH to a range of approximately 6 to 7 pH.

10. The method of claim 7, further comprising:

monitoring a blood glucose concentration in the patient following consumption of a meal by the patient; and

estimating the time that gastric emptying occurs as a function of the blood glucose concentration.

11. The method of claim 7, further comprising:

monitoring a position of at least one of the first and second devices device in the gastrointestinal system; and

estimating the time that gastric emptying occurs as a function of the position.

12. A system comprising:

a first consumable device including a transmitter, the first consumable device configured to transit the gastrointestinal system of a patient and to transmit a first signal;

a second consumable device configured to transit the gastrointestinal system and to transmit a second signal;

at least two receivers to receive the first and second signals signal from the first and second consumable devices when the first and second consumable devices transit the gastrointestinal system; and

a processor to compute positions of the first and second consumable devices in the gastrointestinal system as a function of the received first and second signals.

13. The system of claim 12, wherein the first consumable device is sized differently from the second consumable device.

14. The system of claim 12, wherein the signals define an amplitude and a phase, and wherein the processor computes the positions of the consumable devices as a function of the amplitudes and the phases of the received signals.

15. The system of claim 12, wherein at least one of the first and second consumable devices comprises a sensor to generate a sensor signal in response to a condition.

16. The system of claim 15, wherein the sensor is at least one of a pH sensor, a temperature sensor, a pressure sensor, a moisture sensor, an impedance sensor, and a bile concentration sensor.

17. The system of claim 12, wherein the first consumable device is configured to transmit a first identification signal and the second consumable device is configured to transmit a second identification signal.

18. A method comprising:

monitoring a first position signal from a first device in a gastrointestinal system of a patient;

monitoring a second position signal from a second device in the gastrointestinal system;

estimating the time that gastric emptying occurs in the patient as a function of first and second position signals.

19. The method of claim 18, further comprising monitoring a condition signal from the first device.

20. The method of claim 19, wherein the condition signal varies as function of at least one of pH level, temperature, pressure, moisture, impedance and bile concentration.

21. The method of claim 18, further comprising monitoring a blood glucose concentration in the patient following consumption of a meal by the patient.

22. The method of claim 18, wherein monitoring the first position signal comprises monitoring the first position signal with at least two receivers configured to receive the first position signal.

23. The method of claim 22, wherein monitoring the first position signal comprises computing the position of the first device as a function of the first position signal received by the receivers.

24. A system comprising:

a first consumable device including a transmitter, the first consumable device configured to transit the gastrointestinal system of a patient and to transmit a first pH signal;

a second consumable device configured to transit the gastrointestinal system of the patient and to transmit a second pH signal;

at least one receiver to receive the first and second pH signals signal from the first and second consumable devices when the first and second consumable devices transit the gastrointestinal system; and

a processor to estimate the time that gastric emptying occurs in the patient as a function of the first and second pH signals.

25. The system of claim 24, wherein the first consumable device is configured to transmit a first identification signal and the second consumable device is configured to transmit a second identification signal.

26. The system of claim 24, wherein the first consumable device is sized differently from the second consumable device.

27. The system of claim 26, wherein the sensor signal comprises at least one of a temperature signal, a pressure signal, a moisture signal, an impedance.

29. The system of claim 24, wherein the first consumable device is further configured to transmit a position signal, and wherein the processor is further configured to compute a position of the first consumable device in the gastrointestinal system as a function of the position signal.

28. The system of 24, wherein the first consumable device comprises a sensor to generate a sensor signal in response to a condition. signal, and a bile concentration signal.