Analysis and regulation of food intake

• US 8,417,329 B2
• Filed: 05/11/2008
• Issued: 04/09/2013
• Est. Priority Date: 05/09/2007
• Status: Active Grant

• Current Assignee: Tylerton International Inc.
• Original Assignee: MetaCure Limited (MetaCure (USA), Inc.)
• Inventors: Grossman, Aharon, Kliger, Anat, Policker, Shal
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): WILSON, KAYLEE R
• Application Number:
  US12/599,350
• Publication Number:
  US 20100305468A1
• Time in Patent Office: 1,794 Days
• Field of Search: 607/40, 607/62, 607/133, 600/37, 600/547, 600/593
• US Class Current: 600/547
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/4238 stomach
• CPC Class Codes: A61B 5/6871 Stomach
• CPC Class Codes: A61F 2005/0016 comprising measuring means
• CPC Class Codes: A61F 5/0059 with wireless means
• CPC Class Codes: A61F 5/0069 in the wall of the stomach
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

Apparatus (18, 18′) is provided, which includes one or more fundic sensors (74), configured to be applied to a fundus of a subject (10), and to generate a fundic signal. The apparatus further includes a control unit (90), which is configured to make a tentative determination of ingestion by the subject (10), determine fundic impedance responsively to the fundic signal, and calculate a duration of a period during which the fundic impedance rose during the tentatively-determined ingestion. Upon finding that the duration is less than a fundic rise duration threshold value, the control unit (90) determines that the tentative determination of ingestion is a false positive. Other embodiments are also described.

Claims

1. Apparatus comprising:

one or more antral sensors, configured to be applied to an antrum of a subject, and to generate an antral signal; and

a control unit, configured to;

detect ingestion of food by the subject,

determine antral impedance responsively to the antral signal, and

interpret a change in antral impedance vs. a as line value of less than a threshold value as indicating that the ingested food is predominantly solid.

2. no apparatus according to claim 1, further comprising:

gastrointestinal (GI) tract attachment element, configured to be coupled to a portion of a (GI)tract of a subject such that the element surrounds less than 360 degrees of the GI tract, and applies a constrictive force to the GI tract portion that causes at least a 5% reduction in a cross-sectional area of the GI tract in a vicinity of the portion; and

at least one electrode, electrically coupled to the control unit and coupled to the attachment element such that the electrode contacts the GI tract portion when the attachment element is coupled to the GI tract portion.

3. The apparatus according to claim 1, further comprising a gastric band, wherein the control unit is configured to cause tightening of the gastric band in response to a determination that the ingested food is predominantly solid.

4. The apparatus according to claim 1, wherein the control unit is configured to detect the ingestion of the food by;

making a tentative determination of ingestion of solid food by the subject, and

determining that the tentative determination is not a false positive upon finding that the ingested food is predominantly solid.

5. The apparatus according to claim 4, further comprising one or more fundic sensors, configured to be applied to a fundus of a subject, and to generate a fundic signal, wherein the control unit is configured to determine fundic impedance responsive to the fundic signal, calculate a duration of a period during which the fundic impedance rose during the tentatively-determined ingestion, and determine that the tentative determination is a false positive upon finding that the duration is less than a fundic rise duration threshold value.

6. The apparatus according to claim 1, further comprising:

an external device, which comprises a device wireless communication module; and

an implantable wireless device communication module, which is coupled to control unit,

wherein the control unit is configured to dike the implantable wireless device communication module to wirelessly transmit, to the device wireless communication module, an indication that the ingested food is predominantly solid.

7. A method comprising:

detecting ingestion of food by a subject;

determining antral impedance of antral impedance of the subject; and

interpreting a change in anti-al impedance vs. a baseline value of less than a threshold value as indicating that the ingested hand is predominantly solid.

8. Apparatus comprising:

one or more fundic sensors, configured to be applied to a fundus of a subject, and to generate a fundic signal; and

a control unit, configured to;

detect ingestion of food by the subject,

determine fundic impedance responsively to the fundic signal,

calculate a duration of it period during which the fundic impedance rose during the ingestion, and

determine that the ingested food is predominantly solid upon finding that the duration of the period is greater than a threshold value.

9. The apparatus according to claim 8, wherein the threshold value is between one and five minutes.

10. The apparatus according to claim 8, wherein the threshold value includes a first threshold value, and wherein the control unit is configured to determine that the ingested food is predominantly liquid upon finding that the duration of the period is less than a second threshold value.

11. The apparatus according to claim 10 wherein the second threshold value is between 10 seconds and five minutes.

12. The apparatus according to claim 8, further comprising a gastric band, wherein the control unit is configured to cause tightening of the gastric band in response to determining that the ingested food is predominantly solid.

13. The apparatus according to claim 8, wherein the control unit is configured to detect the ingestion of the food by:

making a tentative determination of ingestion of solid food by the subject, and

determining that the tentative determination is not a false positive upon determining that the ingested food is predominantly solid.

14. The apparatus according to claim 8, further comprising;

an external device, which comprises a device wireless communication module; and

an implantable wireless device communication module, which is coupled to control unit,

wherein the control unit is configured to drive the implantable wireless device communication module to wirelessly transmit, to the device wireless communication module, an indication that the ingested food is predominantly solid.

15. The apparatus according to claim 8, further comprising:

a gastrointestinal (GI) tract attachment element, configured to be coupled to a portion of a GI tract of a subject such that the element surrounds less than 360 degrees of the GI tract, and applies a constrictive force to the GI tract portion that causes at least a 5% reduction in a cross-sectional area of the GI tract in a vicinity of the portion; and

least one electrode, coupled to the control ant and coupled to the attachment element such that the electrode;

contacts the GI tract portion when the attachment element is coupled to the GI tract portion.

16. A method comprising;

detecting ingestion of food by a subject;

determining fundic impedance of a fundus of the subject;

calculating a duration of a period during which the fundic impedance rose during the ingestion; and

determining that the ingested food is predominantly solid upon finding that the duration of the period is greater than a threshold value.

17. Apparatus comprising:

one or more antral sensors, configured to be applied m an antrum of a subject, and to generate an antral signal; and

a control unit, configured to

detect ingestion of food by the subject,

calculate an antral local sense rate responsively to the antral signal, and

determine that the ingested food is predominantly liquid upon finding that a reduction in the rate over a period of time is greater than a first threshold value, the period of time commencing during the ingestion of the food and having a period duration of less than a second threshold value.

18. The apparatus according to claim 17, wherein the period duration equals the duration at between one and three detected antral waves.

19. The apparatus according to claim 17, wherein the control unit is configured to receive an antral local sense baseline rate, and to set the first threshold value to be. between 25% and 75% of the baseline rate.

20. The apparatus according to claim 17, wherein the control unit is configured to receive an antral local sense baseline rate, and to determine that the ingested food is predominantly liquid only upon finding that the reduction in the rate over the period of time is greater than the first threshold value, and that the rate returns to the baseline rate after a conclusion of the period of time.

21. The apparatus according to claim 17, further comprising a gastric band, wherein the control unit is configured to cause loosening of the gastric hand responsively to determining that the ingested food is predominantly liquid.

22. The apparatus according to claim 17, wherein the control unit is configured to detect the ingestion of the food by:

making a tentative determination of ingestion of solid food by the subject, and

determining that the tentative determination is a false positive upon determining that the ingested food is predominantly liquid.

23. The apparatus according to claim 22 further comprising one one or more fundic sensors, configured to be applied to a fundus of a subject, and to generate fundic signal, wherein the control unit is configured to determine fundic impedance responsively to the fundic signal, calculate a duration of a period during which the fundic impedance rose during the tentatively-determined ingestion, and determine that the tentative determination is a false positive upon finding that the duration is less than a fundic rise duration threshold value.

24. The apparatus according to claim 17, further comprising:

an external device, which comprises a device wireless communication module; and

an implantable wireless device communication module, which is coupled to control unit,

wherein the control unit is configured to drive the implantable wireless device communication module to wirelessly transmit, to the device wireless communication module, an indication of the extent to which the ingested food includes solid food.

25. A method comprising;

detecting ingestion of food by a subject;

calculating an antral local sense rate of an antrum of the subject, and

determining that the ingested food is predominantly liquid upon finding that a reduction in the rate over a period of time is greater than a first threshold value, the period of time commencing during the ingestion of the food and having a period duration of less than a second threshold value.

26. Apparatus comprising:

one or more fundic sensors, configured to be applied to a fundus of a subject, and to generate a fundic signal; and

a control unit, configured to;

make a determination of ingestion of food by the subject,

determine fundic impedance responsively to the fundic signal,

calculate a maximum rise rate, expressible as a measure of resistance over a measure of time, in the fundic impedance during a least one period of the ingestion, and

determine that ingested food is liquid upon finding that the rise is at least equal to a fundic rise threshold value.

27. The apparatus according to claim 26, wherein the fundic rise threshold value is between one and 30 ohms per second.

28. The apparatus according to claim 26, further comprising a gastric band, wherein the control unit is configured to cause loosening of the gastric band responsively to determining that the digested food is liquid.

29. The apparatus according to claim 26, wherein the control unit is configured to detect the ingestion of the food by:

making a tentative determination of ingestion of solid food by the subject, and

determining that the tentative determination is a false positive upon determining that the ingested food is predominantly liquid.

30. The apparatus according to claim 26, further comprising:

an external device, which comprises a device wireless communication module; and

an implantable wireless device communication module, which is coupled to control unit,

wherein the control unit is configured to drive the implantable wireless device communication module to wirelessly transmit, to the device wireless communication module, an indication of the extent to which the ingested hand includes solid food.

31. A method comprising:

making a determination of ingestion of food by a subject;

determining fundic impedance of a fundus of the subject;

calculating a maximum rise rate, expressible as a measure of resistance over a measure of time, in the fundic impedance during at least one period of the ingestion; and

determining that the ingested food is liquid upon finding that the rise is at least equal to a fundic rise threshold value.