Gastrointestinal methods and apparatus for use in treating disorders

• US 7,502,649 B2
• Filed: 06/20/2004
• Issued: 03/10/2009
• Est. Priority Date: 06/20/2003
• Status: Expired due to Fees

• Current Assignee: Tylerton International Inc.
• Original Assignee: MetaCure Limited (MetaCure (USA), Inc.)
• Inventors: Ben-Haim, Shlomo, Policker, Shai, Aviv, Ricardo, Glasberg, Ofer
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US10/561,491
• Publication Number:
  US 20070179556A1
• Time in Patent Office: 1,724 Days
• Field of Search: 607/2, 607 40- 41, 607/62, 607/133, 600546-547, 600/593
• US Class Current: 607/40
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/4238 stomach
• CPC Class Codes: A61B 5/6871 Stomach
• CPC Class Codes: A61F 5/0026 Anti-eating devices using electrical stimulation
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61K 49/00 Preparations for testing in vivo
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61P 3/04 Anorexiants; Antiobesity agents

Abstract

A method is provided for detecting a change in posture of a subject. An electrical impedance is measured between two or more sites on a stomach (20) of the subject, and an impedance signal is generated responsive thereto. The change in posture is detected by performing a posture analysis of the impedance signal. A method is also provided for treating a subject. The method includes applying an electrical signal to a site of the subject selected from the list consisting of: a colon (402) of the subject, and a distal small intestine (408) of the subject. The signal is configured to stimulate cells of the subject to increase secretion of glucagon-like-peptide-1 (GLP-1) or PYY, or to decrease secretion of ghrelin, in order to treat the subject.

Claims

1. A method for treating a subject, comprising:

applying an electrical signal to a site of the subject selected from the group consisting of;

a colon of the subject, and a distal small intestine of the subject; and

configuring the signal to stimulate cells of the subject to increase secretion of glucagon-like-peptide-1 (GLP-1), in order to treat the subject,

wherein configuring the signal comprises;

detecting an occurrence selected from the group consisting of an occurrence of eating, an occurrence of excessive eating, and an occurrence of an elevated blood glucose level; and

responsive to detecting the occurrence, increasing a strength of the signal.

2. The method according to claim 1, wherein applying the signal comprises applying the signal in bursts of pulses, and wherein increasing the strength of the signal comprises increasing a frequency of the pulses in each of the bursts.

3. The method according to claim 1, wherein applying the signal comprises applying the signal in bursts of pulses, and wherein increasing the strength of the signal comprises decreasing a spacing between successive bursts.

4. A method for treating a subject, comprising:

applying an electrical signal to a site of the subject selected from the group consisting of;

a colon of the subject, and a distal small intestine of the subject;

configuring the signal to stimulate cells of the subject to increase secretion of glucagon-like-peptide-1 (GLP-1), in order to treat the subject; and

detecting eating by the subject, wherein applying the electrical signal comprises applying the signal responsive to detecting the eating.

5. The method according to claim 4, wherein the cells include L-cells, and wherein configuring the signal comprises configuring the signal to stimulate the L-cells to increase the secretion of the GLP-1.

6. The method according to claim 4, wherein the site includes the colon, and wherein applying the signal comprises applying the signal to the colon.

7. The method according to claim 4, wherein the site includes the distal small intestine, and wherein applying the signal comprises applying the signal to the distal small intestine.

8. The method according to claim 4, further comprising selecting a subject suffering from obesity, and wherein applying the signal comprises applying the signal to the site of the selected subject.

9. The method according to claim 4, further comprising selecting a subject suffering from a condition selected from the group consisting of NIDDM, heart disease, and hypertension, and wherein applying the signal comprises applying the signal to the site of the selected subject.

10. The method according to claim 4, wherein applying the signal comprises applying the signal periodically.

11. The method according to claim 4, wherein configuring the signal comprises varying at least one parameter of the signal in real time.

12. The method according to claim 4, wherein applying the signal comprises applying an excitable tissue control (ETC) signal to the site.

13. The method according to claim 12, comprising sensing natural electrical activity of the site, wherein applying the ETC signal comprises applying the ETC signal responsive to the sensed natural electrical activity.

14. The method according to claim 4, wherein applying the signal comprises applying the signal in bursts of pulses.

15. The method according to claim 14, wherein configuring the signal comprises configuring a spacing between successive bursts to have a duration of between about 1 and about 10 seconds.

16. The method according to claim 14, wherein configuring the signal comprises configuring a frequency of the pulses within each of the bursts to be between about 1 and about 200 Hz.

17. The method according to claim 16, wherein configuring the signal comprises configuring a frequency of the pulses within each of the bursts to be between about 5 and about 50 Hz.

18. The method according to claim 4, wherein applying the signal responsive to detecting the eating comprises commencing applying the signal at a time selected from the group consisting of substantially simultaneously with a commencement of the eating, between about one and about 5 minutes after the commencement of the eating, and between about one and about 5 minutes prior to the commencement of the eating.

19. The method according to claim 4, wherein detecting the eating comprises:

measuring an electrical impedance between two or more sites on a stomach of the subject, and generating an impedance signal responsive thereto;

detecting a change in posture of the subject by performing a posture analysis of the impedance signal;

detecting an indication of potential eating by the subject by performing an eating analysis of the impedance signal; and

responsive to the posture analysis, interpreting the impedance signal as indicative of the eating.

20. The method according to claim 4, wherein detecting the eating comprises:

measuring an electrical impedance between two or more sites on a stomach of the subject, and generating an impedance signal responsive thereto;

comparing a measure of a sudden, sustained change in the impedance signal to a threshold; and

detecting the eating by analyzing the impedance signal, and responsive to the comparing.

21. The method according to claim 4, wherein detecting the eating comprises analyzing an electrical measurement of the stomach, and, responsive to the analysis, determining whether an electrical event indicative of a slow wave has occurred.

22. Apparatus for treating a subject, comprising:

at least one electrode, adapted to be coupled to a site of the subject selected from the group consisting of;

a colon of the subject, and a distal small intestine of the subject;

a detection unit configured to detect an occurrence selected from the group consisting of;

an occurrence of eating, an occurrence of excessive eating, and an occurrence of an elevated blood glucose level, and generate a detection unit signal in response thereto; and

a control unit, adapted to drive the at least one electrode to apply an electrical treatment signal to the site, and to configure the treatment signal to stimulate cells of the subject to increase secretion of glucagon-like-peptide-1 (GLP-1), in order to treat the subject, and

responsive to receiving the detection unit signal indicative of the detected occurrence, increase a strength of the treatment signal.

23. The apparatus according to claim 22, wherein the control unit is adapted to apply the treatment signal in bursts of pulses, and to increase the strength of the treatment signal by increasing a frequency of the pulses in each of the bursts.

24. The apparatus according to claim 22, wherein the control unit is adapted to apply the treatment signal in bursts of pulses, and increase the strength of the treatment signal by decreasing a spacing between successive bursts.

25. Apparatus for treating a subject, comprising:

p1 at least one electrode, adapted to be coupled to a site of the subject selected from the group consisting of;

a colon of the subject, and a distal small intestine of the subject;

a detection unit adapted to detect eating by the subject, and generate a detection unit signal in response thereto; and

a control unit, adapted to drive the at least one electrode to apply an electrical treatment signal to the site responsive to receiving the detection unit signal indicative of the detected eating, and to configure the treatment signal to stimulate cells of the subject to increase secretion of glucagon-like-peptide-1 (GLP-1), in order to treat the subject.

26. The apparatus according to claim 25, wherein the cells include L-cells, and wherein the control unit is adapted to configure the treatment signal to stimulate the L-cells to increase the secretion of the GLP-1.

27. The apparatus according to claim 25, wherein the site includes the colon, and wherein the control unit is adapted to apply the treatment signal to the colon.

28. The apparatus according to claim 25, wherein the site includes the distal small intestine, and wherein the control unit is adapted to apply the treatment signal to the distal small intestine.

29. The apparatus according to claim 25, wherein the control unit is adapted to configure the treatment signal to be suitable for treating a condition selected from the group consisting of obesity, NIDDM, heart disease, and hypertension.

30. The apparatus according to claim 25, wherein the control unit is adapted to apply the treatment signal periodically.

31. The apparatus according to claim 25, wherein the control unit is adapted to vary at least one parameter of the treatment signal in real time.

32. The apparatus according to claim 25, wherein to apply the treatment signal, the control unit is adapted to apply an excitable tissue control (ETC) signal to the site.

33. The apparatus according to claim 32, wherein the control unit is adapted to sense natural electrical activity of the site, and to apply the ETC signal responsive to the sensed natural electrical activity.

34. The apparatus according to claim 25, wherein the control unit is adapted to apply the signal in bursts of pulses.

35. The apparatus according to claim 34, wherein the control unit is adapted to configure a spacing between successive bursts to have a duration of between about 1 and about 10 seconds.

36. The apparatus according to claim 34, wherein the control unit is adapted to configure a frequency of the pulses within each of the bursts to be between about 1 and about 200 Hz.

37. The apparatus according to claim 36, wherein the control unit is adapted to configure the frequency of the pulses within each of the bursts to be between about 5 and about 50 Hz.

38. The apparatus according to claim 25, wherein to apply the treatment signal responsive to receiving the detection unit signal indicative of the detected eating, the control unit is adapted to commence applying the treatment signal at a time selected from the group consisting of substantially simultaneously with a commencement of the eating, between about one and about 5 minutes after the commencement of the eating, and between about one and about 5 minutes prior to the commencement of the eating.

39. The apparatus according to claim 25, wherein to detect the eating, the detection unit is adapted to:

measure an electrical impedance between two or more sites on a stomach of the subject, and generate an impedance signal responsive thereto,

detect a change in posture of the subject by performing a posture analysis of the impedance signal,

detect an indication of potential eating by the subject by performing an eating analysis of the impedance signal, and

responsive to the posture analysis, interpreting the impedance signal as indicative of the eating.

40. The apparatus according to claim 25, wherein to detect the eating, the detection unit is adapted to:

measure an electrical impedance between two or more sites on a stomach of the subject, and generate an impedance signal responsive thereto,

compare a measure of a sudden, sustained change in the impedance signal to a threshold, and

detect the eating by analyzing the impedance signal, and responsive to the comparing.

41. The apparatus according to claim 25, wherein to detect the eating, the detection unit is adapted to analyze an electrical measurement of the stomach, and, responsive to the analysis, detennine whether an electrical event indicative of a slow wave has occurred.