EXTERNAL SENSING SYSTEMS AND METHODS FOR GASTRIC RESTRICTION DEVICES

• US 20080097188A1
• Filed: 07/18/2007
• Published: 04/24/2008
• Est. Priority Date: 10/20/2006
• Status: Abandoned Application

• Current Assignee: Ellipse Technologies, Inc. (Nuvasive Incorporated)
• Original Assignee: Ellipse Technologies, Inc. (Nuvasive Incorporated)
• Inventors: Chang, Arvin, McCoy, Jay R., Pool, Scott
• Application Number:
  US11/779,818
• Publication Number:
  US 20080097188A1
• Time in Patent Office: Days
• US Class Current: 600/409
• CPC Class Codes: A61B 17/1355 Automated control means therefor
• CPC Class Codes: A61B 2017/00057 Light
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2090/063 for measuring volume
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61F 5/0003 Apparatus for the treatment of obesity; Anti-eating devices surgical instruments or methods for treatment of obesity, devices specially adapted therefor A61B17/00; hollow or tubular parts of organs A61F2/04
• CPC Class Codes: A61F 5/0053 remotely adjustable

Abstract

Methods and apparatus for quantifying the amount or rate of magnetically susceptible fluid within a gastric lumen are described. In one aspect, a magnetic sensor located external to the patient is configured to detect a quantity of fluid disposed within the gastric lumen. The quantity of fluid may include fluid that is contained upstream with respect to a restriction formed in the gastric lumen (e.g., by a gastric restriction device). The quantity of fluid disposed within the gastric lumen is determined by the magnetic sensor. This quantity may be evaluated over time to then calculate a real time flow rate which can then be displayed to the physician. The methods and devices allow a physician or other trained person to dynamically view real time development of fluid flow within a restricted gastric lumen and may be used in conjunction with adjustments to the gastric restriction device to achieve target or desired flow rates.

Claims

1. A method for determining the flow rate of a fluid passing through a restricted portion of a gastric lumen of a patient comprising:

providing a magnetic sensor external to the patient, the magnetic sensor configured to detect a quantity of fluid disposed upstream of the restricted portion of the gastric lumen;

measuring the quantity of fluid disposed upstream of the restricted portion of the gastric lumen at a first time with the magnetic sensor;

measuring the quantity of fluid disposed upstream of the restricted portion of the gastric lumen at a second time with the magnetic sensor; and

determining the flow rate by subtracting the quantity of fluid disposed upstream of the restricted portion of the gastric lumen at the second time from the quantity of fluid disposed upstream of the restricted portion of the gastric lumen at the first time and dividing the subtracted value by the elapsed time between the first time and the second time.

2. The method of claim 1, wherein the elapsed time between the first time and the second time is less than 0.5 seconds.

3. The method of claim 1, further comprising displaying the determined flow rate on a display operatively coupled to the magnetic sensor.

4. The method of claim 1, wherein the restricted portion of the gastric lumen comprises a portion of the patient'"'"'s stomach at least partially restricted by a gastric restriction device.

5. The method of claim 1, wherein the quantity of fluid disposed upstream of the restricted portion of the gastric lumen at the first time is obtained after the patient consumes a known volume of fluid.

6. The method of claim 1, wherein the quantity of fluid disposed upstream of the restricted portion of the gastric lumen at the first time is obtained after the patient consumes an unknown volume of fluid.

7. The method of claim 1, further comprising measuring the quantity of fluid disposed upstream of the restricted portion of the gastric lumen at a third time and determining the flow rate by subtracting the quantity of fluid disposed upstream of the restricted portion of the gastric lumen at the third time from the quantity of fluid disposed upstream of the restricted portion of the gastric lumen at the second time and dividing the subtracted value by the elapsed time between the third time and the second time.

8. The method of claim 1, wherein the measured quantity of fluid disposed upstream of the restricted portion of the gastric lumen at the second time is zero.

9. A method of claim 1, wherein the fluid comprises a mixture of magnetic material contained within a carrier fluid.

10. A method of claim 9, wherein the magnetic material comprises a plurality of particles.

11. A method of claim 1, wherein the fluid comprises a mixture of conductive material contained within a carrier fluid.

12. The method of claim 11, wherein the conductive material comprises a plurality of particles.

13. The method of claim 9, wherein the magnetic material comprises magnetite.

14. The method of claim 9, wherein the magnetic material comprises a gadolinium compound.

15. A method of adjusting a gastric restriction device configured to restrict a portion of a gastric lumen of a patient comprising:

administering a volume of test fluid to a patient, the test fluid comprising a carrier fluid and a magnetically detectable component;

measuring the flow rate of the test fluid through the restriction of the gastric lumen using a magnetic sensor device located external to the patient; and

adjusting the gastric restriction device to achieve a target flow rate through the restriction.

16. The method of claim 15, wherein the gastric restriction device is manually adjusted in response to the measured flow rate.

17. The method of claim 15, wherein the gastric restriction device is automatically adjusted in response to the measured flow rate.

18. The method of claim 15, wherein the flow rate through the restriction is measured at least in part by comparing the quantity of test fluid located upstream of the restriction at a plurality of different times.

19. The method of claim 15, wherein the flow rate of test fluid through the restriction is measured repeatedly.

20. The method of claim 19, wherein the gastric restriction device is adjusted between flow rate measurements.

21. The method of claim 15, wherein the magnetic sensor device comprises a transmit coil and a receive coil.

22. The method of claim 15, wherein the magnetic sensor device is configured to move adjacent to an external surface of the patient.

23. A method of determining the quantity of fluid within a gastric lumen of the patient comprising:

administering a quantity of test fluid to a patient, the test fluid comprising a carrier fluid and a magnetically detectable component; and

measuring the quantity of test fluid contained in the gastric lumen using a magnetic sensor device located external to the patient.

24. The method of claim 23, wherein the test fluid is contained in the patient'"'"'s stomach.

25. The method of claim 23, wherein the test fluid is contained in the patient'"'"'s esophagus.

26. A system for determining the flow rate of fluid passing through a restricted portion of a gastric lumen of a patient comprising:

at least one transmit coil operatively coupled to an alternating current source; and

at least one receive coil configured for detecting a quantity of a magnetically detectable fluid contained in the gastric lumen, the at least one receive coil operatively coupled to a controller configured to output a signal corresponding to the quantity of magnetically detectable fluid contained in at least a portion of the gastric lumen over a period of time.

27. The system of claim 26, wherein the at least one transmit coil comprises two transmit coils and the at least one receive coil comprises two receive coils.

28. The system of claim 26, wherein the at least one transmit coil and the at least one receive coil comprise the same coil.

29. The system of claim 26, further comprising a display operatively coupled to the controller.

30. The system of claim 29, wherein the display provides the user with an indication of a mass per unit of time of the magnetically detectable fluid that passes through the gastric lumen.

31. The system of claim 29, wherein the display provides the user with an indication of the volume per unit of time of the magnetically detectable fluid that passes through the gastric lumen.

32. The system of claim 26, further comprising an external adjustment device operatively coupled to the controller, the external adjustment device being configured to adjust a gastric restriction device disposed about the restricted gastric lumen of the patient.

33. The system of claim 32, wherein the controller automatically adjusts the gastric restriction device via the external adjustment device in response to the output signal corresponding to the quantity of magnetically detectable fluid contained in the gastric lumen.

34. The system of claim 33, wherein adjustment of the gastric restriction device is stopped once a target flow rate of the magnetically detectable fluid is reached.

35. The system of claim 26, wherein the magnetically detectable fluid comprises a mixture of magnetic material contained within a carrier fluid.

36. The system of claim 35, wherein the magnetic material comprises a plurality of particles.

37. The system of claim 35, wherein the magnetic material comprises magnetite.

38. The system of claim 35, wherein the magnetic material comprises a gadolinium compound.

39. The system of claim 26, wherein the magnetically detectable fluid comprises a mixture of conductive material contained within a carrier fluid.

40. The system of claim 39, wherein the conductive material comprises a plurality of particles.

41-44. -44. (canceled)