External sensing system for gastric restriction devices

• US 20080097249A1
• Filed: 04/02/2007
• 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: Davtyan, David G., McCoy, Jay R., Pool, Scott, Walker, Blair, Quick, Richard L., Moaddeb, Shahram
• Application Number:
  US11/732,431
• Publication Number:
  US 20080097249A1
• Time in Patent Office: Days
• US Class Current: 600/586
• 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 useful for monitoring fluid flow past a gastric restriction device using noninvasive means are described. Some methods involve the use of acoustic energy, e.g., Doppler ultrasound, to monitor the passage of fluid past the restriction device, and apparatus to detect the acoustic energy. In some embodiments the method detects a sound-producing fluid using a microphone, stethoscope, or ultrasound probe and detector combination. In some embodiments, there are described methods of using Doppler ultrasound to monitor the flow of a fluid through a stomal opening, allowing a flow condition, e.g., a flow rate, to be determined, so that a physician can accurately adjust the gastric restriction device.

Claims

1. A method of adjusting a restriction device that affects a size of a gastric lumen of a patient, to produce a desired flow condition within the lumen, the method comprising:

administering a volume of a test substance to the patient;

detecting with a sensor a presence of the test substance flowing within the lumen, wherein the sensor produces an output signal that is correlated with a movement of the test substance within the gastric lumen and past the restriction device; and

adjusting the restriction device so that the output signal from the sensor indicates the presence of the desired flow condition.

2. The method of claim 1, further comprising determining a time for a volume of the test substance to move within the lumen past the restriction device.

3. The method of claim 1, wherein the test substance comprises a fluid.

4. The method of claim 3, wherein the fluid comprises a liquid having a viscosity ranging from about 0.5 cP to about 2.0 cP at a temperature of about 20°

C.

5. The method of claim 1, wherein the sensor detects the presence of the test substance in the lumen by detecting acoustic energy.

6. The method of claim 5, wherein the acoustic energy comprises at least one of sound, ultrasound, and Doppler shift echoes from ultrasound.

7. The method of claim 1, wherein the test substance comprises a sound-producing fluid, and the sensor comprises at least one of a microphone, a stethoscope, and an electronic stethoscope.

8. The method of claim 7, wherein the sound-producing fluid comprises an effervescent solution.

9. The method of claim 7, wherein the sound-producing fluid comprises a fluid and at least one of an acoustic capsule, an acoustic pill, and an acoustic bean.

10. The method of claim 1, wherein the sensor comprises a Doppler ultrasound instrument configured to detect Doppler shift echoes produced as the test substance moves through the lumen.

11. The method of claim 10, wherein the test substance comprises a fluid that includes at least one scattering agent that increases the production of Doppler shift echoes.

12. The method of claim 1, wherein the test substance comprises at least one of a low-viscosity solution, a medium-viscosity solution and a high-viscosity solution.

13. The method of claim 1, further comprising repeating at least one of the steps of administering, detecting, and adjusting during a test session.

14. The method of claim 1, further comprising equilibrating the test substance to a desired temperature, the desired temperature being other than ambient room temperature, prior to administering the test substance to the patient.

15. The method of claim 14, wherein the desired temperature is substantially equal to the body temperature of the patent.

16. The method of claim 1, wherein the desired flow condition comprises a desired flow rate.

17. The method of claim 16, wherein the desired flow rate is in the range from about 1 mL per second to about 20 mL per second.

18. The method of claim 16, wherein the desired flow rate is in the range of about 5 mL per second to about 15 mL per second.

19. A kit for use in a method of measuring flow in a stomach past a gastric restriction device, the kit comprising:

at least one standardized test substance of known approximate volume; and

instructions on the use of the at least one standardized test substance in a method of measuring a flow of the test substance in the stomach and past the gastric restriction device.

20. The kit of claim 19, wherein the kit comprises a plurality of test substances.

21. The kit of claim 20, wherein the plurality of test substances comprises at least one solution selected from the group consisting of a low-viscosity solution, a medium-viscosity solution, and a high-viscosity solution.

22. The kit of claim 19, further comprising a device for adjusting the temperature of the at least one standardized test substance to a desired temperature.

23. The kit of claim 22, wherein the desired temperature is about equal to the body temperature of the patient.

24. The kit of claim 19, further comprising a Doppler ultrasound instrument configured to detect Doppler shift echoes correlated with movement of the test substance past a stomal opening.

25. An apparatus for detecting movement of a test substance in a stomach lumen past a gastric restriction device, comprising:

an acoustic-energy detector configured to detect sound energy having at least one of a frequency and an intensity that correlates with movement of the test substance within the stomach lumen and past the gastric restriction device; and

an adjustment module that operates to adjust the gastric restriction device to change a dimension of the stomach lumen, and wherein the adjustment module is coupled to the acoustic-energy detector.

26. The apparatus of claim 25, wherein the acoustic-energy detector comprises an ultrasound transducer that operates to detect Doppler shift echoes that correlate with movement of the test substance.

27. The apparatus of claim 25, further comprising a display, the display operative to indicate a parameter of flow of the test substance flowing in the stomach lumen and past the gastric restriction device.

28. The apparatus of claim 27, wherein the display means provides at least one of an audible, visible, and tactile alert.

29. The apparatus of claim 27, wherein the display comprises at least one of an audible tone, an LED, a video display, a numerical display, vibration, and heat.

30. The apparatus of claim 27, wherein the parameter comprises at least one of a presence of flow, a rate of flow, and a change in a rate of flow.

31. The apparatus of claim 25, wherein the adjustment module operates from substantially outside the patient'"'"'s body to adjust the gastric restriction device to change a dimension of the stomach lumen.

32. The apparatus of claim 25, wherein the adjustment module is electrically coupled to the acoustic-energy detector.

33. The apparatus of claim 25, further comprising a microprocessor that is operative to collect and interpret output signals received from the acoustic- energy detector.

34. The apparatus of claim 33, further comprising a memory module, operative to store data collected during one or more test sessions.

35. A gastric flow-detection system, comprising:

a flow-detection module, comprising;

an acoustic-energy detector configured to detect sound that correlates with movement of a test substance within a patient'"'"'s stomach lumen and past a gastric restriction device that has been placed in the patient; and

an attachment module that is coupled to the flow-detection module, the attachment module being attachable to the body of the patient.

36. The system of claim 35, further comprising a display that indicates a parameter of flow of the test substance flowing in the stomach lumen and past the gastric restriction device.

37. The system of claim 36, wherein the display means provides at least one of an audible, visible, and tactile alert.

38. The system of claim 36, wherein the display comprises at least one of an audible tone, an LED, a video display, a numerical display, vibration, and heat.

39. The system of claim 36, wherein the parameter comprises at least one of a presence of flow, a rate of flow, and a change in a rate of flow.

40. The system of claim 35, wherein the attachment module comprises a strap.

41. The system of claim 35, wherein the attachment module comprises at least one adhesive strip.

42. The system of claim 35, further comprising an adjustment module that operates to adjust the gastric restriction device to change a dimension of the stomach lumen, wherein the adjustment module is coupled to the flow-detection module.

43. The system of claim 42, wherein the adjustment module is electrically coupled to the flow-detection module.

44. The system of claim 35, further comprising a microprocessor that is operative to collect and interpret output signals received from the acoustic-energy detector.

45. The system of claim 35, further comprising a memory module, operative to store data collected during one or more test sessions.

46. A system for detecting movement of a test substance in a patient'"'"'s stomach lumen past a gastric restriction device, comprising:

means for detecting acoustic energy that correlates with movement of the test substance within the stomach lumen and past the gastric restriction device; and

means for indicating a parameter of flow of the test substance flowing in the stomach lumen and past the gastric restriction device.

47. The system of claim 46, wherein the means for detecting comprises a sensor that is configured to detect at least one of sound, ultrasound, and Doppler shift echoes produced by ultrasound.

48. The system of claim 46, wherein the means for indicating comprises at least one of an audible, visible, and tactile alert.

49. The system of claim 46, wherein the means for indicating comprises at least one of an audible tone, an LED, a video display, a numerical display, vibration, and heat.

50. The system of claim 46, further comprising means for attaching the means for detecting to the patient.

51. The system of claim 50, wherein the means for attaching comprises a strap.

52. The system of claim 50, wherein the means for attaching comprises at least one adhesive strip.

53. The system of claim 46, further comprising means for adjusting the gastric restriction device to change a dimension of the stomach lumen.

54. An apparatus for detecting movement of a test substance in a stomach lumen past a gastric restriction device, comprising:

an acoustic-energy detector configured to detect sound energy having at least one of a frequency and an intensity that correlates with movement of the test substance within the stomach lumen and past the gastric restriction device; and

a display that indicates a parameter of flow of the test substance flowing in the stomach lumen and past the gastric restriction device;

wherein the display is coupled to the acoustic-energy detector.

55. A system for ascertaining flow of fluid passing through a restricted portion of a gastric lumen of a patient, the system comprising:

a test fluid comprising a carrier fluid and a metal; and

a metal detector configured to output a signal corresponding, at least in part, to flow of the test fluid through the restricted portion of the gastric lumen.

56. The system of claim 55, wherein the output signal corresponds to the flow rate of the test fluid through the restricted portion of the gastric lumen.

57. The system of claim 55, wherein the metal comprises Barium.