METHODS AND DEVICES FOR DIAGNOSING PERFORMANCE OF A GASTRIC RESTRICTION SYSTEM

• US 20090192533A1
• Filed: 01/28/2008
• Published: 07/30/2009
• Est. Priority Date: 01/28/2008
• Status: Active Grant

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Ortiz, Mark S., Harris, Jason L., Dlugos, Daniel F. JR., Plescia, David N., Marcotte, Amy L., Zeiner, Mark S., Byrum, Randal T.
• Granted Patent: US 8,337,389 B2
• Time in Patent Office: Days
• US Class Current: 606/157
• CPC Class Codes: A61B 5/037 Measuring oesophageal pressure
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/687 Oesophagus
• CPC Class Codes: A61B 5/6871 Stomach
• CPC Class Codes: A61F 5/005 Gastric bands
• CPC Class Codes: A61F 5/0059 with wireless means

Abstract

Methods and devices are provided for diagnosing performance of a gastric restriction system. In general, the methods and devices can enable patients, health care providers, and others to use pressure data as a feedback mechanism to monitor efficacy of an implantable restriction device and to identify, train, and/or prescribe treatment plan options. Pressure data monitoring can be used locally and/or remotely to monitor a restriction in a patient and compare gathered pressure data with a typical pressure of the restriction. Based on the results of the comparison, possible problems related to the patient and the restriction can be identified and diagnosed with possible cause(s) and solution(s). Notice of any detected possible problems, causes, and/or solutions can be provided to a user.

Claims

1. A method of monitoring a restriction in a patient, comprising:

comparing a sequence of gathered pressure data values regarding a restriction device implanted in a patient to form a restriction against a baseline sequence of pressure data values characteristic of the patient; and

determining, if the sequence of gathered pressure data values varies from the baseline sequence of pressure data values, a possible cause of the variation.

2. The method of claim 1, further comprising gathering the sequence of pressure data values using an implantable pressure measuring device in communication with the restriction device.

3. The method of claim 1, further comprising gathering the sequence of pressure data values using an external sensing system.

4. The method of claim 1, further comprising determining, if the sequence of gathered pressure data values varies from the baseline sequence of pressure data values, a suggested corrective action to address the determined possible cause of the variation.

5. The method of claim 4, wherein the suggested corrective action includes any one of adjusting an amount of fluid disposed within the restriction device, advising the patient to more thoroughly chew food, advising the patient to seek medical attention, recommending that the patient adjust diet, and recommending that the patient adjust eating habits.

6. The method of claim 4, further comprising triggering an alarm to provide notice of the suggested corrective action.

7. The method of claim 6, wherein triggering an alarm includes immediately providing notice of the suggested corrective action to a patient using a feedback mechanism.

8. The method of claim 1, wherein the possible cause of the variation is any one of too much fluid disposed within the restriction device and too little fluid disposed within the restriction device.

9. The method of claim 1, wherein determining a possible cause of the variation includes determining whether the sequence of gathered pressure data values includes pressure data values above and/or below pressure data values included in the baseline sequence of pressure data values.

10. The method of claim 1, wherein determining a possible cause of the variation includes determining whether a duration of the sequence of gathered pressure data values varies from a duration of the baseline sequence of pressure data values.

11. The method of claim 1, wherein determining a possible cause of the variation includes determining whether a frequency of data values included in the sequence of gathered pressure data values varies from a frequency of data values included in the baseline sequence of pressure data values.

12. The method of claim 1, further comprising correlating the sequence of gathered pressure data with a record of patient satiety levels.

13. The method of claim 1, further comprising correlating the sequence of gathered pressure data with a record of food eaten by the patient and determining, based on the correlation, if an eating habit modification should be suggested to the patient.

14. The method of claim 13, further comprising comparing the record of food eaten by the patient with the patient'"'"'s weight loss trend and determining, based on the comparing, if a corrective action should be taken.

15. A method of monitoring a restriction in a patient, comprising:

determining if a pressure within an implantable restriction device configured to form a restriction in a patient measured over a period of time differs from an expected pressure over the period of time; and

triggering an alarm if the pressure measured over the period of time differs from the expected pressure over the period of time.

16. The method of claim 15, wherein triggering an alarm includes displaying on a display device a notice that the pressure measured over the period of time was determined to differ from the expected pressure over the period of time.

17. The method of claim 15, further comprising generating the expected pressure over the period of time using historical pressure data for the implantable restriction device in the patient.

18. The method of claim 15, wherein the expected pressure includes an expected pressure for a typical patient.

19. The method of claim 15, further comprising diagnosing at least one possible cause of the difference between the pressure measured over the period of time and the expected pressure over the period of time.

20. The method of claim 19, further comprising choosing the alarm to be triggered based on at least one diagnosed possible cause.

21. A system for monitoring a restriction in a patient, comprising:

a pressure measuring element configured to measure a pressure within an implantable restriction device configured to form a restriction in a patient; and

a processor configured to compare a pressure profile including two or more pressure data values measured by the pressure measuring element with a baseline pressure profile for the patient and to determine if the pressure profile differs from the baseline pressure profile.

22. The system of claim 21, wherein the baseline pressure profile includes typical pressure data values for the patient over a time of day corresponding to a time of day when the pressure measuring element gathered the pressure data values included in the pressure profile.

23. The system of claim 21, wherein the baseline pressure profile includes pressure data values for a typical patient over a time of day corresponding to a time of day when the pressure measuring element gathered the pressure data values included in the pressure profile.

24. The system of claim 21, further comprising a base unit including the processor, wherein the base unit is at a location remote from the patient.

25. The system of claim 21, further comprising an external storage mechanism including the processor, wherein the external storage mechanism is at a location local to the patient.

26. The system of claim 21, further comprising an external display device configured to provide a notice if the pressure profile differs from the baseline pressure profile.

27. The system of claim 26, wherein the display device is configured to allow a user to trigger a corrective action to address the difference.

28. The system of claim 21, wherein the processor is configured to determine, if the pressure profile differs from the baseline pressure profile, at least one possible cause of the difference and a possible corrective action to address the difference.

29. The system of claim 21, further comprising a storage mechanism configured to store pressure data values measured by the pressure measuring element, wherein the processor is configured to retrieve stored pressure data values from the storage mechanism.

30. The system of claim 29, wherein the processor is configured to generate a pressure profile using pressure data values retrieved from the storage mechanism.