Methods and devices for diagnosing performance of a gastric restriction system

• US 8,337,389 B2
• Filed: 01/28/2008
• Issued: 12/25/2012
• Est. Priority Date: 01/28/2008
• Status: Expired due to Fees

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Dlugos, Daniel F. Jr., Ortiz, Mark S., Marcotte, Amy L., Byrum, Randal T., Plescia, David N., Harris, Jason L., Zeiner, Mark S.
• Primary Examiner(s): Hoekstra, Jeffrey G
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US12/020,880
• Publication Number:
  US 20090192533A1
• Time in Patent Office: 1,793 Days
• Field of Search: 600/587, 600/593, 600 29- 32, 600/37, 128897-899, 606139-141, 606/157, 606201-203, 606/213, 606/228, 606/151, 606/192, 604 27- 28, 604/909
• US Class Current: 600/37
• 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:

receiving a first set of data manually input by a patient, the first set of data including at least one of patient satiety level and a type of food eaten by the patient;

correlating a first sequence of gathered pressure data values regarding a restriction device implanted in the patient to form a restriction with the first set of data to determine a baseline correlation;

after determining the baseline correlation, receiving a second sequence of gathered pressure data values regarding the restriction device;

comparing the baseline correlation against the second sequence of pressure data values characteristic of the patient;

determining, if the second sequence of gathered pressure data values varies from the baseline correlation of pressure data values, a possible cause of the variation and a suggested corrective action to be performed by a user externally of the patient to address the determined possible cause of the variation;

determining, based on the determined suggested corrective action, at least one user among a plurality of users to receive notice of the suggested corrective action; and

providing notice of the possible cause of the variation and the suggested corrective action to the at least one user suggesting that the at least one user perform the suggested corrective action externally of the patient.

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

4. The method of claim 1, wherein the suggested corrective action to be performed by the user includes any one of more thoroughly chewing food, seeking medical attention, adjusting diet, and adjusting eating habits.

5. The method of claim 1, wherein providing notice of the suggested corrective action includes providing notice of the suggested corrective action to the user using a feedback mechanism immediately after determining of the suggested corrective action.

6. 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.

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

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

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

10. The method of claim 1, further comprising comparing the type 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.

11. The system of claim 1, wherein the user includes at least one of the patient and a physician.

12. The method of claim 1, wherein the first of data is manually inputted by the patient at regular time intervals.

13. 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 in frequency, magnitude, or duration;

if the pressure varies from the expected pressure, determining at least one user among a plurality of users to receive notice of an alarm;

triggering the alarm; and

communicating the alarm to the at least one user in real time with determining if the pressure varies from the expected pressure, wherein the alarm informs the at least one user of an action for the patient to perform after receiving the alarm to address the difference between the measured pressure and the expected pressure, the action including an eating habit modification for a subsequent meal.

14. The method of claim 13, wherein triggering an alarm includes displaying on a display device a notice that the measured pressure over the period of time was determined to differ from the expected pressure over the period of time.

15. The method of claim 13, wherein the expected pressure includes historical pressure data for the implantable restriction device in the patient.

16. The method of claim 13, wherein the expected pressure includes an expected pressure for a typical patient.

17. The method of claim 13, further comprising diagnosing at least one possible cause of the difference between the measured pressure over the period of time and the expected pressure over the period of time.

18. The method of claim 17, further comprising choosing the alarm to be triggered based on at least one diagnosed possible cause.

19. 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;

an input device configured to receive variable data manually input by the patient; and

a processor configured to determine a baseline correlation between a pressure profile including two or more pressure data values measured by the pressure measuring element with the variable data collected by the input device and received by the processor;

wherein the processor is configured to determine, if a measured correlation between the variable data input by the patient and the pressure profile varies from the baseline correlation, at least one possible cause of the difference and a possible corrective action to be performed by a user external to the patient to address the difference; and

wherein the processor is configured to provide notice of the possible corrective action to the user suggesting that the user perform the possible corrective action externally of the patient if the measured correlation varies from the baseline correlation;

wherein the variable data includes at least one of food type and satiety level of the patient, the food type being solid or liquid food.

20. The system of claim 19, wherein the 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.

21. The system of claim 19, wherein the 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.

22. The system of claim 19, further comprising a base unit including the processor, wherein the base unit is at a location remote from the patient.

23. The system of claim 19, further comprising an external storage mechanism including the processor, wherein the external storage mechanism is at a location local to the patient.

24. The system of claim 19, further comprising an external display device configured to provide the notice if the pressure profile differs from the baseline pressure profile.

25. The system of claim 24, wherein the display device is configured to allow the user to trigger the possible corrective action to address the difference.

26. The system of claim 19, 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.

27. The system of claim 26, wherein the processor is configured to generate a pressure profile using pressure data values retrieved from the storage mechanism.