SYSTEMS AND METHODS FOR ADJUSTING GASTRIC BAND PRESSURE

• US 20120083650A1
• Filed: 09/30/2010
• Published: 04/05/2012
• Est. Priority Date: 09/30/2010
• Status: Abandoned Application

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Raven, Joseph S.
• Application Number:
  US12/894,718
• Publication Number:
  US 20120083650A1
• Time in Patent Office: Days
• US Class Current: 600/37
• 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 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61F 5/0056 using injection ports
• CPC Class Codes: A61F 5/0059 with wireless means

Abstract

The present invention provides for an obesity treatment system for use in conjunction with a gastric band suitable for laparoscopic placement around a stomach of a patient to create a stoma. The obesity treatment system may use real-time objective measurement and clinical data to provide an optimal gastric band adjustment for the patient. The obesity treatment system may include a pressure sensing device coupled to the gastric band, and configured to detect a maximum tolerable pressure, and a pressure changing device coupled to the gastric band, and configured to adjust the gastric band for asserting an optimal pressure against the stomach of the patient, the optimal pressure based on an optimal pressure percentage and the maximum tolerable pressure.

Claims

1. An obesity treatment system for use in conjunction with a gastric band suitable for laparoscopic placement around a stomach of a patient to create a stoma, the obesity treatment system using real-time objective measurement and clinical data to provide an optimal gastric band adjustment for the patient, the obesity treatment system comprising:

a pressure sensing device coupled to the gastric band, and configured to detect a maximum tolerable pressure asserted by the gastric band against the stomach of the patient; and

a pressure changing device coupled to the gastric band, and configured to adjust the gastric band for asserting an optimal pressure against the stomach of the patient, the optimal pressure based on an optimal pressure percentage and the maximum tolerable pressure.

2. The system of claim 1, wherein the maximum tolerable pressure is an iso-static pressure asserted by the gastric band against the stomach of the patient.

3. The system of claim 1, wherein the maximum tolerable pressure is representative of the patient'"'"'s tolerance to a pressure asserted by the gastric band.

4. The system of claim 3, wherein the maximum tolerable pressure is the pressure causing the stoma of the stomach of the patient to be substantially closed.

5. The system of claim 3, wherein the maximum tolerable pressure is the pressure causing the patient to experience a discomfort selected from a group consisting of lower thoracic tightness, nausea, stomach obstruction, regurgitation, reflux, pressured back throat and combinations thereof.

6. The system of claim 3, wherein the maximum tolerable pressure is the pressure causing the stomach or an esophagus of the patient to induce a series of reactive pressure spikes against the gastric band while the patient is swallowing a bolus, and wherein the pressure sensing device is configured to sense the series of reactive pressure spikes, thereby detecting the maximum tolerable pressure.

7. The system of claim 1, wherein the optimal pressure percentage is based on a normal distribution of a plurality of clinical data from a plurality of subjects, each implanted with a subject gastric band, having weight loss results range from about 20% to about 50% excess weight loss within about one year after implanted with the subject gastric bands.

8. The system of claim 7, wherein the weight loss results range from about 30% to about 40% excessive weight loss.

9. The system of claim 1, wherein the optimal pressure percentage is based on a normal distribution of a plurality of clinical data from a plurality of subjects, each implanted with a subject gastric band, having a total occurrence rate of hiatal hernia ranges from about 0.5% to about 0.00001%.

10. The system of claim 1, wherein the gastric band has:

an inflatable portion placed around the stomach of the patient, the inflatable portion configured to control a size of the stoma; and

an access port configured to maintain the pressure within the inflatable portion of the gastric band by retaining a fluid disposed therein.

11. The system of claim 10, wherein the pressure changing device comprises:

a needle having a tapered end and a base end, the tapered end of the needle configured to coupled to the inflatable portion of the gastric band via the access port,

a multi-port device having first, second, and third ports, the first port coupled to the base end of the needle, the second port coupled to the pressure sensing device, and

an adjustable volume chamber coupled to the third port of the multi-port device, and configured to add or remove the fluid from the inflatable portion of the gastric band, thereby adjusting the pressure therein.

12. An obesity treatment system for use in conjunction with a gastric band suitable for laparoscopic placement around a stomach of a patient to create a stoma, the obesity treatment system using real-time objective measurement and clinical data to provide optimal gastric band adjustment for the patient, the system comprising:

an external controller configured to calculate an optimal pressure percentage, and telemetrically transmit an adjustment signal carrying an adjustment command based on the optimal pressure percentage; and

an implantable controller coupled to the gastric band, configured to receive and process the adjustment signal, thereby retrieving the adjustment command, the implantable controller having;

a pressure sensing device configured to detect a maximum tolerable pressure asserted by the gastric band against the stomach of the patient, and

a pressure changing device configured to adjust the gastric band for asserting an optimal pressure against the stomach of the patient, the optimal pressure based on the adjustment command and the maximum tolerable pressure.

13. The system of claim 12, wherein the maximum tolerable pressure is a pressure, asserted by the gastric band against the stomach of the patient, causing the stoma to be substantially closed.

14. The system of claim 12, wherein the maximum tolerable pressure is a pressure, asserted by the gastric band against the stomach of the patient, causing the patient to experience a discomfort selected from a group consisting of lower thoracic tightness, nausea, stomach obstruction, regurgitation, reflux, pressured back throat and combinations thereof.

15. The system of claim 12, wherein the maximum tolerable pressure is a pressure, asserted by the gastric band against the stomach of the patient, causing the stomach or esophagus of the patient to induce a series of reactive pressure spikes against the gastric band while the patient is swallowing a bolus, and wherein the pressure sensing device is configured to sense the series of reactive pressure spikes, thereby detecting the maximum tolerable pressure.

16. The system of claim 12, wherein the optimal pressure percentage is based on a normal distribution of a plurality of clinical data from a plurality of subjects, each implanted with a subject gastric band, and each having:

a subject gastric band pressure based on the subject'"'"'s maximum tolerable pressure;

a weight loss result ranges from about 30% to about 40% excessive weight loss within about one year after the subjects are implanted with the subject gastric bands, and

the successful safety result is defined by an occurrence rate of hiatal hernia among the plurality of subjects, the occurrence rate ranges from about 0.5% to about 0.00001%.

17. An obesity treatment system, used in conjunction with a gastric band suitable for laparoscopic placement around a stomach of a patient to create a stoma, for determining the patient'"'"'s maximum tolerance to a pressure asserted by the gastric band against the patient'"'"'s stomach, the obesity treatment system comprising:

a pressure changing device configured to be coupled to the gastric band, the pressure changing device configured to repeatedly increase the pressure before the patient swallows a bolus at a step increment for every predetermined time period until a maximum tolerance event occurs; and

a pressure sensing device configured to be coupled to the gastric band, the pressure sensing device configured to detect a maximum tolerable pressure when the maximum tolerance event occurs.

18. The system of claim 17, wherein the maximum tolerance event is defined as:

the patient experiences a discomfort selected from a group consisting of lower thoracic tightness, nausea, stomach obstruction, regurgitation, reflux, pressured back throat and combinations thereof, or

the stomach of the patient induces a series of reactive pressure spikes against the gastric band and the series of reactive pressure spikes is sensed by the pressure sensing device.

19. The system of claim 17, wherein the step increment is about 0.3 psi to about 1 psi, and wherein the predetermined time period is about 1 minute to 2 minutes.

20. An obesity treatment system for collecting, processing and utilizing clinical data from a plurality of patients, each patient implanted with a gastric band suitable for laparoscopic placement around the patient'"'"'s stomach to create a stoma, the system comprising:

a memory configured to store a plurality of records, each record having excess weight loss percentage and an adverse event rate relatable to at least one of the plurality of patients; and

a processor, coupled to the memory, configured to;

create a target group of records from the plurality of records based on a weight loss criterion or a safety criterion, the weight loss criterion selecting the record having the excess weight loss percentage ranges from about 20% to about 50%, the safety criterion selecting the record having the adverse event rate at about 0.05% to about 0.01%,

determine a normal distribution of the target group of records, and

calculate an optimal pressure percentage based on the normal distribution.

21. The system of claim 20, wherein each of the plurality of record comprises:

a maximum tolerable pressure value representative of the respective patient'"'"'s maximum tolerance of a pressure asserted by the respective gastric band against the stomach of the respective patient;

a current gastric band pressure value indicating a current pressure asserted by the respective gastric band against the stomach of the respective patient; and

a pressure percentage value based on a ratio between the current gastric band pressure value and the maximum tolerable pressure value.

22. The system of claim 21, wherein the maximum tolerable pressure is an iso-static pressure asserted by the respective gastric band against the stomach of the respective patient.

23. The system of claim 21, wherein the maximum tolerable pressure is the pressure causing the stoma of the stomach of the respective patient to be substantially closed.

24. The system of claim 21, wherein the maximum tolerable pressure is the pressure causing the patient to experience a discomfort selected from a group consisting of lower thoracic tightness, nausea, stomach obstruction, regurgitation, reflux, pressured back throat and combinations thereof.

25. The system of claim 21, wherein the maximum tolerable pressure is the pressure causing the stomach or an esophagus of the patient to induce a series of reactive pressure spikes against the gastric band while the patient is swallowing a bolus.

26. The system of claim 21, wherein the adverse event rate is defined by a frequency of occurrence of an adverse event selected from a group consisting of hiatal hernia, bleeding, symmetrical pouch dilatation, death, serious bodily injury, and combinations thereof, the frequency of occurrence measured among a group of records having the pressure percentage values that are substantially close to one another.

27. The system of claim 20, wherein each of the plurality of records comprises:

an initial weight of the respective patient before implanted with the respective gastric band;

a current weight of the respective patient about one year after implanted with the respective gastric band; and

the excess weight loss percentage defined by a ratio of a difference between the initial weight and the current weight over a difference between the initial weight and a predefined nominal weight.

28. The system of claim 20, wherein the weight loss criterion selects the record having the excess weight loss percentage ranges from about 30% to about 40%.

29. The system of claim 20, wherein the safety criterion selects the record having the adverse event rate ranges from about 0.1% to 0.0001%.

30. A method for treating obesity, used in conjunction with a gastric band suitable for laparoscopic placement around a stomach of a patient to create a stoma, the method using real-time objective measurement and clinical data to provide optimal gastric band adjustment for the patient, the method comprising the steps of:

detecting a maximum tolerable pressure asserted by the gastric band against the stomach of the patient;

receiving an optimal pressure percentage based on a plurality of clinical data from a plurality of subjects using a plurality of subject gastric bands; and

adjusting the gastric band for asserting an optimal pressure against the stomach of the patient, the optimal pressure based on the optimal pressure percentage and the maximum tolerable pressure.

31. The method of claim 30, wherein detecting the maximum tolerable pressure comprises the steps of:

repeatedly increasing, using a pressure changing device configured to be coupled to the gastric band, a gastric band pressure, at a step increment for every predetermined time period, against the stomach of the patient before the patient swallows a bolus until a maximum tolerance event occurs; and

detecting, using a pressure sensing device configured to be coupled to the gastric band, the maximum tolerable pressure when the maximum tolerance event occurs.

32. The method of claim 31, wherein the maximum tolerance event is defined as:

the patient experiences a discomfort selected from a group consisting of stomach tightness, nausea, lower thoracic tightness, obstruction, regurgitation, reflux, pressured back throat, and combinations thereof, or

the stomach or an esophagus of the patient induces a series of reactive pressure spikes against the gastric band and the series of reactive pressure spikes is sensed by the pressure sensing device.

33. The method of claim 31, wherein the step increment is about 0.3 psi to about 1 psi, and wherein the predetermined time period is about 1 minute to 2 minutes.

34. The method of claim 30, wherein the optimal pressure percentage is determined using a method comprising the steps of:

storing, using a memory, a plurality of records, each record having an excess weight loss percentage and an adverse event rate relatable to at least one of the plurality of subjects;

creating, using a processor coupled to the memory, a target group of records from the plurality of records based on a weight loss criterion or a safety criterion, the weight loss criterion selecting the record having the excess weight loss percentage ranges from about 20% to about 50%, the safety criterion selecting the record having the adverse event rate at about 0.05% to about 0.01%;

determining, using the processor, a normal distribution of the target group of records; and

calculating, using the processor, an optimal pressure percentage based on the normal distribution.

35. The method of claim 34, wherein each of the plurality of records comprises:

an initial weight of the respective subject before implanted with the respective subject gastric band;

a current weight of the respective subject about one year after implanted with the respective subject gastric band; and

the excess weight loss percentage defined by a ratio of a difference between the initial weight and the current weight over a difference between the initial weight and a predefined nominal weight.

36. The method of claim 34, wherein the weight loss criterion selects the record having the excess weight loss percentage ranges from about 30% to about 40%.

37. The method of claim 34, wherein each of the plurality of record comprises:

a maximum tolerable pressure value representative of the respective patient'"'"'s maximum tolerance of a pressure asserted by the respective gastric band against the stomach of the respective patient;

a current gastric band pressure value indicating a current pressure asserted by the respective gastric band against the stomach of the respective patient; and

pressure percentage value based on a ratio between the current gastric band pressure value and the maximum tolerable pressure value.

38. The method of claim 37, wherein the adverse event rate is defined by a frequency of occurrence of an adverse event selected from a group consisting of hiatal hernia, bleeding, symmetrical pouch dilatation, death, serious bodily injury, and combinations thereof, the frequency of occurrence measured among a group of records having the pressure percentage values that are substantially close to one another.

39. The method of claim 34, wherein the safety criterion selects the record having the adverse event rate at about 0.05%.

40. A gastric band adjustment device, used in conjunction with a gastric band suitable for laparoscopic placement around a stomach of a patient to create a stoma, the gastric band having a pressure sensing device for sensing a pressure asserted by the gastric band against the stomach of the patient and a pressure changing device for changing the pressure asserted by the gastric band, the gastric band adjustment device comprising:

a memory configured to store an optimal pressure percentage value; and

a processor, coupled to the memory, configured to;

receive the pressure detected by the pressure sensing device of the gastric band,

derive a maximum tolerable pressure based on the pressure detected by the pressure sensing device and a maximum tolerance event, the maximum tolerable pressure representative of the patient'"'"'s maximum tolerance to the pressure asserted by the gastric band,

calculate an optimal pressure based on the optimal pressure percentage and the maximum tolerable pressure,

generate a pressure adjustment command based on the optimal pressure, and

remotely adjust the gastric band pressure by transmitting the pressure adjustment command to the pressure changing device of the gastric band via the external transceiver.

41. The device of claim 40, wherein the maximum tolerance event is defined as:

the patient experiences a discomfort selected from a group consisting of stomach tightness, nausea, stomach obstruction, regurgitation, and combinations thereof, or

the stomach or an esophagus of the patient induces a series of reactive pressure spikes against the gastric band and the series of reactive pressure spikes is sensed by the pressure sensing device.

42. The device of claim 40, wherein the optimal pressure percentage is based on a normal distribution of a plurality of clinical data from a plurality of subjects, each implanted with a subject gastric band, and each having:

a subject gastric band pressure based on the subject'"'"'s maximum tolerable pressure;

a weight loss result ranges from about 30% to about 40% excess weight loss within about one year after the subjects are implanted with the subject gastric bands, and

the successful safety result is defined by an occurrence rate of hiatal hernia among the plurality of subjects, the occurrence rate ranges from about 0.1% to about 0.0001%.