INTRAGASTRIC VOLUME OCCUPYING DEVICE WITH ACTIVE AGENTS

• US 20120245553A1
• Filed: 03/25/2011
• Published: 09/27/2012
• Est. Priority Date: 03/25/2011
• Status: Abandoned Application

• Current Assignee: Apollo Endosurgery, Inc. (Boston Scientific Corporation)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Raven, Joseph S., Birk, Janel A.
• Application Number:
  US13/072,594
• Publication Number:
  US 20120245553A1
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61F 5/004 remotely adjustable
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61N 1/0509 Stomach and intestinal electrodes
• CPC Class Codes: A61N 1/0517 Esophageal electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves

Abstract

An implantable intragastric volume occupying device system is provided which generally includes a volume occupying device and an active agent, for example, a metabolic agent or satiety inducing agent. The volume occupying device may be structured to contain the agent and permit controlled release of the agent to the patient while the volume occupying device is positioned within the patient'"'"'s stomach. Methods for treating obesity are also provided which include positioning a volume occupying device in the stomach of a patient and administering a satiety inducing agent to the patient while the volume occupying device is positioned in the stomach. In one embodiment, the active agent may be contained in a reservoir and dispensed to a portion of the patient'"'"'s body.

Claims

1. An implantable intragastric volume occupying system for the treatment of obesity comprising:

a volume occupying device configured to occupy volume within a patient'"'"'s stomach;

an implantable sensor coupled to the volume occupying device and configured to sense a biological characteristic of the patient; and

an external control device configured to receive a telemetric signal sent in response to the biological characteristic being sensed by the implantable sensor, and to produce a notification to perform an action effective to vary the biological characteristic sensed by the implantable sensor.

2. The system of claim 1, wherein the biological characteristic sensed by the implantable sensor is a hormone level of the patient.

3. The system of claim 1, wherein the telemetric signal is sent telemetrically from a transmitter integrated with the implantable sensor.

4. The system of claim 1, wherein the notification is selected from a group consisting of a visual notification, an auditory notification, a movement of the external control device, and combinations thereof.

5. The system of claim 1, wherein the action is selected from a group consisting of injection of a hormone into the patient'"'"'s body;

inhalation of a hormone by the patient;

drinking of a hormone by the patient;

application of a patch to the patient'"'"'s body being capable of distributing a hormone to the patient;

spraying of a hormone into the patient'"'"'s mouth;

swallowing of a pill by the patient containing a hormone;

insertion of a gum or film containing a hormone into the patient'"'"'s mouth; and

combinations thereof.

6. An implantable intragastric volume occupying device system for the treatment of obesity comprising:

a volume occupying device configured to occupy volume within a patient'"'"'s stomach, and including a reservoir configured to contain an active agent being effective, when released into the patient, to at least assist in effecting weight loss in the patient, at least a portion of the volume occupying device including a semi-permeable membrane configured to allow the active agent to exit the reservoir and contact a portion of the patient'"'"'s body.

7. The system of claim 6, wherein the volume occupying device includes an inflatable balloon.

8. The system of claim 7, wherein the inflatable balloon has a shape selected from a group consisting of a substantially spherical shape, a substantially disk-like shape, and combinations thereof.

9. The system of claim 7, wherein the reservoir is positioned within the inflatable balloon.

10. The system of claim 6, wherein at least a portion of the volume occupying device forms a shell around the reservoir.

11. The system of claim 6, wherein the volume occupying device includes a tube extending from the reservoir, and the semi-permeable membrane forms at least a portion of a tube.

12. The system of claim 6, wherein the volume occupying device includes a tube having a first end connected to the reservoir and a second end configured to dispense the active agent from the reservoir to a portion of the patient'"'"'s body.

13. The system of claim 12, wherein the second end of the tube is configured to be positioned in the patient'"'"'s upper intestine and dispense the active agent from the reservoir to the patient'"'"'s upper intestine.

14. The system of claim 6, wherein the semi-permeable membrane forms an outer surface of the reservoir.

15. The system of claim 6, further comprising a pump configured to allow the active agent to exit the reservoir and contact a portion of the patient'"'"'s body.

16. The system of claim 15, further comprising a sensor configured to detect a hormone level of the patient.

17. The system of claim 16, wherein the sensor is configured to transmit a signal to the pump in response to a hormone level detected by the sensor.

18. The system of claim 6, wherein the reservoir includes a one-way valve.

19. The system of claim 18, wherein the one-way valve is configured to allow the active agent to exit the reservoir in response to a force exerted against the reservoir by the patient'"'"'s stomach or by food in the patient'"'"'s stomach.

20. The system of claim 6, further comprising an electrode configured to produce an electrical charge on a side of the semi-permeable membrane, to enhance or impede diffusion of the active agent through the semi-permeable membrane.

21. The system of claim 6, further comprising an electrode configured to apply a voltage to the semi-permeable membrane.

22. The system of claim 21, wherein the voltage causes a size of a pore of the semi-permeable membrane to vary.

23. The system of claim 6, wherein the semi-permeable membrane is made from a material having a property that causes a size of a pore of the semi-permeable membrane to vary automatically in response to an environmental condition in the patient'"'"'s body.

24. The system of claim 6, wherein the reservoir is configured to store bacteria that produce the active agent.

25. The system of claim 24, wherein pores of the semi-permeable membrane are sized to prevent the bacteria from exiting the reservoir.

26. The system of claim 6, further comprising an active agent.

27. The system of claim 26, wherein the active agent is selected from a group consisting of Glucagon-like peptide (GLP-1), Oxyntomodulin (OXM), Peptide YY (PYY), Pancreatic Polypeptide (PP), Insulin, Leptin, Gastrin, Gherlin blocker, inhibitors of DPP-IV, Amylin, Cholecystokinin (CCK), Pro-opiomelanocortin (POMC), and combinations thereof.

28. The system of claim 6, further comprising an electrode coupled to the volume occupying device and being configured to apply electric stimulation to a portion of the patient'"'"'s body.

29. The system of claim 6, wherein an outer surface of the volume occupying device is coated with an active agent being effective, when released into the patient, to at least assist in effecting weight loss in the patient.

30. A method for the treatment of obesity comprising the step of:

implanting a volume occupying device into a patient'"'"'s stomach, the volume occupying device being configured to occupy volume within the patient'"'"'s stomach, and including a reservoir configured to contain an active agent being effective, when released into the patient, to at least assist in effecting weight loss in the patient, at least a portion of the volume occupying device including a semi-permeable membrane configured to allow the active agent to exit the reservoir and contact a portion of the patient'"'"'s body.

31. The method of claim 30, wherein the volume occupying device includes an inflatable balloon.

32. The method of claim 31, further comprising a step of inflating the inflatable balloon.

33. The method of claim 32, wherein the active agent fills the inflatable balloon to inflate the inflatable balloon.

34. The method of claim 30, wherein the volume occupying device includes a tube having a first end coupled to the reservoir and a second end configured to dispense the active agent from the reservoir to the portion of the patient'"'"'s body.

35. The method of claim 34, further comprising a step of positioning the second end of the tube in the patient'"'"'s upper intestine.

36. A method for the treatment of obesity comprising the steps of:

inserting an electrode into a patient'"'"'s body laparoscopically; and

coupling the electrode to the lower third of the patient'"'"'s esophagus, the electrode configured to apply electric stimulation to the lower third of the patient'"'"'s esophagus,

wherein the electrode is utilized in combination with a volume occupying device positioned within the patient'"'"'s stomach.

37. The method of claim 36, wherein the electric stimulation promotes a sensation of satiety for the patient.

38. The method of claim 36, wherein the electrode is coupled to a control device configured to cause the electrode to apply the electric stimulation to the lower third of the patient'"'"'s esophagus.

39. The method of claim 38, wherein the volume occupying device is configured to transmit a signal to the control device that causes the electrode to apply the electric stimulation to the lower third of the patient'"'"'s esophagus.

40. The method of claim 39, wherein the volume occupying device is configured to transmit the signal in response to a force being exerted against the volume occupying device by the patient'"'"'s stomach or by food in the patient'"'"'s stomach.

41. The method of claim 36, wherein the step of inserting the electrode into the patient'"'"'s body laparoscopically further comprises inserting a plurality of electrodes into the patient'"'"'s body laparoscopically, and the step of coupling the electrode to the lower third of the patient'"'"'s stomach further comprises coupling the plurality of electrodes to the lower third of the patient'"'"'s esophagus along the vagus nerve.