REMOTELY ADJUSTABLE GASTRIC BANDING SYSTEM

• US 20110201874A1
• Filed: 02/12/2010
• Published: 08/18/2011
• Est. Priority Date: 02/12/2010
• Status: Abandoned Application

• Current Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Leslie, Dustin, Tezel, Ahmet, Snow, Sean, Birk, Janel
• Application Number:
  US12/705,245
• Publication Number:
  US 20110201874A1
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0056 using injection ports
• CPC Class Codes: A61F 5/0059 with wireless means

Abstract

An implantable device comprises a reservoir for holding a fluid and a sensor positioned between the gastric band and the reservoir. The sensor monitors a parameter of the fluid when filling and draining the inflatable portion of the gastric band. A first flow control device controls a flow of the fluid when filling and draining the inflatable portion of the gastric band. A pumping device moves the fluid into and out of the inflatable portion of the gastric band, and the pumping device is capable of being activated and deactivated using a telemetric signal received from a remote device.

Claims

1. An implantable device for filling and draining an inflatable portion of a gastric band, the implantable device comprising:

a reservoir for holding a fluid;

a sensor positioned between the gastric band and the reservoir, the sensor having a first inlet and a second inlet, the fluid flowing from the first inlet to the second inlet when filling the inflatable portion of the gastric band, the fluid flowing from the second inlet to the first inlet when draining the inflatable portion of the gastric band, the sensor monitoring a parameter of the fluid when filling and draining the inflatable portion of the gastric band;

a first flow control device, coupled to the first inlet of the sensor, for controlling a flow of the fluid when filling and draining the inflatable portion of the gastric band; and

a pumping device, coupled between the reservoir and the first flow control device, for moving the fluid into and out of the inflatable portion of the gastric band, the pumping device capable of being activated and deactivated using a telemetric signal received from a remote device.

2. The implantable device of claim 1 wherein the sensor includes two pressure sensors and a calibrated orifice positioned fluidly between the two pressure sensors.

3. The implantable device of claim 1 wherein the first flow control device is selected from a group consisting of a valve, a membrane, a tube, a pressure regulator, an ultrasonic flow meter, a thermal mechanism, a mass flow sensor, a turbine, a paddle wheel, and combinations thereof.

4. The implantable device of claim 1 further comprising a second flow control device coupled to the second inlet of the sensor for controlling movement of the fluid when draining the gastric band.

5. The implantable device of claim 4 wherein the second flow control device is selected from a group consisting of a valve, a membrane, a tube, a pressure regulator, an ultrasonic flow meter, a thermal mechanism, a mass flow sensor, a turbine, a paddle wheel, and combinations thereof.

6. The implantable device of claim 1 wherein the pumping device is selected from a group consisting of a pump, a piezoelectric motor, an electromagnetic motor, an AC motor, a DC motor, a stepper motor, and combinations thereof.

7. The implantable device of claim 1 wherein the parameter is selected from a group consisting of a flow speed, a pressure, a fill volume, a stress, a strain, a linear measurement, and combinations thereof.

8. The implantable device of claim 1 wherein the reservoir is selected from a group consisting of an elastic polymer, a balloon, a rubber container, a silicone container, and combinations thereof.

9. The implantable device of claim 4 further comprising an access port fluidly coupled between the second flow control device and the inflatable portion of the gastric band.

10. The implantable device of claim 1 wherein the fluid is selected from a group consisting of a drug, a saline solution, and combinations thereof.

11. The implantable device of claim 1 wherein the pumping device comprises a non-magnetic electrical drive.

12. An remotely adjustable gastric banding system comprising:

a gastric band having an inflatable portion;

a reservoir for holding a fluid for filling and draining the inflatable portion of the gastric band;

flexible tubing connecting the reservoir to the inflatable portion of the gastric band;

a sensor module positioned between the gastric band and the reservoir, the sensor module comprising;

a first inlet;

a second inlet;

a first flow meter coupled to the first inlet;

a second flow meter coupled to the second inlet; and

a calibrated orifice disposed between the first flow meter and the second flow meter, the fluid flowing from the first inlet to the second inlet when filling the inflatable portion of the gastric band, the fluid flowing from the second inlet to the first inlet when draining the inflatable portion of the gastric band, the sensor module monitoring a parameter of the fluid when filling and draining the inflatable portion of the gastric band;

a first valve, coupled to the first inlet of the sensor module, for controlling a flow of the fluid when filling and draining the inflatable portion of the gastric band;

a piezoelectric pump coupled between the reservoir and the first valve, for moving the fluid into and out of the inflatable portion of the gastric band, the piezoelectric pump capable of being activated and deactivated using a telemetric signal received from a remote device, the pumping device comprising a non-magnetic electrical drive;

a second valve coupled in parallel with the piezoelectric pump, wherein the second valve and the piezoelectric pump are coupled to the first valve and the reservoir, wherein the first valve remains closed while the second valve is opened to allow the piezoelectric pump to stabilize before opening the first valve to facilitate filling and draining the gastric band; and

an access port fluidly coupled between the second flow control device and the inflatable portion of the gastric band.

13. The remotely adjustable gastric banding system of claim 12, further comprising a third valve disposed between the second inlet of the sensor module and the gastric band to facilitate reducing a leak rate of the remotely adjustable gastric banding system.

14. An implantable, motorized device that facilitates movement of fluid to an inflatable portion of a gastric band, the implantable, motorized device comprising:

a housing having a fluid port;

an integrated reservoir positioned within the housing and adjacent to the fluid port and capable of holding the fluid;

a first piston positioned within the housing and adjacent to the integrated reservoir, the first piston capable of moving a portion of the fluid from the integrated reservoir to the inflatable portion of the gastric band;

a first leadscrew coupled to the first piston and causing the first piston to move between a first position and a second position; and

a motor attached to the housing and coupled to the first leadscrew, the motor moving the first piston between the first position and the second position, and when the first piston is in the first position, the integrated reservoir having a larger volume than when the first piston is in the second position, the motor being controlled by a telemetric signal received from a remote device.

15. The implantable, motorized device of claim 14 wherein the integrated reservoir is selected from a group consisting of a balloon, an elastic polymer, a flexible bladder, a rubber container, a silicone container, and combinations thereof.

16. The implantable, motorized device of claim 14 further comprising an external reservoir, coupled to the fluid port, for filling the integrated reservoir with additional fluid.

17. The implantable, motorized device of claim 14 wherein the external reservoir is selected from a group consisting of a balloon, an elastic polymer, a flexible bladder, a rubber container, a silicone container, a non-elastomeric container, a bellows, and combinations thereof.

18. The implantable, motorized device of claim 14 wherein the motor comprises a non-magnetic electrical drive or a magnetic motor.

19. The implantable, motorized device of claim 14 further comprising a first flow control device coupled to the fluid port for controlling movement of the fluid when filling the gastric band.

20. The implantable, motorized device of claim 19 wherein the first flow control device is selected from a group consisting of a valve, a tube, and a regulator, and combinations thereof.

21. The implantable, motorized device of claim 19 further comprising a second flow control device coupled to the external reservoir for controlling movement of the fluid when filling the gastric band.

22. The implantable, motorized device of claim 14 wherein the fluid is selected from a group consisting of a drug, a saline solution, and combinations thereof.

23. The implantable, motorized device of claim 14 wherein the motor moves the first leadscrew by rotational movement.

24. The implantable, motorized device of claim 14 wherein the first leadscrew comprises a rod and the motor moves the rod by translational movement.

25. The implantable, motorized device of claim 14 further comprising a seal connected to the first piston and positioned between the first piston and the integrated reservoir.

26. The implantable, motorized device of claim 14 further comprising a slidable seal connected to the first piston, wherein the slidable seal maintains a seal with the housing as the first piston moves from the first position to the second position.

27. The implantable, motorized device of claim 14 wherein the first piston is positioned between the first leadscrew and the integrated reservoir.

28. The implantable, motorized device of claim 14 further comprising a second leadscrew coupled to the motor.

29. The implantable, motorized device of claim 14 further comprising a second piston coupled to the first leadscrew.

30. The implantable, motorized device of claim 14 wherein the housing is made of a material selected from a group consisting of a rigid material and a flexible material.

31. The implantable, motorized device of claim 14 wherein the housing comprises a plurality of housing walls defining boundaries of the integrated reservoir.

32. The implantable, motorized device of claim 14 wherein the housing defines a chamber for housing the integrated reservoir, the first piston, the first leadscrew, and the motor.

33. The implantable, motorized device of claim 14 wherein the piston does not include a seal.

34. An implantable, motorized piston pump that facilitates movement of fluid to an inflatable portion of a gastric band, the implantable, motorized piston pump comprising:

a housing having a fluid port;

an integrated reservoir positioned within the housing and adjacent to the fluid port and capable of holding the fluid, wherein the integrated reservoir comprises a container having a volume of between approximately 0.1-5 cc, and wherein the container is attached to the fluid port;

a piston positioned within the housing and adjacent to the integrated reservoir, the piston capable of moving a portion of the fluid from the integrated reservoir to the inflatable portion of the gastric band, wherein the piston is capable of moving the portion of the fluid without a seal;

a leadscrew coupled to the piston and causing the piston to move between a first position and a second position;

a motor attached to the housing and coupled to the leadscrew, the motor moving the piston between the first position and the second position, and when the piston is in the first position, the integrated reservoir having a larger volume than when the piston is in the second position, the motor being controlled by a telemetric signal received from a remote device;

an external reservoir, coupled to the fluid port, for filling the integrated reservoir with additional fluid, wherein the external reservoir has a volume of between approximately 1-10 cc;

a first valve coupled to the fluid port for controlling movement of the fluid when filling or draining the gastric band;

a second valve coupled to the external reservoir for controlling movement of the fluid when filling or draining the integrated reservoir, wherein the fluid flows between the external reservoir and the integrated reservoir as the piston reciprocates in the housing when the first valve is closed and the second valve is opened; and

a bladder disposed in the housing and coupled to the external reservoir, wherein the bladder increases in volume as the piston moves from the first position to the second position to compensate for the integrated reservoir having a smaller volume than when the piston is in the first position.

35. The implantable, motorized piston pump of claim 34 wherein the fluid flows between the integrated reservoir and the gastric band as the piston reciprocates within the housing when the second valve is closed and the first valve is opened.

36. The implantable, motorized piston pump of claim 34 wherein the housing comprises a flexible segment to compensate for a vacuum/pressure mismatch.

37. An implantable, motorized device that facilitates movement of fluid to an inflatable portion of a gastric band, the implantable, motorized device comprising:

a housing having a first fluid port and a second fluid port;

a first reservoir positioned within the housing and adjacent to the first fluid port and capable of holding a first portion of the fluid;

a second reservoir positioned within the housing and adjacent to the second fluid port and capable of holding a second portion of the fluid;

a first piston positioned within the housing and adjacent to the first reservoir, the first piston capable of moving the first portion of the fluid out of the first reservoir into the inflatable portion of the gastric band;

a second piston positioned within the housing and adjacent to the second reservoir, the second piston capable of moving the second portion of the fluid into the second reservoir;

a bellows disposed between the first piston and the second piston; and

a motor located within the bellows and coupled to the first piston and the second piston to facilitate moving the first piston and the second piston within the housing, wherein the bellows is hermetically sealed and expands and contracts as the first piston and the second piston move within the housing.

38. The implantable, motorized device of claim 37 wherein the first piston and the second piston act oppositely during a stroke of the motor to facilitate a nearly continuous pumping action.

39. The implantable, motorized device of claim 37 wherein the first piston moves the first portion of the fluid out of the first reservoir and the second piston moves the second portion of the fluid into the second reservoir during a stroke of the motor.

40. The implantable, motorized device of claim 37 wherein the first piston and the second piston are configured to reduce the overall size of the implantable, motorized device.

41. The implantable, motorized device of claim 37 wherein the first piston and the second piston are configured to minimize the parasitic effects of a vacuum.