Implantable pump system with calibration

• US 8,376,929 B2
• Filed: 07/09/2009
• Issued: 02/19/2013
• Est. Priority Date: 07/14/2008
• Status: Expired due to Fees

• Current Assignee: Apollo Endosurgery US, Inc. (Boston Scientific Corporation)
• Original Assignee: Allergan, Inc. (Canada) (Abbvie Incorporated)
• Inventors: Birk, Janel A., Snow, Sean
• Primary Examiner(s): Gilbert, Samuel
• Assistant Examiner(s): LANNU, JOSHUA DARYL DEANON
• Application Number:
  US12/500,464
• Publication Number:
  US 20100010291A1
• Time in Patent Office: 1,321 Days
• Field of Search: 600 29- 32, 600/37, 128897-899, 623/23.68, 604/9, 606/151
• US Class Current: 600/37
• CPC Class Codes: A61F 5/0053 remotely adjustable
• CPC Class Codes: A61F 5/0059 with wireless means

Abstract

A system for facilitating obesity control includes an inflatable gastric banding device, a fluid reservoir couplable to the inflatable portion, and an implantable fluid handling device coupled to the fluid reservoir and the inflatable portion. The fluid handling device includes remotely operable components housed in a biocompatible housing. The fluid handling device includes a micropump effective to pump fluid to the band and a flow sensor. The system also includes a controller/microprocessor including an algorithm programmed to automatically calibrate the pump using data from the flow sensor, prior to adjustments made to the inflation of the gastric band.

Claims

1. A system for facilitating obesity control comprising:

a gastric banding device including an inflatable portion;

a fluid reservoir couplable to the inflatable portion;

an implantable fluid handling device couplable to the fluid reservoir and the inflatable portion, and including

a pump;

a first valve;

a second valve;

a flow measurement device; and

a controller/microprocessor system in communication with the implantable fluid handling device and configured to operate an algorithm programmed to automatically calibrate the pump with steps including;

pumping fluid from the pump through the first valve and to the inflatable portion of the gastric banding device for a predetermined number of pump cycles;

opening the second valve to allow fluid to drain from the inflatable portion of the gastric banding device;

measuring with the flow measurement device a flow rate of the fluid allowed to drain from the inflatable portion of the gastric banding device;

calculating based on the measured flow rate a volume of the fluid allowed to drain from the inflatable portion of the gastric banding device; and

calculating an actual pump rate of the pump based on the calculated volume of the fluid allowed to drain from the inflatable portion of the gastric banding device and based on the predetermined number of pump cycles, the actual pump rate for use to calculate a number of pump cycles for the pump to adjust a volume of fluid in the inflatable portion of the gastric banding device.

2. The system of claim 1 wherein the controller/microprocessor system comprises an external microcontroller.

3. The system of claim 1 wherein the algorithm is programmed to calibrate the pump prior to initiation of a pumping operation for adjusting volume of the inflatable portion.

4. The system of claim 1 wherein the algorithm comprises a sequence of operation of the flow measurement device, the first valve, the second valve, the pump, and a pressure sensor.

5. The system of claim 1 wherein the pump is in line with the first valve.

6. The system of claim 1 wherein the flow measurement device is in line with the second valve.

7. The system of claim 1 wherein the pump is a one way pump.

8. The system of claim 1 wherein the pump is in parallel with the flow measurement device.

9. The system of claim 1 wherein the algorithm includes a calculation of the actual pump rate based on repeated measurements of pressure and flow rate during inflating or draining the inflatable portion.

10. The system of claim 1 further comprising a pressure sensor.

11. The system of claim 10 wherein the algorithm includes:

measuring with the pressure sensor a pressure of fluid in the inflatable portion of the gastric banding device prior to the pump pumping fluid through the first valve and to the inflatable portion of the gastric banding device for a predetermined number of pump cycles, to take a first pressure reading;

measuring with the pressure sensor a pressure of fluid in the inflatable portion of the gastric banding device after the second valve is opened to allow fluid to drain from the inflatable portion of the gastric banding device, to take a second pressure reading; and

measuring with the flow measurement device the flow rate of the fluid allowed to drain from the inflatable portion of the gastric banding device until the second pressure reading is not greater than the first pressure reading.

12. A method of adjusting a stoma size of a gastric banding patient having an implanted gastric band, the method comprising the steps of:

remotely commanding an adjustment of a volume of fluid in an inflatable portion of an implanted gastric band;

calibrating a pump in fluid communication with the inflatable portion of the implanted gastric band including initiating a sequence of operation of a pump, a first valve, a second valve, and a flow measurement device, including;

pumping fluid from the pump through the first valve and to the inflatable portion of the implanted gastric band for a predetermined number of pump cycles;

opening a second valve to allow fluid to drain from the inflatable portion of the implanted gastric band;

measuring with the flow measurement device a flow rate of the fluid allowed to drain from the inflatable portion of the implanted gastric band;

calculating based on the measured flow rate a volume of the fluid allowed to drain from the inflatable portion of the implanted gastric band; and

calculating an actual pump rate of the pump based on the calculated volume of the fluid allowed to drain from the inflatable portion of the implanted gastric band and based on the predetermined number of pump cycles, the actual pump rate for use to calculate a number of pump cycles for the pump to adjust a volume of fluid in the inflatable portion of the implanted gastric band; and

activating the calibrated pump to cause the adjustment remotely commanded for the volume of fluid in the inflatable portion of the implanted gastric band.

13. The method of claim 12 wherein the initiating a sequence of operation includes initiating a sequence of operation of the pump, the first valve, the second valve, the flow measurement device, and a pressure sensor.

14. The method of claim 13 wherein the pressure sensor is within the flow measurement device.

15. The method of claim 12 wherein the step of calibrating includes calculating the actual pump rate based on at least two flow parameters measured by the flow measurement device.

16. The method of claim 12 wherein the step of calibrating includes calculating the actual pump rate based on measured pressures and flow rates.

17. The method of claim 12 wherein the predetermined number of pump cycles is based on at least one of a fixed number, a pressure measurement, and a requested volume measurement.

18. The method of claim 12 wherein the step of calibrating includes:

measuring a pressure of fluid in the inflatable portion of the implanted gastric band prior to the pump pumping fluid through the first valve and to the inflatable portion of the implanted gastric band for a predetermined number of pump cycles, to take a first pressure reading;

measuring a pressure of fluid in the inflatable portion of the implanted gastric band after the second valve is opened to allow fluid to drain from the inflatable portion of the implanted gastric band, to take a second pressure reading; and

measuring with the flow measurement device the flow rate of the fluid allowed to drain from the inflatable portion of the implanted gastric band until the second pressure reading is not greater than the first pressure reading.