Syringe-based leak detection system

• US 8,725,435 B2
• Filed: 04/13/2011
• Issued: 05/13/2014
• Est. Priority Date: 04/13/2011
• Status: Expired due to Fees

• Current Assignee: Apollo Endosurgery US, Inc. (Boston Scientific Corporation)
• Original Assignee: Apollo Endosurgery, Inc. (Boston Scientific Corporation)
• Inventors: Snow, Sean, O'Donnell, Mark, Tezel, Amy, Borrell, Marcos
• Primary Examiner(s): Le, John H
• Application Number:
  US13/085,906
• Publication Number:
  US 20120265456A1
• Time in Patent Office: 1,126 Days
• Field of Search: 702/47, 702/50, 702/51, 702/55, 702/67, 702/98, 128/861, 128/899, 600/30, 600/37, 606/157, 606/192
• US Class Current: 702/51
• CPC Class Codes: A61F 2005/002 for sensing mechanical parameters
• CPC Class Codes: A61F 5/0056 using injection ports
• CPC Class Codes: G01M 3/04 by detecting the presence of fluid at the leakage point
• CPC Class Codes: G01M 3/26 by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors

Abstract

Generally described herein are devices, methods and systems related to detecting a leak present in a gastric banding system for the treatment of obesity. For example, a leak detector may include a syringe, a leak sensing unit and a needle, and may measure a pressure decay within a gastric banding system after the needle penetrates the patient'"'"'s skin and is inserted into an access port connected to the gastric band of the gastric banding system. The pressure decay may be interpreted to determine if a leak is present in the gastric banding system.

Claims

1. A leak sensing unit for determining a presence of a leak within a gastric band placed around a patient'"'"'s stomach for the treatment of obesity, the leak sensing unit comprising:

a pressure sensor for sensing a pressure level within the gastric band;

a processor coupled to the pressure sensor for determining whether the sensed pressure level indicates a leak in the gastric band;

a timing unit coupled to the processor, the timing unit for determining timing information used by the processor in determining whether the sensed pressure level indicates a leak in the gastric band;

a memory coupled to the processor for storing the sensed pressure levels; and

a digital display coupled to the processor for displaying information related to the sensed pressure level,

wherein the pressure sensor, the processor, the timer, the memory, and the digital display are retained as a unit.

2. The leak sensing unit of claim 1 wherein the processor determines whether the sensed pressure level indicates a leak in the gastric band by solving a two-point difference equation for Δ

P, where Δ

P=(P2−

P1)/(T2−

T1), and wherein P2 is a pressure at the end of a test period, P1 is a pressure at the beginning of the test period, T2 is a time at the end of the test period, and T1 is a time at the beginning of the test period.

3. The leak sensing unit of claim 1 wherein the processor determines whether the sensed pressure level indicates a leak in the gastric band by solving a pressure drop equation for Δ

P, where Δ

P=2 (P2−

P1)/[(P2+P1)(T2−

T1)], and wherein P2 is a pressure at the end of a test period, P1 is a pressure at the beginning of the test period, T2 is a time at the end of the test period, and T1 is a time at the beginning of the test period.

4. The leak sensing unit of claim 1 wherein the processor determines whether the sensed pressure level indicates a leak in the gastric band by comparing the sensed pressure level with a predetermined threshold.

5. The leak sensing unit of claim 1 wherein the timing unit is triggered in response to the sensed pressure level decreasing beyond a predetermined threshold.

6. The leak sensing unit of claim 1 wherein the digital display displays a numerical pressure reading in a first portion and a numerical rate of pressure change reading in a second portion.

7. The leak sensing unit of claim 1 wherein the digital display displays a numerical pressure reading in a first portion and a graphical pressure drop reading in a second portion.

8. The leak sensing unit of claim 1 wherein the digital display displays a graphical representation of a leak detector gauge with a needle.

9. The leak sensing unit of claim 1 wherein the pressure sensor is triggered when fluid is passed through the leak sensing unit into the gastric band.

10. A leak detector for determining a leak within a gastric banding system placed about the cardia of a patient'"'"'s stomach for the treatment of obesity, the leak detector comprising:

a syringe having a plunger and a barrel;

a leak sensing unit fluidly coupled to the syringe, the leak sensing unit including;

a pressure sensor for obtaining pressure readings within the gastric banding system,

a processor coupled to the pressure sensor, the processor for interpreting whether the obtained pressure readings within the gastric banding system indicate a leak in the gastric banding system,

a timer coupled to the processor, the timer for counting and relaying counting information used by the processor in interpreting whether the obtained pressure readings within the gastric banding system indicate a leak in the gastric banding system,

a memory coupled to the processor for storing the obtained pressure readings, and

a digital display coupled to the processor for displaying information related to the obtained pressure readings; and

a needle fluidly coupled to both the leak sensing unit and the syringe, the needle for establishing a fluid connection with an access port of the gastric banding system,

wherein the pressure sensor, the processor, the timer, the memory, and the digital display are retained as a unit in a location between the barrel and the needle.

11. The leak detector of claim 10 wherein the processor determines whether the obtained pressure readings indicate a leak in the gastric banding system by solving a two-point difference equation for Δ

P, where Δ

P=(P2−

P1)/(T2−

T1), and wherein P2 is a pressure at the end of a test period, P1 is a pressure at the beginning of the test period, T2 is a time at the end of the test period, and T1 is a time at the beginning of the test period.

12. The leak detector of claim 10 wherein the processor determines whether the obtained pressure readings indicate a leak in the gastric banding system by solving a pressure drop equation for Δ

P, where Δ

P=2(P2−

P1)/[(P2+P1)(T2−

T1)], and wherein P1 is a pressure at the end of a test period, P1 is a pressure at the beginning of the test period, T2 is a time at the end of the test period, and T1 is a time at the beginning of the test period.

13. The leak detector of claim 10 wherein the processor determines whether the obtained pressure readings indicate a leak in the gastric banding system by comparing the obtained pressure readings with a predetermined threshold.

14. The leak detector of claim 10 wherein the timer is triggered in response to the obtained pressure readings decreasing beyond a predetermined threshold.

15. The leak detector of claim 10 wherein the digital display displays a numerical pressure reading in a first portion and a numerical rate of pressure change in a second portion.

16. The leak detector of claim 10 wherein the digital display displays a numerical pressure reading in a first portion and a graphical pressure drop reading in a second portion.

17. The leak detector of claim 10 wherein the digital display displays a graphical representation of a leak detector gauge with a needle.

18. The leak detector of claim 10 wherein the pressure sensor is triggered to obtain pressure readings when fluid is passed through the leak sensing unit into the access port.

19. A leak detector for determining a leak within a gastric banding system placed about the cardia of a patient'"'"'s stomach for the treatment of obesity, the leak detector comprising:

a needle for establishing a fluid connection with an access port of the gastric banding system;

a syringe having a plunger and a barrel, the syringe configured to hold fluid in the barrel, and further configured to transfer the fluid from the barrel to a gastric banding system through the needle; and

a leak sensing unit disposed between the needle and the syringe, the leak sensing unit including;

a pressure sensor for obtaining pressure data of the gastric banding system when the needle is inserted into the access port and after the fluid is transferred from the barrel to the gastric banding system,

a processor coupled to the pressure sensor, the processor for interpreting whether the obtained pressure data of the gastric banding system indicate a leak in the gastric banding system,

a timer coupled to the processor, the timer for counting and relaying counting information used by the processor in interpreting whether the obtained pressure data within the gastric banding system indicate a leak in the gastric banding system,

a memory coupled to the processor for storing the obtained pressure data, and

a digital display coupled to the processor for displaying information related to the obtained pressure data.

20. The leak detector of claim 19 wherein the processor determines whether the obtained pressure data indicate a leak in the gastric banding system by solving a two-point difference equation for Δ

P, where Δ

P=(P2−

P1)/(T2−

T1), and wherein P2 is a pressure at the end of a test period, P1 is a pressure at the beginning of the test period, T2 is a time at the end of the test period, and T1 is a time at the beginning of the test period.

21. The leak detector of claim 19 wherein the processor determines whether the obtained pressure data indicate a leak in the gastric banding system by solving a pressure drop equation for Δ

P, where Δ

P=2(P2−

P1)/[(P2+P1)(T2−

T1)], and wherein P2 is a pressure at the end of a test period, P1 is a pressure at the beginning of the test period, T2 is a time at the end of the test period, and T1 is a time at the beginning of the test period.