IP Library Granted Patent US 9,005,121
Granted Patent B2
US 9,005,121 · App. 13/456,841 · Granted Apr 14, 2015

System and method of testing the gastric valve and urethral sphincter

Inventors: W. Robert Addington (Melbourne Beach, FL); Stuart P. Miller (Indialantic, FL); Robert E. Stephens (Parkville, MO)
Assignee: Pneumoflex Systems, LLC
A61B5/20A61B5/7282G06F19/34A61B5/04882A61B5/0816A61B5/0823A61B5/113A61B5/202A61B5/227A61B5/4211A61B5/4884A61B5/6852A61B6/481A61B2562/0247A61M15/009A61M2209/06A61B5/03A61B5/08
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Quick Facts
Patent No.
US 9,005,121
App. No.
13/456,841
Granted
Apr 14, 2015
Kind
B2
Abstract

A system and method tests the gastric valve and urethral sphincter in a patient. A contrast agent is administered into the esophagus of a patient followed by inducing an involuntary reflex cough epoch within the patient to isolate the gastric valve from the lower esophageal sphincter (LES) and isolate the external urethral sphincter from the internal urethral sphincter. An imaging sensor detects the flow of the contrast agent during the involuntary reflex cough epoch and determines whether stomach reflux occurred indicative of a malfunctioning gastric valve. A determination is made if urine leakage occurs indicative of stress urinary incontinence (SUI).

Claims (49)

1. A method of testing the gastric valve and urethral sphincter in a patient, comprising:

administering a contrast agent into the esophagus of a patient followed by;

inducing an involuntary reflex cough epoch within the patient to isolate the gastric valve from the lower esophageal sphincter (LES) and isolate the external urethral sphincter from the internal urethral sphincter;

detecting using an imaging sensor the flow of the contrast agent during the involuntary reflex cough epoch and determining whether stomach reflux occurred indicative of a malfunctioning gastric valve;

determining if urine leaked indicative of stress urinary incontinence (SUI);

inserting a urinary catheter having a pressure sensor within the bladder;

obtaining an electromyogram (EMG) from involuntary cough activated intercostals and/or paraspinals; and

processing, using a processor, the data from the pressure sensor with the EMG to estimate the severity of the SUI.

2. The method according to claim 1 , further comprising detecting the flow of contrast agent at the level of the LES.

3. The method according to claim 1 , wherein the imaging sensor comprises a fluoroscopic instrument configured to image the contrast agent.

4. The method according to claim 1 , further comprising introducing a chemo-irritant for inducing the involuntary reflex cough epoch.

5. The method according to claim 1 , further comprising administering Barium sulfate as the contrast agent.

6. The method according to claim 1 , further comprising administering the contrast agent by having the patient swallow the contrast agent.

7. The method according to claim 1 , further comprising inducing the involuntary reflex cough epoch immediately following the administration of the contrast agent.

8. The method according to claim 1 , further comprising positioning the patient in a semi-recumbent lithotomy position when inducing the involuntary reflex cough epoch.

9. A method of testing the gastric valve and urethral sphincter in a patient, comprising:

administering a contrast agent into the esophagus of a patient followed by;

inducing an involuntary reflex cough epoch within the patient to isolate the gastric valve from the lower esophageal sphincter (LES) and isolate the external urethral sphincter from the internal urethral sphincter;

detecting using an imaging sensor the flow of the contrast agent during the involuntary reflex cough epoch and determining whether stomach reflux occurred indicative of a malfunctioning gastric valve;

determining if urine leaked indicative of stress urinary incontinence (SUI);

inserting a urinary catheter having a pressure sensor within the bladder;

obtaining an electromyogram (EMG) from the involuntary cough activated intercostals and/or paraspinals; and

processing, using a processor, the data from the pressure sensor with the EMG to estimate the severity of the SUI; and

measuring the amount of reflux that occurs during the involuntary reflex cough epoch to estimate the severity of the malfunctioning gastric valve.

10. The method according to claim 9 , further comprising measuring the amount of reflux that occurs during the involuntary reflex cough epoch using a Ng/Og catheter.

11. The method according to claim 9 , further comprising measuring the amount of reflux that occurs during the involuntary reflex cough epoch by comparing a plurality of photomontages taken by the image sensor during the involuntary reflex cough epoch.

12. The method according to claim 9 , further comprising detecting the flow of contrast agent at the level of the LES.

13. The method according to claim 9 , wherein the imaging sensor comprises a fluoroscopic instrument configured to image the contrast agent.

14. The method according to claim 9 , further comprising introducing a chemo-irritant for inducing the involuntary reflex cough epoch.

15. The method according to claim 9 , further comprising administering Barium sulfate as the contrast agent.

16. The method according to claim 9 , further comprising administering the contrast agent by having the patient swallow the contrast agent.

17. The method according to claim 9 , further comprising inducing the involuntary reflex cough epoch immediately following the administration of the contrast agent.

18. The method according to claim 9 , further comprising positioning the patient in a semi-recumbent lithotomy position when inducing the involuntary reflex cough epoch.

19. A system for testing the gastric valve and urethral sphincter in a patient, comprising:

a contrast agent that is administered into the esophagus of a patient;

a nebulizer containing a chemo-irritant agent that induces an involuntary reflex cough epoch within the patient after administration of the contrast agent to the patient in order to isolate the gastric valve from the lower esophageal sphincter (LES) and isolate the external urethral sphincter from the internal urethral sphincter;

an imaging sensor positioned adjacent to the patient and configured to detect and display the flow of the contrast agent during the involuntary cough epoch such that reflux from the stomach that occurs during the involuntary reflex cough epoch is displayed indicative of a malfunctioning gastric valve;

a urine leakage detector configured to detect urine leakage during the involuntary reflex cough epoch indicative of stress urinary incontinence (SUI);

a urinary catheter having a pressure sensor within the bladder;

at least one electromyogram pad configured for obtaining an electromyogram (EMG) from the involuntary cough activated intercostals and/or paraspinals; and

a processor configured to receive data from the pressure sensor and EMG and estimate the severity of the SUI.

20. The system according to claim 19 , wherein the imaging sensor is positioned to detect the flow of contrast agent at the level of the LES.

21. The system according to claim 19 , wherein the imaging sensor comprises a fluoroscopic instrument configured to image the contrast agent.

22. The system according to claim 19 , wherein the chemo-irritant agent comprises a composition of L-tartrate in a pharmaceutically acceptable carrier.

23. The system according to claim 19 , wherein the contrast agent comprises Barium sulfate.

24. The system according to claim 19 , and further comprising a Ng/Og catheter configured to measure the amount of reflux that occurs during the involuntary reflex cough epoch wherein the measured amount of reflux is indicative of an estimate of the severity of the malfunctioning gastric valve.

25. The system according to claim 19 , and further comprising a platform that supports the patient, said imaging sensor mounted to the platform in a position to image the flow of contrast through the esophagus at the LES, and a movable support arm and swivel adapter mounting the nebulizer.

26. The system according to claim 19 , and further comprising a processor connected to the imaging sensor that receives imaging data from the imaging sensor regarding the flow of contrast agent and reflux and configured to process the data and determine severity of the malfunctioning gastric valve.

27. The system according to claim 19 , wherein the urine leakage detector comprises a urinary catheter.

Assignments (2)
SECURITY INTEREST Recorded Feb 29, 2024
From: PNEUMOFLEX SYSTEMS, LLC
To: ALLEN, DYER, DOPPELT + GILCHRIST, P.A.
Reel/Frame 066603/0431 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 10, 2012
From: ADDINGTON, W. ROBERT; MILLER, STUART P.; STEPHENS, ROBERT E.
To: PNEUMOFLEX SYSTEMS, LLC
Reel/Frame 028519/0265 →
Continuity (3)
Provisional Application 61480625 · Apr 29, 2011
Provisional Application 61533389 · Sep 12, 2011
Related Publication 20120277547A1 · Nov 1, 2012