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System and method for testing the gastric valve

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System and method for testing the gastric valve


A system and method tests the gastric valve in a patient. A contrast agent is supplied into the stomach of the patient. An involuntary reflex cough epoch is induced within the patient to isolate the gastric valve from the lower esophageal sphincter (LES). A fluoroscopic instrument is used to detect whether stomach reflux has occurred indicative of a malfunctioning gastric valve.
Related Terms: Cough Epoch Involuntary Lower Esophageal Sphincter Reflex Sphincter

Browse recent Pneumoflex Systems, LLC patents - Melbourne, FL, US
Inventors: W. Robert ADDINGTON, Stuart P. MILLER, Robert E. STEPHENS
USPTO Applicaton #: #20120277583 - Class: 600431 (USPTO) - 11/01/12 - Class 600 
Surgery > Diagnostic Testing >Detecting Nuclear, Electromagnetic, Or Ultrasonic Radiation >Detectable Material Placed In Body

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The Patent Description & Claims data below is from USPTO Patent Application 20120277583, System and method for testing the gastric valve.

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RELATED APPLICATION(S)

This application is based upon U.S. provisional application Ser. No. 61/480,625 filed Apr. 29, 2011 and U.S. provisional application Ser. No. 61/533,389 filed Sep. 12, 2011, the disclosures which are hereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

This invention relates to testing the gastric valve in a patient and assessing the functioning of a patient\'s gastric valve and external urethral sphincter using an involuntary reflex cough test.

BACKGROUND OF THE INVENTION

Commonly assigned U.S. application Ser. No. 13/354,100 filed Jan. 19, 2012 by the same inventors, the disclosure which is hereby incorporated by reference in its entirety, discloses a system and method of diagnosing acid reflux using an involuntary reflex cough test. In one example as disclosed, a nasogastric/orogastric (Ng/Og) device is inserted into the stomach and the involuntary reflex cough epoch induced. The intra-abdominal pressure and elevational reflux along the Ng/Og device is measured. In an example, the functional status of the gastric valve is determined based on the measured intra-abdominal pressure and elevational reflux along the catheter. This is a limited analysis that is not always accurate to determine whether there is a reflux problem, requiring an Ng/Og device, which in some cases can interfere with the gastric valve and the lower esophageal sphincter. In another example, an Ng/Og device with an esophageal cuff is used with a sequence of steps, such as inflating a cuff, inducing the involuntary reflex cough epoch, determining if acid reflux has occurred, deflating the esophageal cuff, and again inducing the involuntary reflex cough epoch. Results can be used to determine the functional status of the gastric valve. This is a limited type of test that has not always been found advantageous.

Use of the involuntary reflex cough test with or without a voluntary cough test is also disclosed in commonly assigned U.S. patent application Ser. Nos. 11/608,316 filed Dec. 8, 2006; Ser. No. 11/550,125 filed Oct. 17, 2006; Ser. No. 12/643,134 filed Dec. 21, 2009; Ser. No. 12/643,251 filed Dec. 21, 2009; Ser. No. 12/878,257 filed Sep. 9, 2010; Ser. No. 12/878,281 filed Sep. 9, 2010; and Ser. No. 12/878,316 filed Sep. 9, 2010; the disclosures which are all hereby incorporated by reference in their entirety. The \'257, \'281 and \'316 applications disclose oral-esophageal-gastric devices, some with esophageal cuffs and/or reflux measurement systems that can be used to assess GERD or determine stress urinary incontinence in some examples using the involuntary reflex cough tests alone or in combination with the voluntary cough test.

In one current test used to determine gastric reflux, fluoroscopy is used. A clinician or doctor will conduct a radiology sweep and use fluoroscopy, also termed video fluoroscopy. A patient swallows a barium drink, for example, containing barium sulphate, typically about 500 to about 1,000 milliliters. The patient lays on a table and the pictures are taken. Often, a tablet or drink is ingested, also termed a fizzy, to produce gas, which acts similar to Alka-Seltzer. Thus, the barium and gas exists in the stomach. Often the patient will lay on their left or right side or the clinician will tilt the patient over such that the head is down. At this point, it is possible to determine if there is acid reflux (or stomach back-up into the esophagus) by viewing the barium. In that respect, the clinician is testing the gastric valve, but the clinician also often claims they are also testing the lower esophageal sphincter (LES). Practitioners have found that test confusing and note reliable indicators are required to determine competency of the gastric valve relative to the lower esophageal sphincter (LES).

SUMMARY

OF THE INVENTION

A system and method in accordance with a non-limiting example tests the gastric valve in a patient. A contrast agent is administered into the esophagus of the patient, followed by inducing an involuntary reflex cough epoch within the patient to isolate the gastric valve from the lower esophageal sphincter (LES). The flow of contrast agent is detected during the involuntary reflex cough epoch using an image sensor to determine whether stomach reflux occurred indicative of a malfunctioning gastric valve. A fluoroscopic instrument is used to detect whether stomach reflux has occurred in one example.

The involuntary reflex cough epoch can be induced by introducing a chemo-irritant using a nebulizer by having the patient inhale the irritant. It is also possible to supply the contrast agent by having the patient swallow Barium Sulfate.

The flow of contrast agent can be detected at the level of the LES. In another example, the contrast agent is swallowed and the patient is positioned in a semi-incumbent lithotomy position when inducing the involuntary reflex cough epoch. A platform supports the patient in one example and the imaging sensor is mounted to the support in a position to image the flow of contrast through the esophagus at the LES. A moveable support arm and swivel adapter mounts the nebulizer. In another example, a processor is connected to the imaging sensor and receives imaging data from the imaging sensor regarding the flow of contrast agent and reflux and is configured to process the data and estimate the severity of the malfunctioning gastric valve.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects, features and advantages of the present invention will become apparent from the detailed description of the invention which follows, when considered in light of the accompanying drawings in which:

FIG. 1 is a flowchart illustrating a sequence of steps for isolating the gastric valve to assess its function in accordance with a non-limiting example.

FIG. 2 is another flowchart illustrating a sequence of steps for isolating the gastric valve and external urethral sphincter to assess their function in accordance with a non-limiting example.

FIG. 3A is a fragmentary view of an example of a kit having components for use with the methodology described relative to FIGS. 1 and 2 in accordance with a non-limiting example.

FIG. 3B is a view showing a system that includes a patient bed as a platform and imaging sensor for performing the methodology of FIGS. 1 and 2.

FIG. 4A are images for the inspiration continence reflex (ICR) as part of the involuntary reflex cough test and showing the LES.

FIG. 4B is a nerve conduction graph showing the inspiration continence reflex.

FIG. 5A are images showing a barium swallow during breath-hold.

FIG. 5B is a nerve conduction graph for the barium swallow during breath-hold.

FIG. 6 are images of a barium swallow during breath-hold in the LES.

FIG. 7A are images showing the barium swallow during the laryngeal expiration reflex.

FIG. 7B is a nerve conduction graph showing the laryngeal expiratory reflex.

FIG. 8 are graphs showing pressure recordings of the internal urethral sphincter (IUS) and LES that are synchronized with respiration.

FIG. 9 is a graph showing the relative latencies of the IUS and LES with deep inspiration and expiration.

FIGS. 10A and 10B are respective urodynamic (UD) tracings of a series of forcible voluntary cough in a female subject who has moderate/severe SUI followed by the induced reflex cough test.

FIG. 11 is a graph showing the results of the breath-hold with the maintained pressure elevation in the LES and IUS.

FIGS. 12-16 are EMG and catheter pressure results for the LES-IUS in which dotted vertical lines in FIGS. 12, 13 and 16 indicate the internal urethral sphincter (IUS) synchronously contracted with deep inhalation (inspiration).

FIG. 17 is a simplified plan view of a catheter that can be used for urodynamic and medical diagnostic testing in accordance with a non-limiting example.

FIG. 18 is a simplified plan view of another example of a catheter similar to that shown in FIG. 17 that can be used for urodynamic and medical diagnostic testing in accordance with a non-limiting example.

FIG. 19 shows a urinary continence pad that can be used with urodynamic catheters of FIGS. 17 and 18.

FIG. 20 is a plan view of an Ng/Og device or catheter that can be used for testing for acid reflux.

FIG. 21 is a fragmentary plan view of a handheld processing device that can be used in conjunction with various catheters and Ng/Og devices or other catheters and/or nebulizers.

FIG. 22 is a block diagram showing example components of a handheld processing device such as shown in FIG. 21.

FIG. 23 is a block diagram showing an outline of the laryngeal expiratory reflex (LER) and results with the intrinsic sphincter deficiency and esophageal, urinary and fecal continence.

FIGS. 24A and 24B are graphs detailing what occurs during LER with intrinsic sphincter activity (FIG. 24A) and voluntary cough pathways (FIG. 243).

DETAILED DESCRIPTION

OF THE PREFERRED EMBODIMENTS

Different embodiments will now be described more fully hereinafter with reference to the accompanying drawings, in which preferred embodiments are shown. Many different forms can be set forth and described embodiments should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope to those skilled in the art.

Research on the LES and gastric valve indicates there is a problem often with the gastric valve and there is a need for a more ready test to assess the competency of the gastric valve. In accordance with a non-limiting example, the involuntary maneuver, i.e., the involuntary cough test is employed, such as described in the copending and commonly assigned U.S. patent applications identified above.

FIG. 1 is a flowchart showing a general sequence of steps that can be used for isolating the gastric valve and determine if the gastric valve is competent and functioning adequately in one example. The kit shown in FIG. 3A can include the components for use with this methodology described relative to FIG. 1 and be used with the test system shown in FIG. 3B as explained below.

The sequence begins with a barium swallow (block 30) immediately followed by the involuntary reflex cough test, i.e., iRCT, such as by inhaling a chemo-irritant such as L-tartrate through a nebulizer in one non-limiting example (block 32). The involuntary reflex cough test isolates the gastric valve from the LES. A determination is made using video fluoroscopy, for example, if the reflux has occurred (block 34). If not, the gastric valve is competent and correctly functioning (block 36). If reflux occurs, then the gastric valve is incompetent and is malfunctioning since it is allowing the reflux (block 38). It is possible to determine the severity of the reflux (block 40), for example, by measuring the amount of reflux that occurs during the involuntary reflex cough epoch to estimate the severity of the malfunctioning gastric valve. This can be accomplished using enhanced fluoroscopy or using a Ng/Og catheter located at the LES or other location as later described to determine the extent of reflux.

FIG. 2 is another flowchart showing a sequence of steps used for assessing the competency of the gastric valve and isolating the gastric valve from the LES and also isolating the external urethral sphincter from the internal urethral sphincter to determine stress urinary incontinence.

The process begins by inserting a urinary catheter in the patient with a pressure sensor in one example and a sensor located at the internal urethral sphincter in an example. The Ng/Og tube may include at least one sensor to be positioned at the LES and pH sensor at different positions. EMG pads can also be positioned at appropriate locations at the mid-axillary line of the T7-8 internal space (block 50). This could also include the paraspinals. The bladder is filled such as with saline solution (block 52). Barium or other contrast material is swallowed (block 54) and the involuntary reflex cough test induced (block 56). Two analysis paths are shown. A determination is made whether urine leakage occurred (block 58). If not, then the external urethral sphincter is competent and functioning adequately (block 60). If yes, then the external urethral sphincter leaked indicative of stress urinary incontinence (SUI) (block 62). Some determination of the severity of SUI or other problems can possibly be determined through analyzing the EMG results together with any intra-abdominal pressure that has been recorded during the involuntary reflex cough epoch. Reference is also made to the incorporated by reference applications for appropriate data and analysis regarding same. A determination is also made whether reflux occurred (block 64). If not, then the gastric valve is competent and functioning adequately (block 66). If yes, then the gastric valve is incompetent and is not functioning correctly (block 68). By using a Ng/Og tube or advanced imaging of the contrast agent, e.g., Barium Sulfate, it is possible to determine the severity of the reflux (block 70) such as measuring the amount of reflux at the LES and other locations within the esophagus.

A patient kit for assessing the gastric valve in conjunction with fluoroscopy and the EUG can be provided and an example is shown in FIG. 3A at 100. Items in this illustrated kit include:

1) Pneumoflex or USA Flex 20% tartaric acid in 3 ml unit dose vial 102;

2) 1000 ml Barium sulfate USP 104;

3) Ion Nebulizer or Crossfire Nebulizer 106;

4) Swivel adapter for nebulizer 108;



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stats Patent Info
Application #
US 20120277583 A1
Publish Date
11/01/2012
Document #
13456882
File Date
04/26/2012
USPTO Class
600431
Other USPTO Classes
International Class
61B6/00
Drawings
31


Cough
Epoch
Involuntary
Lower Esophageal Sphincter
Reflex
Sphincter


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