News Column

"Device with Active Valve to Block Emesis and Reflux Blockage Device and Associated System and Method" in Patent Application Approval Process

September 11, 2014



By a News Reporter-Staff News Editor at Politics & Government Week -- A patent application by the inventors ADDINGTON, W. Robert (Melbourne Beach, FL); Miller, Stuart P. (Indialantic, FL), filed on February 15, 2013, was made available online on August 28, 2014, according to news reporting originating from Washington, D.C., by VerticalNews correspondents.

This patent application is assigned to Pneumoflex Systems, Llc.

The following quote was obtained by the news editors from the background information supplied by the inventors: "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 though the mouth or nose and through the esophagus and 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 procedure is sometimes a limited analysis that is not always accurate to determine whether there is a reflux problem, and thus, 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. A sequence of steps occur, e.g., inflating the esophageal 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 are analyzed to determine the functional status of the gastric valve.

"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. No. 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 nasogastric/orogastric (Ng/Og) devices, some with or without esophageal cuffs and/or reflux measurement systems that can be used to assess GERD or determine stress urinary incontinence or other physiological abnormalities using the involuntary reflex cough tests alone or in combination with the voluntary cough test.

"These applications also disclose summary results when the involuntary reflex cough test is induced. In one embodiment, a handheld or other processing device processes the test results. Various urinary bladder catheters are also disclosed that may include various indicators. In another example, the Ng/Og device includes an esophageal cuff carried by the device and positioned in the esophagus to reduce or diminish gastric reflux and/or emesis in surgical, neurological and/or trauma patients. These applications also disclose further developments regarding use of the involuntary reflex cough test.

"Commonly assigned U.S. patent application Ser. Nos. 13/456,841 and 13/456,882, the disclosures which are hereby incorporated by reference in their entirety, disclose systems and methods that test the gastric valve and urethral sphincter. A contrast agent is administered into the esophagus of a patient followed by inducing an involuntary reflex cough epoch to isolate the gastric valve from the Lower Esophageal Sphincter (LES). In an example, it is possible to 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 may be made if urine leakage occurs indicative of Stress Urinary Incontinence (SUI). In these types of tests an emesis and reflux blocking can be important and improved devices that block emesis and/or reflux and during the involuntary reflex cough test are desirable."

In addition to the background information obtained for this patent application, VerticalNews journalists also obtained the inventors' summary information for this patent application: "In accordance with a non-limiting example, a device blocks emesis and/or reflex and includes a tube insertable into the esophagus. The tube includes an inflation lumen. A valve is carried by the tube and includes a flexible sheath having an upper edge secured onto the tube and a lower circumferential edge. An inflatable balloon is in communication with the inflation lumen. The inflatable balloon can be a separate balloon member carried by the tube under the sheath or formed by the flexible sheath that includes a folded back section at the lower circumferential edge and an edge secured on the tube to form a balloon member that expands outward when inflated. Upon inflation of the balloon, the flexible sheath opens in a concave configuration towards the stomach and the lower circumferential edge engages the esophageal wall and blocks emesis and/or reflux from the stomach passing into the esophagus past the valve.

"In an example, the flexible sheath is formed to close when the balloon is deflated. In another example, the tube has a distal end and a proximal end is configured for insertion through a patient's esophagus such that the distal end is received within the patient's stomach. A sump lumen extends the length of the tube and a sump port is positioned at the distal end of the tube and communicates with the sump lumen and is configured to vent gas. In an example, the valve is positioned on the tube to be mid-esophagus below the aortic notch when the tube is received through the esophagus. The valve in an example includes radio-opaque markings to aid in positioning the valve below the aortic notch. In an example, the valve is configured to be positioned at about 2 to about 3 cm below the aortic notch when the tube is received through the esophagus.

"In another example, the flexible sheath is formed from a multiple density flexible material with the closed position as a normal state. The material forming the lower circumferential edge is formed to minimize damage to the esophageal wall as it makes contact therewith. The flexible sheath may be formed to open in a concave formation upon a predetermined pressure of emesis and/or reflux from the stomach. In another example, the tube is formed of multiple lumens and includes a lumen for suction. At least one pressure sensor may be carried by the tube.

"In another example, a system for diagnosing a physiological abnormality in a patient is disclosed. A tube is insertable into the esophagus. The tube includes an inflation lumen. A valve is carried by the tube and includes a flexible sheath having an upper edge secured onto the tube and a lower edge. An inflatable balloon is in communication with the inflation lumen. Upon inflation of the balloon, the flexible sheath opens in a concave configuration towards the stomach and the lower circumferential edge engages the esophageal wall and blocks emesis and/or reflux from the stomach passing into the esophagus past the valve to protect a patient's airway during an involuntary reflex cough event. At least one sensor senses a physiological condition of the patient during the involuntary reflex cough event. A processing device is connected to the at least one sensor and configured to process the sensed physiological condition that occurs during the involuntary reflex cough event to determine a physiological abnormality.

"In an example, the at least one sensor is formed as a pressure sensor carried by the tube and configured to measure intra-abdominal pressure (LAP). An electromyogram (EMG) pad is configured to obtain an EMG from the involuntary cough activated paraspinal muscles. The processing device is configured to receive the IAP and EMG and correlate the IAP and EMG with the involuntary reflex cough event to determine a physiological abnormality. A second pressure sensor is carried by the tube and the processing device correlates sensed pressure from the second pressure sensor with the IAP and EMG. In another example, a pH sensor is carried by the tube and the processing device correlates pH measurements from the pH sensor with the IAP and EMG. The processing device in an example includes a housing and at least one interface to receive measurements from the at least one sensor obtained during the involuntary reflex cough event. A processor is carried by the housing and configured to receive the measurements from the at least one sensor obtained during the involuntary reflex cough event. In another example, a nebulizer lumen extends along the tube and includes a port through which medication is delivered for administering an involuntary reflex cough test.

"A method aspect is also disclosed.

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 diagrammatic view of a patient and showing the device in accordance with a non-limiting example inserted through the mouth into the esophagus and the valve positioned below the aortic notch.

"FIG. 2 is a fragmentary plan view of a single lumen passive device in accordance with a non-limiting example and showing a passive valve in a closed position.

"FIG. 3 is a fragmentary plan view of the device shown in FIG. 2 and showing the passive valve in an open position.

"FIG. 4 is an enlarged plan view of the passive valve and showing a securement maintaining the passive valve in a closed position in accordance with a non-limiting example.

"FIG. 5 is a plan view of the passive valve shown in FIG. 3 and in an opened configuration.

"FIG. 6 is an enlarged sectional view taken along line 6-6 of FIG. 5 and showing a sliding ring that may be used as a securement in accordance with a non-limiting example.

"FIG. 7 is a fragmentary plan view of a dual lumen device similar to the single lumen device shown in FIG. 3 and showing a balloon positioned at the distal end.

"FIG. 8 is another fragmentary plan view of the dual lumen device similar to that shown in FIG. 7 and showing a sensor at the distal end.

"FIG. 9 is an enlarged plan view of the distal end of the device in FIG. 8 and showing a suction port and sensor.

"FIG. 10 is a fragmentary plan view of a triple lumen device showing an opened passive valve and a balloon positioned at the distal end in accordance with a non-limiting example.

"FIG. 11 is an enlarged plan view of the opened passive valve shown in FIG. 10.

"FIG. 12 is an enlarged plain view of the balloon shown in FIG. 10.

"FIG. 13 is a partial sectional view taken along line 13-13 of FIG. 11.

"FIG. 14 is a sectional view taken along line 14-14 of FIG. 12.

"FIG. 15 is a sectional view taken along line 15-15 of FIG. 11.

"FIG. 16 is a fragmentary plan view of a quad lumen device that may include an additional lumen for suction above the valve or for other purposes.

"FIG. 17 is an enlarged plan view of the passive valve shown in FIG. 16.

"FIG. 18 is an enlarged plan view of the balloon shown in FIG. 16.

"FIG. 19 is a fragmentary plan view of an active emesis containment device having an active valve that includes an inflatable balloon carried by the tube under the flexible sheath to open the valve upon inflation of the balloon in accordance with a non-limiting example.

"FIG. 20 is a sectional view of the device taken along line 20-20 of FIG. 19.

"FIG. 21 is a fragmentary view of a triple lumen, active device similar to that active device shown in FIG. 19 and showing a balloon at the distal end.

"FIG. 22 is an enlarged plan view of the active valve shown in FIG. 21.

"FIG. 23 is an enlarged plan view of the balloon shown in FIG. 21.

"FIG. 24 is a fragmentary plan view of another embodiment of the device that uses an alternate configuration of an active valve with a different balloon configuration.

"FIG. 25 is an enlarged plan view of the active valve shown in FIG. 24.

"FIG. 26 is a sectional view of the active valve taken along line 26-26.

"FIG. 27 is a sectional view of the active valve taken in the direction of line 27-27 of FIG. 25.

"FIGS. 28 and 29 show an example six-channel system for a processing device such as a portable handheld device, including a schematic circuit diagram in FIG. 29 and block diagram in FIG. 28.

"FIGS. 30A through 30F are figures showing an embodiment of an nasogastric/orogastric (Ng/Og) device and having a nebulizing, pH sensing and pressure sensing function and an active valve such as shown in the embodiments of FIGS. 19-27.

"FIGS. 31A through 31F are views similar to those shown in FIGS. 30A-30F but showing instead a device configuration with a passive instead of active valve."

URL and more information on this patent application, see: ADDINGTON, W. Robert; Miller, Stuart P. Device with Active Valve to Block Emesis and Reflux Blockage Device and Associated System and Method. Filed February 15, 2013 and posted August 28, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1737&p=35&f=G&l=50&d=PG01&S1=20140821.PD.&OS=PD/20140821&RS=PD/20140821

Keywords for this news article include: Pneumoflex Systems, Pneumoflex Systems Llc, Vomiting.

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