Continuous pH monitoring system and method of using same

• US 5,411,022 A
• Filed: 07/01/1993
• Issued: 05/02/1995
• Est. Priority Date: 07/01/1993
• Status: Expired due to Fees

• Current Assignee: Don J. Cretzler, Michael Mccue, Richard A. Roshon, Sam Z. Malhas
• Original Assignee: Don J. Cretzler, Michael Mccue, Richard A. Roshon, Sam Z. Malhas
• Inventors: McCue, Michael, Malhas, Sam Z., Roshon, Richard A., Cretzler, Don J.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US08/085,769
• Time in Patent Office: 670 Days
• Field of Search: 128/632, 128/633, 128/634, 128/635, 128/636, 128/642, 128/747, 128/8, 128/716, 128/719, 128/772, 128/780, 128/773, 128/734, 128/696, 607/124
• US Class Current: 600/361
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence
• CPC Class Codes: A61B 5/4238 stomach
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6853 with a balloon

Abstract

A continuous pH monitoring system and method of using it, includes a catheter assembly having a flexible compressible multipassagewayed tube, an anchor assembly connected to the tube to secure it within the nasal cavity, an indicator assembly having a sensor device within the tube to monitor the pH in the stomach, a vent within the tube to equalize pressure inside the stomach with the ambient pressure, and an aspirating assembly attached to the tube for removing stomach fluid.

Claims

1. A monitoring system for use with a pH meter means for monitoring the pH levels in a stomach of a patient and suction means for facilitating withdrawing stomach fluids from the stomach of the patient, comprising:

a tube device defining at least one internal passageway, having a proximal end and a distal end;

electrical detecting means disposed at the distal end of said tube device for sensing pH levels in a patient'"'"'s stomach fluids;

electrical pressure sensing means disposed at the distal end of said tube device for detecting pressure within a patient'"'"'s stomach;

pH meter conductor means disposed within said at least one passageway, for extending from said detecting means to said pH meter means, for carrying pH information to said pH meter means; and

pressure sensing conductor means disposed within said at least one passageway for extending from said pressure sensing means to the suction means, for conveying a deactivating signal to the suction means for deactivating the suction means when the pressure within the stomach decreases below a predetermined pressure.

2. A monitoring system according to claim 1, further comprising:

anchor assembly means disposed on a portion of the tube device adapted to be directly adjacent to nasal cavity of a patient for securing said tube device within the nasal cavity of the patient to prevent relative motion between the nasal cavity and said tube device.

3. A system according to claim 2, further including a lower anchor assembly means for securing said distal end to prevent said distal end from contacting a patient'"'"'s stomach lining, said lower anchor assembly means having a balloon device connected circumferentially to an exterior surface of said tube device and adjacent to said distal end to brace said tube device within a patient'"'"'s esophagus, a lower inflation member connected integrally to said at least one internal passageway and extending into and terminating within said balloon device to create an air passage between said internal passageway and said balloon device, and compressor means for supplying air under pressure connected integrally to said internal inner passageway at said proximal end of said tube device to inflate said balloon device.

4. A system according to claim 2, further including feeding tube means for introducing nutritional elements into the patient'"'"'s stomach, said tube means having a sheath member sized and dimensioned to be inserted within said at least one internal passageway and an inner tube sized and dimensioned to be inserted in and removed from said sheath member.

5. A monitoring system according to claim 1, further comprising:

vent means adapted to be in fluid communication with the stomach of the patient to permit atmospheric air to enter the stomach for equalizing substantially the air pressure within the stomach with atmospheric air pressure.

6. A monitoring system for use with a pH meter means for monitoring the pH level in a stomach of a patient, comprising:

a tube device having a distal end to be inserted into the stomach of a patient;

detecting means disposed at said distal end of said tube device for sensing pH levels of fluids within the stomach of the patient;

pH meter conductor means for extending from said detecting means to said pH meter means, for carrying pH information to said pH meter means;

anchor assembly means disposed on a portion of the tube device adapted to be directly adjacent to a nasal cavity of the patient for securing said tube device within the nasal cavity to prevent relative motion between the nasal cavity and said tube device; and

said anchor assembly means is an inflatable cuff assembly, said inflatable cuff assembly including an inflatable balloon device to expand within the nasal cavity of the patient, an inflation member located outside of said tube device having a proximal end and a distal end, said distal end being within said balloon device and said proximal end extending outside of said balloon device to allow inflation of said balloon device, and a pump device connected to said proximal end for permitting expansion of said balloon device.

7. A monitoring system for use with a pH meter means, comprising:

a tube device having a distal end to be inserted into a stomach of a patient;

detecting means disposed at said distal end of said tube device for sensing pH levels of fluids within the stomach of the patient;

pH meter conductor means for extending from said detecting means to said pH meter means, for carrying pH information to said pH meter means;

anchor assembly means disposed on a portion of the tube device adapted to be directly adjacent to a nasal cavity of the patient for securing said tube device within the nasal cavity to prevent relative motion between the nasal cavity and said tube device; and

wherein said anchor assembly means is a sponge member, said sponge member being of such density as to contract when compressed for insertion into the nasal cavity and to expand when in place within said nasal cavity to hold frictionally said tube device.

8. A monitoring system for use with a pH meter means for monitoring a pH levels in the stomach of a patient, comprising:

a tube device having a distal end to be inserted into the stomach of a patient;

detecting means disposed at said distal end of said tube device for sensing pH levels of fluids within the stomach of the patient;

pH meter conductor means for extending from said detecting means to said pH meter means, for carrying pH information to said pH meter means;

aspirating means for removing fluid from a patient'"'"'s stomach;

a suction pump device attached to said tube device to cause said fluid from the stomach to be transported extracorporeally; and

manometer means for controlling said aspirating means, said manometer means having a sensor device to detect pressure within the stomach of the patient and a switch device connected to said sensor device to stop said aspirating means, to prevent vacuum contacting an inner lining of the stomach, and causing damage to that inner lining.

9. A method for monitoring pH levels of stomach fluids of a patient, comprising:

coupling a tube device having at least one internal passageway to pH meter means for measuring the pH levels of the patient'"'"'s stomach fluid;

extending conductor means within said at least one passageway of said tube device for carrying pH information to the pH meter means;

inserting said tube device into a patient'"'"'s stomach;

generating signals indicative of the pH levels of the stomach fluids of the patient;

coupling said signals to said conductor means;

accessing the patient'"'"'s stomach with a tube device, said tube device being a flexible collapsible tube having a proximal end and a distal end for insertion into a nasal cavity, through an esophagus and into the stomach, said distal end being rounded and bulbous to aid in insertion of said tube;

said tube device also having at least one internal passageway substantially equal in length to said tube for providing separate isolated passageways between said distal end and said proximal end;

securing said tube device within said nasal cavity with an anchor assembly connected circumferentially to an exterior surface of said tube to prevent relative motion between said nasal cavity and said tube;

disposing an electrical conductor substantially within one of said passageways and connected at one end to pressure sensing means to transmit a signal and a pressure detecting device connected at another end of said electrical conductor to produce said signal for indicating the pressure within the stomach;

attaching a recording device to said pH meter means to register pH of fluids within the stomach;

supplying the stomach with atmospheric air through a vent included in said at least one internal passageway for permitting atmospheric air to enter the stomach to equalize substantially air pressure within the stomach with the atmospheric air pressure; and

removing fluid from the stomach with an aspirating assembly having a suction pump device attached to said at least one passageway to transport extracorporeally fluid from the stomach.

10. A method according to claim 9, further including securing said distal end with another anchor assembly to prevent said distal end from contacting the stomach, said another anchor assembly having a lower balloon device connected circumferentially to said exterior surface and adjacent to said distal end to brace said tube within said esophagus, a lower inflation member connected integrally to said at least one passageway and extending into and terminating within said lower balloon device to create an air passage between said at least one passageway and said lower balloon device, and compressor means for supplying air under pressure connected integrally to said at least one passageway at said proximal end to inflate said lower balloon device, said step of securing including a step of supplying air to the lower inflation member.