Ambulatory reflux monitoring system

• US 5,479,935 A
• Filed: 10/21/1993
• Issued: 01/02/1996
• Est. Priority Date: 10/21/1993
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Synectics Medical, Inc.
• Inventors: Essen-Moller, Anders
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/139,117
• Time in Patent Office: 803 Days
• Field of Search: 128/632, 128/634, 128/635, 128/734, 128/642, 128/733, 128/780
• US Class Current: 600/547
• CPC Class Codes: A61B 5/037 Measuring oesophageal pressure
• CPC Class Codes: A61B 5/0535 Impedance plethysmography for measuring blood flow A61B5/0295
• 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 5/4211 Diagnosing or evaluating reflux

Abstract

An ambulatory system for recording and analyzing gastroesophageal reflux is presented. The system comprises a digital recorder, an analysis software package and a catheter for measurement of changes in esophageal impedance. For the first time, gastroesophageal reflux can be detected with a pH above 4 (called alkaline reflux), which is the normal pH environment of the healthy esophagus. In addition, one embodiment of the invention allows for the determination of the direction of flow of the detected material in the esophagus, thus enabling the system to distinguish between swallowed saliva and alkaline gastroesophageal reflux. In yet a further embodiment, the present invention allows for recording and analysis of reflux on a non-invasive basis, by using pairs of externally worn impedance sensors. In another embodiment, the invention measures impedance simultaneously with other bio-parameters, such as pH or pressure.

Claims

1. A system for monitoring gastroesophageal reflux comprising:

(a) an electrical connector,

(b) a gastroesophageal catheter with a distal end and a proximal end, with an impedance sensor attached to the catheter near the distal end and electrically communicating with said electrical connector at the proximal end,

(c) an ambulatory recorder connected to said electrical connector adapted to record impedance data generated by said impedance sensor and communicated to the recorder through said connector, and

(d) executable software, resident in the recorder, adapted to determine a presence of gastroesophageal reflux from said impedance data and graphically project said impedance data generated by said impedance sensor and communicated to said recorder through said connector.

2. The system defined in claim 1, further comprising:

an output device for the data recorded in the recorder, the output device being one of (1) a display on the recorder, (2) a printer electrically connected to the recorder, (3) a modem electrically connected to the recorder, and (4) a connector electrically connected to the recorder.

3. The system defined in claim 2, wherein said impedance sensor is a first sensor and further comprising a second impedance sensor attached to the catheter, near the first sensor but closer to the proximal end of the catheter than the first sensor, said second sensor electrically communicating with the electrical connector, said software further adapted to analyze and graphically project impedance data generated by said second sensor and communicated to said recorder through said connector, said recorder further adapted to record impedance data generated by said second sensor and communicated through said connector.

4. The system defined in claim 3, wherein each of the first sensor and the second sensor includes a pair of gold rings encircling an outer surface of the catheter, about 2 mm apart, and further comprising a wire electrically communicating each gold ring to the electrical connector, the first sensor being separated from the second sensor by about 1 cm, said recorder being adapted to record impedance data generated by the gold rings and communicated through said electrical connector, said software being further adapted to analyze and graphically project impedance data generated by each of said first sensor and said second sensor and communicated to said recorder through said connector.

5. The system defined in claim 3, wherein each of said first sensor and said second sensor includes a pair of gold rings encircling am outer surface of the catheter, about 2 mm, apart, and a single gold ring, encircling the outer surface of the catheter, about 2 mm closer to the proximal end of the catheter than said first sensor, electrically communicating with said electrical connector through a wire, and adapted to act variously as a pair with the one of the pair of gold rings and the other of the pair of gold rings of one of said first sensor and said second sensor.

6. The system defined in claim 1, further comprising:

(a) a pH sensor attached near the distal end of the catheter, electrically communicating pH signals to the electrical connector, the recorder further adapted to record the pH signals, and the software further adapted to analyze and graphically project the pH signals, and

(b) a pressure sensor attached near the distal end of the catheter, electrically communicating pressure signals to the electrical connector, the recorder further adapted to record the pressure signals, and the software further adapted to analyze and graphically project the pressure signals.

7. A system for monitoring gastroesophageal reflux comprising:

(a) a gastroesophageal catheter with a distal end and a proximal end,

(b) an electrical connector at the proximal end of the catheter,

(c) a first impedance sensor attached to the catheter near the distal end, said sensor electrically communicating with the electrical connector, said sensor further comprising a pair of gold rings encircling an outer surface of the catheter, about 2 mm apart, each gold ring electrically communicating with the electrical connector through a wire,

(d) a second impedance sensor attached to the catheter, near the first sensor but closer to the proximal end of the catheter than the first sensor, said second sensor electrically communicating with the electrical connector, the second sensor comprising a pair of gold rings encircling the outer surface of the catheter, about 2 mm apart, each gold ring electrically communicating with the electrical connector through a wire, the first sensor being separated from the second sensor by about 1 cm,

(e) an ambulatory recorder connected to said electrical connector adapted to record impedance data generated by said sensors and communicated through said connector,

(f) executable software, resident in the recorder, adapted to determine a presence of gastroesophageal reflux from said impedance data and graphically project impedance data generated by said sensors and communicated to said recorder through said connector,

(g) an output device for the data recorded in the recorder, the output device being one of (1) a display on the recorder, (2) a printer electrically connected to the recorder, (3) a modem electrically connected to the recorder, and (4) a connector electrically connected to the recorder,

(h) a single gold ring, encircling the outer surface of the catheter, about 2 mm closer to the proximal end of the catheter than said first sensor, and electrically communicating to said electrical connector through a wire, and adapted to act variously as a pair with a first ring of the first sensor and a second ring of the first sensor as two alternate configurations of said first sensor,

(i) a pH sensor attached near the distal end of the catheter, electrically communicating pH signals to the electrical connector, the recorder further adapted to record the pH signals, and the software further adapted to analyze and graphically project the pH data, and

(j) a pressure sensor attached near the distal end of the catheter, electrically communicating pressure signals to the electrical connector, the recorder further adapted to record the pressure signals, and the software further adapted to analyze and graphically project the pressure signals.

8. A method of monitoring gastroesophageal reflux, comprising the steps of:

(a) placing a number of impedance sensors, each sensor adapted to generate electric impedance signals measuring impedance at a location in an esophagus,

(b) electrically connecting said sensors to an electrical connector,

(c) connecting an ambulatory recorder to the connector, the recorder adapted to record data communicated through the connector,

(d) generating the impedance signals with the sensors, the impedance signals generated in a pattern determined by software resident in the recorder,

(e) determining a presence of gastroesophageal reflux from said impedance signals

(f) communicating the signals to the recorder through the connector,

(g) recording the signals with the recorder,

(h) analyzing and graphically projecting recorded data using the software resident in the recorder.

9. The method defined in claim 8, further comprising the steps of:

(a) providing the impedance sensors on a gastroesophageal catheter, with a distal end and a proximal end, so that the impedance sensors are near the distal end of the catheter,

(b) inserting the impedance sensors and the distal end of the catheter into the esophagus,

(c) electrically connecting the impedance sensors to the connector by wires running through the catheter, and

(d) disposing the connector at the proximal end of the catheter.

10. The invention in claim 9, further comprising the steps of:

(a) generating pH signals with a pH sensor attached near the distal end of the catheter, electrically communicating the pH signals to the electrical connector, recording the pH signals with the recorder, and analyzing and graphically projecting the pH data using the software, and

(b) generating pressure signals with a pressure sensor attached near the distal end of the catheter, electrically communicating the pressure signals to the electrical connector, recording the pressure signals with the recorder, and analyzing and graphically projecting the pressure data using the software.