Implantable monitoring probe

• US 9,962,108 B2
• Filed: 01/13/2015
• Issued: 05/08/2018
• Est. Priority Date: 04/07/1999
• Status: Expired due to Fees

• Current Assignee: Given Imaging Limited (Medtronic Plc)
• Original Assignee: Given Imaging Limited (Medtronic Plc)
• Inventors: Kilcoyne, John T, Tsukashima, Ross, Johnson, George M, Klecher, Christopher
• Primary Examiner(s): Towa, Rene
• Assistant Examiner(s): Nguyen, Huong Q.
• Application Number:
  US14/595,491
• Publication Number:
  US 20150297116A1
• Time in Patent Office: 1,211 Days
• CPC Class Codes: A61B 1/00148 using anchoring means
• CPC Class Codes: A61B 1/041 Capsule endoscopes for imaging
• CPC Class Codes: A61B 5/0008 Temperature signals
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/037 Measuring oesophageal pressure
• CPC Class Codes: A61B 5/073 Intestinal transmitters
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• 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 5/4233 oesophagus
• CPC Class Codes: A61B 5/6882 Anchoring means

Abstract

Disclosed is an ambulatory system for monitoring one or more physiological parameters in a body lumen, such as the esophagus. The system includes an implantable probe having a sensor for the physiological parameter and a transmitter for transmitting data to an external receiver. The probe may be used for monitoring any of various physiological parameters, including pH, temperature, and pressure, within the esophagus or other body lumens. Methods and deployment catheters are also disclosed.

Claims

1. An implantable gastroesophageal reflux monitor, comprising:

a streamlined and smooth outer shell, shaped to pass through the gastrointestinal tract and to be excreted in the stool without injury to the gastrointestinal mucosa, the shell comprising;

a securing structure for securing the shell to the wall of the esophagus, such that a portion of the wall of the esophagus is secured within an attachment cavity of the shell, comprising a pin or a clip configured to penetrate the mucosa of the esophagus;

a pH sensor;

a radiofrequency transmitter for transmitting pH data sensed by the pH sensor; and

a power source.

2. The monitor of claim 1, said shell comprising a microprocessor configured to periodically receive a signal from the pH sensor and induce the radiofrequency transmitter to send a radiofrequency signal indicative of the pH measured by the pH sensor.

3. The monitor of claim 2, wherein the microprocessor is configured to periodically enable the pH sensor during a first interval of each measurement cycle to obtain a pH signal and then disable the pH sensor during a second interval.

4. The monitor of claim 2, wherein the microprocessor is configured to enable the radiofrequency transmitter during the second interval and disable the radiofrequency transmitter during periods of each cycle other than the second interval and disable the pH sensor during periods of each cycle other than the first interval.

5. The monitor of claim 1, wherein the shell comprises an auxiliary sensor to measure an auxiliary physiological parameter that is not a pH parameter.

6. The monitor of claim 5, wherein the auxiliary physiological parameter is selected from the group consisting of:

an ion concentration, a temperature, and a pressure.

7. The monitor of claim 1, wherein the shell comprises a vacuum lumen for drawing tissue into the attachment cavity.

8. The monitor of claim 7, wherein the securing structure comprises a pin configured to be movable from a retracted position within the shell to an extended position which extends at least part way across the attachment cavity.

9. The monitor of claim 1, wherein the securing structure comprises a pin and the shell comprises a blind end to receive a distal end of the pin.

10. The monitor of claim 9, wherein blind end comprises a lock.

11. A system comprising:

a monitor comprising;

a streamlined and smooth outer shell, shaped to pass through the gastrointestinal tract and to be excreted in the stool without injury to the gastrointestinal mucosa, the shell comprising;

a securing structure for securing the shell to the wall of the esophagus, such that a portion of the wall of the esophagus is secured within an attachment cavity of the shell, comprising a pin or a clip configured to penetrate the mucosa of the esophagus;

a pH sensor;

a radiofrequency transmitter for transmitting pH data sensed by the pH sensor; and

a power source; and

a receiver configured to be worn by the patient.

12. The system of claim 11, wherein the receiver comprises circuitry configured to sense a position of the patient, and the receiver is configured to periodically record the position of the patient.

13. The system of claim 11, wherein the receiver is configured to monitor a change in pH as a function of distance from a lower esophageal sphincter.

14. The system of claim 11, wherein the shell comprises an auxiliary sensor to measure an auxiliary physiological parameter that is not a pH parameter and wherein the receiver is configured to receive a pH reading from the pH sensor and to adjust the pH reading based on the measured value of the physiological parameter.