Calibrated pH sensor

• US 10,321,861 B2
• Filed: 06/11/2013
• Issued: 06/18/2019
• Est. Priority Date: 06/13/2012
• Status: Active Grant

• Current Assignee: Softcell Medical Limited
• Original Assignee: Softcell Medical Limited
• Inventors: McIntosh, Kirsty
• Primary Examiner(s): Weston, Tiffany
• Assistant Examiner(s): Tran, Tho Q
• Application Number:
  US14/407,861
• Publication Number:
  US 20150164395A1
• Time in Patent Office: 2,198 Days
• CPC Class Codes: A61B 2560/0228 using calibration standards
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 2560/028 Arrangements to prevent overuse, e.g. by counting the number of uses
• CPC Class Codes: A61B 2562/242 Packaging, i.e. for packaging the sensor or apparatus before use
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: G01N 27/4165 for pH meters

Abstract

The present invention relates to a pH sensor adapted to be inserted into all soft tissues, such as muscle, fat or other organs e.g. heart, lung, kidney, liver, pancreas, renal gland etc., comprising one or more of: a) means to provide sensor calibration performance information; b) a sensor dislodgement alert, providing an indication to the user if the pH reading falls outside a predetermined range; c) an alert to indicate that the sensor has exceeded its usage period; and d) an alert to indicate that the sensor had exceeded its shelf life. There is also provided a method of assessing the efficacy of a treatment regime comprising the steps of determining any change in the pH of the soft tissue during treatment, where any change in the pH towards the preferred range for the tissue type is indicative of an effective treatment regime and any change in the pH away from the preferred range for the tissue type is indicative of a worsening in the condition of the tissue, and thus an ineffective treatment regime.

Claims

1. A pH sensor package comprising a pH sensor adapted to be inserted into soft tissue, means to store calibration performance information of the pH sensor at a time of manufacture thereof, one or more calibration indicator compositions comprising a first calibration indicator composition, an indication associated with the first calibration indicator composition, and a closed housing;

wherein the pH sensor comprises;

a shaft,

a tip at one end of the shaft comprising a sensing membrane having an internal surface and an external surface,

a reference electrode,

an internal solution contacting the internal surface of the sensing membrane,

a measuring electrode extending into the internal solution, and

a connection means suitable for connecting the sensor to a meter;

wherein the means to store calibration performance information comprises calibration performance information comprising details of individual performance parameters of the pH sensor at different temperatures at the time of manufacture;

wherein the pH sensor is surrounded by the closed housing, and the closed housing is suitable for maintaining the sterility of the pH sensor;

wherein the first calibration indicator composition is at a first pH;

wherein the indication conveys the first pH of the first calibration indicator composition; and

wherein each of the one or more calibration indicator compositions is maintained separate from the pH sensor in the pH sensor package.

2. The pH sensor package as claimed in claim 1, wherein the first calibration indicator composition is in the form of a buffered gel.

3. The pH sensor package as claimed in claim 1, wherein the first calibration indicator composition is in the form of a hydrogel coating.

4. The pH sensor package as claimed in claim 1, wherein the first pH is in the range of 6 to 7.5.

5. The pH sensor package as claimed in claim 1, wherein the indication is provided integrally to the sensor package.

6. The pH sensor package as claimed in claim 1, wherein the means to store performance information is in the form of a chip including an algorithm including information of the performance of the pH sensor at the time of manufacture, under different temperatures and humidities.

7. The pH sensor package as claimed in claim 1, further comprising a pH sensor dislodgement alert;

wherein the pH sensor is configured to determine a second pH proximate the sensing membrane; and

wherein the pH sensor dislodgement alert is configured to be activated in response to detecting the second pH of the first calibration indicator composition falling outside of a predetermined pH range.

8. The pH sensor package as claimed in claim 7, wherein the predetermined pH range is 5.0 to 8.0.

9. The pH sensor package as claimed in claim 7, wherein activation of the pH sensor dislodgment alert causes a visual alert and an audible alert to be broadcast.

10. The pH sensor package as claimed in claim 7, wherein the pH sensor dislodgment alert is activated within 1 minute or less of detecting the second pH of the first calibration indicator composition failing outside of the predetermined pH range.

11. The pH sensor package as claimed in claim 1, further comprising an alert;

wherein the alert is configured to be activated to convey that the pH sensor has exceeded, or is about to exceed, a usage period associated with the pH sensor.

12. The pH sensor package as claimed in claim 11, wherein the usage period is 72 hours from connection of the pH sensor to a meter.

13. The pH sensor package as claimed in claim 11, wherein the alert is configured to be activated 30 minutes prior to expiry of the usage period.

14. The pH sensor package as claimed in claim 1, further comprising an alert;

wherein the alert is configured to be activated to convey that the pH sensor has exceeded, or is about to exceed a shelf life associated with the pH sensor.

15. The pH sensor package as claimed in claim 14, wherein the shelf life is 1 year from the time of manufacture.

16. The pH sensor package as claimed in claim 14, wherein the shelf life is 3 years from the time of manufacture.

17. The pH sensor package as claimed in claim 14, wherein the alert is configured to be activated immediately after being connected to a meter if the pH sensor has exceeded, or is about to exceed, the shelf life.

18. The pH sensor package as claimed in claim 11, wherein activation of the alert causes a visual alert and an audible alert to be provided.