Apparatus for in vivo detection and quantification of analytes in the peritoneal fluid

• US 10,070,808 B2
• Filed: 06/03/2016
• Issued: 09/11/2018
• Est. Priority Date: 06/03/2016
• Status: Active Grant

• Current Assignee: King Abdullah International Medical Research Center, King Saud Bin Abdulaziz University For Health Sciences, National Guard Health Affairs
• Original Assignee: King Abdullah International Medical Research Center, King Saud Bin Abdulaziz University For Health Sciences, National Guard Health Affairs
• Inventors: Farooqui, Mahfooz Alam
• Primary Examiner(s): Cheng, Jacqueline
• Assistant Examiner(s): MESSERSMITH, ERIC J
• Application Number:
  US15/173,016
• Publication Number:
  US 20170347926A1
• Time in Patent Office: 830 Days
• CPC Class Codes: A61B 2562/222 Electrical cables or leads therefor, e.g. coaxial cables or ribbon cables
• CPC Class Codes: A61B 5/0017 transmitting optical signals transmission by light H04B10/00
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• 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 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/6853 with a balloon
• 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: G16H 40/67 for remote operation

Abstract

A device for in vivo detecting and quantifying a concentration of an analyte in a peritoneal fluid of a subject. The device includes (a) a catheter having an open proximal end configured to be disposed external to the subject, an open distal end configured to be disposed within the peritoneal cavity comprising the peritoneal fluid, an anchor portion, an outer wall, and an inner wall, (b) a sensor disposed adjacent to the open distal end and configured to detect and quantify the concentration of the analyte in the peritoneal fluid, and (c) a main control unit disposed external to the subject, connected to the sensor via a wire, and configured to control the sensor, receive and store detection and quantification data from the sensor, and transmit the data to a second device. A portion of the wire is disposed between the inner wall and the outer wall of the catheter.

Claims

1. A device for in vivo detecting and quantifying a concentration of at least one analyte in a peritoneal fluid of a subject, the device comprising:

(a) a catheter configured for insertion through an abdominal wall into a peritoneal cavity comprising the peritoneal fluid of the subject,

wherein the catheter comprises an elongated tube having an open proximal end, an open distal end, an anchor portion disposed between the open proximal end and the open distal end, an outer wall, and an inner wall disposed within the outer wall and defining a central lumen for conveying the peritoneal fluid,

wherein the open proximal end is configured to be disposed external to the subject, the open distal end is configured to be disposed within the peritoneal cavity of the subject, and the anchor portion is configured to be disposed within and anchored to the abdominal wall,

(b) at least one sensor disposed on a surface of the inner wall of the catheter at or adjacent to the open distal end,

wherein the at least one sensor is configured to contact the peritoneal fluid and to detect and quantify the concentration of at least one analyte in the peritoneal fluid in real time, wherein the at least one analyte is selected from the group consisting of glucose, hydrogen ion, urea, and creatinine, and

(c) a processing circuitry disposed external to the subject and connected to the at least one sensor via at least one wire, wherein at least a portion of the at least one wire is disposed between the inner wall and the outer wall of the catheter,

wherein the processing circuitry is configured to control the at least one sensor, to receive and store data of the detection and quantification of the at least one analyte in the peritoneal fluid from the at least one sensor via the at least one wire, and to transmit the data to a second device having a second processing circuitry,

wherein the processing circuitry and/or the second processing circuitry of the second device are configured to determine a relationship of the concentration of the at least one analyte of glucose, hydrogen ion, urea, and creatinine with time based on the data received from the at least one sensor,

wherein the relationship is represented by a curve indicative of the concentration at each time,

wherein the processing circuitry and/or the second processing circuitry of the second device are configured to calculate an area under the curve indicative of the concentration at each time,

wherein the processing circuitry and/or the second processing circuitry of the second device are further configured to generate and/or transmit an alert if the area under the curve varies from a pre-set value.

2. The device of claim 1, wherein the catheter further comprises a plurality of openings disposed on a distal portion of the catheter, wherein the plurality of openings pass through the outer wall and the inner wall without the at least one wire therebetween, and wherein the distal portion of the catheter is configured to contact the peritoneal fluid.

3. The device of claim 1, further comprising a display for displaying the data.

4. The device of claim 1, wherein the processing circuitry is further configured to analyze the data.

5. The device of claim 1, wherein the processing circuitry is configured to transmit the data to the second device via a wired link, a wireless link, or a combination thereof.

6. The device of claim 5, wherein the wireless link is at least one selected from the group consisting of a Bluetooth link, an infrared link, a Wi-Fi link, and a satellite link.

7. The device of claim 1, wherein the second device is at least one selected from the group consisting of a computer, a smart phone, a smart watch, a pager, and a cloud computer server.

8. The device of claim 1, wherein the second processing circuitry of the second device is configured to analyze the data.

9. The device of claim 1, wherein the subject is a human or an animal.

10. The device of claim 1, wherein the at least one wire is made of a non-magnetic conductive material.

11. The device of claim 10, wherein the non-magnetic conductive material is at least one selected from the group consisting of aluminum, copper, zinc, titanium, gold, silver, platinum, graphite, a polyfluorene, a polyphenylene, a polypyrene, a polyazulene, a polynaphthalene, a polypyrrole, a polycarbazole, a polyindole, a polyazepine, a polyaniline, a polythiophene, poly(3,4-ethylenedioxythiophene), poly(p-phenylene sulfide), a polyacetylene, and polyphenylene vinylene.

12. The device of claim 1, wherein a Dacron cuff is disposed on the outer wall of the anchor portion for anchoring the catheter in the abdominal wall.

13. The device of claim 1, further comprising an extension set connected to the open proximal end of the catheter.

14. The device of claim 1, wherein the processing circuitry and/or the second processing circuitry of the second device are configured to generate and/or transmit an alert if the data vary from a baseline.

15. The device of claim 14, wherein the baseline is a baseline previously established from the subject.

16. The device of claim 1, wherein the processing circuitry and/or the second processing circuitry of the second device are configured to determine a relationship of the concentration of the at least one analyte of glucose, hydrogen ion, urea, and creatinine with time based on the data received from the at least one sensor and calculate a rate of change in the concentration of the at least one analyte of glucose, hydrogen ion, urea, and creatinine at each time and/or over a period of time based on the relationship.

17. The device of claim 16, wherein the processing circuitry and/or the second processing circuitry of the second device are further configured to generate and/or transmit an alert if the rate of change varies from a pre-set value.