Methods and devices for analyte sensing in potential spaces

• US 10,610,134 B2
• Filed: 06/21/2017
• Issued: 04/07/2020
• Est. Priority Date: 12/31/2014
• Status: Active Grant

• Current Assignee: Theranova, Llc
• Original Assignee: Theranova, Llc
• Inventors: Burnett, Daniel R., Luxon, Evan S.
• Primary Examiner(s): Stiles, Amber R
• Application Number:
  US15/629,337
• Publication Number:
  US 20170281062A1
• Time in Patent Office: 1,021 Days
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• 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 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 takes precedence
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6858 with a distal basket, e.g. expandable basket
• CPC Class Codes: A61B 5/6867 specially adapted to be attached or implanted in a specific body part A61B5/6847 takes precedence
• CPC Class Codes: A61B 5/6874 Bladder

Abstract

Use of the peritoneal space provides a more direct tracking of blood glucose, capturing faster glucose kinetics, avoiding membrane/encapsulation effects, having less lag time and lag time variability, and eliminating the effect of variations in skin temperature, cardiac output, and body position during sleep. A peritoneal sensor system may be implanted within the peritoneal space and may generally include a sensor/sampler portion, which is implanted in the peritoneal space, and a control portion/controller, which may be implanted elsewhere, such as subcutaneously, or may be external to the patient.

Claims

1. A peritoneal fluid sensing apparatus, comprising:

a catheter having a distal tip and defining a sampling lumen and a flushing lumen each at least partially through the catheter;

a sensor configured to sense for a presence of one or more analytes when contacting peritoneal fluid of a subject;

a controller in communication with the sensor, wherein the sensor is positioned within the controller;

a filter positioned at or near the distal tip of the catheter and in fluid communication with the sensor, wherein the filter is permeable to the one or more analytes; and

a port in fluid communication with the flushing lumen at least partially through the catheter and the sensor such that infusion of a fluid through the port flushes the filter at or near the distal tip with the fluid.

2. The apparatus of claim 1 wherein the controller is configured to receive sensed information from the sensor and determine a glucose level within the peritoneal fluid.

3. The apparatus of claim 2 wherein the controller is further configured to infuse insulin based on the determined glucose level.

4. The apparatus of claim 1 wherein the analyte comprises glucose.

5. The apparatus of claim 1 further comprising a sleeve or cuff sized to slidingly receive the catheter therethrough.

6. The apparatus of claim 5 further comprising an anchoring cuff or tunnel positioned along the catheter or sleeve and configured to promote tissue ingrowth.

7. The apparatus of claim 1 wherein the controller is located remotely from a second sensor.

8. The apparatus of claim 1 wherein the controller is configured to automatically infuse the fluid into the port to intermittently flush the sensor.

9. The apparatus of claim 1 wherein the fluid comprises insulin, saline, peritoneal fluid, or combinations thereof.

10. The apparatus of claim 1 further comprising a pump in fluid communication with the catheter and in electrical communication with the controller.

11. The apparatus of claim 10 further comprising a fluid reservoir in fluid communication with the pump.

12. The apparatus of claim 1 wherein the tip of the catheter is made from a material which inhibits cell ingrowth.

13. The apparatus of claim 1 wherein the controller further includes a sterilization element.

14. The apparatus of claim 13 wherein the sterilization element comprises an ultraviolet light source.

15. The apparatus of claim 1 wherein the controller is in fluid communication with the fluid.

16. The apparatus of claim 1 wherein the filter is comprised of a permeable membrane.

17. The apparatus of claim 1 wherein the filter is positioned within the catheter.

18. The apparatus of claim 1 wherein the sensor is configured for light spectroscopy.