Devices, systems and methods for using and monitoring tubes in body passageways

• US 10,524,694 B2
• Filed: 06/25/2015
• Issued: 01/07/2020
• Est. Priority Date: 06/25/2014
• Status: Active Grant

• Current Assignee: Canary Medical Switzerland AG
• Original Assignee: Canary Medical, Inc.
• Inventors: Hunter, William L.
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US15/320,275
• Publication Number:
  US 20170196478A1
• Time in Patent Office: 1,657 Days
• Field of Search: 623 111- 134
• CPC Class Codes: A61B 2560/0266 for monitoring or limiting apparatus function
• CPC Class Codes: A61B 2562/12 Manufacturing methods specially adapted for producing sensors for in-vivo measurements
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/067 using accelerometers or gyroscopes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/20 for measuring urological functions restricted to the evaluation of the urinary system A61B5/4375 takes precedence
• CPC Class Codes: A61B 5/6847 mounted on an invasive device
• CPC Class Codes: A61B 5/6885 Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip

Abstract

Tubes (e.g., catheters, endotracheal or chest tubes and bypass grafts) are provided, comprising a catheter and a plurality of sensors. Briefly stated, a wide variety of tubes (e.g., catheters, endotracheal or chest tubes, bypass grafts, balloon catheters, urinary catheters, central lines and dialysis catheters), as well as related delivery devices (e.g., guidewires) are provided with a number of sensors to monitor the integrity, patency and efficaciousness of the device.

Claims

1. A method for determining degradation of a tube, comprising the steps of a) providing to a body passageway of a subject a medical device, where the medical device comprises a medical tube and a plurality of sensors positioned within or upon said medical tube, and b) detecting a change in a sensor positioned within or upon said medical tube, and thus determining degradation of the tube.

2. The method according to claim 1 wherein said one or more sensors includes a sensor within the matrix of the medical tube.

3. The method according to claim 1 wherein said plurality of sensors includes a sensor within or upon said medical tube.

4. The method according to claim 1 wherein said plurality of sensors are selected from the group consisting of fluid pressure sensors, contact sensors, position sensors, pulse pressure sensors, liquid volume sensors, liquid flow sensors, chemistry sensors, metabolic sensors, accelerometers, mechanical stress sensors and temperature sensors.

5. The method according to claim 1 wherein said medical tube is a catheter.

6. The method according to claim 1 wherein said medical tube is a balloon catheter.

7. The method according to claim 1 wherein said medical tube is a graft or drainage tube.

8. The method according to claim 1 where said plurality of sensors are positioned on said medical tube at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per square centimeter.

9. The method according to claim 1 wherein said plurality of sensors are positioned within said medical tube at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per cubic centimeter.

10. The method according to claim 1 wherein said plurality of sensors are placed randomly within the medical tube.

11. The method according to claim 1 wherein said plurality of sensors are placed at specific locations within the medical tube.

12. The method according to claim 1 wherein said plurality of sensors are capable of detecting one or more physiological and/or locational parameters.

13. The method of claim 1 wherein said plurality of sensors detect at least one of contact, fluid flow, pressure and temperature.

14. The method according to claim 1 wherein said plurality of sensors detect a location with the subject.

15. The method according to claim 1 wherein said plurality of sensors move upon degradation of the medical tube.

16. The method according to claim 1 wherein said plurality of sensors are eliminated by the body upon degradation of the medical tube.

17. The method according to claim 1 wherein the step of detecting is a series of detections over time.

18. The method according to claim 1 wherein said medical tube is a biodegradable medical tube.

19. The method according to claim 1 wherein said medical tube is a vascular catheter.

20. The method according to claim 1 wherein said medical tube is a ureteral catheter.

21. The method according to claim 1 wherein said plurality of sensors comprises a plurality of contact sensors.

22. The method according to claim 1 wherein said plurality of sensors comprises a plurality of pressure sensors.

23. The method according to claim 1 wherein said plurality of sensors are positioned at different depths within said medical tube.

24. A method for determining an infection associated with a tube, comprising the steps of a) providing to a body passageway of a subject a medical device, where the medical device comprises a medical tube and a plurality of sensors positioned within or upon said medical tube, wherein said plurality of sensors comprises at least one temperature sensor and/or metabolic sensor, and b) detecting a change in said temperature sensor and/or metabolic sensor, and thus determining the presence of an infection.

25. The method according to claim 24 wherein said one or more sensors includes a sensor within the matrix of the medical tube.

26. The method according to claim 24 wherein said plurality of sensors includes a sensor within or upon said medical tube.

27. The method according to claim 24 wherein said plurality of sensors are selected from the group consisting of fluid pressure sensors, contact sensors, position sensors, pulse pressure sensors, liquid volume sensors, liquid flow sensors, chemistry sensors, metabolic sensors, accelerometers, mechanical stress sensors and temperature sensors.

28. The method according to claim 24 wherein said medical tube is a catheter.

29. The method according to claim 24 wherein said medical tube is a balloon catheter.

30. The method according to claim 24 wherein said medical tube is a graft or drainage tube.

31. The method according to claim 24 where said plurality of sensors are positioned on said medical tube at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per square centimeter.

32. The method according to claim 24 wherein said plurality of sensors are positioned within said medical tube at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per cubic centimeter.

33. The method according to claim 24 wherein said plurality of sensors are placed randomly within the medical tube.

34. The method according to claim 24 wherein said plurality of sensors are placed at specific locations within the medical tube.

35. The method according to claim 24 wherein the step of detecting is a series of detections over time.

36. The method according to claim 24 wherein said change is greater than a 1% change over the period of one hour.

37. The method according to claim 24 wherein said change is a continually increasing temperature and/or metabolic activity over the course of 4 hours.

38. The method according to claim 24 wherein said medical tube is selected from a CVC, endotracheal tube, chest tube, drainage tube, Foley catheter, hemodialysis access graft and bypass graft.