DEVICES, SYSTEMS AND METHODS FOR USING AND MONITORING TUBES IN BODY PASSAGEWAYS

• US 20170196478A1
• Filed: 06/25/2015
• Published: 07/13/2017
• Est. Priority Date: 06/25/2014
• Status: Active Grant

• Current Assignee: Canary Medical Switzerland AG
• Original Assignee: Canary Medical, Inc.
• Inventors: Hunter, William L.
• Granted Patent: US 10,524,694 B2
• Time in Patent Office: Days
• 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 medical tube comprising:

a medical tube and one or more sensors positioned within or upon said medical tube.

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

3. The medical tube of claim 1 wherein said one or more sensors includes a sensor within or upon said medical tube.

4. The medical tube according to any one of claims 1 to 4 wherein said sensor is 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 medical tube according to claim 1 wherein said medical tube is a catheter.

6. The medical tube according to claim 5 wherein said catheter is a balloon catheter.

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

8. A medical device, comprising a balloon catheter according to claim 6, and a stent comprising one or more sensors.

9. The medical device according to claim 8 wherein said sensor on said stent is selected from the group consisting of accelerometers, pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolic sensors, mechanical stress sensors and temperature sensors.

10. The medical device according to claim 9 wherein said accelerometer detects acceleration, tilt, vibration, shock and or rotation.

11. The medical tube according to any one of claims 1 to 7 or medical device according to any one of claim 9 or 10 further comprising:

an electronic processor positioned upon and/or inside the catheter or medical device that is electrically coupled to sensors.

12. The catheter or medical device according to claim 11 wherein the electric coupling is a wireless coupling.

13. The tube or medical device according to claim 11 further including:

a memory coupled to the electronic processor and positioned upon and/or inside the tube or medical device.

14. A kit comprising the tube according to any one of claims 1 to 15, further comprising a guidewire.

15. The kit according to claim 14 wherein said guidewire further comprises one or more sensors position on or within said guidewire.

16. The tube, medical device or kit according to any one of claims 1 to 15 wherein said sensor is a plurality of sensors which are positioned on or within said tube, medical device and/or kit at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per square centimeter.

17. The tube, medical device or kit according to any one of claims 1 to 15 wherein said sensor is a plurality of sensors which are positioned on or within said tube, medical device and/or kit at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per cubic centimeter.

18. The tube, medical device, or kit according to any one of claims 1 to 17 wherein said sensors are placed randomly within the tube, medical device or kit.

19. The tube, medical device, or kit according to any one of claims 1 to 18 wherein the one or more of the sensors are placed at specific locations within the tube, medical device or kit.

20. A method comprising:

obtaining data from a sensor positioned at a plurality of locations between on and/or within a tube, medical device or kit according to any one of claims 1 to 19 of a subject;

storing the data in a memory device located on or within the tube, medical device or kit; and

transferring the data from the memory to a location outside the tube or medical device.

21. A method according to claim 20, further comprising the step of analyzing said data.

22. A method for detecting and/or recording an event in a subject with a tube, medical device or kit as provided in any one of claims 1 to 19, comprising the step of interrogating at a desired point in time the activity of one or more sensors within the tube, medical device or kit, and recording said activity.

23. The method according to claim 22 wherein the step of interrogating is performed by a subject which has an implanted tube, and the step of recording is performed on a wearable device.

24. The method according to any one of claim 22, or 23, wherein said recording is provided to a health care provider.

25. A method for imaging a tube, medical device or kit, comprising the steps of

(a) detecting the location of one or more sensors of a tube, medical device or kit according to any one of claims 1 to 19;

and

(b) visually displaying the location of said one or more sensors, such that an image of the tube, medical device or kit is created.

26. The method according to claim 25 wherein the step of detecting occurs over time.

27. The method according to claim 25 or 26, wherein said visual display shows changes in the positions of said sensors over time, and/or changes in temperature of the sensors or surrounding tissue over time.

28. The method according to any one of claims 25 to 27 wherein said visual display is a three-dimensional image of said tube.

29. A method for inserting a tube, medical device or kit into a subject, comprising the steps of

(a) inserting a tube, medical device or kit according to any one of claims 1 to 19 into a subject;

and

(b) imaging the placement of said tube, medical device or kit according to the method of any one of claims 25 to 28.

30. A method for examining a tube, medical device or kit according to any one of claims 1 to 19 which has been previously inserted into a patient, comprising the step of imaging the tube according to the method of any one of claims 25 to 28.

31. A method of monitoring a tube, medical device, or kit within a subject, comprising:

transmitting a wireless electrical signal from a location outside the body to a location inside the subject'"'"'s body;

receiving the signal at a sensor positioned on a tube, medical device, or kit according to any one of claims 1 to 19 located inside the body;

powering the sensor using the received signal;

sensing data at the sensor; and

outputting the sensed data from the sensor to a receiving unit located outside of the body.

32. The method according to claim 31 wherein said receiving unit is a watch, wrist band, cell phone or glasses.

33. The method according to claim 31 or 32 wherein said receiving unit is located within a subject'"'"'s residence or office.

34. The method according to claims any one of claims 31 to 33 wherein said sensed data is provided to a health care provider.

35. The method according to any one of claims 31 to 34 wherein said sensed data is posted to one or more websites.

36. A non-transitory computer-readable storage medium whose stored contents configure a computing system to perform a method, the method comprising:

identifying a subject, the identified subject having at least one wireless tube, medical device, or kit according to any one of claims 1 to 19, each wireless tube, medical device, or kit having one or more wireless sensors;

directing a wireless interrogation unit to collect sensor data from at least one of the respective one or more wireless sensors; and

receiving the collected sensor data.

37. The non-transitory computer-readable storage medium of claim 36 whose stored contents configure a computing system to perform a method, the method further comprising:

identifying a plurality of subjects, each identified subject having at least one wireless tube, medical device, or kit, each wireless tube, medical device, or kit having one or more wireless sensors;

directing a wireless interrogation unit associated with each identified subject to collect sensor data from at least one of the respective one or more wireless sensors;

receiving the collected sensor data; and

aggregating the collected sensor data.

38. The non-transitory computer-readable storage medium of claim 36 whose stored contents configure a computing system to perform a method, the method further comprising:

removing sensitive subject data from the collected sensor data; and

parsing the aggregated data according to a type of sensor.

39. The non-transitory computer-readable storage medium of claim 36 whose stored contents configure a computing system to perform a method, wherein directing the wireless interrogation unit includes directing a control unit associated with the wireless interrogation unit.

40. The non-transitory computer readable storage medium according to any one of claims 36 to 39, wherein said tube, medical device, or kit is an assembly according to any one of claims 1 to 19.

41. The storage medium according to any one of claims 36 to 40 wherein said collected sensor data is received on a watch, wrist band, cell phone or glasses.

42. The storage medium according to any one of claims 36 to 41 wherein said collected sensor data is received within a subject'"'"'s residence or office.

43. The storage medium according to any one of claims 36 to 42 wherein said collected sensed data is provided to a health care provider.

44. The storage medium according to any one of claims 36 to 43 wherein said sensed data is posted to one or more websites.

45. The method according to any one of claims 31 to 35, or storage medium according to any one of claims 36 to 44, wherein said data is analyzed.

46. The method or storage medium according to claim 45 wherein said data is plotted to enable visualization of change over time.

47. The method or storage medium according to claim 45 or 46 wherein said data is plotted to provide a three-dimensional image.

48. A method for determining degradation of a tube, comprising the steps of a) providing to a body passageway of a subject a tube according to any one of claims 1 to 7 or 16 to 19, and b) detecting a change in a sensor, and thus determining degradation of the tube.

49. The method according to claim 48 wherein said sensor is capable of detecting one or more physiological and/or locational parameters.

50. The method according to claim 48 or 49 wherein said sensor detects contact, fluid flow, pressure and/or temperature.

51. The method according to any one of claims 48 to 50 wherein said sensor detects a location within the subject.

52. The method according to any one of claims 48 to 50 wherein said sensor moves and/or is eliminated by the body upon degradation of the tube.

53. The method according to any one of claims 48 to 52 wherein the step of detecting is a series of detections over time.

54. A method for determining an infection associated with a tube, comprising the steps of a) providing to a body passageway of a subject a tube according to any one of claims 1 to 7 or 16 to 19, wherein said tube 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.

55. The method according to claim 54 wherein the step of detecting is a series of detections over time.

56. The method according to claim 54 or 55 wherein said change is greater than a 1% change over the period of one hour.

57. The method according to claims 54 to 56 wherein said change is a continually increasing temperature and/or metabolic activity over the course of 4 hours.