Apparatus and method for ensuring safe operation of a thermal treatment catheter

• US 8,321,019 B2
• Filed: 07/21/2006
• Issued: 11/27/2012
• Est. Priority Date: 07/21/2005
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Esch, Brady David, Farley, Brian Eugene
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): HUPCZEY, JR, RONALD JAMES
• Application Number:
  US11/490,638
• Publication Number:
  US 20070049999A1
• Time in Patent Office: 2,321 Days
• Field of Search: 606 32- 50
• US Class Current: 607/27
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 2017/00132 Setting operation time of a device A61B2017/00123 takes precedence
• CPC Class Codes: A61B 2018/00636 Sensing and controlling the application of energy
• CPC Class Codes: A61B 2018/00666 using a threshold value
• CPC Class Codes: A61B 2018/00779 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00827 Current
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/3925 ultrasonic
• CPC Class Codes: A61B 2090/3937 Visible markers
• CPC Class Codes: A61B 2090/3945 Active visible markers, e.g. light emitting diodes
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers

Abstract

A working end of a catheter includes at least one therapeutic element, such as a resistive heating element, usable to deliver energy for ligating, or reducing the diameter of, a hollow anatomical structure. In certain examples, the catheter includes a lumen to accommodate a guide wire or to allow fluid delivery. In certain embodiments, a balloon is inflated to place resistive element(s) into apposition with a hollow anatomical structure and to occlude the structure. Indexing devices and methods are also disclosed for successively treating portions of the hollow anatomical structure. In certain examples, marks along the catheter shaft provide visual verification to the physician of the relative position of the therapeutic element of the catheter. Embodiments of indexing devices may include pairs of rings and/or hinged arms that move a catheter a desired indexed position between successive treatments.

Claims

1. A method of preventing a heating coil of a treatment device from powering up outside anatomy of a biological entity, the method comprising:

sensing a temperature on a heating coil of a blood vessel treatment device, the heating coil having at least one insulated layer configured to prevent electrical conduction into tissue of a blood vessel to be treated while at the same time allowing heat conduction into that same tissue of the blood vessel;

determining whether said heating coil is disposed within the anatomy of the biological entity by determining whether said temperature satisfies a required initial temperature condition, the required initial temperature condition comprising a temperature that is significantly above an expected ambient room temperature;

receiving a request to initiate power delivery to said heating coil of said blood vessel treatment device;

if said temperature does not satisfy said required initial temperature condition, performing a safety procedure to interrupt a normal power-up process for the heating coil by preventing the heating coil of the treatment device from powering up outside the anatomy of the biological entity having the blood vessel to be treated.

2. The method of claim 1, further comprising:

if said temperature satisfies said required initial temperature condition, allowing said normal power-up process for the heating coil.

3. The method of claim 1, wherein determining whether said temperature satisfies said required initial temperature condition, comprises determining whether said temperature has satisfied said required initial temperature condition at any time during a temperature sensing period.

4. The method of claim 3, wherein said temperature sensing period begins after connection of said treatment device to a power source.

5. The method of claim 4, wherein said temperature sensing period ends before delivery of therapeutic energy from said power source to said treatment device.

6. The method of claim 1 wherein said safety procedure comprises preventing the initiation of power delivery to said heating coil.

7. The method of claim 1, wherein said safety procedure comprises ceasing the delivery of power to said heating coil.

8. The method of claim 1, wherein said required initial temperature condition comprises that said temperature meet or exceed a minimum temperature.

9. The method of claim 8, wherein said minimum temperature is substantially at an expected internal temperature of the blood vessel to be treated with the treatment device.

10. The method of claim 8, wherein said minimum temperature is 5 to 10 degrees Celsius lower than the normal physiologic internal temperature of a blood vessel of the type normally treated with the treatment device.

11. The method of claim 1, wherein said required initial temperature condition comprises that said temperature fall within an acceptable temperature range.

12. The method of claim 11, wherein said temperature range brackets an expected internal temperature of the blood vessel to be treated with the treatment device.

13. The method of claim 11, wherein said temperature range brackets a temperature which is 5 to 10 degrees Celsius lower than the normal physiologic internal temperature of a blood vessel of the type normally treated with the treatment device.

14. The method of claim 1, further comprising, if said temperature does not satisfy said required initial temperature condition, providing a warning.

15. The method of claim 1, further comprising, if said temperature does not satisfy said required initial temperature condition:

verifying that said heating coil is properly disposed with a blood vessel of a patient; and

manually overriding said safety procedure and initiating a power-up process for the heating coil.

16. An apparatus for use in treating a blood vessel, the apparatus comprising:

a heat application device adapted to receive power from a power source, the heat application device comprising a heating coil, the heating coil having at least one insulated layer configured to prevent electrical conduction into tissue of the blood vessel while at the same time allowing heat conduction into that same tissue of the blood vessel;

a user interface adapted to receive a request from a user to initiate power delivery to said heating coil of said heat application device;

a temperature measuring device configured to measure a temperature on said heating coil of said heat application device in order to deter mine whether said heating coil is disposed within anatomy of a biological entity having the blood vessel to be treated; and

a module in communication with said temperature measuring device and said user interface, said module configured to determine whether a temperature measured by said temperature measuring device satisfies a required initial temperature condition and said module configured to follow a safety procedure if said temperature measured by said temperature measuring device does not satisfy said required initial temperature condition;

said module further configured to follow the safety procedure to interrupt a normal power-up process for the heating coil of the heat application device if said temperature measured by said temperature measuring device does not satisfy said required initial temperature condition by preventing delivery of power to the heating coil of the heat application device, the required initial temperature condition comprising a temperature that is substantially at an expected internal temperature of the blood vessel, thereby preventing the heating coil of the heat application device from powering up outside the anatomy of the biological entity having the blood vessel to be treated.

17. The apparatus of claim 16, wherein said module is further configured to follow a normal power-up process for the heating coil if said temperature measured by said temperature measuring device satisfies said required initial temperature condition.

18. The apparatus of claim 16, wherein said module is further configured to determine whether said temperature has satisfied said required initial temperature condition at any time during a temperature sensing period.

19. The apparatus of claim 16, wherein said safety procedure comprises preventing the initiation of power delivery to said heating coil.

20. The apparatus of claim 16, wherein said safety procedure comprises ceasing the delivery of power to the heating coil.

21. The apparatus of claim 16, wherein said required initial temperature condition comprises that said temperature meet or exceed a minimum temperature.

22. The apparatus of claim 21, wherein said minimum temperature is above an expected ambient room temperature.

23. The apparatus of claim 21, wherein said minimum temperature is 5 to 10 degrees Celsius lower than the normal physiologic internal temperature of a blood vessel of the type normally treated with the treatment device.

24. The apparatus of claim 16, wherein said required initial temperature condition comprises that said temperature fall within an acceptable temperature range.

25. The apparatus of claim 16, wherein said temperature range is significantly above an expected ambient room temperature.

26. The apparatus of claim 16, wherein said temperature range brackets a temperature which is 5 to 10 degrees Celsius lower than the normal physiologic internal temperature of a blood vessel of the type normally treated with the treatment device.

27. The apparatus of claim 16, further comprising:

a warning device in communication with said module; and

wherein said module is further configured to cause said warning device to provide a warning if said temperature does not satisfy said required initial temperature condition.

28. The apparatus of claim 16, wherein said user interface is further adapted to receive a request from a user to manually override said safety procedure;

and wherein said module is further configured to initiate a power-up process for said heating coil upon receiving a user request to manually override said safety procedure.

29. A method of preventing a heating element of a treatment device from powering up outside anatomy of a biological entity to be treated, the method comprising:

providing power to the treatment device;

sensing a temperature on the heating element of the treatment device, the heating element comprising electrical insulation configured to prevent electrical conduction into tissue while allowing heat conduction into tissue;

determining whether said heating element is disposed within the anatomy of the biological entity to be treated by determining whether said temperature satisfies a required initial temperature condition, the required initial temperature condition comprising a temperature that is 5 to 10 degrees Celsius lower than a normal physiologic internal temperature of a hollow anatomical structure of the biological entity to be treated;

receiving a request to initiate power delivery to the heating element of the treatment device;

if said temperature does not satisfy the required initial temperature condition, preventing power delivery to the heating element, thereby improving safety by preventing the heating element from powering up outside the anatomy of the biological entity.