Therapeutic system with energy application device and programmed power delivery

• US 8,636,729 B2
• Filed: 07/21/2006
• Issued: 01/28/2014
• 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, Tantisira, Radit
• Primary Examiner(s): HUPCZEY, JR, RONALD JAMES
• Application Number:
  US11/491,424
• Publication Number:
  US 20070055327A1
• Time in Patent Office: 2,748 Days
• Field of Search: 606 32- 52, 607/96, 607/113
• US Class Current: 606/28
• 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 blood vessel therapy system comprising:

an energy application device comprising an electrically insulated heating coil suitable for insertion into a hollow anatomical structure, the electrically insulated heating coil configured to prevent electrical contact and electrical conduction with tissue and configured to engage a blood vessel for heat conduction with tissue;

a power source in communication with said energy application device, said power source comprising a processor and program instructions executable by said processor such that said power source is operable to;

(a) deliver power to said heating coil during a first power delivery phase;

(b) measure time elapsing during power delivery;

(c) assess performance of said therapy system during said first power delivery phase;

(d) if said performance of said therapy system during said first power delivery phase is satisfactory, deliver a decreasing amount of power to said heating coil during a second power delivery phase; and

(e) cease power delivery in preparation for movement within the blood vessel to a new treatment segment in the blood vessel;

the electrically insulated heating coil being elongate and configured for discrete segmental movement within the blood vessel; and

the power source configured to receive an input from a user and further operable to;

(f) deliver power to said heating coil during a third power delivery phase upon input from the user, the third power delivery phase configured to be after movement of the therapy system within the blood vessel; and

(g) if said operation of said heating coil during or after said third power delivery phase is acceptable, deliver power to said heating coil after said third power delivery phase during a fourth power delivery phase.

2. A blood vessel therapy system in accordance with claim 1, wherein said heating coil comprises an energy coupling surface, said surface having a distal-to-proximal length which is at least fifteen times a width of said heating coil.

3. A blood vessel therapy system in accordance with claim 1, further comprising a catheter having a shaft to which said energy application device is coupled.

4. A blood vessel therapy system in accordance with claim 1, further comprising a temperature sensor configured to sense at least one of (i) a temperature of at least a portion of said energy application device, and (ii) a temperature of tissue in thermal communication with said energy application device.

5. A blood vessel therapy system in accordance with claim 4, wherein said program instructions are executable by said processor such that said power source is further operable to:

deliver power to said energy application device to reach a first treatment temperature; and

deliver power to said energy application device to reach a subsequent second treatment temperature which is lower than said first treatment temperature.

6. A blood vessel therapy system in accordance with claim 4, wherein said program instructions are executable by said processor such that said power source is further operable to determine expiration of said first power delivery phase based on temperature measurement results obtained by said temperature sensor.

7. A blood vessel therapy system in accordance with claim 4, wherein satisfactory performance of said therapy system comprises reaching or exceeding a target temperature within a time limit.

8. A blood vessel therapy system in accordance with claim 7, wherein said program instructions are executable by said processor such that said power source proceeds to said second power delivery phase only when said temperature sensor senses said target temperature within said time limit.

9. A blood vessel therapy system in accordance with claim 4, wherein said program instructions are executable by said processor such that said power source is further operable to determine expiration of said first power delivery phase when said temperature sensor senses a target temperature within a time limit.

10. A blood vessel therapy system in accordance with claim 9, wherein said time limit is six seconds or less.

11. A blood vessel therapy system in accordance with claim 9, wherein said target temperature is approximately 120 degrees Celsius.

12. A blood vessel therapy system in accordance with claim 1, wherein said first power delivery phase is 10 seconds or less in duration.

13. A blood vessel therapy system in accordance with claim 1, wherein the combined duration of said first power delivery phase and said second power delivery phase is 60 seconds or less.

14. A blood vessel therapy system comprising:

a heat delivery device comprising an electrically insulated heating element suitable for insertion into a blood vessel, the electrically insulated heating element configured to prevent electrical contact and electrical conduction with tissue;

a power source in communication with said heat delivery device, said power source being programmed to;

(a) deliver power to said heating element during a temperature ramp-up phase;

(b) measure time elapsing during power delivery;

(c) monitor operation of said heat delivery device; and

(d) if said operation of said heating element either during or after said temperature ramp-up phase is acceptable, deliver a decreasing amount of power to said heat delivery device after said temperature ramp-up phase and maintain said heating element within a constant temperature range.

15. A blood vessel therapy system in accordance with claim 14, wherein said heating element includes an energy coupling surface, said surface having a distal-to-proximal length which is at least fifteen times a width of said heating element.

16. A blood vessel therapy system in accordance with claim 14, further comprising a catheter having a shaft to which said heat delivery device is coupled.

17. A blood vessel therapy system in accordance with claim 14, further comprising a temperature sensor configured to sense at least one of (i) a temperature of a portion of said heat delivery device, and (ii) a temperature of tissue in thermal communication with said heat delivery device.

18. A blood vessel therapy system in accordance with claim 14, wherein acceptable operation of said heat delivery device during or after said temperature ramp-up phase comprises reaching or exceeding a target temperature within a time limit.

19. A blood vessel therapy system in accordance with claim 14, wherein acceptable operation of said heat delivery device during or after said temperature ramp-up phase comprises falling below a target temperature within a time limit.

20. A blood vessel therapy system in accordance with claim 14, wherein the combined duration of said temperature ramp-up phase and a subsequent power delivery phase is 60 seconds or less.

21. A blood vessel therapy system in accordance with claim 14, wherein said power source is further programmed to:

deliver power to said heat delivery device to reach a first treatment temperature within said constant temperature range; and

deliver power to said heat delivery device to reach a subsequent second treatment temperature, which is lower than said first treatment temperature, within said constant temperature range.

22. A method of treating a blood vessel, said method comprising:

inserting a heat delivery device into a blood vessel comprising an electrically insulated heating element configured to prevent electrical contact and electrical conduction with tissue, and while within the blood vessel;

delivering power to said heating element during a temperature ramp-up phase;

measuring time elapsing during power delivery;

monitoring operation of said heat delivery device;

if said operation of said heat delivery device during or after said temperature ramp-up phase is acceptable, delivering power to said heating element after said temperature ramp-up phase during a temperature maintenance phase;

suspending power delivery after said temperature maintenance phase;

moving the heat delivery device to a new location within the blood vessel;

delivering power to said heating element during a subsequent temperature ramp up phase after said moving of said heat delivery device to said new location within the blood vessel; and

if said operation of said heating element during or said subsequent temperature ramp-up phase is acceptable, delivering power to said heating element after said subsequent temperature ramp-up phase during a subsequent temperature maintenance phase.

23. A method of treating a blood vessel in accordance with claim 22, further comprising:

delivering power to said heating element to reach a first treatment temperature; and

delivering power to said heating element to reach a subsequent second treatment temperature which is lower than said first treatment temperature.

24. A method of treating a blood vessel in accordance with claim 22, wherein said heat delivery device comprises an energy coupling surface, said surface having a distal-to-proximal length which is at least fifteen times a width of said heating element.

25. A method of treating a blood vessel in accordance with claim 22, additionally comprising measuring a temperature of at least one of (i) at least a portion of said heat delivery device, and (ii) a portion of said blood vessel being treated.

26. A method of treating a blood vessel in accordance with claim 25, wherein monitoring operation of said heat delivery device comprises determining whether said measured temperature reaches or exceeds a target temperature within a time limit.

27. A method of treating a blood vessel in accordance with claim 26, additionally comprising proceeding to deliver power to said heating element after said temperature ramp-up phase only when said target temperature is reached or exceeded within said time limit.

28. A method of treating a blood vessel in accordance with claim 25, wherein monitoring operation of said heat delivery device comprises determining whether said measured temperature falls below a target temperature within a time limit.

29. A method of treating a blood vessel in accordance with claim 28, additionally comprising proceeding to deliver power to said heating element after said temperature ramp-up phase only when said target temperature falls below said target temperature within said time limit.

30. A method of treating a blood vessel in accordance with claim 22, wherein monitoring operation of said heat delivery device comprises comparing a measurement of electrical impedance with a reference waveform.

31. A method of treating a blood vessel in accordance with claim 22, additionally comprising:

if said operation of said heat delivery device during said temperature ramp-up phase is not acceptable, displaying an instruction to adjust treatment of said blood vessel.

32. A method of treating a blood vessel in accordance with claim 31, wherein displaying an instruction to adjust treatment of said blood vessel comprises displaying an instruction to adjust compression of said blood vessel.

33. A method of treating a blood vessel in accordance with claim 22, wherein said blood vessel comprises a vein.

34. A method of treating a blood vessel in accordance with claim 22, wherein power delivery during the temperature maintenance phase comprises decreasing the power delivery.

35. A method of treating a blood vessel in accordance with claim 22, wherein suspending power delivery comprises the automatic cessation of power delivery after a set time period.