Control systems for delivering energy

• US 7,594,925 B2
• Filed: 04/21/2006
• Issued: 09/29/2009
• Est. Priority Date: 04/21/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Asthmatx, Inc. (Boston Scientific Corporation)
• Inventors: Laufer, Michael D., Danek, Christopher J., Wizeman, William J., Dalbec, Tim R., French, Glendon E.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Behringer; Luther G
• Application Number:
  US11/408,668
• Publication Number:
  US 20060247683A1
• Time in Patent Office: 1,257 Days
• Field of Search: 600/381, 600/437, 600/510, 606/96, 607/1, 607/122
• US Class Current: 607/96
• CPC Class Codes: A61B 18/1233 with circuits for assuring patient safety
• 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 2017/00119 alarm; indicating an abnormal situation
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00541 Lung or bronchi
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00702 Power or energy
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00898 Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2034/2051 Electromagnetic tracking systems
• CPC Class Codes: A61B 2090/309 using white LEDs
• CPC Class Codes: A61B 2090/365 augmented reality, i.e. correlating a live optical image with another image
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/403 for thermotherapy, e.g. hyperthermia

Abstract

Methods for treating a network of organs including generating a map of at least a portion of the network of organs using a rendering system; selecting at least one treatment location within the luminal passageway of the network of organs; and applying an energy therapy to the treatment location to treat the smooth muscle tissue, where the energy therapy applied to the respective treatment location is defined by a plurality of parameters that are associated with a map. Such a system allows for historical or ideal treatment parameters to be identified, visually or otherwise to actual treatment locations. Also, control systems and methods for delivery of energy that may include control algorithms that prevent energy delivery if a fault is detected and may provide energy delivery to produce a substantially constant temperature at a delivery site. In some embodiments, the control systems and methods may be used to control the delivery of energy, such as radiofrequency energy, to body tissue, such as lung tissue.

Claims

1. A method for treating smooth muscle tissue surrounding a luminal passageway in an asthmatic lung of a patient, the method comprising:

generating a map representing at least a portion of luminal passageways in the lung using a rendering system;

selecting at least one treatment location within the luminal passageway of the lung, wherein a substantial portion of the map is generated before selecting at least one treatment location;

providing a separate real-time visual display module displaying the treatment location from within the luminal passageway of the lung via a bronchoscope, wherein an actual position of the treatment location on the map and the separate real-time visual display module displaying the luminal passageways are displayed concurrently;

applying an energy therapy to the treatment location to treat the smooth muscle tissue, where the energy therapy applied to the respective treatment location is defined by a plurality of parameters; and

generating a treatment history profile where the treatment history profile includes a virtual position of the device at each treatment location when applying the energy therapy.

2. The method of claim 1, further comprising correlating the map with a plurality of locations in the lung.

3. The method of claim 1, further comprising using the actual position of the treatment location on the map to select the treatment location.

4. The method of claim 1, further comprising imposing at least a portion of the map on the real-time visual display from within the luminal passageway.

5. The method of claim 1, further comprising advancing a device into the lung, where the device comprises at least one locating implement that communicates with a locating system to establish the virtual position of the device on the map.

6. The method of claim 5, where displaying the real time image of the luminal passageways on the visual display includes imposing the virtual position of the device on the visual display.

7. The method of claim 5, further comprising displaying the map and the virtual position of the device on a monitor.

8. The method of claim 5, where applying the energy therapy comprises inserting an energy delivery element into the lung where the energy delivery element is coupled to a control system configured to provide energy for the energy therapy.

9. The method of claim 8, where the energy delivery element is affixed to a treatment device.

10. The method of claim 8, where the energy delivery element is affixed to the device.

11. The method of claim 10, further comprising applying the energy therapy with the device at a plurality of treatment locations.

12. The method of claim 1, where the treatment history profile is electronically recorded.

13. The method of claim 1, where the treatment history profile further includes at least one of the plurality of parameters of the respective energy therapy associated with the virtual position of the device at each treatment location.

14. The method of claim 1, where displaying at least a portion of the treatment history profile allows a medical caregiver to avoid overlapping treatment locations when applying one or more energy therapies.

15. The method of claim 14, where the control system is prevented from providing the energy therapy if the medical caregiver overlaps treatment locations.

16. The method of claim 1, further comprising providing an auditory output to signal a relationship between a current treatment location and the treatment history profile.

17. The method of claim 1, further comprising displaying at least a portion of the treatment history profile on either the monitor or the visual display.

18. The method of claim 17, where displaying the treatment history profile comprises visually marking a portion of the luminal passageway on the visual display to identify a previous treatment site.

19. The method of claim 18, where visually marking the portion of the luminal passageway comprises coloring the portion of the luminal passageway on the visual display.

20. The method of claim 17, further comprising providing a suggested treatment location on either the visual display or the monitor.

21. The method of claim 20 where the control system is prevented from providing the energy therapy if a medical caregiver fails to apply the energy therapy to the suggested treatment location.

22. The method of claim 20, where providing the suggested treatment location comprises visually distinguishing a location of the luminal passageway from portions of the luminal passageway that correspond to the treatment history profile.

23. The method of claim 22, where the suggested treatment location does not overlap with portions of the luminal passageway that correspond to the treatment history profile.

24. The method of claim 23, where the suggested treatment location is spaced from portions of the lurninal passageway that correspond to the treatment history profile.

25. The method of claim 20, where providing the suggested treatment location comprises using the map to calculate a minimum distance to a neighboring organ or anatomical marker.

26. The method of claim 25, where providing the suggested treatment location further comprises displaying a suggested path on either the visual display or monitor, where the suggested path comprises directions through the lung to reach the suggested treatment location.

27. The method of claim 25, further comprising calculating a minimum time based on an algorithm that minimizes a factor of time, difficulty of navigation, or size difference between organs.

28. The method of claim 1, further comprising generating an ideal procedure profile based on the map, where the ideal procedure profile comprises a plurality of ideal parameters.

29. The method of claim 28, where the plurality of ideal parameters includes at least one ideal virtual treatment location.

30. The method of claim 29, where the plurality of ideal parameters further includes at least one ideal energy therapy parameter associated with the respective ideal virtual treatment location.

31. The method of claim 30, where the ideal energy therapy parameters comprise parameters selected from the group consisting of ideal time, ideal temperature, ideal energy, ideal rate of change in temperature, ideal rate of change in energy, ideal impedance of the treatment location, and a combination thereof.

32. The method of claim 28, further comprising comparing the ideal procedure profile to the treatment history profile.

33. The method of claim 32, where comparing the ideal procedure profile to the treatment history profile occurs during applying the energy therapy to the treatment location.

34. The method of claim 1, further comprising analyzing the map to determine an anatomical characteristic of the lung.

35. The method of claim 34, where the anatomical characteristic comprise features selected from the group consisting of luminal passageway diameter, branching points of the organs, depth of smooth muscle tissue, amount of smooth muscle tissue, wall thickness of the organ, proximity of the organ relative to a separate organ, periphery of the organs, degree of fluids in the organ, number of folds in the organ, condition of an epithelial or endothelial layer in the organ, fluid flow in the organ, presence of additional tissue in the organ, presence of vessels, presence of cartilage, and degree of contraction when the smooth muscle is stimulated.

36. The method of claim 35, where the energy therapy is generated by a control system and where the control system adjusts at least one of the plurality of parameters in response to the anatomical features.

37. The method of claim 1, where the map is a three dimensional map.

38. The method of claim 1, where the plurality of parameters comprises at least one of time, temperature, energy, rate of change in temperature, rate of change in energy, and impedance of the treatment location.

39. The method of claim 38, further comprising displaying at least one parameter of the energy therapy on the visual display.

40. The method of claim 39, where displaying at least one parameter of the energy treatment occurs in real time during the application of energy.

41. The method of claim 1, where the lung comprises airways within a lobe of the lung, and the method further comprises applying the energy therapy to a plurality of airways.

42. The method of claim 1, where a treatment device having an energy delivery portion is used to apply energy therapy to the treatment location, and where the treatment device transmits information to the rendering system to generate at least a portion of the map as it advances through the lung.

43. The method of claim 42, further comprising correlating the portion of the map with a plurality of locations in the lung.

44. The method of claim 42, where the treatment device further includes a sensor assembly in communication with the rendering system and that detects movement of the device within the organs to generate the portion of the map.

45. The method of claim 44, where the sensor assembly comprises a light emitting source, a sensor, and a digital signal processor where the light emitting source reflects light off of a wall of the organ to the sensor and the sensor transmits a plurality of images to the digital signal processor which determines movement of the device by comparing images.

46. The method of claim 45, where the light emitting source comprises a light emitting diode and the sensor comprise a complimentary metal-oxide semiconductor.

47. The method of claim 42, where the treatment device further includes at least one locating implement that communicates with an external locating system to generate the portion of the map.