Modification of airways by application of energy

• US 8,257,413 B2
• Filed: 09/22/2006
• Issued: 09/04/2012
• Est. Priority Date: 10/17/2000
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Asthmatx, Inc. (Boston Scientific Corporation)
• Inventors: Danek, Christopher James, Biggs, Michael, Burger, Keith M., Loomas, Bryan, Keast, Thomas, Haugaard, Dave
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US11/534,621
• Publication Number:
  US 20070100390A1
• Time in Patent Office: 2,174 Days
• Field of Search: 606/41, 606 48- 50, 607 96-102, 607113-116, 607/122
• US Class Current: 607/96
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 18/1477 Needle-like probes
• 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 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00123 and automatic shutdown
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00541 Lung or bronchi
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00982 combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1475 Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2018/1497 Electrodes covering only part of the probe circumference
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/403 for thermotherapy, e.g. hyperthermia
• CPC Class Codes: A61N 5/00 Radiation therapy ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00

Abstract

This relates to methods and devices for treating reversible chronic obstructive pulmonary disease, and more particularly, relates to a device for exchanging energy with airway tissue such as that found in the airway of human lungs. The exchange of energy with this airway tissue in the airways reduces the ability of the air ways to constrict and/or reduces the resistance within the airway to the flow of air through the airway. This also relates to a method for decreasing responsiveness or decreasing resistance to airflow of airways involves the transfer of energy to or from the airway walls to prevent or reduce airway constriction and other symptoms of lung diseases. The treatment reduces the ability of the airway to contract during an acute narrowing of the airways, reduces mucus plugging of the airways, and/or increases the airway diameter. The methods according to the present invention provide a longer duration and/or more effective treatment for lung diseases than currently used drug treatments, and obviate patient compliance issues. This also includes additional steps that reduce the ability of the lung to produce at least one of the symptoms of reversible obstructive pulmonary disease and to reduce the resistance to the flow of air through a lung.

Claims

1. An energy delivery device comprising:

an elongate body having a proximal end and a distal end;

a plurality of energy delivery elements disposed at the distal end of the elongate body, wherein the energy delivery elements comprise expandable legs that are configured to contact a wall of an airway in an expanded radial configuration;

at least one temperature sensing element attached to one of the expandable legs and having two leads separately coupled to the one of the expandable legs such that the temperature sensing element forms an intrinsic junction with the one of the expandable legs, wherein the intrinsic junction is adapted to contact the wall of the airway when the expandable legs are in the expanded radial configuration, and wherein the leads extend along an exterior surface of the one of the expandable legs; and

a power supply coupled to the expandable legs such that the same power is applied concurrently to the expandable legs.

2. The device of claim 1, wherein the elongate body is sufficiently flexible to navigate tortuous anatomy.

3. The device of claim 1, wherein the plurality of energy delivery elements comprise four electrode legs.

4. The device of claim 3, wherein each of the legs comprises an insulated portion and a non-insulated, active energy delivery portion.

5. The device of claim 3, wherein each of the legs comprises a single active energy delivery region located midway between a first and second end of each leg.

6. The device of claim 3, wherein each of the legs comprises a distal end that is coupled to a distal joint and a proximal end that is coupled to a proximal joint, wherein the proximal joint is affixed to the elongate body.

7. The device of claim 3, wherein each of the legs comprises wire shaped electrodes.

8. The device of claim 1, wherein the leads are separately coupled to an inward surface of the one of the expandable legs, wherein the inward surface is configured to not contact the body conduit when the one of the expandable legs is in the expanded configuration.

9. The device of claim 1, wherein the leads are formed from chromel or alumel alloys.

10. The device of claim 1, wherein the at least one temperature sensing element comprises a thermocouple.

11. The device of claim 1, further comprising a lead electrically coupled to the power supply and commonly electrically coupled to the plurality of expandable legs.

12. The delivery device of claim 1, further comprising a lead electrically coupled to the power supply and commonly electrically coupled to the plurality of expandable legs, and wherein each expandable leg comprises a proximal dielectric covering, a distal dielectric covering, and a single active region between the proximal and distal dielectric coverings.

13. The device of claim 1, wherein the at least one temperature sensing element is attached to a curved region of the expandable legs.

14. A system for delivering radio frequency energy to an airway wall of a human lung so as to treat asthma, the device comprising:

a catheter body having a proximal end, a distal end, and a size suitable for insertion within an airway of a human lung;

a plurality of radio frequency electrodes disposed at the distal end of the catheter body, the plurality of electrodes comprising flexible legs configured to bow outwardly from a longitudinal axis and contact a wall of the lung airway when in an expanded radial configuration;

at least one thermocouple coupled to at least one of the plurality of electrodes, wherein the thermocouple is configured to provide feedback of tissue temperature, wherein the thermocouple is coupled to at least one electrode that is configured to contact the wall of the lung airway when in the expanded radial configuration such that the thermocouple forms an intrinsic junction with the at least one electrode, wherein the thermocouple comprises two leads that form separate joints with the at least one electrode, and wherein the leads extend along an exterior surface of the at least one electrode;

a radio frequency generator commonly coupled to the radio frequency electrodes; and

a controller operatively coupled to the radio frequency generator and the thermocouple, the controller being programmed to operate the radio frequency generator based on feedback from the thermocouple to deliver energy to the electrodes for 5 to 10 seconds and heat the airway wall such that the radio frequency electrodes have a temperature up to about 75°

C. so as to ensure sufficient energy transfer to the airway wall of the lung so as to reduce airway smooth muscle tissue in the treatment of asthma.

15. The device of claim 14, wherein the catheter body has a diameter equal to or less than 2 mm.

16. The device of claim 14, further comprising a power supply configured to deliver monopolar or bipolar energy to the plurality of electrodes.

17. The device of claim 16, wherein the power supply is configured to adjust an amount of energy being delivered such that a specified temperature is maintained.

18. The device of claim 16, wherein the power supply is configured to stop delivery of energy if a predetermined temperature change is not detected within a predetermined time from commencing energy delivery.

19. The device of claim 16, wherein the power supply is configured to stop delivery of energy if the thermocouple detects a predetermined maximum temperature.

20. The device of claim 16, wherein the power supply is configured to deliver energy at a specified temperature for up to a predetermined maximum amount of time per location.

21. The system of claim 14, wherein each flexible leg comprises a conductive element, a proximal dielectric covering at a proximal end of the conductive element, a distal dielectric covering at a distal end of the conductive element, and a single active region between the proximal and distal dielectric coverings.

22. The device of claim 14, wherein the thermocouple is coupled to a curved region of the at least one electrode.

23. An energy delivery device for use in a lung airway, the device comprising:

an elongate body having a proximal end and a distal end;

a plurality of energy delivery elements disposed at the distal end of the elongate body, the plurality of energy delivery elements being configured to bow outward from a longitudinal axis such that a portion that bows out furthest from the longitudinal axis is adapted to contact a lung airway wall when in an expanded radial configuration, wherein each energy delivery element comprises a conductive leg having a proximal dielectric covering, a distal dielectric covering, and an exposed active region at the portion that bows out furthest from the longitudinal axis; and

at least one temperature sensing element having two leads separately coupled to at least one of the energy delivery elements at the portion that bows out farthest from the longitudinal axis of the elongate body such that the temperature sensing element forms an intrinsic junction with the at least one energy delivery element, wherein the leads extend along an exterior surface of the at least one energy delivery element.

24. The device of claim 23, wherein the temperature sensing element is coupled to a curved region of the energy delivery element.

25. An energy delivery device comprising:

an elongate body having a proximal end and a distal end;

a plurality of energy delivery elements disposed at distal end of the elongate body, wherein the energy delivery elements comprise expandable legs that are configured to contact a wall of an airway in an expanded radial configuration;

at least one temperature sensing element attached to one of the expandable legs and having two leads separately coupled to the one of the expandable legs in a curved region of the expandable legs such that the temperature sensing element forms an intrinsic junction with the one of the expandable legs, wherein the intrinsic junction is adapted to contact the wall of the airway when the expandable legs are in the expanded radial configuration, and wherein the leads extend along an exterior surface of the one of the expandable legs; and

a power supply coupled to the expandable legs such that the same power is applied concurrently to the expandable legs.

26. The device of claim 25, wherein the at least one temperature sensing element is attached to an inwardly-facing surface of the expandable legs.