Control system and process for application of energy to airway walls and other mediums

• US 8,888,769 B2
• Filed: 11/11/2010
• Issued: 11/18/2014
• Est. Priority Date: 10/17/2000
• Status: Expired due to Fees

• Current Assignee: Asthmatx, Inc. (Boston Scientific Corporation)
• Original Assignee: Asthmatx, Inc. (Boston Scientific Corporation)
• Inventors: Biggs, Michael, Stern, Roger A., Danek, Christopher J.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US12/944,238
• Publication Number:
  US 20110172655A1
• Time in Patent Office: 1,468 Days
• Field of Search: 606 32- 35, 606/41, 607101-102
• US Class Current: 606/34
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 2018/00541 Lung or bronchi
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals

Abstract

The present invention includes a system for delivering energy to an airway wall of a lung comprising an energy delivering apparatus and a PID controller having one or more variable gain factors which are rest after energy deliver has begun. The energy delivering apparatus may include a flexible elongated member and a distal expandable basket having at least one electrode for transferring energy to the airway wall and at least one temperature sensor for measuring temperature. The PID controller determines a new power set point base on an error between a preset temperature and the measured temperature. The algorithm can be P_i+1=P_i+G(αe_i+βe_i−1+γe_i−2) where α, β and γ are preset values and α is from 1 to 2; β is from −1 to −2; and γ is from −0.5 to 0.5. In another variation, the controller is configured to shut down if various measured parameters are exceeded such as, for example, energy, impedance, temperature, temperature differences, activation time and combinations thereof. Methods for treating a target medium using a PID algorithm are also provided.

Claims

1. A system for delivering energy to an airway wall of a lung comprising:

an energy delivering apparatus comprising a flexible elongated member and a distal expandable member, said expandable member having at least one electrode for transferring energy to said airway wall and at least one sensor for measuring a parameter of said airway wall when energy is delivered to said airway wall; and

a safety mechanism for automatically terminating the energy transferred from the electrode to the airway wall based on the measured parameter, wherein the measured parameter includes a rate of change of a temperature associated with tissue of the airway wall, wherein the safety mechanism is configured to terminate energy delivery when a sensed temperature does not increase by at least 10°

C. in an initial 3 seconds from an initiation of energy delivery.

2. The system of claim 1, wherein the measured parameter includes energy delivered to the airway wall.

3. The system of claim 1, wherein the measured parameter includes an impedance of tissue associated with the airway wall.

4. The system of claim 3, wherein the impedance is measured by the at least one electrode.

5. The system of claim 3, further comprising a second electrode different from the at least one electrode, wherein the impedance is measured by the second electrode.

6. The system of claim of 3, wherein the safety mechanism is configured to terminate energy transfer when the impedance is below a preset impedance threshold.

7. The system of claim 3, wherein the impedance of tissue associated with the airway wall includes impedance across a treated area of tissue.

8. The system of claim 7, wherein the impedance of tissue associated with the airway wall includes impedance measured at more than one site within the lung.

9. The system of claim 1, wherein the safety mechanism is configured to terminate energy delivery when the sensed temperature does not increase by at least 10°

C. in an initial 1 second from the initiation of energy delivery.

10. The system of claim 1, wherein the safety mechanism is configured to terminate energy delivery when a sensed temperature changes by at least 10°

C. in a time period from 0.1 to 1 seconds at any point during energy delivery.

11. A system for delivering energy to an airway wall of a lung, the system comprising:

an energy delivery apparatus including;

an elongate shaft having a proximal end, a distal end, and a lumen extending therebetween;

an expandable member disposed within the lumen, wherein the expandable member is configured to transition between a collapsed configuration when within the lumen and an expanded configuration when deployed out of the lumen, wherein the expandable member includes an electrode for delivering energy to tissue associated with the airway wall;

a temperature sensor coupled to the expandable member; and

a safety mechanism configured to automatically terminate energy delivery in response to a rate of temperature change derived from a temperature sensed by the temperature sensor, wherein the safety mechanism is configured to terminate energy delivery when a sensed temperature changes by at least 10°

C. in a time period from 0.1 to 1 seconds at any point during energy delivery.

12. The system of claim 11, wherein the energy delivered is configured to penetrate the surface of the tissue to affect tissue below an epithelial layer of the tissue.

13. The system of claim 11, wherein the safety mechanism includes an algorithm programmed within a controller.

14. The system of claim 11, wherein the system is configured to terminate energy delivery when the sensed temperature exceeds a predetermined threshold.

15. The system of claim 11, wherein the system is configured to terminate energy delivery when the rate of change of the sensed temperature exceeds a predetermined rate of change.

16. The system of claim 11, wherein the system is configured to terminate energy delivery when the rate of change of the sensed temperature is less than a predetermined rate of change.

17. The system of claim 11, wherein the safety mechanism is further configured to automatically terminate energy delivery in response to a sensed impedance.

18. A system for delivering energy to an airway wall of a lung comprising;

an energy delivering apparatus comprising a flexible elongated member and a distal expandable member, said expandable member having at least one electrode for transferring energy to said airway wall;

a temperature sensor configured to measure a temperature of one or more of the at least one electrode or airway wall;

an impedance sensor configured to measure an impedance of the airway wall; and

a safety mechanism for automatically terminating the energy transferred from the electrode to the airway wall under each of the following conditions;

a sensed temperature by the temperature sensor does not increase by at least 10°

C. in an initial 1 to 3 seconds from the initiation of energy delivery;

a sensed temperature exceeds a high temperature threshold at any time during energy delivery, wherein the high temperature threshold is from 60°

C. to 80°

C.;

a total amount of energy delivered to the airway wall in a single activation of the energy delivering apparatus is at least 120 joules;

a determined rate of temperature change derived from temperatures sensed by the temperature sensor differs from an accepted rate of temperature change;

a fault of the temperature sensor is determined; and

a sensed impedance by the impedance sensor is below an impedance threshold.