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

• US 10,016,592 B2
• Filed: 10/17/2014
• Issued: 07/10/2018
• Est. Priority Date: 10/17/2001
• Status: Expired due to Term

• Current Assignee: Asthmatx, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Biggs, Michael, Stern, Roger A., Danek, Christopher J.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US14/517,611
• Publication Number:
  US 20150038959A1
• Time in Patent Office: 1,362 Days
• 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 disclosure may include 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. 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.

Claims

1. A system for delivering energy to a medium, comprising:

an expandable member including a plurality of energy delivery elements spaced 90 degrees from one another about a longitudinal axis of the expandable member, wherein a first energy delivery element of the plurality of energy delivery elements includes an exposed active region defined at first and second ends by insulating material, and the plurality of energy delivery elements includes exactly four energy delivery elements;

at least one temperature sensor for measuring a temperature (T_M) of the medium or at least one of the energy delivery elements when energy is delivered to the medium;

a PID controller for determining a new power set point (P_i+1) based on an error at a present time step (e_i) between a preset temperature (T_S) and the measured temperature (T_M), and an error at a previous time step (e<sub>i−

1</sub>) between the preset temperature (T_S) and the measured temperature (T_M), wherein the PID controller is configured to terminate energy delivery when the measured 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 PID controller also determines the new power set point (P_i+1) based on an error at two previous time steps (e_i−

2), the PID controller also determines the new power set point (P_i+1) based on a previous power set point (P_i), the PID controller applies an algorithm having a variable gain factor (G), the algorithm is P_i+1=P_i+G(α

e_i+β

e<sub>i−

1</sub>+γ

e<sub>i−

2</sub>), and α

, β and

γ

are preset values.

3. The system of claim 2, wherein α

is from 1 to 2, β

is from −

1 to −

2, and γ

is from −

0.5 to 0.5.

4. The system of claim 2, wherein the controller is configured such that G is reset 0.1 to 2 seconds after energy delivery has begun, to 0.9 to 1.0 if a temperature rise in °

C. per Joule is less than or equal to 2.5, to 0.4 to 0.5 if a temperature rise in °

C. per Joule is from 2.5 to 5.0, to 0.2 to 0.3 if a temperature rise in °

C. per Joule is from to 5.0 to 7.5, or to 0.1 to 0.2 if a temperature rise in °

C. per Joule is greater than 7.5.

5. The system of claim 2, wherein the variable gain factor (G) is initially equal to a value from 0.4 and 0.5.

6. The system of claim 1, wherein the PID controller also determines the new power set point (P_i+1) based on an error at two previous time steps (e_i−

2), the PID controller determines the new power set point (P_i+1) based on a previous power set point (P_i), and the PID controller applies an algorithm having a plurality of variable gain factors, wherein the algorithm is P_i+1=P_i+(G₁e_i+G₂e<sub>i−

1</sub>+G₃e<sub>i−

2</sub>) where G₁, G₂ and G₃ are variable gain factors, the controller is configured such that the variable gain factors are reset 0.1 to 2 seconds after energy delivery has begun, the controller is configured such that G₁, G₂ and G₃ are reset to 0.90 to 2.00, −

0.90 to −

2.00 and 0.5 to −

0.5, respectively, if a temperature rise in °

C. per Joule is less than or equal to 2.5, are reset to 0.40 to 1.00, −

0.40 to −

1.00 and 0.25 to −

0.25, respectively, if a temperature rise in °

C. per Joule is from 2.5 to 5.0, are reset to 0.20 to 0.60, −

0.20 to −

0.60 and 0.15 to −

0.15, respectively, if a temperature rise in °

C. per Joule is from to 5.0 to 7.5, are reset to 0.10 to 0.40, −

0.10 to −

0.40 and 0.10 to −

0.10, respectively, if a temperature rise in °

C. per Joule is greater than 7.5, and each of the variable gain factors is equal to a product of at least one preset value and at least one variable value.

7. The system of claim 1, wherein the controller is configured:

such that the energy delivery is terminated if the energy delivered exceeds 120 joules;

to deliver energy for an activation time period up to 15 seconds; and

such that T_S is from 60°

C. to 80°

C.

8. The system of claim 1, wherein the controller is configured to measure impedance, and the energy delivery is terminated when the impedance drops below 40 to 60 ohms.

9. The system of claim 1, wherein the controller is configured to terminate the energy delivery if the T_M exceeds T_S by 10°

C. to 20°

C., or if the measured temperature drops by 10 or more °

C. in a sample period from 0.2 to 1.0 seconds.

10. The system of claim 1, wherein the expandable member is configured to deliver an amount of power up to 10 to 40 watts.

11. The system of claim 1, wherein the insulating material covers conductive portions of the first energy delivery element.

12. The system of claim 1, wherein the PID controller is further configured to terminate energy delivery when the measured temperature changes by at least 10°

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

13. The system of claim 1, wherein the PID controller is configured to terminate energy delivery when the measured temperature does not increase by at least 10°

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

14. A system for delivering energy to a medium, comprising:

an energy source configured to generate radiofrequency energy;

an expandable basket including a plurality of radiofrequency electrodes disposed about a longitudinal axis of the expandable basket, wherein one or more of the plurality of radiofrequency electrodes are coupled to a first pole of the energy source;

an external electrode coupled to a second pole of the energy source, the second pole being opposite the first pole;

at least one temperature sensor for measuring temperature (T_M) of the medium or a radiofrequency electrode of the plurality of radiofrequency electrodes when energy is delivered to the medium; and

a PID controller for determining a new power set point (P_i+1) based on an error (e) between a preset temperature (T_S) and the measured temperature (T_M), wherein the controller is configured to terminate the energy delivery if the output power is greater than or equal to a nominal output power and the T_M drops by a critical temperature difference within a sampling period, and is configured to terminate energy delivery when the measured temperature changes by at least 10°

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

15. The system of claim 14, wherein the nominal output power is at least 15 watts, the sampling period is at least 0.5 seconds, and the critical temperature difference is 2°

C.

16. The system of claim 14, wherein:

the expandable basket further includes a distal tip distal to each of the plurality of radiofrequency electrodes;

distal ends of the plurality of radiofrequency electrodes converge toward the distal tip;

each of the plurality of radiofrequency electrodes is curved; and

the expandable basket includes exactly four radiofrequency electrodes spaced 90 degrees from one another about a central longitudinal axis of the expandable basket.

17. The system of claim 16, further including a wire extending from proximal of a proximal end of the expandable basket, through an interior volume defined by the plurality of radiofrequency electrodes, to the distal tip, wherein applying a proximal pulling force on the wire causes the plurality of radiofrequency electrodes to radially expand, and releasing the proximal pulling force causes the plurality of radiofrequency electrodes to radially contract, and the wire is configured to deliver current to each of the plurality of radiofrequency electrodes.

18. The system of claim 17, wherein:

each of the plurality of radiofrequency electrodes includes an exposed active region defined at first and second ends by an insulating material covering conductive portions of the respective radiofrequency electrode;

the at least one temperature sensor includes a thermocouple with two leads coupled to the exposed active region of one of the plurality of radiofrequency electrodes; and

the exposed active region of the radiofrequency electrode coupled with the two leads forms a thermocouple junction with the two leads upon which temperature measurement is based.

19. A system for delivering energy to a medium, comprising:

a treatment device including a basket having a plurality of radiofrequency electrodes circumferentially spaced about a longitudinal axis of the treatment device for delivering energy to the medium, the plurality of electrodes converging at a distal tip, at least one of the radiofrequency electrodes including an exposed electrically conductive portion extending from a first end toward a second end;

a first nonconductive region coupled to the first end of the exposed electrically conductive portion;

a second nonconductive region coupled to the second end of the exposed electrically conductive portion;

a member extending from proximal of a proximal end of the basket, through an interior volume defined by the plurality of radiofrequency electrodes, to the distal tip, wherein applying a proximal pulling force on the member causes the plurality of radiofrequency electrodes to radially expand, and releasing the proximal pulling force causes the plurality of radiofrequency electrodes to radially contract, and the member is configured to deliver current to each of the plurality of radiofrequency electrodes; and

at least one temperature sensor for measuring temperature (T_M) of the medium or the at least one radiofrequency electrode when energy is delivered to the medium;

a PID controller for determining a new power set point (P_i+i) based on an error (e) between a preset temperature (T_S) and the measured temperature (T_M); and

wherein the controller is configured to terminate the energy delivery if the T_M averaged over a time window exceeds T_S by a fixed temperature difference, and is configured to terminate energy delivery when the measured temperature changes by at least 10°

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

20. The system of claim 19, wherein the fixed temperature difference is from 1 and 10°

C., and wherein the time window is from 1 and 5 seconds.