Methods and apparatuses for remodeling tissue of or adjacent to a body passage

• US 9,037,259 B2
• Filed: 12/21/2012
• Issued: 05/19/2015
• Est. Priority Date: 12/23/2011
• Status: Active Grant

• Current Assignee: Vessix Vascular, Inc. (Boston Scientific Corporation)
• Original Assignee: Vessix Vascular, Inc. (Boston Scientific Corporation)
• Inventors: Mathur, Prabodh
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US13/725,843
• Publication Number:
  US 20130165916A1
• Time in Patent Office: 879 Days
• Field of Search: None
• US Class Current: 607/102
• 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 18/16 Indifferent or passive electrodes for grounding
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00654 with individual control of each of a plurality of energy emitting elements
• CPC Class Codes: A61B 2018/00678 upper
• CPC Class Codes: A61B 2018/00767 Voltage
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/124 switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 5/00 Radiation therapy ultrasound therapy A61N7/00; devices or apparatus applicable to both therapy and diagnosis A61B6/00

Abstract

Medical devices and methods for making and using the same are disclosed. An example method may include a method for treating tissue near a body passageway using an apparatus including a catheter having a plurality of electrodes, a radio-frequency energy generator, and a controller coupling the energy generator to the plurality of electrodes and configured to selectively energize the electrodes. The method may include using the apparatus to subject the tissue near the body passageway to a plurality of energy treatment cycles. The treatment cycle may include determining desired voltages for at least a subset of the electrodes for maintaining a predetermined target temperature profile proximate the subset of electrodes, setting an output voltage of the energy generator to correspond to the desired voltage determined for one of the electrodes, and energizing at least some of the electrodes at the output voltage to deliver energy to the body passageway.

Claims

1. A method for treating tissue near a body passageway using an apparatus including a catheter having a plurality of electrodes, a radio-frequency energy generator, and a controller coupling the energy generator to the plurality of electrodes and configured to selectively energize the electrodes, the method comprising:

(a) using the apparatus to subject the tissue near the body passageway to a plurality of energy treatment cycles, wherein a treatment cycle comprises;

(i) determining desired voltages for at least a subset of the electrodes for maintaining a predetermined target temperature profile proximate the subset of electrodes;

(ii) setting an output voltage of the energy generator to correspond to the desired voltage determined for one of the electrodes;

(iii) energizing at least some of the electrodes at the output voltage to deliver energy to the body passageway;

(b) wherein the electrode used to set the output voltage changes in subsequent treatment cycles in at least some instances; and

wherein determining a desired voltage for an electrode of the subset of electrodes is based on a previous output voltage applied to the electrode of the subset of electrodes.

2. The method of claim 1, wherein the treatment cycle further comprises identifying a first electrode;

wherein the first electrode is used to set the output voltage if the determined voltage requirement for the first electrode is greater than zero.

3. The method of claim 2, wherein the identification of the first electrode cycles through the plurality of electrodes from treatment cycle to treatment cycle.

4. The method of claim 2, wherein the treatment cycles further comprises identifying at least one electrode that is leakage-inducingly proximate to the first electrode, wherein the at least one electrode that is leakage-inducingly proximate to the first electrode is not energized during the treatment cycle.

5. The method of claim 4, wherein the plurality of electrodes comprises a plurality of bipolar electrodes, and wherein identifying the at least one electrode that is leakage-inducingly proximate to the first electrode comprises identifying at least one electrode having a negative pole that is leakage-inducingly proximate a positive pole of the first electrode.

6. The method of claim 1, wherein determining desired voltage for the electrode of the subset of electrodes is also based on differences between a measured temperature proximate the electrode of the subset of electrodes and the target temperature.

7. The method of claim 1, wherein determining desired voltage for the electrode of the subset of electrodes is based on a current temperature error as well as an average temperature error over time for the electrode of the subset of electrodes.

8. The method of claim 1, wherein desired voltage equals:

V=K_LV_L+K_PT_e+K_I∫

^t_{t-n sec}T_{e AVE}

wherein V is the desired voltage, V_L is the previously calculated output voltage, T_e is a temperature error for the electrode of the subset of electrodes, K_L, K_P and K_I are constants, and n is a time value ranging from 0 to t seconds.

9. The method of claim 1, wherein desired voltage equals:

10. A method for treating a body passageway using an apparatus comprising an energy delivery device having a plurality of discrete energy delivery sites, an energy generator, and a controller coupling the energy delivery sites to the energy generator and configured to selectively energize the plurality of energy delivery sites, the method comprising:

(a) using the apparatus to subject the body passageway to a plurality of treatment cycles, wherein at least some of the treatment cycles comprise;

(i) determining a plurality of possible output levels for at least a subset of the energy delivery sites for maintaining a predetermined parameter of the treatment;

(ii) setting an actual output level of the energy generator to correspond to the possible output level determined for one of the energy delivery sites;

(iii) energizing at least some of the energy delivery sites at the actual output level to deliver energy to the body passageway;

(b) wherein the energy delivery site used to set the actual output level changes from treatment cycle to treatment cycle in at least some instances; and

wherein determining the possible output level for one of the energy delivery sites is based on an output level applied at the energy delivery site in an immediately preceding treatment cycle.

11. The method of claim 10, wherein determining a plurality of possible output levels comprises determining a plurality of possible energization times, determining a plurality of possible output voltages, or both.

12. The method of claim 10, wherein energizing at least some of the energy delivery sites at the actual output level comprises energizing at least some of the energy delivery sites associated with a possible output level that is equal to or greater than the actual output level set during the treatment cycle.

13. The method of claim 10, wherein determining the possible output level for one of the energy delivery sites is also based on a characterization of an error between an actual condition proximate the energy delivery site and the predetermined parameter.

14. The method of claim 10, wherein at least some of the treatment cycles further comprise identifying from the plurality of energy delivery sites a first energy delivery site.

15. The method of claim 14, wherein the identification of the first energy delivery site cycles through the plurality of energy delivery sites from treatment cycle to treatment cycle.

16. The method of claim 15, wherein the possible output level determined for the first energy delivery site is used to set the actual output level if the possible output level determined for the first energy delivery site is greater than zero.

17. The method of claim 15, wherein at least some of the energy delivery sites proximate the first energy delivery site are not energized during the treatment cycle.

18. A method for treating tissue near a body passageway using an apparatus including a catheter having a plurality of monopolar electrodes, a radio-frequency energy generator, and a controller coupling the energy generator to the monopolar electrodes and configured to selectively energize the monopolar electrodes, the method comprising:

(a) using the apparatus to subject the tissue near the body passageway to a plurality of energy treatment cycles, where a treatment cycle comprises;

(i) determining desired voltages for at least a subset of the monopolar electrodes for determining a predetermined target temperature profile proximate the subset of monopolar electrodes;

(ii) setting an output voltage of the energy generator to correspond to the desired voltage determined for one of the monopolar electrodes;

(iii) energizing at least one of the monopolar electrodes at the output voltage to deliver energy to the body passageway;

(b) wherein the monopolar electrode used to set the output voltage changes in subsequent treatment cycles is based on an output level applied to the tissue near the body passageway in an immediately preceding treatment cycle.