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

• US 9,028,472 B2
• Filed: 12/21/2012
• Issued: 05/12/2015
• 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, Nassif, Rabih, Moaddeb, Shahram
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US13/725,894
• Publication Number:
  US 20130165917A1
• Time in Patent Office: 872 Days
• Field of Search: 606/32
• US Class Current: 606/32
• 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 renal-denervation treatment method. The method may include delivering an RF energy treatment to a tissue proximate a renal artery using a catheter assembly of a renal denervation catheter system. The denervation system may include an RF energy generator coupled with the catheter assembly by a controller. The method may also include applying neural activity stimulation to the tissue proximate the renal artery using the catheter assembly, assessing stimulated neural activity response of the tissue using the catheter assembly, and determining a parameter of the RF energy treatment based on the assessed neural activity.

Claims

1. A renal-denervation treatment method, comprising:

(a) delivering an RF energy treatment to a tissue proximate a renal artery using a catheter assembly of a renal denervation catheter system, wherein the denervation system includes an RF energy generator coupled with the catheter assembly by a controller;

(b) applying neural activity stimulation to the tissue proximate the renal artery using the catheter assembly;

(c) assessing stimulated neural activity response of the tissue using the catheter assembly; and

(d) determining a parameter of the RF energy treatment based on the assessed neural activity.

2. The method of claim 1, further comprising outputting data relating to the assessed neural activity.

3. The method of claim 2, wherein outputting data comprises outputting whether a sufficient decrease in neural activity has occurred.

4. The method of claim 1, wherein assessing the neural activity comprises taking at least a first neural activity measurement and a second neural activity measurement.

5. The method of claim 4, wherein taking the first neural activity measurement comprises taking the first neural activity measurement before beginning the delivery of the RF energy treatment to establish a base line neural activity measurement;

wherein taking the second neural activity measurement comprises taking the second neural activity measurement after beginning the delivery of the RF energy treatment; and

wherein the method further comprises determining whether neural activity has changed from the base line.

6. The method of claim 5, wherein determining whether neural activity has changed from the base line comprises determining whether the change in neural activity is at, above or below a threshold.

7. The method of claim 6, further comprising terminating the RF energy treatment once the change in neural activity is at or above the threshold.

8. The method of claim 1, wherein assessing stimulated neural activity response comprises periodically measuring for stimulated neural activity response during the RF energy treatment.

9. The method of claim 1, wherein applying neural activity stimulation comprises energizing at least one electrode of the catheter assembly;

and wherein assessing stimulated neural activity response comprises using a second electrode of the catheter assembly to monitor for the nerve response signal.

10. The method of claim 9, wherein delivering the RF energy treatment comprises using the at least one electrode and the second electrode to deliver RF energy to the tissue.

11. The method of claim 9, wherein monitoring for the nerve response signal comprises at least one of measuring an amplitude of the nerve response signal, measuring a time delay between the nerve stimulation signal and the nerve response signal, and measuring a fractionated amplitude of the nerve response signal.

12. The method of claim 9, further comprising measuring at least one of an amplitude of the nerve response signal, a pulse width of the nerve response signal, a slope or change in slope of the nerve response signal, a velocity of the nerve response signal, or a time delay of the nerve response signal.

13. The method of claim 12, further comprising comparing the measurement to a base line measurement of an earlier nerve response signal.

14. The method of claim 1, wherein determining the at least one parameter of the RF energy treatment comprises adjusting the at least one parameter based on the assessed neural activity.

15. The method of claim 14, wherein adjusting the at least one parameter comprises adjusting a temperature profile of the RF energy treatment.

16. The method of claim 15, wherein adjusting the at least one parameter comprises adjusting a length of time at a target temperature of the target temperature profile.

17. A renal-denervation method, comprising:

(a) applying a first neural activity stimulation to a tissue proximate a catheter assembly of a renal denervation system;

(b) measuring a first stimulated neural activity response of the tissue using the catheter assembly; and

(c) delivering an energy treatment to the tissue proximate the renal artery using the catheter assembly;

(d) measuring a second neural activity response of the neural tissue using the catheter assembly; and

(e) determining a parameter of the energy treatment by comparing the first and second measured neural activities.

18. A renal-denervation treatment system, comprising:

(a) an elongate catheter including an expandable structure at or near a distal end of the catheter, the expandable structure including a plurality of electrodes;

(b) a power source electrically coupled to the plurality of electrodes; and

(c) a processor configured to (1) energize at least a subset of the electrodes at a renal-denervation energy level;

(2) energize one or more of the electrodes at a neural activity stimulation level; and

(3) monitor for, using one or more of the electrodes, a neural activity response.

19. The system of claim 18, wherein the neural activity stimulation level is a voltage in the range of about 0.1 V to about 5 V applied for about 1 second or less.

20. The method of claim 19, wherein the neural activity stimulation level is about 0.5 V applied for about 0.5 milliseconds.