System and method for locating and identifying the functional nerves innervating the wall of arteries and catheters for same

• US 9,014,821 B2
• Filed: 08/24/2012
• Issued: 04/21/2015
• Est. Priority Date: 08/26/2011
• Status: Active Grant

• Current Assignee: Symap Medical suzhou Ltd
• Original Assignee: Symap Holding Limited
• Inventors: Wang, Jie
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): CAREY, MICHAEL JAMES
• Application Number:
  US14/241,061
• Publication Number:
  US 20140213873A1
• Time in Patent Office: 970 Days
• Field of Search: 607/44, 607/117, 607/118, 607/148, 607/149
• US Class Current: 607/118
• 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 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• 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 2018/00505 Urinary tract
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00708 switching the power on or off
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/00875 Resistance or impedance
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0538 invasively, e.g. using a catheter
• CPC Class Codes: A61B 5/201 Assessing renal or kidney functions
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4833 : Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/4836 : Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4893 : Nerves
• CPC Class Codes: A61B 5/6852 : Catheters
• CPC Class Codes: A61B 5/6853 : with a balloon
• CPC Class Codes: A61N 1/36117 : for treating hypertension
• CPC Class Codes: A61N 2007/003 : Destruction of nerve tissue
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

Abstract

This invention provides a method of using a catheter for mapping parasympathetic or sympathetic renal nerve for treatment of disease caused by systemic renal nerve hyperactivity, wherein the catheter comprises a shaft having a proximal end configured to be connected to an energy source, and a distal end (catheter tip) which is in the form of a single helix, double helix or multiple prongs having one or more electrodes.

Claims

1. A method of using a catheter for mapping parasympathetic or sympathetic renal nerve for treatment of disease caused by systemic renal nerve hyperactivity, wherein said catheter comprises a shaft, wherein the proximal end of said shaft is configured to be connected to an energy source, and the distal end (catheter tip) of said shaft is in the form of a single helix, double helix or multiple prongs having one or more electrodes;

said mapping comprises the steps of;

a. introducing said catheter into the lumen of a renal artery such that the tip of said catheter contacts a site on the inner renal artery wall;

b. measuring one or more physiological parameters to obtain baseline measurements before introducing electrical current to the site, said physiological parameters are selected from the group consisting of systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate;

c. applying electrical stimulation by introducing electrical current to the site via the catheter, wherein said electrical current is controlled to be sufficient to elicit changes in said physiological parameters when there is an underlying nerve at the site;

d. measuring said physiological parameters at a specific time interval after each electrical stimulation, wherein an increase of said physiological parameters over the baseline measurements after said electrical stimulation would indicate that a sympathetic renal nerve has been mapped at said site;

a decrease of said physiological parameters over the baseline measurements after said electrical stimulation would indicate that a parasympathetic renal nerve has been mapped at said site; and

e. applying radiofrequency energy through the catheter to the site identified in step (d) for ablation of the underlying nerve to treat disease caused by systemic renal nerve hyperactivity.

2. The method of claim 1, wherein the electrodes may be activated independently of one another.

3. The method of claim 1, wherein the entire catheter is between 0.5 and 2 m in length, wherein the catheter tip is between 2 and 8 cm in length and between 0.5 mm and 10 mm in diameter.

4. The method of claim 1, wherein said helix or said prongs comprises coil that is substantially round or flat in shape, and the electrodes are spaced along the length of said coil or prongs, wherein said electrodes are embedded in said coil or prongs, or lie on the surface of said coil or prongs.

5. The method of claim 1, wherein the electrodes are evenly spaced along the length of said coil at 90°

or 120°

from each other.

6. The method of claim 1, wherein the catheter tip is configured to hold a balloon inflatable to fill the space within the coil of said helix or prongs.

7. The method of claim 1, wherein said prongs are rejoined at the distal end.

8. The method of claim 1, wherein said method further comprises repeating the the steps of (b) to (d) on the site identified in step (d), wherein a lack of change in said physiological parameters confirms nerve ablation.

9. The method of claim 1, wherein the catheter tip is moved in the renal artery in the following sequence:

a. turning 90°

or less from the anterior wall to the posterior wall of the artery;

b. turning 90°

or less from the posterior wall to the superior wall of the artery; and

c. turning 90°

or less from the superior wall to the inferior wall of the artery.

10. The method of claim 1, wherein the electrical current delivered falls within the following ranges:

a. voltage of between 2 and 30 volts;

b. resistance of between 100 and 1000 ohms;

c. current of between 5 and 40 milliamperes;

d. time of application between 0.1 and 20 milliseconds.

11. The method of claim 1, wherein said catheter is a cardiac ablation catheter.

12. The method of claim 1, wherein said catheter is an ablative catheter designed specifically for mapping renal nerves for ablative procedures.

13. The method of claim 1, wherein said specific time interval in step (d) is from about 5 seconds to about 2 minutes.

14. The method of claim 1, wherein said increase in systolic blood pressure is in the range of 4 to 29 mmHg.

15. The method of claim 1, wherein said increase in diastolic blood pressure is in the range of 1.5 to 20 mmHg.

16. The method of claim 1, wherein said increase in mean arterial pressure is in the range of 3 to 17 mmHg.

17. The method of claim 1, wherein said increase in heart rate is in the range of 4 to 12 beats/min.