Mapping sympathetic nerve distribution for renal ablation and catheters for same

• US 9,743,845 B2
• Filed: 04/07/2014
• Issued: 08/29/2017
• Est. Priority Date: 08/26/2011
• Status: Active Grant

• Current Assignee: Symap Medical suzhou Ltd
• Original Assignee: Symap Medical suzhou Ltd
• Inventors: Wang, Jie
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US14/247,244
• Publication Number:
  US 20140221805A1
• Time in Patent Office: 1,240 Days
• Field of Search: 600547, 600554, 606 32, 606 41, 607 44, 607115
• 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 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00285 Balloons
• 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 2018/1405 Electrodes having a specific shape
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 5/0036 including treatment, e.g., using an implantable medical device, ablating, ventilating
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• 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 5/02444 Details of sensor A61B5/02427 takes precedence
• CPC Class Codes: A61B 5/201 Assessing renal or kidney functions
• CPC Class Codes: A61B 5/367 Electrophysiological study [EPS], e.g. electrical activation mapping or electro-anatomical mapping
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61N 1/36114 : Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

This invention provides methods for mapping and ablating renal nerves to treat disease caused by systemic renal nerve hyperactivity, e.g. hypertension, heart failure, renal failure and diabetes. Also provided are catheters for performing the mapping and ablating functions.

Claims

1. A method for identifying patients responsive to renal ablation for treatment of disease caused by systemic renal nerve hyperactivity, comprising the steps of:

a. introducing a catheter into the lumen of a renal artery of a patient such that a 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 an 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 said electrical current to the site via the catheter, wherein said electrical current is controlled to be sufficient to elicit an increase in said one or more physiological parameters when there is an underlying nerve at the site;

d. measuring said one or more 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 said patient is responsive to renal ablation; and

e. performing renal ablation on said patient.

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

3. The method of claim 1, wherein said one or more physiological parameters includes systolic blood pressure, and said increase in systolic blood pressure is in the range of 4 to 29 mmHg.

4. The method of claim 1, wherein said one or more physiological parameters includes diastolic blood pressure, and said increase in diastolic blood pressure is in the range of 1.5 to 20 mmHg.

5. The method of claim 1, wherein said one or more physiological parameters includes mean arterial pressure, and said increase in mean arterial pressure is in the range of 3 to 17 mmHg.

6. The method of claim 1, wherein said one or more physiological parameters includes heart rate, and said increase in heart rate is in the range of 4 to 12 beats/min.

7. The method of claim 1, wherein the electrical current sufficient to elicit changes in the physiological parameters comprises one or more of the following parameters:

a. voltage of between 2 and 30 volts;

b. resistance of between 100 and 1000 ohms;

c. current of between 5 and 40 miliamperes;

or

d. applied between 0.1 and 20 milliseconds.