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

• US 9,022,948 B2
• Filed: 08/24/2012
• Issued: 05/05/2015
• 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): Hindenburg, Max
• Assistant Examiner(s): Foreman, Jonathan M
• Application Number:
  US14/241,058
• Publication Number:
  US 20140194866A1
• Time in Patent Office: 984 Days
• Field of Search: 600/546, 600/547, 600/554, 607/2, 607/40, 607/115, 607/116, 607/44, 606/32, 606/41
• US Class Current: 600/554
• 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

System and method for locating and identifying nerves innervating the wall of arteries such as the renal artery are disclosed. The present invention identifies areas on vessel walls that are innervated with nerves; provides indication on whether a dose of energy is delivered accurately to a targeted nerve; and provides immediate post-procedural assessment of the effect of the energy delivered to the nerve. The method includes at least the steps to evaluate a change in physiological parameters after a dose of energy is delivered to an arterial wall; and to determine the type of nerve that the energy was directed to (none, sympathetic or parasympathetic) based on the results of the evaluation. The system includes at least a device for delivering a dose of energy to the wall of an artery; sensors for detecting physiological signals from a subject; and indicators to display the results obtained using the said method.

Claims

1. A method of mapping parasympathetic or sympathetic renal nerve 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 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 one or more 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 one or more physiological parameters when there is an underlying nerve at the site; and

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

2. The method of claim 1, wherein said catheter is an ablative catheter currently in use to treat cardiac arrhythmias.

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

4. The method of claim 1, further comprises the step of 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.

5. The method of claim 4, further comprises repeating the steps (b) to (d) on the ablated site, wherein a lack of change in said one or more physiological parameters confirms nerve ablation.

6. A system when used for mapping parasympathetic or sympathetic renal nerve, comprising:

(i) a catheter configured to deliver electrical current to one or more locations on the inner renal artery wall sufficient to stimulate a nerve innervating said renal artery;

(ii) one or more measuring devices for measuring one or more physiological parameters associated with the innervation of said renal artery, wherein said one or more physiological parameters are selected from the group consisting of systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, and heart rate;

(iii) a computing device configured to couple to the one or more measuring devices, wherein said computing device computes a baseline for said one or more physiological parameters prior to delivery of said electrical current and computes any increase or decrease in the physiological parameters against said baseline after delivery of said electrical current; and

(iv) a display device for displaying the location or identity of a nerve innervating said inner renal artery wall, wherein said display device will display signal for sympathetic nerve when said one or more physiological parameters increase relative to said baseline, and wherein said display device will display signal for parasympathetic nerve when said one or more physiological parameters decrease relative to said baseline.

7. The system of claim 6, wherein said measuring devices are placed inside the renal artery, femoral artery or outside the body.

8. The system of claim 6, wherein said catheter could also deliver ablative energy selected from the group consisting of radiofrequency, mechanical, ultrasonic, radiation, optical and thermal energies.

9. The system of claim 6, wherein said computing device comprises one or more microcontrollers or computers.

10. The system of claim 6, wherein the location or identity of the parasympathetic or sympathetic nerve is displayed as numbers, texts, symbols, colors, sound, waveforms, or a combination thereof.

11. The system of claim 6, wherein said catheter is an ablative catheter currently in use to treat cardiac arrhythmias.

12. The system of claim 6, wherein said catheter is an ablative catheter designed specifically for mapping renal nerves for ablative procedures.

13. A method of using the system of claim 6 for mapping parasympathetic or sympathetic renal nerve, comprising the steps of:

a) introducing a 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 one or more 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 one or more physiological parameters when there is an underlying nerve at the site; and

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

14. The method of claim 13, wherein said catheter is an ablative catheter currently in use to treat cardiac arrhythmias.

15. The method of claim 13, wherein said catheter is an ablative catheter designed specifically for mapping renal nerves for ablative procedures.

16. The method of claim 13, further comprises the step of 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.

17. The method of claim 16, further comprises repeating the steps (b) to (d) on the ablated site, wherein a lack of change in said one or more physiological parameters confirms nerve ablation.