Device for mapping and ablating renal nerves distributed on the renal artery

• US 9,770,291 B2
• Filed: 08/23/2013
• Issued: 09/26/2017
• Est. Priority Date: 08/26/2011
• Status: Active Grant

• Current Assignee: Symap Medical suzhou Ltd
• Original Assignee: Symap Medical suzhou Ltd
• Inventors: Wang, Jie, Li, Chuwu, Zou, Bo, Wang, Jiancong
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): GOOD, SAMANTHA M
• Application Number:
  US14/421,869
• Publication Number:
  US 20150216590A1
• Time in Patent Office: 1,495 Days
• 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

A device for mapping and ablating the renal nerves distributed on the renal artery is provided, said device comprising a guide catheter (11), a mapping-ablation catheter (12), a handle (13) and a connector (15). The guide catheter (11) had at least one lumen and a distal end with adjustable curvature. The mapping-ablation catheter (12) is housed in one of the lumens of the guide catheter (11) and its distal end has one or more electrodes (22) and one or more detecting devices (23). The distal end of the mapping-ablation catheter (12) is curved, rotatable, and can be extended out of or retracted into the guide catheter (11). The handle (13) connects the guide catheter (11) and mapping-ablation catheter (12), and comprises one or more controlling components for controlling the movement of the guide catheter (11) and mapping-ablation catheter (12). The connector (15) is designed to supply energy to the electrodes (22).

Claims

1. A device for mapping and ablating the renal nerves distributed on the renal artery, comprising a guide catheter, a mapping-ablation catheter, a handle and a connector, wherein:

said guide catheter comprises one lumen, a distal end of said guide catheter, and a mechanism for controlling curvature of said distal end from the handle, said mechanism comprising a first traction wire having a first end and a second end, said first end being connected to said distal end of said guide catheter and said second end being connected to a controlling component at said handle, wherein pulling said first traction wire by the controlling component will cause the distal end of the guide catheter to bend;

said mapping-ablation catheter is housed in said lumen of the guide catheter and has a distal end that comprises one or more electrodes and one or more detecting devices, wherein said one or more electrodes are for delivering electrical energy, radio frequency energy, laser energy, or high intensity focused ultrasound, or for carrying out cryoablation, wherein at least one of said one or more electrodes is larger than the lumen of said guide catheter and fits neatly on an open end of the guide catheter to form a sealing mechanism between a tip of the mapping-ablation catheter and the guide catheter to control fluid entry or exit;

said distal end of the mapping-ablation catheter can be extended out of or retracted into the guide catheter and is rotatable along a central axis of an open end of the guide catheter;

wherein the distal end of said mapping-ablation catheter has a fixed curvature that is spontaneously resumed when extended out of the guide catheter, said curvature being maintained by using either;

(i) a second traction wire having a first end and a second end, said first end of the second traction wire is fixed to the distal end of the mapping-ablation catheter while said second end of the second traction wire is fixed to a spring inside the handle, wherein when the distal end of the mapping-ablation catheter is retracted into the guide catheter, said distal end of the mapping-ablation catheter is confined by the lumen of said guide catheter and the spring is compressed, wherein when the distal end of the mapping-ablation catheter is extended out of the guide catheter, said distal end of the mapping-ablation catheter is no longer confined by the lumen of said guide catheter and the spring restores naturally and pulls the second traction wire to cause bending of the distal end of the mapping-ablation catheter;

or

(ii) a Ni—

Ti shape memory alloy with said fixed curvature for the distal end of the mapping-ablation catheter; and

said handle connects the guide catheter and said mapping-ablation catheter.

2. The device of claim 1, wherein said handle further comprises a fluid-exchange conduit connected to the guide catheter for controlling fluid entering or leaving the guide catheter.

3. The device of claim 1, wherein said one or more detecting devices comprise temperature detecting device and resistance detecting device.

4. The device of claim 1, wherein said guide catheter comprises a distal end, a middle part and a proximal end, said guide catheter is made of three materials of different hardness values in the range of 90 A to 80 D in the Shore hardness scale, wherein the distal end of said guide catheter is made of a material with low hardness value, the middle part of the guide catheter is made of a material with intermediate hardness value and the proximal end of the guide catheter is made of a material with high hardness value.

5. The device of claim 1, wherein said handle further comprises a control knob that causes the distal end of the guide catheter to bend.

6. The device of claim 1, wherein said handle further comprises a control knob that causes the distal end of the mapping-ablation catheter to extend out of or withdraw into the guide catheter.

7. The device of claim 1, wherein said handle further comprises a control knob that causes the distal end of the mapping-ablation catheter to rotate.

8. The device of claim 1, wherein said handle further comprises a control knob that causes the distal end of the mapping-ablation catheter to rotate or to extend out of or withdraw into the guide catheter.