APPARATUS FOR EFFECTIVE ABLATION AND NERVE SENSING ASSOCIATED WITH DENERVATION

• US 20190015002A1
• Filed: 07/13/2018
• Published: 01/17/2019
• Est. Priority Date: 10/25/2013
• Status: Active Grant

• Current Assignee: Ablative Solutions, Inc.
• Original Assignee: Ablative Solutions, Inc.
• Inventors: Fischell, David R., Fischell, Tim A., Ghazarossian, Vartan, Almany, Steven, John, Michael Sasha
• Granted Patent: US 10,420,481 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/320068 using mechanical vibrations, e.g. ultrasonic A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745
• CPC Class Codes: A61B 18/0218 with open-end cryogenic probe, e.g. for spraying fluid directly on tissue or via a tissue-contacting porous tip
• CPC Class Codes: A61B 18/1233 with circuits for assuring patient safety
• CPC Class Codes: A61B 18/1477 Needle-like probes
• 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 18/1815 using microwaves
• CPC Class Codes: A61B 2017/00039 Electric or electromagnetic phenomena other than conductivity, e.g. capacity, inductivity, Hall effect
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• 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 2018/00541 Lung or bronchi
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00642 with feedback, i.e. closed loop control
• CPC Class Codes: A61B 2018/00666 using a threshold value
• CPC Class Codes: A61B 2018/00738 Depth, e.g. depth of ablation
• CPC Class Codes: A61B 2018/00779 Power or energy
• CPC Class Codes: A61B 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/00827 Current
• 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 2018/00892 : Voltage
• CPC Class Codes: A61B 2018/00898 : Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/00916 : with means for switching or controlling the main function of the instrument or device
• CPC Class Codes: A61B 2018/0212 : using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/046 : in liquid form
• CPC Class Codes: A61B 2018/048 : in gaseous form
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/143 : multiple needles
• CPC Class Codes: A61B 2018/1432 : curved
• CPC Class Codes: A61B 2018/1467 : using more than two electrodes on a single probe
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2090/376 : using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/3966 : Radiopaque markers visible in an X-ray image
• 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 5/4035 : Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/6848 : Needles
• CPC Class Codes: A61B 5/6852 : Catheters
• CPC Class Codes: A61M 2025/0095 : being one or more needles protruding from the distal tip and which are not used for injection nor for electro-stimulation, e.g. for fixation purposes

Abstract

An intravascular catheter for nerve activity ablation and/or sensing includes one or more needles advanced through supported guide tubes (needle guiding elements) which expand to contact the interior surface of the wall of the renal artery or other vessel of a human body allowing the needles to be advanced though the vessel wall into the extra-luminal tissue including the media, adventitia and periadvential space. The catheter also includes structures which provide radial and lateral support to the guide tubes so that the guide tubes open uniformly and maintain their position against the interior surface of the vessel wall as the sharpened needles are advanced to penetrate into the vessel wall. Electrodes near the distal ends of the needles allow sensing of nerve activity before and after attempted renal denervation. In a combination embodiment ablative energy or fluid is delivered from the needles in or near the adventitia to ablate nerves outside of the media while sparing nerves within the media.

Claims

1. A catheter for sensing the activity from nerves outside of the lumen of a target vessel of a human body comprising:

a catheter body having a distal end for insertion into a patient, a proximal end for controlling the movement of at least one needle, and a central axis extending in a longitudinal direction;

a connector configured to connect to external electronic equipment outside of a proximal end of the catheter, said equipment having a sensing subsystem configured for sensing local nerve activity within a patient, and configured to be connected to at least one additional electrode in electrical contact with the patient;

at least one needle guiding element adapted to expand outwardly from the catheter body toward the interior wall of the target vessel;

at least one needle, the needle having at least one distal electrode, the needle adapted to be advanced outwardly, guided by the at least one needle guiding element to penetrate and advance through the interior wall of the target vessel into the tissue outside of the vessel lumen; and

at least one wire for conducting electrical signals between the at least one electrode and the connector for communicating with said external electronic equipment.

2. The catheter of claim 1, wherein the at least one needle guiding element is a guide tube having a lumen.

3. The catheter of claim 2, wherein the at least one needle is advanced outwardly coaxially through the lumen of the guide tube.

4. The catheter of claim 1, including at least three needle guiding elements, at least three needles, and at least three insulated wires, wherein the at least one additional electrode is positioned proximate a distal end of one of the at least three needles.

5. The catheter of claim 4, wherein the at least three needle guiding elements are disposed equidistantly around the circumference of the catheter.

6. The catheter of claim 4, wherein the at least three needle guiding elements are not disposed equidistantly and the space between at least two of the at least three needles is less than 50 degrees.

7. The catheter of claim 1, wherein the sensing subsystem of the external electronic equipment and the distal electrode is configured to provide monopolar sensing.

8. The catheter of claim 1, wherein the at least one additional electrode is in proximity to the distal electrode and configured to operate with the sensing subsystem of the external electronic equipment to provide bipolar sensing.

9. The catheter of claim 1, wherein the sensing subsystem of the external electronic equipment and the distal electrode is configured to provide monopolar stimulation.

10. The catheter of claim 1, wherein the at least one additional electrode is in proximity to the distal electrode and configured to operate with the sensing subsystem of the external electronic equipment to provide bipolar stimulation.

11. The catheter of claim 1, further including radiopaque markers attached to or within a portion of one or more of the structures selected from the group of:

a) the at least one needle, b) the at least one needle guiding element and c) a portion of the catheter body.

12. The catheter of claim 1, further including the external electronic equipment, where electrical current from the external electronic equipment delivers radiofrequency energy to the distal electrode and the at least one additional electrode, the radiofrequency energy adapted to ablate the nerves.

13. The catheter of claim 1, further including a mechanical support structure adapted to support the at least one needle guiding element in an expanded configuration in a direction selected from the group consisting of:

a) radial, in which the mechanical support structure supports the at least one needle guiding element in a radial direction, and b) lateral, in which the mechanical support structure supports the at least one needle guiding element in a lateral direction.

14. The catheter of claim 1, further including the external electronic equipment, wherein the external electronic equipment is configured to be connected to the distal and at least one additional electrode through the at least one wire is adapted to both sense nerve activity from signals received by the distal and at least one additional electrode and provide electrical energy from the distal electrode and the at least one additional electrode to the nerves outside of a media of the vessel.

15. The catheter of claim 1, further including a proximal fluid injection port, at least one distal fluid egress port near the distal end of the at least one needle and one or more lumens providing fluid communication from the proximal fluid injection port to the at least one distal fluid egress port.

16. The catheter of claim 1, further including the external electronic equipment.

17. A system for sensing the nerves in extravascular tissue at a target site in a human body, comprising:

a catheter with an elongate, flexible body;

at least one flexible extendable arm having a sharpened tissue penetrating tip carried by the body of the catheter, the extendable arm movable between a first position in which the sharpened tip is positioned within the body of the catheter and a second position in which the tip is displaced radially outwardly from the body to penetrate tissue and reach the target site;

a first electrode carried by the arm; and

a first electrical conductor, extending through the body of the catheter and in electrical communication with the first electrode;

a second electrode; and

a second electrical conductor, in electrical communication with the second electrode; and

external electronic equipment having a sensing subsystem configured for measuring local nerve activity within a patient using the first and second electrode.

18. The system as in claim 17, where the catheter includes three flexible extendable arms.

19. The system of claim 17, where the catheter includes a support tube movable between a first position within the body of the catheter and a second position extending away from the body of the catheter, wherein the flexible extendable arm extends through the support tube.

20. The system of claim 17, where the external electronic equipment is also adapted to provide electrical energy to the at least two electrodes to ablate the nerves outside of a media of an artery, the at least two wires also adapted for conducting electrical current to the at least two electrodes, the wires connecting the electrodes to external electronic equipment outside of the catheter.

21. The system of claim 20, where the electrical energy is radiofrequency energy.