Apparatus for effective ablation and nerve sensing associated with denervation

• US 9,949,652 B2
• Filed: 12/08/2015
• Issued: 04/24/2018
• 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
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): ANTISKAY, BRIAN MICHAEL
• Application Number:
  US14/963,179
• Publication Number:
  US 20160242661A1
• Time in Patent Office: 868 Days
• Field of Search: 600372-375, 600378, 600381, 600466-467, 607115, 607118-119, 607126, 607128, 607133
• 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 a 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, and a central axis extending in a longitudinal direction;

a first needle guiding element and a second needle guiding element adapted to expand outwardly from the catheter body toward an interior wall of the target vessel;

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

wherein the first needle guiding element and the second needle guiding element are configured to maintain their position against the interior wall of the target vessel as the first needle and the second needle are advanced into the target tissue; and

a wire for conducting electrical signals, the wire extending between the distal electrode and a proximal connector, the proximal connector configured to connect to external electronic equipment, the external electronic equipment having a sensing subsystem configured for sensing local nerve activity within a patient.

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

3. The catheter of claim 2, wherein the first 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 including the first needle guiding element, the second needle guiding element, and a third needle guiding element, at least three needles including the first needle, the second needle, and a third needle.

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 spacing between the at least three needle guiding elements is non-uniform.

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

8. The catheter of claim 1, wherein 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 are configured to provide monopolar stimulation.

10. The catheter of claim 1, wherein 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:

the first needle, the second needle, the first needle guiding element, the second needle guiding element, and 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 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 first needle guiding element and the second 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 first needle guiding element and the second needle guiding element in a radial direction, and b) lateral, in which the mechanical support structure supports the first needle guiding element and the second 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 electrode and at least one additional electrode, wherein the external electronic equipment is adapted to both sense nerve activity from signals received by the distal electrode and at least one additional electrode and provide electrical energy from the distal electrode and at least one additional electrode to the nerves outside of a media of the target vessel.

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

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

17. A system for sensing at least one nerve in an extravascular tissue in a human body, comprising:

a catheter with an elongate, flexible catheter body;

a first guide element adapted to advance outwardly from the elongate, flexible catheter body,

a first flexible extendable arm having a first sharpened tissue penetrating tip, the first flexible extendable arm movable between a first position in which the first sharpened tissue penetrating tip is positioned within the first guide element and a second position in which the first sharpened tissue penetrating tip is displaced radially outwardly from the first guide element to penetrate the extravascular tissue and reach a target site;

a first electrode carried by the first flexible extendable arm;

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

a second guide element adapted to advance outwardly from the elongate, flexible catheter body,

a second flexible extendable arm having a second sharpened tissue penetrating tip, the second flexible extendable arm movable between a first position in which the second sharpened tissue penetrating tip is positioned within the second guide element and a second position in which the second sharpened tissue penetrating tip is displaced radially outwardly from the second guide element to penetrate the extravascular tissue and reach the target site;

a second electrode;

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

wherein the first guide element and the second guide element are configured to maintain their position against an interior wall of the extravascular tissue as the first flexible extendable arm and the second flexible extendable arm penetrate the extravascular tissue and reach the target site;

wherein the first electrical conductor and the second electrical conductor are configured to connect to external electronic equipment having a sensing subsystem configured for measuring local nerve activity within a patient using the first electrode and the second electrode.

18. The system as in claim 17, where the catheter includes three flexible extendable arms including the first flexible extendable arm, the second flexible extendable arm and a third flexible extendable arm.

19. The system of claim 17, further including the external electronic equipment, where the external electronic equipment is adapted to provide electrical energy to the first electrode and the second electrode to ablate a nerve outside of a media of an artery.

20. The system of claim 19, where the electrical energy is radiofrequency energy.