# US 12,239,361 B2 · Method for denervation with reduced pain

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- Number: US 12,239,361 B2
- Document ID: US12239361B2
- Status: Granted
- Kind: B2
- Application number: 18/049,443
- Filed: 2022-10-25
- Published: 2023-03-09
- Granted: 2025-03-04
- Earliest claimed: 2013-10-25
- Assignees: Ablative Solutions, Inc.
- Applicants: Ablative Solutions, Inc.
- Inventors: David R. Fischell; Steven Almany
- Web page: https://patentgrep.com/patent/US12239361B2

## CPC

- A61B 18/1477: {Needle-like probes}
- A61B 5/201: {Assessing renal or kidney functions}
- A61B 5/388: Nerve conduction study, e.g. detecting action potential of peripheral nerves
- A61B 5/6852: {Catheters}
- A61B 17/2202: {the ultrasound transducer being inside patient's body at the distal end of the catheter}
- 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)}
- A61B 18/06: caused by chemical reaction {, e.g. moxaburners}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61B 5/021: Measuring pressure in heart or blood vessels
- A61B 5/024: Measuring pulse rate or heart rate
- A61B 5/6848: {Needles}
- A61B 18/0218: {with open-end cryogenic probe, e.g. for spraying fluid directly on tissue or via a tissue-contacting porous tip}
- A61B 18/1815: {using microwaves}
- A61B 2017/22014: {the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire}
- A61B 2018/00214: {Expandable means emitting energy, e.g. by elements carried thereon}
- A61B 2018/00404: {Blood vessels other than those in or around the heart}
- A61B 2018/00434: {Neural system}
- A61B 2018/00511: {Kidney}
- A61B 2018/00577: {Ablation}
- A61B 2018/00666: {using a threshold value}
- A61B 2018/00738: {Depth, e.g. depth of ablation}
- A61B 2018/00779: {Power or energy}
- A61B 2018/00791: {Temperature}
- A61B 2018/00827: {Current}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/00875: {Resistance or impedance}
- A61B 2018/00892: {Voltage}
- A61B 2018/00898: {Alarms or notifications created in response to an abnormal condition}
- A61B 2018/0212: {using an instrument inserted into a body lumen, e.g. catheter}
- A61B 2018/046: {in liquid form}
- A61B 2018/1425: {Needle}
- A61B 2018/143: {multiple needles}
- A61B 2018/1432: {curved}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61M 2025/0087: {Multiple injection needles protruding laterally from the distal tip}
- A61N 7/022: {intracavitary}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## 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 at the distal ends of the guide tubes allow sensing of nerve activity before and after attempted renal denervation. In a combination embodiment ablative energy or fluid is delivered to ablate nerves outside of the media.

## Claims

### Claim 1

A method comprising:
advancing a distal portion of a catheter having at least three needle guide elements and at least three needles to a site within a human body;
advancing the at least three needle guide elements to expand outwardly against tissue within the human body, wherein the at least three needle guide elements are configured to maintain their position against the tissue;
advancing the at least three needles through the at least three needle guide elements into the tissue, wherein the at least three needle guide elements are configured to maintain their position against the tissue as the at least three needles are advanced into the tissue; and
ablating sympathetic nerve fibers while minimizing or eliminating pain to the patient.

### Claim 2 (depends on 1)

The method of claim 1, wherein the site within the human body lies within an artery or a vein of the human body.

### Claim 3 (depends on 1)

The method of claim 1, wherein ablating sympathetic nerve fibers comprises injecting a fluid.

### Claim 4 (depends on 3)

The method of claim 3, wherein the fluid is selected from the group consisting of alcohol, ethanol, saline, heated fluid, and cooled fluid.

### Claim 5 (depends on 1)

The method of claim 1, wherein ablating sympathetic nerve fibers comprises delivering energy.

### Claim 6 (depends on 1)

The method of claim 1, wherein the type of energy is selected from the group consisting of radiofrequency (RF), microwave, cryogenic, ultrasound, electrocautery, and heat.

### Claim 7 (depends on 1)

The method of claim 1, wherein at least one needle of the at least three needles is adapted to sense electrical energy from the tissue.

### Claim 8 (depends on 1)

The method of claim 1, wherein ablating sympathetic nerve fibers comprises injecting a fluid which serves as a local analgesic prior to the fluid's effect as an ablative agent.

### Claim 9 (depends on 1)

The method of claim 1, wherein ablating sympathetic nerve fibers comprises providing for analgesia in the region of ablation.

### Claim 10 (depends on 1)

The method of claim 1, wherein the at least three needle guide elements are advanced together.

### Claim 11 (depends on 1)

The method of claim 1, wherein the at least three needles are advanced together.

### Claim 12

A method comprising:
advancing a distal portion of a catheter having at least three needle guide elements and at least three needles to a site within a human body;
advancing the at least three needle guide elements to expand outwardly against tissue within the human body, wherein the at least three needle guide elements are configured to maintain their position against the tissue;
advancing the at least three needles through the at least three needle guide elements into the tissue, wherein the at least three needle guide elements are configured to maintain their position against the tissue as the at least three needles are advanced into the tissue; and
ablating sympathetic nerve fibers beyond the endothelium to reduce or eliminate pain to the patient.

### Claim 13 (depends on 12)

The method of claim 12, wherein ablating sympathetic nerve fibers comprises injecting a fluid.

### Claim 14 (depends on 12)

The method of claim 12, wherein ablating sympathetic nerve fibers comprises delivering energy.

### Claim 15 (depends on 12)

The method of claim 12, wherein ablating sympathetic nerve fibers comprises sparing unmyelinated C-fibers.

### Claim 16

A method of renal denervation comprising:
advancing a distal portion of a catheter having at least three needle guide elements and at least three needles to a site within an artery within a human body;
advancing the at least three needle guide elements to expand outwardly against an inside wall of the artery, wherein the at least three needle guide elements are configured to maintain their position against the inside wall of the artery;
advancing the at least three needles through the at least three needle guide elements into the tissue, wherein the at least three needle guide elements are configured to maintain their position against the inside wall of the artery as the at least three needles are advanced into the tissue; and
ablating sympathetic nerve fibers located outside of the media of the artery while minimizing or eliminating pain to the patient.

### Claim 17 (depends on 16)

The method of claim 16, wherein ablating sympathetic nerve fibers comprises injecting a fluid or delivering energy.

### Claim 18 (depends on 16)

The method of claim 16, wherein ablating sympathetic nerve fibers comprises avoiding nonspecific destruction of nerves associated with a vessel wall.

### Claim 19 (depends on 16)

The method of claim 16, wherein ablating sympathetic nerve fibers comprises injecting a fluid slowly over a period at least 10 seconds.

### Claim 20 (depends on 16)

The method of claim 16, wherein ablating sympathetic nerve fibers comprises injecting a fluid slowly over a period longer than 30 seconds.

### Claim 21 (depends on 1)

The method of claim 1, wherein ablating sympathetic nerve fibers while minimizing or eliminating pain to the patient comprises injecting ethanol.

### Claim 22 (depends on 12)

The method of claim 12, wherein ablating sympathetic nerve fibers beyond the endothelium to reduce or eliminate pain to the patient comprises injecting ethanol.

### Claim 23 (depends on 16)

The method of claim 16, wherein ablating sympathetic nerve fibers located outside of the media of the artery while minimizing or eliminating pain to the patient comprises injecting ethanol.