# US 2023/0404457 A1 · Intravascular catheter with peri-vascular nerve activity sensors

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- Number: US 2023/0404457 A1
- Document ID: US20230404457A1
- Status: Published application
- Kind: A1
- Application number: 18/358,444
- Filed: 2023-07-25
- Published: 2023-12-21
- Earliest claimed: 2013-10-25
- Assignees: Ablative Solutions, Inc.
- Applicants: Ablative Solutions, Inc.
- Inventors: David R. Fischell; Tim A. Fischell; Vartan Ghazarossian; Steven Almany
- Web page: https://patentgrep.com/patent/US20230404457A1

## CPC

- A61B 5/6852: {Catheters}
- A61B 5/4035: {Evaluating the autonomic nervous system}
- A61B 5/6848: {Needles}
- A61B 5/201: {Assessing renal or kidney functions}
- A61B 18/1477: {Needle-like probes}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 18/1815: {using microwaves}
- A61B 2017/320069: {for ablating tissue}
- A61B 2018/00214: {Expandable means emitting energy, e.g. by elements carried thereon}
- A61B 2018/00434: {Neural system}
- A61B 2018/00577: {Ablation}
- A61B 2018/00642: {with feedback, i.e. closed loop control}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- 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 2090/3966: {Radiopaque markers visible in an X-ray image}
- 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}
- 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)}

## Abstract

An intravascular catheter for peri-vascular nerve activity sensing or measurement includes multiple needles advanced through supported guide tubes (needle guiding elements) which expand with open ends around a central axis 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 perivascular space. The system also may include means to limit and/or adjust the depth of penetration of the needles. 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. The addition of an injection lumen at the proximal end of the catheter and openings in the needles adds the functionality of ablative fluid injection into the perivascular space for an integrated nerve sending and ablation capability.

## Claims

### Claim at position 1

1-22. (canceled)

### Claim 23

A catheter for placement into a vessel of a human body comprising:
a catheter body having a central lumen;
at least two needle guiding elements comprising a curved shape adapted to advance outwardly from the catheter body toward an interior wall of a target vessel;
at least two needles adapted to advance outwardly, guided by the at least two needle guiding elements to penetrate the interior wall of the target vessel, wherein the at least two needle guiding elements are configured to maintain their position against the interior wall of the target vessel as the at least two needles penetrate the interior wall of the target vessel to a target tissue; and
a structure to reduce the internal volume of the catheter, wherein the structure extends the entire length of the catheter.

### Claim 24 (depends on 23)

The catheter of claim 23, wherein the structure comprises a wire.

### Claim 25 (depends on 23)

The catheter of claim 23, wherein the structure comprises an insulated wire.

### Claim 26 (depends on 23)

The catheter of claim 23, wherein the catheter is configured to inject a volume of between 0.15 ml and 0.6 ml of ablative fluid.

### Claim 27 (depends on 23)

The catheter of claim 23, wherein the internal volume of the catheter is less than 0.5 ml.

### Claim 28 (depends on 23)

The catheter of claim 23, wherein the catheter is configured to inject a volume of 0.3 ml of ablative fluid.

### Claim 29 (depends on 23)

The catheter of claim 23, wherein the structure is within the central lumen.

### Claim 30

A catheter for placement into a target vessel of a human body comprising:
a catheter body having a lumen for fluid delivery;
at least two needle guiding elements comprising a curved shape adapted to advance outwardly from the catheter body toward the interior wall of the target vessel;
at least two needles, each needle comprising a lumen for fluid delivery, the at least two needles adapted to advance outwardly, guided by the at least two needle guiding elements to penetrate the interior wall of the target vessel, wherein the at least two needle guiding elements are configured to maintain their position against the interior wall of the target vessel as the at least two needles penetrate the interior wall of the target vessel; and
wherein an injection of about 0.6 ml is sufficient to fill the needed volume including the sympathetic nerves.

### Claim 31 (depends on 30)

The catheter of claim 30, where the fluid delivered comprises a lipophilic fluid.

### Claim 32 (depends on 30)

The catheter of claim 30, where the fluid delivered comprises a hygroscopic fluid.

### Claim 33 (depends on 30)

The catheter of claim 30, where the fluid delivered is configured to spread within the peri-vascular space.

### Claim 34 (depends on 30)

The catheter of claim 30, where the injection is configured such that the volume would not harm a kidney if accidentally discharged into a renal artery.

### Claim 35 (depends on 30)

The catheter of claim 30, further comprising a means to provide feedback on the effectiveness of ablation.

### Claim 36

A method, comprising:
providing a catheter having a catheter body with a proximal end, a distal end, and a first needle and a second needle;
providing a first guiding element and a second guiding element, the first needle coaxial with the first guiding element and the second needle coaxial with the second guiding element;
positioning the distal end of the catheter within a patient;
advancing the first guiding element and the second guiding element outwardly from the catheter body toward a vessel wall;
advancing the first needle through the first guiding element and into the vessel wall and advancing the second needle through the second guiding element and into the vessel wall, wherein the first guiding element and the second guiding element are configured to maintain their position against the vessel wall as the first needle and the second needle are advanced into the vessel wall; and
injecting a volume of less than 1 ml of ablative fluid, wherein the success of ablation is assessed during the procedure.

### Claim 37 (depends on 36)

The method of claim 36, wherein the ablative fluid is ethanol.

### Claim 38 (depends on 36)

The method of claim 36, wherein the ablative fluid produces a multiplicity of ablation zones that intersect to form an ablative ring around the circumference of the target vessel.

### Claim 39 (depends on 36)

The method of claim 36, further comprising monitoring activity of sympathetic nerves being ablated.

### Claim 40 (depends on 36)

The method of claim 36, wherein the ablative fluid comprises a lipophilic fluid.

### Claim 41 (depends on 36)

The method of claim 36, wherein the ablative fluid comprises a hygroscopic fluid.

### Claim 42 (depends on 36)

The method of claim 36, wherein the ablative fluid is configured to spread within a peri-vascular space