# US 12,053,238 B2 · Peri-vascular tissue ablation catheters

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- Number: US 12,053,238 B2
- Document ID: US12053238B2
- Status: Granted
- Kind: B2
- Application number: 17/127,151
- Filed: 2020-12-18
- Published: 2021-07-08
- Granted: 2024-08-06
- Earliest claimed: 2012-10-29
- Assignees: Ablative Solutions, Inc.
- Applicants: Ablative Solutions, Inc.
- Inventors: David R. Fischell; Tim A. Fischell; Robert Ryan Ragland; Darrin James Kent; Andy Edward Denison; Eric Thomas Johnson; Jeff Alan Burke; Christopher Scott Hayden
- Web page: https://patentgrep.com/patent/US12053238B2

## CPC

- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 5/388: Nerve conduction study, e.g. detecting action potential of peripheral nerves
- A61B 17/3403: {Needle locating or guiding means}
- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61B 18/04: by heating (by applying electromagnetic radiation A61B18/18)
- A61B 18/1477: {Needle-like probes}
- A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers}
- A61M 25/0084: {being one or more injection needles}
- A61B 5/0205: Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
- A61B 2017/22071: {Steering}
- A61B 2018/00267: {having a basket shaped structure}
- A61B 2018/00285: {Balloons}
- A61B 2018/00351: {Heart}
- A61B 2018/00434: {Neural system}
- A61B 2018/00505: {Urinary tract}
- A61B 2018/00547: {Prostate}
- A61B 2018/00577: {Ablation}
- A61B 2018/046: {in liquid form}
- A61B 2018/048: {in gaseous form}
- A61B 2018/1425: {Needle}
- A61B 2018/1475: {Electrodes retractable in or deployable from a housing}
- A61B 2090/376: {using X-rays, e.g. fluoroscopy}
- A61B 2090/3966: {Radiopaque markers visible in an X-ray image}
- A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body}
- A61M 25/0662: {Guide tubes}
- A61M 2025/0004: {having two or more concentrically arranged tubes for forming a concentric catheter system}
- A61M 2025/0087: {Multiple injection needles protruding laterally from the distal tip}
- A61M 2025/0186: {Catheters with fixed wires, i.e. so called "non-over-the-wire catheters"}
- A61M 2205/02: characterised by a particular materials
- A61M 2205/32: with radio-opaque indicia
- 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 and/or peri-urethral tissue ablation includes multiple needles advanced through supported guide tubes which expand around a central axis to engage the interior surface of the wall of the renal artery or other vessel of a human body allowing the injection an ablative fluid for ablating tissue, and/or nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. The system may also include a means to limit and/or adjust the depth of penetration of the ablative fluid into and beyond the tissue of the vessel wall. The catheter may also include structures which provide radial and/or lateral support to the guide tubes so that the guide tubes expand uniformly and maintain their position against the interior surface of the vessel wall as the sharpened injection needles are advanced to penetrate into the vessel wall. A method can involve injection/infusion of the ablative fluid over an extended time period of at least 10 seconds or with two injections at two different penetration depths to reduce or eliminate patient pain during ablation.

## Claims

### Claim 1

A catheter for fluid delivery into a tissue outside of an interior wall of a target vessel of a human body comprising:
a catheter body having a fluid injection lumen;
at least two needle guiding elements adapted to advance outwardly toward the interior wall of the target vessel;
at least two injector tubes having distal sharpened needles, each injector tube having an injector tube lumen in fluid communication with the fluid injection lumen of the catheter body, at least two injector tubes adapted to advance outwardly, guided by the at least two needle guiding elements;
each injector tube having an elongate structure located inside the injector tube lumen, wherein the elongate structure is configured to equalize a flow rate between the at least two injector tubes, wherein a total cross-sectional area of the at least two injector tubes with the elongate structures is less than the cross-sectional area of the fluid injection lumen of the catheter.

### Claim 2 (depends on 1)

The catheter of claim 1, wherein the elongate structure is a wire.

### Claim 3 (depends on 1)

The catheter of claim 1, wherein the elongate structure is a ribbon.

### Claim 4 (depends on 1)

The catheter of claim 1, wherein the elongate structure comprises a radiopaque material.

### Claim 5 (depends on 1)

The catheter of claim 1, wherein the elongate structure comprises platinum, gold, tantalum, or tungsten.

### Claim 6 (depends on 1)

The catheter of claim 1, wherein the at least two needle guiding elements comprise a radiopaque material.

### Claim 7 (depends on 1)

The catheter of claim 1, wherein the cross-section of the elongate structure is at least 25% of the cross-section of the injector tube lumen.

### Claim 8 (depends on 1)

The catheter of claim 1, wherein the cross-section of the elongate structure is at least 50% of the cross-section of the injector tube lumen.

### Claim 9 (depends on 1)

The catheter of claim 1, wherein the cross-section of the elongate structure is at least 75% of the cross-section of the injector tube lumen.

### Claim 10 (depends on 1)

The catheter of claim 1, wherein the at least two needle guiding elements comprise a radiopaque marker band.

### Claim 11 (depends on 1)

The catheter of claim 1, wherein the elongate structure comprises a bend configured to prevent movement of elongate structure in a distal direction.

### Claim 12 (depends on 1)

The catheter of claim 1, wherein the elongate structure extends the full length of the catheter.

### Claim 13 (depends on 1)

The catheter of claim 1, wherein the elongate structure increases resistance to flow of fluid in the at least two injector tubes.

### Claim 14

A catheter for fluid delivery into tissue outside of an interior wall of a target vessel of a human body comprising:
a catheter body having a fluid injection lumen;
at least two needle guiding elements;
at least two injector tubes, each injector tube having an injector tube lumen and a distal sharpened needle, the injector tube lumen in fluid communication with the fluid injection lumen of the catheter body, each distal sharpened needle having an opening for fluid delivery, each injector tube adapted to be advanced outwardly, guided by a respective needle guiding element;
at least two elongate structures, each of the elongate structures are located inside of the injector tube lumens, the at least two elongate structures extending along at least a portion of the length of the at least two injector tubes, wherein the at least two elongate structures are configured to increase pressure of fluid in the at least two injector tubes, wherein a total cross-sectional area of the at least two injector tubes with the elongate structures is less than the cross-sectional area of the fluid injection lumen of the catheter.

### Claim 15 (depends on 14)

The catheter of claim 14, wherein the at least two elongate structures are wires.

### Claim 16 (depends on 14)

The catheter of claim 14, wherein a cross-section of an elongate structure of the at least two elongate structures is at least 50% of the cross-section of the injector tube lumen.

### Claim 17 (depends on 14)

The catheter of claim 14, wherein the at least two elongate structures extend the full length of the catheter.