# US 10,945,787 B2 · Peri-vascular tissue ablation catheters

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- Number: US 10,945,787 B2
- Document ID: US10945787B2
- Status: Granted
- Kind: B2
- Application number: 15/947,619
- Filed: 2018-04-06
- Published: 2019-03-14
- Granted: 2021-03-16
- 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/US10945787B2

## CPC

- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- 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 5/3286: {Needle tip design, e.g. for improved penetration}
- 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 2018/00166: {Multiple lumina}
- 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 2205/192: Avoiding coring, e.g. preventing formation of particles during puncture
- A61M 2205/195: by the needle tip shape
- 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 tissue outside of an interior wall of a target vessel of a human body comprising:
a catheter body having a central axis extending in a longitudinal direction and also having a fluid injection lumen;
a needle guiding element adapted to expand outwardly toward the interior wall of the target vessel;
an injector tube having an injector tube lumen, the injector tube comprising a longitudinal axis extending along an outer cylindrical surface of the injector tube, the injector tube further connected to a distal sharpened needle, the injector tube lumen being in fluid communication with the fluid injection lumen of the catheter body, the injector tube adapted to be advanced outwardly, guided by the needle guiding element, wherein the needle guiding element defines a curved trajectory for the injector tube with the distal sharpened needle, the distal sharpened needle having a distal opening for fluid delivery into the tissue outside of the interior wall of the target vessel,
the distal sharpened needle further being a non-coring needle having a curved shape where a proximal end of the curve begins on a first point on the outer cylindrical surface of the injector tube and a distal sharpened needle point lies on the longitudinal axis extending along the outer cylindrical surface of the injector tube, wherein lateral sides extending from the distal sharpened needle point are concave relative to the longitudinal axis, the injector tube with the distal sharpened needle being flimsy and needing radial and lateral support provided by the needle guiding element.

### Claim 2 (depends on 1)

The catheter of claim 1, further including a ground heel of the distal sharpened needle at the proximal end of the curve.

### Claim 3 (depends on 1)

The catheter of claim 1, further including two or more needle guiding elements.

### Claim 4 (depends on 1)

The catheter of claim 1, further including three needle guiding elements.

### Claim 5 (depends on 1)

The catheter of claim 1, further including a wire located inside the injector tube lumen of the injector tube.

### Claim 6 (depends on 1)

The catheter of claim 1, wherein the distal sharpened needle point is linearly aligned with the outer cylindrical surface of the injector tube.

### Claim 7 (depends on 1)

The catheter of claim 1, further include two sharpened edges extending from the distal sharpened needle point.

### Claim 8 (depends on 7)

The catheter of claim 7, wherein the two sharpened edges are separated by a chamfered surface.

### Claim 9 (depends on 7)

The catheter of claim 7, wherein the two sharpened edges at least partially surround the distal opening for fluid delivery.

### Claim 10

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 central axis extending in a longitudinal direction and also having a fluid injection lumen;
a needle guiding element adapted to expand outwardly toward the interior wall of the target vessel;
an injector tube having an injector tube lumen, the injector tube formed with a distal sharpened non-coring needle, the injector tube lumen being in fluid communication with the fluid injection lumen of the catheter body, the injector tube adapted to be advanced outwardly, guided by the needle guiding element, wherein the needle guiding element defines a curved trajectory for the injector tube with the distal sharpened non-coring needle, the distal sharpened non-coring needle having a distal opening for fluid delivery into the tissue outside of the interior wall of the target vessel;
the distal sharpened non-coring needle further having a sharpened needle tip that is the first surface to penetrate tissue, the sharpened needle tip formed in a curve that positions the sharpened needle tip to be aligned with an axis extending along the outer surface of the injector tube in the distal direction, the distal sharpened non-coring needle comprising lateral curved sides that curve inward from the axis, the injector tube with the distal sharpened non-coring needle being flimsy and needing radial and lateral support provided by the needle guiding element.

### Claim 11 (depends on 10)

The catheter of claim 10, further including a radiopaque wire located inside the injector tube lumen.

### Claim 12 (depends on 10)

The catheter of claim 10, further including a chamfered heel diametrically opposed from the sharpened needle tip.

### Claim 13 (depends on 10)

The catheter of claim 10, further including two or more needle guiding elements.

### Claim 14

A catheter for fluid delivery into tissue outside of the interior wall of a target vessel of a human body comprising:
a catheter body having a central axis extending in a longitudinal direction and also having a fluid injection lumen;
at least one needle guiding element adapted to expand outwardly toward the interior wall of the target vessel;
at least one injector tube having an injector tube lumen, the at least one injector tube including a distal sharpened non-coring needle, the injector tube lumen being in fluid communication with the fluid injection lumen of the catheter body, the at least one injector tube adapted to be advanced outwardly, guided by the at least one needle guiding element, wherein the at least one needle guiding element defines a curved trajectory for the at least one injector tube with the distal sharpened non-coring needle, the at least one distal sharpened non-coring needle having a distal opening for fluid delivery into the tissue outside of the interior wall of the target vessel;
the distal sharpened non-coring needle further having a needle tip surrounding the distal opening, the needle tip having a sharpened distal ridge, two lateral sides extending from the sharpened distal ridge and formed in a curve, and a chamfer at a heel extending between the two lateral sides, wherein the sharpened distal ridge extends along an axis that lies along the length of the injector tube and the two lateral sides curve away from the axis, the at least one injector tube with the distal sharpened non-coring needle being flimsy and needing radial and lateral support provided by the at least one needle guiding element.

### Claim 15 (depends on 14)

The catheter of claim 14, further including a radiopaque wire located inside the injector tube lumen.

### Claim 16 (depends on 14)

The catheter of claim 14, where the two lateral sides are substantially symmetrical about the distal opening.

### Claim 17 (depends on 14)

The catheter of claim 14, where the two lateral sides are sharpened.

### Claim 18 (depends on 14)

The catheter of claim 14, where the two lateral sides are configured to facilitate entry.

### Claim 19 (depends on 14)

The catheter of claim 14, where the two lateral sides and the chamfer at the heel form an edge of the distal opening.

### Claim 20 (depends on 14)

The catheter of claim 14, where the two lateral sides form a concave shape.