# US 2019/0167918 A1 · Expandable catheter system for fluid injection into and deep to the wall of a blood vessel

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- Number: US 2019/0167918 A1
- Document ID: US20190167918A1
- Status: Published application
- Kind: A1
- Application number: 16/178,940
- Filed: 2018-11-02
- Published: 2019-06-06
- Earliest claimed: 2011-08-24
- Assignees: Ablative Solutions, Inc.
- Applicants: Ablative Solutions, Inc.
- Inventors: David R. Fischell; Tim A. Fischell
- Web page: https://patentgrep.com/patent/US20190167918A1

## CPC

- A61M 5/46: having means for controlling depth of insertion
- A61M 25/0026: {Multi-lumen catheters with stationary elements (catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175)}
- A61M 25/0084: {being one or more injection needles}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 25/0662: {Guide tubes}
- A61B 5/6848: {Needles}
- A61M 2025/0039: {characterized by lumina being arranged coaxially}
- A61M 2025/0085: {Multiple injection needles protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip}
- A61M 2025/0086: {the needles having bent tips, i.e. the needle distal tips are angled in relation to the longitudinal axis of the catheter}
- A61M 2025/0681: {Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube}
- A61M 2202/0007: introduced into the body
- A61M 2205/0266: Shape memory materials
- A61M 2210/12: Blood circulatory system
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A catheter-based/intravascular fluid injection system with application to renal denervation includes a multiplicity of needles which expand open around a central axis to engage the wall of a blood vessel, or the wall of the left atrium, allowing the injection of a cytotoxic and/or neurotoxic solution for ablating conducting tissue, or nerve fibers around the ostium of the pulmonary vein, or circumferentially in or just beyond the outer layer of the renal artery. The expandable delivery system includes expandable components that facilitate positioning of a multiplicity of injection needles against the inside wall of a blood vessel from where they can be advanced. The system also includes means to limit and/or adjust the depth of penetration of the ablative fluid into the tissue of the wall of the targeted blood vessel.

## Claims

### Claim at position 1

1-30. (canceled)

### Claim 31

An intravascular nerve ablation system for delivery of an ablative fluid to a volume of tissue in proximity to a vessel wall of a target vessel comprising:
a catheter body having a central axis;
at least a first guide tube and a second guide tube, each guide tube having a distal end and a central lumen, each guide tube having a distal portion that is movable between a first position aligned with the central axis and a second position inclined away from the central axis;
at least a first injector tube and a second injector, the first and second injector located coaxially inside of the first and second guide tubes respectively, wherein the distal ends of the first guide tube and the second guide tube are configured to press against, but not penetrate, the vessel wall of the target vessel as the first injector and the second injector are advanced into the volume of tissue; and
wherein the first injector and the second injector are configured to advance relative to the first guide tube and the second guide tube, respectively, until the first injector and the second injector are prevented from forward movement relative to the first guide tube and the second guide tube.

### Claim 32 (depends on 31)

The system of claim 31 where the first injector and the second injector are coupled for simultaneous movement.

### Claim 33 (depends on 31)

The system of claim 31 where a proximal section of the intravascular nerve ablation system includes a port in fluid communication with the first and second injectors.

### Claim 34 (depends on 31)

The system of claim 31 where the depth of penetration is preset during manufacturing.

### Claim 35 (depends on 31)

The system of claim 31 further including an injection handle located near a proximal section of the intravascular nerve ablation system, the injection handle further adapted to control the distal and proximal movement of the first and second injectors.

### Claim 36 (depends on 31)

The system of claim 31 further comprising a guide tube handle located near a proximal section of the intravascular nerve ablation system, the guide tube handle further adapted to control the distal and proximal movement of the first and second guide tubes.

### Claim 37

An intravascular nerve ablation system for delivery of an ablative fluid to a volume of tissue in proximity to a vessel wall of a target vessel comprising:
a catheter body having a central axis;
a first guide tube having a first distal end and a central lumen, the first guide tube having a distal portion adapted to move outward;
a first injector, a portion of the first injector located coaxially inside of the first guide tube, the first injector being adapted to slide in the distal and proximal directions within the first guide tube;
a second guide tube having a second distal end and a central lumen, the second guide tube having a distal portion adapted to move outward;
a second injector, a portion of the second injector located coaxially inside of the second guide tube, the second injector being adapted to slide in the distal and proximal directions within the second guide tube;
wherein the first distal end of the first guide tube and the second distal end of the second guide tube are configured to advance to rest against the vessel wall of the target vessel without penetrating the vessel wall of the target vessel;
wherein the first injector and the second injector are configured to advance beyond the first distal end of the first guide tube and the second distal end of the second guide tube, respectively, to penetrate the vessel wall of the target vessel until the depth of penetration of the first injector and the second injector into the vessel wall of the target vessel is limited.

### Claim 38 (depends on 37)

The system of claim 37 where the first injector and the second injector are coupled for simultaneous movement.

### Claim 39 (depends on 37)

The system of claim 37 where the depth of penetration can be adjusted by the user to increase or decrease the depth of penetration.

### Claim 40 (depends on 38)

The system of claim 38 where the intravascular nerve ablation system includes a scale to facilitate adjusting the depth of penetration.

### Claim 41 (depends on 37)

The system of claim 37 where the handle includes a port in fluid communication with the first and second injectors.

### Claim 42 (depends on 37)

The system of claim 37 where the depth of penetration is preset during manufacturing.

### Claim 43

An intravascular nerve ablation system for circumferential delivery of an ablative fluid to a volume of tissue in proximity to a vessel wall of a target vessel comprising:
a catheter body having a central axis;
a first guide tube having a first distal end and a first central lumen, the first guide tube having a first distal portion adapted to move outward such that a first distal surface of the first guide tube comprises a blunt distal tip;
a first injector, a portion of the first injector located coaxially inside of the first guide tube, the first injector being adapted to move in the distal and proximal directions within the first guide tube;
a second guide tube having a second distal end and a second central lumen, the second guide tube having a second distal portion adapted to move outward such that a second distal surface of the second guide tube comprises a blunt distal tip, and the first and second guide tubes are configured to not penetrate the vessel wall;
a second injector, a portion of the second injector located coaxially inside of the second guide tube, the second injector being adapted to move in the distal and proximal directions within the second guide tube; and
wherein the first injector and the second injector are configured to advance relative to the first distal end of the first guide tube and the second distal end of the second guide tube, respectively, to penetrate the vessel wall of the target vessel.

### Claim 44 (depends on 43)

The system of claim 43 where the first injector and the second injector are coupled for simultaneous movement.

### Claim 45 (depends on 43)

The system of claim 43 where the first guide tube and the second guide tube are coupled for simultaneous movement.

### Claim 46 (depends on 43)

The system of claim 43 where the depth of penetration can be adjusted by the user to increase or decrease the depth of penetration.

### Claim 47 (depends on 43)

The system of claim 43 where the intravascular nerve ablation system includes a scale to facilitate adjusting the depth of penetration.

### Claim 48 (depends on 43)

The system of claim 43 where a proximal portion of the intravascular nerve ablation system includes a port in fluid communication with the first injector and the second injector.

### Claim 49 (depends on 43)

The system of claim 43 where the depth of penetration is preset during manufacturing.
