Intravascular fluid catheter with minimal internal fluid volume

• US 10,576,246 B2
• Filed: 08/22/2012
• Issued: 03/03/2020
• Est. Priority Date: 08/24/2011
• Status: Active Grant

• Current Assignee: Ablative Solutions, Inc.
• Original Assignee: Ablative Solutions, Inc.
• Inventors: Fischell, David R., Fischell, Tim A.
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US13/643,065
• Publication Number:
  US 20140358079A1
• Time in Patent Office: 2,750 Days
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 2562/0209 Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61B 5/6876 Blood vessel
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: 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
• CPC Class Codes: A61M 2025/0087 Multiple injection needles protruding laterally from the distal tip
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2202/0468 non-physiological
• CPC Class Codes: A61M 2210/12 Blood circulatory system
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

A catheter-based/intravascular ablation (denervation) system 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 or/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 needle delivery system is formed with self-expanding materials and include structures, near the end portion of the needles, or using separate guide tubes. 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. The preferred embodiment of the catheter delivered through the vascular system of a patient includes a multiplicity of expandable guide tubes that engage the wall of a blood vessel. Injection needles having injection egress at or near their sharpened distal end are then advanced through the guide tubes to penetrate the wall of the blood vessel to a prescribed depth. The ability to provide PeriVascular injection so as to only affect the outer layer(s) of a blood vessel without affecting the media has particular application for PeriVascular Renal Denervation (PVRD) of the sympathetic nerves which lie in the adventitia or outside the adventitia of the renal artery.

Claims

1. A percutaneously deliverable system for peri-vascular fluid delivery comprising:

a fluid delivery catheter having a proximal control portion, a central catheter body, and a distal fluid delivery portion,

wherein the distal fluid delivery portion includes two or more guide tubes adapted to advance simultaneously, each guide tube having a distal end and a lumen, wherein distal movement of the two or more guide tubes causes the two or more guide tubes to curve outward toward a target vessel wall but not penetrate the target vessel wall, the distal fluid delivery portion includes two or more injection needles, each injection needle having an injection needle lumen and an outlet, each injection needle adapted to move distally and proximally relative to and within a lumen of a respective guide tube of the two or more guide tubes, the two or more injection needles further adapted to move distally outward to penetrate the target vessel wall, each injection needle adapted to extend beyond the respective guide tube of the two of more guide tubes until further extension is prevented such that each injection needle extends beyond the respective guide tube up to a maximum distance;

wherein the proximal control portion includes a proximal port for injection of fluids;

wherein the central catheter body includes an injection lumen that provides fluid communication between the proximal port for injection of fluids and the injection needle lumens of the injection needles;

wherein the fluid delivery catheter further includes an internal fluid volume extending from a proximal end of the proximal port of the proximal control portion to the outlets of the injection needles, the internal fluid volume being less than 0.5 ml.

2. The system of claim 1, wherein the internal fluid volume of the fluid delivery catheter is less than 0.2 ml.

3. The system of claim 1, wherein the internal fluid volume of the fluid delivery catheter is less than 0.1 ml.

4. The system of claim 1, wherein at least one of the injection needle lumens of the injection needles comprises a volume occupying structure.

5. The system of claim 4, wherein the volume occupying structure comprises a wire configured to reduce the internal fluid volume.

6. The system of claim 5, wherein the wire is formed from a radiopaque material to enhance visualization of at least one of the injection needles under fluoroscopy.

7. The system of claim 1, wherein the two or more injection needles comprise at least three injection needles providing circumferential delivery via their outlets.

8. The system of claim 1, wherein said fluid delivery catheter includes a fixed guide wire.

9. The system of claim 1, wherein the system is configured to be advanced coaxially over a separate guide wire.

10. The system of claim 1, wherein each outlet is near a distal end of the respective injection needle of the two or more injection needles.

11. The system of claim 1, wherein the distal fluid delivery portion is a distal expanding portion.

12. The system of claim 1, further including a sheath that allows the distal fluid delivery portion to move outward when the sheath is retracted to a proximal open position.

13. The system of claim 12, wherein the sheath has a distal closed position, wherein the sheath extends in a distal direction so as to completely cover the outlets in the distal closed position.

14. The system of claim 1, further including a sheath that includes a radiopaque marker.

15. The system of claim 1, wherein a portion of the distal fluid delivery portion is formed from NITINOL.

16. A system for fluid delivery comprising:

a fluid delivery catheter having a proximal portion, a central catheter body, and a distal fluid delivery portion,

wherein the distal fluid delivery portion includes two or more guide tubes adapted to advance simultaneously, wherein distal movement of the two or more guide tubes causes the two or more guide tubes to curve outward toward a target vessel wall but not penetrate the target vessel wall, wherein each guide tube has a distal end and a lumen, wherein the distal fluid delivery portion includes two or more injection needles, wherein each injection needle has an injection needle lumen and an outlet, each injection needle adapted to move distally and proximally relative to and within a lumen of a respective guide tube of the two or more guide tubes, wherein the two or more injection needles are adapted to move radially outward to penetrate the target vessel wall, each injection needle adapted to advance beyond the distal end of the respective guide tube of the two or more guide tubes until further advancement is prevented such that each injection needle extends beyond the respective guide tube up to a maximum distance;

wherein the proximal portion includes a port;

wherein the central catheter body includes an injection lumen that provides fluid communication between the port and each injection needle lumen of the two injection needles.