Expandable catheter system for fluid injection into and deep to the wall of a blood vessel

• US 10,118,004 B2
• Filed: 06/12/2015
• Issued: 11/06/2018
• 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): Bosques, Edelmira
• Application Number:
  US14/738,776
• Publication Number:
  US 20150343156A1
• Time in Patent Office: 1,243 Days
• Field of Search: 604507
• CPC Class Codes: A61B 5/6848 Needles
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2025/0085 Multiple injection needles protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• 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 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2205/0266 Shape memory materials
• CPC Class Codes: A61M 2210/12 Blood circulatory system
• CPC Class Codes: 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
• 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 25/0662 Guide tubes
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

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

1. 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 extending in a longitudinal direction and a fluid injection lumen;

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 expandable 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 tube, each injector tube having an injection lumen for delivering the ablative fluid, the first and second injector tubes located coaxially inside of the first and second guide tubes respectively, each injector tube having a sharpened injection needle, each injection needle having injection egress, 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 tube and the second injector tube are advanced into the volume of tissue; and

wherein the first injector tube and the second injector tube are configured to advance simultaneously relative to the first guide tube and the second guide tube, respectively, until a penetration depth limitation mechanism stops forward movement of the first injector tube and the second injector tube.

2. The system of claim 1 where a proximal section of the intravascular nerve ablation system includes a port in fluid communication with the injection lumens of the first and second injector tubes.

3. The system of claim 1 where the depth of penetration is preset during manufacturing.

4. The system of claim 1 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 injector tubes.

5. The system of claim 1 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.

6. 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 extending in a longitudinal direction and a fluid injection lumen;

a first guide tube having a first distal end and a central lumen, the first guide tube having a distal portion adapted to expand outward;

a first injector tube having an injection lumen in fluid communication with the fluid injection lumen of the catheter body, a portion of the first injector tube located coaxially inside of the first guide tube, the first injector tube having a first sharpened injection needle, the first injection needle having a first injection egress, the first injector tube 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 expand outward;

a second injector tube having an injection lumen in fluid communication with the fluid injection lumen of the catheter body, a portion of the second injector tube located coaxially inside of the second guide tube, the second injector tube having a second sharpened injection needle, the second injection needle having a second injection egress, the second injector tube being adapted to slide in the distal and proximal directions within the second guide tube; and

wherein the first distal end of the first guide tube and the second distal end of the second guide tube are configured to advance simultaneously to rest against the vessel wall of the target vessel without penetrating the vessel wall of the target vessel;

wherein the first injector tube and the second injector tube are configured to advance simultaneously 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 wherein a penetration depth limitation mechanism is configured to simultaneously limit the depth of penetration of the first injection needle and the second injection needle into the vessel wall of the target vessel.

7. The system of claim 6 where the penetration depth limitation mechanism is configured to be adjusted by the user to increase or decrease the depth of penetration.

8. The system of claim 7 where the intravascular nerve ablation system includes a scale to facilitate adjusting the penetration depth limitation mechanism.

9. The system of claim 6 where the penetration depth limitation mechanism is configured to be accessible to the user.

10. The system of claim 6 where the handle includes a port in fluid communication with the injection lumens of the first and second injector tubes.

11. The system of claim 6 where the depth of penetration is preset during manufacturing.

12. 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 extending in a longitudinal direction and a fluid injection lumen;

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 expand outward such that a first distal surface of the first guide tube comprises a blunt distal tip;

a first injector tube having a first injection lumen in fluid communication with the fluid injection lumen of the catheter body, a portion of the first injector tube located coaxially inside of the first guide tube, a first injection needle having a first injection egress, the first injector tube 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 second central lumen, the second guide tube having a second distal portion adapted to expand 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 tube having a second injection lumen in fluid communication with the fluid injection lumen of the catheter body, a portion of the second injector tube located coaxially inside of the second guide tube, a second injection needle having a second injection egress, the second injector tube being adapted to slide in the distal and proximal directions within the second guide tube; and

wherein the first injector tube and the second injector tube are configured to advance simultaneously 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 wherein a penetration depth limitation mechanism limits the advancement of the first injection needle and the second injection needle.

13. The system of claim 12 where the penetration depth limitation mechanism is configured to be adjusted by the user to increase or decrease the depth of penetration.

14. The system of claim 13 where the intravascular nerve ablation system includes a scale to facilitate adjusting the penetration depth limitation mechanism.

15. The system of claim 12 where the penetration depth limitation mechanism is configured to be accessible to the user.

16. The system of claim 12 where a proximal portion of the intravascular nerve ablation system includes a port in fluid communication with the injection lumens of the first injector tube and the second injector tube.

17. The system of claim 12 where the depth of penetration is preset during manufacturing.