Catheter systems and packaged kits for dual layer guide tubes

• US 10,485,951 B2
• Filed: 03/09/2018
• Issued: 11/26/2019
• 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:
  US15/917,532
• Publication Number:
  US 20180193596A1
• Time in Patent Office: 627 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 packaged catheter, the catheter for placement into a vessel of a human body, the packaged catheter including:

a tubular member with distal and proximal ends;

at least one needle adapted to penetrate through a wall of the vessel;

at least one needle guiding element, wherein a respective needle of the at least one needle is disposed within a respective needle guiding element of the at least one needle guiding element, wherein the respective needle is movable relative to the respective needle guiding element, wherein the at least one needle guiding element is movable between a closed configuration and an open configuration, wherein the at least one needle guiding element is configured to be constrained within the tubular member in the closed configuration, wherein the at least one needle guiding element is adapted to extend outward from the tubular member in the open configuration; and

a sterile package containing the tubular member, the at least one needle, and the at least one needle guiding element in the open configuration.

2. The packaged catheter of claim 1, wherein the at least one needle guiding element comprises plastic.

3. The packaged catheter of claim 1, further including a radiopaque marker.

4. The packaged catheter of claim 1, wherein the at least one needle guiding element includes an inner layer and an outer layer.

5. The packaged catheter of claim 4, wherein the inner layer and the outer layer comprise different plastics.

6. The packaged catheter of claim 1, wherein a distal portion of the at least one needle guiding element is in line with a longitudinal axis of the tubular member in the closed configuration.

7. The packaged catheter of claim 1, wherein the open configuration allows the at least one needle to extend outwardly from the at least one needle guiding element, for injection of an ablative fluid.

8. The packaged catheter of claim 1, where the at least one needle guiding element and the at least one needle are retracted within the tubular member in the closed configuration for delivery into the human body.

9. The packaged catheter of claim 1, further including a handle adapted to move the at least one needle out of the at least one needle guiding element.

10. The packaged catheter of claim 1, wherein an injection volume of fluid of the catheter is less than 1 ml.

11. The packaged catheter of claim 10, wherein the fluid comprises an alcohol.

12. The packaged catheter of claim 1, wherein the at least one needle guiding element is straight in the closed configuration.

13. The packaged catheter of claim 1, further including a radiopaque marker near a distal end of the at least one needle guiding element.

14. The packaged catheter of claim 1, wherein an internal fluid volume of the catheter is less than 1 ml.

15. The packaged catheter of claim 1, wherein the at least one needle guiding elements comprises at least two needle guiding elements and wherein the at least one needle comprises at least two needles.

16. A packaged catheter, including:

a tubular member;

at least two needles;

at least two needle guiding elements, wherein each needle is disposed within a respective needle guiding element, wherein each needle is movable relative to the respective needle guiding element to extend from the respective needle guiding element, wherein the at least two needle guiding elements are movable between a closed configuration and an open configuration, wherein the at least two needle guiding elements are within the tubular member in the closed configuration, wherein the at least two needle guiding elements extend outward from the tubular member in the open configuration; and

a sterile package containing the tubular member, the at least two needles, and the at least two needle guiding elements in the open configuration.

17. A packaged catheter, including:

a tubular member;

at least one needle comprising a shape memory material;

at least one needle guiding element comprising a pre-formed curved shape, wherein a respective needle of the at least one needle is disposed within a respective needle guiding element of the least one needle guiding element, wherein the respective needle is movable relative to the respective needle guiding element, wherein the at least one needle guiding element is movable between a closed configuration and an open configuration, wherein the at least one needle guiding element is within the tubular member in the closed configuration, wherein the at least one needle guiding element extends outward from the tubular member in the open configuration; and

a sterile package containing the tubular member, the at least one needle, and the at least one needle guiding element in the open configuration.