Peri-vascular tissue ablation catheter with support structures

• US 10,350,392 B2
• Filed: 12/19/2016
• Issued: 07/16/2019
• Est. Priority Date: 10/29/2012
• Status: Active Grant

• Current Assignee: Ablative Solutions, Inc.
• Original Assignee: Ablative Solutions, Inc.
• Inventors: Fischell, David R., Fischell, Tim A., Ragland, Robert Ryan, Kent, Darrin James, Denison, Andy Edward, Johnson, Eric Thomas, Burke, Jeff Alan, Hayden, Christopher Scott, Fischell, Robert E.
• Primary Examiner(s): Hayman, Imani N
• Application Number:
  US15/383,528
• Publication Number:
  US 20170304594A1
• Time in Patent Office: 939 Days
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 18/04 by heating by applying electromagnetic radiation A61B18/18; hyperthermia using electric or magnetic fields, radiation or ultrasound A61N
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00279 deployable
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00517 Urinary bladder or urethra
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61M 2005/1585 Needle inserters
• CPC Class Codes: A61M 2025/0087 Multiple injection needles protruding laterally from the distal tip
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body

Abstract

An intravascular catheter for peri-vascular 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, such as nerve fibers in the outer layer or deep to the outer layer of the vessel, or in prostatic tissue. The system may also control 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 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.

Claims

1. A catheter comprising:

a catheter body having a central axis extending in a longitudinal direction and a fluid injection lumen;

at least two needle guiding elements adapted to advance outwardly toward an interior wall of a target vessel;

a control mechanism adapted to control the outward advancement of the at least two needle guiding elements without inflating a balloon;

at least two injection needles, each injection needle having an injection lumen in fluid communication with the fluid injection lumen of the catheter body, the at least two injection needles adapted to be advanced outwardly, guided by at least two needle guiding elements, to penetrate the interior wall of the target vessel, each injection needle having a distal opening for fluid delivery; and

an injection needle control mechanism adapted to control the outward advancement of the at least two injection needles beyond the distal ends of the at least two needle guiding elements.

2. The catheter of claim 1, wherein the at least two needle guiding elements are adapted to advance outwardly toward the interior wall of the target vessel when the control mechanism is moved between a distal position and a proximal position.

3. The catheter of claim 1, wherein the at least two injection needles are adapted to advance outwardly to penetrate the interior wall of the target vessel when the injection needle control mechanism is moved between a distal position and a proximal position.

4. The catheter of claim 1, further comprising a support structure adapted to provide support for the at least two needle guiding elements.

5. The catheter of claim 1, wherein the at least two injection needles are movable between an open and a fully closed configuration, the fully closed configuration having the at least two injection needles being withdrawn into the at least two needle guiding elements and the at least two needle guiding elements withdrawn into the catheter body.

6. A catheter comprising:

a catheter body having a central axis extending in a longitudinal direction and a fluid injection lumen;

at least two needle guiding elements disposed within the catheter body and adapted to advance outwardly from the catheter body toward an interior wall of a target vessel, wherein ends of at least two needle guiding elements return to a curved shape when unconstrained from the catheter body;

a support structure disposed within the catheter body and adapted to support each needle guiding element as the at least two needle guiding elements advance outwardly from the catheter body toward the interior wall of the target vessel;

at least two injection needles, each injection needle having an injection lumen in fluid communication with the fluid injection lumen of the catheter body, the at least two injection needles adapted to be advanced outwardly, guided by the at least two needle guiding elements to penetrate the interior wall of the target vessel, each injection needle having a distal opening for fluid delivery.

7. The catheter of claim 6, wherein the support structure is a central buttress support.

8. The catheter of claim 6, the support structure having a distal opening through which at least one of the needle guiding elements is advanced.

9. The catheter of claim 6, comprising at least three needle guiding elements and at least three injection needles.

10. The catheter of claim 6, wherein at least one needle guiding element has a curved distal portion with a first radius of curvature and at least one injection needle has a curved distal portion with a second radius of curvature, the first radius of curvature and second radius of curvature being preset to within 25 percent of each other.

11. The catheter of claim 6, further comprising a fixed distal guide wire.

12. The catheter of claim 6, wherein the total internal volume or dead space from a proximal end to a distal end of an infusion flow path of the catheter is less than 0.3 ml.

13. The catheter of claim 6, further comprising a radiopaque marker attached to or within a portion of one or more of the structures selected from the group consisting of:

a) the injection needle, b) the needle guiding element, c) the catheter body, and d) the support structure.

14. The catheter of claim 6, further comprising a fluid injection port located near a proximal end of the catheter.

15. A catheter comprising:

a catheter body having a central axis extending in a longitudinal direction and a fluid injection lumen;

at least three needle guiding elements adapted to move toward an interior wall of a target vessel, wherein the at least three needle guiding elements are configured to center a portion of the catheter body; and

at least three injection needles guided by the at least three needle guiding elements toward the interior wall of the target vessel, wherein the at least three injection needles curve backward in a proximal direction as the at least three injection needles extend from distal ends of the at least three needle guiding elements, each injection needle having an injection lumen in fluid communication with the fluid injection lumen of the catheter body, the at least three injection needles are adapted to penetrate the interior wall of the target vessel and deliver a fluid.

16. The catheter of claim 15, wherein the at least three needle guiding elements are configured to rest against the interior wall of the target vessel.

17. The catheter of claim 15, wherein the at least three needle guiding elements have uniform spacing when the at least three needle guiding elements center the portion of the catheter body.

18. The catheter of claim 15, wherein the at least three needle guiding elements are configured for simultaneous movement.

19. The catheter of claim 15, wherein the at least three injection needles are configured for simultaneous movement.