Peri-vascular tissue ablation catheter with support structures

• US 9,526,827 B2
• Filed: 04/30/2014
• Issued: 12/27/2016
• 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:
  US14/266,726
• Publication Number:
  US 20140236103A1
• Time in Patent Office: 972 Days
• US Class Current: 1/1
• 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 include a controls 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 and/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 for fluid delivery, the catheter including:

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

a tubular member having a distal position and a proximal position;

at least two self-expanding guide tubes adapted to expand outwardly toward a luminal surface of a target vessel when the tubular member is moved between the distal position and the proximal position;

a handle located near a proximal end of the catheter, the handle adapted to move the tubular member in the longitudinal direction;

at least two injector tubes with distal injection needles, each of the at least two injector tubes with distal injection needles having an injection lumen in fluid communication with the fluid injection lumen of the catheter body, the at least two injector tubes with distal injection needles adapted to be advanced outwardly, guided by the at least two self-expanding guide tubes to penetrate the luminal surface of the target vessel, each of the at least two injector tubes with distal injection needles having a distal opening adapted for fluid delivery into a tissue outside of the luminal surface of the target vessel; and

a mechanical support structure, the mechanical support structure is adapted to provide support for the at least two self-expanding guide tubes in a direction selected from the group consisting of a) radial, in which the mechanical support structure is adapted to support each guide tube of the at least two guide tubes in a radial direction, and b) lateral, in which the mechanical support structure is adapted to support each guide tube of the at least two guide tubes in a lateral direction.

2. The catheter of claim 1, wherein the mechanical support structure includes an obturator movable in the longitudinal direction.

3. The catheter of claim 1, wherein the mechanical support structure includes an intraluminal centering mechanism.

4. The catheter of claim 1, wherein the catheter includes at least three self-expanding guide tubes and at least three injector tubes with distal injection needles with each injection needle having a sharpened distal end.

5. The catheter of claim 1, wherein the at least two self-expanding guide tubes have a curved distal portion with a first radius of curvature and the at least two injector tubes with distal injection needles have 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.

6. The catheter of claim 1, further including a fixed distal guide wire.

7. The catheter of claim 1, wherein the total internal volume or dead space from a proximal part to a distal end of an infusion flow path of the catheter is less than 0.3 ml.

8. The catheter of claim 1, further including radiopaque markers operably connected to a portion of one or more of the structures selected from the group consisting of:

a) the at least two injector tubes with distal injection needles, b) the at least two self-expanding guide tubes, c) the mechanical support structure, and d) the catheter body.

9. The catheter of claim 1, further including a single fluid injection port located near the proximal end of the catheter, the single fluid injection port being in fluid communication with the fluid injection lumen of the catheter body.

10. The catheter of claim 1, wherein distal ends of the at least two injector tubes with distal injection needles are movable between an open and a fully closed configuration, the fully closed configuration having the distal ends being withdrawn into the at least two self-expanding guide tubes and the at least two self-expanding guide tubes withdrawn into the catheter body, the fully closed position disallowing needlestick injuries from the distal ends of the at least two injector tubes with distal injection needles.

11. The catheter of claim 1, wherein the mechanical support structure is a central buttress support located internal to a distal portion of the catheter body.

12. The catheter of claim 1, including three self-expanding guide tubes, three injection needles, and three injector tubes, a distal end of each injector tube coupled to one of the injection needles.

13. The catheter of claim 1, further including a tubular shaft located within a distal portion of the catheter body, the tubular shaft having a distal opening through which one of the at least two self-expanding guide tubes is adapted to be advanced.

14. The catheter of claim 13, wherein the catheter is transformable from an open position to a closed position, wherein distal ends of the at least two injector tubes with distal injection needles are withdrawn into the at least two self-expanding guide tubes and the at least two self-expanding guide tubes are withdrawn into the tubular shaft, wherein the closed position is adapted to prevent needlestick injuries from the distal ends of the at least two injector tubes with distal injection needles.

15. The catheter of claim 1, wherein the mechanical support structure is coupled to a longitudinally movable mechanism.

16. The catheter of claim 1, wherein the longitudinally movable mechanism is an obturator.

17. The catheter of claim 1, further comprising a control mechanism adapted to control the movement and outward expansion of the at least two self-expanding guide tubes.

18. The catheter of claim 1, further including an injection port located near the proximal end of the catheter, the fluid injection port having a non-standard connector that is a different from any other fitting on the handle of the catheter.

19. The catheter of claim 18, further including a custom syringe having a distal end adapted to mate with the non-standard connector.