Steerable guidewire and method of use

Patent metadata

Field	Value
Publication number	US-2017259041-A1
Application number	US-201715454924-A
Country	US
Kind code	A1
Filing date	Mar 9, 2017
Priority date	Mar 14, 2016
Publication date	Sep 14, 2017
Grant date	—

Abstract

This invention is a transvascularly placed steerable guidewire, further including internal steerability and the ability to articulate in a direction at right angles to its longitudinal axis at or near its distal end. The steerable guidewire is generally fabricated from stainless steel and includes an outer tube, an inner tube, hub structures, and a distal articulating region. The steerable guidewire can be advanced through a body lumen in its straight configuration and then be selectively articulated or curved to permit negotiation of tortuous curvature. The steerable guidewire hub can be removed to permit advancement of catheters over its proximal end followed by re-attachment of the hub to permit deflection of the distal end of the steerable guidewire. Removal of the hub can result in a limp guidewire or maintenance of a forced curvature of the distal end of the guidewire.

First claim

We claim:

1 . An apparatus adapted for steering a distal end of a guidewire configured for advancement into a mammalian body, the apparatus comprising:
an inner tube having a proximal end, a distal end, and a lumen within the inner tube that extends substantially the length of the inner tube; an outer tube having a proximal end, a distal end, a lumen within the outer tube that extends substantially the length of the outer tube, said outer tube comprising a bendable region defined by a plurality of substantially laterally oriented slots extending part way into the outer tube but not completely transecting the outer tube; wherein one or more longitudinal slits in the inner tube divide the inner tube into one or more longitudinally extending control rods, the one or more control rods being separated from each other within a region of the laterally oriented slots in the outer tube, the one or more control rods of the inner tube being affixed to the outer tube distal to the region of the laterally oriented slots in the outer tube; a hub affixed to the proximal end of the inner tube and comprising an internal lumen; a jack-screw traveler element affixed to the proximal end of the outer tube, wherein the jack-screw traveler element comprises a traveler thread, wherein the outer tube can be tensioned axially relative to the hub and the inner tube in response to movement of the jack-screw traveler element; wherein the internal lumen of the hub is capable of receiving the jack-screw traveler element and preventing the jack-screw traveler element from rotating about the longitudinal axis of the hub, and wherein the inner tube is constrained not to move relative to the hub; and a knob affixed to the hub, wherein the knob is capable of being rotated by a user, and wherein the knob comprises a knob thread such that the knob thread and the jackscrew traveler thread engage.

2 . The apparatus of claim 1 wherein the inner tube is a solid rod for at least a portion of its length.

3 . The apparatus of claim 1 wherein longitudinal movement of the outer tube relative to the inner tube causes distortion of the outer tube in a region of the laterally oriented slots and results in selective bending of the outer tube and inner tube in the region of the partially formed laterally oriented slots.

4 . The apparatus of claim 1 wherein the distal end the outer tube can controllably curve between about 0 degrees and at least about 180 degrees from the longitudinal axis of the outer tube.

5 . The apparatus of claim 1 wherein attachments of the inner tube and the outer tube to the hub and to the jack-screw traveler are reversed such that the inner tube moves relative to the hub and the outer tube is affixed to the hub.

6 . The apparatus of claim 1 wherein the hub is removable from a proximal end of the apparatus, and when the hub is removed from the proximal end of the apparatus, an outer diameter of the apparatus is approximately the same along a length of the apparatus.

7 . The apparatus of claim 1 further comprising features preventing axial or longitudinal motion of the inner tube and the outer tube upon removal of the hub.

8 . The apparatus of claim 10 wherein the features preventing axial or longitudinal motion comprise spring loaded pins that engage openings in a wall of the inner tube or a wall of the outer tube, or both.

9 . The apparatus of claim 10 wherein the features preventing axial or longitudinal motion comprise leaf springs integral with the inner tube that engage the proximal end of the outer tube.

10 . The apparatus of claim 1 further comprising a catheter configured to be routed alongside the guidewire by means of fasteners that open and close around the outer tube.

11 . The apparatus of claim 1 further comprising features that protrude from the inner tube, proximate a proximal end of the apparatus such that the hub can engage the features and lock thereto.

12 . The apparatus of claim 1 further comprising a removable obturator slidably disposed within the central lumen of the inner tube, wherein the obturator can be advanced forward out the distal end of the inner tube or it can be removed from the inner tube by withdrawal through the proximal end of the inner tube.

13 . The apparatus of claim 1 wherein the bendable portion of the outer tube comprises a plurality of approximately laterally oriented slots.

14 . The apparatus of claim 1 wherein the inner tube imparts off-center forces due to a discontinuity in a structure of the inner tube.

15 . The apparatus of claim 1 wherein the hub is capable of being removed and re-attached to a proximal end of the guidewire, further wherein following re-attachment of the hub, the guidewire deflection at its distal end can be controlled by the re-attached hub.

16 . The apparatus of claim 1 wherein the outer tube is a composite and comprises coils of wire along at least a portion of its length.

17 . The apparatus of claim 1 wherein the inner tube comprises a protrusion near its proximal end and the outer tube comprises a longitudinal slot having one or more cul-de-sacs wherein the protrusion on the inner tube can move longitudinally or axially within the longitudinal slot in the outer tube and rest within the one or more cul-de-sacs such that further longitudinal movement of the inner tube relative to the outer tube is prevented.

18 . A method of steering a guidewire into a body lumen, tissue, or cavity of mammalian body comprising the steps of:
inserting the guidewire into the body lumen, tissue, or cavity and routing the guidewire to a target site, wherein the guidewire is substantially straight and uncurved, wherein the guidewire comprises an inner tube formed into at least one control rod at its distal end, an outer tube, a bendable region near a distal end of the guidewire and a hub that comprises a control element at a proximal end on the guidewire; deflecting the bendable region near the distal end of the guidewire into a curve, wherein the deflecting step is performed by application of force by the control element on the proximal end of the guidewire; removing the hub of the guidewire; and advancing a catheter over the curved guidewire to the target site by way of a lumen in the catheter or dilator comprised by the catheter.

19 . The method of claim 18 wherein removal of the hub from the guidewire results in control forces being removed from the guidewire.

20 . The method of claim 18 wherein removal of the hub from the guidewire results in control forces being maintained within the guidewire such that the curve is approximately maintained.

21 . The method of claim 18 wherein a side of the catheter is releasably affixed to the guidewire and the catheter is slidably routed beside the guidewire to the target site.

22 . The method of claim 18 further comprising the step of locking the guidewire such that when the hub is removed, the curve of the guidewire is maintained.

Assignees

• Indian Wells Medical Inc

Inventors

• Lenker Jay A

Classifications

• A61M2025/09166

  having radio-opaque features · CPC title

• A61M25/09041 Primary

  Mechanisms for insertion of guide wires · CPC title

• A61M25/0662

  Guide tubes · CPC title

• A61M2025/09116

  Design of handles or shafts or gripping surfaces thereof for manipulating guide wires · CPC title

• A61M25/09025

  with sliding mandrils · CPC title