Magnetically Trackable Stylets and Methods Thereof

Patent metadata

Field	Value
Publication number	US-2022347433-A1
Application number	US-202217731169-A
Country	US
Kind code	A1
Filing date	Apr 27, 2022
Priority date	Apr 28, 2021
Publication date	Nov 3, 2022
Grant date	—

Abstract

Disclosed herein are magnetically trackable stylets and methods thereof. A magnetically trackable stylet can include a stylet body including a core wire, a magnetic assembly, and an outer construction over the core wire and the magnetic assembly. The magnetic assembly can include one or more magnetic field-producing elements disposed alongside the core wire in a magnetically trackable distal portion of the stylet body. The outer construction, which can be an overmolded layer, a reflowed layer, a potting layer, or a shrink-wrapped layer, can be around the core wire and the magnetic assembly. The stylet body can be configured to be disposed in a lumen of a medical device such as a catheter for magnetically tracking a tip of the medical device in vivo without breakage of the stylet body due to bending-related fatigue. A method of such a magnetically trackable stylet can include a method of using the stylet.

First claim

1 . A magnetically trackable stylet, comprising:
a stylet body having a magnetically trackable distal portion, the stylet body including:
a core wire;
a flexible magnetic assembly including one or more magnetic field-producing elements disposed alongside the core wire in the distal portion of the stylet body; and
a casing around the core wire and the magnetic assembly, the stylet body configured to be disposed in a lumen of a catheter for magnetically tracking a catheter tip in vivo without breakage of the stylet body due to bending-related fatigue.

2 . The stylet of claim 1 , wherein the core wire is tapered in the distal portion of the stylet body alongside the one-or-more magnetic field-producing elements.

3 . The stylet of claim 1 , further comprising a sealed stylet tip, the stylet tip including a seal sealing the one-or-more magnetic field-producing elements in the distal portion of the stylet body.

4 . The stylet of claim 1 , wherein the one-or-more magnetic field-producing elements include one or more polymer-bonded magnets, the one-or-more polymer-bonded magnets configured to bend and, thereby, allow the stylet to bend in accordance with an anatomy of a patient without breaking.

5 . The stylet of claim 4 , wherein the one-or-more polymer-bonded magnets include a single cylindrical polymer-bonded magnet.

6 . The stylet of claim 4 , wherein the one-or-more polymer-bonded magnets include a plurality of cylindrical polymer-bonded magnets.

7 . The stylet of claim 1 , wherein the one-or-more magnetic field-producing elements include one-or-more sintered magnets.

8 . The stylet of claim 7 , wherein the one-or-more sintered magnets include a plurality of cylindrical sintered magnets having radiused ends, the radiused ends of the cylindrical magnets configured to allow the cylindrical magnets to bend into each other and, thereby, allow the stylet to bend in accordance with an anatomy of a patient without breaking.

9 . The stylet of claim 7 , wherein the one-or-more sintered magnets include a plurality of cylindrical sintered magnets alternating with a plurality of spherical sintered magnets forming articulable joints therebetween, the joints configured to allow the cylindrical magnets to bend into each other and, thereby, allow the stylet to bend in accordance with an anatomy of a patient without breaking.

10 . The stylet of claim 7 , wherein the one-or-more sintered magnets include a plurality of cylindrical sintered magnets alternating with a plurality of non-metallic spheres forming articulable joints therebetween, the joints configured to allow the cylindrical magnets to bend into each other and, thereby, allow the stylet to bend in accordance with an anatomy of a patient without breaking.

11 . The stylet of claim 7 , wherein the one-or-more sintered magnets include a plurality of cylindrical sintered magnets alternating with a plurality of septa sectioning a groove of a magnet holder in which the sintered magnets are disposed, the septa forming articulable joints between the cylindrical magnets configured to allow the cylindrical magnets to bend into each other and, thereby, allow the stylet to bend in accordance with an anatomy of a patient without breaking.

12 . The stylet of claim 7 , wherein the one-or-more sintered magnets include a plurality of cylindrical sintered magnets disposed in a plurality of magnet holders forming articulable joints therebetween, the joints configured to allow the cylindrical magnets to bend into each other and, thereby, allow the stylet to bend in accordance with an anatomy of a patient without breaking.

13 . The stylet of claim 12 , wherein each magnet holder of the magnet holders includes a ball end and a socket end, the joints being ball-and-socket joints.

14 . The stylet of claim 12 , wherein the magnet holders include ball-ended magnet holders having a pair of ball ends and socket-ended magnet holders having a pair of socket ends, the joints being ball-and-socket joints.

15 . The stylet of claim 12 , wherein the magnet holders are links and the joints are interlinks between the links chained together.

16 . The stylet of claim 1 , wherein the one-or-more magnetic field-producing elements include one or more magnetic wires twisted or braided with the core wire, the one-or-more magnetic wires configured to bend and, thereby, allow the stylet to bend in accordance with an anatomy of a patient without breaking.

17 . A magnetically trackable stylet, comprising:
a stylet body having a magnetically trackable distal portion, the stylet body including:
a flexible magnetic assembly of one or more magnetic wires in the distal portion of the stylet body; and
a casing around the magnetic assembly, the stylet body configured to be disposed in a lumen of a catheter for magnetically tracking a catheter tip in vivo without breakage of the stylet body due to bending-related fatigue.

18 . The stylet of claim 17 , wherein the one-or-more magnetic wires include a single magnetic wire.

19 . The stylet of claim 18 , further comprising a core wire in the distal portion of the stylet body, the magnetic wire twisted with the core wire.

20 . The stylet of claim 18 , further comprising a core wire in the distal portion of the stylet body, the magnetic wire helically wrapped around the core wire.

21 . The stylet of claim 17 , wherein the one-or-more magnetic wires include a plurality of magnetic wires.

22 . The stylet of claim 21 , further comprising a core wire in the distal portion of the stylet body, the magnetic wires twisted or braided with the core wire.

23 . The stylet of claim 21 , further comprising: a core wire in the distal portion of the stylet body, the magnetic wires twisted or braided around the core wire.

24 . The stylet of claim 17 , further comprising a sealed stylet tip including a seal sealing the magnetic wires in the distal portion of the stylet body.

25 - 49 . (canceled)

Assignees

• Bard Access Systems Inc

Inventors

• Davis Michael
• Lackey Breanna E
• Bell Edward D
• Urry Robin Scott
• Blanchard Daniel B
• Isaacson Shawn Ray
• Vanderstek Bradley J
• Eley Taylor Matthew
• Russon Austin
• Tran Huy Ngoc

Classifications

• A61M2025/09133

  having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque · CPC title

• A61M25/0127 Primary

  Magnetic means; Magnetic markers · CPC title

• A61M25/0102

  Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod · CPC title

• A61B2034/2051

  Electromagnetic tracking systems · CPC title

• A61M2025/09191

  made of twisted wires · CPC title