Re-entry stylet for catheter

• US 10,335,173 B2
• Filed: 03/15/2013
• Issued: 07/02/2019
• Est. Priority Date: 09/06/2012
• Status: Active Grant

• Current Assignee: Avinger Inc.
• Original Assignee: Avinger Inc.
• Inventors: Simpson, John B., Fabro, Myra L., Sucgang, Eduardo, Gupta, Priyanshu, Ketai, Theodore W.
• Primary Examiner(s): Bosques, Edelmira
• Application Number:
  US14/424,266
• Publication Number:
  US 20150320975A1
• Time in Patent Office: 2,300 Days
• Field of Search: 604510
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61M 2025/0197 for creating an artificial passage within the body, e.g. in order to go around occlusions
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/0194 Tunnelling catheters

Abstract

A stylet for re-entry into a vessel includes an elongate body including a proximal portion, a middle curved portion, a pointed distal end, and a longitudinal axis extending through the proximal portion, the middle curved portion, and the pointed distal end. The proximal portion and the middle curved portion have substantially circular cross-sections. The middle curved portion has a pre-shaped curve along the longitudinal axis configured to match a curve of an occlusion-crossing device. The pointed distal end has an s-curve along the longitudinal axis and a flattened portion along the longitudinal axis, the flattened portion having a substantially oblong cross-section.

Claims

1. A stylet for re-entry into a vessel comprising:

an elongate body having a proximal portion, a middle curved portion, a pointed distal end, and a longitudinal axis extending through the proximal portion, the middle curved portion, and the pointed distal end;

wherein the proximal portion and the middle curved portion have substantially circular cross-sections, and wherein the middle curved portion has a pre-shaped curve along the longitudinal axis configured to match a curve of an occlusion-crossing device;

wherein the pointed distal end has an s-shaped curve along the longitudinal axis and a flattened portion along the longitudinal axis, the flattened portion having a substantially oblong cross-section; and

wherein the flattened portion tapers to a sharp tip at the pointed distal end.

2. The stylet of claim 1, wherein the s-shaped curve is within the flattened portion.

3. The stylet of claim 1, wherein at least one of the distal end or the middle curved portion comprises nitinol.

4. The stylet of claim 1, wherein the proximal portion comprises stainless steel.

5. The stylet of claim 1, wherein the pre-shaped curve forms an angle of 130 to 170 degrees.

6. The stylet of claim 5, wherein the angle is approximately 150 degrees.

7. The stylet of claim 1, wherein the s-shaped curve has two curves, the first curve forming a first angle of 120 to 160 degrees and the second curve forming an angle of 120 to 160 degrees.

8. The stylet of claim 1, wherein the s-shaped curve has a first curve and a second curve, the second curve distal to the first curve, and wherein the pre-shaped curve is aligned in substantially the same direction as the second curve.

9. The stylet of claim 1, wherein the pointed distal end includes an anchor.

10. The stylet of claim 1, wherein the pointed distal end is configured to penetrate a vessel wall.

11. The stylet of claim 1, wherein the pointed distal end has the s-shaped curve when deployed from the occlusion-crossing device.

12. A method of re-entering a true lumen during occlusion-crossing comprising:

orienting a distal end of a catheter having a bend therein towards the true lumen of a vessel;

introducing a stylet through a guidewire channel of the catheter, the stylet comprising;

an elongate body having a proximal portion, a middle curved portion, a pointed distal end, and a longitudinal axis extending through the proximal portion, the middle curved portion, and the pointed distal end,

wherein the proximal portion and the middle curved portion have substantially circular cross-sections, and wherein the middle curved portion has a pre-shaped curve along the longitudinal axis configured to match a curve of an occlusion-crossing device,

wherein the pointed distal end has an s-shaped curve along the longitudinal axis and a flattened portion along the longitudinal axis, the flattened portion having a substantially oblong cross-section,

wherein the flattened portion tapers to a sharp tip at the pointed distal end, and

wherein inserting the stylet comprises inserting until the curved middle portion of the stylet aligns with the bend in the catheter and the pointed distal end of the stylet extends out of a distal end of the catheter; and

advancing the stylet such that the pointed distal end pierces through a wall of the vessel; and

directing the catheter over the stylet and into the true lumen of the vessel.

13. The method of claim 12, further comprising orienting the stylet within the catheter such that the pointed distal end of the stylet curves towards the vessel wall before advancing the stylet.

14. The method of claim 12, further comprising reorienting the catheter within the true lumen after directing the catheter over the stylet.

15. The method of claim 12, wherein reorienting the catheter comprises reorienting without puncturing an opposite vessel wall.

16. The method of claim 12, further comprising determining an orientation of the stylet based upon an alignment of the curved middle portion with the bend in the catheter.

17. The method of claim 12, further comprising using image guidance to orient the catheter.