SYSTEM AND METHOD FOR RE-ENTERING A VESSEL LUMEN

• US 20130006282A1
• Filed: 09/14/2011
• Published: 01/03/2013
• Est. Priority Date: 06/29/2011
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Wilkinson, Matthew
• Granted Patent: US 8,920,449 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• 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 17/3421 Cannulas
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22071 Steering
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61B 2017/3409 including needle or instrument drives
• CPC Class Codes: A61M 2025/0087 Multiple injection needles protruding laterally from the distal tip
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• 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 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: Y10T 29/49609 Spring making

Abstract

This disclosure is directed to systems and methods for re-entering the true lumen of a vessel. The re-entry catheters employ deflectable struts to stabilize and support the distal tip in a subintimal location while a passageway back into the true lumen is formed. Re-entry to the true lumen can be effected with a cutting element or with a conventional guidewire.

Claims

1. A re-entry catheter for facilitating formation of a passageway from a subintimal area to a lumen of a vessel, comprising an elongated outer tubular member having a distal end and a window adjacent the distal end, a plurality of deflectable struts arranged longitudinally within the window, and an actuating member coaxially disposed within the outer tubular member, wherein proximal ends of the deflectable struts are operatively connected to a distal end of the actuating member, such that axial motion of the actuating member relative to the outer tubular member deflects the struts radially outward.

2. The re-entry catheter of claim 1, further comprising a lateral port in the outer tubular member in a location opposing the window.

3. The re-entry catheter of claim 1, wherein the struts are formed from a nickel-titanium alloy.

4. The re-entry catheter of claim 1, wherein the outer tubular member has a circumference and wherein the window occupies a portion of the circumference corresponding to a range of approximately 120°

to 240°

.

5. The re-entry catheter of claim 1, wherein tension applied to the actuating member increases stiffness at the distal end of the elongated tubular member.

6. The re-entry catheter of claim 1, further comprising a membrane supported by the struts and configured to distribute force between the struts.

7. The re-entry catheter of claim 2, further comprising a cutting member coaxially disposed within the actuating member.

8. The re-entry catheter of claim 7, wherein the cutting member comprises a cannula configured to be advanced out of the lateral port.

9. The re-entry catheter of claim 8, wherein the cutting member is formed from nickel-titanium alloy.

10. The re-entry catheter of claim 1, wherein the actuating member is operatively connected to a mechanical handle configured to move the actuating member distally in an axial direction by incremental amounts.

11. The re-entry catheter of claim 1, wherein the catheter has a diameter in the range of approximately 6 French and smaller.

12. A method for forming a passageway from a subintimal area to a lumen of a vessel comprising the steps of:

a) providing a re-entry catheter with an elongated outer tubular member having a distal end and a window adjacent the distal end, a plurality of deflectable struts arranged longitudinally within the window, an actuating member coaxially disposed within the outer tubular member, wherein proximal ends of the deflectable struts are operatively connected to a distal end of the actuating member, and a lateral port positioned opposing the window;

b) advancing the distal end of the catheter through a subintimal area;

c) moving the actuating member in a distal direction to deflect the struts radially outward; and

d) advancing a re-entry device through the lateral port and through an intimal layer of the vessel into the lumen.

13. The method of claim 12, wherein the step of moving the actuating member in a distal direction to deflect the struts radially outward engages an adventitial layer of the vessel and positions the lateral port against the intimal layer.

14. The method of claim 12, wherein the step of advancing a device through the lateral port comprises advancing a guidewire.

15. The method of claim 12, wherein the step of providing a re-entry catheter further comprises providing the catheter with a re-entry device comprising a cannula coaxially disposed within the actuating member and wherein the step of advancing a re-entry device through the lateral port comprises sliding the cannula through the actuating member.

16. The method of claim 12, further comprising the steps of stiffening the distal end of the cathether by applying tension to the actuating member and navigating the distal end of the catheter through vasculature to reach the subintimal area.

17. The method of claim 12, wherein the step of providing a re-entry catheter further comprises providing the catheter with a mechanical handle operative connected to the actuating member, further comprising the step of actuating the handle to move the actuating member distally in an axial direction by an incremental amount.

18. The method of claim 12, further comprising the steps of moving the actuating member in a distal direction to deflect the struts radially outward to create a space between the intimal layer and an adventitial layer and advancing the distal tip of the catheter into the space.

19. The method of claim 12, wherein the subintimal area is adjacent a lesion occluding the vessel and wherein the step of advancing a re-entry device through the lateral port further comprises penetrating at least a portion of the lesion.