Path Creation Through Occlusion

• US 20170143355A1
• Filed: 09/01/2016
• Published: 05/25/2017
• Est. Priority Date: 11/20/2015
• Status: Active Application

• Current Assignee: Teleflex Life Sciences Limited (Teleflex Incorporated)
• Original Assignee: Vascular Solutions Incorporated
• Inventors: Nicholson, William, Kugler, Chad, Brenizer, Joshua, Root, Howard
• Application Number:
  US15/254,386
• Publication Number:
  US 20170143355A1
• Time in Patent Office: Days
• 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 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61B 2090/08021 of the patient or his organs

Abstract

This patent document discloses assemblies, alignment devices and methods for creating a bi-directional path through an occlusion. An alignment device can include a positioning member and a tubular member. The tubular member can be coupled with a distal end portion of the positioning member and can include proximal and distal progressive size-changing shapes separated by a narrow neck passageway. An assembly can include the alignment device, a guide catheter having a lumen in which the alignment device is at least partially positioned, a guidewire, and a specialty catheter for supporting the guidewire. The alignment device and the guide catheter can be advanced in an antegrade direction to a proximal end of the occlusion, and the guidewire and the specialty catheter can be advanced in a retrograde direction to a distal end of the occlusion. The guidewire and the specialty catheter can be manipulated through the occlusion and into the distal end of the tubular member.

Claims

1. An assembly for creating a bi-directional path through an occlusion, comprising:

an alignment device including a positioning member and a tubular member defining a passageway,

a distal end portion of the positioning member coupled with the tubular member,

a proximal end portion and a distal end portion of the tubular member including a configuration having a progressive size-changing shape, each size-changing shape having an opening with a diameter greater than a diameter of an intermediate portion of the tubular member.

2. The assembly of claim 1, wherein the positioning member is eccentrically coupled with the tubular member.

3. The assembly of claim 1, wherein the proximal end portion of the tubular member includes an angled side opening.

4. The assembly of claim 1, wherein the positioning member includes an elongated hypotube, ribbon, or wire.

5. The assembly of claim 1, wherein an intermediate portion or the distal end portion of the positioning member includes an arcuate cross-sectional shape configured to cradle a guidewire.

6. The assembly of claim 1, wherein the progressive size-changing shape at the proximal end portion and the distal end portion of the tubular member is a funnel.

7. The assembly of claim 1, wherein the progressive size-changing shape at the proximal end of the tubular member defines a narrowing portion of the passageway in a proximal-to-distal direction.

8. The assembly of claim 7, wherein the progressive size-changing shape at the distal end of the tubular member defines an enlarging portion of the passageway in a proximal-to-distal direction.

9. The assembly of claim 8, wherein the progressive size-changing shape at the distal end of the tubular member is sized and shaped to receive a tip of a specialty catheter.

10. The assembly of claim 1, further comprising a guide catheter having a proximal end, a distal end, a lumen extending between the proximal end and the distal end, and an inner surface, wherein the tubular member is configured to be positioned at least partially in the lumen;

and

wherein an outer surface portion of at least one progressive size-changing shape of the tubular member is engageable with the inner surface of the guide catheter.

11. The assembly of claim 10, wherein a diameter of the outer surface portion of each progressive size-changing shape, in a relaxed configuration, is larger than a diameter of the inner surface of the guide catheter.

12. The assembly of claim 10, wherein a diameter of the outer surface portion of each progressive size-changing shape is expandable.

13. An alignment device for use with a guide catheter, comprising:

a tubular member defining a passageway; and

a positioning member eccentrically coupled at least to a proximal end portion of the tubular member and extending proximally therefrom for slidably positioning the tubular member within the guide catheter,

a distal end portion of the tubular member including a funnel having an opening for alignment with a distal opening of the guide catheter and configured to receive a tip of a specialty catheter when positioned within or at least partially beyond the distal opening of the guide catheter.

14. The alignment device of claim 13, wherein a diameter of an outer surface portion of the funnel, in a relaxed configuration, is larger than an inner diameter of the guide catheter.

15. The alignment device of claim 13, wherein a proximal end portion of the tubular member includes a second funnel having an opening facing away from the opening of the funnel at the distal end portion of the tubular member.

16. A method, comprising:

advancing a first guide catheter, introduced into a blood vessel at a location upstream of an occlusion, in an antegrade direction toward a proximal end of the occlusion;

advancing an alignment device, including a positioning member and a tubular member having bi-directional proximal and distal funnels separated by a narrow neck passageway, through the first guide catheter such that the distal funnel is near or partially beyond a distal end portion of the first guide catheter, including allowing the proximal funnel to engage against an inner surface of the first guide catheter and allowing the distal funnel to engage against the inner surface of the first guide catheter or an adjacent luminal wall of the blood vessel; and

advancing a first guidewire and a specialty catheter, introduced into the blood vessel at a location downstream of the occlusion, in a retrograde direction, including manipulating the first guidewire and the specialty catheter toward and through the occlusion and into the distal funnel of the tubular member.

17. The method of claim 16, wherein manipulating the first guidewire and the specialty catheter through the occlusion includes creating a continuous channel between proximal and distal ends of the occlusion.

18. The method of claim 16, wherein manipulating the first guidewire and the specialty catheter into the distal funnel of the tubular member includes aligning a lumen of the specialty catheter and the narrow neck passageway of the tubular member.

19. The method of claim 18, further comprising withdrawing the first guidewire from the blood vessel from the location downstream of the occlusion, and advancing a second guidewire, introduced into the blood vessel from the location upstream of the occlusion, through the narrow neck passageway of the tubular member and into the lumen of the specialty catheter.

20. The method of claim 19, further comprising withdrawing the specialty catheter from the blood vessel from the location downstream of the occlusion, and withdrawing the alignment device from the blood vessel from the location upstream of the occlusion.

21. The method of claim 20, further comprising introducing a treatment device into the first guide catheter and, using the second guidewire as a rail, advancing the treatment device in the antegrade direction to the occlusion.

22. The method of claim 16, further comprising introducing a second guide catheter into the blood vessel at the location downstream of the occlusion, and using a lumen of the second guide catheter to advance the first guidewire and the specialty catheter.

23. The method of claim 16, further comprising:

advancing a guide extension catheter through the first guide catheter in the antegrade direction to a position near the proximal end of the occlusion, thereby creating an extension to the first guide catheter, and

wherein advancing the alignment device through the first guide catheter such that the distal funnel is near or partially beyond the distal end portion of the first guide catheter includes allowing the proximal funnel to engage against an inner surface of the guide extension catheter and allowing the distal funnel to engage against the inner surface of the guide extension catheter or the adjacent luminal wall.