SUBINTIMAL RECANALIZATION WITH BIO-ABSORBABLE STENT

• US 20130150880A1
• Filed: 12/07/2012
• Published: 06/13/2013
• Est. Priority Date: 12/09/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Anderson, James
• Granted Patent: US 9,302,084 B2
• Time in Patent Office: Days
• US Class Current: 606/194
• 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 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues of bone tissue onto implantable joints A61F2002/3093
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A recanalization catheter assembly and method for establishing a subintimal pathway around an occlusion in a blood vessel. The recanalization catheter assembly an inflatable balloon structure including a distal anchoring portion configured to expand within a true lumen portion of the blood vessel distal of the occlusion to anchor the recanalization catheter from unintentional movement during expansion of a stent in the subintimal pathway. The expandable stent, such as a bioabsorbable stent, may be configured to promote native tissue regrowth around the stent to create a superficial intimal layer along the subintimal pathway.

Claims

1. A recanalization catheter assembly for establishing a subintimal pathway around an occlusion in a blood vessel, the recanalization catheter assembly comprising:

an elongate catheter shaft extending distally from a hub assembly;

an inflatable balloon structure mounted on a distal portion of the catheter shaft, the inflatable balloon structure configured to be expanded from a deflated configuration to an inflated configuration with a fluid delivered to an interior of the inflatable balloon structure through an inflation lumen extending through the catheter shaft;

a stent surrounding a body portion of the inflatable balloon structure, with a distal anchoring portion of the inflatable balloon structure positioned distal of the stent;

wherein the distal anchoring portion of the inflatable balloon structure is configured to expand within a true lumen portion of the blood vessel distal of the occlusion to anchor the recanalization catheter from unintentional movement during expansion of the stent in the subintimal pathway.

2. The recanalization catheter assembly of claim 1, wherein the distal anchoring portion of the inflatable balloon structure has an outer diameter in the inflated configuration greater than an outer diameter of the stent in an expanded configuration.

3. The recanalization catheter assembly of claim 1, wherein the stent has a length measured from a proximal end of the stent to a distal end of the stent, wherein the distal anchoring portion of the inflatable balloon structure extends distal of the stent for a distance of at least 10% of the length of the stent.

4. The recanalization catheter assembly of claim 1, wherein the stent has a length measured from a proximal end of the stent to a distal end of the stent, wherein the distal anchoring portion of the inflatable balloon structure extends distal of the stent for a distance of at least 20% of the length of the stent.

5. The recanalization catheter assembly of claim 1, wherein the distal anchoring portion of the inflatable balloon structure is inflatable independent of inflation of the body portion of the inflatable balloon structure.

6. The recanalization catheter assembly of claim 5, wherein the distal anchoring portion is an anchoring balloon and the body portion is a dilatation balloon distinct from the anchoring balloon.

7. The recanalization catheter assembly of claim 6, further comprising a slotted tubular member extending between the dilatation balloon and the anchoring balloon.

8. The recanalization catheter assembly of claim 1, wherein the inflatable balloon structure includes a proximal anchoring portion positioned proximal of the stent configured to expand within a true lumen portion of the blood vessel proximal of the occlusion to anchor the recanalization catheter from unintentional movement during expansion of the stent in the subintimal pathway.

9. The recanalization catheter assembly of claim 1, wherein the body portion is a dilatation balloon and the distal anchoring portion is a distal cone portion of the dilatation balloon.

10. A method of recanalizing a blood vessel by establishing a subintimal pathway around an occlusion, the method comprising:

creating a subintimal pathway between a proximal opening into a vessel wall proximal of an occlusion and a distal opening into the vessel wall distal of the occlusion;

positioning an expandable stent in the subintimal pathway;

expanding the expandable stent in the subintimal pathway; and

promoting native tissue regrowth around the stent to create a superficial intimal layer along the subintimal pathway.

11. The method of claim 10, wherein expanding the expandable stent comprises:

inflating a body portion of an inflatable balloon structure within the expandable stent to radially expand the expandable stent.

12. The method of claim 10, wherein the inflatable balloon structure includes an inflatable anchoring portion configured to be inflated in a true lumen portion of the blood vessel distal of the occlusion.

13. The method of claim 10, wherein the superficial intimal layer is created between an intimal tissue layer defining a true lumen of the blood vessel and an adventitial tissue layer of the blood vessel.

14. A method of recanalizing a blood vessel by establishing a subintimal pathway around an occlusion, the method comprising:

creating a subintimal pathway between a proximal opening into a vessel wall proximal of an occlusion and a distal opening into the vessel wall distal of the occlusion;

positioning an expandable stent surrounding a body portion of an inflatable balloon structure in the subintimal pathway with a distal anchoring portion of the inflatable balloon structure positioned in a true lumen portion of the blood vessel distal of the occlusion;

inflating the distal anchoring portion of the inflatable balloon structure in the true lumen portion distal of the occlusion; and

inflating the body portion of the inflatable balloon structure to expand the expandable stent in the subintimal pathway;

wherein the inflated distal anchoring portion anchors the inflatable balloon structure from unintentional proximal movement while the stent is expanded in the subintimal pathway to maintain proper placement of the stent in the subintimal pathway.

15. The method of claim 14, wherein the expandable stent has an expanded diameter in the subintimal pathway less than a diameter of the distal anchoring portion of the inflatable balloon structure in an inflated configuration.

16. The method of claim 14, wherein the distal anchoring portion is inflated against an intimal wall of the true lumen distal of the occlusion.

17. The method of claim 14, wherein the distal anchoring portion is at least partially inflated prior to inflating the body portion of the inflatable balloon structure.

18. The method of claim 14, wherein the distal anchoring portion is inflated independent of inflating the body portion of the inflatable balloon structure.

19. The method of claim 14, further comprising:

inflating a proximal anchoring portion of the inflatable balloon structure in a true lumen portion proximal of the occlusion;

wherein the inflated proximal anchoring portion anchors the inflatable balloon structure from unintentional distal movement while the stent is expanded in the subintimal pathway to maintain proper placement of the stent in the subintimal pathway.

20. The method of claim 19, wherein the proximal anchoring portion is at least partially inflated prior to inflating the body portion of the inflatable balloon structure.