Endovascular devices and methods for exploiting intramural space

• US 10,166,035 B2
• Filed: 03/07/2016
• Issued: 01/01/2019
• Est. Priority Date: 09/12/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: BridgePoint Medical, Inc. (Boston Scientific Corporation)
• Inventors: Kugler, Chad J., Olson, Matthew J., Atkinson, Robert E.
• Primary Examiner(s): Osinski, Bradley J
• Application Number:
  US15/062,979
• Publication Number:
  US 20160183953A1
• Time in Patent Office: 1,030 Days
• CPC Class Codes: A61B 17/00008 Vein tendon strippers tube strippers A61M1/83
• 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 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/32037 for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2017/00252 for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel
• CPC Class Codes: A61B 2017/003 Steerable
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61B 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• CPC Class Codes: A61B 2017/320741 for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61M 2025/006 having a special surface topography or special surface properties, e.g. roughened or knurled surface
• 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 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 25/104 : used for angioplasty

Abstract

Devices and methods for the treatment of chronic total occlusions are provided. One disclosed embodiment comprises a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method includes providing a first intravascular device having a distal portion with a concave side, inserting the first device into the vascular lumen, positioning the distal portion in the vascular wall, and orienting the concave side of the distal portion toward the vascular lumen.

Claims

1. A method of bypassing an occlusion disposed in a lumen of a vessel having a vascular wall, the method comprising:

inserting a distal end of an elongate shaft of an intravascular device into the lumen proximal of the occlusion;

entering the vascular wall of the vessel with the distal end of the elongate shaft of the intravascular device at a location proximal of the occlusion;

advancing the distal end of the elongate shaft between first and second tissue layers of the vascular wall to a location distal of the occlusion;

advancing a re-entry device through the elongate shaft of the intravascular device, the re-entry device having a tissue penetrating distal tip;

penetrating the first tissue layer of the vascular wall with the tissue penetrating distal tip of the re-entry device such that the tissue-penetrating distal tip enters the lumen of the vessel distal of the occlusion; and

thereafter, advancing the distal end of the elongate shaft of the intravascular device from the vascular wall into the lumen of the vessel distal of the occlusion such that the elongate shaft of the intravascular device extends from the lumen of the vessel proximal of the occlusion, through a subintimal space between the first and second tissue layers along the occlusion, to the lumen of the vessel distal of the occlusion.

2. The method of claim 1, further comprising rotationally orienting the elongate shaft of the intravascular device in the subintimal space after advancing the distal end of the elongate shaft between the first and second tissue layers of the vascular wall to the location distal of the occlusion.

3. The method of claim 1, wherein the elongate shaft of the intravascular device includes a concave side.

4. The method of claim 3, further comprising rotationally orienting the concave side of the elongate shaft of the intravascular device toward the first tissue layer after advancing the distal end of the elongate shaft between the first and second tissue layers of the vascular wall to the location distal of the occlusion.

5. The method of claim 1, wherein the elongate shaft of the intravascular device includes a deployable element.

6. The method of claim 5, wherein the deployable element is expandable from a collapsed configuration to a deployed configuration.

7. The method of claim 6, wherein the deployable element is constrained within an actuatable sheath while in the collapsed configuration.

8. The method of claim 7, wherein the actuatable sheath is retracted from the deployable element to permit the deployable element to expand to the deployed configuration.

9. The method of claim 5, further comprising:

expanding the deployable element in first and second opposite directions between the first and second tissue layers.

10. The method of claim 5, wherein the deployable element is an expandable lattice structure.

11. The method of claim 10, wherein the expandable lattice structure is formed of nickel titanium.

12. The method of claim 1, further comprising:

advancing a guidewire through the elongate shaft of the intravascular device into the lumen distal of the occlusion.

13. The method of claim 12, wherein the guidewire is advanced through the elongate shaft of the intravascular device into the lumen distal of the occlusion with the distal end of the elongate shaft of the intravascular device positioned in the lumen distal of the occlusion.

14. The method of claim 13, further comprising:

retaining the guidewire in the lumen distal of the occlusion while withdrawing the elongate shaft of the intravascular device from the vessel.

15. The method of claim 14, further comprising:

advancing an angioplasty balloon catheter over the guidewire into the subintimal space after withdrawing the elongate shaft of the intravascular device.

16. The method of claim 15, further comprising dilating the subintimal space with the angioplasty balloon catheter.

17. The method of claim 14, further comprising:

stenting the subintimal space after withdrawing the elongate shaft of the intravascular device.