Endovascular devices and methods

• US 20070093779A1
• Filed: 09/11/2006
• Published: 04/26/2007
• 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: Atkinson, Robert, Kugler, Chad
• Granted Patent: US 7,938,819 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• 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 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 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22077 with a part piercing the tissue A61B2017/22044 takes precedence
• 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 2017/320056 Tunnelers
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
• 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 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

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 an intravascular device having a distal portion with a side port, inserting the device into the vascular lumen, positioning the distal portion in the vascular wall, directing the distal portion within the vascular wall such that the distal portion moves at least partially laterally, and directing the side port towards the vascular lumen.

Claims

1. A method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the method comprising:

providing an intravascular device having a distal portion with a side port;

inserting the device into the vascular lumen;

positioning the distal portion in the vascular wall;

directing the distal portion within the vascular wall such that the distal portion moves at least partially laterally; and

directing the side port towards the vascular lumen.

2. The method of claim 1, wherein the distal portion of the intravascular device is advanced in a direction substantially parallel to the vascular lumen.

3. The method of claim 1, wherein the distal portion of the intravascular device is advanced in a substantially helical path such that the distal portion of the intravascular device encircles a portion of the vascular lumen.

4. The method of claim 3, wherein the distal portion of the intravascular device encircles a portion of the occlusion.

5. The method of claim 3, wherein providing an intravascular device having a distal portion with a side port comprises providing a distal portion having a helical shape in a relaxed configuration such that the side port is directed toward the center of the helix.

6. The method of claim 1, wherein the intravascular device includes an internal lumen, the method further comprising providing a re-entry device within the internal lumen and directing a distal portion of the re-entry device to exit from the side port and advancing the re-entry device toward a location of the vascular lumen distally beyond the occlusion.

7. A method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the method comprising:

providing a first intravascular device having a distal portion with a side port;

providing a re-entry device having a curved distal portion;

inserting the first device into the vascular lumen;

positioning the distal portion of the first device in the vascular wall;

directing the distal portion within the vascular wall such that the distal portion moves at least partially laterally; and

positioning the curved distal portion of the re-entry device in the distal portion of the first device.

8. The method of claim 7, wherein directing the distal portion comprises directing the side port towards the vascular lumen.

9. The method of claim 7, wherein directing the distal portion comprises advancing the distal portion of the first device in a direction substantially parallel to the vascular lumen.

10. The method of claim 7, wherein directing the distal portion comprises advancing the distal portion of the first device in a substantially helical path such that the distal portion of the first device encircles a portion of the vascular lumen.

11. The method of claim 10, wherein the distal portion of the first device encircles a portion of the occlusion.

12. The method of claim 10, wherein providing an intravascular device having a distal portion with a side port comprises providing a distal portion having a helical shape in a relaxed configuration such that the side port is directed toward the center of the helix.

13. The method of claim 7, further comprising directing the curved distal portion of the re-entry device to exit from the side port, and advancing the re-entry device toward a location of the vascular lumen distally beyond the occlusion.

14. The method of claim 7, wherein the re-entry device includes a tissue penetrating tip, the method further comprising directing the curved distal portion of the re-entry device to exit from the side port, and advancing the re-entry device to penetrate tissue of the vascular wall such that the re-entry device enters a location of the vascular lumen distally beyond the occlusion.

15. The method of claim 7, wherein the distal portion of the first intravascular device comprises a shaft wrapped with an external helical wire coil, and wherein directing the distal portion comprises rotating the shaft such that wire coil acts as external threads engaging vascular tissue to advance the distal portion.

16. A method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the method comprising:

providing a first intravascular device having a distal portion;

inserting the device into the vascular lumen;

positioning the distal portion in the vascular wall; and

delivering pulsatile fluid into the vascular wall via the distal portion.

17. The method of claim 16, wherein delivering fluid dissects tissue to define a subintimal path.

18. The method of claim 16, wherein the fluid is delivered by a pumping mechanism including a linear actuator.

19. The method of claim 18, wherein delivering fluid further comprises adjusting fluid delivery by adjusting a stroke length, a stroke rate, or a stroke volume produced by the actuator.

20. The method of claim 19, wherein the stoke volume is adjustable between approximately 0.01 cc and approximately 1.00 cc of fluid.

21. The method of claim 18, wherein the actuator includes an elongate rod slidable within a shaft.

22. A medical device for facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the device comprising:

an elongate tubular shaft configured for intravascular navigation, the shaft having a proximal end, a distal end, and a lumen extending therethrough to a distal opening;

an elongate rod movably disposed in the lumen of the tubular shaft, the rod extending from the proximal end of the tubular shaft to a point proximal of the distal opening;

a seal disposed in the lumen of shaft around the rod;

a pulsatile pumping mechanism connected to the rod; and

wherein the device has a stroke volume between 0.01 cc and 1.0 cc.

23. The method of claim 22, wherein the seal is a ring seal.

24. The method of claim 22, wherein at least one of a stroke length, a stroke rate, or a stroke volume is adjustable.

25. A method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the method comprising:

providing a first intravascular device having a distal balloon;

providing a re-entry device having a distal portion;

inserting the first device into the vascular lumen;

positioning the distal balloon in the vascular wall;

inflating the balloon within the vascular wall; and

positioning the distal portion of the re-entry device adjacent the balloon within the vascular wall.

26. The method of claim 25, wherein inflating the balloon distends a portion of tissue along the vascular wall.

27. The method of claim 26, wherein the re-entry device includes a tissue penetrating tip, and the method further comprising advancing the re-entry device to penetrate tissue of the vascular wall such that the re-entry device enters a location of the vascular lumen distally beyond the occlusion.

28. The method of claim 25, wherein the first intravascular device includes an internal lumen extending through the balloon and terminating at a distal opening, and wherein positioning the distal portion of the re-entry device comprises advancing the re-entry device through the lumen and beyond the distal opening.

29. The method of claim 28, wherein inflating the balloon distends a portion of tissue along the vascular wall, wherein the re-entry device includes a tissue penetrating tip, and the method further comprising advancing the re-entry device to penetrate distended tissue of the vascular wall such that the re-entry device enters a location of the vascular lumen distally beyond the occlusion.

30. The method of claim 25, wherein positioning the distal balloon in the vascular wall comprises inserting a guidewire into subintimal space within the vascular wall, past the occlusion, and advancing the first device over the guidewire.

31. The method of claim 30, further comprising removing the guidewire.

32. The method of claim 25, wherein positioning the distal balloon in the vascular wall comprises advancing the balloon distally of the occlusion.

33. The method of claim 32, wherein inflating the balloon orients a distal tip of the first device toward the vascular lumen.