Endovascular devices and methods for exploiting intramural space

• US 20070093781A1
• Filed: 09/11/2006
• Published: 04/26/2007
• Est. Priority Date: 09/12/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: BridgePoint Medical, Inc. (Boston Scientific Corporation)
• Inventors: Olson, Matthew, Atkinson, Robert, Kugler, Chad
• Granted Patent: US 8,323,261 B2
• Time in Patent Office: Days
• US Class Current: 604/510
• CPC Class Codes: A61B 17/00008 Vein tendon strippers tube strippers A61M1/83
• 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 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• 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 17/3476 Powered trocars, e.g. electrosurgical cutting, lasers, powered knives
• 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 2017/00455 Orientation indicators, e.g. recess on the handle
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• 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 2017/2212 : having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/320004 : abrasive
• CPC Class Codes: A61B 2017/320044 : Blunt dissectors
• CPC Class Codes: A61B 2017/320064 : with tissue or sample retaining means
• 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: A61B 2017/3405 : using mechanical guide means
• CPC Class Codes: A61B 2017/3454 : Details of tips
• 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 2025/018 : Catheters having a lateral opening for guiding elongated means lateral to the catheter
• CPC Class Codes: A61M 2025/09175 : having specific characteristics at the distal tip
• CPC Class Codes: A61M 2025/09191 : made of twisted wires
• CPC Class Codes: A61M 2025/105 : having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/003 : characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• 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 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0074 : Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 : Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0152 : with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

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 inserting an intramural crossing device into the vascular lumen, positioning at least the distal tip of the crossing device in the vascular wall, advancing an orienting device over the crossing device such that an orienting element of the orienting device resides in the vascular wall, inserting a re-entry device, and re-entering the true 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 a first intravascular device having a distal portion with lateral projections;

inserting the first device into the vascular lumen;

positioning the distal portion in the vascular wall; and

directing the lateral projections in substantially equal and opposite directions within the vascular wall in a substantially planar manner.

2. The method of claim 1, further comprising providing a re-entry device having a distal portion configured to penetrate the vascular wall, positioning the distal portion of the re-entry device in the distal portion of the first intravascular device;

and penetrating the vascular wall toward the vascular lumen with the re-entry device.

3. The method of claim 1, wherein the lateral projections comprise a wire preformed to exhibit a deployed configuration comprising a substantially planar sinusoid.

4. The method of claim 2, wherein the first intravascular device includes a side port oriented at an approximately right angle to the plane of the lateral projections, and wherein positioning the distal portion of the re-entry device comprises advancing the re-entry device out of the side port.

5. The method of claim 4, wherein positioning the distal portion of the first intravascular device comprises confirming that the side port is directed toward the vascular lumen.

6. The method of claim 4a, further comprising using radiographic visualization to confirm that the side port is directed toward the vascular lumen.

7. The method of claim 1 wherein the lateral projections comprise a plurality of hinged wings configured for lateral expansion within the vascular wall.

8. The method of claim 2, the distal tip of the re-entry device penetrates the vascular wall through rotation of the re-entry device.

9. The method of claim 1, wherein an external sheath is provided over a distal portion of the first intravascular device during delivery of the first device within the vasculature.

10. The method of claim 9, wherein the lateral projections are directed by withdrawal of the sheath relative to the first device.

11. The method of claim 10, wherein the distal portion of the first intravascular device is collapsed in a delivery configuration and expanded when lateral projections are directed in a deployed configuration.

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

providing an intramural crossing device having an elongate shaft and an enlarged distal tip;

providing an intramural guide catheter having a distal end;

inserting the intramural crossing device into the vascular lumen;

positioning at least the enlarged distal tip of the crossing device in the vascular wall;

advancing the guide catheter over the crossing device such that the distal end of the guide catheter resides in the vascular wall; and

withdrawing the crossing device through the guide catheter.

13. The method of claim 12, wherein prior to withdrawing the crossing device, providing a second intramural guide catheter having an outside diameter larger than an outside diameter of the first intramural guide catheter;

and

advancing the second guide catheter over the first guide catheter such that the distal end of the second guide catheter resides in the vascular wall.

14. The method of claim 13, wherein the second intramural guide catheter is more rigid than the first intramural guide catheter.

15. The method of claim 12, wherein the intramural guide catheter has an atraumatic tip that is more flexible than a remaining portion of the catheter.

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

providing an intramural crossing device having an elongate shaft and a distal tip;

providing an intramural orienting device having an elongate shaft with a lumen extending therethrough and a distal orienting element;

providing a re-entry device having a distal tip configured to penetrate vascular tissue;

inserting the intramural crossing device into the vascular lumen;

positioning at least the distal tip of the crossing device in the vascular wall;

advancing the orienting device over the crossing device such that the orienting element of the orienting device resides in the vascular wall;

withdrawing the crossing device through the lumen of the orienting device;

inserting the re-entry device into the lumen of the orienting device; and

positioning at least the distal tip of the re-entry device in the vascular wall.

17. The method of claim 16, wherein the intramural orienting device comprises an elongate shaft with a lumen extending therethrough to a distal side opening, the orienting device further comprising a distal orienting element having one or more lateral extensions, wherein the side opening faces orthogonally relative to the lateral extensions.

18. The method of claim 17, wherein the lateral extensions comprise at least two hinged wings configured for movement between a collapsed delivery configuration and an expanded substantially planar deployed configuration.

19. The method of claim 17, further comprising moving the lateral extensions to a deployed configuration.

20. The method of claim 17, wherein positioning the distal tip of the re-entry device comprises extending the distal tip of the re-entry device out of the side opening in a direction orthogonal to the lateral extensions.

21. The method of claim 16, wherein the orienting device approximates the curvature of the vascular lumen such that a concave side of the orienting device is directed toward the vascular lumen.

22. The method of claim 20, wherein extending the distal tip of the re-entry device out of the side opening directs the re-entry device toward the vascular lumen.

23. The method of claim 17, wherein the lateral extensions have a distal end and a proximal end, a distal end of the elongate shaft is connected to a distal end of the lateral extensions, and an outer tube slidably receives a proximal portion of the elongate shaft and has a distal end connected to a proximal end of the lateral extensions, such that relative movement between the elongate shaft and the outer tube controls deployment of the lateral extensions.

24. The method of claim 16, wherein positioning the distal tip of the re-entry device comprises penetrating the vascular wall through rotation of the re-entry device with a rotary drive unit.

25. The method of claim 17, wherein advancing the orienting device comprises confirming that the side opening is directed toward the vascular lumen.

26. The method of claim 25, further comprising using radiographic visualization to confirm that the side opening is directed toward the vascular lumen.

27. A system for facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the system comprising:

an intramural orienting device having an elongate shaft with a lumen extending therethrough to a distal side opening, the device including a distal orienting element comprising one or more lateral extensions, wherein the side opening exits the shaft at an acute angle relative to a longitudinal axis of the shaft and faces orthogonally relative to the lateral extensions; and

a re-entry device having a distal tip configured to penetrate vascular tissue, the re-entry device sized and configured to be inserted into the lumen of the orienting device.

28. A system of claim 27, wherein the orienting device further comprises a flap disposed in the lumen to direct a front-loaded device toward the side port and permitting a back-loaded device to pass proximally through the lumen.

29. The system of claim 27, wherein the lateral extensions comprise at least two hinged wings configured for movement between a collapsed delivery configuration and an expanded substantially planar deployed configuration.

30. The system of claim 29, wherein the wings extend in substantially equal and opposite directions in the deployed configuration.

31. The system of claim 27, wherein the lateral extensions have a distal end and a proximal end, a distal end of the elongate shaft is connected to a distal end of the lateral extensions, and an outer tube slidably receives a proximal portion of the elongate shaft and has a distal end connected to a proximal end of the lateral extensions, such that relative movement between the elongate shaft and the outer tube controls deployment of the lateral extensions.

32. The system of claim 27, wherein a portion of the elongate shaft proximal to the distal side opening includes a spiral cut therein.

33. The system of claim 28, wherein the flap is biased to form a ramp in the lumen that directs a front-loaded device toward the side port.

34. The system of claim 33, wherein the elongate shaft includes a slot to accommodate the flap.

35. The system of claim 29, wherein the wings are defined by a cut metal tube.

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

providing an intramural orienting device having an elongate shaft with a distal orienting element and a lumen extending therethrough with an associated distal side port;

providing a re-entry device having a distal tip configured to penetrate vascular tissue;

inserting the orienting device into the vascular lumen;

positioning at least the orienting element and side port of the orienting device in the vascular wall;

deploying the orienting element such that the side port is oriented either toward the vascular lumen or away from the vascular lumen;

determining if the side port is oriented either toward the vascular lumen or away from the vascular lumen;

rotating the orienting element approximately 180 degrees and re-deploying the orienting element if the side port is oriented away from the vascular lumen such that the side port is oriented toward the vascular lumen;

inserting the re-entry device into the lumen of the orienting device; and

advancing at least the distal tip of the re-entry device out of the side port and into the vascular wall such that it is directed toward the vascular lumen.

37. The method of claim 36, wherein positioning the orienting element comprises confirming that the side port is directed toward the vascular lumen.

38. The method of claim 37, further comprising using radiographic visualization to confirm that the side port is directed toward the vascular lumen.

39. The method of claim 36, wherein the intramural orienting device comprises an elongate shaft with a lumen extending therethrough to the distal side port, the distal orienting element comprising one or more lateral extensions, and wherein the side port faces orthogonal to the lateral extensions.

40. The method of claim 39, wherein the lateral extensions comprise at least two hinged wings configured for movement between a collapsed delivery configuration and an expanded substantially planar deployed configuration.

41. The method of claim 39, wherein deploying the orienting device comprises moving the lateral extensions to a deployed configuration.

42. The method of claim 39, wherein advancing the re-entry device comprises extending the distal tip of the re-entry device out of the side opening in a direction orthogonal to the lateral extensions.

43. The method of claim 36, wherein the orienting device approximates the curvature of the vascular lumen such that a concave side of the orienting device is directed toward the vascular lumen.

44. The method of claim 43, wherein extending the distal tip of the re-entry device out of the side port directs the re-entry device toward the vascular lumen.

45. The method of claim 39, wherein the lateral extensions have a distal end and a proximal end, a distal end of the elongate shaft is connected to a distal end of the lateral extensions, and an outer tube slidably receives a proximal portion of the elongate shaft and has a distal end connected to a proximal end of the lateral extensions, such that relative movement between the elongate shaft and the outer tube controls deployment of the lateral extensions.

46. The method of claim 36, wherein advancing the distal tip of the re-entry device comprises penetrating the vascular wall through rotation of the re-entry device with a rotary drive unit.

47. A re-entry device for facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein, the re-entry comprising:

an elongate drive shaft having a distal tapered section;

an abrasive tip connected to the distal end of the drive shaft, the abrasive tip having an abrasive coating along an exterior surface of the tip; and

wherein the distal tapered section is configured to allow flexure of the tip such that after penetration of the re-entry device into the vascular lumen penetration of an opposite vascular wall is prevented.

48. The device of claim 47 wherein the coating is a grit diamond coating.

49. The device of claim 47, wherein the re-entry device is configured for rotation by a rotary drive.