Apparatus and system for removing an obstruction from a lumen

• US 20030216760A1
• Filed: 05/20/2002
• Published: 11/20/2003
• Est. Priority Date: 05/20/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: DiCarlo, Paul, Welch, Eric, DeVries, Robert B., Voss, Michael J., Hubbart, Erice N.
• Granted Patent: US 7,179,269 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• 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 17/221 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 17/320758 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 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• 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 2217/005 with suction drainage system
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

An apparatus and system for removing an obstruction from a body lumen simultaneously mechanically dislodges the obstruction, macerates the obstruction, and aspirates the effluent caused thereby. The maceration is effected by directing pressurized fluid to the obstruction, while the obstruction is dislodged by a tip portion formed on the end of a guidewire. The apparatus includes a flexible catheter having at least two channels individually accommodating fluid flow paths towards and away from the obstruction. The guidewire may be disposed in either of the channels or a third channel formed in the flexible catheter. The apparatus also includes a drive unit for rotating the guidewire. The drive unit may be an external drive unit, such as an electrical motor, or may include drive elements formed on the guidewire within a drive chamber, across which the fluid flows and imparts energy against the drive elements to cause rotation of the guidewire.

Claims

1. An apparatus for removing an obstruction from inside of a lumen, comprising:

a catheter defining a first channel and a second channel extending between a proximal end of said catheter and a distal end of said catheter, wherein at least a portion of said catheter is adapted for insertion into the lumen, said first channel accommodates an inlet fluid flow path from said proximal end towards said distal end for providing pressurized fluid into the lumen, and said second channel accommodates a return fluid flow path from said distal end of said catheter towards said proximal end;

a guidewire longitudinally extending through one of said first channel or said second channel and having a tip portion extending beyond said distal end of said catheter for dislodging the obstruction upon rotation; and

means for rotating said guidewire to cause said tip portion to dislodge the obstruction.

2. The apparatus of claim 1 further comprising an inlet fluid tube which defines said inlet fluid flow path and is disposed in said first channel, and wherein said guidewire is disposed in said second channel.

3. The apparatus of claim 1 further comprising an inlet fluid tube which defines said inlet fluid flow path and is disposed in said first channel, and wherein said guidewire is disposed in said first channel with said inlet fluid tube.

4. The apparatus of claim 1 further comprising a inlet fluid tube which defines said first channel and wherein said inlet fluid tube is disposed within said second channel and said guidewire is also disposed in said second channel.

5. The apparatus of claim 1 further comprising a nozzle formed at the distal end of said first channel for extending into said lumen and configured to direct pressurized fluid to said lumen and said return fluid flow path.

6. The apparatus of claim 1, wherein said tip portion is retractable into said catheter for aiding introduction of said catheter into the lumen.

7. The apparatus of claim 1, wherein said tip portion and a segment of a straight portion of said guidewire extend beyond the distal end of said catheter in operation.

8. The apparatus of claim 7, wherein said tip portion has a shape selected from the group consisting of a spiral, a curve, a sine wave, a straight section, a multiplane sine wave, a multiple coil, an oval, a basket comprising a plurality of ovals, a sphere comprising a plurality of circles, a helix, a half sine wave, and a multi-helix.

9. The apparatus of claim 7, wherein said tip portion has a termination selected from the group consisting of a plain distal tip, an open loop distal tip, a closed loop distal tip, and a ball weld distal tip.

10. The apparatus of claim 8, wherein said tip portion has a termination selected from the group consisting of a plain distal tip, an open loop distal tip, a closed loop distal tip, and a ball weld distal tip.

11. The apparatus of claim 7, wherein said tip portion comprises a base filament and a plurality of cutting filaments extending perpendicularly from said base filament.

12. The apparatus of claim 7, wherein said tip portion comprises a circular element and a plurality of cutting filaments extending radially outward from said circular element.

13. The apparatus of claim 7, wherein said tip portion has a proximal end and a distal end and a first radiopaque marker at the proximal end of said tip portion and a second radiopaque marker at the distal end of said tip portion.

14. The apparatus of claim 7, wherein said tip portion has a radiopaque marker at a radially outermost point of said tip portion.

15. The apparatus of claim 1, wherein said means for rotating said guidewire comprise an external driver coupled to said guidewire.

16. The apparatus of claim 15, wherein said external driver is selected from the group consisting of a pneumatic driver and an electrical driver.

17. The apparatus of claim 1, wherein said catheter has a diameter of five to seven french.

18. The apparatus of claim 1, wherein said guidewire has a first segment and said means for rotating said guidewire comprise:

a housing defining a chamber having an inlet port for receiving fluid and in fluid flow communication with said first channel, wherein said first segment of said guidewire is located within said chamber; and

a drive element affixed to said first segment of said guidewire for transferring energy from fluid flowing through said chamber to cause rotation of said guidewire.

19. The apparatus of claim 18, wherein said guidewire is disposed in said second channel and further comprising a first supplemental element affixed to a second segment of said guidewire for assisting in driving the fluid through said return fluid flow path, wherein said second segment is located within said second channel near said distal end thereof.

20. The apparatus of claim 18, wherein said guidewire is disposed in said second channel and further comprising a second supplemental element affixed to a third segment of said guidewire for creating suction in said return fluid flow path, wherein said third segment is located within said second channel near said housing.

21. The apparatus of claim 18, wherein said housing is in the form of a handle.

22. The apparatus of claim 18, wherein said chamber has a varying cross-sectional area along its length for altering the fluid velocity, wherein the axial position of said drive element affects the speed of rotation of said guidewire.

23. The apparatus of claim 18, wherein said chamber has an adjustable cross-sectional area for altering the fluid velocity and the speed of rotation of said guidewire.

24. An apparatus for removing an obstruction from inside of a lumen, comprising:

a catheter defining a first channel, a second channel, and a third channel extending between a proximal end of said catheter and a distal end of said catheter, wherein at least a portion of said catheter is adapted for insertion into the lumen, said first channel accommodates an inlet fluid flow path from said proximal end towards said distal end for providing pressurized fluid into the lumen, and said second channel accommodates a return fluid flow path from said distal end of said catheter towards said proximal end;

a guidewire, longitudinally extending through said third channel and having a tip portion extending beyond said distal end of said catheter for dislodging the obstruction upon rotation; and

means for rotating said guidewire to cause said tip portion to dislodge the obstruction.

25. The apparatus of claim 24 further comprising a nozzle formed at the distal end of said first channel for extending into said lumen and configured to direct pressurized fluid to said lumen and said return fluid flow path.

26. The apparatus of claim 24, wherein said tip portion is retractable into said catheter for aiding introduction of said catheter into the lumen.

27. The apparatus of claim 24, wherein said tip portion and a segment of a straight portion of said guidewire extend beyond the distal end of said catheter in operation.

28. The apparatus of claim 27, wherein said tip portion has a shape selected from the group consisting of a spiral, a curve, a sine wave, a straight section, a multiplane sine wave, a multiple coil, an oval, a basket comprising a plurality of ovals, a sphere comprising a plurality of circles, a helix, a half sine wave, and a multi-helix.

29. The apparatus of claim 27, wherein said tip portion has a termination selected from the group consisting of a plain distal tip, an open loop distal tip, a closed loop distal tip, and a ball weld distal tip.

30. The apparatus of claim 28, wherein said tip portion has a termination selected from the group consisting of a plain distal tip, an open loop distal tip, a closed loop distal tip, and a ball weld distal tip.

31. The apparatus of claim 27, wherein said tip portion comprises a base filament and a plurality of cutting filaments extending perpendicularly from said base filament.

32. The apparatus of claim 27, wherein said tip portion comprises a circular element and a plurality of cutting filaments extending radially outward from said circular element.

33. The apparatus of claim 27, wherein said tip portion has a proximal end and a distal end and a first radiopaque marker at the proximal end of said tip portion and a second radiopaque marker at the distal end of said tip portion.

34. The apparatus of claim 27, wherein said tip portion has a radiopaque marker at a radially outermost point of said tip portion.

35. The apparatus of claim 24, wherein said means for rotating said guidewire comprise an external driver coupled to said guidewire.

36. The apparatus of claim 35, wherein said external driver is selected from the group consisting of a pneumatic driver and an electrical driver.

37. The apparatus of claim 24, wherein said catheter has a diameter of five to seven french.

38. An apparatus for removing an obstruction from inside of a lumen, comprising:

a catheter defining a first channel and a second channel extending between a proximal end of said catheter and a distal end of said catheter, wherein at least a portion of said catheter is adapted for insertion into the lumen and one of said first channel or said second channel accommodates a return fluid flow path from said distal end of said catheter towards said proximal end;

a first fluid tube having a distal end for providing fluid;

a second fluid tube having a proximal end and a distal end and disposed in said first channel for providing pressurized fluid into the lumen;

a housing defining a chamber, wherein said chamber is interposed between said distal end of said first fluid tube and said proximal end of said second fluid tube and is in fluid flow communication with said first fluid tube and said second fluid tube;

a guidewire, longitudinally extending through said chamber and said second channel, and having a tip portion extending beyond said distal end of said second channel for dislodging the obstruction upon rotation; and

a drive element affixed to a first segment of said guidewire, wherein said first segment is located within said chamber, for transferring energy from fluid flowing through the chamber to cause rotation of said guidewire.

39. The apparatus of claim 38 further comprising:

a first seal forming a first sealing engagement at the proximal end of said chamber and around said guidewire; and

a second seal forming a second sealing engagement at the distal end of said chamber and around said guidewire.

40. The apparatus of claim 38 further comprising an external driver coupled to said guidewire for rotating said guidewire.

41. The apparatus of claim 40, wherein said external driver is selected from the group consisting of a pneumatic driver and an electrical driver.

42. The apparatus of claim 38, wherein said drive element comprises a plurality of helical fins.

43. The apparatus of claim 42, wherein said plurality of helical fins are pitched to cause the guidewire to rotate when the fluid impacts said plurality of helical fins.

44. An apparatus for removing an obstruction from inside of a lumen, comprising:

a catheter defining a first channel and a second channel extending between a proximal end of said catheter and a distal end of said catheter, wherein at least a portion of said catheter is adapted for insertion into the lumen and said first channel accommodates an inlet fluid flow path from said proximal end of the catheter to said distal end for providing pressurized fluid into the lumen and said second channel accommodates a return fluid flow path from said distal end of said catheter towards said proximal end;

an input fluid tube having a distal end for providing fluid;

a housing defining a chamber, wherein said chamber is interposed between said distal end of said input fluid tube and said proximal end of said first channel and is in fluid flow communication with said input fluid tube and said first channel;

a guidewire, longitudinally extending through said chamber and said second channel and having a tip portion extending beyond said distal end of said second channel for dislodging the obstruction upon rotation; and

a drive element affixed to a first segment of said guidewire, wherein said first segment is located within said chamber, for transferring energy from fluid flowing through the chamber to cause rotation of said guidewire.

45. The apparatus of claim 44 further comprising a nozzle formed at the distal end of said first channel for extending into said lumen and configured to direct pressurized fluid to said lumen and said return fluid flow path.

46. An apparatus for removing an obstruction from inside of a lumen, comprising:

a catheter defining a first channel and a second channel extending between a proximal end of said catheter and a distal end of said catheter, wherein at least a portion of said catheter is adapted for insertion into the lumen and said first channel accommodates a return fluid flow path from said distal end of said catheter towards said proximal end;

a first fluid tube having a distal end for providing fluid;

a second fluid tube having a proximal end and a distal end and disposed in said first channel for providing pressurized fluid into the lumen;

a housing defining a chamber, wherein said chamber is interposed between said distal end of said first fluid tube and said proximal end of said second fluid tube and is in fluid flow communication with said first fluid tube and said second fluid tube;

a guidewire longitudinally extending through said chamber and said second channel and having a tip portion extending beyond said distal end of said catheter for dislodging the obstruction upon rotation; and

a drive element affixed to a first segment of said guidewire, wherein said first segment is located within said chamber, for transferring energy from fluid flowing through the chamber to cause rotation of said guidewire.

47. The apparatus of claim 46 further comprising:

a first seal formed around said guidewire for providing a first sealing engagement at said proximal end of said chamber;

a second seal formed around said guidewire for providing a second sealing engagement at said distal end of said chamber; and

a third seal formed around said second fluid tube for preventing fluid flow between said return fluid flow path and said chamber.

48. A system for removing an obstruction from inside of a lumen, comprising:

a catheter defining a first channel and a second channel extending between a proximal end of said catheter and a distal end of said catheter, wherein at least a portion of said catheter is adapted for insertion into the lumen, said first channel accommodates an inlet fluid flow path from said proximal end towards said distal end for providing pressurized fluid into the lumen, and said second channel accommodates a return fluid flow path from said distal end of said catheter towards said proximal end;

a guidewire longitudinally extending through one of said first channel or said second channel and having a tip portion extending beyond said distal end of said catheter for dislodging the obstruction upon rotation;

means for rotating said guidewire to cause said tip portion to dislodge the obstruction;

a fluid source coupled to said first channel for providing fluid;

a fluid return tube connected to said catheter and in fluid communication with said return fluid flow path;

a suction pump connected to said fluid return tube for creating a suction on the fluid as it returns through said return fluid flow path; and

a tank connected to the output of said suction pump for receiving the fluid after it has passed through the fluid return tube.

49. The apparatus of claim 48, wherein said guidewire has a first segment and said means for rotating said guidewire comprise:

a housing defining a chamber having an inlet port for receiving fluid from said fluid source and in fluid flow communication with said first channel, wherein said first segment of said guidewire is located within said chamber; and

a drive element affixed to said first segment of said guidewire for transferring energy from fluid flowing through said chamber to cause rotation of said guidewire.

50. The apparatus of claim 48, wherein said means for rotating said guidewire comprise an external driver coupled to said guidewire.

51. The apparatus of claim 48, wherein said guidewire has a first segment and said means for rotating said guidewire comprise an external driver coupled to said guidewire and:

a housing defining a chamber having an inlet port for receiving fluid from said fluid source and in fluid flow communication with said first channel, wherein said first segment of said guidewire is located within said chamber; and

a drive element affixed to said first segment of said guidewire for transferring energy from fluid flowing through said chamber to cause rotation of said guidewire.