Apparatus and method for removing occlusive material within blood vessels

• US 20040006306A1
• Filed: 05/13/2003
• Published: 01/08/2004
• Est. Priority Date: 05/14/2002
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Bacchus Vascular Incorporated (Medtronic Plc)
• Inventors: Khairkhahan, Alexander, Demarais, Denise, Evans, Michael A., Decicco, Dino
• Granted Patent: US 7,399,307 B2
• Time in Patent Office: Days
• US Class Current: 604/101.03
• 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 17/3207 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 17/320708 Curettes, e.g. hollow scraping instruments
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• 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: A61M 2025/018 Catheters having a lateral opening for guiding elongated means lateral to the catheter
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

An apparatus for treating an occlusive region of a blood vessel includes a catheter including a first lumen extending from an end port to a first side port, and a second lumen extending from a proximal end of the catheter to a second side port. A balloon is mounted on the catheter between the first and second side ports. During use, a guidewire is placed into an occlusive region, and the guidewire is backloaded through the first and second lumens. The catheter is advanced over the guidewire, and the balloon is expanded to isolate the occlusive region. The guidewire is removed, and an agitator is advanced through the second lumen. After the agitator is agitated to dislodge occlusive material from the occlusive region, the agitator is removed, and the loose occlusive material is aspirated via the second side port.

Claims

1. An apparatus for treating an occlusive region within a patient'"'"'s vasculature, comprising:

a tubular member comprising proximal and distal ends, and a distal portion comprising a first lumen therein, the first lumen comprising an end port at or adjacent to the distal end and a first side port located proximally to the end port, the tubular member further comprising a second lumen extending from the proximal end to a second side port located proximally to the first side port; and

an expandable member on the tubular member between the first and second side ports.

2. The apparatus of claim 1, wherein the expandable member comprises a balloon, and wherein the tubular member comprises a third lumen extending from the proximal end and communicating with an interior of the balloon.

3. The apparatus of claim 2, wherein the balloon comprises I a compliant balloon.

4. The apparatus of claim 1, wherein the expandable member comprises a first balloon, and wherein the apparatus further comprises a second balloon on the tubular member proximally to the second side port.

5. The apparatus of claim 4, wherein the tubular member further comprises a third lumen extending from the proximal end and communicating with an interior of the second balloon.

6. The apparatus of claim 5, wherein the third lumen also communicates with an interior of the first balloon.

7. The apparatus of claim 1, further comprising a guidewire extending from the end port through the first lumen, exiting the first side port, and entering the second side port, the guidewire extending proximally into the second lumen.

8. The apparatus of claim 1, further comprising a source of aspiration connected to the proximal end of the tubular member, the source of aspiration communicating with the second lumen for creating a vacuum at the second side port.

9. The apparatus of claim 1, further comprising a treatment element insertable through the second lumen.

10. The apparatus of claim 9, wherein the treatment element comprises an agitator including a nonlinear portion, the distal portion of the tubular member further comprising a flexible portion proximal to the expandable member, the nonlinear portion i being insertable into the flexible portion for deforming the flexible portion into a nonlinear configuration.

11. The apparatus of claim 10, wherein the nonlinear configuration is generally sinusoidal.

12. An apparatus for treating an occlusive region within a patient'"'"'s vasculature, comprising:

a tubular member comprising proximal and distal ends, a distal portion, and a guidewire lumen therein extending from the proximal end to a side port in the distal portion;

an expandable member on the tubular member between the side port and the distal end of the tubular member;

a loop extending from the distal end of the tubular member, the loop defining an aperture for receiving a guidewire i therethrough.

13. The apparatus of claim 12, further comprising a guidewire extending through the aperture defined by the loop and entering the side port, the guidewire extending proximally into the guidewire lumen.

14. The apparatus of claim 12, further comprising a treatment element insertable through the second lumen, the treatment element comprising a nonlinear portion, the distal portion of the tubular member comprising a flexible portion proximal to the expandable member, the nonlinear portion being insertable into the flexible portion for deforming the flexible portion into a predetermined configuration.

15. The apparatus of claim 12, wherein the loop comprises a plurality of turns disposed adjacent to one another defining an aperture therethrough.

16. A method for treating an occlusive region of a patient'"'"'s vasculature using a tubular member comprising proximal and distal ends, and a distal portion comprising a first lumen therein, the first lumen comprising an end port at or adjacent i the distal end and a first side port located proximally to the end port, the tubular member further comprising a second lumen extending from the proximal end to a second side port located proximally to the first side port, and an expandable member between the first and second side ports, the method comprising:

placing a guidewire through a patient'"'"'s vasculature to an occlusive region to be treated;

backloading the guidewire through the first lumen, around the expandable member, and through the second lumen;

advancing the distal portion of the tubular member over the guidewire to the occlusive region;

expanding the expandable member on the tubular member to at least partially isolate the occlusive region;

advancing a treatment element into the occlusive region in cooperation with the tubular member; and

treating the occlusive region.

17. The method of claim 16, wherein the step of advancing a treatment element comprises:

removing the guidewire from the second lumen; and

advancing the treatment element through the second lumen to the occlusive region.

18. The method of claim 17, wherein the treatment element causes at least a portion of the distal portion of the tubular member to assume a nonlinear configuration.

19. The method of claim 18, wherein the treating step comprises agitating the treatment element to disrupt or dislodge occlusive material from the occlusive region.

20. The method of claim 16, wherein the treating step comprises introducing a therapeutic or diagnostic agent into the occlusive region.

21. The method of claim 20, wherein the therapeutic or diagnostic agent comprises a thrombolytic agent.

22. The method of claim 18, wherein the treating step further comprises creating a vacuum at the second side port to aspirate occlusive material from the occlusive region.

23. The method of claim 22, wherein the treatment element is removed from the second lumen before creating a vacuum.

24. The method of claim 16, wherein the expandable member comprises a distal expandable member, and wherein the method further comprises:

expanding a proximal expandable member to isolate at least a portion of the occlusive region.

25. The method of claim 24, wherein the proximal expandable member is disposed on the tubular member at a location proximal to the second side port.

26. The method of claim 24, wherein the proximal expandable member is carried on a distal portion of an elongate member advanced to the occlusive region.

27. The method of claim 26, wherein the elongate member comprises a balloon catheter that is advanced over the tubular member to the occlusive region.

28. The method of claim 16, further comprising removing the guidewire from the distal portion of the elongate member before expanding the expandable member.

29. A method for treating an occlusive region of a patient'"'"'s vasculature using a tubular member comprising proximal and distal ends, a lumen therein extending from the proximal end to a side port in the distal portion, an expandable member on the distal portion between the side port and the distal end, and a loop on the distal end, the method comprising:

placing a guidewire through a patient'"'"'s vasculature to an occlusive region to be treated;

backloading the guidewire through the loop, around the expandable member, and through the lumen;

advancing the distal portion of the tubular member over the guidewire to the occlusive region;

expanding the expandable member on the tubular member to at least partially isolate the occlusive region;

removing the guidewire from the lumen;

advancing a treatment element through the lumen into the distal portion; and

treating the occlusive region using the treatment element.

30. The method of claim 29, wherein the treatment element causes at least a portion of the distal portion of the tubular member to assume a nonlinear configuration.

31. The method of claim 30, wherein the treating step comprises agitating the treatment element to disrupt or dislodge occlusive material from the occlusive region.

32. The method of claim 31, wherein the treating step further comprises introducing a thrombolytic agent into the occlusive region.

33. The method of claim 31, wherein the treating step further comprises creating a vacuum at the second side port to aspirate occlusive material from the occlusive region.

34. The method of claim 29, wherein the guidewire is removed from the lumen before expanding the expandable member.