Apparatus and method for performing thrombolysis

• US 20030097114A1
• Filed: 11/20/2001
• Published: 05/22/2003
• Est. Priority Date: 11/20/2001
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Greenberg, Roy K., Goodson, Harry B., Ouriel, Kenneth
• Granted Patent: US 6,755,813 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• 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 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked

Abstract

An apparatus (10) for delivery of an infusate into a body lumen (12) to perform thrombolysis comprises a catheter (24) having an infusion section (40) defined by a plurality of infusion ports (42) for delivering the infusate. The infusion ports (42) are spaced axially apart along the length of the infusion section (40). A sheath (50) coaxially surrounds a portion of the catheter (24). The sheath (50) is axially movable relative to the catheter (24) to selectively uncover at least a portion of the infusion ports (42) and thereby control the amount and distribution of the infusate delivered by the infusion section (40).

Claims

1. An apparatus for delivery of an infusate into a body lumen to perform thrombolysis, said apparatus comprising:

a catheter having an infusion section defined by a plurality of infusion ports for delivering the infusate, said plurality of infusion ports being spaced axially apart along the length of said infusion section; and

a sheath coaxially surrounding a portion of said catheter, said sheath being axially movable relative to said catheter to selectively uncover at least a portion of said plurality of infusion ports and thereby control the amount and distribution of the infusate delivered by said infusion section.

2. The apparatus of claim 1 wherein said sheath has an inner diameter that is approximately equal to an outer diameter of said catheter to prevent infusate from being delivered through a portion of said plurality of infusion ports covered by said sheath.

3. The apparatus of claim 1 wherein said plurality of infusion ports are spaced along said infusion section in a helical pattern.

4. The apparatus of claim 1 wherein said sheath has a distal end that seals around said catheter.

5. The apparatus of claim 1 further comprising a tubular member extending through said catheter and projecting axially beyond said infusion section of said catheter.

6. The apparatus of claim 5 wherein said catheter has a distal end that seals around said tubular member.

7. The apparatus of claim 5 wherein said plurality of infusion ports can deliver the infusate at a flow rate of up to 200 cc/hr.

8. An apparatus for dissolving thrombus in a body lumen, said apparatus comprising:

relatively movable first and second tubular members, said first tubular member being at least partially disposed coaxially within said second tubular member, said first tubular member having a plurality of infusion ports for directing the flow of a thrombolytic liquid, said plurality of infusion ports being spaced axially apart, at least a portion of said plurality of infusion ports being coverable by said second tubular member; and

an infusion section having an axial length that is variable, said infusion section being defined by an uncovered portion of said plurality of infusion ports, said axial length of said infusion section being varied by relative movement between said first and second tubular members which changes the quantity of said infusion ports in said uncovered portion of said plurality of infusion ports.

9. The apparatus of claim 8 wherein said plurality of infusion ports can deliver the thrombolytic fluid at a flow rate of up to 200 cc/hr.

10. The apparatus of claim 9 wherein said plurality of infusion ports are spaced along said infusion section in a helical pattern.

11. The apparatus of claim 8 wherein said axial length of said infusion section can be varied from 0 to 50 centimeters.

12. The apparatus of claim 8 wherein said second tubular member has a distal end that seals around said first tubular member.

13. The apparatus of claim 8 further comprising a catheter extending through said first tubular member and projecting axially beyond said infusion section.

14. The apparatus of claim 13 wherein said first tubular member has a distal end that seals around said catheter.

15. The apparatus of claim 14 wherein said plurality of infusion ports vary in size and increase in diameter toward said distal end of said first tubular member.

16. The apparatus of claim 8 wherein said axial length of said infusion section can be varied while the thrombolytic fluid is being directed through said plurality of infusion ports.

17. An apparatus for dissolving thrombus in a body lumen, said apparatus comprising:

a catheter assembly having an infusion section with a variable axial length, said infusion section including an axially spaced plurality of infusion ports for directing the flow of a thrombolytic fluid;

said catheter assembly including means for selectively covering a portion of said plurality of infusion ports to control said variable axial length of said infusion section and thereby control the distribution of thrombolytic fluid flow.

18. The apparatus of claim 17 wherein said catheter assembly comprises relatively movable first and second tubular members that are coaxially disposed.

19. The apparatus of claim 18 wherein said plurality of infusion ports is located in said first tubular member.

20. The apparatus of claim 18 wherein said means for selectively covering a portion of said plurality of infusion ports comprises said second tubular member.

21. The apparatus of claim 17 wherein said plurality of infusion ports are spaced along said infusion section in a helical pattern.

22. The apparatus of claim 17 wherein said plurality of infusion ports can deliver the thrombolytic fluid at a flow rate of up to 200 cc/hr.

23. The apparatus of claim 17 wherein said means for selectively covering a portion of said plurality of infusion ports can vary said axial length of said infusion section from 0 to 50 centimeters.

24. The apparatus of claim 17 wherein said means for selectively covering a portion of said plurality of infusion ports is operable to vary said axial length of said infusion section while the thrombolytic fluid is being directed through said plurality of infusion ports.

25. A method for dissolving thrombus in a body lumen, said method comprising the steps of:

providing a catheter assembly having an infusion section with an adjustable axial length, the infusion section including a plurality of infusion ports for directing flow of a thrombolytic agent;

adjusting the axial length of the infusion section to a desired length based on the size and location of thrombotic material in a body lumen;

inserting the catheter assembly into the body lumen containing the thrombotic material and positioning the catheter assembly in the body lumen so that the plurality of infusion ports lie adjacent the thrombotic material; and

infusing a thrombolytic agent through the catheter assembly and directing the flow of the thrombolytic agent against the thrombotic material to dislodge and dissolve the thrombotic material.

26. The method of claim 25 wherein said step of adjusting the axial length of the infusion section comprises relative axial movement between coaxial first and second tubular members which results in a portion of the plurality of infusion being covered or uncovered.

27. The method of claim 25 wherein said step of adjusting the axial length of the infusion section is repeated during said step of infusing a thrombolytic agent to account for changes in the size and location of the thrombotic material during said step of infusing a thrombolytic agent.