Methods and apparatuses for drug delivery to an intravascular occlusion

• US 20020062119A1
• Filed: 12/28/2001
• Published: 05/23/2002
• Est. Priority Date: 05/20/1996
• Status: Active Grant

• Current Assignee: Mirage IP LLC (IP Edge LLC)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Zadno-Azizi, Gholam-Reza
• Granted Patent: US 6,958,059 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• 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 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 2017/22048 Balloons
• 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 2217/005 with suction drainage system
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61M 2025/0018 having a plug, e.g. an inflatable plug for closing catheter lumens
• CPC Class Codes: A61M 2025/09008 having a balloon
• CPC Class Codes: A61M 2025/09116 Design of handles or shafts or gripping surfaces thereof for manipulating guide wires
• CPC Class Codes: A61M 2025/09125 Device for locking a guide wire in a fixed position with respect to the catheter or the human body
• CPC Class Codes: A61M 2025/09141 made of shape memory alloys which take a particular shape at a certain temperature
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• 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 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1079 : having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1081 : having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2025/109 : having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 2025/1093 : having particular tip characteristics
• CPC Class Codes: A61M 2210/0693 : Brain, cerebrum
• CPC Class Codes: A61M 25/0009 : Making of catheters or other medical or surgical tubes
• 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 25/0051 : made from fenestrated or weakened tubing layer
• CPC Class Codes: A61M 25/0052 : Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: A61M 25/0053 : having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/0054 : with regions for increasing flexibility
• CPC Class Codes: A61M 25/0068 : Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0071 : Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026
• CPC Class Codes: A61M 25/0075 : Valve means
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: A61M 25/09033 : with fixed mandrils, e.g. mandrils fixed to tip; Tensionable wires
• 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
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 25/10182 : Injector syringes
• CPC Class Codes: A61M 25/10184 : Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/104 : used for angioplasty

Abstract

A method for delivering a drug to the site of an intravascular occlusion. A guidewire having a balloon at one end is advanced across the occlusion using a guide catheter, and the balloon is inflated distal to the occlusion to occlude the blood vessel. An aspiration catheter is then inserted into the vessel with its tip less than about 5 mm from the surface of the balloon, and a drug is delivered which flows distal to proximal to treat the occlusion.

Claims

1. A method for treating an intravascular occlusion, comprising the step of delivering fluid containing an occlusion-treating drug such that at least a portion of the drug contacts an intravascular occlusive device.

2. The method of claim 1, wherein said occlusive device is a balloon.

3. The method of claim 1, wherein said drug is a thrombolytic agent.

4. The method of claim 1, wherein said drug is an anticoagulant.

5. The method of claim 1, wherein said drug is a radioisotope.

6. The method of claim 1, wherein said drug is delivered at a flow rate of between about 0.1 and 10 cc/second.

7. The method of claim 6, wherein said drug is delivered at a flow rate of between about 0.5 and 2 cc/second.

8. The method of claim 7, wherein said drug is delivered at a flow rate of between about 0.5 and 1 cc/second.

9. A method for treating an intravascular occlusion, comprising:

delivering an occlusive device into a blood vessel to a site near said occlusion;

delivering a catheter having a proximal end and distal end to the site of said occlusion such that the distal end of said catheter is proximal to the occlusive device;

actuating said occlusive device at a location distal to said occlusion to at least partially occlude blood flow through said vessel; and

delivering a drug-containing fluid from the distal end of said catheter such that at least a portion of the drug-containing fluid contacts said occlusive device.

10. The method of claim 9, whereby said drug travels in a distal to proximal direction after contacting said occlusive device.

11. The method of claim 9, wherein said occlusive device is a balloon.

12. The method of claim 9, wherein said drug is a thrombolytic agent.

13. The method of claim 9, wherein said drug is an anticoagulant.

14. The method of claim 9, wherein said drug is a radioisotope.

15. The method of claim 9, wherein said drug is delivered at a flow rate of between about 0.1 and 10 cc/second.

16. The method of claim 15, wherein said drug is delivered at a flow rate of between about 0.5 and 2 cc/second.

17. The method of claim 16, wherein said drug is delivered at a flow rate of between about 0.5 and 1 cc/second

18. The method of claim 9, wherein said catheter is an aspiration catheter.

19. The method of claim 18, further comprising aspirating particles broken off from the occlusion during delivery of the guidewire past the occlusion through said aspiration catheter.

20. The method of claim 9, wherein the tip of said catheter is placed between about 0.5 and 10 mm from the surface of said occlusive device.

21. The method of claim 20, wherein the tip of said catheter is placed between about 1 and 5 mm from the surface of said occlusive device.

22. The method of claim 9, further comprising aspirating particles broken off from said occlusion through said catheter after delivering the drug-containing fluid.

23. The method of claim 9, wherein the occlusive device is provided on a distal end of a guidewire.

24. The method of claim 23, wherein the catheter is delivered over the guidewire.

25. The method of claim 23, wherein the catheter is delivered before delivering the guidewire.

27. The method of claim 26, further comprising the steps of removing said catheter, performing further treatment and aspirating particles generated by the further treatment.

28. The method of claim 26, further comprising the step of aspirating while crossing the occlusion with the guidewire.

29. The method of claim 26, wherein a guidewire lacking an occlusive device is delivered to create space, then exchanged for the guidewire having an occlusive device.

30. The method of claim 26, wherein said guidewire has holes at its proximal end.

31. The method of claim 26, wherein said occlusive device is a balloon.

32. The method of claim 26, wherein said catheter rides over said guidewire.

33. The method of claim 26, wherein said catheter and said guidewire are delivered simultaneously.

34. The method of claim 26, wherein said guidewire is delivered first.

35. The method of claim 26, wherein said catheter is delivered first.

37. The method of claim 36, wherein the fluids are delivered through side ports in the hollow wire.

38. The method of claim 36, wherein the fluids are delivered through an irrigation hole at the distal end of the hollow wire.

39. The method of claim 36, wherein the hollow wire includes an occlusive device at its distal end.

40. The method of claim 36, wherein the occlusive device is an inflatable balloon.

41. The method of claim 36, wherein the inflatable balloon is inflated through the lumen using said fluids.

26. A method of treating an intravascular occlusion in a blood vessel, comprising:

delivering a guidewire having an occlusive device to the site of the occlusion such that the occlusive device is distal to the occlusion;

delivering a catheter having a proximal end and a distal end and a lumen extending therethrough to the site of the occlusion such that the distal end of the catheter is proximal to the occlusive device;

actuating the occlusive device to at least partially obstruct blood flow through the blood vessel;

delivering a treatment fluid through the lumen of the catheter such that the fluid flows in a proximal to distal direction out of the distal end of the catheter, and then flows in a distal to proximal direction after contacting the occlusive device; and

aspirating particles generated by the action of the treatment fluid on the occlusion through the lumen of the catheter at the distal end.

36. A method for crossing an intravascular occlusion in a blood vessel, the method comprising:

delivering a hollow wire in a proximal to distal direction past the occlusion; and

delivering fluids through a lumen in said hollow wire to dissolve said occlusion while crossing of the occlusion with the hollow wire.

42. A method for treating an intravascular occlusion, comprising:

delivering a catheter having a proximal end and a distal end and a lumen extending therethrough into a blood vessel to a site near said occlusion, the catheter having an occlusive device on the distal end;

actuating said occlusive device at a location distal to said occlusion to at least partially occlude blood flow through said vessel; and

delivering a drug-containing fluid injected through the lumen of said catheter across said occlusion in a distal to proximal direction.

43. The method of claim 42, wherein the drug-containing fluid is delivered through a plurality of holes in the catheter proximal to the occlusive device.

44. The method of claim 42, wherein the occlusive device is a balloon.

45. The method of claim 44, wherein the drug-containing fluid is delivered through a plurality of holes in a proximal face of the balloon.

46. The method of claim 45, wherein the drug-containing fluid delivered through the lumen is used to inflate the balloon.

47. The method of claim 42, wherein the drug-containing fluid is delivered at a flow rate of between about 0.1 to 3 cc/second.