Methods and Apparatus for Sclerosing the Wall of a Varicose Vein

• US 20060189930A1
• Filed: 05/03/2006
• Published: 08/24/2006
• Est. Priority Date: 07/21/2000
• Status: Active Grant

• Current Assignee: Lary Research & Development LLC
• Original Assignee: Lary Research & Development LLC
• Inventors: Slater, Charles R., Pinchuk, Leonard, Lary, Banning G., Gottlieb, Saul
• Granted Patent: US 7,985,200 B2
• Time in Patent Office: Days
• US Class Current: 604/101.10
• 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 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• 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 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• 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

Abstract

A preferred apparatus for delivering an intravascular drug such as a sclerosing agent (or a microfoam sclerosing agent) to a varicose vein includes a catheter having three concentric tubes. The innermost tube has a guide wire lumen and an inflation lumen. The distal end of the innermost tube has an integral inflatable occlusion balloon in fluid communication with the inflation lumen. The intermediate tube has a lumen through which the innermost tube extends. The distal end of the intermediate tube has a self-expanding balloon with a plurality of fluid pores in fluid communication with the intermediate tube lumen. The outer tube has a lumen through which the intermediate tube extends. Sclerosing agent is dispensed through the intermediate tube to pores located at the distal end of the intermediate tube or in the self-expanding balloon. Veins are sclerosed as the self-expanding balloon is pulled through and ultimately out of the vein.

Claims

1. An apparatus for delivering an intravascular drug, said apparatus comprising:

a) a first catheter tube having a proximal end, a distal end, and a fluid lumen extending from its proximal end to its distal end;

b) an inflatable balloon coupled to said distal end of said first catheter and in fluid communication with said fluid lumen;

c) a second catheter tube having a proximal end, a distal end, and a lumen extending from its proximal end to its distal end, said first catheter tube extending through said lumen of said second catheter tube;

d) a self-expanding balloon coupled to said distal end of said second catheter tube, said first catheter tube extending through said self-expanding balloon; and

e) a third catheter tube having a proximal end, a distal end, and a lumen extending from its proximal end to its distal end, said second catheter tube extending through said lumen of said third catheter tube, wherein

at least one of said second catheter tube and said third catheter tube is adapted to receive and deliver the intravascular drug to the location of said self-expanding balloon.

2. An apparatus according to claim 1, wherein:

said first catheter tube has a guide wire lumen extending from its proximal end to its distal end.

3. An apparatus according to claim 1, wherein:

said second catheter tube is adapted to receive and deliver the intravascular drug, and

said self-expanding balloon includes a plurality of fluid pores, said fluid pores being in fluid communication with said lumen of said second catheter tube.

4. An apparatus according to claim 1, wherein:

said second catheter tube is adapted to receive and deliver the intravascular drug, and

said distal end of said lumen of said second catheter tube has a plurality of fluid pores.

5. An apparatus according to claim 1, wherein:

said third catheter tube is adapted to receive and deliver the intravascular drug.

6. An apparatus according to claim 1, wherein:

said third catheter tube has a proximal locking means for locking the location of said second catheter tube relative to said third catheter tube.

7. An apparatus according to claim 1, wherein:

said first catheter tube is adapted to receive the intravascular drug by having a proximal port in fluid communication with said fluid lumen of said first catheter tube.

8. An apparatus according to claim 1, wherein:

said second catheter tube is adapted to receive the intravascular drug by having a proximal port at said proximal end of said second catheter tube in fluid communication with said fluid lumen of said second catheter tube.

9. An apparatus according to claim 1, further comprising:

f) a fourth catheter tube having a proximal end, a distal end, and a lumen extending from its proximal end to its distal end, said third catheter tube extending through said lumen of said fourth catheter tube; and

g) a second inflatable balloon coupled to the distal end of said fourth catheter.

10. An apparatus according to claim 1, further comprising:

f) a drug dispenser having a drug reservoir and a drug outlet, said drug outlet being fluidly coupled to said fluid delivery means, said drug dispenser being adapted to automatically dispense the drug from the reservoir into the fluid delivery means as said second catheter tube is moved through a blood vessel.

11. An apparatus according to claim 10, wherein:

said drug reservoir is a syringe having a plunger, and

said drug dispenser includes means for moving said plunger as said second catheter tube is moved through a blood vessel.

12. An apparatus according to claim 11, wherein:

said means for moving said plunger includes a gear coupled to said plunger, a spool coupled to said gear, and a filament, ribbon, or cable coupled to said spool.

13. An apparatus according to claim 10, wherein:

said drug dispenser includes means for coupling said drug reservoir to a patient'"'"'s limb.

14. An apparatus according to claim 10, wherein:

said drug dispenser includes means for coupling said drug reservoir to one of said catheter tubes.

31. An apparatus according to claim 11, wherein:

said means for moving said plunger includes a filament, pull wire, ribbon, or cable.

15. An apparatus for delivering an intravascular drug, said apparatus comprising:

a) a catheter having a proximal end, a distal end, and a lumen extending from its proximal end to its distal end;

b) a drug reservoir having a drug outlet, said drug outlet being fluidly coupled to the proximal end of the lumen of the catheter,

c) dispensing means coupled to said drug reservoir, said dispensing means being adapted to automatically dispense the drug from the reservoir into the lumen of the catheter as the catheter is moved through a blood vessel.

16. An apparatus according to claim 15, wherein:

said drug reservoir is a syringe having a plunger, and

said dispensing means includes means for moving said plunger as said catheter is moved through a blood vessel.

17. An apparatus according to claim 16, wherein:

said means for moving said plunger includes a gear coupled to said plunger, a spool coupled to said gear, and a filament or cable coupled to said spool.

18. An apparatus according to claim 15, further comprising:

d) attachment means for attaching said drug reservoir to a patient'"'"'s limb.

19. An apparatus according to claim 15, further comprising:

d) attachment means for attaching said drug reservoir to said catheter.

32. An apparatus according to claim 16, wherein:

said means for moving said plunger includes a filament, pull wire, ribbon, or cable.

33. An apparatus according to claim 32, further comprising:

d) attachment means for attaching said drug reservoir to a patient'"'"'s limb.

34. An apparatus according to claim 32, further comprising:

d) attachment means for attaching said drug reservoir to said catheter.

20. An apparatus for delivering an intravascular drug, said apparatus comprising:

a) a first catheter tube having a proximal end, a distal end, and a lumen extending from its proximal end to its distal end;

b) a self-expanding balloon coupled to said distal end of said first catheter tube; and

c) a second catheter tube having a proximal end, a distal end, and a lumen extending from its proximal end to its distal end, said first catheter tube extending through said lumen of said second catheter tube, wherein

at least one of said first catheter tube and said self-expanding balloon includes pores, and said first catheter tube is adapted to receive and deliver the intravascular drug to said pores.

21. An apparatus according to claim 20, wherein:

said self-expanding balloon is comprised of spring wires and a thin membrane coupled to said spring wires.

22. An apparatus according to claim 20, wherein:

said self-expanding balloon includes an abrasive outer surface.

23. An apparatus according to claim 20, wherein:

said self-expanding balloon is made of plastic.

24. An intravascular apparatus, comprising:

a) a first catheter tube having a proximal end, a distal end, and a lumen extending from its proximal end to its distal end;

b) a self-expanding balloon coupled to said distal end of said second catheter tube and having an abrasive outer surface; and

c) a second catheter tube having a proximal end, a distal end, and a lumen extending from its proximal end to its distal end, said first catheter tube extending through said lumen of said second catheter tube.

25. An intravascular apparatus according to claim 24, wherein:

at least one of said first catheter tube and said self-expanding balloon includes pores, and said first catheter tube is adapted to receive and deliver an intravascular drug to said pores.

26. A kit for the intravascular treatment of a blood vessel, said kit comprising:

a) a catheter having an expandable balloon at its distal end and a drug delivery lumen; and

b) a drug dispenser having a drug reservoir fluidly coupled to said drug delivery lumen, wherein

said drug dispenser includes means for automatically dispensing a drug from said drug reservoir into said drug delivery lumen in response to movement of said catheter through the blood vessel.

27. A kit according to claim 26, wherein:

said drug reservoir includes a syringe having a plunger and said means for automatically dispensing includes means for depressing said plunger.

28. An apparatus for delivering an intravascular drug, said apparatus comprising:

a) a first catheter tube having a proximal end, a distal end, and a first lumen extending from its proximal end to its distal end;

b) a first inflatable balloon coupled to said distal end of said first catheter and in fluid communication with said first lumen;

c) a second catheter tube having a proximal end, a distal end, and a second lumen extending from its proximal end to its distal end, said first catheter tube extending through said second lumen;

d) a second inflatable balloon coupled to said distal end of said second catheter tube and in fluid communication with said second lumen; and

e) a third catheter tube having a proximal end, a distal end, and a third lumen extending from its proximal end to its distal end, said second catheter tube extending through said third lumen, wherein

said third lumen is adapted to receive and deliver the intravascular drug to the location of said second inflatable balloon.

29. An apparatus for delivering an intravascular drug, said apparatus comprising:

a) a first catheter tube having a proximal end, a distal end, and a lumen extending from its proximal end to its distal end; and

b) a brush having a plurality of hollow bristles coupled to said distal end of said first catheter tube and being in fluid communication with said lumen, wherein

said first catheter tube includes means for injecting a vascular drug into said lumen such that the drug exits through said hollow bristles of said brush.

30. An apparatus according to claim 29, further comprising:

c) a second catheter tube having a proximal end, a distal end, and a lumen extending from its proximal end to its distal end, said first catheter tube extending through said lumen of said second catheter tube.