Drug delivery PTCA catheter and method for drug delivery

• US 5,397,307 A
• Filed: 12/07/1993
• Issued: 03/14/1995
• Est. Priority Date: 12/07/1993
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Schneider Electric SE
• Inventors: Goodin, Richard
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/163,852
• Time in Patent Office: 462 Days
• Field of Search: 604/96-103, 604/265, 604/266, 604/52, 604/53, 606/192-196
• US Class Current: 604/103.07
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An intravascular material delivery dilation catheter having a pair of longitudinally spaced inflatable balloons with a drug delivery region defined therebetween. The catheter is ideally suited for use after a PTCA procedure, wherein the proximate balloon seals the blood vessel while the distal balloon is uniquely contoured when inflated to define fluid communication paths therepast and proximate a blood vessel to be treated. The distal balloon, when inflated, has four lobes but could also be textured. Each lobe is separated from the next by a groove, which groove in combination with the blood vessel inner wall forms a fluid communication path therebetween. Upon inflation of both balloons in a blood vessel, a medicament such as heparin can be injected, via the drug delivery region between the inflated balloons, wherein the medicament flows past the distal balloon at a selected rate. Accordingly, a medicament can be injected directly to a treatment site rather than injected as a bolus dose, thus, a smaller dosage may be employed to minimize side effects. Alternatively, perfusion can be accomplished by only partially inflating the proximate balloon to constrict flow therepast, or eliminating the proximate balloon entirely, where the drug delivery region is disposed upstream of the contoured distal balloon.

Claims

1. An intravascular drug delivery dilatation catheter comprising:

an elongated, flexible, tubular catheter shaft having a proximal end and a distal end with a first, second and third lumen each extending therealong, said shaft having first and second inflatable balloons longitudinally spaced from one another proximate said distal end and with a drug delivery region disposed between said first and second balloons, said first and second lumens being in fluid communication with said first and second balloons, respectively, and said third lumen being in fluid communication with said drug delivery region, said second balloon when inflated having an outer contoured surface for creating a fluid flow path from said drug delivery region and along said second balloon outer surface when said second balloon is inflated in a patient'"'"'s blood vessel.

2. The drug delivery dilation catheter as specified in claim 1 wherein said second balloon comprises a plurality of lobes when inflated, there being a longitudinal fluid path between each pair of adjacent ones of said lobes.

3. The drug delivery dilation catheter as specified in claim 2 wherein said second balloon has a balloon wall of a varying thickness to define said lobes when inflated.

4. The drug delivery dilation catheter as specified in claim 2 wherein said fluid paths are located angularly equidistantly from one another to facilitate uniform passage of a medication dispensed from said drug delivery region along said outer surface of said second balloon.

5. The drug delivery catheter as specified in claim 1 wherein said second balloon outer surface is textured when inflated for creating said fluid flow path.

6. The drug delivery catheter as specified in claim 1 wherein said second balloon outer surface includes a plurality of outwardly extending protrusions when inflated.

7. The drug delivery catheter as specified in claim 1 wherein said second balloon is comprised of a distensible material.

8. The drug delivery catheter as specified in claim 1 wherein said second balloon is comprised of a nondistensible material.

9. The drug delivery dilation catheter as specified in claim 1 wherein said first and second lumen are in fluid communication with each other to facilitate simultaneous inflation of said first and second balloons.

10. The drug delivery dilation catheter as specified in claim 1 further including a fourth lumen extending therethrough from said proximal end to said distal end for receiving a guidewire therethrough.

11. An intravascular drug delivery catheter, comprising:

an elongated, flexible, tubular catheter shaft having a proximal end and a distal end with a first and second lumen extending therealong, said shaft having an inflatable balloon disposed at the distal end thereof and with a drug delivery region disposed between said proximal end and said balloon, said first lumen being in fluid communication with said balloon and said second lumen being in communication with said drug delivery region, said balloon when inflated having an outer contoured surface for creating a fluid flow path from said drug delivery region and along said balloon outer surface when said balloon is inflated in a patient'"'"'s blood vessel.

12. The drug delivery dilation catheter as specified in claim 11 wherein said balloon comprises a plurality of lobes when inflated, there being a longitudinal fluid path between each pair of adjacent ones of said lobes.

13. The drug delivery dilation catheter as specified in claim 12 wherein said balloon has a balloon wall of a varying thickness to define said lobes when inflated.

14. The drug delivery dilation catheter as specified in claim 12 wherein said fluid paths are located angularly equidistantly from one another to facilitate uniform passage of a medication dispensed from said drug delivery region along said outer surface of said balloon.

15. The drug delivery catheter as specified in claim 11 wherein said balloon outer surface is textured when inflated for creating said fluid flow path.

16. The drug delivery catheter as specified in claim 11 wherein said balloon outer surface includes a plurality of outwardly extending protrusions when inflated.

17. The drug delivery catheter as specified in claim 11 wherein said balloon is comprised of a distensible material.

18. The drug delivery catheter as specified in claim 11 wherein said balloon is comprised of a nondistensible material.

19. The drug delivery dilation catheter as specified in claim 11 further including a fourth lumen extending therethrough from said proximal end to said distal end for receiving a guidewire therethrough.

20. The drug delivery dilation catheter as specified in claim 11 wherein said drug delivery region is disposed proximate said balloon.

21. A method of delivering a dispersant into a selected portion of a patient'"'"'s blood vessel comprising steps of:

(a) providing an elongated, flexible catheter having first and second inflatable balloons longitudinally spaced from one another proximate a distal end of said catheter with a drug delivery region disposed between said first and second balloons;

(b) inserting said catheter into the patient'"'"'s blood vessel such that said second balloon is disposed adjacent an inner wall of said blood vessel along said selected portion thereof;

(c) inflating said first balloon to seal against the blood vessel inner wall;

(d) inflating said second balloon such that a first portion thereof is disposed closely proximate but spaced from said blood vessel'"'"'s inner wall;

(e) injecting said dispersant through said drug delivery region into the blood vessel between said first and second balloon such that the dispersant flows between and past said inflated second balloon and said blood vessel inner wall.

22. The method as specified in claim 21 wherein said second balloon is contoured when expanded causing said first portion of said second balloon to be spaced from said blood vessel inner wall while a second portion of said second balloon engages the blood vessel inner wall, whereby at least one drug flow path is defined between said blood vessel inner wall and said first portion of said inflated second balloon.

23. The method as specified in claim 22 comprising the step of injecting a drug-containing liquid as said dispersant.

24. The method as specified in claim 21 wherein said second balloon is positioned proximate an atherosclerotic lesion in step (b).

25. A method of delivering a dispersant into a selected portion of a patient'"'"'s blood vessel, comprising the steps of:

(a) providing a catheter having a first and second longitudinally spaced flow impeding members with a drug delivery region defined therebetween;

(b) disposing said catheter in said patient'"'"'s blood vessel such that said first flow impeding member is positioned upstream of said blood vessel selected portion and said second flow impeding member is positioned downstream thereof and closely proximate said blood vessel selected portion;

(c) impeding flow in said blood vessel at said first flow impeding member, and impeding flow in said blood vessel at said second flow impeding member such that a fluid can flow past said second flow impeding member and adjacent the blood vessel selected portion; and

(d) dispensing a dispersant from the catheter drug delivery region such that said dispersant flows past said second flow impeding member and closely proximate said blood vessel selected portion.

26. The method as specified in claim 25 wherein said first flow impeding member seals said blood vessel in step (c) to prevent flow therepast.

27. The method as specified in claim 25 wherein said second flow impeding member is an inflatable balloon with a contoured outer surface when inflated, and step (c) includes the step of disposing said contoured outer surface proximate said blood vessel selected portion to constrict flow therepast.

28. The method as specified in claim 27 wherein said first flow impeding member is an inflatable balloon, and is inflated in step (c) to impede flow in said blood vessel.

29. The method as specified in claim 28 wherein said second flow impeding member is positioned in step (b) proximate an atherosclerotic lesion.

30. The method as specified in claim 25 comprising the step of injecting a drug containing liquid as said dispersant.

31. The method as specified in claim 25 including the step of introducing a guidewire through the patient'"'"'s blood vessel to the blood vessel selected portion prior to introducing said catheter, and subsequently positioning said catheter over said guidewire and through the patient'"'"'s blood vessel.

32. A method of delivering a dispersant into a selected portion of a patient'"'"'s blood vessel, comprising the steps of:

(a) providing a catheter having a proximate end and a distal end, a first flow impeding member at said distal end, and a drug delivery region disposed between said catheter proximate end and said flow impeding member;

(b) disposing said catheter in said patient'"'"'s blood vessel such that said flow impeding member is positioned proximate said blood vessel selected portion and said drug delivery region is positioned upstream thereof;

(c) impeding flow in said blood vessel at said flow impeding member such that fluid can flow past said flow impeding member and adjacent said blood vessel selected portion; and

(d) dispensing a dispersant from the catheter drug delivery region such that said dispersant flows past said flow impeding member and closely proximate said blood vessel selected portion.

33. The method as specified in claim 32 wherein said flow impeding member is an inflatable balloon with a contoured outer surface when inflated, and step (c) includes the step of disposing said contoured outer surface proximate said blood vessel selected portion to constrict flow therepast.

34. The method as specified in claim 33 further comprising the step of inflating said balloon such that a portion of said contoured outer surfaces engages said blood vessel selected portion.