Stent and therapeutic delivery system

• US 5,685,847 A
• Filed: 07/27/1995
• Issued: 11/11/1997
• Est. Priority Date: 06/30/1994
• Status: Expired due to Term

• Current Assignee: Boston Scientific Corporation
• Original Assignee: Boston Scientific Corporation
• Inventors: Barry, James
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/507,844
• Time in Patent Office: 838 Days
• Field of Search: 604/96, 604/101, 604/102, 604/103, 604/104, 604/53, 604/52, 604/157-163, 604/49, 606/192-194
• US Class Current: 604/96.01
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• 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 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Apparatus and a method for treating an irregularity in a wall of a vessel of a patient defined by an irregular or afflicted wall portion with adjacent normal wall portions comprises a catheter having a distal end portion for being guided through the vessel to the site of the irregularity. A balloon associated with said distal end portion of the catheter for selective inflating to contact the walls of the vessel urges a stent carried by the distal end portion of the catheter in a constricted condition for passage through the vessel into an expanded form with the stent spanning the afflicted wall portion and contacting the adjacent wall portions. The catheter is formed with lumens for inflating the balloon, for receiving a guidewire for guiding the catheter through the vessel, and for connecting a port in the catheter proximate the afflicted wall portion to enable delivery of a therapeutic agent into the vessel to contact the stent and the irregular wall portion.

Claims

1. A catheter assembly for dispensing a stent and administering a therapeutic agent in a patient'"'"'s vessel, said catheter assembly comprising:

A. elongated flexible tube means including lumens therein, said flexible tube means having a distal end portion for delivering a stent positioned distally on said flexible tube means to the site of the irregularity in the vessel and a proximal end portion for controlling said distal end portion through said lumens;

B. expansible means at said distal end portion for being extended and retracted responsive to manipulation at said proximal end portion through one of said lumens, the extension of said expansible means causing a deployment of the stent; and

C. delivery means associated with said flexible tube means for delivering a therapeutic agent proximate the stent and adjacent portions of the vessel responsive to manipulation of said proximal end portion.

2. An assembly as recited in claim 1 further comprising a balloon means carried by said flexible tube means at a location that is spaced from said expansible means for limiting the opening in the vessel upon inflation of said balloon means.

3. An assembly as recited in claim 2 further comprising second balloon means carried by said flexible tube means oppositely spaced from said expansible means relative to said first balloon means for limiting the opening in the vessel upon inflation of said second balloon means.

4. An assembly as recited in claim 1 further including vacuum port in said distal end portion for selectively evacuating fluid proximate said expansible means.

5. An assembly as recited in claim 4 further comprising a balloon means carried by said flexible tube means at a location that is spaced from said expansible means for limiting the opening in the vessel upon inflation of said balloon means.

6. An assembly as recited in claim 5 wherein said lumens include an inflation lumen for inflating and deflating said balloon means.

7. An assembly as recited in claim 5 further comprising second balloon means carried by said flexible tube means oppositely spaced from said expansible means relative to said first balloon means for limiting the opening in the vessel upon inflation of said second balloon means.

8. An assembly as recited in claim 7 wherein said lumens include at least one inflation lumen for inflating and deflating said first and second balloon means.

9. An assembly as recited in claim 4 further comprising a vacuum source wherein said lumens include an evacuation lumen connecting said vacuum source with said vacuum port to enable evacuation of fluid in the vessel proximate the stent.

10. An assembly as recited in claim 9 wherein said delivery means includes said vacuum port and evacuation lumen and a source means for selectively delivering the therapeutic agent through said vacuum port proximate the stent.

11. An assembly as recited in claim 1 wherein said delivery means includes source means for providing the therapeutic agent proximate the stent.

13. An assembly as recited in claim 11 wherein said therapeutic agent comprises an antiplatelet therapeutic agent.

14. An assembly as recited in claim 11 wherein said therapeutic agent comprises a genetic agent.

15. An assembly as recited in claim 11 wherein said therapeutic agent includes an antiproliferative agent.

16. An assembly as recited in claim 11 wherein said therapeutic agent includes a chemotherapeutic agent.

17. An assembly as recited in claim 11 wherein said therapeutic agent includes an antioxidant agent.

18. An assembly as recited in claim 11 wherein said therapeutic agent comprises a vasorelaxant agent.

19. An assembly as recited in claim 11 wherein said therapeutic agent is a drug with multiple effects.

20. An assembly as recited in claim 19 wherein said drug comprises nitric oxide.

21. An assembly as recited in claim 11 wherein said therapeutic agent comprises an active agent and carrier means for attaching proximate the irregularity in the vessel.

22. An assembly as recited in claim 21 wherein said carrier means includes polymers.

23. An assembly as recited in claim 21 wherein said carrier means encapsulates said active agent.

24. An assembly as recited in claim 21 wherein said carrier means attaches to the stent.

12. An assembly as recited in 11 wherein said therapeutic agent comprises an antithrombin agent.

25. A method for treating an irregularity in a vessel wall adjacent normal wall portions by disposing a stent in contact with the vessel wall, the stent being carried at a distal end of a catheter and said method comprising the steps of:

A. positioning the distal end of the catheter proximate the vessel wall irregularity from a proximal end of the catheter;

B. expanding the stent carried by the catheter to span the irregularity and contact the adjacent normal wall portions;

C. inflating a balloon formed as part of the catheter proximate the distal end of the catheter to expand the balloon proximate the vessel walls to limit the flow of bodily fluid through the vessel past the stent; and

D. introducing from the proximal end of the catheter a therapeutic agent for contacting the vessel proximate the irregular wall portion and the stent.

26. A method for treating an irregularity in the wall of a vessel as recited in claim 25 further comprising defining an isolated volume in the vessel extending at least proximally of the stent and evacuating at least a portion of fluid the isolated volume.

27. A method for treating an irregularity in the wall of a vessel as recited in claim 26 further comprising deflating the balloon to enable unobstructed flow of the bodily fluid through the vessel and enable withdrawal of the distal end of the catheter through the deployed stent, wherein said step of delivering the therapeutic agent delivers the therapeutic agent into the isolated volume.

28. A method for treating an irregularity in the wall of a vessel as recited in claim 27 further comprising the step of inflating a second balloon at the distal end of the catheter through a second inflation lumen in the catheter positioned proximate a stenotic portion of the vessel so as to dilate and open the vessel thereat wherein said steps of inflating the first balloon, deploying the stent and delivering the therapeutic agent treat occur after said step of inflating said second balloon.

29. A method for treating an irregularity in the wall of a vessel as recited in claim 27 further comprising inflating a second balloon spaced from said first balloon at the distal end of the catheter such that the isolated volume defined in the vessel by the first balloon extends between the first and second balloon and includes the irregular wall portion wherein said step of delivering the therapeutic agent delivers the therapeutic agent into the isolated volume.

30. A method for treating an irregularity in the wall of a vessel as recited in claim 27 wherein the step of evacuating includes removing portions of the therapeutic agent delivered by said delivery step from the isolated volume through a vacuum port in the catheter proximate the balloon.