Drug delivery catheter with manifold

• US 5,554,119 A
• Filed: 01/27/1994
• Issued: 09/10/1996
• Est. Priority Date: 08/02/1991
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: SciMed Ltd. (Cardinal Health, Inc.)
• Inventors: Miller, Matthew J., Holman, Thomas J., Harrison, Kent D., Lafontaine, Daniel M., Robinson, David B., Hendrickson, Gary L.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): Bockelman, Mark
• Application Number:
  US08/187,614
• Time in Patent Office: 957 Days
• Field of Search: 604/96-103, 606/192-194
• US Class Current: 604/103.01
• CPC Class Codes: A61M 16/0431 with a cross-sectional shape other than circular
• CPC Class Codes: A61M 16/0459 one cuff behind another
• CPC Class Codes: A61M 16/0481 through the cuff wall
• 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 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

A drug delivery catheter which may be inserted into a vessel, such as a blood vessel is disclosed. The drug delivery catheter comprises any elongated tubular member which has a proximal end and a distal end. A drug lumen which provides a communication path for fluid is provided in the elongated tubular member for delivering a fluid, such as the drug to be administered. An inflatable balloon assembly is provided at the distal end of the elongated tubular member. The balloon assembly includes apertures which communicate with the drug lumen. The balloon assembly comprises a tubular balloon which is helically wound through the elongated tubular member and a sheath. The sheath is attached to the helically wound tubular balloon such that when the balloon member is uninflated, the first fluid in the vessel flows around the balloon assembly and such that when the balloon member is inflated, sections of the helically wound balloon contact the vessel wall to form a containment pocket between the vessel wall, the contacting sections of the balloon and the sheath. The apertures are provided in the containment pocket. An inflatable lumen is defined through the interior of the helically wound balloon and the sheath to allow perfusion of the first fluid.

Claims

1. A drug delivery catheter for insertion into a vessel which contains a first flowing fluid, the drug delivery catheter comprising:

an elongated tubular member having a proximal end and a distal end;

a drug lumen in fluid communication with the distal end of the tubular member for delivering a second fluid;

an inflatable balloon assembly disposed at the distal end of the tubular member, the balloon assembly including an inflatable balloon member having an uninflated state and an inflated state;

aperture means for delivering the second fluid from said drug lumen to said vessel;

the balloon assembly, comprising a tubular balloon helically wound through the elongated tubular member creating balloon members and a sheath attached between the balloon members such that (1) when the balloon members are in an uninflated state, the first fluid in the vessel may flow around the balloon assembly, and (2) when the balloon members are in an inflated state, sections of the balloon members contact the vessel wall defining at least one containment pocket for containing the second fluid between the vessel wall, the contacting sections of the balloon assembly and the sheath, the aperture means being disposed in the containment pocket and an inflatable lumen being defined through the interior of the balloon members and sheath to allow the first fluid to flow through the balloon members; and

an inflation lumen in fluid communication with the balloon members for inflating the balloon members.

2. The drug delivery catheter of claim 1 wherein the balloon member has a diameter of between approximately 2.0 mm and 6.0 mm in the inflated state.

3. The drug delivery catheter of claim 2 wherein the inflatable lumen has an internal diameter of at least 0.035 inches.

4. The drug delivery catheter of claim 1 wherein the sheath is formed around the outer periphery of the balloon member.

5. The drug delivery catheter of claim 1 wherein the inflatable lumen has an internal diameter of at least 0.035 inches.

6. The drug delivery catheter of claim 1 wherein the apertures in the balloon assembly comprise slits in the elongated tubular member.

7. The drug deliver catheter of claim 1 wherein the aperture is located in the elongated tubular member such that fluid flowing from the drug lumen and through the aperture enters the containment pockets.

8. A drug delivery catheter for insertion into a vessel which contains a first flowing fluid, the drug delivery catheter comprising:

an elongated tubular member having a proximal end and a distal end;

a drug lumen in fluid communication with the distal end of the tubular member for delivering a second fluid;

a first inflatable balloon assembly disposed at the distal end of the tubular member, the balloon assembly including a tubular balloon helically wound through the elongated tubular member forming a first set of inflatable balloon members having an uninflated state and an inflated state;

aperture means for delivering the second fluid from said drug lumen to said vessel;

a second inflatable balloon assembly disposed proximal of the first balloon assembly and separated therefrom by a space, the second balloon assembly including a tubular balloon helically Wound through the elongated tubular member forming a second set of inflatable galloon members having an uninflated state and an inflated state;

aperture means for delivering the second fluid from said drug lumen to said vessel;

each of first and second balloon assemblies comprising a sheath attached between each of the balloon members in that respective balloon assembly such that (1) when the first and second sets of balloon members are in an uninflated state, the first fluid in the vessel may flow around the first and second balloon assemblies, and (2) when the first and second sets of balloon members are in an inflated state, sections of the first set of balloon members contact the vessel wall defining a first containment pocket while containing the second fluid between the vessel wall and within the contacting sections of the first balloon assembly, sections of the second set of balloon members contact the vessel wall defining a second containment pocket for containing the second fluid between the vessel wall, the contacting sections of the second balloon assembly and the second sheath, the aperture means being disposed in first and second containment pockets, an inflatable lumen being defined through the interior of the balloon member and sheath of each balloon assembly to allow the first fluid to flow through the balloon member, and the space between the first and second balloon assemblies defining a side opening in the inflatable lumen; and

an inflation lumen in fluid communication with the balloon members for inflating the balloon members.

9. The drug delivery catheter of claim 8 comprising a first market coil disposed under the first set of balloons and a second marker coil disposed under the second set of balloons, said marker coils bonded to the elongated tubular member.

10. The drug delivery catheter of claim 8 wherein the first set and second set of balloons comprise a single tubular balloon helically wound through the elongated tubular member.

11. The drug delivery catheter of claim 8 wherein the sheath is formed around the outer periphery of the balloon member.

12. The drug delivery catheter of claim 8 wherein the inflatable lumen has an internal diameter of at least 0.035 inches.

13. The drug delivery catheter of claim 8 wherein the apertures are located in the elongated tubular member such that fluid flowing from the drug lumen and through the aperture enters the containment pockets.

14. The drug delivery catheter of claim 8 wherein the apertures in the balloon assembly comprise slits in the elongated tubular member.

15. The drug delivery catheter of claim 8 wherein the balloon member has a diameter of between approximately 2.0 mm and 6.0 mm in the inflated state.

16. The drug delivery catheter of claim 15 wherein the inflatable lumen has an internal diameter of at least 0.035 inches.