Dimpled porous infusion balloon

• US 6,048,332 A
• Filed: 10/09/1998
• Issued: 04/11/2000
• Est. Priority Date: 10/09/1998
• Status: Expired due to Term

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Ave Connaught
• Inventors: O'Loughlin, Micheal, Duffy, Niall
• Primary Examiner(s): Stright, Ronald
• Assistant Examiner(s): Thissell, Jeremy
• Application Number:
  US09/169,340
• Time in Patent Office: 550 Days
• Field of Search: 604/96, 604/97, 604/99, 604/101, 604/104, 604/912, 604/915, 604/917, 604/919, 604/500, 604/508, 604/509, 604/523, 604/536
• US Class Current: 604/103.08
• 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 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence

Abstract

The systems and methods described herein include drug delivery catheters that have dimpled porous balloons mounted onto the distal end of the catheter. In one embodiment, the balloons are adapted for delivering therapeutic agents to the tissue wall of a body lumen, and to this end include a plurality of dimples formed in the exterior surface of the balloon, with each dimple having at least one aperture through which a fluid delivered into the interior of the balloon can extravasate. It is understood that the balloons described herein provide, inter alia, increased coverage of the tissue wall to which the agent is being delivered and less traumatic contact between the agent being delivered and the tissue wall.

Claims

1. Apparatus for applying a fluid vehicle carrying a therapeutic agent to an interior surface of a body lumen, comprising:

a catheter having a distal portion, a proximal portion and a lumen therethrough; and

a balloon mounted on the distal portion of the catheter having an interior in fluid communication with the lumen of the catheter and having a wall capable of being expanded within the body lumen to contact the interior surface of the body lumen, said wall being penetrated by at least one aperture situated within a concavity in the wall of the balloon;

whereby the therapeutic agent can be delivered from the interior of the balloon through the aperture in the wall of the balloon to contact the interior surface of the body lumen.

2. Apparatus according to claim 1 wherein the wall of the balloon bears a plurality of concavities, each of said concavities containing within it at least one aperture adapted for permitting the egress of the fluid vehicle carrying the therapeutic agent.

3. Apparatus according to claim 1 wherein the concavity in the wall of the balloon spaces the aperture away from the tissue wall for decreasing the velocity at which the fluid vehicle carrying the therapeutic agent contacts the interior surface of the body lumen.

4. Apparatus according to claim 1 wherein the concavity in the wall of the balloon permits accumulation of the fluid vehicle under pressure.

6. Apparatus according to claim 2 wherein each concavity is penetrated substantially at its base by at least one aperture.

7. Apparatus according to claim 1 wherein the catheter and the balloon are dimensionally adapted to be disposed within a blood vessel.

5. Apparatus according to claim wherein the concavity is substantially hemispherical.

8. Apparatus for applying a fluid vehicle carrying a therapeutic agent to an interior surface of a body lumen, comprising:

a catheter having a distal portion and a proximal portion and a lumen therethrough; and

a first balloon mounted on said distal portion of the catheter having an interior in fluid communication with the lumen of the catheter and having a wall capable of being expanded within the body lumen to contact the interior surface of the body lumen, said wall being indented by a plurality of concavities, each of said concavities being penetrated by at least one aperture permitting egress of the fluid vehicle carrying the therapeutic agent;

wherein the concavities in the wall of the balloon distance the apertures in the wall from the interior surface of the body lumen and accumulate the therapeutic agent within the concavities, thereby bringing the therapeutic agent into contact with the interior surface of the body lumen.

9. Apparatus according to claim 8, wherein the concavities are substantially hemispherical.

10. Apparatus according to claim 8, wherein at least one aperture is situated substantially at the base of each concavity.

11. Apparatus according to claim 8, wherein the catheter and the balloon are dimensionally adapted to be disposed within a blood vessel.

12. Apparatus according to claim 8, wherein at least one additional balloon is mounted on the distal portion of the catheter.

13. Apparatus according to claim 12 wherein the first balloon is disposed exterior to and coaxial with at least one additional balloon.

14. Apparatus according to claim 12, wherein at least one additional balloon is a dilating balloon adapted for the dilatation of a stenosis of a body lumen.

15. A method for applying at therapeutic agent to an interior surface of a body lumen, comprising:

providing a catheter having a distal portion and a proximal portion and a lumen therethrough, a balloon disposed on the distal portion of the catheter with an interior in fluid communication with the lumen of the catheter and with a wall having a plurality of apertures and a plurality of concavities each bearing at least one aperture, a means for inflating the balloon and a means for directing a fluid vehicle carrying the therapeutic agent through the inner lumen of the catheter to the interior of the balloon;

inserting the catheter into a patient;

positioning the balloon within the body lumen;

inflating the balloon in the body lumen to attain contact with the inner surface of the body lumen;

maintaining a level of fluid pressure in the balloon so that the fluid vehicle carrying the therapeutic agent extravasates through the perforations in the wall at a flow rate selected to deliver a desired quantity of the therapeutic agent to the inner surface of the body lumen;

deflating the balloon; and

removing the catheter from the body lumen.

16. A method according to claim 15 including dilating a stenotic region of the body lumen.