Drug delivery catheter having a highly compliant balloon with infusion holes

• US 6,623,452 B2
• Filed: 12/19/2000
• Issued: 09/23/2003
• Est. Priority Date: 12/19/2000
• Status: Expired due to Term

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Chien, Thomas Yung-Hui, Cornil, Alain, Nita, Henry
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Han, Mark K.
• Application Number:
  US09/741,278
• Publication Number:
  US 20020077594A1
• Time in Patent Office: 1,008 Days
• Field of Search: 604/103.01, 604/103.1, 604/96.01, 604/99.01, 604/99.02, 604/99.03, 604/101.01, 604/101.05, 604/102.01, 604/103.11, 604/164.13, 604/167.06, 604/102.03
• US Class Current: 604/103.01
• 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 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 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/10185 Valves
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An intravascular drug delivery balloon catheter incorporating a highly compliant balloon having a plurality of infusion holes. The highly compliant balloon elastically expands at a low inflation pressure (e.g., less than 1.0 ATM), and preferably has a compliance of 2.0 mm/ATM or more at pressures less than 2.0 ATM. A pressure relief valve may be incorporated into the catheter to avoid over pressurization. The infusion holes may be open when the balloon is deflated and may enlarge when the balloon is inflated. The balloon may define a single lobe or two inflatable lobes with the infusion holes disposed therebetween.

Claims

1. An intravascular drug delivery balloon catheter, comprising:

an elongate shaft having a proximal end and a distal end; and

an inflatable balloon carried by the distal end of the shaft, the balloon comprising a compliant material such that the balloon elastically expands at an inflation pressure of less than 1.0 ATM, the balloon including a plurality of infusion holes.

2. An intravascular drug delivery balloon catheter as in claim 1, wherein the compliant material has a diametric compliance of 2.0 mm/ATM or more at inflation pressures less than 2.0 ATM.

3. An intravascular drug delivery balloon catheter as in claim 1, further comprising a relief valve in fluid communication with the balloon.

4. An intravascular drug delivery balloon catheter as in claim 3, wherein the relief valve vents at an inflation pressure of 1.5 ATM or more.

5. An intravascular drug delivery balloon catheter as in claim 1, wherein the infusion holes are open when the balloon is deflated and enlarge when the balloon is inflated.

6. An intravascular drug delivery balloon catheter as in claim 1, wherein the balloon defines two inflatable lobes.

7. An intravascular drug delivery balloon catheter as in claim 6, wherein the infusion holes are disposed between the lobes.

8. An intravascular drug delivery system, comprising:

a balloon catheter comprising an elongate shaft having a proximal end, a distal end and an inflation lumen extending therethrough, an inflatable balloon connected to the distal end of the shaft, the balloon including a wall defining an interior in fluid communication with the inflation lumen, the balloon wall comprising a compliant material such that the balloon wall elastically expands at an inflation pressure of less than 1.0 ATM, the balloon wall including a plurality of infusion holes, the distal end of the shaft including a guidewire seal; and

a guidewire disposed in the inflation lumen, the guidewire seal forming a fluid seal about the guidewire such that fluid passes from the inflation lumen, into the balloon, and through the infusion holes, and such that the guidewire is free to move relative to the guidewire seal.

9. An intravascular drug delivery system as in claim 8, wherein the compliant material has a diametric compliance of 2.0 mm/ATM or more at inflation pressures less than 2.0 ATM.

10. An intravascular drug delivery system as in claim 8, further comprising a relief valve in fluid communication with the balloon.

11. An intravascular drug delivery system as in claim 10, wherein the relief valve vents at an inflation pressure of 1.5 ATM or more.

12. An intravascular drug delivery system as in claim 8, wherein the infusion holes are open when the balloon is deflated and enlarge when the balloon is inflated.

13. An intravascular drug delivery system as in claim 8, wherein the balloon defines two inflatable lobes.

14. An intravascular drug delivery system as in claim 13, wherein the infusion holes are disposed between the lobes.

15. A method of delivering a drug intravascularly, the method comprising the steps of:

providing a drug delivery balloon catheter comprising an elongate shaft having a proximal end and a distal end, an inflatable balloon carried by the distal end of the shaft, the balloon comprising a compliant material such that the balloon elastically expands at an inflation pressure of less than 1.0 ATM, the balloon including a plurality of infusion holes which are open when the balloon is deflated and which enlarge when the balloon is inflated;

inserting the catheter into a patient'"'"'s vasculature;

positioning the balloon adjacent a treatment site; and

inflating the balloon such that the balloon elastically expands and the drug passes through the infusion holes.

16. A method of delivering a drug intravascularly as in claim 15, further comprising the step of increasing inflation pressure to increase infusion rate.

17. A method of delivering a drug intravascularly as in claim 16, wherein the step of increasing inflation pressure is pulsatile.