Simultaneous angioplasty and phoretic drug delivery

• US 5,498,238 A
• Filed: 08/27/1993
• Issued: 03/12/1996
• Est. Priority Date: 06/15/1990
• Status: Expired due to Term

• Current Assignee: Vention Medical Advanced Components, Inc. (Nordson Corporation)
• Original Assignee: Cortrak Medical Incorporated
• Inventors: Knudson, Mark B., Shimada, Jin, Racchini, Joel R., Shapland, James E.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Bockelman, Mark
• Application Number:
  US08/113,273
• Time in Patent Office: 928 Days
• Field of Search: 604/20, 604/21, 604/22, 604/52, 604/53, 604/96-103, 601/2, 606/194
• US Class Current: 604/501
• CPC Class Codes: A61M 16/0443 Special cuff-wall materials A61M16/0481, A61M16/0422 take precedence
• CPC Class Codes: A61M 16/0456 one cuff within another
• CPC Class Codes: A61M 16/0481 through the cuff wall
• CPC Class Codes: A61M 16/0486 Multi-lumen tracheal tubes
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• 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 25/104 used for angioplasty
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A method of simultaneous angioplasty and drug delivery to a localized portion of coronary or peripheral arteries or any other type of body passage that has a stricture. The invention contemplates positioning a drug delivery device in a body passageway and then selectively introducing a selected drug so that the device is expanded in order to dilate the passage and then simultaneously causing the drug to be transported across a drug transport wall of the device for direct contact with the passageway wall. A more specific aspect of the present invention involves treating a dilated vessel in the area of a stenotic lesion with a fixative or other drug to render the vessel biologically inert and to form a biological stent or prevent restenosis using specifically selected drugs.

Claims

1. A method for simultaneously performing percutaneous translumenal coronary angioplasty and delivering a drug to a localized area of a passageway with a catheter having a proximal end, a distal end, and a balloon operably connected to the distal end, wherein the balloon has a single chamber and a plurality of pores having a diameter of about 1 μ

or less, the method comprising the steps of;

a) advancing the catheter through the passageway until the balloon is adjacent to the localized area;

b) injecting a fluid through an injection lumen in the catheter and into the single chamber of the balloon causing the balloon to inflate to a pressure of about 2 atmospheres or more and apply a pressure against the localized area of the passageway thereby dilating the localized area of the passageway; and

c) phoretically transporting the drug to the localized area while simultaneously dilating the localized area of the passageway.

2. The method of claim 1 wherein the step of transporting the drug is performed while the localized area of the passageway is dilated.

3. The method of claim 1 wherein the drug comprises at least a portion of the fluid and further wherein the step of transporting the drug further comprises transporting the drug through a selectively permeable portion of the balloon.

4. The method of claim 3 wherein the step of transporting the drug through a selectively permeable portion of the balloon further comprises transporting the drug through a microporous membrane.

5. The method of claim 4 wherein the step of transporting the drug through a microporous membrane further comprises passing the drug through pores in the microporous membrane that have a size between 0.05 μ

and 1.0 μ

.

6. The method of claim 3 further comprising the step of withdrawing at least a portion of the fluid from the chamber through a recovery lumen.

7. The method of claim 6 wherein the step of injecting the fluid further comprises injecting the fluid into the chamber and withdrawing the fluid from the chamber at a rate that maintains the balloon in an inflated state.

8. The method of claim 7 wherein the step of transporting the drug through a selectively permeable portion of the balloon further comprises transporting the drug through a microporous membrane.

9. The method of claim 8 wherein the step of transporting the drug through a microporous membrane further comprises passing the drug through pores in the microporous membrane that have a size between 0.05 μ

and 1.0 μ

.

10. The method of claim 3 wherein the step of transporting the drug through a selectively permeable portion of the balloon further comprises phonophoretically transferring the drug through the selectively permeable portion of the balloon.

11. The method of claim 3 wherein the step of phoretically transporting the drug through a selectively permeable portion of the balloon further comprises iontophoretically transferring the drug through the selectively permeable portion of the balloon.

12. The method of claim 11 wherein the step of iontophoretically transferring the drug further comprises passing a wave form of electrical pulses through the selectively permeable portion.

13. The method of claim 1 further comprising the step of coating a portion of an outer surface of the balloon with a gel before the catheter is advanced through the passageway.

14. The method of claim 13 wherein the gel contains the drug and the step of transporting the drug to the localized area further comprises transferring the drug from the gel to the localized area of the passage.

15. The method of claim 1 further comprising the step of coating a portion of an inner surface of the balloon with a gel before the catheter is advanced through the passageway.

16. The method of claim 15 wherein the step of transporting the drug further comprises passing the fluid from the chamber, through the gel, and through a selectively permeable portion of the balloon.