Phoretic balloon catheter with hydrogel coating

• US 5,628,730 A
• Filed: 07/18/1994
• Issued: 05/13/1997
• 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, Shapland, James E.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/276,540
• Time in Patent Office: 1,030 Days
• Field of Search: 604/20-21, 604/96-103, 604/52-53, 604/890.1, 604/265, 604/264, 604/22, 601/2, 606/192-194, 607/120, 607/116, 607/122, 607/124
• US Class Current: 604/21
• CPC Class Codes: A61M 16/0481 through the cuff wall
• 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 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• 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 drug delivery apparatus and method for delivering a drug locally to internal body tissue. The invention contemplates positioning a drug delivery device in a body passageway or within body tissue and then selectively introducing a selected drug so that it is transported across a drug transport wall of the device for direct contact with the passageway wall or body tissue. A further 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. A still further aspect of the present invention involves treating a tumor or local or regional tissue mass with antitumor sensitizing agents, biological modifiers, antibiotics or other types of drugs by delivery of the drug to the tumor or tissue area directly or through the passageway wall.

Claims

1. A drug delivery device for local delivery of a drug to an internal body tissue target area comprising:

(a) a catheter having a distal end and a proximal end;

(b) an inflatable balloon positioned on the catheter distal end, the balloon being formed from a permeable membrane and defining a drug receiving and dispensing chamber bounded by the catheter distal end and the membrane;

(c) a drug delivery lumen on said catheter and having a distal end in fluid flow communication with said chamber, said lumen extending from the distal end to the proximal end of the catheter for the delivery of a drug therethrough;

(d) a hydrogel coating on said permeable membrane and in fluid flow communication with said chamber; and

(e) phoresis means positioned within the chamber in immediate proximity to the distal end of the catheter to generate a force for transporting a drug from the chamber outwardly through the permeable membrane.

2. A drug delivery apparatus according to claim 1 wherein said membrane includes an outer surface and said hydrogel coats said outer surface.

3. A drug delivery apparatus according to claim 1 wherein said membrane includes an inner surface and said hydrogel coats said inner surface.

4. A drug delivery apparatus according to claim 1 wherein said hydrogel is impregnated with the drug.

5. The drug delivery device of claim 1 wherein:

said balloon is of single wall construction.

6. The drug delivery device of claim 1 wherein:

said phoresis means comprises first and second electrodes configured to be connected to a power supply, the first electrode being positioned on the catheter within the chamber, and the second electrode being configured for positioning externally of the catheter.

7. The drug delivery device of claim 1 wherein:

said phoresis means comprises an ultrasonic transducer positioned within the chamber.

8. A drug delivery device for local delivery of a drug to an internal body tissue target area comprising:

(a) a catheter having a distal end and a proximal end;

(b) a single inflatable balloon positioned on the catheter distal end, the balloon being formed from a permeable membrane and defining a drug receiving and dispensing chamber bounded by the catheter distal end and the membrane;

(c) a drug delivery lumen on said catheter and having a distal end in fluid flow communication with said chamber, said lumen extending from the distal end to the proximal end of the catheter for the delivery of a drug therethrough;

(d) a hydrogel coating on said permeable membrane and in fluid flow communication with said chamber; and

(e) iontophoresis means comprising a first electrode positioned within the chamber on the distal end of the catheter to generate a force for transporting a drug from the chamber outwardly through the permeable membrane, and a second electrode configured for connection to a power supply.