Drug delivery apparatus and method

• US 5,286,254 A
• Filed: 08/28/1992
• Issued: 02/15/1994
• 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): Rosenbaum, C. Fred
• Assistant Examiner(s): Rafa, Michael
• Application Number:
  US07/937,464
• Time in Patent Office: 536 Days
• Field of Search: 604/20-22, 604/52-53, 604/96-103, 128/24 AA
• 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 apparatus having a distal end and a proximal end for local delivery of a drug to internal body tissue comprising:

(a) a flexible catheter for insertion into an internal target area of a body;

(b) drug delivery means connected to said catheter for delivering a drug to said target area, said drug delivery means having a fluid delivery passageway for delivering said drug to said distal end, an outer wall and a selectively permeable microporous outer membrane portion proximate said distal end of said drug delivery apparatus, said microporous outer membrane further comprising pores sized from about 10 Å

to about 1 micron and at least one impermeable end portion to enhance precise delivery of said drug to said internal target area; and

(c) phoresis means for assisting the transport of said drug across said selectively permeable microporous outer membrane.

2. A drug delivery apparatus according to claim 1 wherein said outer of said drug delivery means further comprises one or more openings to provide fluid communication from said fluid delivery passageway to said outer membrane portion.

3. The drug delivery apparatus of claim 1 wherein said selectively permeable outer membrane portion forms part of said outer wall.

4. A drug delivery apparatus according to claim 1 wherein said drug delivery means is coaxially aligned about said flexible catheter.

5. A drug delivery apparatus according to claim 1 wherein said catheter body includes an integral introducer.

6. A drug delivery apparatus according to claim 1 wherein said microporous outer membrane pore sizes range from about 600 Å

to about 1 micron.

7. A drug delivery apparatus according to claim 1 wherein said drug delivery means further includes a drug recovery lumen extending from said drug chamber to the proximal end of said flexible catheter.

8. A drug delivery apparatus according to claim 1 wherein said means for assisting transport of said drug is a phonophoresis means.

9. The drug delivery apparatus of claim 8 wherein said phonophoresis means is an ultrasonic transducer.

10. A drug delivery apparatus according to claim 1 wherein said means for assisting transport of said drug is an iontophoresis means.

11. The drug delivery apparatus of claim 10 wherein said iontophoresis means is an electrode.

12. A drug delivery apparatus for local delivery of a drug to an internal body passageway having an elongated passageway wall comprising:

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

(b) drug delivery means connected to said catheter for delivery of a drug to said passageway wall, said drug delivery means comprising a balloon near said distal end of said flexible catheter for engagement with a local area of said passageway wall, said balloon having an outer wall with a selectively permeable microporous membrane portion and a drug delivery chamber within said balloon, a drug delivery lumen extending from said drug delivery chamber to said proximal end of said flexible catheter and a drug recovery lumen extending from said drug delivery chamber to said proximal end of said flexible catheter, said microporous membrane portion of said outer wall further comprising pores sized from about 10 Å

to about 1 micron and at least one impermeable end portion to enhance precise delivery of said drug to said local area of said passageway wall; and

(c) phoresis means for assisting the transport of said drug across said selectively permeable microporous membrane portion of said outer wall.

13. A drug delivery apparatus according to claim 12 wherein said microporous membrane pore sizes range from about 600 Å

to about 1 micron.

14. A drug delivery apparatus according to claim 12 wherein said means for assisting transport of said drug is a phonophoresis means.

15. The drug delivery apparatus of claim 14 wherein said phonophoresis means is an ultrasonic transducer.

16. A drug delivery apparatus according to claim 12 wherein said means for assisting transport of said drug is an iontophoresis means.

17. The drug delivery apparatus of claim 16 wherein said iontophoresis means is an electrode.