Drug delivery apparatus and method

• US 5,282,785 A
• Filed: 10/05/1992
• Issued: 02/01/1994
• 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, Hildebrand, Keith R., Shapland, James E.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Rafa, Michael
• Application Number:
  US07/956,789
• Time in Patent Office: 484 Days
• Field of Search: 604/20-22, 604/96-103, 604/52-53, 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 radially restricted 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 radially restricted delivery of a drug to said internal body tissue, said drug delivery means comprising;

(1) a fluid delivery passageway and a drug delivery chamber proximate said distal end of said drug delivery apparatus, said drug delivery chamber having an outer wall with a selectively permeable outer membrane portion; and

(2) a non-permeable balloon affixed to and surrounding a portion of said drug delivery chamber, said balloon, when inflated, securing said drug delivery chamber at an internal body tissue target area and radially restricting local delivery of said drug by providing intimate contact between said balloon and a portion of said internal body tissue; and

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

2. A drug delivery apparatus according to claim 1 wherein said selectively permeable membrane is a perforated membrane.

3. A drug delivery apparatus according to claim 1 wherein said selectively permeable membrane is a semipermeable membrane.

4. A drug delivery apparatus according to claim 1 wherein said selectively permeable membrane is a microporous membrane.

5. A drug delivery apparatus according to claim 4 wherein said microporous membrane has pores sized from about 10 Å

to about 1 micron.

6. A drug delivery apparatus according to claim 4 wherein said microporous membrane has pores of about 150 Å

.

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, including an ultrasonic transducer in said catheter.

9. A drug delivery apparatus according to claim 1 wherein said means for assisting transport of said drug is an iontophoresis means, including an electrode in said catheter.

10. The drug delivery apparatus according to claim 1 wherein said drug delivery chamber further includes circumferential lips immediately adjacent the proximal and distal ends of the drug delivery area that act to minimize movement of a drug beyond a segment of internal tissue to be treated.

11. A drug delivery apparatus according to claim 1 wherein said non-permeable balloon has an angle of contact with said tissue of about 120 to 240 degrees when inflated.

12. A drug delivery apparatus having a distal end and a proximal end for radially restricted 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 radially restricted delivery of a drug to said internal body tissue, said drug delivery means comprising;

(1) a drug delivery chamber proximate said distal end of said drug delivery apparatus, said drug delivery chamber having a drug delivery area with a selectively permeable outer membrane portion and circumferential lips immediately adjacent the proximal and distal ends of the drug delivery area that act to minimize movement of a drug beyond a segment of internal tissue, and a fluid delivery passageway extending from said drug delivery chamber to the proximal end of said catheter; and

(2) a non-permeable balloon affixed to and surrounding a portion of said drug delivery chamber, said balloon, when inflated, securing said drug delivery chamber at an internal body tissue target area and radially restricting local delivery of said drug by providing intimate contact between said balloon and a portion of said internal body tissue; and

(c) means for assisting the transport of said drug across said selectively permeable outer membrane without application of pressure.

13. A drug delivery apparatus according to claim 12 wherein said selectively permeable membrane is a perforated membrane.

14. A drug delivery apparatus according to claim 12 wherein said selectively permeable membrane is a semipermeable membrane.

15. A drug delivery apparatus according to claim 12 wherein said selectively permeable membrane is a microporous membrane.

16. A drug delivery apparatus according to claim 15 wherein said microporous membrane has pores sized from about 10 Å

to about 1 micron.

17. A drug delivery apparatus according to claim 16 wherein said microporous membrane has pores of about 150 Å

.

18. A drug delivery apparatus according to claim 12 wherein said drug delivery means further includes a drug recovery lumen extending from said drug chamber to the proximal end of said flexible catheter.

19. A drug delivery apparatus according to claim 12 wherein said means for assisting transport of said drug is a phonophoresis means, including an ultrasonic transducer in said catheter.

20. A drug delivery apparatus according to claim 12 wherein said means for assisting transport of said drug is an iontophoresis means, including an electrode in said catheter.

21. A drug delivery apparatus having a distal end and a proximal end for radially restricted 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 radially restricted delivery of a drug to said internal body tissue, said drug delivery means comprising;

(1) a drug delivery chamber proximate said distal end of said drug delivery apparatus, said drug delivery chamber having a drug delivery area with a selectively permeable microporous outer membrane portion and circumferential lips immediately adjacent the proximal and distal ends of the drug delivery area that act to minimize movement of a drug beyond a segment of internal tissue, and a fluid delivery passageway extending from said drug delivery chamber to the proximal end of said catheter, and a drug recovery lumen extending from said drug chamber to the proximal end of said flexible catheter; and

(2) a non-permeable balloon affixed to and surrounding a portion of said drug delivery chamber, said balloon, when inflated, securing said drug delivery chamber at an internal body tissue target area and radially restricting local delivery of said drug by providing intimate contact between said balloon and a portion of said internal body tissue; and

(c) means for assisting the transport of said drug across said selectively permeable outer membrane without application of pressure.