Drug delivery

• US 5,954,706 A
• Filed: 06/07/1995
• Issued: 09/21/1999
• Est. Priority Date: 12/28/1990
• Status: Expired due to Term

• Current Assignee: Boston Scientific Corporation
• Original Assignee: Boston Scientific Corporation
• Inventors: Sahatjian, Ronald A.
• Primary Examiner(s): Stright, Ronald
• Assistant Examiner(s): NGUYEN, ANH TUAN TUONG
• Application Number:
  US08/473,136
• Time in Patent Office: 1,567 Days
• Field of Search: 604/20, 604/28, 604/53, 604/96, 604/99, 604/101, 604/265, 604/266, 604/93, 604/43, 606/192, 606/194
• US Class Current: 604/509
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61K 38/49 Urokinase; Tissue plasminogen activator
• CPC Class Codes: A61K 48/00 Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61L 2300/256 Antibodies, e.g. immunoglobulins, vaccines
• CPC Class Codes: A61L 2300/258 Genetic materials, DNA, RNA, genes, vectors, e.g. plasmids
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2300/606 Coatings
• CPC Class Codes: A61L 2300/622 Microcapsules
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 33/0023 : using a quaternized group or a protonated amine group of the substrate
• CPC Class Codes: A61L 33/0029 : using an intermediate layer of polymer
• CPC Class Codes: A61M 16/0481 : through the cuff wall
• CPC Class Codes: A61M 2025/0046 : Coatings for improving slidability
• 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 2025/09183 : having tools at the distal tip
• 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 2025/1086 : having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2205/0266 : Shape memory materials
• CPC Class Codes: A61M 25/0045 : multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/104 : used for angioplasty
• CPC Class Codes: C08L 33/02 : Homopolymers or copolymers of acids; Metal or ammonium salts thereof
• CPC Class Codes: C08L 35/00 : Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a carboxyl radical, and containing at least one other carboxyl radical in the molecule, or of salts, anhydrides, esters, amides, imides or nitriles thereof; Compositions of derivatives of such polymers

Abstract

The invention features a catheter and methods for delivering drug to tissue at a desired location of the wall of a body lumen. The catheter is constructed for insertion in a body lumen and has a catheter shaft and an expandable portion mounted on the catheter shaft. The expandable portion is expandable to a controlled pressure to fill the cross-section of the body lumen and press against the wall of the body lumen. In one embodiment, at least a portion of the exterior surface of the expandable portion is defined by a coating of a tenaciously adhered swellable hydrogel polymer. Incorporated in the hydrogel polymer is an aqueous solution of a preselected drug to be delivered to the tissue or plaque. The hydrogel polymer and drug are selected to allow rapid release of a desired dosage of the drug from the hydrogel polymer coating during compression of the hydrogel polymer coating against the wall of the lumen when the expandable portion is expanded. In other embodiments the polymer is released from the expandable portion in response to pressure, to coat the wall of the body lumen.

Claims

1. A method for rapidly delivering a drug into a tissue or occlusive formation at a desired location of a body lumen, comprising:

providing a catheter having a catheter shaft constructed for delivery to said tissue or occlusive formation, and an expandable portion mounted on said catheter shaft, said expandable portion being expandable in response to controlled inflation pressure, the expandable portion being characterized by a coating of a tenaciously adhered swellable hydrogel polymer having said drug incorporated therein, said coating, when swelled, being responsive to compressive pressure elevated above said inflation pressure, to reduce the coating thickness and forcing said drug into said tissue or occlusive formation,

preparing said expandable portion by introducing said drug to said coating,

positioning said expandable portion in said body lumen at the point of desired drug application,

expanding said expandable portion against said tissue or occlusive formation to cause delivery of said drug to said tissue or occlusive formation in about thirty minutes or less,

deflating said expandable portion, and

removing said catheter from said body.

2. The method of claim 1, further comprising introducing said catheter to an artery.

3. The method of claim 1 or 2, wherein said expandable portion is adapted for application of heat to said polymer material to control the rate of administration.

4. The method of claim 1, wherein said expandable portion includes a stent, placeable in said lumen by expansion thereof.

5. The method of claim 4, including a binding of said drug and said hydrogel polymer in a coating upon said stent for slow time release of drug remaining in said hydrogel polymer on said stent after compression of said hydrogel polymer by said expansion.

6. The method of claim 4, wherein said stent is balloon-expandable stent and said expandable portion is a stent positioned about said balloon.

7. The method of claim 6, wherein said stent and balloon both include said swellable hydrogel polymer coating incorporating said drug.

8. The method of claim 1, further comprising positioning said expandable portion at a point of occlusion in a body lumen and expanding said expandable portion at pressures sufficient to simultaneously dilate said lumen and deliver said drug by compression of said hydrogel polymer coating.

9. The method of claim 1, wherein said expandable portion is an inflatable balloon expandable to pressures in the range of about 1 to 20 atmospheres.

10. The method of claim 9, further comprising delivering about 20% or more of said drug during said compression.

11. The method of claim 1, wherein said drug is delivered in about ten minutes or less.

12. The method of claim 1, wherein said hydrogel polymer is selected from the group consisting of polycarboxylic acids, cellulosic polymers, gelatin polyvinylpyrrolidone, maleic anhydride polymers, polamides, polyvinyl alcohols, and polyethylene oxides.

13. The method of claim 12 wherein said hydrogel polymer is polyacrylic acid.

14. The method of any one of claims 1, 2 or 13 wherein said drug is a monoclonal antibody.

15. The method of claim 1, wherein said drug is delivered in about fifteen minutes or less.

16. The method of claim 1, wherein said drug is delivered in about one to ten minutes.

17. The method of claim 16, wherein said drug is delivered in about one to five minutes.

18. The method of claim 1 wherein said drug is heparin.