Triggered release hydrogel drug delivery system

• US 7,066,904 B2
• Filed: 10/25/2002
• Issued: 06/27/2006
• Est. Priority Date: 12/28/1990
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Barry, James J., Sahatjian, Ronald, Rosenthal, Arthur
• Primary Examiner(s): Bianco, Patricia
• Application Number:
  US10/279,861
• Publication Number:
  US 20030114791A1
• Time in Patent Office: 1,341 Days
• Field of Search: 604/19, 604/27, 604/28, 604/47, 604/48, 604/500, 604506-509, 604/514, 604/518, 604/522, 604/96.01, 60410301-10302, 60410307-10308, 604113-114, 604264-265, 604/523, 604/789, 604/290, 604/103.06, 606/191, 606/192, 606/194, 606/195, 606/198, 600433-435, 427/2.1, 427/2.22, 427/2.12, 427/2.13, 427/2.24, 427/2.25, 427/2.3
• US Class Current: 604/103.08
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• 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 2300/602 Type of release, e.g. controlled, sustained, slow
• 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: 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 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 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• 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

Abstract

The invention features a method for triggering release of a drug from a hydrogel polymer to tissue at a desired location of the body using a catheter. A portion of the catheter is coated on its outer surface with a polymer having the capacity to incorporate a predetermined substantial amount of drug which is immobilized in the polymer until released by a triggering agent or condition that is different from physiological conditions. Upon contact with a triggering agent or condition, the polymer reacts, e.g., swells or contracts, such that the drug is delivered to the desired body tissue. A balloon catheter is shown in which the hydrogel is carried on the exterior surface of the balloon.

Claims

1. A catheter for delivering a drug to tissue at a desired location in the body, comprising:

a solution comprising a triggering agent that has a pH that differs from ambient pH;

a catheter constructed for insertion in a body lumen having a catheter shaft with an expandable balloon portion mounted on said catheter shaft and having a lumen carrying the solution, the lumen in communication with said expandable balloon portion, said balloon portion having pores through which the solution can pass to its outer surface;

said balloon portion being expandable to engage said tissue at a controlled pressure to fill a cross-section of the body lumen and press against said wall of said body lumen;

said balloon portion being coated on its outer surface with a hydrogel polymer having a predetermined substantial amount of said drug incorporated therein, said drug being immobilized in said polymer until released by the solution.

2. The catheter of claim 1, wherein the triggering agent is a solution with a pH that induces a volume phase transition of the hydrogel, thereby triggering release of the drug.

3. The catheter of claim 2, wherein the solution has a pH of greater than about 7.5.

4. The catheter of claim 2, wherein the solution has a pH of less than about 7.3.

5. The catheter of claim 1, wherein the solution comprises a saline solution having a molarity of at least 0.2 molar.

6. The catheter of claim 1, wherein the drug is cationic and the hydrogel is anionic.

7. The catheter of claim 1, wherein the drug is anionic and the hydrogel is cationic.

8. The catheter of claim 1, wherein the drug is an anti-proliferative drug.

9. The catheter of claim 1, wherein the drug is an anti-thrombogenic drug.

10. The catheter of claim 1, wherein the drug is a thrombolytic drug.

11. A kit comprising (a) a catheter constructed for insertion in a body lumen having a catheter shaft having an expandable balloon portion mounted on said catheter shaft, said balloon portion carrying a hydrogel polymer having the capacity to incorporate a predetermine substantial amount of drug;

(b) said drug, wherein said drug is capable of being immobilized in said polymer until released by a triggering agent; and

(c) a solution of said triggering agent that has a pH that differs from ambient pH.