Controlled drug delivery

• US 20040022824A1
• Filed: 07/31/2002
• Published: 02/05/2004
• Est. Priority Date: 07/31/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Couto, Weenna Bucay, Li, Jianmin
• Granted Patent: US 8,685,427 B2
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61K 31/216 of acids having aromatic rings, e.g. benactizyne, clofibrate
• CPC Class Codes: A61K 31/407 condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
• 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 2300/204 with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
• CPC Class Codes: A61L 2300/21 Acids
• 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 2420/06 Coatings containing a mixture of two or more compounds
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/148 Materials at least partially resorbable by the body
• 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 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50

Abstract

A medical device is placed entirely or partially within a body of a patient, and a drug is released from the device into the body. The composition of the device results in a controlled drug release profile.

Claims

1. A medical device for placement in a body of a mammal, comprising:

a polymeric matrix forming the device and defining a lumen through the device, the matrix comprising polymer macromolecules and defining spaces between the polymer macromolecules;

a drug contained within at least some of the spaces of the matrix; and

a material contained within at least some of the spaces of the matrix to affect diffusion of the drug out of the polymeric matrix when the medical device is placed in the body of the mammal.

2. The medical device of claim 1 wherein the medical device is a ureteral stent or a catheter.

3. The medical device of claim 1 wherein the polymeric matrix comprises ethylene vinyl acetate (EVA).

4. The medical device of claim 1 wherein the polymeric matrix is hydrophobic.

5. The medical device of claim 1 wherein at least some of the spaces that contain the drug also contain the material.

6. The medical device of claim 1 wherein the drug comprises oxybutynin chloride or ketorolac.

7. The medical device of claim 1 wherein the material comprises polyethylene glycol (PEG).

8. The medical device of claim 1 wherein the material is biodegradable.

9. The medical device of claim 1 wherein each of the material and the drug has a molecular weight, the molecular weight of the drug being less than the molecular weight of the material.

10. The medical device of claim 1 wherein the material chemically associates with at least the drug such that the drug must dissociate from the material before diffusing out of the matrix.

11. A hydrophobic polymeric matrix for coating a medical device that is placeable in a body of a mammal, the matrix comprising polymer macromolecules and spaces between the polymer macromolecules, a drug contained within at least some of the spaces of the polymeric matrix, and a material contained within at least some of the spaces of the polymeric matrix, the material affecting diffusion of the drug out of the polymeric matrix when the device is placed in the body of the mammal.

12. The polymeric matrix of claim 11 wherein the medical device is a lead wire, a ureteral stent, or a catheter.

13. The polymeric matrix of claim 11 wherein the polymeric matrix comprises ethylene vinyl acetate (EVA).

14. The polymeric matrix of claim 11 wherein at least some of the spaces that contain the drug also contain the material.

15. The polymeric matrix of claim 11 wherein the drug comprises oxybutynin chloride or ketorolac.

16. The polymeric matrix of claim 11 wherein the material comprises polyethylene glycol (PEG).

18. The polymeric matrix of claim 11 wherein each of the material and the drug has a molecular weight, the molecular weight of the drug being less than the molecular weight of the material.

19. The polymeric matrix of claim 11 wherein the material chemically associates with at least the drug such that the drug must dissociate from the material before diffusing out of the matrix.

17. The polymeric matrix of claim 111 wherein the material is biodegradable.

20. A method of drug delivery, comprising:

placing a medical device into a body of a mammal, the device capable of delivering a therapeutic level of a drug to the body at a predetermined time after the device is placed into the body; and

providing a second drug to the body prior to the predetermined time to deliver a therapeutic level of the second drug to the body before the predetermined time.

21. The method of claim 20 wherein the placing step comprises placing the medical device which comprises:

a polymeric matrix forming the device and defining a lumen through the device, the matrix comprising polymer macromolecules and defining spaces between the polymer macromolecules;

the drug contained within at least some of the spaces of the matrix; and

a material contained within at least some of the spaces of the matrix to affect diffusion of the drug out of the polymeric matrix when the medical device is placed in the body of the mammal.

22. The method of claim 20 wherein the providing step comprises providing the second drug which is different than the drug deliverable by the device.

23. The method of claim 20 wherein the providing step comprises providing the second drug which is the same as the drug deliverable by the device.