Controlled drug delivery

• US 8,685,427 B2
• Filed: 07/31/2002
• Issued: 04/01/2014
• Est. Priority Date: 07/31/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Li, Jianmin, Bucay Couto, Weenna
• Primary Examiner(s): Arnold, Ernst
• Assistant Examiner(s): Song, Jianfeng
• Application Number:
  US10/209,476
• Publication Number:
  US 20040022824A1
• Time in Patent Office: 4,262 Days
• Field of Search: 424/422, 424/1
• 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 for placement in a body of a mammal is provided. The medical device comprises (1) 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; (2) a drug contained within at least some of the spaces of the matrix; and (3) 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.

Claims

1. A medical device selected from a ureteral stent and a urinary catheter for placement in a body of a mammal, comprising:

a polymeric matrix forming the medical device entirely or partially and defining a lumen through the medical device, the matrix comprising polymer macromolecules comprising ethylene vinyl acetate, wherein the polymer macromolecules have spaces and voids and provided the polymer matrix is not a coating;

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 the rate of diffusion of the drug out of the polymeric matrix when the medical device is placed in the body of the mammal, wherein said material is selected from carboxymethyl cellulose, hydroxypropyl cellulose, dextrin, pore formers, sugar, glucose, starch, hyaluronic acid, chelating agents, polyethylene oxide, and copolymers thereof.

2. A method of drug delivery, comprising:

placing a medical device in accordance with claim 1, medical device capable of delivering a therapeutic level of said drug as a first drug to the body at a predetermined time after the medical device is placed into the body; and

directly providing a second drug to the body via instillation to deliver a therapeutic level of the second drug to the body before the delivery of the first drug at the predetermined time, wherein the second drug is selected from an antispasmodic, an anti-inflammatory drug and a smooth muscle relaxant.

3. The method of claim 2 wherein the providing step comprises providing the second drug which is different than the first drug deliverable by the medical device.

4. The method of claim 2 wherein the providing step comprises providing the second drug which is the same as the first drug deliverable by the medical device.

7. The method of claim 2, wherein said second drug is delivered to the body by intravesical delivery and the first drug is delivered via said ureteral stent.

12. The method of claim 2, wherein the second drug is delivered via a ureteral catheter.

13. A method of drug delivery according to claim 2 wherein the instillation is accomplished via a second medical device that is different from said medical device selected from a ureteral stent and a urinary catheter.

14. The method of claim 2, wherein first drug is delivered via said ureteral stent.

15. The method of claim 14, wherein said second drug is delivered by a ureteral catheter.

16. The method of claim 14, wherein the second drug is administered at the distal end of said ureteral stent after placement.

17. The method of claim 14, wherein the first and second drugs are non-steroidal anti-inflammatory drugs.

18. The method of claim 14, wherein the first and second drugs are ketorolac.

19. The method of claim 14, wherein the first and second drugs are anti-spasmodic drugs.

20. The method of claim 14, wherein the first and second drugs are oxybutynin chloride.

5. A ureteral stent comprising two retention end portions and a central portion, said ureteral stent comprising a polymeric matrix forming the medical device entirely or partially and defining a lumen through the medical device, the matrix comprising polymer macromolecules comprising ethylene vinyl acetate, and defining spaces between the polymer macromolecules and provided the polymer matrix is not a coating, 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 the rate of diffusion of the drug out of the polymeric matrix when the medical device is placed in the body of a mammal, wherein said material is selected from carboxymethyl cellulose, hydroxypropyl cellulose, dextrin, pore formers, sugar, glucose, starch, hyaluronic acid, chelating agents, polyethylene oxide, and copolymers thereof.

8. A medical procedure comprising placing a ureteral stent in accordance with claim 5 in a ureter of a patient.

6. A ureteral stent comprising two retention end portions and a central portion, said ureteral stent comprising a polymeric matrix forming the medical device entirely or partially and defining a lumen through the medical device, the polymeric matrix comprising ethylene vinyl acetate (EVA) polymer macromolecules, and defining spaces between the polymer macromolecules, a drug selected from oxybutynin chloride and ketorolac 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 the rate of diffusion of the drug out of the polymeric matrix when the medical device is placed in the body of a mammal, wherein said material is selected from carboxymethyl cellulose, hydroxypropyl cellulose, dextrin, pore formers, sugar, glucose, starch, hyaluronic acid, chelating agents, polyethylene oxide, and copolymers thereof.

9. A medical procedure comprising placing a ureteral stent in accordance with claim 6 in a ureter of a patient.

21. The ureteral stent of claim 6, wherein the drug is ketorolac.

22. The ureteral stent of claim 6, wherein the drug is oxybutynin chloride.

10. A ureteral stent comprising two retention end portions and a central portion, said ureteral stent comprising a polymeric matrix forming the medical device entirely or partially and defining a lumen through the medical device, the matrix comprising polymer macromolecules comprising ethylene vinyl acetate and defining spaces between the polymer macromolecules and provided the polymer matrix is not a coating;

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 the rate of diffusion of the drug out of the polymeric matrix when the medical device is placed in the body of a mammal, wherein said material is selected from carboxymethyl cellulose, hydroxypropyl cellulose, dextrin, pore formers, sugar, glucose, starch, hyaluronic acid, chelating agents, polyethylene oxide, and copolymers thereof.

11. A medical procedure comprising placing a ureteral stent in accordance with claim 10 in a ureter of a patient.