Medical devices for controlled drug release

• US 9,248,121 B2
• Filed: 08/15/2007
• Issued: 02/02/2016
• Est. Priority Date: 08/21/2006
• Status: Expired due to Fees

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Roorda, Wouter
• Primary Examiner(s): Epps-Smith, Janet
• Assistant Examiner(s): BROWN, COURTNEY A
• Application Number:
  US11/839,093
• Publication Number:
  US 20080057101A1
• Time in Patent Office: 3,093 Days
• Field of Search: 424/400, 424/425, 424/427, 424/484, 514/291
• US Class Current: 1/1
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61K 31/436 the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61L 2300/608 having two or more layers
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61P 39/00 General protective or antinoxious agents
• CPC Class Codes: A61P 41/00 Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: B22F 10/14 by jetting of binder onto a bed of metal powder
• CPC Class Codes: B22F 2003/1051 by electric discharge
• CPC Class Codes: B22F 2003/1054 by microwave
• CPC Class Codes: B22F 3/105 by using electric current other than for infrared radiant energy, laser radiation or plasma B22F3/11 takes precedence; by ultrasonic bonding B22F3/115 takes precedence
• CPC Class Codes: Y02P 10/25 Process efficiency

Abstract

The present invention is a medical device for controlling the release of an active agent. The medical device has a supporting structure having a porous body disposed therein. At least one elution rate controlling matrix containing an effective amount of at least one active agent is disposed within the pores of the porous body in a manner that protects the matrix from mechanical damage. The medical device may therefore be used for controlled drug release applications. Additionally, the present invention discloses a method for using the medical device for the treatment and prevention of diseases in mammals. This invention further relates to a method for using the medical device for treating and preventing vascular diseases.

Claims

1. A medical device for controlling the release of an active agent, the medical device comprising:

a supporting structure configured and dimensioned to be used within a body of a human or an animal;

a porous body disposed on and at least partially covering the supporting structure, said porous body being constructed of a first biocompatible material and said porous body having a plurality of pores, the first biocompatible material being a metal, a ceramic, or a combination of metal and ceramic;

a therapeutically effective amount of an active agent disposed within the pores; and

an elution rate controlling matrix within the pores to contain the active agent, said matrix comprising a second biocompatible material that controls an elution rate of the active agent from the pores; and

wherein the second biocompatible material is biodegradable and degrades in a period less than five years upon exposure to a physiological solution, and each pore comprises an upper volume and a lower volume, the active agent occupies the upper volume and the lower volume, and the upper volume is separated from the lower volume by an intermediate layer of the matrix.

2. The medical device according to claim 1, wherein the porous body has a thickness ranging from about 10 nanometers to about 1 millimeter, and the pores have a diameter from about 10 nanometers to about 1 millimeter.

3. The medical device according to claim 1, wherein the medical device is selected from the group consisting of endoprostheses, drug delivery stents, drug delivery catheters, grafts, drug delivery balloons, guidewires, orthopedic implants, dental implants, fixation screws, indwelling catheters, ocular implants, pharmacotherapeutic implants, blood-contacting components of extracorporeal devices, staples, filters, needles, tubes, coils, wires, clips, screws, sensors, plates, conduits, portions thereof, and combinations thereof.

4. The medical device according to claim 1, wherein said second biocompatible material degrades between about one hour and several weeks upon exposure to the physiological solution.

5. The medical device according to claim 1, wherein said second biocompatible material comprises at least one polymeric material selected from the group consisting of phosphorylcholines, phosphorylcholine linked macromolecules, polyesters, polyanhydrides, polyphosphazenes, polyacrylates, poly(lactide-co-glycolides) (PLGA), polylactic acids (PLA), poly(hydroxybutyrates), poly(hydroxybutyrate-co-valerates), polydioxanones (PDO), polyorthoesters, polyglycolic acids (PGA), polycaprolactones (PCL), poly(glycolic acid-co-trimethylene carbonates), polyphosphoesters, polyphosphoester urethanes, poly(amino acids), cyanoacrylates, poly(trimethylene carbonate), poly(iminocarbonate), polyalkylene oxalates, polyiminocarbonates, aliphatic polycarbonates, fibrins, fibrinogens, celluloses, starchs, collagens, polycarbonate urethanes, plasticized polyethylene terephthalates, polyethylene terepthalates, polybutylene terepthslate-co-PEG, PCL-co-PEG, PLA-co-PEG-polyamides, copolymers thereof, polymer derivatives thereof, and combinations thereof.

6. The medical device according to claim 1, wherein said active agent comprises at least one member of the group consisting of analgesics, antipyretics, antiasthamatics, antibiotics, antidepressants, antidiabetics, antifungal agents, antihypertensive agents, anti-inflammatories including non-steroidal and steroidal, antineoplastics, antianxiety agents, immunosuppressive agents, antimigraine agents, sedatives, hypnotics, antianginal agents, antipsychotic agents, antimanic agents, antiarrhythmics, antiarthritic agents, antigout agents, anticoagulants, thrombolytic agents, antifibrinolytic agents, hemorheologic agents, antiplatelet agents, anticonvulsants, antiparkinson agents, antihistamines, anti-restenosis agents, antipruritics, agents useful for calcium regulation, antibacterial agents, antiviral agents, antimicrobials, anti-infectives, bronchodilators, steroidal compounds or hormones, and combinations thereof.

7. The medical device according to claim 1, wherein said active agent comprises at least one member of the group consisting of rapamycin, rapamycin analogs, zotarolimus, sirolimus, everolimus, dexamethasone, prednisone, hydrocortisone, estradiol, acetaminophen, ibuprofen, naproxen, sulidac, heparin, taxol, paclitaxel, and combinations thereof.

8. The medical device according to claim 1, wherein the active agent comprises a first active agent composition and a second active agent composition differrent in composition from the first active agent composition, and the first active agent composition and the second active agent composition are separated from each other by being contained in separate groups of the microspheres disposed within the pores.

9. The medical device according to claim 1, wherein the upper volume of the agent is covered by an outer layer of the matrix.

10. The medical device according to claim 1, wherein the active agent comprises a first active agent composition and the second active agent composition different in composition from the first active agent composition, the intermediate layer separates the first active agent compostion from the second active agent composition, the first active agent composition is contained in the upper volume, and the second active agent compostion is contained in the lower volume.

11. The medical device according to claim 1, wherein the supporting structure is configured and dimensioned as a stent and is configured to expand from a delivery orientation to a deployed orientation.

12. The medical device according to claim 1, wherein said first biocompatible material is a metal.

13. The medical device according to claim 1, wherein said first biocompatible material is a ceramic.