METHODS OF USING MEDICAL DEVICES FOR CONTROLLED DRUG RELEASE

• US 20080057103A1
• Filed: 08/15/2007
• Published: 03/06/2008
• Est. Priority Date: 08/21/2006
• Status: Abandoned Application

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Roorda, Wouter
• Application Number:
  US11/839,121
• Publication Number:
  US 20080057103A1
• Time in Patent Office: Days
• US Class Current: 424/425
• 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 method of treating and/or preventing a disease in an animal by controlling the release of an active agent, the method comprising:

providing a medical device configured and dimensioned to be used within a body of an animal, the medical device comprising;

a supporting structure;

a porous body disposed on and at least partially covering the supporting structure, said porous body including a first biocompatible material having a plurality of pores;

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

an elution rate controlling matrix disposed on at least one surface of the porous body so as to contain the active agent within said at least a portion of the pores, said matrix including a second biocompatible material that controls the elution of the active agent from the pores;

deploying the medical device into the body of the animal; and

allowing the active agent to elute from the pores into the body of the animal, where the elution rate controlling matrix controls the elution of the active agent from the pores.

2. A method according to claim 1, wherein the porous body is characterized by at least one of the following:

the porous body has a thickness ranging from about 10 nanometers to about 1 millimeter;

or

the porous body comprises pores having a diameter of from about 10 nanometers to about 1 millimeter.

3. A method according to claim 1, further comprising eluting the active agent from said medical device, which includes at least one 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, or combinations thereof.

4. A method according to claim 1, further comprising eluting the active agent from said second biocompatible material, which includes at least one polymeric material comprised of phosphorylcholines, phosphorylcholine linked macromolecules, polyolefins, poly(meth)acrylates, polyurethanes, polyesters, polyanhydrides, polyphosphazenes, polyacrylates, acrylic polymers, poly(lactide-coglycolides) (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, polyisoprenes, polyisobutylenes, polybutadienes, polyethylenes, plasticized polyethylene terephthalates, polyethylene terepthalates, polymethylmethacrylates, ethylene ethylacrylates, polyethyl hexylacrylates, plasticized ethylene vinylacetates, polyvinyl acetates, ethylene vinyl acetates, ethylene vinyl alcohols, polyvinyl alcohols, cross-linked polyvinyl alcohols, cross-linked polyvinyl butyrates, polyvinylbutyrates, polybutylmethacrylates, polyvinyl chlorides, ethylene vinylchloride copolymers, silicones, polysiloxanes, substituted polysiloxanes, polyethylene oxides, polyethylene glycols (PEG), polybutylene terepthalate-co-PEG, PCL-co-PEG, PLA-co-PEG, polyvinyl acetals, polyvinyl acetates, polyamides, polyvinyl pyrrolidones, polyacrylamides, polyvinyl esters, copolymers thereof, polymer derivatives thereof, or combinations thereof.

5. A method according to claim 1, wherein said active agent comprises at least one 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, antipruritics, agents useful for calcium regulation, antibacterial agents, antiviral agents, antimicrobials, anti-infectives, bronchodilators, steroidal compounds and hormones, or combinations thereof.

6. A method according to claim 1, wherein said active agent comprises at least one of rapamycin, rapamycin analog, zotarolimus, sirolimus, everolimus, dexamethasone, prednisone, hydrocortisone, estradiol, acetaminophen, ibuprofen, naproxen, sulidac, heparin, taxol, paclitaxel, or combinations thereof.

7. A method according to claim 1, further comprising placing said medical device into or in contact with a body or fluid of an animal.

8. The method according to claim 1, further comprising placing said medical device within the vascular system of an animal.

9. The method according to claim 1, further comprising eluting a therapeutically effective amount of said active agent to treat and/or prevent a disease in which said active agent is useful as a therapy.

10. The method according to claim 9, wherein said disease is a vascular disease.

11. The method according to claim 10, wherein said disease is restenosis.

12. A method of treating and/or preventing a disease in an animal by controlling the release of an active agent, the method comprising:

providing a medical device configured and dimensioned to be used within a body of a human, the medical device comprising;

a superelastic metal supporting structure;

a porous layer disposed on and covering said supporting structure, said porous layer including a first biocompatible material having a plurality of pores;

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

an elution rate controlling matrix disposed on at least one surface of the porous body so as to contain the active agent within said at least a portion of the pores, said pores being configured to determine in part the elution rate of the active agent from the pores, said matrix including a second biocompatible material that determines in part the elution rate of the active agent from the pores, wherein said elution rate controlling matrix is disposed within the pores such that substantially none of the matrix protrudes from the pores and the porous body protects the matrix;

deploying the medical device into the body of the human; and

allowing the active agent to elute from the pores into the body of the human, where the elution rate controlling matrix and the pores of the porous layer determines the elution rate of the active agent from the pores.

13. A method according to claim 12, wherein the porous body is characterized by at least one of the following:

the porous body has a thickness ranging from about 10 nanometers to about 1 millimeter;

or

the porous body comprises pores having a diameter of from about 10 nanometers to about 1 millimeter.

14. A method according to claim 12, further comprising eluting the active agent from said medical device, which includes at least one 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, or combinations thereof.

15. A method according to claim 12, further comprising eluting the active agent from said second biocompatible material, which includes at least one polymeric material comprised of phosphorylcholines, phosphorylcholine linked macromolecules, polyolefins, poly(meth)acrylates, polyurethanes, polyesters, polyanhydrides, polyphosphazenes, polyacrylates, acrylic polymers, poly(lactide-coglycolides) (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, polyisoprenes, polyisobutylenes, polybutadienes, polyethylenes, plasticized polyethylene terephthalates, polyethylene terepthalates, polymethylmethacrylates, ethylene ethylacrylates, polyethyl hexylacrylates, plasticized ethylene vinylacetates, polyvinyl acetates, ethylene vinyl acetates, ethylene vinyl alcohols, polyvinyl alcohols, cross-linked polyvinyl alcohols, cross-linked polyvinyl butyrates, polyvinylbutyrates, polybutylmethacrylates, polyvinyl chlorides, ethylene vinylchloride copolymers, silicones, polysiloxanes, substituted polysiloxanes, polyethylene oxides, polyethylene glycols (PEG), polybutylene terepthalate-co-PEG, PCL-co-PEG, PLA-co-PEG, polyvinyl acetals, polyvinyl acetates, polyamides, polyvinyl pyrrolidones, polyacrylamides, polyvinyl esters, copolymers thereof, polymer derivatives thereof, or combinations thereof.

16. A method according to claim 12, wherein said active agent comprises at least one 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, antipruritics, agents useful for calcium regulation, antibacterial agents, antiviral agents, antimicrobials, anti-infectives, bronchodilators, steroidal compounds and hormones, or combinations thereof.

17. A method according to claim 12, wherein said active agent comprises at least one of rapamycin, rapamycin analog, zotarolimus, sirolimus, everolimus, dexamethasone, prednisone, hydrocortisone, estradiol, acetaminophen, ibuprofen, naproxen, sulidac, heparin, taxol, paclitaxel, or combinations thereof.

18. A method according to claim 12, further comprising placing said medical device into or in contact with a body or fluid of an animal.

19. The method according to claim 12, further comprising placing said medical device within the vascular system of an animal.

20. The method according to claim 12, further comprising eluting a therapeutically effective amount of said active agent to treat and/or prevent a disease in which said active agent is useful as a therapy.

21. The method according to claim 20, wherein said disease is a vascular disease.

22. The method according to claim 21, wherein said disease is restenosis.