Implantable device for drug delivery and improved visibility

• US 20090149947A1
• Filed: 06/09/2005
• Published: 06/11/2009
• Est. Priority Date: 06/09/2004
• Status: Abandoned Application

• Current Assignee: J.A.C.C. GmbH
• Original Assignee: J.A.C.C. GmbH
• Inventors: Frohwitter, Bernhard
• Application Number:
  US11/628,929
• Publication Number:
  US 20090149947A1
• Time in Patent Office: Days
• US Class Current: 623/1.420
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/003 differing in adsorbability or resorbability, i.e. in adsorption or resorption time
• CPC Class Codes: A61F 2250/0032 differing in radiographic density
• CPC Class Codes: A61F 2250/0035 differing in release or diffusion time
• CPC Class Codes: A61F 2250/0045 differing in electromagnetical properties
• 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: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

The present invention provides an implantable device as delivery device for at least one therapeutic agent being composed of at least one type of base material comprising at least two types of reservoirs for at least one therapeutic agent whereby each type of reservoir independently provides identical or different release rates for the at least one therapeutic agent.

Claims

1. An implantable device as a delivery device for at least one therapeutic agent being composed of at least one type of base material comprising at least two types of reservoirs for at least one therapeutic agent whereby each type of reservoir independently provides identical or different release rates for the at least one therapeutic agent.

2. An implantable device according to claim 1 characterized in that the base material is selected from the group of metallic, plastic and/or biodegradable materials.

3. An implantable device according to claim 2 characterized in that the implantable device is made of a combination of a metallic and a biodegradable material.

4. An implantable device according to claim 2 characterized in that the implantable device is made of a combination of a plastic and a biodegradable material.

5. An implantable device according to one of claims 1 to 4 characterized in that the base material of the implantable device is made at least partly of a material such that detection of the implantable device after insertion into the body lumen is facilitated.

6. An implantable device according to one of claims 1 to 4 characterized in that the base material of the implantable device is made at least partly of a material such that after insertion into the body lumen, the healing process within the body lumen can be better observed.

7. An implantable device according to one of claims 1 to 4 characterized in that the metallic base material is selected from at least one of tantalum, titanium, gold, platinum, chromium, iridium, silver, tungsten, cobalt or alloys of any of these or stainless steel or nitinol or another biocompatible metal.

8. An implantable device according to claim 7 characterized in that the metallic base material is a cobalt/chromium alloy.

9. An implantable device according to claims 1 to 4 characterized in that the plastic and/or biodegradable base material is selected from at one of cellulose acetate, cellulose nitrate, polylactic acid, polyglycolic acid or copolymers thereof, carbon or carbon fiber;

a polyanhydride, polycaprolactone, polyhydroxybutyrate valerate or another biodegradable polymer, or mixtures or copolymers of these;

silicone, polyethylene teraphthalate, polyurethane, polyamide, polyester, polyorthoester, polyanhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, polytetrafluoroethylene, or another biocompatible polymeric material, or mixtures or copolymers of these;

a protein, an extracellular matrix component, collagen, fibrin, starch or another biologic agent;

or a suitable mixture of any of these.

15. An implantable device according to one of claims 1 to 4 or 10 to 14 characterized in that the reservoirs for the at least one therapeutic agent comprises at least one therapeutic agent selected from the group of immunosuppressive agents, antitumor and/or chemotherapeutic agents, antimitotics, antiproliferatives, non-steroidal anti-inflammatory drugs, antimicrobials or antibiotics, growth factors and growth factor antagonists, thrombolytics, vasodilators, antihypertensive agents, anti secretory agents, antipolymerases, antiviral agents, photodynamic therapy agents, antibody targeted therapy agents, prodrugs, sex hormones, free radical scavengers, antioxidants, biologic agents, radiotherapeutic agents, radiopaque agents and radiolabeled agents.

16. An implantable device according to claim 15 characterized in that the reservoirs for the at least one therapeutic agent comprises at least one therapeutic agent selected from the group of cyclosporin, rapamycin, SDZ RAD or another immunosuppressive agent;

taxol, or other anti-cancer chemotherapeutic agents;

methotrexate or another antimetabolite or antiproliferative agent;

tamoxifen citrate;

dexamethasone, dexamethasone sodium phosphate, dexamethasone acetate or another dexamethasone derivative, or another antiinflammatory steroid or non-steroidal antiinflammatory agent;

an antiangiogenic agent (e.g. taxol, retinoic acid, anti-invasive factor, TNP-470, squalamine, plasminogen activator inhibitor-1 and -2 etc.);

colchicine or another antimitotic, or another microtubule inhibitor;

smooth muscle migration and/or contraction inhibitors (e.g. cytochalasin B, C, and D) or another actin inhibitor;

another growth factor antagonist;

dopamine, bromocriptine mesylate, pergolide mesylate or another dopamine agonist;

a growth hormone antagonist such as angiopeptin and angiogenin;

heparin, covalent heparin, or another thrombin inhibitor, hirudin, another antithrombogenic agent, or mixtures thereof;

urokinase, streptokinase, a tissue plasminogen activator, or another thrombolytic agent, or mixtures thereof;

a fibrinolytic agent;

a vasospasm inhibitor;

a protein kinase inhibitor (e.g. stauroporin);

a calcium channel blocker;

a nitrate, nitric oxide, a nitric oxide promoter or another vasodilator;

an antiatherosclerotic agent;

an antihypertensive agent;

an antiplatelet agent;

an antihistamic and/or antiallergic agent (e.g. terfenadine);

an antimicrobial agent or antibiotics (e.g. penicillin, streptomycin, cephalosporin, vancomycin, erythromycin, polymyxin, rifampycin, tetracycline, chloramphenicol etc.);

deoxyribonucleic acid, an antisense nucleotide or another agent for molecular genetic intervention;

⁶⁰Co, ¹⁹²Ir, ³²P, ¹¹¹In, ⁹⁰Y, ⁹⁹mTc or another radiotherapeutic agent;

iodine-containing compounds, barium-containing compounds, gold, tantalum, platinum, tungsten or another heavy metal functioning as a radiopaque agent;

a peptide, a protein, an enzyme, an extracellular matrix component, a cellular component or another biologic agent;

a free radical scavenger, iron chelator or antioxidant;

progesterone, estrogen or another sex hormone;

an antiviral agent, AZT or other antipolymerases;

acyclovir, famciclovir, rimantadine hydrochloride, ganciclovir sodium, Norvir or Crixivan;

gene therapy agents;

or analogs or derivatives or functional equivalents thereof.

17. An implantable device according to one of claims 1 to 4 or 10 to 14 characterized in that the at least two types of reservoirs for at least one therapeutic agent allows to independently configure desired controlled release patterns of the therapeutic agent(s) in view of the disease to be treated, the disease state, the body lumen, the type of therapeutic agent (e.g. hydrophilic, lipophilic, biologies, small molecules etc.), desired concentration of at least one therapeutic agent, favorable combinations of therapeutic agents, desired kinetic release patterns (zero order pulsatile, increasing, decreasing, sinusoidal etc.).

18. An implantable device according to one of claims 1 to 4 or 10 to 14 characterized in that the implantable device is a stent, a hip joint, an artificial heart valve, a pace maker, a catheter, an ophthalmic lens, an orthopedic prosthesis or a dental prosthesis.

19. An implantable device according to claim 18 characterized in that the implantable device is a stent adapted for introduction into the esophagus, trachea, colon, biliary tract, urinary tract, vascular system or other lumens of a body portion such as passage, lumen or blood vessel in a living human or animal.

10. An implantable device characterized in that the implantable device comprises at least one therapeutic composition within at least two different reservoirs for the at least one therapeutic agent wherein the therapeutic composition is directly affixed to a surface structure of the implantable device as a biodegradable or porous or permeable non-biodegradable coating;

the therapeutic composition is contained within openings in the implantable device; and

/or the therapeutic composition is impregnated in the base material of the implantable device.

11. An implantable device according to claim 10 characterized in that a combination of filled openings and a coated surface is used as reservoirs for the at least one therapeutic agent.

12. An implantable device according to claim 10 characterized in that the device comprises a combination of filled openings and an impregnated base material.

13. An implantable device according to claim 10 characterized in that the device comprises a combination of a coated surface and an impregnated base material.

14. An implantable device according to claim 10 characterized in that the device comprises a combination of filled openings, coated surface areas and impregnated base material.

20. Use of composition loaded on an implantable device as a delivery device for at least one therapeutic agent being composed of at least one type of base material comprising at least two types of reservoirs for at least one therapeutic agent whereby each type of reservoir independently provides identical or different release rates for the at least one therapeutic agent for the treatment of cancer, atherosclerosis and angiogenesis-dependent diseases.

21. Use of composition loaded on an implantable device as a delivery device for at least one therapeutic agent being composed of at least one type of base material comprising at least two types of reservoirs for at least one therapeutic agent whereby each type of reservoir independently provides identical or different release rates for the at least one therapeutic agent for use in medical applications such surgery, bone-replacement, prosthodontics, dental roots, crowns and orthopedic joints.

22. Use of composition loaded on an implantable device as a delivery device for at least one therapeutic agent being composed of at least one type of base material comprising at least two types of reservoirs for at least one therapeutic agent whereby each type of reservoir independently provides identical or different release rates for the at least one therapeutic agent for the treatment of antimicrobial resistance.

23. A device suitable for implantation in a living animal comprising a first region and at least a second region wherein the first region is of a material having a first response characteristic to electromagnetic radiation and the second region has a second response characteristic to electromagnetic radiation different to said first response characteristic, characterized in that the second region is incorporated into the structure of the device to provide, at least temporarily, substantially the same physical properties as if it were fabricated of the first material but because of its differing response characteristic to electromagnetic radiation provides an improved image generating capability in relation to an imaging technique used for internally imaging the device in the living animal compared with if the second region was fabricated of the first material.

24. A stent for implantation in a lumen of a patient characterized in that said stent comprises a plurality of first supporting regions having metal lumen wall supporting means and at least one second supporting region within or between the metal supporting regions, the second supporting region comprising a structural polymer lumen wall supporting means.

25. A stent according to claim 24, characterized in that the at least one second supporting region comprises an arrangement of metal struts joined to metal lumen wall supporting means, the metal struts of the polymer supporting region having a projected surface area per unit surface area of the stent ratio substantially less than a projected surface area to unit surface area of the stent ratio of the metal lumen wall supporting means.

26. A stent according to claim 24 or claim 25, wherein the structural polymer is biodegradable.

27. A stent according to any one of claims 24 or 25 wherein the structural polymer is drug-eluting.

28. A stent according to any one of claims 24 or 25 wherein the metal lumen wall supporting means are drug eluting.

29. An implantable device for implantation in a patient characterized that the device comprises a metallic structure having windows therein filled by a polymer.

30. An implantable device according to claim 29 wherein said polymer is a biodegradable polymer.

31. An implantable device according to claim 29 or claim 30 wherein the polymer is a drug-eluting polymer.

32. An implantable device according to one of claims 29 or 30 wherein said metallic structure incorporates drug-eluting regions.

33. An implantable device according to one of claims 29 or 30 wherein said device is a stent.

34. A device for implantation in the body of an animal characterized that it includes a composite material comprising a polymer and drug eluting fibers.

35. A device according to claim 34 wherein said drug eluting fibers are woven.

36. A stent characterized in that it comprises a self-expanding support structure and a biodegradable drug-eluting layer on an outer surface thereof wherein the self expanding support structure expands after insertion into a patient as the coating is adsorbed into the patient.

37. A stent according to claim 36 wherein the support structure is a self expanding metal support structure.

38. A stent according to claim 36 or claim 37 wherein the self-expanding support structure includes drug-eluting means.

39. A stent according to one of claims 36 or 37 wherein the stent further comprises a drug eluting layer on an inner surface of the support structure.